FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/97ISR Number: 100000053Report Type:Expedited (15-DaCompany Report #DE97093301A Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Foreign Zyprexa PS 10.00 MG Hospitalization - Circulatory Collapse Health Diazepam C 20.00 MG Initial or Prolonged Professional Date:11/03/97ISR Number: 100000061Report Type:Expedited (15-DaCompany Report #US97105236A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS ORAL PO Professional Zolpidem C Lorazepam C Thioridazine C Date:11/03/97ISR Number: 100000061Report Type:Expedited (15-DaCompany Report #US97104963A Age:6 WK Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS TRANSPLACENTAL UNK 28 WK Cardiac Murmur Professional Maternal Drugs Affecting Foetus Date:11/03/97ISR Number: 100000061Report Type:Expedited (15-DaCompany Report #US97105197A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Fibrosis Health Zyprexa PS 20.00 MG Professional DAILY Haloperidol C Benadryl C Zoloft C Cogentin C Klonopin C Pravachol C Tenormin C Nitroglycerin C Date:11/03/97ISR Number: 100000062Report Type:Expedited (15-DaCompany Report #GB97103619A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL PO Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 1 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 100000062Report Type:Expedited (15-DaCompany Report #DE97104120A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 10.00 MG; PO Health Professional Date:11/03/97ISR Number: 100000062Report Type:Expedited (15-DaCompany Report #GB97103925A Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa PS ORAL 15.00 MG; PO Hospitalization - Phosphokinase Increased Health Levodopa/Benserazide C ORAL 62.50 MG Initial or Prolonged Immobile Professional ;004/DAY; PO Joint Stiffness Other Fluoxetine C ORAL 20.00 MG PO Neuroleptic Malignant Thioridazine C ORAL 30.00 MG PO Syndrome Lisinopril C ORAL 5.00 MG PO Pneumonia Bisacodyl C ORAL 5.00 MG PO Date:11/03/97ISR Number: 100000062Report Type:Expedited (15-DaCompany Report #IT97103688A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Musculoskeletal Stiffness Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Pneumonia Health DAILY PO Pyrexia Professional Depakine C ORAL 400.00 MG; Stupor 3/DAY; PO Tavor C ORAL 5.00MG; PO Micoren C ORAL 20. MN 1/DAY; ORAL Tavor C INTRAVENOUS 4.00MG; 1/DAY; IV Date:11/03/97ISR Number: 100000076Report Type:Expedited (15-DaCompany Report #CL97075797A Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Dyspnoea Consumer DAILY PO Echolalia Health Prozac C ORAL 80.00 MG Increased Appetite Professional DAILY; ORAL Mania Company Weight Increased Representative Other Date:11/03/97ISR Number: 100000076Report Type:Expedited (15-DaCompany Report #US97070292A Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Consumer Zyprexa PS ORAL 10.00 MG Initial or Prolonged Rhabdomyolysis Health DAILY; PO Other Professional Acetaminophen C 24-Jun-2005 12:19 PM Page: 2 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 100000076Report Type:Expedited (15-DaCompany Report #DE97090310A Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Alanine Aminotransferase Health PO Increased Professional Fluanxol C Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Hepatocellular Damage Hepatomegaly Hypersensitivity Jaundice Oedema Pyrexia Splenomegaly Date:11/03/97ISR Number: 3005364-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Murmur Olanzapine PS Lilly Congenital Anomaly Complications Of Maternal Exposure To Therapeutic Drugs Sudden Infant Death Syndrome Date:11/03/97ISR Number: 3011590-8Report Type:Periodic Company Report #US97074846A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS ORAL 10 MG DAILY Chest Pain Professional PO Dehydration Calcium Carbonate C Pyrexia Osteoarthritis C Rhabdomyolysis Sedation Date:11/03/97ISR Number: 3011594-5Report Type:Periodic Company Report #US97080142A Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Condition Aggravated Health PO Delusion Professional Hydrochlorothiazide C Drug Ineffective Synthroid C K-Dur C Metoprolol C Lorazepam C 24-Jun-2005 12:19 PM Page: 3 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011595-7Report Type:Periodic Company Report #US97080964A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Zyprexa PS ORAL 5.00 MF DAILY Initial or Prolonged Distress Syndrome Professional Provenil C Blood Pressure Increased Atrovent C Coma Convulsion Tachycardia Date:11/03/97ISR Number: 3011598-2Report Type:Periodic Company Report #US97081306A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Irritability Health DAILY PO Mania Professional Date:11/03/97ISR Number: 3011600-8Report Type:Periodic Company Report #US97082461A Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Paranoia Health Refusal Of Treatment By Professional Patient Date:11/03/97ISR Number: 3011604-5Report Type:Periodic Company Report #US97082704A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Study Zyprexa PS ORAL 5MG DAILY PO Initial or Prolonged Eye Injury Health Calcium Carbonate C Eye Penetration Professional Colace C Pred-Forte C Timoptic C Ecotrin C Phospholine-Iodide C Dulcolax C Date:11/03/97ISR Number: 3011607-0Report Type:Periodic Company Report #US97084039A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Health Lithium Carbonate C Professional Risperdal C Ativan C Date:11/03/97ISR Number: 3011612-4Report Type:Periodic Company Report #US97084498A Age:87 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cellulitis Initial or Prolonged Delirium Fall 24-Jun-2005 12:19 PM Page: 4 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Peripheral Pain In Extremity Periorbital Haematoma Report Source Product Role Manufacturer Route Dose Duration Pyrexia Study Zyprexa PS ORAL 10.00 MG Rash Erythematous Health DAILY PO Professional Multivitamins C Nutrition C Peri-Colace C Dulcolax C Lactulose C Date:11/03/97ISR Number: 3011617-3Report Type:Periodic Company Report #US97085023A Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Study Zyprexa PS ORAL 5.00 MG Other Coma Health DAILY PO Hypotension Professional Cipro C Pain Ferrous Sulfate C Prilosec C Peri-Colace C Albuterol C Alprazolam C Date:11/03/97ISR Number: 3011621-5Report Type:Periodic Company Report #US97085167A Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Condition Aggravated Health PO Drug Ineffective Professional Vitamin B12 C Oedema Peripheral K-Dur C Artificial Tears C Milk Of Magnesia C Date:11/03/97ISR Number: 3011623-9Report Type:Periodic Company Report #US97090373A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Anger Health PO Hostility Professional Mania Paranoia Psychotic Disorder Date:11/03/97ISR Number: 3011625-2Report Type:Periodic Company Report #US97092296A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Delusion Health PO Drug Withdrawal Syndrome Professional 24-Jun-2005 12:19 PM Page: 5 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011627-6Report Type:Periodic Company Report #US97092452A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Health Valium C Professional Prozac C Salsalate C Benazepril Hydrochloride C Date:11/03/97ISR Number: 3011628-8Report Type:Periodic Company Report #US97092461A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Study Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Suicidal Ideation Health Valium C Professional Date:11/03/97ISR Number: 3011630-6Report Type:Periodic Company Report #US97092806A Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Suicide Attempt Health Salsalate C Other Professional Ativan C Lithium C Lasix C Coumadin C Date:11/03/97ISR Number: 3011632-XReport Type:Periodic Company Report #US97070766A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa PS ORAL 25 MJG DAILY Abnormal Professional PO Nausea Valproic Acid C Vomiting Date:11/03/97ISR Number: 3011633-1Report Type:Periodic Company Report #US97070775A Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Zyprexa PS ORAL 20.00 MG Initial or Prolonged Drooling Health DAILY PO Ear Infection Professional Trilafon C Eye Movement Disorder Trazodone C Parkinsonism Urinary Retention Date:11/03/97ISR Number: 3011635-5Report Type:Periodic Company Report #US97071180A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Other Neuroleptic Malignant Health Syndrome Professional Company 24-Jun-2005 12:19 PM Page: 6 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Date:11/03/97ISR Number: 3011637-9Report Type:Periodic Company Report #US97072128A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Consumer Zyprexa PS Initial or Prolonged Feeling Cold Health Lithium C Oedema Peripheral Professional Social Avoidant Behaviour Other Stress Date:11/03/97ISR Number: 3011640-9Report Type:Periodic Company Report #US97072134A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Phosphokinase Increased Professional DAILY PO Cognitive Disorder Company Haldol C Depressed Level Of Representative Haldol Decanoate C Consciousness Charcoal, Activated C Dyskinesia Dysphagia Joint Stiffness Muscle Rigidity Neuroleptic Malignant Syndrome Parkinsonian Gait Pyrexia Syncope Tongue Oedema Vomiting Date:11/03/97ISR Number: 3011644-6Report Type:Periodic Company Report #US97072320A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Health Zyprexa PS 15.00MG DAILY Dysphagia Professional PO Respiratory Disorder Depakote C Prozac C Date:11/03/97ISR Number: 3011647-1Report Type:Periodic Company Report #US97072476A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Consumer Zyprexa PS ORAL 20.00 MG Initial or Prolonged Hypertension Health DAILY Other Hypomania Professional Diltiazem C Clonazepam C Lisinopril C Aspirin C Lipitor C Estrogens C 24-Jun-2005 12:19 PM Page: 7 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Valproate Sodium C Date:11/03/97ISR Number: 3011651-3Report Type:Periodic Company Report #US97072785A Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Zyprexa PS ORAL 2.50 MG 2/DAY Initial or Prolonged Extrapyramidal Disorder Professional Other Pneumonia Aspiration Other Date:11/03/97ISR Number: 3011654-9Report Type:Periodic Company Report #US97072791A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperhidrosis Other Zyprexa PS ORAL 10.00 MG Initial or Prolonged Lack Of Spontaneous DAILY PO Speech Muscle Rigidity Tremor Date:11/03/97ISR Number: 3011656-2Report Type:Periodic Company Report #US97072797A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Increased Appetite Health Zyprexa PS ORAL 15 MG DAILY 6 MON Initial or Prolonged Oedema Professional Depakote C Polydipsia Other Lasix C Polyuria Amoxicillin C Vomiting Weight Increased Date:11/03/97ISR Number: 3011659-8Report Type:Periodic Company Report #US97072800A Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Postural Health Zyprexa PS ORAL 2.5 MG DAILY Initial or Prolonged Myocardial Infarction Professional PO Syncope Other Date:11/03/97ISR Number: 3011662-8Report Type:Periodic Company Report #US97072812A Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS 2.50MG DAILY Abnormal Professional PO Tongue Oedema Ativan C Cardizem Cd C Bactrim Ds C Axid C Effexor C 24-Jun-2005 12:19 PM Page: 8 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011665-3Report Type:Periodic Company Report #US97072998A Age:46 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Zyprexa PS Professional Date:11/03/97ISR Number: 3011669-0Report Type:Periodic Company Report #US97073046A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Zyprexa PS ORAL 50.00 MG UNK Professional PO Zoloft C Date:11/03/97ISR Number: 3011671-9Report Type:Periodic Company Report #US97073247A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Phosphokinase Increased Professional DAILY PO 3 MON Myalgia Myoglobinuria Rhabdomyolysis Date:11/03/97ISR Number: 3011674-4Report Type:Periodic Company Report #US97073268A Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Zyprexa PS ORAL 10 MG DAILY Dyspnoea Professional PO Macroglossia Company Cogentin C Representative Ibuprofen C Date:11/03/97ISR Number: 3011677-XReport Type:Periodic Company Report #US97073934A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Zyprexa PS ORAL 30.00 MG Inhibition Professional DAILY PO 5 Oedema Peripheral Other WEEKS Ativan C Premarin C Provera C Prazosin C Elavil C K-Dur C Robaxin C Zoloft C Ibuprofen C Lasix C Lotensin C Magnesium Oxide C Norvasc C Risperdal C Albuterol C 24-Jun-2005 12:19 PM Page: 9 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011678-1Report Type:Periodic Company Report #US97073961A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Consumer Prozac PS ORAL 10.00 MG Initial or Prolonged Movement Disorder Health DAILY PO Pyrexia Professional Zyprexa SS ORAL 5.00 MG Tremor DAILY PO Tylenol C Lithium C Inderal C Fosamax C Calcium Carbonate C Date:11/03/97ISR Number: 3011682-3Report Type:Periodic Company Report #US97074255A Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa PS ORAL 5.00 MG Initial or Prolonged Fall Professional 2/DAY PO Feeling Hot Other Lethargy Neuroleptic Malignant Syndrome Pyrexia Urine Analysis Abnormal Date:11/03/97ISR Number: 3011683-5Report Type:Periodic Company Report #US97074300A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa PS UNK Professional Date:11/03/97ISR Number: 3011684-7Report Type:Periodic Company Report #US97074306A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS ORAL 15.00 MG Initial or Prolonged Blood Sodium Decreased Professional DAILY PO 1 WK Hyponatraemia Other Clonazepam C Miosis Albuterol C Sedation Metformin C Vasotec C Lasix C Tegretol C Date:11/03/97ISR Number: 3011687-2Report Type:Periodic Company Report #US97074690A Age:64 YR Gender:Male I/FU:I Outcome PT Other Blood Creatine Phosphokinase Increased Drooling Dyskinesia Dysphagia Hypertension Lethargy 24-Jun-2005 12:19 PM Page: 10 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukocytosis Mental Impairment Muscle Rigidity Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa PS ORAL 10.00 MG Syndrome Professional DAILY PO Parkinsonian Gait Other Navane C Pneumonia Pyrexia Salivary Hypersecretion Sedation Tachycardia Upper Respiratory Tract Infection Date:11/03/97ISR Number: 3011691-4Report Type:Periodic Company Report #US97074819A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa PS ORAL 30.00 MG Initial or Prolonged Blood Creatine Professional DAILY PO Other Phosphokinase Increased Paxil C Delirium Synthroid C Disorientation Drug Level Above Therapeutic Hyperhidrosis Hypertension Restlessness Serotonin Syndrome Tachycardia Urinary Incontinence Date:11/03/97ISR Number: 3011694-XReport Type:Periodic Company Report #US97080403A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Health Zyprexa PS Intervention to Blood Creatine Professional Prevent Permanent Phosphokinase Increased Company Impairment/Damage Dysphagia Representative Hypertonia Hyperventilation Leukocytosis Liver Function Test Abnormal Neuroleptic Malignant Syndrome Pyrexia Tachycardia Tremor Date:11/03/97ISR Number: 3011695-1Report Type:Periodic Company Report #US97081750A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Renal Failure Professional DAILY PO 4 MON Urine Flow Decreased Nafcillin C 24-Jun-2005 12:19 PM Page: 11 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vancomycin C Prozac C Klonopin C Date:11/03/97ISR Number: 3011698-7Report Type:Periodic Company Report #US97082602A Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Zyprexa PS ORAL 5.00 MG Hospitalization - Dyspnoea Professional 2/DAY PO Initial or Prolonged Heart Rate Increased Company Clonazepam C Herpangina Representative Herpes Virus Infection Hypersensitivity Laryngeal Oedema Lung Disorder Pneumonia Aspiration Pyrexia Respiratory Distress Respiratory Failure Respiratory Rate Increased Date:11/03/97ISR Number: 3011701-4Report Type:Periodic Company Report #US97082614A Age:12 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Zyprexa PS Agitation Professional Heart Rate Increased Lethargy Sedation Tachypnoea Date:11/03/97ISR Number: 3011704-XReport Type:Periodic Company Report #US97082809A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Zyprexa PS ORAL 10MG DAILY PO 10 DAY Initial or Prolonged Convulsion Professional Cogentin C Synthroid C Date:11/03/97ISR Number: 3011706-3Report Type:Periodic Company Report #US97083556A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS ORAL 5.00 MG Initial or Prolonged Catatonia Professional DAILY PO Coma Vitamin E C Eye Movement Disorder Benztropine C Face Oedema Haemorrhagic Stroke Hypoaesthesia Oral Tongue Oedema 24-Jun-2005 12:19 PM Page: 12 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011710-5Report Type:Periodic Company Report #US97083568A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Health Zyprexa PS ORAL 25.00 MG Condition Aggravated Professional DAILY PO Muscle Twitching Benadryl C Date:11/03/97ISR Number: 3011713-0Report Type:Periodic Company Report #US97083577A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Zyprexa PS 30.00 MG UNK Hallucination, Auditory Professional UNK Company Representative Date:11/03/97ISR Number: 3011715-4Report Type:Periodic Company Report #US97083601A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa PS 15.00 MG Initial or Prolonged Gait Disturbance Professional Paxil C Company Clonapin C Representative Buspar C Date:11/03/97ISR Number: 3011719-1Report Type:Periodic Company Report #US97083793A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersomnia Health Zyprexa PS ORAL PO 6 MON Initial or Prolonged Narcolepsy Professional Dilantin C Company Representative Date:11/03/97ISR Number: 3011724-5Report Type:Periodic Company Report #US97084135A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS 25.00MG DAILY Initial or Prolonged Hyperglycaemia Professional PO Other Ketoacidosis Depakote C Polydipsia Polyuria Thirst Date:11/03/97ISR Number: 3011727-0Report Type:Periodic Company Report #US97084261A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Zyprexa PS ORAL 140MG PO Coordination Abnormal Professional Lithium C Dysarthria Klonopin C Sedation Synthroid C 24-Jun-2005 12:19 PM Page: 13 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011731-2Report Type:Periodic Company Report #US97084792A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Zyprexa PS Initial or Prolonged Suicidal Ideation Professional Company Representative Date:11/03/97ISR Number: 3011733-6Report Type:Periodic Company Report #US97085020A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Zyprexa PS ORAL 25.00 MG Aggression Health DAILY PO Anxiety Professional Lorazepam C Hypervigilance Psychotic Disorder Date:11/03/97ISR Number: 3011737-3Report Type:Periodic Company Report #US97085128A Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Blood Creatine Professional PO 4 DAY Phosphokinase Increased Depakote C Confusional State Sinemet C Depressed Level Of Consciousness Drug Interaction Dyskinesia Dysphagia Extrapyramidal Disorder Heart Rate Increased Hyperhidrosis Hypotension Muscle Rigidity Neuroleptic Malignant Syndrome Posturing Salivary Hypersecretion Tremor Date:11/03/97ISR Number: 3011740-3Report Type:Periodic Company Report #US97090457A Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa PS 5.00 Initial or Prolonged Parkinsonism Professional Clozaril C Date:11/03/97ISR Number: 3011745-2Report Type:Periodic Company Report #US97090832A Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS ORAL 2.5 MG DAILY Initial or Prolonged Confusional State Professional Paranoia Sedation 24-Jun-2005 12:19 PM Page: 14 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011749-XReport Type:Periodic Company Report #US97091057A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Health Zyprexa PS 25.00MG UNK Professional UNK Company Representative Date:11/03/97ISR Number: 3011753-1Report Type:Periodic Company Report #US97091084A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS 1 WEEKS Initial or Prolonged Phosphokinase Increased Professional Haldol C Joint Stiffness Company Mental Disorder Representative Pyrexia White Blood Cell Count Increased Date:11/03/97ISR Number: 3011754-3Report Type:Periodic Company Report #US97091330A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS Initial or Prolonged Hyperglycaemia Professional Polydipsia Company Representative Date:11/03/97ISR Number: 3011759-2Report Type:Periodic Company Report #US97092005A Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Zyprexa PS ORAL 30 MG DAILY Tegretol C Lithium C Date:11/03/97ISR Number: 3011762-2Report Type:Periodic Company Report #US97092314A Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Zyprexa PS ORAL 2.50 MG DAILY Initial or Prolonged Sedation Professional PO/ 3 WEEKS 3 WK Date:11/03/97ISR Number: 3011768-3Report Type:Periodic Company Report #US97092821A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Zyprexa PS ORAL 5 MG DAILY Initial or Prolonged Health Lotensin C Professional 24-Jun-2005 12:19 PM Page: 15 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011772-5Report Type:Periodic Company Report #US97093190A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Consumer Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Complications Of Maternal PO/3 MONTH 3 MON Exposure To Therapeutic Klonopin C Drugs Vaginal Haemorrhage Date:11/03/97ISR Number: 3011777-4Report Type:Periodic Company Report #US97093442A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Consumer Zyprexa PS ORAL 40MG DAILY PO Health Elavil C Professional Klonopin C Date:11/03/97ISR Number: 3011780-4Report Type:Periodic Company Report #US97093487A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Twitching Health Zyprexa PS ORAL 30.00 MG Professional DAILY PO Zoloft C Date:11/03/97ISR Number: 3011784-1Report Type:Periodic Company Report #US97093700A Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Consumer Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Hypertension PO Oedema Mouth Clonazepam C Speech Disorder Tongue Oedema Date:11/03/97ISR Number: 3011787-7Report Type:Periodic Company Report #US97074024A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa PS ORAL 10.00 MG Hyperglycaemia Professional DAILY PO Sertraline C Date:11/03/97ISR Number: 3011790-7Report Type:Periodic Company Report #US97074051A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Discomfort Health Zyprexa PS ORAL 10.00 MG Fatigue Professional DAILY PO Sedation Methocarbamol C 24-Jun-2005 12:19 PM Page: 16 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011794-4Report Type:Periodic Company Report #US97074246A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS 20.00 MG Leukopenia Professional DAILY UNK Neutrophilia Company Representative Date:11/03/97ISR Number: 3011798-1Report Type:Periodic Company Report #US97074288A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysgraphia Health Zyprexa PS 5.00 MG 2/DAY Movement Disorder Professional PO Tremor Date:11/03/97ISR Number: 3011802-0Report Type:Periodic Company Report #US97074294A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Zyprexa PS ORAL 5.00 MG 2/DAY Movement Disorder Professional PO Date:11/03/97ISR Number: 3011805-6Report Type:Periodic Company Report #US97074303A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS ORAL 5MG DAILY PO 1 WK Tremor Professional Date:11/03/97ISR Number: 3011807-XReport Type:Periodic Company Report #US97074315A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10MG DAILY PO Weight Increased Date:11/03/97ISR Number: 3011810-XReport Type:Periodic Company Report #US97074321A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Consumer Zyprexa PS ORAL PO 4 MON Health Artane C Professional Prozac C Date:11/03/97ISR Number: 3011813-5Report Type:Periodic Company Report #US97074357A Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL 5MG DAILY PO 1 MON Professional Lasix C Company Synthroid C Representative Procardia C Coumadin C Potassium C 24-Jun-2005 12:19 PM Page: 17 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premarin C Date:11/03/97ISR Number: 3011816-0Report Type:Periodic Company Report #US97074360A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Uric Acid Increased Health Zyprexa PS ORAL 5MG DAILY PO Professional Lithium C Date:11/03/97ISR Number: 3011818-4Report Type:Periodic Company Report #US97074363A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Prozac PS ORAL 20.00MG DAILY Professional PO Zyprexa SS ORAL 20MG DAILY PO Ferrous Sulfate C Folic Acid C Oral Contraceptive Nos C Date:11/03/97ISR Number: 3011822-6Report Type:Periodic Company Report #US97074369A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 10 MG DAILY Professional Company Representative Date:11/03/97ISR Number: 3011824-XReport Type:Periodic Company Report #US97074372A Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 5 MG DAILY Professional Depakote C Lopid C Synthroid C Date:11/03/97ISR Number: 3011828-7Report Type:Periodic Company Report #US97074375A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eating Disorder Consumer Zyprexa PS Hallucination, Auditory Date:11/03/97ISR Number: 3011832-9Report Type:Periodic Company Report #US97074378A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL 10 MG DAILY Professional Amitriptyline C Trazodone C Loxitane C 24-Jun-2005 12:19 PM Page: 18 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011834-2Report Type:Periodic Company Report #US97074390A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS ORAL 10.00 MG Extrapyramidal Disorder Professional DAILY PO Mania Valproic Acid C Muscle Rigidity Restlessness Tongue Disorder Date:11/03/97ISR Number: 3011837-8Report Type:Periodic Company Report #US97074519A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Zyprexa PS ORAL PO 9 MON Paranoia Professional Date:11/03/97ISR Number: 3011839-1Report Type:Periodic Company Report #US97074525A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Health Zyprexa PS ORAL 10MG DAILY PO Bruxism Professional Lithium C Date:11/03/97ISR Number: 3011840-8Report Type:Periodic Company Report #US97074528A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Consumer Zyprexa PS ORAL 20MG DAILY PO Grunting Prozac C Insomnia Tegretol C Date:11/03/97ISR Number: 3011842-1Report Type:Periodic Company Report #US97074534A Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Vesicular Health Zyprexa PS ORAL 5MG DAILY PO 3 WK Professional Trazodone C Zoloft C Ativan C Verapamil C Imitrex C Meclomen C Date:11/03/97ISR Number: 3011845-7Report Type:Periodic Company Report #US97074540A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Health Zyprexa PS ORAL 20MG DAILY PO 3 MON Professional Klonopin C 24-Jun-2005 12:19 PM Page: 19 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011848-2Report Type:Periodic Company Report #US97074555A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Uric Acid Increased Health Zyprexa PS ORAL 20MG DAILY PO Professional Lithobid C Synthroid C Effexor C Diazepam C Date:11/03/97ISR Number: 3011850-0Report Type:Periodic Company Report #US97074558A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS ORAL 10MG DAILY PO 3 WK Oedema Peripheral Professional Paxil C Date:11/03/97ISR Number: 3011852-4Report Type:Periodic Company Report #US97074588A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS ORAL 15MG DAILY PO Professional Lamictal C Date:11/03/97ISR Number: 3011854-8Report Type:Periodic Company Report #US97074612A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Health Zyprexa PS ORAL 20 MG DAILY Fluctuation Professional Other Date:11/03/97ISR Number: 3011856-1Report Type:Periodic Company Report #US97074615A Age:55 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Health Zyprexa PS ORAL 20MG DAILY PO Fluctuation Professional Enalapril C Trifluoperazine C Chlorthalidone C Valproic Acid C Date:11/03/97ISR Number: 3011858-5Report Type:Periodic Company Report #US97074621A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Health Zyprexa PS ORAL 5 MG DAILY Syncope Professional Depakote C Tachycardia Other Date:11/03/97ISR Number: 3011860-3Report Type:Periodic Company Report #US97074624A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Coordination Abnormal Health Road Traffic Accident Professional 24-Jun-2005 12:19 PM Page: 20 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa PS Clonazepam C Lithium C Date:11/03/97ISR Number: 3011862-7Report Type:Periodic Company Report #US97074630A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Health Zyprexa PS ORAL 10 MG DAILY Dermatitis Professional Tylenol C Other Date:11/03/97ISR Number: 3011864-0Report Type:Periodic Company Report #US97074645A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Above Health Zyprexa PS ORAL 20 MG DAILY Therapeutic Professional Lithium C Fatigue Other Date:11/03/97ISR Number: 3011867-6Report Type:Periodic Company Report #US97074651A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Zyprexa PS ORAL 10MG PO Muscle Twitching Professional Haloperidol C Tremor Other Date:11/03/97ISR Number: 3011871-8Report Type:Periodic Company Report #US97074669A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS 7.50 MG DAILY Professional Lithium C Other Date:11/03/97ISR Number: 3011873-1Report Type:Periodic Company Report #US97074693A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pigmentation Disorder Health Zyprexa PS 10.00 MG Rash Papular Professional 2/DAY Other Date:11/03/97ISR Number: 3011877-9Report Type:Periodic Company Report #US97074978A Age:71 YR Gender:Male I/FU:I Outcome PT Asthenia Dyskinesia Lethargy Therapeutic Agent 24-Jun-2005 12:19 PM Page: 21 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Toxicity Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Other Lithium C Date:11/03/97ISR Number: 3011879-2Report Type:Periodic Company Report #US97074993A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Health Zyprexa PS ORAL 10MG DAILY PO 1 WK Oedema Peripheral Professional Amoxil C Depakote C Date:11/03/97ISR Number: 3011883-4Report Type:Periodic Company Report #US97074999A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS ORAL 10MG DAILY PO Dermatitis Professional Zoloft C Pyrexia Risperdal C Klonopin C Date:11/03/97ISR Number: 3011885-8Report Type:Periodic Company Report #US97075005A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Zyprexa PS ORAL 5MG DAILY PO Abdominal Pain Professional Benztropine C Constipation Glyburide C Urinary Retention Docusate Sodium C Date:11/03/97ISR Number: 3011887-1Report Type:Periodic Company Report #US97075008A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Health Zyprexa PS ORAL 5MG DAILY PO Professional Date:11/03/97ISR Number: 3011891-3Report Type:Periodic Company Report #US97075011A Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aphasia Health Zyprexa PS 10.MG DAILY Dysphagia Professional Humabid L.A. C Salivary Hypersecretion Ativan C Date:11/03/97ISR Number: 3011893-7Report Type:Periodic Company Report #US97075014A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS ORAL 20MG DAILY PO Oedema Peripheral Professional Risperdal C Weight Increased Other Cogentin C 24-Jun-2005 12:19 PM Page: 22 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zestril C Depakote C Theo-Dur C Ventolin C Vistaril C Lasix C Date:11/03/97ISR Number: 3011895-0Report Type:Periodic Company Report #US97075023A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Disorder Health Zyprexa PS ORAL 5MG 2/DAY PO Dermatitis Professional Sertraline C Sedation Other Acetaminophen C Date:11/03/97ISR Number: 3011897-4Report Type:Periodic Company Report #US97075026A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS ORAL 10 MG DAILY Dizziness Professional Trazodone C Extrapyramidal Disorder Other Date:11/03/97ISR Number: 3011900-1Report Type:Periodic Company Report #US97075032A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3011903-7Report Type:Periodic Company Report #US97075044A Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 15.00 MG Potentiation Professional DAILY PO Drug Level Above Other Clozaril C Therapeutic Procardia Xl C Depakote C Date:11/03/97ISR Number: 3011905-0Report Type:Periodic Company Report #US97075047A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Zyprexa PS ORAL 10 MG DAILY Paraphilia Multivitamins C Psychomotor Hyperactivity Restlessness 24-Jun-2005 12:19 PM Page: 23 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011908-6Report Type:Periodic Company Report #US97075050A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 20 MG DAILY 2 MON Professional Date:11/03/97ISR Number: 3011910-4Report Type:Periodic Company Report #US97075056A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Fibrosis Health Zyprexa PS ORAL PO Professional Date:11/03/97ISR Number: 3011912-8Report Type:Periodic Company Report #US97075071A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Health Zyprexa PS ORAL 10MG DAILY PO Tardive Dyskinesia Professional Other Date:11/03/97ISR Number: 3011916-5Report Type:Periodic Company Report #US97075074A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Health Zyprexa PS 10.00 MG Oedema Peripheral Professional DAILY Weight Increased Other Prozac C Diazepam C Depakote C Pepcid C Hydrocortisone C Date:11/03/97ISR Number: 3011919-0Report Type:Periodic Company Report #US97075077A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Health Zyprexa PS ORAL 5.00 MG Injury Professional 3/DAY PO Oedema Peripheral Other Lovothyroxine C Ibuprofen C Plaquenil C Date:11/03/97ISR Number: 3011921-9Report Type:Periodic Company Report #US97075083A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hostility Health Zyprexa PS Professional Company Representative 24-Jun-2005 12:19 PM Page: 24 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011923-2Report Type:Periodic Company Report #US97075089A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Health Zyprexa PS ORAL 5 MG DAILY PO Loss Of Control Of Legs Professional Maxzide C Carbidopa C Levodopa C Date:11/03/97ISR Number: 3011925-6Report Type:Periodic Company Report #US97075092A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS Delusion Professional Schizophrenia Company Representative Date:11/03/97ISR Number: 3011929-3Report Type:Periodic Company Report #US97075098A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Zyprexa PS ORAL 10MG DAILY PO Weight Decreased Professional Vitamin E C Depakote C Buspar C Date:11/03/97ISR Number: 3011932-3Report Type:Periodic Company Report #US97075104A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bipolar Disorder Health Zyprexa PS ORAL 10 MG DAILY Drug Interaction Professional PO Inhibition Other Depakote C Date:11/03/97ISR Number: 3011934-7Report Type:Periodic Company Report #US97075107A Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Health Zyprexa PS ORAL 5MG DAILY PO Dizziness Professional Valproate Sodium C Hypotension Other Pallor Sedation Date:11/03/97ISR Number: 3011938-4Report Type:Periodic Company Report #US97075125A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Consumer Zyprexa PS ORAL 15 MG DAILY 2 MON Seborrhoea Prolixin C 24-Jun-2005 12:19 PM Page: 25 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011941-4Report Type:Periodic Company Report #US97075134A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Serzone C Date:11/03/97ISR Number: 3011942-6Report Type:Periodic Company Report #US97075158A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 20.00 MG Hallucination, Auditory Professional DAILY PO Intentional Self-Injury Vitamin E C Paxil C Haldol C Xanax C Dalmane C Date:11/03/97ISR Number: 3011945-1Report Type:Periodic Company Report #US97075164A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 20 MG DAILY Hallucination, Auditory Professional PO Klonopin C Date:11/03/97ISR Number: 3011948-7Report Type:Periodic Company Report #US97075173A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Zyprexa PS ORAL 15 MG DAILY Professional PO Company Representative Date:11/03/97ISR Number: 3011950-5Report Type:Periodic Company Report #US97075188A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Consumer Zyprexa PS ORAL 10 MG DAILY Face Oedema PO Date:11/03/97ISR Number: 3011954-2Report Type:Periodic Company Report #US97075197A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa PS ORAL 10.00 MG Dehydration Health 2/DAY PO Depression Professional Desipramine C Dizziness Ativan C Polydipsia Artane C Restlessness Serzone C Temperature Intolerance 24-Jun-2005 12:19 PM Page: 26 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011958-XReport Type:Periodic Company Report #US97075284A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Stiffness Health Zyprexa PS ORAL 15MG DAILY PO Professional Tegretol C Klonopin C Cogentin C Prozac C Date:11/03/97ISR Number: 3011960-8Report Type:Periodic Company Report #US97075335A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Zyprexa PS ORAL 10 MG DAILY Joint Stiffness PO Pain Carbamazepine C Fluoxetine C Clonazepam C Benztropine C Date:11/03/97ISR Number: 3011963-3Report Type:Periodic Company Report #US97075389A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS ORAL 10 MD DAILY Professional PO 5 MON Zithromax C Date:11/03/97ISR Number: 3011965-7Report Type:Periodic Company Report #US97075416A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa PS ORAL 7.5 MG DAILY Sedation PO Serzone C Klonopin C Date:11/03/97ISR Number: 3011967-0Report Type:Periodic Company Report #US97075425A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa PS ORAL 5 MG DAILY PO 2 MON Sedation Date:11/03/97ISR Number: 3011968-2Report Type:Periodic Company Report #US97075473A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Zyprexa PS ORAL 5 MG 2/DAY Professional PO 8 MON Artane C Vitamin E C 24-Jun-2005 12:19 PM Page: 27 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011982-7Report Type:Periodic Company Report #US97075437A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Other Zyprexa PS ORAL 17.5 MG DAILY Fatigue PO Illusion Nefazodone C Date:11/03/97ISR Number: 3011983-9Report Type:Periodic Company Report #US97075479A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10 MG DAILY Professional PO 2 MON Date:11/03/97ISR Number: 3011986-4Report Type:Periodic Company Report #US97075485A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Faecal Incontinence Consumer Zyprexa PS ORAL 5 MG DAILY PO 2 WK Weight Increased Date:11/03/97ISR Number: 3011988-8Report Type:Periodic Company Report #US97075494A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10 MG DAILY Professional PO 1 MON Paxil C Date:11/03/97ISR Number: 3011989-XReport Type:Periodic Company Report #US97075506A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS ORAL 20MG DAILY PO 6 WK Health Anafranil C Professional Date:11/03/97ISR Number: 3011991-8Report Type:Periodic Company Report #US97075509A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 15MG DAILY PO Potentiation Professional Vistaril C Hallucination Date:11/03/97ISR Number: 3012015-9Report Type:Periodic Company Report #US97092953A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNKNOWN Professional Company Representative 24-Jun-2005 12:19 PM Page: 28 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012016-0Report Type:Periodic Company Report #US97092959A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Prozac C Date:11/03/97ISR Number: 3012017-2Report Type:Periodic Company Report #US97092962A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Professional Company Representative Date:11/03/97ISR Number: 3012018-4Report Type:Periodic Company Report #US97092965A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL UNK;DAILY; PO 1 MON Abnormal Professional Tegretol C Ativan C Date:11/03/97ISR Number: 3012021-4Report Type:Periodic Company Report #US97093184A Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Complications Of Maternal Health Zyprexa PS 20.00MG DAILY Exposure To Therapeutic Professional PO Drugs Folic Acid C Nutritional Supplements C Date:11/03/97ISR Number: 3012023-8Report Type:Periodic Company Report #US97093196A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS UNK Professional Luvox C Date:11/03/97ISR Number: 3012025-1Report Type:Periodic Company Report #US97093199A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Distractibility Health Zyprexa PS ORAL 10.00 MG Flight Of Ideas Professional DAILY PO 1 WK Sedation Valproic Acid C Suspiciousness Weight Increased 24-Jun-2005 12:19 PM Page: 29 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012028-7Report Type:Periodic Company Report #US97093244A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS UNK Professional Luvox C Date:11/03/97ISR Number: 3012030-5Report Type:Periodic Company Report #US97093274A Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Health Zyprexa PS ORAL 2.5MG DAILY Professional PO Date:11/03/97ISR Number: 3012032-9Report Type:Periodic Company Report #US97093388A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Health Zyprexa PS ORAL 15.00 MG Aggression Professional DAILY PO Irritability Clonazepam C Obsessive Thoughts Lamotrigine C Nefazodone C Cytomel C Date:11/03/97ISR Number: 3012035-4Report Type:Periodic Company Report #US97093400A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hostility Health Zyprexa PS ORAL 10.00 MG Irritability Professional DAILY PO/ 1 Logorrhoea WEEKS 1 WK Mania Lorazepam C Paranoia Valproic C Sedation Suspiciousness Date:11/03/97ISR Number: 3012037-8Report Type:Periodic Company Report #US97093481A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa PS ORAL 40MG PO Professional Navane C Doxepin C Depakote C Date:11/03/97ISR Number: 3012039-1Report Type:Periodic Company Report #US97093496A Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Health Zyprexa PS ORAL 7.50 MG DAILY Delusion Professional PO 24-Jun-2005 12:19 PM Page: 30 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012041-XReport Type:Periodic Company Report #US97093529A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Consumer Zyprexa PS Date:11/03/97ISR Number: 3012044-5Report Type:Periodic Company Report #US97093532A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Health Zyprexa PS ORAL 7.50 MG DAILY Professional PO Date:11/03/97ISR Number: 3012047-0Report Type:Periodic Company Report #US97092926A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Health Zyprexa PS ORAL 5.00 MG DAILY Urinary Incontinence Professional PO Prozac SS UNK Date:11/03/97ISR Number: 3012049-4Report Type:Periodic Company Report #US97092929A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Consumer Zyprexa PS ORAL 20.00 MG 2/DAY PO Zoloft C Zestril C Date:11/03/97ISR Number: 3012052-4Report Type:Periodic Company Report #US97092932A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 20MG DAILY PO Professional Clozaril C Company Depakote C Representative Date:11/03/97ISR Number: 3012054-8Report Type:Periodic Company Report #US97092935A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Prozac C Date:11/03/97ISR Number: 3012058-5Report Type:Periodic Company Report #US97092938A Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Prozac SS ORAL 20.00 MG DAILY PO Valium C 24-Jun-2005 12:19 PM Page: 31 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012062-7Report Type:Periodic Company Report #US97092944A Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Health Zyprexa PS ORAL 20.00 MG Faecal Incontinence Professional DAILY PO Urinary Incontinence Prozac SS ORAL 10.00 MG DAILY PO Lithium C Levothyroxine C Date:11/03/97ISR Number: 3012067-6Report Type:Periodic Company Report #US97092947A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Retroperitoneal Oedema Professional Company Representative Date:11/03/97ISR Number: 3012076-7Report Type:Periodic Company Report #US97092869A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Consumer Zyprexa PS ORAL 30.00 MG Drug Ineffective DAILY PO 3 MON Medication Error Paxil C Date:11/03/97ISR Number: 3012079-2Report Type:Periodic Company Report #US97092872A Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Triglycerides Health Zyprexa PS ORAL 10.00 MG Increased Professional DAILY PO Liver Function Test Clonidine C Abnormal Claritin C Thorazine C Date:11/03/97ISR Number: 3012084-6Report Type:Periodic Company Report #US97092875A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Zyprexa PS SUBCUTANEOUS 7.50MG DAILY Paranoia Health SC 3 MON Sedation Professional Date:11/03/97ISR Number: 3012087-1Report Type:Periodic Company Report #US97092893A Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Health Zyprexa PS 20.00 MG Professional Company Representative 24-Jun-2005 12:19 PM Page: 32 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012089-5Report Type:Periodic Company Report #US97092896A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa PS 25.00MG DAILY Hallucination Professional Serzone C Ativan C Date:11/03/97ISR Number: 3012093-7Report Type:Periodic Company Report #US97092899A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10 MG DAILY Professional PO Vitamin E C Lorazepam C Date:11/03/97ISR Number: 3012113-XReport Type:Periodic Company Report #US97092917A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperbilirubinaemia Health Zyprexa PS ORAL 15 MG DAILY Professional PO Cogentin C Klonopin C Amantadine C Date:11/03/97ISR Number: 3012117-7Report Type:Periodic Company Report #US97092923A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3012121-9Report Type:Periodic Company Report #US97092455A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS ORAL 15 MG DAILY Phosphokinase Increased Professional PO Sertraline C Lasix C Librium C Insulin C Prevacid C Imdur C Synthroid C Date:11/03/97ISR Number: 3012124-4Report Type:Periodic Company Report #US97092491A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Discharge Other Zyprexa PS UNK 24-Jun-2005 12:19 PM Page: 33 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012141-4Report Type:Periodic Company Report #US97092506A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS ORAL 15.00 MG Weight Increased DAILY PO 3 MON Prozac C Date:11/03/97ISR Number: 3012142-6Report Type:Periodic Company Report #US97092851A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15..00 MG Professional DAILY PO Cogentin C Depakote C Ativan C Ativan C Date:11/03/97ISR Number: 3012146-3Report Type:Periodic Company Report #US97092854A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 20.00 MG Abnormal Professional DAILY PO Risperdal C Date:11/03/97ISR Number: 3012149-9Report Type:Periodic Company Report #US97092863A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antepartum Haemorrhage Consumer Zyprexa PS ORAL 10MG DAILY PO Date:11/03/97ISR Number: 3012153-0Report Type:Periodic Company Report #US97092866A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS 5.00MG/DAILY/ PO Klonopin C Trazodone C Depakote C Date:11/03/97ISR Number: 3012155-4Report Type:Periodic Company Report #US97092080A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 5.00MG/DAILY/ Sleep Disorder PO Weight Increased 24-Jun-2005 12:19 PM Page: 34 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012159-1Report Type:Periodic Company Report #US97092083A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 20.00MG/DAILY Professional /PO 6 MON Prozac C Date:11/03/97ISR Number: 3012161-XReport Type:Periodic Company Report #US97092086A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Health Zyprexa PS Prolonged Professional Oedema Company Representative Date:11/03/97ISR Number: 3012162-1Report Type:Periodic Company Report #US97092089A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akinesia Health Zyprexa PS ORAL 10.00MG/DAILY Hypoaesthesia Oral Professional /PO Weight Increased Paxil C Date:11/03/97ISR Number: 3012165-7Report Type:Periodic Company Report #US97092098A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Zyprexa PS ORAL 10.00MG Chest Discomfort 3/WEEK PO Lithium C Date:11/03/97ISR Number: 3012168-2Report Type:Periodic Company Report #US97092104A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS 15 MG Professional Company Representative Date:11/03/97ISR Number: 3012171-2Report Type:Periodic Company Report #US97092107A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Health Zyprexa PS ORAL 15 MG DAILY Delusion Professional PO Hallucination, Auditory Date:11/03/97ISR Number: 3012173-6Report Type:Periodic Company Report #US97092110A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 7.5 DAILY PO Professional Depakote C 24-Jun-2005 12:19 PM Page: 35 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012176-1Report Type:Periodic Company Report #US97092122A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Consumer Zyprexa PS ORAL 10 MG DAILY Hyperhidrosis Health PO 2 MON Weight Increased Professional Risperdal C Date:11/03/97ISR Number: 3012178-5Report Type:Periodic Company Report #US97092332A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3012211-0Report Type:Periodic Company Report #US97092446A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Weight Increased Professional Date:11/03/97ISR Number: 3025923-XReport Type:Periodic Company Report #US97092008A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 2 MON Date:11/03/97ISR Number: 3025926-5Report Type:Periodic Company Report #US97092017A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cytomegalovirus Infection Other Zyprexa PS ORAL 15.00 MG Hepatic Function Abnormal DAILY PO 3 DAY Lithium C Lorazepam C Date:11/03/97ISR Number: 3025930-7Report Type:Periodic Company Report #US97092023A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Oedema Health Zyprexa PS ORAL 15.00 MG Face Oedema Professional DAILY PO 1 MON Oedema Peripheral Lorazepam C Prozac C Date:11/03/97ISR Number: 3025933-2Report Type:Periodic Company Report #US97092029A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 9 MON Klonopin C 24-Jun-2005 12:19 PM Page: 36 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3025937-XReport Type:Periodic Company Report #US97092041A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Health Zyprexa PS ORAL 20.00 MG Restlessness Professional DAILY PO 2 MON Company Representative Date:11/03/97ISR Number: 3025940-XReport Type:Periodic Company Report #US97092074A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS 10.00 MG Professional Depakote C Company Representative Date:11/03/97ISR Number: 3025942-3Report Type:Periodic Company Report #US97091435A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS ORAL 20.00 MG DAILY PO 8 WK Ativan C Zoloft C Date:11/03/97ISR Number: 3025945-9Report Type:Periodic Company Report #US97091438A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Serzone C Klonopin C Wellbutrin C Neurontin C Date:11/03/97ISR Number: 3025948-4Report Type:Periodic Company Report #US97091444A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Irritability Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 3 MON Tegretal C Date:11/03/97ISR Number: 3025949-6Report Type:Periodic Company Report #US97091450A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Formication Consumer Zyprexa PS ORAL 15.00 MG Nausea DAILY PO 2 MON Pruritus Cogentin C Vomiting Navane C 24-Jun-2005 12:19 PM Page: 37 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3025954-XReport Type:Periodic Company Report #US97091486A Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS ORAL 10.00 MG Extrapyramidal Disorder Professional DAILY PO Tremor Company Clozaril C Representative Date:11/03/97ISR Number: 3025957-5Report Type:Periodic Company Report #US97091954A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 6 MON Company Representative Date:11/03/97ISR Number: 3025960-5Report Type:Periodic Company Report #US97091417A Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Health Zyprexa PS ORAL 15.00 MG Throat Tightness Professional DAILY PO Effexor C Buspar C Date:11/03/97ISR Number: 3025965-4Report Type:Periodic Company Report #US97091411A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Irritability Health Zyrexa PS ORAL 10.00 MG Professional DAILY PO Lithium C Depakote C Date:11/03/97ISR Number: 3025966-6Report Type:Periodic Company Report #US97091402A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Tightness Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Effexor C Cogentin C Date:11/03/97ISR Number: 3025967-8Report Type:Periodic Company Report #US970191405A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Polydipsia Health Zyprexa PS ORAL 20.00 MG Thirst Professional DAILY PO 2 MON Glucotrol C Prinivil C Nortriptyline C 24-Jun-2005 12:19 PM Page: 38 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3025970-8Report Type:Periodic Company Report #US97090868A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS ORAL 2.50 MG PO Parkinson'S Disease Professional Date:11/03/97ISR Number: 3025973-3Report Type:Periodic Company Report #US97090871A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS 2.50 35 DAY Professional L-Dopa C Pergolide C Clozaril C Date:11/03/97ISR Number: 3025975-7Report Type:Periodic Company Report #US97090874A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS 5.00 22 DAY Professional L-Dopa C Clozaril C Date:11/03/97ISR Number: 3025979-4Report Type:Periodic Company Report #US97091069A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Health Zyprexa PS ORAL 10.00 MG Dyskinesia Professional DAILY PO Other Dexedrine C Date:11/03/97ISR Number: 3025982-4Report Type:Periodic Company Report #US97091072A Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Other Date:11/03/97ISR Number: 3025984-8Report Type:Periodic Company Report #US97091075A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Zyprexa PS Professional Desipramine C Company Representative Date:11/03/97ISR Number: 3025986-1Report Type:Periodic Company Report #US97091078A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Health Prozac PS Professional Zyprexa SS 24-Jun-2005 12:19 PM Page: 39 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3025989-7Report Type:Periodic Company Report #US97091111A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3025990-3Report Type:Periodic Company Report #US97091204A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS ORAL 5.00 MG DAILY Dysphonia Health PO Throat Irritation Professional Lithium C Ativan C Date:11/03/97ISR Number: 3025994-0Report Type:Periodic Company Report #US97090859A Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS ORAL 2.50 MG PO 36 DAY Professional L-Dopa C Clozaril C Date:11/03/97ISR Number: 3025996-4Report Type:Periodic Company Report #US97090862A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS ORAL 2.50 MG PO 14 DAY Professional L-Dopa C Pergolide C Clozaril C Date:11/03/97ISR Number: 3025998-8Report Type:Periodic Company Report #US97090865A Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS 2.50 24 DAY Professional L-Dopa C Amantadine C Clozaril C Date:11/03/97ISR Number: 3026002-8Report Type:Periodic Company Report #US97090847A Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 2.50 PO Insomnia Professional Date:11/03/97ISR Number: 3026003-XReport Type:Periodic Company Report #US97090850A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS Professional 24-Jun-2005 12:19 PM Page: 40 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3026004-1Report Type:Periodic Company Report #US97090853A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS ORAL 2.5 MG PO Professional Date:11/03/97ISR Number: 3026006-5Report Type:Periodic Company Report #US97090856A Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS 2.5 MG 6 DAY Professional L-Dopa C Amantadine C Clozaril C Date:11/03/97ISR Number: 3026007-7Report Type:Periodic Company Report #US97084879A Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Zyprexa PS ORAL 2.5 MG DAILY Panic Attack Health PO 6 WK Professional Xanax C Date:11/03/97ISR Number: 3026008-9Report Type:Periodic Company Report #US97084888A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Photopsia Health Zyprexa PS ORAL PO Professional Other Date:11/03/97ISR Number: 3026011-9Report Type:Periodic Company Report #US97084858A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional Other Date:11/03/97ISR Number: 3026013-2Report Type:Periodic Company Report #US97084801A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 1 MON Haldol C N/A C Date:11/03/97ISR Number: 3026014-4Report Type:Periodic Company Report #US97084816A Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Fluid Retention Health Influenza Like Illness Professional Company 24-Jun-2005 12:19 PM Page: 41 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS 10 MG Lithium C Date:11/03/97ISR Number: 3026017-XReport Type:Periodic Company Report #US97084855A Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Health Zyprexa PS Tic Professional Clonidine C Tourette'S Disorder Date:11/03/97ISR Number: 3026019-3Report Type:Periodic Company Report #US97084783A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS ORAL 10 MG DAILY Drug Level Above Health PO 5 MON Therapeutic Professional Zocor C Zoloft C Synthroid C Prilosec C Premarin C Naproxen C Date:11/03/97ISR Number: 3026021-1Report Type:Periodic Company Report #US97084753A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa PS UNK 2 WK Back Pain Risperdal C Date:11/03/97ISR Number: 3026022-3Report Type:Periodic Company Report #US97084780A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3026024-7Report Type:Periodic Company Report #US97084579A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Professional Depakote C Company Zoloft C Representative 24-Jun-2005 12:19 PM Page: 42 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3026025-9Report Type:Periodic Company Report #US97084570A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Professional Depakote C Company Paxil C Representative Date:11/03/97ISR Number: 3026027-2Report Type:Periodic Company Report #US97084564A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Lithium C Company Serzone C Representative Date:11/03/97ISR Number: 3026028-4Report Type:Periodic Company Report #US97084339A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3026029-6Report Type:Periodic Company Report #US97084534A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot Consumer Zyprexa PS ORAL PO Flushing Oedema Peripheral Date:11/03/97ISR Number: 3026031-4Report Type:Periodic Company Report #US97084231A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Health Zyprexa PS ORAL 10 MG DAILY Professional PO Lithium C Date:11/03/97ISR Number: 3026033-8Report Type:Periodic Company Report #US97084267A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS ORAL 5 MG DAILY PO 2 WK Fatigue Health Clonazepam C Professional Neurontin C Hydrochlorothiazide C Potassium C 24-Jun-2005 12:19 PM Page: 43 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3026036-3Report Type:Periodic Company Report #US97084309A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Consumer Zyprexa PS ORAL 2.5 MG DAILY Restlessness Health PO 2 WK Sedation Professional Ativan C Premarin C Progesterone C Ginkobiloba C Date:11/03/97ISR Number: 3026039-9Report Type:Periodic Company Report #US97084108A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Hypersensitivity Health Zyprexa PS Pruritus Professional Company Representative Date:11/03/97ISR Number: 3026041-7Report Type:Periodic Company Report #US97084117A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocythaemia Health Zyprexa PS ORAL 15 MG DAILY Professional PO Lithium C Lorazepam C Date:11/03/97ISR Number: 3026043-0Report Type:Periodic Company Report #US97084123A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 5 MG DAILY PO 2 MON Professional Lithium C Date:11/03/97ISR Number: 3026047-8Report Type:Periodic Company Report #US97084138A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 5 MG DAILY PO 2 WK Professional Company Representative Date:11/03/97ISR Number: 3026048-XReport Type:Periodic Company Report #US97084228A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fluid Retention Health Zyprexa PS ORAL 10 MG DAILY Oedema Professional PO Weight Increased 24-Jun-2005 12:19 PM Page: 44 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3026051-XReport Type:Periodic Company Report #US97083883A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS 20 MG UNK Professional Company Representative Date:11/03/97ISR Number: 3026053-3Report Type:Periodic Company Report #US97083886A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Deafness Health Zyprexa PS Professional Risperdal C Company Representative Date:11/03/97ISR Number: 3026056-9Report Type:Periodic Company Report #US97083892A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Consumer Zyprexa PS ORAL 10 MG DAILY Tremor Health PO Professional Date:11/03/97ISR Number: 3026057-0Report Type:Periodic Company Report #US97084057A Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 5 MG DAILY PO Drug Level Above Professional Depakote C Therapeutic Ativan C Date:11/03/97ISR Number: 3026059-4Report Type:Periodic Company Report #US97083877A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bone Pain Health Zyprexa PS 5 MG UNK 2 MON Pyrexia Professional Company Representative Date:11/03/97ISR Number: 3026060-0Report Type:Periodic Company Report #US97083880A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS ORAL 10 MG PO 1 MON Weight Increased Professional Company Representative 24-Jun-2005 12:19 PM Page: 45 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027333-8Report Type:Periodic Company Report #US97081042A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 5.00 MG DAILY Health PO Professional Date:11/03/97ISR Number: 3027335-1Report Type:Periodic Company Report #US97081045A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Prozac PS 3 MON Professional Zyprexa SS 3 MON Date:11/03/97ISR Number: 3027336-3Report Type:Periodic Company Report #US97081156A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS 1 YR Professional Paxil C Cogentin C Haldol C Benadryl C Zantac C Depo-Provera C Date:11/03/97ISR Number: 3027338-7Report Type:Periodic Company Report #US97081180A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa PS ORAL 2.5 MG DAILY Professional PO 1 WK Lithium C Date:11/03/97ISR Number: 3027339-9Report Type:Periodic Company Report #US97081186A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Sedation Professional DAILY PO 1 MON Weight Increased Lasix C Effexor C Date:11/03/97ISR Number: 3027340-5Report Type:Periodic Company Report #US97081318A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 15.00 MG Hostility Professional DAILY PO Sedation 24-Jun-2005 12:19 PM Page: 46 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027341-7Report Type:Periodic Company Report #US97081510A Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 6 WK Company Maxzide C Representative Date:11/03/97ISR Number: 3027342-9Report Type:Periodic Company Report #US97080988A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 MON Lithium C Tegretol C Date:11/03/97ISR Number: 3027343-0Report Type:Periodic Company Report #US97081012A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Emotional Disorder Consumer Zyprexa PS ORAL 10.00 MG Feeling Abnormal DAILY PO 1 WK Loxapine C Date:11/03/97ISR Number: 3027344-2Report Type:Periodic Company Report #US97081015A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Serzone C Representative Zoloft C Date:11/03/97ISR Number: 3027345-4Report Type:Periodic Company Report #US97081018A Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 1 MON Benztropine C Date:11/03/97ISR Number: 3027346-6Report Type:Periodic Company Report #US97081024A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Zoloft C Representative 24-Jun-2005 12:19 PM Page: 47 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027347-8Report Type:Periodic Company Report #US97081030A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Desyrl C Representative Date:11/03/97ISR Number: 3027348-XReport Type:Periodic Company Report #US97081033A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS Professional Depakote C Company Representative Date:11/03/97ISR Number: 3027349-1Report Type:Periodic Company Report #US97081036A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 WK Company Depakote C Representative Navane C Date:11/03/97ISR Number: 3027350-8Report Type:Periodic Company Report #US97080229A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agoraphobia Consumer Zyprexa PS ORAL 12.5 MG DAILY PO 7 WK Inderal C Date:11/03/97ISR Number: 3027351-XReport Type:Periodic Company Report #US97080238A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 3 WK Pamelor C Tranxene C Date:11/03/97ISR Number: 3027352-1Report Type:Periodic Company Report #US97080295A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharitis Health Zyprexa PS Professional Company Representative 24-Jun-2005 12:19 PM Page: 48 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027353-3Report Type:Periodic Company Report #US97080301A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Health Zyprexa PS ORAL 1.25 MG DAILY Professional PO 1 WK Valproic C Date:11/03/97ISR Number: 3027354-5Report Type:Periodic Company Report #US97080517A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Risperdal C Date:11/03/97ISR Number: 3027355-7Report Type:Periodic Company Report #US97080526A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Haldol C Klonopin C Date:11/03/97ISR Number: 3027356-9Report Type:Periodic Company Report #US97080856A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eyelid Disorder Health Zyprexa PS Professional Zyprexa C Company A C Representative Zyprexa I Date:11/03/97ISR Number: 3027357-0Report Type:Periodic Company Report #US97080985A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL Other Depakote C Artane C Date:11/03/97ISR Number: 3027359-4Report Type:Periodic Company Report #US97075668A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa PS ORAL 15.00 MG Decreased Professional DAILY PO Company Risperdal C Representative 24-Jun-2005 12:19 PM Page: 49 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027360-0Report Type:Periodic Company Report #US97075728A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataract Consumer Prozac PS 2 YR Sedation Zyprexa SS ORAL 10.00 MG Vision Blurred DAILY PO Weight Increased Haldol C Benadryl C Date:11/03/97ISR Number: 3027361-2Report Type:Periodic Company Report #US97075887A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027362-4Report Type:Periodic Company Report #US97075908A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 DAY Risperdal C Prozac C Wellbutrin C Ativan C Buspar C Date:11/03/97ISR Number: 3027363-6Report Type:Periodic Company Report #US97075917A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Zyprexa PS ORAL 30.00 MG Constipation Professional DAILY PO 3 MON Faecaloma Date:11/03/97ISR Number: 3027364-8Report Type:Periodic Company Report #US97075923A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa PS ORAL 15.00 MG DAILY PO Depakote C Serenil C Date:11/03/97ISR Number: 3027365-XReport Type:Periodic Company Report #US97075926A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Company Lasix C Representative 24-Jun-2005 12:19 PM Page: 50 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027366-1Report Type:Periodic Company Report #US97075932A Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Consumer Zyprexa PS ORAL 5.00 MG DAILY Weight Increased PO Ritalin C Date:11/03/97ISR Number: 3027367-3Report Type:Periodic Company Report #US97076055A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pruritus Consumer Zyprexa PS Date:11/03/97ISR Number: 3027368-5Report Type:Periodic Company Report #US97076103A Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 5.00 MG PO Hallucination Professional Vasotec C Muscle Rigidity Other Paxil C Tremor Asa C Date:11/03/97ISR Number: 3027369-7Report Type:Periodic Company Report #US97076154A Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS ORAL 5.00 MG 2/DAY Professional PO 2 MON Depakote C Benztropine C Date:11/03/97ISR Number: 3027370-3Report Type:Periodic Company Report #US97076157A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Memory Impairment Consumer Zyprexa PS ORAL 5.00 MG DAILY Vision Blurred PO 6 DAY Effexor C Ery-Tab C Dihistine C Date:11/03/97ISR Number: 3027371-5Report Type:Periodic Company Report #US97076199A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Health Zyprexa PS 5.00 MG Photophobia Professional Company Representative 24-Jun-2005 12:19 PM Page: 51 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027372-7Report Type:Periodic Company Report #US97076202A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Zyprexa PS ORAL 10.00 MG Paranoid Personality DAILY PO Disorder Date:11/03/97ISR Number: 3027373-9Report Type:Periodic Company Report #US97076208A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS ORAL 20.00 MG Livedo Reticularis Professional DAILY PO Purpura Haldol C Prozac C Lorazepam C Artane C Date:11/03/97ISR Number: 3027374-0Report Type:Periodic Company Report #US97076211A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Facial Palsy Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027375-2Report Type:Periodic Company Report #US97076217A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3027376-4Report Type:Periodic Company Report #US97076226A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Consumer Zyprexa PS ORAL 20.00 MG DAILY PO 4 WK Date:11/03/97ISR Number: 3027377-6Report Type:Periodic Company Report #US97076238A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paraesthesia Health Zyprexa PS ORAL 1 MON Professional Prolixin C Naprosyn C Cogentin C Prozac C 24-Jun-2005 12:19 PM Page: 52 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027378-8Report Type:Periodic Company Report #US97076250A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Date:11/03/97ISR Number: 3027379-XReport Type:Periodic Company Report #US97076253A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Health Zyprexa PS ORAL 10.00 MG Dyspnoea Professional DAILY PO Heart Rate Increased Date:11/03/97ISR Number: 3027442-3Report Type:Periodic Company Report #US97076259A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 30.00 MG Professional DAILY PO Paxil C Loxitane C Dilantin C Remeron C Tegretol C Date:11/03/97ISR Number: 3027445-9Report Type:Periodic Company Report #US97076262A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiv Test Positive Health Zyprexa PS ORAL 20.00 MG White Blood Cell Count Professional DAILY PO 3 WK Decreased Haldol C Date:11/03/97ISR Number: 3027450-2Report Type:Periodic Company Report #US97080145A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Zoloft C Reglan C Date:11/03/97ISR Number: 3027453-8Report Type:Periodic Company Report #US97080148A Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Bilirubin Increased Consumer Zyprexa PS ORAL 10.00 MGDAILY Cholelithiasis Health PO Liver Function Test Professional Depakote C Abnormal Tylenol C 24-Jun-2005 12:19 PM Page: 53 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027924-4Report Type:Periodic Company Report #US97093754A Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Glucose Tolerance Professional DAILY PO Decreased Company Haldol C Hyperlipidaemia Representative Paxil C Oesophagitis Weight Increased Date:11/03/97ISR Number: 3027927-XReport Type:Periodic Company Report #US97093775A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Zyprexa PS ORAL 40.00 MG Increased Professional DAILY PO Date:11/03/97ISR Number: 3027929-3Report Type:Periodic Company Report #US97094222A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Mental Impairment Professional DAILY PO Synthroid C Haloperidol C Date:11/03/97ISR Number: 3027932-3Report Type:Periodic Company Report #US97094585A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Phosphokinase Increased Professional DAILY PO 4 MON Coma Company Delirium Representative Hyponatraemia Neuroleptic Malignant Syndrome Polydipsia Psychogenic Pyrexia Date:11/03/97ISR Number: 3027935-9Report Type:Periodic Company Report #US97094795A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS ORAL 600.00 MG PO Initial or Prolonged Hypotension Professional Zoloft C Other Overdose Depakote C Coumadin C Date:11/03/97ISR Number: 3027938-4Report Type:Periodic Company Report #US97095449A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Health Zyprexa PS 150.00 MG Sedation Professional Venlafaxine C Tachycardia 24-Jun-2005 12:19 PM Page: 54 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027940-2Report Type:Periodic Company Report #US97095674A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Health Zyprexa PS ORAL 40.00 MG Initial or Prolonged Loss Of Control Of Legs Professional DAILY PO Other Company Trazodone C Representative Glipizide C Date:11/03/97ISR Number: 3027943-8Report Type:Periodic Company Report #US97100151A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Pyrexia Professional PO 2 DAY Sleep Talking Company Trazodone C Tremor Representative Tegretol C Xanax C Date:11/03/97ISR Number: 3027946-3Report Type:Periodic Company Report #US97072011A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Study Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Date:11/03/97ISR Number: 3027949-9Report Type:Periodic Company Report #US97071243A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa PS ORAL 10.00 MG Akathisia Health DAILY PO Nervousness Professional Risperdal C Sedation Date:11/03/97ISR Number: 3027951-7Report Type:Periodic Company Report #US97071261A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Zyprexa PS ORAL 5.00 MG DAILY Hypersomnia PO Urinary Incontinence Synthroid C Date:11/03/97ISR Number: 3027954-2Report Type:Periodic Company Report #US97071264A Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Health Zyprexa PS ORAL 5.00 MG DAILY Feeling Abnormal Professional PO Increased Appetite Depakote C Sedation Tegretol C Paxil C 24-Jun-2005 12:19 PM Page: 55 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027955-4Report Type:Periodic Company Report #US97071285A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 5.00 MG DAILY Abnormal Professional PO 3 MON Pyrexia Company Representative Date:11/03/97ISR Number: 3027958-XReport Type:Periodic Company Report #US97071291A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 7.5 MG DAILY Health PO Professional Prozac C Date:11/03/97ISR Number: 3027960-8Report Type:Periodic Company Report #US97071312A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Consumer Zyprexa PS ORAL 5.00 MG DAILY Vision Blurred PO 1 MON Claritin-D C Date:11/03/97ISR Number: 3027963-3Report Type:Periodic Company Report #US97071315A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Consumer Zyprexa PS ORAL 10.00 MG DAILY PO Valium C Restoril C Date:11/03/97ISR Number: 3027967-0Report Type:Periodic Company Report #US97071318A Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 3 MON Clozaril C Cogentin C Depakote C Ativan C Date:11/03/97ISR Number: 3027970-0Report Type:Periodic Company Report #US97071321A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Consumer Zyprexa PS ORAL 2.5 MG DAILY Epistaxis PO 3 WK Hyperhidrosis Effexor C Klonopin C .25 MG 1/D Klonopin C 1.00 MG 1/D 24-Jun-2005 12:19 PM Page: 56 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027973-6Report Type:Periodic Company Report #US97071324A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS 5.00 MG DAILY Professional Date:11/03/97ISR Number: 3027976-1Report Type:Periodic Company Report #US97071339A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Health Zyprexa PS ORAL 20.00 MG Pyrexia Professional DAILY PO Prozac SS 40.00 MG Trazodone C Demadex C Centrum C Relafen C Date:11/03/97ISR Number: 3027978-5Report Type:Periodic Company Report #US97071483A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027982-7Report Type:Periodic Company Report #US97071498A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS ORAL 30.00 MG Professional DAILY PO Other Date:11/03/97ISR Number: 3027984-0Report Type:Periodic Company Report #US97071531A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027987-6Report Type:Periodic Company Report #US97071534A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027991-8Report Type:Periodic Company Report #US97071543A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS ORAL 30.00 MG Professional DAILY PO Other 24-Jun-2005 12:19 PM Page: 57 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027994-3Report Type:Periodic Company Report #US97071564A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa PS ORAL 25.00 MG Professional DAILY PO Other Haldol C Inderal C Date:11/03/97ISR Number: 3028004-4Report Type:Periodic Company Report #US97071576A Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa PS ORAL 5.00 MG DAILY Dysarthria Professional PO 3 MON Lethargy Carbamazepine C Tremor Calcium Carbonate C Lorazepam C Levothyroxine C Date:11/03/97ISR Number: 3028005-6Report Type:Periodic Company Report #US97071789A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Health Zyprexa PS 20.00 MG 1/ Dystonia Professional Heroin C Date:11/03/97ISR Number: 3028007-XReport Type:Periodic Company Report #UA97071816A Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Paxil C Artane C Monopril C Date:11/03/97ISR Number: 3028010-XReport Type:Periodic Company Report #US97071828A Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Discharge Health Zyprexa PS ORAL 5.00 MG 2/DAY Professional PO 2 MON Zoloft C Date:11/03/97ISR Number: 3028012-3Report Type:Periodic Company Report #US97071831A Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 40.00 TA PO Overdose Professional Company Representative 24-Jun-2005 12:19 PM Page: 58 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028014-7Report Type:Periodic Company Report #US97071837A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa PS ORAL 5.00 MG Decreased Professional DAILY PO 11 DAY Company Clozaril C Representative Depakote C Date:11/03/97ISR Number: 3028016-0Report Type:Periodic Company Report #US97071840A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tooth Discolouration Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Benadryl C Zantac C Klonopin C Date:11/03/97ISR Number: 3028019-6Report Type:Periodic Company Report #US97071846A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Health Zyprexa PS ORAL 10.00 MG Lethargy Professional DAILY PO 3 MON Sedation Humalog C Humulin U C Date:11/03/97ISR Number: 3028021-4Report Type:Periodic Company Report #UA97071861A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 6 WK Trazodone C Clonazepam C Buspar C Date:11/03/97ISR Number: 3028023-8Report Type:Periodic Company Report #US97071864A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3028025-1Report Type:Periodic Company Report #US97072005A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO Haldol C Ativan C Diazepam C Apap C 24-Jun-2005 12:19 PM Page: 59 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maalox C Milk Of Magnesia C Date:11/03/97ISR Number: 3028027-5Report Type:Periodic Company Report #US97072020A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Zyprexa PS ORAL 10.00 MG Increased Professional DAILY PO Date:11/03/97ISR Number: 3028030-5Report Type:Periodic Company Report #US97072044A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Visual Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 10 DAY Klonopin C Trazodone C Date:11/03/97ISR Number: 3028032-9Report Type:Periodic Company Report #US97072047A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10.00 MG DAILY PO Date:11/03/97ISR Number: 3028033-0Report Type:Periodic Company Report #US97072050A Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blister Consumer Zyprexa PS ORAL 5.00 MG DAILY Dermatitis PO Xanax C Date:11/03/97ISR Number: 3028034-2Report Type:Periodic Company Report #US97072053A Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Health Zyprexa PS ORAL 2.5 MG DAILY Syncope Professional PO Date:11/03/97ISR Number: 3028036-6Report Type:Periodic Company Report #US9702056A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 5.00 MG DAILY PO Claritin C 24-Jun-2005 12:19 PM Page: 60 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028038-XReport Type:Periodic Company Report #US97072059A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Consumer Zyprexa PS 4 MON Cogentin C Lithium C Date:11/03/97ISR Number: 3028040-8Report Type:Periodic Company Report #US97072062A Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Depakote C Klonopin C Micro-K C Thiazides C Diuretic C Date:11/03/97ISR Number: 3028041-XReport Type:Periodic Company Report #US97072068A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Cephalexin C Date:11/03/97ISR Number: 3028043-3Report Type:Periodic Company Report #US97072080A Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apnoea Health Zyprexa PS ORAL 5.00 MG 2/DAY Professional PO Iron C Atrovent C Vasotec C Valproic Acid C Date:11/03/97ISR Number: 3028045-7Report Type:Periodic Company Report #US97072089A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Zyprexa PS ORAL 20.00 MG Delusional Perception Health DAILY PO 3 WK Professional Date:11/03/97ISR Number: 3028046-9Report Type:Periodic Company Report #US97072098A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS ORAL 10.00 MG Pharyngolaryngeal Pain DAILY PO 6 WK Lithium C Lamictal C 24-Jun-2005 12:19 PM Page: 61 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028048-2Report Type:Periodic Company Report #US97072104A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa PS ORAL 10.00 MG DAILY PO Date:11/03/97ISR Number: 3028050-0Report Type:Periodic Company Report #US97072116A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Health Zyprexa PS Lethargy Professional Date:11/03/97ISR Number: 3028051-2Report Type:Periodic Company Report #US97072119A Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Prolixin C Paxil C Voltaren C Progesterone C Hydrodiuril C Date:11/03/97ISR Number: 3028053-6Report Type:Periodic Company Report #US97072308A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataplexy Health Zyprexa PS ORAL 10.00 MG Hallucination Professional DAILY PO Rapid Eye Movements Sleep Abnormal Date:11/03/97ISR Number: 3028054-8Report Type:Periodic Company Report #US97072311A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS ORAL 10.00 MG Apathy Health DAILY PO Sedation Professional Inderal C Weight Increased Date:11/03/97ISR Number: 3028055-XReport Type:Periodic Company Report #US97072317A Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS ORAL 2.5 MG DAILY PO Ritalin C Depakene C 24-Jun-2005 12:19 PM Page: 62 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028057-3Report Type:Periodic Company Report #US97072350A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Angioneurotic Oedema Health Zyprexa PS ORAL 5.00 MG DAILY Face Oedema Professional PO 1 DAY Tongue Oedema Biaxin C Asa C Trihexyphenidyl C Atrovent C Norvasc C Insulin C Zoloft C Date:11/03/97ISR Number: 3028059-7Report Type:Periodic Company Report #US97072773A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Other Depakote C Lasix C Potassium C Aspirin C Ambien C Amiodarone C Dilantin C Date:11/03/97ISR Number: 3028061-5Report Type:Periodic Company Report #US97072803A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain Health Zyprexa PS ORAL 15.00 MG Tachyarrhythmia Professional DAILY PO Other Cogentin C Benadryl C Navane C Date:11/03/97ISR Number: 3028064-0Report Type:Periodic Company Report #US97072815A Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Other Zyprexa PS ORAL 10.00 MG Therapeutic Response DAILY PO Unexpected Ativan C Xanax C Lopressor C Date:11/03/97ISR Number: 3028065-2Report Type:Periodic Company Report #US97072950A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coma Health Zyprexa PS ORAL 2.50 MG DAILY Lethargy Professional PO Muscle Rigidity Other Lotrel C Muscle Twitching Aspirin C Xalatan C Bromocriptine C 24-Jun-2005 12:19 PM Page: 63 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028068-8Report Type:Periodic Company Report #US97073034A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS 5.00 MG DAILY Oedema Professional Valproate Sodium C Weight Increased Company Phenelzine C Representative Date:11/03/97ISR Number: 3028073-1Report Type:Periodic Company Report #US97073037A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO Depakote C Paxil C Date:11/03/97ISR Number: 3028076-7Report Type:Periodic Company Report #US97073061A Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Date:11/03/97ISR Number: 3028080-9Report Type:Periodic Company Report #US97073082A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthropathy Health Zyprexa PS 5.00 MG DAILY Carpal Tunnel Syndrome Professional Valproate Sodium C Hypoaesthesia Company Alprazolam C Oedema Representative Fluoxetine C Paraesthesia Weight Increased Date:11/03/97ISR Number: 3028084-6Report Type:Periodic Company Report #US97073127A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Health Zyprexa PS Professional Date:11/03/97ISR Number: 3028087-1Report Type:Periodic Company Report #US97073277A Age:45 YR Gender:Female I/FU:I Outcome PT Blood Creatine Phosphokinase Increased Confusional State Coordination Abnormal Hyperhidrosis Muscle Rigidity Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Posture Abnormal 24-Jun-2005 12:19 PM Page: 64 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 25.00 MG Professional DAILY PO Prozac C Cogentin C Lorazepam C Date:11/03/97ISR Number: 3028090-1Report Type:Periodic Company Report #US97073295A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Buccoglossal Syndrome Consumer Zyprexa PS ORAL 20.00 MG DAILY PO Benztropine C Date:11/03/97ISR Number: 3028093-7Report Type:Periodic Company Report #US97073307A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Attention Health Zyprexa PS ORAL 20.00 MG Deficit/Hyperactivity Professional DAILY PO 1 WK Disorder Haldol C Symmetrel C Date:11/03/97ISR Number: 3028096-2Report Type:Periodic Company Report #US97073313A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Prolixin C Representative Ativan C Benadryl C Date:11/03/97ISR Number: 3028098-6Report Type:Periodic Company Report #US97073316A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Health Zyprexa PS ORAL 5.00 MG DAILY Visual Disturbance Professional PO Sertraline C Estradiol C Date:11/03/97ISR Number: 3028100-1Report Type:Periodic Company Report #US97073322A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Consumer Zyprexa PS ORAL 20.00 MG Health DAILY PO Professional Haloperidol Company Decanoate C Representative Cogentin C Klonopin C Inderal C 24-Jun-2005 12:19 PM Page: 65 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028102-5Report Type:Periodic Company Report #US97073328A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa PS ORAL 12.5 MG DAILY Syndrome Professional PO Pyrexia Sepsis Urinary Tract Infection Date:11/03/97ISR Number: 3028104-9Report Type:Periodic Company Report #US97073331A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Consumer Zyprexa PS ORAL 12.50 MG DAILY PO Risperdal C Ativan C Date:11/03/97ISR Number: 3028105-0Report Type:Periodic Company Report #US97073337A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Zyprexa PS ORAL 10.00 MG Medication Error DAILY PO Speech Disorder Levothroid C Thinking Abnormal Chlorthalidone C Potassium C Lopressor C Date:11/03/97ISR Number: 3028107-4Report Type:Periodic Company Report #US97073346A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asperger'S Disorder Health Zyprexa PS ORAL 10.00 MG Fatigue Professional DAILY PO 14 WK Hyperhidrosis Guanfacine C Hypersomnia Increased Appetite Weight Increased Date:11/03/97ISR Number: 3028109-8Report Type:Periodic Company Report #US97073355A Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Health Zyprexa PS ORAL 15.00 MG Phosphatase Increased Professional DAILY PO Blood Lactate Glyburide C Dehydrogenase Increased Gamma-Glutamyltransferase Increased 24-Jun-2005 12:19 PM Page: 66 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028110-4Report Type:Periodic Company Report #US97073394A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Consumer Zyprexa PS ORAL 10.00 MG Hallucination Health 2/DAY PO 5 MON Weight Decreased Professional Antibiotics C Weight Increased Sertraline C Doxazosin C Date:11/03/97ISR Number: 3028114-1Report Type:Periodic Company Report #US97073547A Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa PS ORAL 15.00 MG Mood Swings Health DAILY PO Professional Serzone C Date:11/03/97ISR Number: 3028116-5Report Type:Periodic Company Report #US97073577A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 1 WK Clozaril C Date:11/03/97ISR Number: 3028119-0Report Type:Periodic Company Report #US97073583A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 2 MON Paxil C Date:11/03/97ISR Number: 3028121-9Report Type:Periodic Company Report #US97073601A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Health Zyprexa PS Professional Date:11/03/97ISR Number: 3028124-4Report Type:Periodic Company Report #US97073604A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Company Zyprexa PS ORAL 5.00 MG DAILY Sedation Representative PO 3 WK Urinary Retention Synthroid C Date:11/03/97ISR Number: 3028127-XReport Type:Periodic Company Report #US97073613A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL PO 1 MON Condition Aggravated Professional Prozac C 24-Jun-2005 12:19 PM Page: 67 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028129-3Report Type:Periodic Company Report #US97073814A Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 5.00 MG DAILY Abnormal Professional PO 2 WK Weight Increased Lithium C Date:11/03/97ISR Number: 3028131-1Report Type:Periodic Company Report #US97073820A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 1 MON Valproate Sodium C Fluvoxamine C Clonazepam C Diphenhydramine C Lorazepam C Ibuprofen C Chlorpromazine C Date:11/03/97ISR Number: 3028134-7Report Type:Periodic Company Report #US97073823A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Stiffness Consumer Zyprexa PS ORAL 10.00 MG Nervousness Health DAILY PO Professional Date:11/03/97ISR Number: 3028137-2Report Type:Periodic Company Report #US97074009A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa PS ORAL 10.00 MG Skin Striae DAILY PO 2 MON Weight Increased Date:11/03/97ISR Number: 3028140-2Report Type:Periodic Company Report #US97074015A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Consumer Zyprexa PS Date:11/03/97ISR Number: 3028142-6Report Type:Periodic Company Report #US97074021A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukocytosis Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Oxycodone And Acetaminofen C 24-Jun-2005 12:19 PM Page: 68 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028613-2Report Type:Periodic Company Report #US970838353A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Zyprexa PS ORAL 2.5 MG DAILY PO Xanax C Date:11/03/97ISR Number: 3028616-8Report Type:Periodic Company Report #US97083859A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Klonopin C Date:11/03/97ISR Number: 3028618-1Report Type:Periodic Company Report #US97083871A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Health Zyprexa PS ORAL 10.00 MG Tardive Dyskinesia Professional DAILY PO Artane C Paxil C Vitamin E C Date:11/03/97ISR Number: 3028620-XReport Type:Periodic Company Report #US97083850A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Health Zyprexa PS ORAL 20.00 MG Glycosuria Professional DAILY PO Haematuria Date:11/03/97ISR Number: 3028621-1Report Type:Periodic Company Report #US97083679A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS ORAL 5.00 MG DAILY Fatigue Professional PO Lung Infiltration Prozac SS Pyrexia Date:11/03/97ISR Number: 3028623-5Report Type:Periodic Company Report #US97083808A Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS Dyskinesia Professional Cardura C Restlessness Company Representative 24-Jun-2005 12:19 PM Page: 69 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028625-9Report Type:Periodic Company Report #US97083823A Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa PS ORAL 20.00 MG Paranoia Professional DALIY PO Thioridazine C Date:11/03/97ISR Number: 3028627-2Report Type:Periodic Company Report #US97083829A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa PS ORAL 10.00 MG Pain Of Skin DAILY PO 1 WK Synthroid C Date:11/03/97ISR Number: 3028628-4Report Type:Periodic Company Report #US97083847A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 12.50 MG DAILY PO Klonopin C Date:11/03/97ISR Number: 3028629-6Report Type:Periodic Company Report #US97083619A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Myalgia Consumer Zyprexa PS ORAL 5.00 MG DAILY PO 6 WK Depakote C Xanax C Synthroid C Date:11/03/97ISR Number: 3028632-6Report Type:Periodic Company Report #US97083622A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO 2 WK Professional Prozac SS ORAL 80.00 MG DAILY PO Dalmane C Xanax C Date:11/03/97ISR Number: 3028634-XReport Type:Periodic Company Report #US97083508A Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Consumer Zyprexa PS ORAL 10.00 MG Dysphagia Health DAILY PO Muscle Rigidity Professional 24-Jun-2005 12:19 PM Page: 70 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028637-5Report Type:Periodic Company Report #US97083490A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS 2 MON Oedema Peripheral Professional Date:11/03/97ISR Number: 3028640-5Report Type:Periodic Company Report #US97083232A Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS ORAL 20.00 MG Weight Increased DAILY PO Date:11/03/97ISR Number: 3028642-9Report Type:Periodic Company Report #US97083247A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 10.00 MG Weight Increased Professional DAILY Date:11/03/97ISR Number: 3028645-4Report Type:Periodic Company Report #US97083253A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Klonopin C Representative Depakote C Levoxyl C Date:11/03/97ISR Number: 3028648-XReport Type:Periodic Company Report #US97083478A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urticaria Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 5 WK Stelazine C Klonopin C Date:11/03/97ISR Number: 3028650-8Report Type:Periodic Company Report #US97082890A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apraxia Consumer Zyprexa PS ORAL 2.5 MG DAILY Muscle Rigidity PO Kemadrin C Rigidity C Sinemet C Date:11/03/97ISR Number: 3028652-1Report Type:Periodic Company Report #US97082893A Age:5 YR Gender:Male I/FU:I Outcome PT Accidental Exposure Agitation 24-Jun-2005 12:19 PM Page: 71 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 14 DAY Zyrtec C Flovent C Date:11/03/97ISR Number: 3028655-7Report Type:Periodic Company Report #US97082896A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 2 WK Depakote C Date:11/03/97ISR Number: 3028658-2Report Type:Periodic Company Report #US97083109A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO Company Representative Date:11/03/97ISR Number: 3028661-2Report Type:Periodic Company Report #US97083148A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Representative Date:11/03/97ISR Number: 3028664-8Report Type:Periodic Company Report #US97082779A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration International Normalised Health Zyprexa PS Ratio Increased Professional Prozac SS 100.00 MG DAILY Coumadin C 2.5 MG DAILY 6 DAY Coumadin C 5.00 MG 1/D 1 DAY Date:11/03/97ISR Number: 3028667-3Report Type:Periodic Company Report #US97082869A Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Therapeutic Response Health Zyprexa PS ORAL 10.00 MG Unexpected Professional DAILY PO 6 WK Paxil C 24-Jun-2005 12:19 PM Page: 72 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028669-7Report Type:Periodic Company Report #US97082887A Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Consumer Zyprexa PS ORAL 2.5 MG DAILY PO Date:11/03/97ISR Number: 3028672-7Report Type:Periodic Company Report #US97082581A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS 5.00 MG 30 DAY Professional Risperdal C Company Benadryl C Representative Date:11/03/97ISR Number: 3028676-4Report Type:Periodic Company Report #US97082623A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lactation Disorder Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 6 WK Company Representative Date:11/03/97ISR Number: 3028677-6Report Type:Periodic Company Report #US97082575A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 12.5 MG DAILY Professional PO 2 MON Klonopin C Luvox C Date:11/03/97ISR Number: 3028679-XReport Type:Periodic Company Report #US97082578A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3028680-6Report Type:Periodic Company Report #US97082563A Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 2 WK Trilafon C Ssri C Ativan C 24-Jun-2005 12:19 PM Page: 73 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028681-8Report Type:Periodic Company Report #US97082569A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS 5.00 MG DAILY Professional Trilafon C Prozac C Cogentin C Clonidine C Date:11/03/97ISR Number: 3028683-1Report Type:Periodic Company Report #US97082572A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 3 MON Synthroid C Multivitamin C Date:11/03/97ISR Number: 3028685-5Report Type:Periodic Company Report #US97082560A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 2 WK Depakote C Date:11/03/97ISR Number: 3028687-9Report Type:Periodic Company Report #US97082335A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disorientation Consumer Zyprexa PS ORAL 5.00 MG DAILY Fatigue Health PO Flashback Professional Synthroid C Hepatic Function Abnormal Depakote C Liver Function Test Abnormal Date:11/03/97ISR Number: 3028689-2Report Type:Periodic Company Report #US97082446A Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Health Zyprexa PS ORAL 20.00 MG Sedation Professional DAILY PO Weight Increased Date:11/03/97ISR Number: 3028691-0Report Type:Periodic Company Report #US97082449A Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperthermia Malignant Health Zyprexa PS ORAL 12.5 MG DAILY Professional PO Cardizem C Lasix C Sinemet C Eldepryl C Parlodel C 24-Jun-2005 12:19 PM Page: 74 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ditropan C Date:11/03/97ISR Number: 3028693-4Report Type:Periodic Company Report #US97082455A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Migraine Consumer Zyprexa PS ORAL 10.00 MG Paraesthesia DAILY PO 2 MON Weight Increased Prozac C Clonidine C Date:11/03/97ISR Number: 3028696-XReport Type:Periodic Company Report #US97082458A Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Posture Abnormal Consumer Zyprexa PS ORAL 2.5 MG DAILY Sedation PO 2 WK Paxil C Sinemet C Amantadine C Date:11/03/97ISR Number: 3028697-1Report Type:Periodic Company Report #US97082476A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperkalaemia Health Zyprexa PS ORAL 15.00 MG PO Hyponatraemia Professional Klonopin C Inappropriate Company Depakote C Antidiuretic Hormone Representative Secretion Date:11/03/97ISR Number: 3028699-5Report Type:Periodic Company Report #US97082059A Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Zyprexa PS ORAL 10.00 MG Depression DAILY PO Muscle Rigidity Antibiotic C Tremor L-Dopa C Paxil C Date:11/03/97ISR Number: 3028700-9Report Type:Periodic Company Report #US97082071A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Weight Increased Professional Date:11/03/97ISR Number: 3028703-4Report Type:Periodic Company Report #US97082074A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 5.00 MG DAILY PO 24-Jun-2005 12:19 PM Page: 75 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028705-8Report Type:Periodic Company Report #US97082077A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 4 MON Demulen C Xanax C Spironolactone C Date:11/03/97ISR Number: 3028707-1Report Type:Periodic Company Report #US97082083A Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Sinemet C Date:11/03/97ISR Number: 3028708-3Report Type:Periodic Company Report #US97082119A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Prozac PS ORAL 20.00 MG Syncope DAILY PO Zyprexa SS ORAL 10.00 MG DAILY PO 5 MON Lithium C Date:11/03/97ISR Number: 3028710-1Report Type:Periodic Company Report #US97082272A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional Anafranil C Date:11/03/97ISR Number: 3028712-5Report Type:Periodic Company Report #US97082278A Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parotid Gland Enlargement Health Zyprexa PS 10.00 MG Professional DAILY Octreotide C Insulin C Albuterol C Sertraline C Levothyroxine C Lansoprazole C Date:11/03/97ISR Number: 3028713-7Report Type:Periodic Company Report #US97082284A Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antinuclear Antibody Health Zyprexa PS 6 WK Positive Professional Buspar C Arthritis 24-Jun-2005 12:19 PM Page: 76 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028715-0Report Type:Periodic Company Report #US97082299A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS ORAL PO Professional Gentamicin C Vancomycin C Serax C Date:11/03/97ISR Number: 3028717-4Report Type:Periodic Company Report #US97081849A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pre-Existing Condition Health Zyprexa PS ORAL 5.00 MG DAILY Improved Professional PO 1 MON Therapeutic Response Prozac C Unexpected Date:11/03/97ISR Number: 3028719-8Report Type:Periodic Company Report #US97081855A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperkalaemia Health Zyprexa PS ORAL 7.50 MG DAILY Professional PO 3 WK Lithium C Lorazepam C Date:11/03/97ISR Number: 3028721-6Report Type:Periodic Company Report #US97081858A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS 10 DAY Nervousness Professional Tylenol C Date:11/03/97ISR Number: 3028724-1Report Type:Periodic Company Report #US97081861A Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa PS ORAL 5.00 MG DAILY Sedation Professional PO Date:11/03/97ISR Number: 3028726-5Report Type:Periodic Company Report #US97081522A Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Other Zyprexa PS Arthritis Buspirone C Weight Increased Date:11/03/97ISR Number: 3028728-9Report Type:Periodic Company Report #US97081588A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Consumer Zyprexa PS ORAL 10.00 MG Tinnitus DAILY PO 2 WK Tremor Remerom C 24-Jun-2005 12:19 PM Page: 77 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premarin C Florinef C Bentyl C Date:11/03/97ISR Number: 3028730-7Report Type:Periodic Company Report #US97081594A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatomegaly Health Zyprexa PS ORAL 10.00 MG Oedema Peripheral Professional DAILY PO Weight Increased Impramine C Date:11/03/97ISR Number: 3028732-0Report Type:Periodic Company Report #US97081597A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Zyprexa PS 15.00 MG Parkinsonian Gait Health DAILY Vertigo Professional Prozac SS Klonopin C Premarin C Date:11/03/97ISR Number: 3028734-4Report Type:Periodic Company Report #US97081657A Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Malaise Consumer Zyprexa PS ORAL 10.00 MG Medication Error DAILY PO 10 DAY Date:11/03/97ISR Number: 3028736-8Report Type:Periodic Company Report #US97081660A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parotid Gland Enlargement Health Zyprexa PS Professional Date:11/03/97ISR Number: 3028740-XReport Type:Periodic Company Report #US97081822A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 7.50 MG DAILY Professional PO Cogentin C Date:11/03/97ISR Number: 3033612-0Report Type:Periodic Company Report #US97095110A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional 24-Jun-2005 12:19 PM Page: 78 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033615-6Report Type:Periodic Company Report #US97095113A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 10.00 MG Skin Disorder Professional DAILY Weight Increased Lithium C Date:11/03/97ISR Number: 3033616-8Report Type:Periodic Company Report #US97095119A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 10.00 MG Skin Disorder Professional DAILY PO Weight Increased Lithium C Bentyl C Date:11/03/97ISR Number: 3033618-1Report Type:Periodic Company Report #US97095137A Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 6 WK Sinemet C Sinequan C Levsinex C Acupril C Inderal La C Permax C Propulsid C Ambien C Date:11/03/97ISR Number: 3033620-XReport Type:Periodic Company Report #US97095170A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS ORAL 20.00 MG White Blood Cell Count Professional DAILY PO Decreased Date:11/03/97ISR Number: 3033622-3Report Type:Periodic Company Report #US97095173A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Acetaminophen C Naprosyn C Klonopin C Entex La C Vancenase C Benadryl C Depakote C Triple Antibiotic Ointment C 24-Jun-2005 12:19 PM Page: 79 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033623-5Report Type:Periodic Company Report #US97095182A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3033624-7Report Type:Periodic Company Report #US97095413A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Professional Date:11/03/97ISR Number: 3033626-0Report Type:Periodic Company Report #US97095422A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain In Extremity Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 MON Date:11/03/97ISR Number: 3033627-2Report Type:Periodic Company Report #US97095431A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Health Zyprexa PS ORAL 10.00 MG Hypotension Professional DAILY PO Medication Error Date:11/03/97ISR Number: 3033629-6Report Type:Periodic Company Report #US97095440A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Pain Health Zyprexa PS ORAL 5.00 MG Nausea Professional DAILY PO Date:11/03/97ISR Number: 3033630-2Report Type:Periodic Company Report #US97095452A Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa PS ORAL 10.00 MG PO Professional Date:11/03/97ISR Number: 3033632-6Report Type:Periodic Company Report #US97095689A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa PS ORAL 7.50 MG Libido Decreased Health DAILY PO Sedation Professional Neurontin C Weight Increased Sunthroid C 24-Jun-2005 12:19 PM Page: 80 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033634-XReport Type:Periodic Company Report #US97095698A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 5.00 MG Skin Discolouration DAILY PO Neurontin C Tegretol C Effexor C Nortriptyline C Date:11/03/97ISR Number: 3033635-1Report Type:Periodic Company Report #US97095701A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 3 MON Depakote C Date:11/03/97ISR Number: 3033637-5Report Type:Periodic Company Report #US97095731A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS ORAL 10.00 MG Muscle Rigidity Professional DAILY PO 1 MON Tachycardia Sertraline C Tetany Synthroid C Torticollis Tremor Date:11/03/97ISR Number: 3033638-7Report Type:Periodic Company Report #US97095737A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 2 WK Date:11/03/97ISR Number: 3033640-5Report Type:Periodic Company Report #US97095755A Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fall Health Zyprexa PS ORAL 2.5 MG DAILY Professional PO 1 WK Date:11/03/97ISR Number: 3033641-7Report Type:Periodic Company Report #US97100175A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot Health Zyprexa PS ORAL 7.5 MG DAILY Hyperhidrosis Professional PO 24-Jun-2005 12:19 PM Page: 81 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033643-0Report Type:Periodic Company Report #US97100181A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Consumer Zyprexa PS ORAL 2.5 MG DAILY Increased PO Vasotec C Depakote C Date:11/03/97ISR Number: 3033644-2Report Type:Periodic Company Report #US97100205A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Memory Impairment Consumer Zyprexa PS ORAL 10.MG DAILY Retinal Oedema Health PO 3 MON Professional Date:11/03/97ISR Number: 3033646-6Report Type:Periodic Company Report #US97100214A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Company Zyprexa PS ORAL 7.5 MG DAILY Hypersomnia Representative PO 4 MON Date:11/03/97ISR Number: 3033647-8Report Type:Periodic Company Report #US97100217A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neck Pain Consumer Zyprexa PS ORAL 20.00 MG DAILY; PO Date:11/03/97ISR Number: 3033649-1Report Type:Periodic Company Report #US97100223A Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa PS ORAL 7.5 MG DAILY Sedation Professional PO Weight Increased Date:11/03/97ISR Number: 3033650-8Report Type:Periodic Company Report #US97100232A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram T Wave Health Zyprexa PS ORAL 10.MG DAILY Inversion Professional PO Tachycardia Date:11/03/97ISR Number: 3033652-1Report Type:Periodic Company Report #US97100466A Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS ORAL 5.0MG DAILY Chills Professional PO Sedation Luvox C 50.MG 002/DAY Vomiting Benztropine C 1.00 MG 2/D Risperdal C 1.00 MG 3/D 24-Jun-2005 12:19 PM Page: 82 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033653-3Report Type:Periodic Company Report #US97100514A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Consumer Zyprexa PS ORAL 5.00 MG DAILY PO 9 MON Lithium C Depakote C Date:11/03/97ISR Number: 3033655-7Report Type:Periodic Company Report #US97100538A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Scoliosis Consumer Zyprexa PS 5 MON Vision Blurred Date:11/03/97ISR Number: 3033656-9Report Type:Periodic Company Report #US97100562A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyporeflexia Health Zyprexa PS ORAL 15.00 MG Professional DAILY; PO Company Paxil C Representative Ativan C Cogentin C Date:11/03/97ISR Number: 3033658-2Report Type:Periodic Company Report #US97100721A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS Galactorrhoea Professional Company Representative Date:11/03/97ISR Number: 3033659-4Report Type:Periodic Company Report #US97100733A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa PS 2 MON Nasopharyngitis Health Lithium C Pallor Professional Date:11/03/97ISR Number: 3033661-2Report Type:Periodic Company Report #US97100736A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intermittent Claudication Health Zyprexa PS ORAL 10.00MG DAILY Pain In Extremity Professional PO Ativan C 24-Jun-2005 12:19 PM Page: 83 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033662-4Report Type:Periodic Company Report #US97100745A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 5.00 MG Professional DAILY;PO 4 DAY Company Trilafon C Representative Date:11/03/97ISR Number: 3033664-8Report Type:Periodic Company Report #US97100760A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Health Zyprexa PS Dysphoria Professional Prolixin C Sedation Date:11/03/97ISR Number: 3033665-XReport Type:Periodic Company Report #US97100763A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Health Zyprexa PS ORAL 10.00MG Hypoaesthesia Professional DAILY; PO Company Representative Date:11/03/97ISR Number: 3033667-3Report Type:Periodic Company Report #US97100919A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS ORAL 2.50 MG Weight Decreased DAILY; PO Zoloft C Date:11/03/97ISR Number: 3033668-5Report Type:Periodic Company Report #US97100967A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Consumer Zyprexa PS ORAL PO 3 MON Date:11/03/97ISR Number: 3033670-3Report Type:Periodic Company Report #US97100982A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 25.00 MG Professional DAILY;PO 2 MON Paxil C Date:11/03/97ISR Number: 3033672-7Report Type:Periodic Company Report #US97100994A Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laryngospasm Health Zyprexa PS SUBCUTANEOUS 20.00 MG Professional DAILY SC Cogentin C Ativan C 24-Jun-2005 12:19 PM Page: 84 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033674-0Report Type:Periodic Company Report #US97101000A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Health Zyprexa PS ORAL 15.00MG DAILY Liver Function Test Professional PO Abnormal Anafranil C Vomiting Prozac C Date:11/03/97ISR Number: 3033675-2Report Type:Periodic Company Report #US97101012A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 5.00 MG 2/DAY 2 MON Professional Date:11/03/97ISR Number: 3033676-4Report Type:Periodic Company Report #US97101018A Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Health Zyprexa PS ORAL 2.50 MG DAILY Professional PO Date:11/03/97ISR Number: 3033678-8Report Type:Periodic Company Report #US97101021A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Rigidity Consumer Zyprexa PS ORAL 10.00 MG Back Pain DAILY PO Blepharospasm Muscle Rigidity Muscle Spasms Tongue Spasm Date:11/03/97ISR Number: 3033680-6Report Type:Periodic Company Report #US97101048A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 3 MON Insulin C Cogentin C Date:11/03/97ISR Number: 3033681-8Report Type:Periodic Company Report #US97101051A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS 20.00 MG Professional Date:11/03/97ISR Number: 3033682-XReport Type:Periodic Company Report #US97101060A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Akathisia Health Professional 24-Jun-2005 12:19 PM Page: 85 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 10.00 MG DAILY PO 1 YR Prozac SS 40.00 MG DAILY Remeron C Date:11/03/97ISR Number: 3033684-3Report Type:Periodic Company Report #US95010928A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Study Zyprexa PS ORAL 20.00 MG Pneumonia Health DAILY PO Productive Cough Professional Vitamin C C Pyrexia Dietary Supplement C Vitamin B C Date:11/03/97ISR Number: 3033686-7Report Type:Periodic Company Report #US97032416A Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Hip Fracture Health PO Disability Professional Bumex C Risperdal C Hydrocortisone C Milk Of Magnesia C Tylenol C Ibuprofen C Aspirin C Zestril C Date:11/03/97ISR Number: 3033687-9Report Type:Periodic Company Report #US97042017A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Depressed Mood Health PO Depression Professional Prozac C Hallucination, Auditory Ativan C Stress Suicidal Ideation Date:11/03/97ISR Number: 3033689-2Report Type:Periodic Company Report #US97054300A Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Health PO Professional Asa C Vitamn B 12 C Folic Acid C Lactulose C Surfak C 24-Jun-2005 12:19 PM Page: 86 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033690-9Report Type:Periodic Company Report #US97064384A Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nervousness Study Zyprexa PS Initial or Prolonged Overdose Health Congentin C Professional Extrapyramidal Syndrome C Date:11/03/97ISR Number: 3033692-2Report Type:Periodic Company Report #US97065605A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Fall Health PO Sleep Disorder Professional Ativan C Date:11/03/97ISR Number: 3033693-4Report Type:Periodic Company Report #US97070175A Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anhedonia Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Depression Health PO Professional Date:11/03/97ISR Number: 3033695-8Report Type:Periodic Company Report #US96123358A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Zyprexa PS ORAL 20 MG DAILY Decreased Professional PO 2 WK Depakote C Oxybutynin C Docusate C Date:11/03/97ISR Number: 3033697-1Report Type:Periodic Company Report #US97022707A Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zyprexa PS 10 MG DAILY 2 WK Pyrexia Professional Depakote C Viral Infection Company Representative Date:11/03/97ISR Number: 3033698-3Report Type:Periodic Company Report #US97031054A Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Health Zyprexa PS ORAL 10 MG 3/DAY Haemoglobin Decreased Professional PO Hyperglycaemia Trilafon C Hypokalaemia Novolin 70/30 C Humulin R C 24-Jun-2005 12:19 PM Page: 87 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033700-9Report Type:Periodic Company Report #US97033847A Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rectal Haemorrhage Health Zyprexa PS ORAL 15 MG DAILY Professional PO Depakote C Wellbutrin C Dynacin C Date:11/03/97ISR Number: 3033701-0Report Type:Periodic Company Report #US97040622A Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa PS ORAL 7.5 MG DAILY Initial or Prolonged Headache Professional PO Hepatic Function Abnormal Hepatitis Pyrexia Vomiting Date:11/03/97ISR Number: 3033702-2Report Type:Periodic Company Report #US97043202A Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Zyprexa PS ORAL 5 MG DAILY PO 4 DAY Professional Company Representative Date:11/03/97ISR Number: 3033704-6Report Type:Periodic Company Report #US97043208A Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Zyprexa PS ORAL 30 MG DAILY Coordination Abnormal Professional PO Drug Interaction Company Benadryl C Sedation Representative Depakote C Navane C Luvox C Eskalith Cr C Ativan C Date:11/03/97ISR Number: 3033705-8Report Type:Periodic Company Report #US97045965A Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Health Zyprexa PS ORAL 100 MG 1 PO Initial or Prolonged Overdose Professional Other Date:11/03/97ISR Number: 3033707-1Report Type:Periodic Company Report #US97054504A Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Zyprexa PS ORAL 50 MG DAILY Professional PO 24-Jun-2005 12:19 PM Page: 88 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haldol C Risperdal C Luvox C Lithium C Date:11/03/97ISR Number: 3033709-5Report Type:Periodic Company Report #US97054936A Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Interaction Health Prozac PS 20 MG Initial or Prolonged Depressed Level Of Professional Zyprexa SS 10 MG Other Consciousness Required Overdose Intervention to Prevent Permanent Impairment/Damage Date:11/03/97ISR Number: 3033710-1Report Type:Periodic Company Report #US97062497A Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Professional PO Other Carbamazepine C Sertraline C Date:11/03/97ISR Number: 3033712-5Report Type:Periodic Company Report #US97064000A Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Culture Positive Health Zyprexa PS ORAL 10 MG 2/DAY Initial or Prolonged Pyrexia Professional PO Lorazepam C Date:11/03/97ISR Number: 3033832-5Report Type:Periodic Company Report #US97093655A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tic Health Zyprexa PS ORAL 500 MG DAILY Professional PO Date:11/03/97ISR Number: 3033834-9Report Type:Periodic Company Report #US97093670A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tic Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Company Representative 24-Jun-2005 12:19 PM Page: 89 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033909-4Report Type:Periodic Company Report #US97093814A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS Professional Depakote C Date:11/03/97ISR Number: 3033911-2Report Type:Periodic Company Report #US97094000A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Zyprexa PS ORAL 5.00 MG DAILY PO Effexor C Date:11/03/97ISR Number: 3033914-8Report Type:Periodic Company Report #US97094009A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Consumer Zyprexa PS ORAL 2.5 MG DAILY Weight Increased PO Zoloft C Date:11/03/97ISR Number: 3033917-3Report Type:Periodic Company Report #US97094012A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa PS ORAL 10.00 MG Anger DAILY PO Euphoric Mood Hypotension Date:11/03/97ISR Number: 3033920-3Report Type:Periodic Company Report #US97094024A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 20.00 MG Abnormal Professional DAILY PO Date:11/03/97ISR Number: 3033923-9Report Type:Periodic Company Report #US97094036A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS ORAL PO 2 MON Professional Date:11/03/97ISR Number: 3033927-6Report Type:Periodic Company Report #US97094072A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa PS ORAL 20.00 MG Health DAILY PO Professional 24-Jun-2005 12:19 PM Page: 90 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033930-6Report Type:Periodic Company Report #US97094078A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Health Zyprexa PS ORAL 10.00 MG PO Sedation Professional 2/DAY PO 6 MON Date:11/03/97ISR Number: 3033933-1Report Type:Periodic Company Report #US97094081A Age:65 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Zyprexa PS Dysphagia Professional Company Representative Date:11/03/97ISR Number: 3033935-5Report Type:Periodic Company Report #US97094084A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cor Pulmonale Health Zyprexa PS 6 WK Pulmonary Hypertension Professional Clozaril C Sleep Apnoea Syndrome Company Representative Date:11/03/97ISR Number: 3033938-0Report Type:Periodic Company Report #US97094252A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Cogentin C Date:11/03/97ISR Number: 3033941-0Report Type:Periodic Company Report #US97094258A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Enzyme Abnormality Health Zyprexa PS ORAL 12.50 MG Haematemesis Professional DAILY PO Zoloft C Asa C Date:11/03/97ISR Number: 3033943-4Report Type:Periodic Company Report #US97094264A Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS ORAL 5.00 MG DAILY Dysphagia Professional PO Klonopin C Date:11/03/97ISR Number: 3033947-1Report Type:Periodic Company Report #US97094321A Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain In Extremity Health Zyprexa PS ORAL 5.00 MG DAILY Paraesthesia Professional PO 24-Jun-2005 12:19 PM Page: 91 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin C Norvasc C Date:11/03/97ISR Number: 3033951-3Report Type:Periodic Company Report #US97094324A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Health Zyprexa PS ORAL 10.00 MG Muscle Twitching Professional DAILY PO 4 MON Company Representative Date:11/03/97ISR Number: 3033953-7Report Type:Periodic Company Report #US97094327A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharospasm Health Zyprexa PS ORAL 10.00 MG PO Professional DAILY 3 MON Company Representative Date:11/03/97ISR Number: 3033957-4Report Type:Periodic Company Report #US97094330A Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS ORAL 10.00 MG Hallucination, Auditory Professional DAILY PO Tegretol C Synthroid C Klonopin C Zoloft C Date:11/03/97ISR Number: 3033960-4Report Type:Periodic Company Report #US97094336A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Consumer Zyprexa PS ORAL 10.00 MG Hypersomnia DAILY PO 2 MON Sedation Paxil C Vomiting Oxazepam C Date:11/03/97ISR Number: 3033964-1Report Type:Periodic Company Report #US97094540A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa PS ORAL 15.00 MG Jaw Disorder DAILY PO Neurosis Palpitations Restless Legs Syndrome Tongue Oedema 24-Jun-2005 12:19 PM Page: 92 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033967-7Report Type:Periodic Company Report #US97094564A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Conjunctival Hyperaemia Health Zyprexa PS ORAL 5.00 MG DAILY Vision Blurred Professional PO Date:11/03/97ISR Number: 3033970-7Report Type:Periodic Company Report #US97094597A Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Cogentin C Sorbitol C Norvasc C Asa C Depakote C Flagyl C Klonopin C Ativan C Tylenol C Augmentin C Cardura C Duragesic C Humulin R C Date:11/03/97ISR Number: 3033972-0Report Type:Periodic Company Report #US97094726A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa PS Professional Date:11/03/97ISR Number: 3033975-6Report Type:Periodic Company Report #US97094765A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Depakote C Effexor C Date:11/03/97ISR Number: 3033978-1Report Type:Periodic Company Report #US97094774A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 7.5 MG DAILY Professional PO Depakote C Cogentin C Lorazepam C Haldol Depot C 24-Jun-2005 12:19 PM Page: 93 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033980-XReport Type:Periodic Company Report #US97094846A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Haldol C Prozac C Depakote C Benadryl C Date:11/03/97ISR Number: 3033984-7Report Type:Periodic Company Report #US97094852A Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 15.00 MG Liver Function Test Professional DAILY PO Abnormal Amitriptyline C Hydrochlorothiazide With Triamterene C Premarin C Date:11/03/97ISR Number: 3033987-2Report Type:Periodic Company Report #US97094864A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3033989-6Report Type:Periodic Company Report #US97094870A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Complications Of Maternal Health Zyprexa PS ORAL 10.00 MG Exposure To Therapeutic Professional DAILYPO 2 MON Drugs Depakote C No Adverse Drug Effect Zoloft C Cogentin C Date:11/03/97ISR Number: 3033992-6Report Type:Periodic Company Report #US97094873A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chromaturia Health Zyprexa PS Pyrexia Professional Company Representative Date:11/03/97ISR Number: 3033995-1Report Type:Periodic Company Report #US97094882A Age:38 YR Gender:Male I/FU:I Outcome PT Delusional Disorder, Unspecified Type Drug Ineffective Hallucination Hypomania 24-Jun-2005 12:19 PM Page: 94 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 10.00 MG Professional 2/DAY PO Prolixin Decanoate C Prolixin C Klonopin C Date:11/03/97ISR Number: 3033998-7Report Type:Periodic Company Report #US97094894A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS ORAL 10.00 MG Pre-Existing Condition Professional DAILY PO 5 MON Improved Luvox C Weight Increased Tenex C Seldane C Propulsid C Prosom C Xanax C Anticholinergics C Date:11/03/97ISR Number: 3034001-5Report Type:Periodic Company Report #US97094900A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Psychiatric Symptom Professional Depakote C Date:11/03/97ISR Number: 3034003-9Report Type:Periodic Company Report #US97094906A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034006-4Report Type:Periodic Company Report #US97095074A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034010-6Report Type:Periodic Company Report #US97095077A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional 24-Jun-2005 12:19 PM Page: 95 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034012-XReport Type:Periodic Company Report #US97095080A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Of Relaxation Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Zestril C Aspirin C Date:11/03/97ISR Number: 3034014-3Report Type:Periodic Company Report #US97095083A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034016-7Report Type:Periodic Company Report #US97095101A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034017-9Report Type:Periodic Company Report #US97095104A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034019-2Report Type:Periodic Company Report #US97095107A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034098-2Report Type:Periodic Company Report #US97084921A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS ORAL 10.00 MG PO 6 MON Professional Trazodone C Company Prozac C Representative Date:11/03/97ISR Number: 3034099-4Report Type:Periodic Company Report #US97084924A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS 10.00 MG Professional Stelazine C Company Representative 24-Jun-2005 12:19 PM Page: 96 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034100-8Report Type:Periodic Company Report #US97084936A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10.00 MG Weight Increased DAILY PO 1 MON Zoloft C Ativan C Date:11/03/97ISR Number: 3034101-XReport Type:Periodic Company Report #US97084939A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Zyprexa PS ORAL 15.00 MG Hallucination, Auditory Health DAILY PO Professional Mellaril C Cogentin C Larazepam C Date:11/03/97ISR Number: 3034102-1Report Type:Periodic Company Report #US97084945A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 2 WK Zoloft C Cogentin C Depakote C Date:11/03/97ISR Number: 3034103-3Report Type:Periodic Company Report #US97084993A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Health Zyprexa PS ORAL 10.00 MG Malaise Professional DAILY PO Nausea Company Depakote C Representative Date:11/03/97ISR Number: 3034104-5Report Type:Periodic Company Report #US97085014A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3034105-7Report Type:Periodic Company Report #US97085017A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Cogentin C 24-Jun-2005 12:19 PM Page: 97 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034106-9Report Type:Periodic Company Report #US97085029A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Zyprexa PS ORAL 10.00 MG Myalgia Health DAILY PO Pain Professional Nadolol C Weight Increased Estrogen C Medroxyprogesterone C Trihexyphenidyl C Fluoxetine C Date:11/03/97ISR Number: 3034107-0Report Type:Periodic Company Report #US97085041A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 15.00 MG Swelling Professional DAILY PO Trilafon C Propranolol C Artane C Prozac C Ativan C Date:11/03/97ISR Number: 3034108-2Report Type:Periodic Company Report #US97085104A Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Enuresis Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Ativan C Date:11/03/97ISR Number: 3034109-4Report Type:Periodic Company Report #US97085113A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Enuresis Other Zyprexa PS ORAL 10.00 MG DAILY PO Paxil C Depakote C Doxepin C Klonopin C Thyroid C Date:11/03/97ISR Number: 3034110-0Report Type:Periodic Company Report #US97085116A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Health Zyprexa PS ORAL 5.00 MG Drug Interaction Professional DAILY PO 4 DAY Extrapyramidal Disorder Sinemet C Fall Depakote C Gait Disturbance Haldol C Hypotension 24-Jun-2005 12:19 PM Page: 98 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034112-4Report Type:Periodic Company Report #US97085122A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3034113-6Report Type:Periodic Company Report #US97085125A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa PS ORAL 10.00 MG Mydriasis Professional 2/DAY PO Paxil C Cogentin C Advil C Date:11/03/97ISR Number: 3034114-8Report Type:Periodic Company Report #US97085134A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 10.00 MG Abnormal Professional DAILY PO Metamucil C Cleocin T C Retin A C Date:11/03/97ISR Number: 3034115-XReport Type:Periodic Company Report #US97085137A Age:70 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS Drug Ineffective Professional Pyrexia Sweating Fever Tremor Date:11/03/97ISR Number: 3034116-1Report Type:Periodic Company Report #US97085143A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Function Abnormal Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034117-3Report Type:Periodic Company Report #US97085152A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blister Consumer Zyprexa PS ORAL 5.00 MG DAILY Dermatitis Health PO Eye Irritation Professional Xanax C Headache Malaise Rhinorrhoea 24-Jun-2005 12:19 PM Page: 99 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034119-7Report Type:Periodic Company Report #US97085161A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 20.00 MG Oedema Peripheral Professional DAILY PO Depakote C Diazepam C Date:11/03/97ISR Number: 3034120-3Report Type:Periodic Company Report #US97085191A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034122-7Report Type:Periodic Company Report #US97085197A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034124-0Report Type:Periodic Company Report #US97085200A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034126-4Report Type:Periodic Company Report #US97085203A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034129-XReport Type:Periodic Company Report #US97085287A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa PS ORAL 7.50 MG DAILY PO 2 MON Date:11/03/97ISR Number: 3034131-8Report Type:Periodic Company Report #US97085293A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS ORAL 10.00 MG Oedema Peripheral Professional DAILY PO Depakote C Klonopin C 24-Jun-2005 12:19 PM Page: 100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034133-1Report Type:Periodic Company Report #US97085299A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Consumer Zyprexa PS ORAL 5.00 MG DAILY Posture Abnormal Health PO 1 WK Professional Sinemet C Date:11/03/97ISR Number: 3034134-3Report Type:Periodic Company Report #US97085305A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO 1 MON Professional Date:11/03/97ISR Number: 3034136-7Report Type:Periodic Company Report #US97085311A Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS 10.00 MG UNK 1 MON Tardive Dyskinesia Professional Company Representative Date:11/03/97ISR Number: 3034138-0Report Type:Periodic Company Report #US97085314A Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa PS 10.00 MG UNK 2 MON Professional Company Representative Date:11/03/97ISR Number: 3034140-9Report Type:Periodic Company Report #US97090229A Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eyelid Function Disorder Consumer Zyprexa PS ORAL 15.00 MG Movement Disorder Health DAILY PO Nasal Discomfort Professional Date:11/03/97ISR Number: 3034142-2Report Type:Periodic Company Report #US97090466A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS 2 WK Professional Depakote C Company Zoloft C Representative 24-Jun-2005 12:19 PM Page: 101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034144-6Report Type:Periodic Company Report #US97090637A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Malaise Health Zyprexa PS ORAL 5.00 MG UNK Medication Error Professional PO Date:11/03/97ISR Number: 3034147-1Report Type:Periodic Company Report #US97090826A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Health Zyprexa PS 5.00 UNK Professional Date:11/03/97ISR Number: 3034149-5Report Type:Periodic Company Report #US97090835A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Health Zyprexa PS 5.00 UNK Professional Date:11/03/97ISR Number: 3034151-3Report Type:Periodic Company Report #US97090838A Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Health Zyprexa PS ORAL 2.50 MG UNK Professional PO Date:11/03/97ISR Number: 3034153-7Report Type:Periodic Company Report #US97090841A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Health Zyprexa PS 5.00 UNK Professional Date:11/03/97ISR Number: 3034156-2Report Type:Periodic Company Report #US97090844A Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Health Zyprexa PS ORAL 20.00 UNK PO Professional Date:11/03/97ISR Number: 3034158-6Report Type:Periodic Company Report #US97094810A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034161-6Report Type:Periodic Company Report #US97094789A Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 24-Jun-2005 12:19 PM Page: 102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Lithium C Effexor C Buspar C Date:11/03/97ISR Number: 3034165-3Report Type:Periodic Company Report #US97094828A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 20.00 MG Liver Function Test Professional DAILY PO Abnormal Depakote C Buspar C Zoloft C Glucotrol C Date:11/03/97ISR Number: 3034168-9Report Type:Periodic Company Report #US97094837A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Paxil C Depakote C L-Thyroxine C Date:11/03/97ISR Number: 3034171-9Report Type:Periodic Company Report #US97094819A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 5.00 MG DAILY Liver Function Test Professional PO Abnormal Lithuim Carbonate C Cogentin C Vitamin E C Date:11/03/97ISR Number: 3034173-2Report Type:Periodic Company Report #US97093541A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS ORAL 20.00 MG DAILY PO Date:11/03/97ISR Number: 3034177-XReport Type:Periodic Company Report #US97093544A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Consumer Zyprexa PS 10.00 MG Dizziness DAILY UNK Nausea Cozaar C Palpitations Lozol C Vision Blurred K-Dur C Lescol C Fosamax C Paxil C 24-Jun-2005 12:19 PM Page: 103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034564-XReport Type:Periodic Company Report #US97065587A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Professional PO 1 MON Company Representative Date:11/03/97ISR Number: 3034568-7Report Type:Periodic Company Report #US97065620A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Hyperglycaemia Professional PO 3 MON Lethargy Company Representative Date:11/03/97ISR Number: 3035318-0Report Type:Periodic Company Report #US97070103A Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Health Zyprexa PS ORAL 25 MG DAILY Sedation Professional PO Date:11/03/97ISR Number: 3035320-9Report Type:Periodic Company Report #US96120745A Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Health Zyprexa PS UNKNOWN 10.00 MG Decreased Professional Florinef C White Blood Cell Count Company Xanax C Decreased Representative Tenormin C Prozac C Imdur C Synthroid C Premarin C Provera C Prinivil C Date:11/03/97ISR Number: 3035322-2Report Type:Periodic Company Report #US96121660A Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lymphocyte Count Health Zyprexa PS ORAL 10.00 MG Increased Professional 2/DAY PO 4 DAY Neutropenia Sodium Valproate C Date:11/03/97ISR Number: 3035325-8Report Type:Periodic Company Report #US96122131A Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 24-Jun-2005 12:19 PM Page: 104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035327-1Report Type:Periodic Company Report #US96123949A Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Zyprexa PS ORAL 20.00 MG White Blood Cell Count Professional DAILY PO Decreased Clozaril C Depakote C Date:11/03/97ISR Number: 3035330-1Report Type:Periodic Company Report #US97011504A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 MON Date:11/03/97ISR Number: 3035332-5Report Type:Periodic Company Report #US97014924A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa PS Professional Clozaril C Company Depakote C Representative Cogentin C Date:11/03/97ISR Number: 3035333-7Report Type:Periodic Company Report #US97015014A Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa PS ORAL 10.00 MG Decreased Professional DAILY PO Company Clonazepam C Representative Valproate Sodium C Lithium C Ssri C Date:11/03/97ISR Number: 3035335-0Report Type:Periodic Company Report #US97020985A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Abnormal Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 2 MON Company Buspar C Representative Date:11/03/97ISR Number: 3035337-4Report Type:Periodic Company Report #US97023181A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 20.00 MG Neutropenia Professional DAILY PO White Blood Cell Count Company Artane C Decreased Representative Trimethoprim C Ascorbic Acid C Ferrous Sulfate C Levothyroxine C Risperidone C 24-Jun-2005 12:19 PM Page: 105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Humulin R C Date:11/03/97ISR Number: 3035339-8Report Type:Periodic Company Report #US97030610A Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Health Zyprexa PS ORAL 10.00 MG Decreased Professional DAILY PO White Blood Cell Count Depakote C Decreased Ativan C Date:11/03/97ISR Number: 3035342-8Report Type:Periodic Company Report #US97031204A Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS 10.00 MG Professional DAILY Company Haldol C Representative Benztropine C Depakote C Thioridazine C Date:11/03/97ISR Number: 3035344-1Report Type:Periodic Company Report #US97032989A Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS 5.00 MG Platelet Count Decreased Professional Depakote C White Blood Cell Count Decreased Date:11/03/97ISR Number: 3035345-3Report Type:Periodic Company Report #US97034036A Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS ORAL 5.00 MG DAILY White Blood Cell Count Professional PO Decreased Valproic Acid C Lithium C Date:11/03/97ISR Number: 3035346-5Report Type:Periodic Company Report #US97035347A Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Prozac C Representative Depakote C Date:11/03/97ISR Number: 3035347-7Report Type:Periodic Company Report #US97035374A Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Blood Pressure Increased Health Professional 24-Jun-2005 12:19 PM Page: 106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL PO Depakote C Trazodone C Orthocept C Symmetrel C Date:11/03/97ISR Number: 3035348-9Report Type:Periodic Company Report #US97035575A Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Below Health Zyprexa PS Therapeutic Professional Carbamazepine C Date:11/03/97ISR Number: 3035350-7Report Type:Periodic Company Report #US97035989A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS 20.00 MG Neutropenia Professional DAILY Company Lorazepam C Representative Thiothixene C Trihexyphenidyl C Date:11/03/97ISR Number: 3035352-0Report Type:Periodic Company Report #US97040817A Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS ORAL 20.00 MG Phosphokinase Increased Professional DAILY PO Blood Lactate Other Dehydrogenase Increased Diarrhoea Liver Function Test Abnormal Pyrexia Date:11/03/97ISR Number: 3035354-4Report Type:Periodic Company Report #US97043247A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Autoimmune Disorder Health Zyprexa PS ORAL 15.00 MG Platelet Count Abnormal Professional DAILY PO Company Haldol C Representative Cogentin C Colace C Benadryl C Date:11/03/97ISR Number: 3035357-XReport Type:Periodic Company Report #US97044495A Age:88 YR Gender:Female I/FU:F Outcome PT Report Source White Blood Cell Count Health Decreased Professional 24-Jun-2005 12:19 PM Page: 107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 10.00 MG DAILY PO Zantac C Digoxin C Cardizem Cd C Trazodone C Ativan C Risperdal C Colace C Date:11/03/97ISR Number: 3035359-3Report Type:Periodic Company Report #US97044624A Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS ORAL 10.00 MG Extrapyramidal Disorder Professional DAILY PO Muscle Spasms Company Eskalith C Representative Prozac C Trazodone C Risperdal C Date:11/03/97ISR Number: 3035361-1Report Type:Periodic Company Report #US97045263A Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperprolactinaemia Health Zyprexa PS ORAL 20.00 MG Mania Professional DAILY PO Company Valproic Acid C Representative Clonazepam C Vitamin E C Amantadine C Date:11/03/97ISR Number: 3035363-5Report Type:Periodic Company Report #US97045797A Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Health Zyprexa PS ORAL 5.00 MG DAILY Haemoglobin Decreased Professional PO Platelet Count Decreased White Blood Cell Count Decreased Date:11/03/97ISR Number: 3035365-9Report Type:Periodic Company Report #US97046298A Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS Phosphokinase Increased Professional Neuroleptic Malignant Company Syndrome Representative 24-Jun-2005 12:19 PM Page: 108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035366-0Report Type:Periodic Company Report #US97046331A Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Health Zyprexa PS ORAL 10.00 MG Irritability Professional DAILY PO Libido Increased Company Anafranil C Mania Representative Dioctyl Sodium Psychomotor Hyperactivity Sulfosuccinate C Cogentin C Klonopin C Depakote C Date:11/03/97ISR Number: 3035368-4Report Type:Periodic Company Report #US97050652A Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 10.00 MG Liver Function Test Professional DAILY PO Abnormal Depakote C Date:11/03/97ISR Number: 3035369-6Report Type:Periodic Company Report #US97051819A Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Zyprexa PS ORAL 10.00 MG Glaucoma DAILY PO Headache Prednisone C Heart Rate Increased Nasacort C Insomnia Medication Error Nausea Sedation Tremor Vision Blurred Vomiting Date:11/03/97ISR Number: 3035371-4Report Type:Periodic Company Report #US97052455A Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS ORAL 15 MG DAILY Systemic Lupus Professional PO Erythematosus Rash Depakote C Thrombocytopenia Aspirin C Date:11/03/97ISR Number: 3035373-8Report Type:Periodic Company Report #US97053790A Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa PS ORAL 10 MG DAILY White Blood Cell Count Professional PO Decreased Cogentin C Inderal C Loxitane C Depakote C 24-Jun-2005 12:19 PM Page: 109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035375-1Report Type:Periodic Company Report #US97055206A Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Felbatol C Lorazepam C Date:11/03/97ISR Number: 3035376-3Report Type:Periodic Company Report #US97060469A Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Company Dilantin C Representative Valium C Doxepin C Lorazepam C Septra C Thiothixene C Phenazopyridine C Date:11/03/97ISR Number: 3035378-7Report Type:Periodic Company Report #US97060949A Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Depakote C Representative Date:11/03/97ISR Number: 3035379-9Report Type:Periodic Company Report #US97061684A Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Robinul C Neostigmine C Atropine C Diprivan C Forane C Fentanyl C Succinylcholine Chloride C Cisatracurium C Glyburide C Lithium C Synthroid C Date:11/03/97ISR Number: 3035381-7Report Type:Periodic Company Report #US97061738A Age: Gender:Female I/FU:F Outcome PT Report Source Anaemia Health Leukopenia Professional Company 24-Jun-2005 12:19 PM Page: 110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 5.00 MG DAILY PO Date:11/03/97ISR Number: 3035383-0Report Type:Periodic Company Report #US97063280A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 10 MG DAILY Potentiation Professional PO Lithium C Depakote C Mellaril C Date:11/03/97ISR Number: 3035384-2Report Type:Periodic Company Report #US97063295A Age:11 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Polydipsia Health Zyprexa PS ORAL 7.5 MG DAILY Polyuria Professional PO 8 WK Lamictal C Risperdal C Date:11/03/97ISR Number: 3035385-4Report Type:Periodic Company Report #US97065122A Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Health Zyprexa PS ORAL 15.00 MG Alanine Aminotransferase Professional DAILY PO Increased Depakote C Aspartate Zoloft C Aminotransferase Thorazine C Increased Blood Lactate Dehydrogenase Increased Drug Interaction Gamma-Glutamyltransferase Increased Liver Function Test Abnormal Weight Increased Date:11/03/97ISR Number: 3035386-6Report Type:Periodic Company Report #US97065602A Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Health Zyprexa PS ORAL 10 MG DAILY Sleep Disorder Professional PO Clozaril C 24-Jun-2005 12:19 PM Page: 111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035387-8Report Type:Periodic Company Report #US97070130A Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS ORAL 7.5 MG DAILY Phosphokinase Increased Professional PO 1 WK Muscle Rigidity Depakote C Pyrexia Digoxin C White Blood Cell Count Lasix C Increased Potassium C Coumadin C Date:11/03/97ISR Number: 3035388-XReport Type:Periodic Company Report #US97070151A Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa PS 10 MG DAILY 2 DAY Syndrome Professional Date:11/03/97ISR Number: 3035389-1Report Type:Periodic Company Report #US97070163A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS 10 MG DAILY Abnormal Professional Valproate Sodium C Date:11/03/97ISR Number: 3035391-XReport Type:Periodic Company Report #US97070190A Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15 MG DAILY Professional PO 2 WK Depakote C Zoloft C Date:11/03/97ISR Number: 3035392-1Report Type:Periodic Company Report #US97070202A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL 5.00 MG DAILY Early Morning Awakening Professional PO 2 MON Swelling Company Effexor C Representative Date:11/03/97ISR Number: 3035393-3Report Type:Periodic Company Report #US97070319A Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional Clozaril C Phenobarbital C 24-Jun-2005 12:19 PM Page: 112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035394-5Report Type:Periodic Company Report #US97070340A Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS 5.00 MG DAILY 3 WK Abnormal Professional Date:11/03/97ISR Number: 3035395-7Report Type:Periodic Company Report #US97070343A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO 1 MON Professional Nardil C Premarin C Date:11/03/97ISR Number: 3035396-9Report Type:Periodic Company Report #US97070346A Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS 10.00 MG Liver Function Test Professional DAILY 2 WK Abnormal Date:11/03/97ISR Number: 3035397-0Report Type:Periodic Company Report #US97070355A Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS 7.5 MG DAILY Phosphokinase Increased Professional Influenza Liver Function Test Abnormal Date:11/03/97ISR Number: 3035398-2Report Type:Periodic Company Report #US97070466A Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL 7.5 MG DAILY Dry Skin Professional PO 6 MON Oedema Date:11/03/97ISR Number: 3035399-4Report Type:Periodic Company Report #US97070547A Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS Professional Lithium C Other Date:11/03/97ISR Number: 3035401-XReport Type:Periodic Company Report #US97070562A Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional 24-Jun-2005 12:19 PM Page: 113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035402-1Report Type:Periodic Company Report #US97070568A Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Swelling Health Zyprexa PS ORAL 5.00 MG DAILY Pain Professional PO 4 MON Buspar C Date:11/03/97ISR Number: 3035404-5Report Type:Periodic Company Report #US97070583A Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Other Zyprexa PS Prozac SS Date:11/03/97ISR Number: 3035406-9Report Type:Periodic Company Report #US97070604A Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Consumer Zyprexa PS ORAL 5.00 MG DAILY Glaucoma Health PO Professional Glyburide C Synthroid C Coumadin C Date:11/03/97ISR Number: 3035407-0Report Type:Periodic Company Report #US97070607A Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Myalgia Health Zyprexa PS ORAL 5 MG DAILY PO 1 MON Professional Coumadin C Trihexin C Lithobid C Propranolol C Date:11/03/97ISR Number: 3035409-4Report Type:Periodic Company Report #US97070613A Age:9 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS ORAL 5 MG 2/DAY 2 MON Enuresis Professional Hypersomnia Medication Error Sedation Vitamin A Deficiency Date:11/03/97ISR Number: 3035412-4Report Type:Periodic Company Report #US97070619A Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatitis Health Zyprexa PS ORAL 5 MG DAILY PO 2 WK Jaundice Professional Thyroxin C Company Representative 24-Jun-2005 12:19 PM Page: 114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3035414-8Report Type:Periodic Company Report #US97070622A Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 5 MG DAILY PO Professional Date:11/03/97ISR Number: 3035417-3Report Type:Periodic Company Report #US97070631A Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS ORAL 10 MG DAILY Professional PO Prozac C Date:11/03/97ISR Number: 3035419-7Report Type:Periodic Company Report #US97070658A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS Professional Depakote C Company Representative Date:11/03/97ISR Number: 3035422-7Report Type:Periodic Company Report #US97070685A Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL 20 MG DAILY Professional PO Date:11/03/97ISR Number: 3055445-1Report Type:Periodic Company Report #US97065584A Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Agitation Professional PO Company Representative Date:11/04/97ISR Number: 3028833-7Report Type:Periodic Company Report #US97080952A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Study Zyprexa PS ORAL 5 MG DAILY PO Initial or Prolonged Hip Fracture Health Dilantin C Other Professional Enalapril C Digoxin C Cefazolin C Levofloxacin C Demerol C 24-Jun-2005 12:19 PM Page: 115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/97ISR Number: 3028835-0Report Type:Periodic Company Report #US97073049A Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Ecchymosis Health DAILY PO Fall Professional Risperdal C Gait Disturbance Schizophrenia C Sedation Multivitamin C Syncope Risperdal C Date:11/04/97ISR Number: 3028838-6Report Type:Periodic Company Report #US97074810A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Health DAILY PO Professional Date:11/06/97ISR Number: 3005698-0Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Olanzapine PS 15MG QHS Valproic Acid SS 1500 MG BID Lorazepam C Tetanus Toxiod C Benztropine C Date:11/10/97ISR Number: 100000202Report Type:Expedited (15-DaCompany Report #US97105689A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Health Zyprexa PS Professional Droperidol C Date:11/10/97ISR Number: 100000202Report Type:Expedited (15-DaCompany Report #US97106025A Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS ORAL 5MG DAILY PO Professional Ciprofloxacin C ORAL 500MG 2/DAY PO Haldol C 1MG PO Date:11/10/97ISR Number: 100000202Report Type:Expedited (15-DaCompany Report #US97106061A Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypotension Health Zyprexa PS 10MG DAILY Hospitalization - Professional Carbidopa C ORAL 25MG 2/DAY PO Initial or Prolonged Levodopa C ORAL 250MG 2/D PO 24-Jun-2005 12:19 PM Page: 116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/97ISR Number: 100000226Report Type:Expedited (15-DaCompany Report #GB97105638A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 20.00 MG Initial or Prolonged Phosphokinase Increased Health Procyclidine Depressed Level Of Professional Hydrochloride C 10.00 MG; Consciousness 2/DAY Drug Interaction Chlormethiazole C 2.00 TABLETS Neuroleptic Malignant Clozapine C 12.50 MG Syndrome Pyrexia Tachycardia Date:11/10/97ISR Number: 100000226Report Type:Expedited (15-DaCompany Report #GB97103901A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS ORAL 20.00 MG Initial or Prolonged Tardive Dyskinesia Health DAILY PO Professional Trifluoperazine C ORAL 5.00 MG Other 2/DAY PO Procyclidine C ORAL 5.00 MG UNK/D PO Haloperidol Decanoate C Aspirin C ORAL 150 MG UNK/D PO Atenolol C ORAL 25.00 MG 1/D PO Zopiclone C ORAL 7.50 MG UNK/D PO Date:11/10/97ISR Number: 100000226Report Type:Expedited (15-DaCompany Report #DK97105716A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS 15.00 MG Initial or Prolonged Neutropenia Health Cisordinol C 6.00 MG Professional UNKNOWN Date:11/10/97ISR Number: 100000226Report Type:Expedited (15-DaCompany Report #ES97105755A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS Health Risperdal C Professional Idalprem C Benzodiazepine C Date:11/10/97ISR Number: 100000226Report Type:Expedited (15-DaCompany Report #BR97105686A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colour Vision Tests Foreign Zyprexa PS ORAL 30.00 MG Abnormal 3/DAY PO 45 DAY Lethargy Chlorpromazine C 24-Jun-2005 12:19 PM Page: 117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/97ISR Number: 100000227Report Type:Expedited (15-DaCompany Report #AU97105278A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS UNK Sudden Death Other Verapamil C Date:11/10/97ISR Number: 3000107-XReport Type:Expedited (15-DaCompany Report #CA97062959A Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS ORAL 20.00 MG Initial or Prolonged Flushing Health DAILY Pain In Extremity Professional Vasodilatation Date:11/10/97ISR Number: 3000116-0Report Type:Expedited (15-DaCompany Report #USA97100640 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Zyprexa PS ORAL 10.00 MG Hospitalization - Professional DAILY PO Initial or Prolonged Company Moban C Representative Klonopin C Date:11/10/97ISR Number: 3000126-3Report Type:Expedited (15-DaCompany Report #F197051042A Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Zyprexa PS ORAL 5.00 MG DAILY Life-Threatening Lung Neoplasm Malignant Health PO Hospitalization - Muscle Rigidity Professional Suprium C Initial or Prolonged Neuroleptic Malignant Effortil C Syndrome Aktipar C Parkinsonism Eldepryl C Pneumonia Pyrexia Date:11/10/97ISR Number: 3000129-9Report Type:Expedited (15-DaCompany Report #ES97103274A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa PS ORAL 10.00 MG Hospitalization - Phosphokinase Increased Health DAILYPO Initial or Prolonged Confusional State Professional Imipramine C Depressed Level Of Sertraline C Consciousness Disseminated Intravascular Coagulation Hyperhidrosis Hypertension Hypotension Multi-Organ Failure Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia 24-Jun-2005 12:19 PM Page: 118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/97ISR Number: 3005747-XReport Type:Direct Company Report # Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Olanzapine PS 10 MG QD 2 WK Initial or Prolonged Dysphagia Atenolol C Weight Decreased Colace C Lovastatin C Buspar C Date:11/17/97ISR Number: 3000744-2Report Type:Expedited (15-DaCompany Report #US97110952A Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Erythematous Health Zyprexa PS ORAL 5.00 MG DAILY Rash Generalised Professional PO Luvox C Cogentin C 1.00 MG 2/D Buspar C 10.00 MG 3/D Paxil C 20.00 MG 1/D Date:11/17/97ISR Number: 3000746-6Report Type:Expedited (15-DaCompany Report #US97106787A Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Zyprexa PS ORAL 5.00 MG 2/DAY Initial or Prolonged Medication Error Professional PO Platelet Count Decreased Bactrim Ds C Thrombocytopenia Risperdal C Date:11/17/97ISR Number: 3000748-XReport Type:Expedited (15-DaCompany Report #US97106181A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa PS ORAL 10.00 MG Initial or Prolonged Blindness Health DAILY PO Other Confusional State Professional Depakote C Deafness Diabetes Mellitus Hepatitis Hyperglycaemia Hypothyroidism Insomnia Memory Impairment Nephritis Pancreatic Insufficiency Pollakiuria Thirst Weight Decreased Date:11/17/97ISR Number: 3000749-1Report Type:Expedited (15-DaCompany Report #CA97106220A Age:24 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Zyprexa PS ORAL 40.00 MG Initial or Prolonged Sedation Health /UNK/PO Other Professional 24-Jun-2005 12:19 PM Page: 119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/97ISR Number: 3000750-8Report Type:Expedited (15-DaCompany Report #US97111288A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS UNK Initial or Prolonged Phosphokinase Increased Professional Wellbutrin C Body Temperature Company Lithium C Increased Representative Depakote C Hypertonia Cytomel C Neuroleptic Malignant Trilafon C Syndrome Date:11/17/97ISR Number: 3000989-1Report Type:Expedited (15-DaCompany Report #DE97104828A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Zyprexa PS ORAL 30.00 MG Health DAILY PO Professional Melleril C 75.00 MG DAILY Date:11/17/97ISR Number: 3000990-8Report Type:Expedited (15-DaCompany Report #DE97106307A Age:12 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa PS UNK Initial or Prolonged Exposure To Therapeutic Health Drugs Professional Convulsion Date:11/17/97ISR Number: 3001236-7Report Type:Expedited (15-DaCompany Report #US97100640A Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening White Blood Cell Count Health Zyprexa PS ORAL 10.00 MG Hospitalization - Decreased Professional DAILY PO Initial or Prolonged Company Moban C Representative Date:11/17/97ISR Number: 3001237-9Report Type:Expedited (15-DaCompany Report #GB97103619A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 20.00 MG Stress Health DAILY PO Professional Fluoxetine C ORAL 40.00 MG Company DAILY PO Representative Date:11/17/97ISR Number: 3001239-2Report Type:Expedited (15-DaCompany Report #GB97103901A Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zyprexa PS ORAL 20.00 MG Initial or Prolonged Tardive Dyskinesia Health DAILY PO Professional Trifluoperazine C Other Procyclidine C 24-Jun-2005 12:19 PM Page: 120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haloperidol C Aspirin C Atenolol C Zopiclone C Date:11/17/97ISR Number: 3001243-4Report Type:Expedited (15-DaCompany Report #DE97084396A Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Foreign Zyprexa PS ORAL 40.00 MG Coma Health DAILY PO Professional Isoket Retard C 20.00 MG DAILY UNK Euglucon C Glucobay C ORAL 400.00 MG UNK/D PO Date:11/17/97ISR Number: 3005717-1Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drooling Zyprexa PS ORAL PO 5MG BID + Intervention to Dysphagia 10 MG HS Prevent Permanent Face Oedema Lithium C Impairment/Damage Glossitis Valproic Acid C Klonopin C Navane C Date:11/17/97ISR Number: 3005794-8Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Zyprexa PS ORAL 10MG EVERYDAY 1 MON Neurontin C Premarin C Klonopin C Date:11/17/97ISR Number: 3006050-4Report Type:Direct Company Report # Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Olanzapine PS ORAL PO Lamotrigine C Date:11/17/97ISR Number: 3031425-7Report Type:Expedited (15-DaCompany Report #US98021327A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Zyprexa PS Professional Company Representative Other 24-Jun-2005 12:19 PM Page: 121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/97ISR Number: 3005965-0Report Type:Direct Company Report # Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Olanzapine PS Lilly ORAL 5 MG PO Initial or Prolonged Sedation Ritalin C Luvox C Oxybutinin C Carbamazepine C Respiradone C Ddavp C Date:11/20/97ISR Number: 3006036-XReport Type:Direct Company Report # Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clonazepam PS Initial or Prolonged Depressed Level Of Professional Amlodipine SS Consciousness Olanzapine SS Lethargy Overdose Respiratory Failure Date:11/21/97ISR Number: 3006527-1Report Type:Direct Company Report # Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aphasia Zyprexa PS ORAL 5MG PO DAILY Required Depressed Level Of Serzone C Intervention to Consciousness Cylert C Prevent Permanent Drug Withdrawal Syndrome Synthroid C Impairment/Damage Nausea Obsessive-Compulsive Disorder Water Intoxication Date:11/21/97ISR Number: 3007243-2Report Type:Expedited (15-DaCompany Report #US96121279A Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL Initial or Prolonged Phosphokinase Increased Professional Clonazepam C Blood Sodium Increased Diazepam C Neuroleptic Malignant Cephalosporin C C Syndrome Cipro C Ativa C Date:11/21/97ISR Number: 3007244-4Report Type:Expedited (15-DaCompany Report #GB97105968A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Bullous Foreign Zyprexa PS ORAL Initial or Prolonged Face Oedema Health Unknown C Hypersensitivity Professional 24-Jun-2005 12:19 PM Page: 122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/97ISR Number: 3007245-6Report Type:Expedited (15-DaCompany Report #GB97105638A Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS ORAL Initial or Prolonged Phosphokinase Increased Health Procyclidine Body Temperature Professional Hydrochloride C ORAL Increased Chlormethiazole C ORAL Depressed Level Of Clozapine C ORAL Consciousness Drug Interaction Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Tachycardia Vomiting Date:11/21/97ISR Number: 3007246-8Report Type:Expedited (15-DaCompany Report #US97061054A Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Health Zyprexa PS 5.OO MG DAILY Initial or Prolonged Confusional State Professional UNK 9 DAY Grand Mal Convulsion Company Prozac C Hyponatraemia Representative Effexor C Date:11/21/97ISR Number: 3007247-XReport Type:Expedited (15-DaCompany Report #US97044960A Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Zyprexa PS ORAL 10 MG/DAY PO Dermatitis Professional Depakote C Glomerulonephritis Company Klonopin C ORAL Proliferative Representative Trilafon C Hypersensitivity Hypertension Nephrotic Syndrome Oedema Peripheral Renal Failure Swelling Weight Increased Date:11/21/97ISR Number: 3007248-1Report Type:Expedited (15-DaCompany Report #US97104963A Age:6 WK Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS 28 WK Cardiac Murmur Professional Complications Of Maternal Exposure To Therapeutic Drugs Sudden Infant Death Syndrome 24-Jun-2005 12:19 PM Page: 123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/97ISR Number: 3007249-3Report Type:Expedited (15-DaCompany Report #US97110952A Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Multiforme Health Zyprexa PS ORAL 5.00 MG Professional DAILY PO Luvox C Cogentin C Buspar C Paxil C Date:11/21/97ISR Number: 3007435-2Report Type:Expedited (15-DaCompany Report #CA97053163A Age:17 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lethargy Foreign Zyprexa PS ORAL 100 MG (10 Hospitalization - Overdose Health 10MG TABS) - Initial or Prolonged Professional OVERDOSE 1 DAY Other Other Date:11/25/97ISR Number: 3002351-4Report Type:Expedited (15-DaCompany Report #US97112359A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Health Zyprexa PS ORAL 3 WK Initial or Prolonged Leukopenia Professional Unknown C Platelet Count Abnormal Platelet Count Decreased Pyrexia Splenomegaly Date:11/25/97ISR Number: 3002352-6Report Type:Expedited (15-DaCompany Report #US97111609A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa PS ORAL 1 WK Initial or Prolonged Grand Mal Convulsion Professional Haldol C Tegretol C Depakote C Date:11/25/97ISR Number: 3002353-8Report Type:Expedited (15-DaCompany Report #US97111315A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS Professional Company Representative Date:11/25/97ISR Number: 3002986-9Report Type:Expedited (15-DaCompany Report #US97035614A Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Hyponatraemia Professional 2/DAY PO Water Intoxication Company Representative 24-Jun-2005 12:19 PM Page: 124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/97ISR Number: 3003477-1Report Type:Expedited (15-DaCompany Report #SI97112794A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Blood Creatine Professional DAILY PO Phosphokinase Increased Diazepam C Catatonia Fluphenazine C Haloperidol C Levomepromazine C Biperiden C Date:11/25/97ISR Number: 3003478-3Report Type:Expedited (15-DaCompany Report #CA97112086A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Zyprexa PS ORAL 5.00MG DAILY Platelet Count Decreased Health PO Pyrexia Professional Valproic Acid C White Blood Cell Count Cogentin C Decreased Tazocin C Date:11/25/97ISR Number: 3003480-1Report Type:Expedited (15-DaCompany Report #US97112521A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Health Zyprexa PS UNK 2 MON Obesity Professional Company Representative Date:11/25/97ISR Number: 3003549-1Report Type:Expedited (15-DaCompany Report #US97111321A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS ORAL 20.00 MG PO 5 MON Depression Professional Drug Ineffective Company Therapeutic Response Representative Unexpected Date:11/25/97ISR Number: 3003551-XReport Type:Expedited (15-DaCompany Report #US97112182A Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Zyprexa PS Initial or Prolonged Increased Professional Sertraline C Blood Urea Increased Company Coma Representative Liver Function Test Abnormal 24-Jun-2005 12:19 PM Page: 125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/97ISR Number: 3002980-8Report Type:Expedited (15-DaCompany Report #IT97103688A Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Musculoskeletal Stiffness Foreign Zyprexa PS ORAL 10.00MG DAILY Initial or Prolonged Pneumonia Health PO Pyrexia Professional Depakine C Stupor Tavor C Microren C Na C Date:11/26/97ISR Number: 3002983-3Report Type:Expedited (15-DaCompany Report #CA97106220A Age:24 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Zyprexa PS 40.00MG PO Initial or Prolonged Sedation Health Other Professional Date:11/26/97ISR Number: 3002984-5Report Type:Expedited (15-DaCompany Report #CA97053163A Age:17 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Level Above Foreign Zyprexa PS ORAL 100.00 MG 1/ Hospitalization - Therapeutic Health PO 1 DAY Initial or Prolonged Lethargy Professional Other Overdose Date:11/26/97ISR Number: 3002989-4Report Type:Expedited (15-DaCompany Report #US97073019A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Lithium C Representative Cogentin C Date:11/26/97ISR Number: 3002991-2Report Type:Expedited (15-DaCompany Report #US97112182A Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Zyprexa PS UNKNOWN UNK Initial or Prolonged Increased Professional Sertraline C Aspartate Company Aminotransferase Representative Increased Blood Creatinine Increased Blood Urea Increased Coma Depressed Level Of Consciousness Liver Function Test Abnormal Renal Impairment 24-Jun-2005 12:19 PM Page: 126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/97ISR Number: 3006037-1Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Olanzapine PS C 4 #1 1 MON Date:12/01/97ISR Number: 3051266-4Report Type:Periodic Company Report #9718419 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Cardura PS ORAL 6.00 MG Professional TOTAL, DAILY, ORAL Olanzapine SS Lithium C Benzodiazepines C Date:12/02/97ISR Number: 3003848-3Report Type:Expedited (15-DaCompany Report #GB97110034A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 15 MG Initial or Prolonged Phosphokinase Increased Health Chlorpromazine C Hyperhidrosis Professional Procyclidine C Hypertension Company Clomipramine C Neuroleptic Malignant Representative Syndrome Pallor Personality Disorder Date:12/02/97ISR Number: 3003859-8Report Type:Expedited (15-DaCompany Report #US97062929A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Health Zyprexa PS ORAL 800.00 MG UNK Increased Professional PO Coordination Abnormal Disorientation Dysarthria Dystonia Intentional Misuse Pain Pyrexia Sedation Tachycardia Date:12/02/97ISR Number: 3003860-4Report Type:Expedited (15-DaCompany Report #US97105440A Age:17 YR Gender:Male I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Depressed Level Of Other Consciousness Hostility Miosis Nervousness Overdose Restlessness 24-Jun-2005 12:19 PM Page: 127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thinking Abnormal Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 500.00 MG 1/ Professional PO Ventolin C Depakote C Date:12/02/97ISR Number: 3003861-6Report Type:Expedited (15-DaCompany Report #US97114162A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Consumer Zyprexa PS ORAL 5.00 MG Initial or Prolonged Thromboplastin Time DAILY PO Prolonged Doxepin C Levothyroxine C Cogentin C Date:12/02/97ISR Number: 3003862-8Report Type:Expedited (15-DaCompany Report #US97113883A Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS 75.00 MG UNK Initial or Prolonged Professional UNK Lithium C Date:12/03/97ISR Number: 3004080-XReport Type:Expedited (15-DaCompany Report #DK97113259A Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Foreign Zyprexa PS ORAL 10.00 MG PO Health Oxazepam C Professional Clonazepam C Truxal C Orphenadrine C Date:12/03/97ISR Number: 3006684-7Report Type:Direct Company Report # Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Rigidity Olanzapine PS Lilly ORAL 20 MG Q HS PO Required Li2 Co3 C Intervention to Fluoxetine C Prevent Permanent Impairment/Damage Date:12/03/97ISR Number: 3007317-6Report Type:Direct Company Report # Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Zyprexa PS 5 MG 1QD Initial or Prolonged Dysphagia Zyprena SS 10MG 1QD Pyrexia Tongue Spasm 24-Jun-2005 12:19 PM Page: 128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/97ISR Number: 3002968-7Report Type:Expedited (15-DaCompany Report #DE97093301A Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Foreign Zyprexa PS ORAL 20.00 MG Hospitalization - Circulatory Collapse Health DAILY PO Initial or Prolonged Professional Diazepam C Haloperidol C Date:12/04/97ISR Number: 3002970-5Report Type:Expedited (15-DaCompany Report #DK97105716A Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Zyprexa PS 15.00 MG Initial or Prolonged Neutropenia Health Cisordinol C Professional Rivotril C Date:12/04/97ISR Number: 3002978-XReport Type:Expedited (15-DaCompany Report #FI97051042A Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa PS ORAL 5.00 MG DAILY Life-Threatening Phosphokinase Increased Health PO Hospitalization - Extrapyramidal Disorder Professional Suprium C Initial or Prolonged Hypertonia Effortil C Disability Lung Neoplasm Malignant Aktipar C Muscle Rigidity Eldepryl C Neuroleptic Malignant Syndrome Parkinsonism Pneumonia Pyrexia Date:12/04/97ISR Number: 3002979-1Report Type:Expedited (15-DaCompany Report #GB97105968A Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Shock Foreign Zyprexa PS ORAL 20.00 MG PO Initial or Prolonged Catatonia Health Dermatitis Bullous Professional Face Oedema Hypersensitivity Date:12/04/97ISR Number: 3002981-XReport Type:Expedited (15-DaCompany Report #CA97112086A Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Macrocytic Foreign Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Folate Deficiency Health PO Other Haemoglobin Decreased Professional Valproic Acid C Leukopenia Cogentin C Neutrophil Count Tazocin C Decreased Pancytopenia Pyrexia Reticulocyte Count Increased Thrombocytopenia 24-Jun-2005 12:19 PM Page: 129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/97ISR Number: 3007563-1Report Type:Direct Company Report # Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Olanzapine PS Lilly ORAL 5MG BID PO 8 MON Benztropine C Divalproex C Date:12/04/97ISR Number: 3007592-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Zyprexa PS Eli-Lilly 5 MG HS Tenex C Date:12/08/97ISR Number: 3004381-5Report Type:Expedited (15-DaCompany Report #ES97105755A Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Oedema Foreign Zyprexa PS ORAL UNK UNK Respiratory Failure Health PO Professional Risperdal C Idalprem C Benzodiazepine C Date:12/08/97ISR Number: 3004385-2Report Type:Expedited (15-DaCompany Report #US97112521A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Health Zyprexa PS 20.00 MG Professional DAILY 2 MON Company Representative Date:12/08/97ISR Number: 3004390-6Report Type:Expedited (15-DaCompany Report #US97111609A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Professional PO 1 WK Company Haldol C Representative Tegretol C Depakote C Date:12/08/97ISR Number: 3004392-XReport Type:Expedited (15-DaCompany Report #US97114162A Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Consumer Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Thromboplastin Time PO Prolonged Doxepin C Asthenia Levothyroxine C Dizziness Cogentin C Extrapyramidal Disorder Hyponatraemia 24-Jun-2005 12:19 PM Page: 130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/97ISR Number: 3004393-1Report Type:Expedited (15-DaCompany Report #US97106181A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zyprexa PS ORAL 10.00 MG Initial or Prolonged Blindness Health DAILY PO Confusional State Professional Depakote C Deafness Diabetes Mellitus Fatigue Hepatomegaly Hydronephrosis Hypothyroidism Insomnia Leukocytosis Memory Impairment Pancreatic Disorder Pollakiuria Proteinuria Renal Disorder Skin Papilloma Thirst Vision Blurred Visual Acuity Reduced Weight Decreased Date:12/08/97ISR Number: 3004394-3Report Type:Expedited (15-DaCompany Report #US97105197A Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lower Respiratory Tract Health Zyprexa PS 20.00 MG Infection Professional DAILY Pulmonary Fibrosis Haloperidol C Benadryl C Zoloft C Cogentin C Klonopin C Pravachol C Tenormin C Nitroglycerin C Buspar C Date:12/08/97ISR Number: 3004771-0Report Type:Expedited (15-DaCompany Report #GB97113169A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Foreign Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Prozac SS ORAL 60 MG DAILY Other PO Date:12/08/97ISR Number: 3004857-0Report Type:Expedited (15-DaCompany Report #IE97113664A Age: Gender:Female I/FU:I Outcome PT Report Source Other Neutropenia Foreign Health Professional Company 24-Jun-2005 12:19 PM Page: 131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS UNK Date:12/08/97ISR Number: 3004889-2Report Type:Expedited (15-DaCompany Report #DE97113979A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 5.00 MG UNK Health PO Professional Haloperidol C Trihexyphenidyl C Date:12/08/97ISR Number: 3004890-9Report Type:Expedited (15-DaCompany Report #GB97113169A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Foreign Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Prozac SS ORAL 60 MG DAILY PO Date:12/08/97ISR Number: 3004894-6Report Type:Expedited (15-DaCompany Report #US97114654A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS ORAL 20 MG DAILY Professional PO Dilantin C Date:12/08/97ISR Number: 3004899-5Report Type:Expedited (15-DaCompany Report #US97114645A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zyprexa PS ORAL 20 MG DAILY Professional PO Date:12/08/97ISR Number: 3004905-8Report Type:Expedited (15-DaCompany Report #US97114621A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Muscle Rigidity Health Zyprexa PS UNK Hospitalization - Neuroleptic Malignant Professional Prolixin C Initial or Prolonged Syndrome Ativan C Psychotic Disorder Cogentin C Pyrexia Tachycardia Date:12/08/97ISR Number: 3004907-1Report Type:Expedited (15-DaCompany Report #AU97114249A Age: Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Overdose Foreign Initial or Prolonged Health 24-Jun-2005 12:19 PM Page: 132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 240 MG DAILY PO Date:12/08/97ISR Number: 3018274-0Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Zyprexa PS Lilly ORAL 600 MG X 1 PO Initial or Prolonged Confusional State Liver Function Test Abnormal Overdose Sedation Date:12/11/97ISR Number: 3007329-2Report Type:Expedited (15-DaCompany Report #A001-002-001737 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Aricept PS Eisai, Inc. ORAL NA, PER ORAL Other Professional Zyprexa SS Date:12/11/97ISR Number: 3007339-5Report Type:Expedited (15-DaCompany Report #970902-SK889 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Calan PS ORAL 560.000 MG QD Other Professional PO 2 YR Olanzapine SS ORAL 5.000 MG BID PO 36 MON Date:12/11/97ISR Number: 3007635-1Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Olanzapine PS ORAL 2.5 MG QHD 1 WK Obsessive-Compulsive Fluvoxamine C Disorder Date:12/11/97ISR Number: 3007636-3Report Type:Direct Company Report # Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Rigidity Olanzapine PS Lilly ORAL 20 MG QHS PO Required Lithium Carbonate C Intervention to Fluoxetine C Prevent Permanent Impairment/Damage 24-Jun-2005 12:19 PM Page: 133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/97ISR Number: 3006836-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Olanzapine PS 10 MG BID QID Abnormal Valproic Acid SS 250 MG QID Phenytoin C Streptomycin C Haldol C Ampicillin C Diazepam C Ferrous Sulfate C Date:12/15/97ISR Number: 3008701-7Report Type:Expedited (15-DaCompany Report #GB97115389A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Zyprexa PS 7.50MG DAILY Health UNK Professional Date:12/15/97ISR Number: 3008709-1Report Type:Expedited (15-DaCompany Report #GB97115263A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS Eli Lilly And Initial or Prolonged Phosphokinase Increased Health Company 15.00 MG Body Temperature Professional Increased Convulsion Lower Respiratory Tract Infection Malaise Nervous System Disorder Neuroleptic Malignant Syndrome Pneumonia Date:12/15/97ISR Number: 3008714-5Report Type:Expedited (15-DaCompany Report #US97074021A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Consumer Zyprexa PS ORAL 10 MG DAILY Health Oxycodone C Professional Acetaminophen C Date:12/15/97ISR Number: 3008720-0Report Type:Expedited (15-DaCompany Report #DE97120985A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS ORAL 15.00 MG; Initial or Prolonged Colitis Health UNK/ PO Diarrhoea Professional Haloperidol C Faeces Discoloured Promethazine C Haemorrhage Diazepam C 24-Jun-2005 12:19 PM Page: 134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/97ISR Number: 3008722-4Report Type:Expedited (15-DaCompany Report #DE97115272A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Zyprexa PS ORAL 100.00 MG PO Initial or Prolonged Intentional Misuse Health Other Suicide Attempt Professional Date:12/15/97ISR Number: 3008725-XReport Type:Expedited (15-DaCompany Report #ES97072485A Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Encephalopathy Foreign Zyprexa PS ORAL 10.00 MG Hospitalization - Mental Disorder Due To A Health DAILY PO Initial or Prolonged General Medical Condition Professional Platelet Count Decreased Company Portal Hypertension Representative Sedation White Blood Cell Count Decreased Date:12/15/97ISR Number: 3008726-1Report Type:Expedited (15-DaCompany Report #AU97120622A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphopenia Foreign Zyprexa PS ORAL 35.00 MG Initial or Prolonged Thrombocytopenia Health DAILY PO Professional Haloperidol C Date:12/15/97ISR Number: 3008728-5Report Type:Expedited (15-DaCompany Report #US97120754A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocyte Count Health Zyprexa PS UNK Increased Professional Date:12/15/97ISR Number: 3008730-3Report Type:Expedited (15-DaCompany Report #US97120859A Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Other Zyprexa PS UNK. Initial or Prolonged Tylenol C Date:12/15/97ISR Number: 3008733-9Report Type:Expedited (15-DaCompany Report #US97120433A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Literature Zyprexa PS ORAL 200.00 MG UNK Initial or Prolonged Sinus Tachycardia PO Other 24-Jun-2005 12:19 PM Page: 135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/97ISR Number: 3008737-6Report Type:Expedited (15-DaCompany Report #US97120520A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Literature Zyprexa PS Initial or Prolonged Coma Health Amitriptyline C Other Therapeutic Agent Professional Lorazepam C Toxicity Depakote C Date:12/16/97ISR Number: 3008281-6Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Olanzapine PS ORAL 20 MG QHS PO (5MG ON 10/25/96 TITRATED UP TO 20 MG BY Buspar C Librium C Date:12/16/97ISR Number: 3008291-9Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Activated Partial Olanzapine PS 20/MG/D Thromboplastin Time Shortened Date:12/16/97ISR Number: 3008292-0Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Olanzapine PS Eli Lilly 20MG /D Dilantin C Date:12/17/97ISR Number: 3011603-3Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Agitation Blood Creatine Phosphokinase Increased Body Temperature Increased Cognitive Disorder Confusional State Delirium Dementia Hallucination Insomnia Movement Disorder Neuroleptic Malignant Syndrome Paranoia Prostatitis Pyrexia Tearfulness 24-Jun-2005 12:19 PM Page: 136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Urinary Retention Report Source Product Role Manufacturer Route Dose Duration Olanzapine PS ORAL 1.25MG, QHS, PO Date:12/17/97ISR Number: 3019064-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Zyprexa PS 20 MG/DAY Drug Interaction Klonopin SS 1 MG/DAY Date:12/18/97ISR Number: 3009290-3Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restlessness Zyprexa PS ORAL 15 MG PO OD 9 MON Tardive Dyskinesia Date:12/18/97ISR Number: 3009323-4Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Joint Stiffness Zyprexa PS 10 MG IN AM AND 20 MG Date:12/19/97ISR Number: 3009130-2Report Type:Expedited (15-DaCompany Report #GB97114861A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Jaundice Foreign Zyprexa PS ORAL 15.00 MG Skin Irritation Health DAILY PO Professional Omeprazole C Other Date:12/19/97ISR Number: 3009618-4Report Type:Expedited (15-DaCompany Report #AU97122107A Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrasystoles Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Health DAILY PO Professional Date:12/19/97ISR Number: 3009622-6Report Type:Expedited (15-DaCompany Report #US97121726A Age:46 YR Gender:Female I/FU:I Outcome PT Death Apnoea Life-Threatening Blood Creatine Hospitalization - Phosphokinase Increased Initial or Prolonged Coma Other Dizziness Hepatic Failure Hyperglycaemia 24-Jun-2005 12:19 PM Page: 137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Lactic Acidosis Nausea Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa PS ORAL 20.00 MG Syndrome Professional DAILY PO Pyrexia Haldol C Renal Failure Benadryl C Respiratory Failure Restoril C Vomiting Anaprox C Soma C Date:12/19/97ISR Number: 3009623-8Report Type:Expedited (15-DaCompany Report #US97121720A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Zyprexa PS Death Professional Date:12/19/97ISR Number: 3009627-5Report Type:Expedited (15-DaCompany Report #DE97121240A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Foreign Zyprexa PS ORAL 10.00 MG PO Initial or Prolonged Hypersensitivity Health Professional Other Date:12/19/97ISR Number: 3009629-9Report Type:Expedited (15-DaCompany Report #DE97121807A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Zyprexa PS ORAL 7.50 MG DAILY Initial or Prolonged Dystonia Health PO Tremor Professional Haloperidol C Lithium C Date:12/19/97ISR Number: 3009633-0Report Type:Expedited (15-DaCompany Report #US97121696A Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Zyprexa PS 5.0 MG DAILY Hospitalization - Blood Pressure Decreased Professional Risperdal C Initial or Prolonged Cerebrovascular Accident Company Thyroid C Heart Rate Decreased Representative Hyperhidrosis Respiratory Failure Stupor Tongue Paralysis Date:12/19/97ISR Number: 3009637-8Report Type:Expedited (15-DaCompany Report #US97121948A Age: Gender:Male I/FU:I Outcome PT Hospitalization - Hyperglycaemia Initial or Prolonged Intentional Misuse Other Malaise 24-Jun-2005 12:19 PM Page: 138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 30.00 MG PO Professional Date:12/19/97ISR Number: 3009640-8Report Type:Expedited (15-DaCompany Report #US97122968A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Professional Date:12/19/97ISR Number: 3009642-1Report Type:Expedited (15-DaCompany Report #US97122557A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Zyprexa PS ORAL 15 MG DAILY Nausea Professional PO Pulmonary Embolism Uniphyl C Vomiting Atrovent C Flovent C Intal C Ventolin C Depakote C Aldactone C Cytomel C Provera C Climara C Xanax C Date:12/19/97ISR Number: 3009645-7Report Type:Expedited (15-DaCompany Report #NZ97104234A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Foreign Zyprexa PS ORAL 20.0 MG DAILY Alanine Aminotransferase Health PO Increased Professional Valproate Sodium C Aspartate Company Aminotransferase Representative Increased Drug Ineffective Leukopenia Neutropenia Date:12/19/97ISR Number: 3009650-0Report Type:Expedited (15-DaCompany Report #NO97121936A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zyprexa PS 20 MG Initial or Prolonged Loss Of Consciousness Health Other Overdose Professional 24-Jun-2005 12:19 PM Page: 139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/97ISR Number: 3009651-2Report Type:Expedited (15-DaCompany Report #GB97122461A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Zyprexa PS Initial or Prolonged Circulatory Collapse Health Electrocardiogram Professional Abnormal Date:12/19/97ISR Number: 3009656-1Report Type:Expedited (15-DaCompany Report #GB97114885A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Zyprexa PS ORAL 20 MG DAILY Dermatitis Health PO Professional Fluoxetine C Other Diazepam C Chlorpheniramine C Thioridazine C Date:12/19/97ISR Number: 3009737-2Report Type:Expedited (15-DaCompany Report #ES97120940A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 20.00MG DAILY Health PO 1 MON Professional Company Representative Date:12/19/97ISR Number: 3009741-4Report Type:Expedited (15-DaCompany Report #DE97106307A Age:12 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Zyprexa PS Initial or Prolonged Health Professional Date:12/19/97ISR Number: 3009745-1Report Type:Expedited (15-DaCompany Report #GB97115389A Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Zyprexa PS 7.50 MG DAILY Sedation Health Haloperidol C Professional Marvelon C Date:12/19/97ISR Number: 3009747-5Report Type:Expedited (15-DaCompany Report #GB97076061A Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Limb Crushing Injury Foreign Zyprexa PS Pulmonary Embolism Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/97ISR Number: 3009750-5Report Type:Expedited (15-DaCompany Report #US97120721A Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Zyprexa PS ORAL 5.00MG DAILY Initial or Prolonged Heart Rate Decreased Professional PO Sedation Other Ritalin C 20 MG BID Luvox C 150 MG Oxybutynin C 5 MG TID Carbamazepine C 500 MG BID Risperidone C 1 MG Ddavp C Date:12/19/97ISR Number: 3009753-0Report Type:Expedited (15-DaCompany Report #AU97120622A Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antibody Test Positive Foreign Zyprexa PS ORAL 35.00 MG Initial or Prolonged Lymphopenia Health DAILY PO Other Thrombocytopenia Professional Haloperidol C Date:12/19/97ISR Number: 3009759-1Report Type:Expedited (15-DaCompany Report #CA97053163A Age:17 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lethargy Foreign Zyprexa PS 100.00 MG 1/ Hospitalization - Overdose Health PO 1 DAY Initial or Prolonged Professional Other Date:12/19/97ISR Number: 3011666-5Report Type:Expedited (15-DaCompany Report #US97121714A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Aspartate Professional DAILY Aminotransferase Company Effexor C Increased Representative Blood Creatine Phosphokinase Increased Coma Delirium Difficulty In Walking Miosis Muscle Rigidity Neuroleptic Malignant Syndrome Neuropathy Peripheral Pyrexia Renal Failure Renal Failure Acute Renal Impairment Rhabdomyolysis Sinus Tachycardia Speech Disorder Stupor Tachycardia 24-Jun-2005 12:19 PM Page: 141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/97ISR Number: 3011672-0Report Type:Expedited (15-DaCompany Report #US97121702A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Zyprexa PS ORAL 12.50 MG UNK Sudden Death Professional PO Company Haldol C Representative Zoloft C Date:12/19/97ISR Number: 3011861-5Report Type:Direct Company Report # Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Zyprexa PS Eli Lilly Initial or Prolonged Aricept SS Ei Sai ORAL 10 MG PO QDAY Date:12/19/97ISR Number: 3011869-XReport Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Fluvoxamine PS Sedation Olanzapine SS Date:12/29/97ISR Number: 3013083-0Report Type:Expedited (15-DaCompany Report #US97121702A Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Zyprexa PS ORAL 12.50 MG PO 5 MON Asphyxia Professional Haldol C Company Zoloft C Representative Date:12/29/97ISR Number: 3013086-6Report Type:Expedited (15-DaCompany Report #US97121720A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Health Zyprexa PS ORAL 25.00 MG Other Professional DAILY PO Glucotrol C Glucophage C Inderal C Procardia C Vasotec C Albuterol C Date:12/29/97ISR Number: 3013476-1Report Type:Expedited (15-DaCompany Report #US97014375A Age:25 YR Gender:Female I/FU:F Outcome PT Hospitalization - Coma Initial or Prolonged Condition Aggravated Other Convulsion Required Depressed Level Of Intervention to Consciousness Prevent Permanent Drooling Impairment/Damage Dystonia Encephalitis Viral 24-Jun-2005 12:19 PM Page: 142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Joint Stiffness Leukocytosis Meningitis Viral Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS ORAL 5.00 MG DAILY Muscle Rigidity Professional PO Neuroleptic Malignant Lithium C Syndrome Paranoia Respiratory Failure Stupor Temperature Regulation Disorder Date:12/29/97ISR Number: 3013479-7Report Type:Expedited (15-DaCompany Report #US97022203A Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Encephalitis Viral Professional PO 2 DAY Other Loss Of Consciousness Lithium C Mental Impairment Cogentin C Neuroleptic Malignant Perphenazine C Syndrome Respiratory Failure Stupor Date:12/29/97ISR Number: 3013514-6Report Type:Expedited (15-DaCompany Report #US97121948A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa PS ORAL 30.00 MG PO Initial or Prolonged Vomiting Professional Other Date:12/29/97ISR Number: 3014991-7Report Type:Expedited (15-DaCompany Report #DE97115272A Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Zyprexa PS ORAL 100.00 MG UNK Initial or Prolonged Suicide Attempt Health PO Other Professional Date:12/29/97ISR Number: 3014992-9Report Type:Expedited (15-DaCompany Report #DE97120985A Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS ORAL 15.00 MG UNK Initial or Prolonged Crohn'S Disease Health PO Diarrhoea Professional Haloperidol C Enterocolitis Promethazine C Haemorrhagic Diazepam C Faeces Discoloured Melaena 24-Jun-2005 12:19 PM Page: 143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/97ISR Number: 3015827-0Report Type:Expedited (15-DaCompany Report #AU97122113A Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoproteinaemia Foreign Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Nephrotic Syndrome Health PO Oedema Peripheral Professional Lithium C Proteinuria Metformin C Frusemide C Potassium Chloride C Amoxycillin C Date:12/29/97ISR Number: 3015829-4Report Type:Expedited (15-DaCompany Report #AU97123034A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Foreign Zyprexa PS 5 MG DAILY Initial or Prolonged Psychotic Disorder Health Sedation Professional Date:12/29/97ISR Number: 3015831-2Report Type:Expedited (15-DaCompany Report #AU97123355A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zyprexa PS ORAL 200 MG DAILY Initial or Prolonged Tachycardia Health PO Other Professional Diazepam C Sertraline C Date:12/29/97ISR Number: 3015833-6Report Type:Expedited (15-DaCompany Report #CA97122977A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 10.00 MG Initial or Prolonged Phosphokinase Increased Health DAILY PO Other Blood Pressure Professional Epival C Fluctuation Chorea Cognitive Disorder Delirium Drooling Dysphagia Extrapyramidal Disorder Hallucination, Visual Hyperhidrosis Muscle Rigidity Mutism Parkinsonian Gait Posturing Urinary Incontinence Date:12/29/97ISR Number: 3015848-8Report Type:Expedited (15-DaCompany Report #US97121564A Age:50 YR Gender:Male I/FU:I Outcome PT Hospitalization - Hyperglycaemia Initial or Prolonged Intentional Misuse Other Malaise 24-Jun-2005 12:19 PM Page: 144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Vomiting Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS 30.00 MG Professional DAILY PO 5 MON Date:12/29/97ISR Number: 3015849-XReport Type:Expedited (15-DaCompany Report #US97082299A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS ORAL 1200.00 MG Initial or Prolonged Dyspnoea Professional 1/ PO 1 DAY Other Electrocardiogram Qt Vancomycin C Prolonged Serax C Heart Rate Increased Gentamicin C Obstructive Airways Disorder Overdose Sedation Sinus Tachycardia Stupor Vomiting Date:12/29/97ISR Number: 3015852-XReport Type:Expedited (15-DaCompany Report #US97123145A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Other Clozaril C Date:12/29/97ISR Number: 3015854-3Report Type:Expedited (15-DaCompany Report #US97124435A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Health Zyprexa PS ORAL 30.00 MG PO Disorder Professional Company Representative Date:12/29/97ISR Number: 3015856-7Report Type:Expedited (15-DaCompany Report #US97124432A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Zyprexa PS ORAL 15.00 MG No Adverse Drug Effect Professional DAILY PO Overdose Depakote C Klonopin C Date:12/29/97ISR Number: 3015859-2Report Type:Expedited (15-DaCompany Report #US97124414A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Zyprexa PS Professional Risperdal C 24-Jun-2005 12:19 PM Page: 145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/97ISR Number: 3015861-0Report Type:Expedited (15-DaCompany Report #GB97115263A Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zyprexa PS 20.00 MG UNK Initial or Prolonged Phosphokinase Increased Health PO Body Temperature Professional Thioridazine C Increased Company Convulsion Representative Lower Respiratory Tract Infection Malaise Nervous System Disorder Neuroleptic Malignant Syndrome Pneumonia Date:12/29/97ISR Number: 3015862-2Report Type:Expedited (15-DaCompany Report #DE97103910A Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Zyprexa PS 10.00 MG Initial or Prolonged Cardiomyopathy Paroxetine C Date:12/29/97ISR Number: 3015865-8Report Type:Expedited (15-DaCompany Report #IE97124525A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS Health Professional 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:12/31/97ISR Number: 3070152-7Report Type:Periodic Company Report #9716809 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Vistaril PS ORAL 37.50 MG Professional TOTAL:TID:ORA L Olanzapine SS ORAL ORAL Lithum C Date:01/02/98ISR Number: 3014083-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Dysarthria Dysphonia Hemiparesis 24-Jun-2005 12:19 PM Page: 146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Idiopathic Thrombocytopenic Purpura Ischaemic Stroke Report Source Product Role Manufacturer Route Dose Duration Olanzapine PS ORAL 15MG POQ HS Synthroid C Multivitamin C Date:01/02/98ISR Number: 3014210-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Zyprexa PS ORAL TABS; 20 MG Joint Stiffness PO HS Restlessness Risperdal SS ORAL TABS; 2 MG PO BID Triphasil-28 C Date:01/02/98ISR Number: 3014216-2Report Type:Direct Company Report # Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Paxil PS Skb ORAL 20 MG QAM PO Hospitalization - Infection Olanzapine SS Lilly ORAL 5 MG Q HS PO Initial or Prolonged Pyrexia Risperdal SS Janssen ORAL 2MG PO BID Required Serotonin Syndrome (TAPERING) Intervention to Tremor Sinemet C Prevent Permanent Ativan C Impairment/Damage Colace C Levothyroxine C Multivitamin C Axid C Tegretol C Date:01/02/98ISR Number: 3014218-6Report Type:Direct Company Report # Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Parotid Gland Enlargement Olanzapine PS Lilly ORAL 15 MG PO HS Intervention to Multivitamin C Prevent Permanent Glyburide C Impairment/Damage Lithium Carbonate C Valproic Acid C Clonazepam C Humulin N C Humulin R C Date:01/02/98ISR Number: 3015542-3Report Type:Direct Company Report # Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Parotid Gland Enlargement Olanzapine PS Lilly ORAL 2.5MG PO QD Intervention to (HS) Prevent Permanent Selenium C Impairment/Damage Valproate C Vitamin E C 24-Jun-2005 12:19 PM Page: 147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/98ISR Number: 3015519-8Report Type:Expedited (15-DaCompany Report #GB97112284A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Dyspnoea Health DAILY PO Metastases To Liver Professional Chlorpromazine C Neoplasm Malignant Company Fluphenazine Pulmonary Embolism Representative Decanoate C Other Reboxetine C Date:01/09/98ISR Number: 3015522-8Report Type:Expedited (15-DaCompany Report #US98010133A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa PS ORAL 10.00MG DAILY Professional PO Company Representative Date:01/09/98ISR Number: 3015527-7Report Type:Expedited (15-DaCompany Report #US98010283A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Representative Date:01/09/98ISR Number: 3015532-0Report Type:Expedited (15-DaCompany Report #US97103220A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa PS ORAL 5.00 MG 2/DAY Initial or Prolonged Blood Creatine Professional PO Phosphokinase Increased Eskalith C Coordination Abnormal Cogentin C ORAL 1.00 MG 2/D Cough PO Diarrhoea Klonopin C ORAL 2.50 MG 2/D Haematochezia PO Headache Musculoskeletal Stiffness Myalgia Nasal Congestion Nausea Neck Pain Neuroleptic Malignant Syndrome Pharyngolaryngeal Pain Photophobia Pyrexia Tremor Urinary Incontinence Vomiting 24-Jun-2005 12:19 PM Page: 148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/98ISR Number: 3015535-6Report Type:Expedited (15-DaCompany Report #IE97124525A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS ORAL PO Health Professional Date:01/09/98ISR Number: 3015539-3Report Type:Expedited (15-DaCompany Report #US97125680A Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Interstitial Lung Disease Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Pneumonia Professional PO Tagamet C Date:01/09/98ISR Number: 3015545-9Report Type:Expedited (15-DaCompany Report #US98010142A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Zyprexa PS Acidosis Professional Nausea Vomiting Date:01/09/98ISR Number: 3016517-0Report Type:Expedited (15-DaCompany Report #US97122968A Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Zyprexa PS ORAL 10.00 MG Overdose Professional DAILY PO Chlorpromazine C Methocarbamol C Prozac C Guiatuss A.C. C Date:01/09/98ISR Number: 3016519-4Report Type:Expedited (15-DaCompany Report #US97123145A Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Zyprexa PS ORAL 10.00 MG DAILY PO Toprol C Daypro C Silver Sulfadiazine C Clozaril C Date:01/09/98ISR Number: 3016521-2Report Type:Expedited (15-DaCompany Report #US97082491A Age:7 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Consumer Zyprexa PS ORAL 5.00 MG 2/DAY Pulse Absent Health PO 7 DAY Respiratory Failure Professional Diphenhydramine C Droperidol C 24-Jun-2005 12:19 PM Page: 149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/98ISR Number: 3016522-4Report Type:Expedited (15-DaCompany Report #US97124432A Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Zyprexa PS ORAL 15.00 MG Drug Toxicity Professional DAILY PO Depakote C Klonopin C Date:01/09/98ISR Number: 3016524-8Report Type:Expedited (15-DaCompany Report #IE97113664A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Zyprexa PS Idiopathic Health Thrombocytopenic Purpura Professional Neutropenia Company Representative Date:01/09/98ISR Number: 3016526-1Report Type:Expedited (15-DaCompany Report #DE97106307A Age:12 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa PS Initial or Prolonged Exposure To Therapeutic Health Drugs Professional Grand Mal Convulsion Date:01/09/98ISR Number: 3016552-2Report Type:Expedited (15-DaCompany Report #GB98010028A Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zyprexa PS ORAL 15.00 MG Initial or Prolonged Health DAILY PO 3 WK Professional Fluphenazine C Date:01/09/98ISR Number: 3016554-6Report Type:Expedited (15-DaCompany Report #NL97124912A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Fatigue Health DAILY PO Professional Cisordinol C Akineton C Date:01/09/98ISR Number: 3016555-8Report Type:Expedited (15-DaCompany Report #IL97125443A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 10.00 MG Enuresis Health DAILY PO Sedation Professional 24-Jun-2005 12:19 PM Page: 150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/98ISR Number: 4657688-XReport Type:Direct Company Report #DQRS 125734 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Dispensing Error Zyrtec 10 Mg Pfizer PS Pfizer ORAL 1 DAILY PO Medication Error Zyprexa 10 Mg Lilly SS Lilly 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: 3018174-6Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Zyprexa PS Eli Lilly ORAL 20 MG PO Q Hospitalization - Cardiac Enzymes Increased HS Initial or Prolonged Confusional State Adalat C Gait Disturbance Lithium Carbonate C Ketoacidosis Myocardial Infarction Polydipsia Polyuria Pulmonary Embolism Respiratory Rate Increased Restlessness Date:01/14/98ISR Number: 3016251-7Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Depakote PS ORAL 250 MG PO BID Initial or Prolonged Abnormal Zyprexa SS Thrombocytopenia Date:01/14/98ISR Number: 3016268-2Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Health Zyprexa PS Eli Lilly ORAL 15 MG PO QHS Hospitalization - Phosphokinase Increased Professional Initial or Prolonged Condition Aggravated Hypertension Leukocytosis Liver Function Test Abnormal Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia 24-Jun-2005 12:19 PM Page: 151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/98ISR Number: 3016959-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flat Affect Risperidal PS ORAL 2MG PO BID; Muscle Rigidity NDC#50458-032 Psychomotor Retardation 0-01 Zyprexa SS ORAL 15 MG PO Q 9 PM; NDC# 0002-4115-33 Zyprexa SS 15MG PO Q9PM; NDC# 0002-4117-33 Date:01/15/98ISR Number: 3016133-0Report Type:Expedited (15-DaCompany Report #FR98011009A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoxia Foreign Zyprexa PS ORAL PO Initial or Prolonged Pneumonia Health Athymil C Professional Nozinan C Lexomil C Date:01/15/98ISR Number: 3016137-8Report Type:Expedited (15-DaCompany Report #AU98010337A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zyprexa PS ORAL 600.00 MG Initial or Prolonged Tachycardia Health DAILY PO Other Professional Date:01/15/98ISR Number: 3016140-8Report Type:Expedited (15-DaCompany Report #US98011090A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Blood Creatine Professional DAILY PO Other Phosphokinase Increased Synthroid C Clonic Convulsion Colace C Depressed Level Of Artane C Consciousness Wellbutrin C Dysarthria Fall Hypothyroidism Inappropriate Affect Muscle Rigidity Neuroleptic Malignant Syndrome Pneumonia Aspiration Pyrexia Weight Decreased Date:01/15/98ISR Number: 3016143-3Report Type:Expedited (15-DaCompany Report #US98010592A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Other Mania Consumer Tardive Dyskinesia Health 24-Jun-2005 12:19 PM Page: 152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 30.00 MG DAILY PO Mellaril C Desipramine C Date:01/15/98ISR Number: 3016146-9Report Type:Expedited (15-DaCompany Report #US98011132A Age:23 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Zyprexa PS ORAL 25.00 MG Other Professional DAILY PO Company Prozac C Representative Date:01/15/98ISR Number: 3016150-0Report Type:Expedited (15-DaCompany Report #US98010595A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Zyprexa PS Date:01/15/98ISR Number: 3017214-8Report Type:Expedited (15-DaCompany Report #US98010124A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Muscle Twitching Professional DAILY PO Pancreatitis Prozac SS 50.00 MG DAILY Omeprazole C Atenolol C Metoprolol C Ms Contin C Dilaudid C Date:01/15/98ISR Number: 3017217-3Report Type:Expedited (15-DaCompany Report #US98010436A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Zyprexa PS ORAL 5.00 MG Professional 2/DAY PO 3 MON Other Calan C Date:01/15/98ISR Number: 3017221-5Report Type:Expedited (15-DaCompany Report #US97120754A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocyte Count Health Zyprexa PS Increased Professional Lymphoma 24-Jun-2005 12:19 PM Page: 153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/15/98ISR Number: 3017224-0Report Type:Expedited (15-DaCompany Report #US98010442A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Other Zyprexa PS Haloperidol C Cogentin C Date:01/15/98ISR Number: 3017228-8Report Type:Expedited (15-DaCompany Report #US98010433A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Pyrexia Professional PO Serotonin Syndrome Paxil C Tremor Risperdal C Sinemet C Ativan C Colace C Axid C Levothyroxine C Multivitamin C Tegretol C Date:01/15/98ISR Number: 3017231-8Report Type:Expedited (15-DaCompany Report #GB98011315A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Zyprexa PS 15.00 MG Health DAILY 12 MON Professional Dothiepin C Company N/A C Representative Date:01/15/98ISR Number: 3017235-5Report Type:Expedited (15-DaCompany Report #GB98010670A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Zyprexa PS Initial or Prolonged Overdose Health Other Professional Date:01/15/98ISR Number: 3018422-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Olanzapine PS ORAL 15MG QD PO Required Lethargy Lithium SS 600 MG BID Intervention to Deponovera C Prevent Permanent Bentotropine C Impairment/Damage Prophxdol C Nifedipine C Phetz C Metzltestzolerod C Malox C Tylenol C Trazadae C Vitamins E C 24-Jun-2005 12:19 PM Page: 154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Halolol C Date:01/20/98ISR Number: 3017897-2Report Type:Expedited (15-DaCompany Report #DE97106307A Age:12 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Zyprexa PS Initial or Prolonged Exposure To Therapeutic Health Drugs Professional Convulsion Neonatal Date:01/20/98ISR Number: 3017900-XReport Type:Expedited (15-DaCompany Report #GB97122461A Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Zyprexa PS Initial or Prolonged Chest Pain Health Circulatory Collapse Professional Electrocardiogram Abnormal Date:01/20/98ISR Number: 3017910-2Report Type:Expedited (15-DaCompany Report #US97062269A Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Zyprexa PS 10.00 Initial or Prolonged Professional MG/DAILY Company Luvox C Representative Wellburtin C Date:01/20/98ISR Number: 3017913-8Report Type:Expedited (15-DaCompany Report #US9706199A Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epileptic Aura Health Zyprexa PS ORAL 10.00 Initial or Prolonged Grand Mal Convulsion Professional MG/DAILY PO 3 WK Luvox C Klonopin C Date:01/20/98ISR Number: 3018613-0Report Type:Direct Company Report # Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Olanzapine PS 5 MG TID Initial or Prolonged Increased Date:01/20/98ISR Number: 3018747-0Report Type:Direct Company Report # Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Zyprexia PS ORAL 5 MG PO QD Initial or Prolonged Pruritus Urticaria 24-Jun-2005 12:19 PM Page: 155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/98ISR Number: 3018354-XReport Type:Expedited (15-DaCompany Report #9720530 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Cardura PS ORAL 6.00 MG Initial or Prolonged Professional TOTAL; DAILY; Required ORAL Intervention to Zyprexa SS 5.00 MG Prevent Permanent TOTAL;DAILY Impairment/Damage Gabapentin C Benazepril C Lansorazole C Temazepam C Triazolam C Date:01/22/98ISR Number: 3018355-1Report Type:Expedited (15-DaCompany Report #9720530 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Cardura PS ORAL Initial or Prolonged Professional Zyprexa SS 5 MG TOTAL Required DAILY Intervention to Gabapentin C Prevent Permanent Benazepril C Impairment/Damage Lansoprazole C Temazepam C Triazolam C Date:01/22/98ISR Number: 3018400-3Report Type:Expedited (15-DaCompany Report #9720530 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erection Increased Health Cardura PS ORAL Initial or Prolonged Professional Zyprexa SS 5MG TOTAL; Required DAILY Intervention to Gabapentin C Prevent Permanent Bemazepril C Impairment/Damage Lansoprazole C Temazepam C Triazolam C Date:01/23/98ISR Number: 3018308-3Report Type:Expedited (15-DaCompany Report #US97124435A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Health Zyprexa PS ORAL 30.00 MG Disorder Professional Prozac C Company Representative Date:01/23/98ISR Number: 3018311-3Report Type:Expedited (15-DaCompany Report #US98010133A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa PS ORAL 10.00 MG Professional DAILY Company Haldol Decanoate C Representative 24-Jun-2005 12:19 PM Page: 156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/98ISR Number: 3018313-7Report Type:Expedited (15-DaCompany Report #US98010283A Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Health Zyprexa PS 10.00 MG Professional DAILY PO Company Representative Date:01/23/98ISR Number: 3018316-2Report Type:Expedited (15-DaCompany Report #US98011132A Age:23 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Zyprexa PS 25.00 MG Other Professional DAILY PO Company Prozac C Representative Date:01/23/98ISR Number: 3018317-4Report Type:Expedited (15-DaCompany Report #GB98010670A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Zyprexa PS Initial or Prolonged Overdose Health Other Suicide Attempt Professional Date:01/23/98ISR Number: 3018318-6Report Type:Expedited (15-DaCompany Report #GB97042461A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Foreign Zyprexa PS ORAL Hospitalization - Distress Syndrome Health Procyclidine C Initial or Prolonged Cardiac Failure Professional Paroxetine C Circulatory Collapse Other Ranitidine C Dyspnoea Ipratropium Bromide C Infection Salbutamol C Myocardial Infarction Prednisolone C Pulmonary Oedema Amiodarone C Warfarin C Paracetamol C Date:01/23/98ISR Number: 3018321-6Report Type:Expedited (15-DaCompany Report #IE97124525A Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zyprexa PS Health Professional Date:01/23/98ISR Number: 3018323-XReport Type:Expedited (15-DaCompany Report #GB97123808A Age: Gender:Female I/FU:F Outcome PT Other Abortion Spontaneous Agitation Dermatitis Emotional Distress 24-Jun-2005 12:19 PM Page: 157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Pruritus Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS ORAL 15.00 MG Health Professional Date:01/23/98ISR Number: 3018478-7Report Type:Expedited (15-DaCompany Report #US98012299A Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Health Zyprexa PS 5.00MG 2/DAY Increased Professional PO Pancytopenia Renal Impairment Date:01/23/98ISR Number: 3018479-9Report Type:Expedited (15-DaCompany Report #US98012686A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Interaction Health Zyprexa PS 10.00MG DAILY Cardiac Arrest Professional PO Company Neurontin C Representative Klonopin C Ambien C Doxepin C Date:01/23/98ISR Number: 3018480-5Report Type:Expedited (15-DaCompany Report #US98012353A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS 10.00MG 2/DAY Initial or Prolonged Phosphokinase Increased Professional PO Catatonia Clozaril C Muscle Rigidity Neuroleptic Malignant Syndrome Date:01/23/98ISR Number: 3018481-7Report Type:Expedited (15-DaCompany Report #DE98012440A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS 30.00MG DAILY Life-Threatening Health PO Professional Date:01/23/98ISR Number: 3018482-9Report Type:Expedited (15-DaCompany Report #DE98012434A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Foreign Zyprexa PS PO Initial or Prolonged Pulmonary Oedema Health Status Epilepticus Professional 24-Jun-2005 12:19 PM Page: 158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/98ISR Number: 3018483-0Report Type:Expedited (15-DaCompany Report #FR98012491A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eyelid Oedema Foreign Zyprexa PS PO Initial or Prolonged Hypersensitivity Health Haldol C Oedema Peripheral Professional Tegretol C Pleural Rub Company Representative Date:01/23/98ISR Number: 3018484-2Report Type:Expedited (15-DaCompany Report #GB98012056A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Foreign Zyprexa PS 5.00 MG DAILY Injury Health Co-Careldopa C Professional Parkinson'S Disease C Company Representative Date:01/23/98ISR Number: 3018814-1Report Type:Direct Company Report # Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Olanzapine PS 10 MG QD THEN Initial or Prolonged White Blood Cell Count Professional 15 MG QD Decreased Date:01/25/98ISR Number: 4517500-6Report Type:Direct Company Report #USP 080935 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zyrtec PS Pfizer TAB Unevaluable Event Zyprexia SS Lilly TAB Date:01/27/98ISR Number: 3021369-9Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Zyprexa PS Lilly ORAL 10MG ORAL Initial or Prolonged Convulsion ONCE 8/25/97 Other Dizziness AT 10PM Facial Bones Fracture Synthroid C Fall Dyazide C Joint Stiffness Atenolol C Loss Of Consciousness Paxil C Paraesthesia Syncope Tremor Date:01/28/98ISR Number: 3022596-7Report Type:Direct Company Report # Age:31 YR Gender: I/FU:I Outcome PT Life-Threatening Agitation Hospitalization - Delusion Initial or Prolonged Depression 24-Jun-2005 12:19 PM Page: 159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Auditory Psychotic Disorder Thinking Abnormal Report Source Product Role Manufacturer Route Dose Duration Olanzapine PS 20MG AM 20MG PM Symmetrel C Thorazine C Ativan C Tegretol C Inderal C Date:01/28/98ISR Number: 3022744-9Report Type:Direct Company Report # Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anoxia Zyprexia PS ORAL ORAL DOSE UNK Initial or Prolonged Blood Creatine Risperidal SS ORAL ORAL DOSE UNK Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Encephalopathy Laceration Neuroleptic Malignant Syndrome Respiratory Distress White Blood Cell Count Increased Date:01/29/98ISR Number: 3020573-3Report Type:Expedited (15-DaCompany Report #DE98012440A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 30.00 MG Drug Interaction Health DAILY PO Suicide Attempt Professional Date:01/29/98ISR Number: 3021106-8Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Zyprexa PS Hospitalization - Overdose Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:01/29/98ISR Number: 3022013-7Report Type:Expedited (15-DaCompany Report #HU98013196A Age:60 YR Gender:Female I/FU:I Outcome PT Death Hepatic Function Abnormal Loss Of Consciousness Neuroleptic Malignant Syndrome 24-Jun-2005 12:19 PM Page: 160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Foreign Zyprexa PS ORAL 10.00 MG Health DAILY Professional Risperdal C Company Representative Date:01/29/98ISR Number: 3022094-0Report Type:Expedited (15-DaCompany Report #US98011090A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Asthenia Professional DAILY PO Other Blood Creatine Synthroid C Phosphokinase Increased Colace C Cerebral Cyst Artane C Clonic Convulsion Wellbutrin C Depressed Level Of Consciousness Drooling Dysphagia Extrapyramidal Disorder Fall Hypothyroidism Inappropriate Affect Muscle Rigidity Mutism Neuroleptic Malignant Syndrome Pneumonia Aspiration Pyrexia Salivary Hypersecretion Stupor Weight Decreased Date:01/29/98ISR Number: 3022095-2Report Type:Expedited (15-DaCompany Report #US98013694A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Zyprexa PS ORAL 30.00 MG DAILY Luvox C Lithium C Ativan C Buspar C Date:01/29/98ISR Number: 3022096-4Report Type:Expedited (15-DaCompany Report #DE98013913A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Foreign Zyprexa PS ORAL 230.00 MG Initial or Prolonged Intentional Misuse Health Other Restlessness Professional Tachycardia 24-Jun-2005 12:19 PM Page: 161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/98ISR Number: 3022097-6Report Type:Expedited (15-DaCompany Report #SE98013496A Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Zyprexa PS Other Date:01/29/98ISR Number: 3022098-8Report Type:Expedited (15-DaCompany Report #GB98013316A Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Ventricular Arrhythmia Health DAILY PO Professional Periciazine C Lithium Carbonate C Frusemide C Atenolol C Glyceryl Trinitrate C Thyroxin C Lorazepam C Sertraline C Peppermint Oil C Loperamide C Carbamazepine C Valproate Sodium C Procyclidine C Date:01/29/98ISR Number: 3022099-XReport Type:Expedited (15-DaCompany Report #DE98014138A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zyprexa PS ORAL 10.00 MG Health Professional Date:01/29/98ISR Number: 3022100-3Report Type:Expedited (15-DaCompany Report #IT98013730A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zyprexa PS ORAL 15.00 MG Murder Health DAILY PO Professional Samyr C Alprazolam C Date:01/29/98ISR Number: 3022101-5Report Type:Expedited (15-DaCompany Report #DE98013577A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 10 MG UNK PO Drug Ineffective Literature Hallucination Health Professional 24-Jun-2005 12:19 PM Page: 162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/98ISR Number: 3022102-7Report Type:Expedited (15-DaCompany Report #GB97123808A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Zyprexa PS ORAL 15.00 MG PO Complications Of Maternal Health Exposure To Therapeutic Professional Drugs Other Dermatitis Pruritus Date:01/29/98ISR Number: 3022131-3Report Type:Expedited (15-DaCompany Report #CL98013079A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 20.00 MG Health DAILY PO Professional Zopiclone C Date:01/29/98ISR Number: 3022132-5Report Type:Expedited (15-DaCompany Report #US98013085A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Below Health Zyprexa PS ORAL 25.00 MG Therapeutic Professional DAILY PO Tegretol C Klonopin C Paxil C Theophylline C Date:01/30/98ISR Number: 3021439-5Report Type:Expedited (15-DaCompany Report #US97106025A Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Ciprofloxacin C Haldol C Date:01/30/98ISR Number: 3021440-1Report Type:Expedited (15-DaCompany Report #US97106061A Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa PS ORAL 10.OO DAILY Hospitalization - Professional Carbidopa C Initial or Prolonged Levodopa C Date:01/30/98ISR Number: 3021441-3Report Type:Expedited (15-DaCompany Report #FI96115119A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Foreign Zyprexa PS ORAL 10.OO MG Initial or Prolonged Convulsions Health DAILY PO Nausea Professional Diazepam C Vertigo Carbamazepine C Vomiting Nitrazepam C Valproic Acid C 24-Jun-2005 12:19 PM Page: 163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3021443-7Report Type:Expedited (15-DaCompany Report #GB97122461A Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Zyprexa PS ORAL Initial or Prolonged Circulatory Collapse Health Electrocardiogram T Wave Professional Peaked Myocardial Infarction Date:01/30/98ISR Number: 3021444-9Report Type:Expedited (15-DaCompany Report #US97121063A Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Study Zyprexa PS ORAL 10.00 MG Life-Threatening Abdominal Pain Upper Health DAILY PO Hospitalization - Faecaloma Professional Magnesium Citrate C Initial or Prolonged Intestinal Obstruction Bisacodyl C Pneumonia Aspiration Milk Of Magnesia C Urinary Tract Obstruction Demerol C Phenergan C Dulcolax C Lanoxin C Diflucan C Lorabid C Proventil C Duragesic C Reglan C Date:01/30/98ISR Number: 3021531-5Report Type:Direct Company Report # Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Omeprazole PS 20 MG BID Initial or Prolonged Confusional State Professional Olanzapine SS 10 MG QD Delusion Drug Interaction Date:01/30/98ISR Number: 3021560-1Report Type:Direct Company Report # Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa PS Lilly ORAL 40 MG PO QD 4 MON Initial or Prolonged Arrhythmia Professional Dilantin C Liver Function Test Prozac C Abnormal Furosemide C Nausea Supraventricular Tachycardia Vomiting Date:01/30/98ISR Number: 3088922-8Report Type:Periodic Company Report #US97115044A Age:36 YR Gender:Male I/FU:I Outcome PT Alopecia Dermatitis Systemic Lupus 24-Jun-2005 12:19 PM Page: 164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Erythematosus Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Klonopin C Buspar C Cogentin C Paxil C Date:01/30/98ISR Number: 3088924-1Report Type:Periodic Company Report #US97115095A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Abnormal Health DAILY PO Professional Zoloft C Lithium Carbonate C Date:01/30/98ISR Number: 3088926-5Report Type:Periodic Company Report #US97115107A Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apathy Consumer Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Depression Health DAILY PO Professional Zoloft C Tegretol C Date:01/30/98ISR Number: 3088928-9Report Type:Periodic Company Report #US97115110A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Consumer Zyprexa PS Eli Lilly And Co ORAL 20.00 MG DAILY PO Zoloft C Date:01/30/98ISR Number: 3088931-9Report Type:Periodic Company Report #US97115113A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thinking Abnormal Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG DAILY PO Dilantin C Serzone C Date:01/30/98ISR Number: 3088933-2Report Type:Periodic Company Report #US97115158A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Health Zyprexa PS Eli Lilly And Co ORAL 30.00 MG Professional DAILY PO 1 WK 24-Jun-2005 12:19 PM Page: 165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3088935-6Report Type:Periodic Company Report #US97115173A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertonia Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Company Depakote C Representative Date:01/30/98ISR Number: 3088938-1Report Type:Periodic Company Report #US97115179A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypercholesterolaemia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Hyperlipidaemia Professional DAILY PO Symmetrel C Depakote C Date:01/30/98ISR Number: 3088941-1Report Type:Periodic Company Report #US97115182A Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthma Consumer Zyprexa PS Eli Lilly And Co ORAL 2.50 MG DAILY Pollakiuria Health PO Weight Increased Professional Albuterol C Asthma C Zithromax C Ritalin C Tenex C Clonidine C Date:01/30/98ISR Number: 3088944-7Report Type:Periodic Company Report #US97115185A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Apnoea Health PO Asthma Professional Ritalin C Drug Ineffective Prozac C Dyspnoea Weight Increased Date:01/30/98ISR Number: 3088947-2Report Type:Periodic Company Report #US97120118A Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3088950-2Report Type:Periodic Company Report #US97120175A Age: Gender:Female I/FU:I Outcome PT Report Source Buccoglossal Syndrome Health Movement Disorder Professional 24-Jun-2005 12:19 PM Page: 166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co ORAL 10.00 MG PO Haldol C Cogentin C Date:01/30/98ISR Number: 3088954-XReport Type:Periodic Company Report #US97120187A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Date:01/30/98ISR Number: 3088956-3Report Type:Periodic Company Report #US971`20250A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO 5 MON Effexor C Depakote C Date:01/30/98ISR Number: 3088959-9Report Type:Periodic Company Report #US97120265A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Company Luvox C Representative Date:01/30/98ISR Number: 3088960-5Report Type:Periodic Company Report #US97120283A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Zyprexa PS Eli Lilly And Co ORAL 2.50 MG 2/DAY Constipation Health PO Dry Mouth Professional Wellbutrin C Insomnia Ambien C Prilosec C Date:01/30/98ISR Number: 3088964-2Report Type:Periodic Company Report #US97120577A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neurosis Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Stupor Professional PO Thirst Serzone C Cylert C Synthroid C 24-Jun-2005 12:19 PM Page: 167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3088966-6Report Type:Periodic Company Report #US97120580A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS Eli Lilly And Co 2 MON Professional Date:01/30/98ISR Number: 3088968-XReport Type:Periodic Company Report #US97120583A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Weight Increased Professional DAILY PO Depakote C Date:01/30/98ISR Number: 3088970-8Report Type:Periodic Company Report #US97120607A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthropathy Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Nervousness PO Sedation Artane C Date:01/30/98ISR Number: 3088973-3Report Type:Periodic Company Report #US97120829A Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3088974-5Report Type:Periodic Company Report #US97120844A Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Health DAILY PO Professional Date:01/30/98ISR Number: 3088977-0Report Type:Periodic Company Report #US97120850A Age:51 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Depakote C Date:01/30/98ISR Number: 3088980-0Report Type:Periodic Company Report #US97120862A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Myocarditis Health Zyprexa PS Eli Lilly And Co Professional Luvox C 24-Jun-2005 12:19 PM Page: 168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3088982-4Report Type:Periodic Company Report #US97120865A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Migraine Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Synthroid C Date:01/30/98ISR Number: 3088986-1Report Type:Periodic Company Report #US97120871A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS Eli Lilly And Co 2 MON Professional Date:01/30/98ISR Number: 3088989-7Report Type:Periodic Company Report #US97120877A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3088990-3Report Type:Periodic Company Report #US97120880A Age:14 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Urinary Incontinence Professional 2/DAY PO Luvox C Date:01/30/98ISR Number: 3088993-9Report Type:Periodic Company Report #US97120883A Age:14 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysgeusia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional 2/DAY PO Luvox C Date:01/30/98ISR Number: 3089010-7Report Type:Periodic Company Report #US97120886A Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Prozac SS ORAL 80.00 MG DAILY PO Date:01/30/98ISR Number: 3089012-0Report Type:Periodic Company Report #US97120889A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Neuroleptic Malignant Health Syndrome Professional Company 24-Jun-2005 12:19 PM Page: 169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Eli Lilly And Co 5.00 MG 3 DAY Prolixin C Ativan C Cogentin C Tylenol C Date:01/30/98ISR Number: 3089016-8Report Type:Periodic Company Report #US97121114A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG PO Professional Company Representative Date:01/30/98ISR Number: 3089018-1Report Type:Periodic Company Report #US97121120A Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Company Clozaril C Representative Paxil C Date:01/30/98ISR Number: 3089019-3Report Type:Periodic Company Report #US97121126A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Lung Disorder Professional DAILY PO Pulmonary Oedema Trazodone C Prozac C Premarin C Klonopin C Date:01/30/98ISR Number: 3089022-3Report Type:Periodic Company Report #US97121135A Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional 2/DAY PO Luvox C Date:01/30/98ISR Number: 3089024-7Report Type:Periodic Company Report #US97121141A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Skin Odour Abnormal Consumer Zyprexa PS Eli Lilly And Co 24-Jun-2005 12:19 PM Page: 170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089025-9Report Type:Periodic Company Report #US97121147A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Thinking Abnormal DAILY PO Depakote C Klonopin C Date:01/30/98ISR Number: 3089026-0Report Type:Periodic Company Report #US97121150A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Company Representative Date:01/30/98ISR Number: 3089029-6Report Type:Periodic Company Report #US97121156A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG PO Professional Company Representative Date:01/30/98ISR Number: 3089031-4Report Type:Periodic Company Report #US97121162A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paranoia Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 2/DAY PO Lithium C Paxil C Trazodone C Date:01/30/98ISR Number: 3089032-6Report Type:Periodic Company Report #US97121186A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arrhythmia Consumer Zyprexa PS Eli Lilly And Co Face Oedema Multivitamin C Nervousness Speech Disorder Tremor Date:01/30/98ISR Number: 3089035-1Report Type:Periodic Company Report #SPEECH DISORDER Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Consumer Zyprexa PS Eli Lilly And Co Altace C Prilosec C Norvasc C 24-Jun-2005 12:19 PM Page: 171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089036-3Report Type:Periodic Company Report #US97121384A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG PO Weight Increased Prozac C Date:01/30/98ISR Number: 3089039-9Report Type:Periodic Company Report #US97121486A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Consumer Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Thinking Abnormal Health DAILY PO Professional Cogentin C Date:01/30/98ISR Number: 3089041-7Report Type:Periodic Company Report #US97121651A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Weight Increased DAILY PO Ritalin C Prozac C Date:01/30/98ISR Number: 3089044-2Report Type:Periodic Company Report #US97121744A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Thinking Abnormal DAILY PO Weight Increased Date:01/30/98ISR Number: 3089046-6Report Type:Periodic Company Report #US97121750A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nervousness Consumer Zyprexa PS Eli Lilly And Co 10.00 MG Sedation Date:01/30/98ISR Number: 3089048-XReport Type:Periodic Company Report #US97121849A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Health Zyprexa PS Eli Lilly And Co 10.00 MG Muscle Spasms Professional Company Representative Date:01/30/98ISR Number: 3089051-XReport Type:Periodic Company Report #US97121861A Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS Eli Lilly And Co 5.00 MG DAILY 24-Jun-2005 12:19 PM Page: 172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089052-1Report Type:Periodic Company Report #US97121867A Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Other Zyprexa PS Eli Lilly And Co Unevaluable Event Haldol C Date:01/30/98ISR Number: 3089053-3Report Type:Periodic Company Report #US97121879A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089055-7Report Type:Periodic Company Report #US97121885A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Health Zyprexa PS Eli Lilly And Co ORAL 25.00 MG Professional DAILY PO 2 MON Date:01/30/98ISR Number: 3089056-9Report Type:Periodic Company Report #US97121996A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Hostility DAILY PO Sedation Dilantin C Weight Increased Ativan C Date:01/30/98ISR Number: 3089059-4Report Type:Periodic Company Report #US97122059A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Consumer Zyprexa PS Eli Lilly And Co 5.00 MG DAILY Rectal Haemorrhage Health Dexedrine C Professional Clonidine C Depakote C Date:01/30/98ISR Number: 3089061-2Report Type:Periodic Company Report #US97122071A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Anxiety Professional DAILY PO Depression Haldol C Drug Ineffective Paxil C Naprosyn C Date:01/30/98ISR Number: 3089064-8Report Type:Periodic Company Report #US97122080A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Misuse Consumer Zyprexa PS Eli Lilly And Co ORAL 25.00 MG Unintended Pregnancy DAILY PO 24-Jun-2005 12:19 PM Page: 173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089067-3Report Type:Periodic Company Report #US97122101A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Extrapyramidal Disorder Professional DAILY PO Muscle Rigidity Ferrous Sulfate C Tremor Gentamicicn Ophthalmic Solution C Dulcolax C Vitamin E C Multivitamin C Oxybutynin C Lorazepam C Lactulose C Peri-Colace C Date:01/30/98ISR Number: 3089069-7Report Type:Periodic Company Report #US97122191A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Visual Disturbance Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG 2 Professional /DAY PO Pravachol C Synthroid C Date:01/30/98ISR Number: 3089071-5Report Type:Periodic Company Report #US97122203A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089073-9Report Type:Periodic Company Report #US97122218A Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Coordination Abnormal Professional DAILY PO Diarrhoea Lithium C Tremor Propranolol C Vomiting Levothyroxine C Date:01/30/98ISR Number: 3089075-2Report Type:Periodic Company Report #US97122227A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089076-4Report Type:Periodic Company Report #US97122236A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS Eli Lilly And Co Professional 24-Jun-2005 12:19 PM Page: 174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089077-6Report Type:Periodic Company Report #US97122245A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089078-8Report Type:Periodic Company Report #US97122281A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Lithium C Haldol Deconoate C Prozac C Date:01/30/98ISR Number: 3089080-6Report Type:Periodic Company Report #US97122290A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyponatraemia Health Zyprexa PS Eli Lilly And Co Professional Maxzide C Date:01/30/98ISR Number: 3089082-XReport Type:Periodic Company Report #US97122299A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accident Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Orthostatic Hypotension Professional PO Sedation Lorazepam C Weight Decreased Date:01/30/98ISR Number: 3089085-5Report Type:Periodic Company Report #US97122347A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Health Zyprexa PS Eli Lilly And Co ORAL 7.50 MG DAILY Extrapyramidal Disorder Professional PO Sedation Buspirone C Amlodipine C Aspirin C Atenolol C Ranitidine C Sinemet - Slow Release C Date:01/30/98ISR Number: 3089088-0Report Type:Periodic Company Report #US97122359A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS Eli Lilly And Co 17.50 MG Pollakiuria Professional DAILY Thirst Luvox C Lithium C 24-Jun-2005 12:19 PM Page: 175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089107-1Report Type:Periodic Company Report #US97122374A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Stupor Professional DAILY PO Metolazone C Captopril C Date:01/30/98ISR Number: 3089108-3Report Type:Periodic Company Report #US97122428A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Zyprexa PS Eli Lilly And Co ORAL DAILY PO Date:01/30/98ISR Number: 3089111-3Report Type:Periodic Company Report #US97122434A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspepsia Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Gastritis DAILY PO Xanax C Date:01/30/98ISR Number: 3089113-7Report Type:Periodic Company Report #US97122437A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arrhythmia Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089116-2Report Type:Periodic Company Report #US97122539A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Glucophage C Date:01/30/98ISR Number: 3089119-8Report Type:Periodic Company Report #US97122542A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS Eli Lilly And Co Professional Glipizide C Date:01/30/98ISR Number: 3089121-6Report Type:Periodic Company Report #US97122551A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co Professional 24-Jun-2005 12:19 PM Page: 176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089125-3Report Type:Periodic Company Report #US97122620A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089127-7Report Type:Periodic Company Report #US97122632A Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG PO Professional Date:01/30/98ISR Number: 3089130-7Report Type:Periodic Company Report #US97122635A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3089131-9Report Type:Periodic Company Report #US97122644A Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG PO 1 DAY Sedation Professional Date:01/30/98ISR Number: 3089133-2Report Type:Periodic Company Report #US97122653A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089194-0Report Type:Periodic Company Report #US97122659A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG PO Hallucination Professional Company Representative Date:01/30/98ISR Number: 3089195-2Report Type:Periodic Company Report #US97122662A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co Professional 24-Jun-2005 12:19 PM Page: 177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089196-4Report Type:Periodic Company Report #US97122665A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089197-6Report Type:Periodic Company Report #US97122668A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Below Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Therapeutic Professional DAILY PO Dilantin C Phenobarbital C Omeprazole C Cascara C Lactulose C Milk Of Magnesia C Date:01/30/98ISR Number: 3089198-8Report Type:Periodic Company Report #US97122686A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Micturition Urgency Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Health DAILY PO Professional Desyrel C Benadryl C Docusate C Calcium C Vitamin E C Vitamin C C Multivitamins W/Minerals C Griseofulvin C Date:01/30/98ISR Number: 3089199-XReport Type:Periodic Company Report #US97122890A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Thinking Abnormal PO Lithium C Lorazepam C Date:01/30/98ISR Number: 3089200-3Report Type:Periodic Company Report #US97123028A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthropathy Consumer Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Eye Disorder Health DAILY PO Headache Professional Sedation 24-Jun-2005 12:19 PM Page: 178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089201-5Report Type:Periodic Company Report #US97123031A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Clonic Convulsion Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Muscle Twitching Professional DAILY PO 3 WK Paraesthesia Depakote C Lithium C Insulin C Date:01/30/98ISR Number: 3089202-7Report Type:Periodic Company Report #US97123352A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG PO Professional Prozac C Date:01/30/98ISR Number: 3089203-9Report Type:Periodic Company Report #US97123448A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS Eli Lilly And Co Pyrexia Professional Date:01/30/98ISR Number: 3089204-0Report Type:Periodic Company Report #US97123547A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thinking Abnormal Consumer Zyprexa PS Eli Lilly And Co ORAL 12.50 MG Health DAILY PO Professional Risperdal C Carbamazepine C Diphenhydramine C Date:01/30/98ISR Number: 3089205-2Report Type:Periodic Company Report #US97123556A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Pyrexia Health PO Weight Decreased Professional Date:01/30/98ISR Number: 3089206-4Report Type:Periodic Company Report #US97123574A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Date:01/30/98ISR Number: 3089207-6Report Type:Periodic Company Report #US97123592A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Jaundice Health Zyprexa PS Eli Lilly And Co ORAL 7.50 MG DAILY Liver Function Test Professional PO Abnormal 24-Jun-2005 12:19 PM Page: 179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089208-8Report Type:Periodic Company Report #US97123673A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unintended Pregnancy Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Remeron C Lorazepam C Date:01/30/98ISR Number: 3089209-XReport Type:Periodic Company Report #US97123733A Age:18 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3089210-6Report Type:Periodic Company Report #US97123757A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS Eli Lilly And Co ORAL 15.00 MG DAILY PO 1 MON Cogentin C Date:01/30/98ISR Number: 3089211-8Report Type:Periodic Company Report #US97123793A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thinking Abnormal Health Zyprexa PS Eli Lilly And Co Professional Company Representative Other Date:01/30/98ISR Number: 3089212-XReport Type:Periodic Company Report #US97123799A Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Health Zyprexa PS Eli Lilly And Co ORAL 2.50 MG DAILY Weight Increased Professional PO Ritalin C Clonidine C Tofranil C Inderal C Date:01/30/98ISR Number: 3089213-1Report Type:Periodic Company Report #US97123811A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Increased Professional DAILY PO Liver Function Test Abnormal 24-Jun-2005 12:19 PM Page: 180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3089214-3Report Type:Periodic Company Report #US97123814A Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Hypoproteinaemia Professional PO Amantadine C Dilantin C Prozac C Date:01/30/98ISR Number: 3089220-9Report Type:Periodic Company Report #US97123817A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3089222-2Report Type:Periodic Company Report #US97123832A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Personality Disorder Consumer Zyprexa PS Eli Lilly And Co ORAL PO Date:01/30/98ISR Number: 3089223-4Report Type:Periodic Company Report #US97123835A Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO 1 WK Ativan C Date:01/30/98ISR Number: 3089225-8Report Type:Periodic Company Report #US97123838A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS Eli Lilly And Co ORAL 2.50 MG DAILY Professional PO Paxil C Date:01/30/98ISR Number: 3089227-1Report Type:Periodic Company Report #US97123841A Age:22 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3091930-4Report Type:Periodic Company Report #US97123844A Age:34 YR Gender:Male I/FU:I Outcome PT Leukopenia Myalgia 24-Jun-2005 12:19 PM Page: 181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Ativan C Date:01/30/98ISR Number: 3091932-8Report Type:Periodic Company Report #US97124021A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co 7.50 MG DAILY Professional Depakote C Vitamin E C Prolixin C Cogentin C Date:01/30/98ISR Number: 3091934-1Report Type:Periodic Company Report #US97124039A Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Professional DAILY PO Haldol C Amantadine C Tegretol C Dilantin C Date:01/30/98ISR Number: 3091936-5Report Type:Periodic Company Report #US97124108A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Prolixin Decaonate C Cogentin C Benadryl C Depakote C Prozac C Klonopin C Redux C Date:01/30/98ISR Number: 3091939-0Report Type:Periodic Company Report #US97124150A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Date:01/30/98ISR Number: 3091942-0Report Type:Periodic Company Report #US97124156A Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Cogentin C 24-Jun-2005 12:19 PM Page: 182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stelazine C Trazodone C Zoloft C Date:01/30/98ISR Number: 3091945-6Report Type:Periodic Company Report #US97124615A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Health Zyprexa PS Eli Lilly And Co 5.00 MG Professional Company Representative Date:01/30/98ISR Number: 3091950-XReport Type:Periodic Company Report #US97124702A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Health DAILY PO 2 MON Professional Date:01/30/98ISR Number: 3091953-5Report Type:Periodic Company Report #US97124711A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Health DAILY PO Professional Date:01/30/98ISR Number: 3091956-0Report Type:Periodic Company Report #US97124720A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Increased Professional DAILY PO Hypertension Lithium C Tachycardia Valproic Acid C Hyzaar C Date:01/30/98ISR Number: 3091958-4Report Type:Periodic Company Report #US97124747A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Company Representative Date:01/30/98ISR Number: 3091962-6Report Type:Periodic Company Report #US97124756A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antinuclear Antibody Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Positive Professional DAILY PO Vasculitis 24-Jun-2005 12:19 PM Page: 183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3091966-3Report Type:Periodic Company Report #US97124762A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unintended Pregnancy Health Zyprexa PS Eli Lilly And Co 20.00 MG Professional DAILY Lithium C Ativan C Anafranil C Date:01/30/98ISR Number: 3091980-8Report Type:Periodic Company Report #US97124765A Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unintended Pregnancy Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Vitamins C Date:01/30/98ISR Number: 3091982-1Report Type:Periodic Company Report #US97124801A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS Eli Lilly And Co Professional Date:01/30/98ISR Number: 3091983-3Report Type:Periodic Company Report #US97124816A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS Eli Lilly And Co 10.00 MG Injury Professional Mellaril C Nervousness Company Benadryl C Representative Date:01/30/98ISR Number: 3091989-4Report Type:Periodic Company Report #US97124840A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3091992-4Report Type:Periodic Company Report #US97125095A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Company Ativan C Representative Effexor C 24-Jun-2005 12:19 PM Page: 184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3091994-8Report Type:Periodic Company Report #US97125203A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Health PO Professional Date:01/30/98ISR Number: 3091996-1Report Type:Periodic Company Report #US97125230A Age:16 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Prozac C Lithium C Date:01/30/98ISR Number: 3091998-5Report Type:Periodic Company Report #US97125386A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Hostility Professional DAILY PO Movement Disorder Depakote C Date:01/30/98ISR Number: 3092001-3Report Type:Periodic Company Report #US97125395A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Faeces Health Zyprexa PS Eli Lilly And Co Professional Company Representative Date:01/30/98ISR Number: 3092005-0Report Type:Periodic Company Report #US97125401A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Consumer Zyprexa PS Eli Lilly And Co ORAL 5.00 MG PO Oedema Peripheral Health Zoloft C Paraesthesia Professional Sedation Date:01/30/98ISR Number: 3092009-8Report Type:Periodic Company Report #US97125407A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Health Zyprexa PS Eli Lilly And Co 20.00 DAILY Paranoia Professional Tranxene C Date:01/30/98ISR Number: 3092013-XReport Type:Periodic Company Report #US97125461A Age:48 YR Gender:Male I/FU:I Outcome PT Confusional State Coordination Abnormal 24-Jun-2005 12:19 PM Page: 185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pruritus Skin Discolouration Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO Depakote C Cogentin C Date:01/30/98ISR Number: 3092016-5Report Type:Periodic Company Report #US97125419A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Hypertonia Professional DAILY PO Masked Facies Depakote C Tremor Inderal C Date:01/30/98ISR Number: 3092021-9Report Type:Periodic Company Report #US97125425A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Disorder Health Zyprexa PS Eli Lilly And Co 17 DAY Increased Appetite Professional Libido Decreased Other Sedation Date:01/30/98ISR Number: 3092024-4Report Type:Periodic Company Report #US97125725A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Consumer Zyprexa PS Eli Lilly And Co ORAL 18.75 MG Apathy Health DAILY PO Hallucination Professional Mevacor C Nervousness Ecotrin C Sedation Centrum C Lorazepam C Effexor C Date:01/30/98ISR Number: 3092028-1Report Type:Periodic Company Report #US97125734A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Date:01/30/98ISR Number: 3092031-1Report Type:Periodic Company Report #US97125746A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Amitriptyline C 24-Jun-2005 12:19 PM Page: 186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092032-3Report Type:Periodic Company Report #US97125773A Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Phosphokinase Increased Professional DAILY PO Blood Creatinine Verapamil C Increased Paxil C Myopathy Tenex C Anafranil C Beclovent C Flovent C Serevent C Atrovent C Albuterol C Albuterol C Synthroid C Digoxin C Date:01/30/98ISR Number: 3092037-2Report Type:Periodic Company Report #US98010271A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa PS Eli Lilly And Co Weight Increased Date:01/30/98ISR Number: 3092040-2Report Type:Periodic Company Report #US98010313A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hostility Health Zyprexa PS Eli Lilly And Co Professional Lithium C Trazodone C Serzone C Date:01/30/98ISR Number: 3092044-XReport Type:Periodic Company Report #US98010316A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Deafness Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Health DAILY PO Professional Zoloft C Trilafon C Date:01/30/98ISR Number: 3092047-5Report Type:Periodic Company Report #US97101183A Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Consumer Zyprexa PS ORAL 40.00 MG Urinary Incontinence Health DAILY PO 6 MON Professional Clozaril C Bethanechol C 24-Jun-2005 12:19 PM Page: 187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092051-7Report Type:Periodic Company Report #US97101204A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Hyperglycaemia Professional DAILY PO 10 MON Lamictal C Lithium C Date:01/30/98ISR Number: 3092055-4Report Type:Periodic Company Report #US97101213A Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS ORAL 7.50 MG DAILY Initial or Prolonged Dysphagia Professional PO Hyperhidrosis Other Trazodone C Hyperventilation Risperdal C Pyrexia Sedation Tachycardia Date:01/30/98ISR Number: 3092058-XReport Type:Periodic Company Report #US97101894A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Aspartate Professional DAILY PO 5 WK Aminotransferase Clozapine C Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Hyponatraemia Leukocytosis Myopathy Neuroleptic Malignant Syndrome Pneumonia Pyrexia Thinking Abnormal Date:01/30/98ISR Number: 3092060-8Report Type:Periodic Company Report #US97102434A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Zyprexa PS ORAL 150.00 MG Dizziness Professional DAILY PO Intentional Misuse Depakote C Sedation Effexor C Date:01/30/98ISR Number: 3092062-1Report Type:Periodic Company Report #US97102728A Age:80 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Chest Pain 24-Jun-2005 12:19 PM Page: 188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Choreoathetosis Dyskinesia Hyperhidrosis Report Source Product Role Manufacturer Route Dose Duration Hypertonia Health Zyprexa PS ORAL 5.00 MG DAILY Hyperventilation Professional PO Hypokalaemia Company Colace C Hypoproteinaemia Representative Naprosyn C Hypotension Tamoxifen C Leukocytosis Congentin C Liver Function Test Tylenol C Abnormal Muscle Rigidity Nausea Neuroleptic Malignant Syndrome Pyrexia Salivary Hypersecretion Tachycardia Trismus Vomiting Date:01/30/98ISR Number: 3092064-5Report Type:Periodic Company Report #US97102800A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Health Zyprexa PS ORAL 50.00 MG Sedation Professional DAILY PO Company Clozaril C Representative Date:01/30/98ISR Number: 3092066-9Report Type:Periodic Company Report #US97103511A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Zyprexa PS ORAL 25.00 MG Back Pain DAILY PO Intentional Misuse Depakote C Muscle Twitching Lamicatal C Pyrexia Congentin C Speech Disorder Tremor Date:01/30/98ISR Number: 3092068-2Report Type:Periodic Company Report #US97103727A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Consumer Zyprexa PS ORAL 40.00 MG Nervousness DAILY PO Tegretol C Lithium C Prozac C Haldol C 24-Jun-2005 12:19 PM Page: 189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092069-4Report Type:Periodic Company Report #US97104543A Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Zyprexa PS Initial or Prolonged Health Fluphenazine C Professional Insulin C Date:01/30/98ISR Number: 3092071-2Report Type:Periodic Company Report #US97104924A Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Zyprexa PS ORAL 30.00 MG Initial or Prolonged Professional DAILY PO Other Synthroid C Dilantin C Risperdal C Lithium C Clonidine C Date:01/30/98ISR Number: 3092073-6Report Type:Periodic Company Report #US97105080A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Dystonia Professional DAILY PO 2 MON Date:01/30/98ISR Number: 3092076-1Report Type:Periodic Company Report #US97105842A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Health Zyprexa PS Syncope Professional Date:01/30/98ISR Number: 3092080-3Report Type:Periodic Company Report #US97106718A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS ORAL 15.00 MG Initial or Prolonged Drug Interaction Professional DAILY PO Hyperglycaemia Company Depakote C Thirst Representative Micronase C Urinary Incontinence Propranolol C Date:01/30/98ISR Number: 3092083-9Report Type:Periodic Company Report #US97106748A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Health Zyprexa PS ORAL 150.00 MG 1/ Intentional Misuse Professional PO 24-Jun-2005 12:19 PM Page: 190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092087-6Report Type:Periodic Company Report #US97106763A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS Initial or Prolonged Nausea Professional Prozac C Other Sedation Tachycardia Date:01/30/98ISR Number: 3092090-6Report Type:Periodic Company Report #US97111450A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Zyprexa PS 10.00 MG Initial or Prolonged Gait Disturbance Professional DAILY Tremor Ativan C Lithium C Depakote C Date:01/30/98ISR Number: 3092095-5Report Type:Periodic Company Report #US97111729A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Health Zyprexa PS ORAL 35.00 MG Weight Increased Professional DAILY PO 1 YR Paxil C Depakote C Date:01/30/98ISR Number: 3092097-9Report Type:Periodic Company Report #US97112431A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Zyprexa PS ORAL 200.00 MG 1 / Initial or Prolonged Liver Function Test Professional PO Other Sedation Date:01/30/98ISR Number: 3092100-6Report Type:Periodic Company Report #US97112467A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Phosphokinase Increased Professional DAILY PO Choreoathetosis Haldol Decanoate C Dyskinesia Congentin C Hyperhidrosis Benadryl C Hypertension Cocaine C Hypertonia Hyperventilation Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Sedation Stupor Tachycardia Tremor Urinary Incontinence 24-Jun-2005 12:19 PM Page: 191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092102-XReport Type:Periodic Company Report #US97113046A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa PS 1 YR Initial or Prolonged Decreased Appetite Professional Diabetic Ketoacidosis Ketonuria Nausea Polydipsia Polyuria Vomiting Date:01/30/98ISR Number: 3092106-7Report Type:Periodic Company Report #US97113076A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Zyprexa PS Professional Date:01/30/98ISR Number: 3092109-2Report Type:Periodic Company Report #US97113514A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Zyprexa PS ORAL 25.00 MG Arthralgia DAILY PO 1 YR Nasal Congestion Levoxyl C Sedation Vision Blurred Weight Increased Date:01/30/98ISR Number: 3092113-4Report Type:Periodic Company Report #US97114108A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Zyprexa PS ORAL 10.00 MG Syndrome Professional DAILY PO Date:01/30/98ISR Number: 3092117-1Report Type:Periodic Company Report #US97114372A Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Delirium Professional DAILY PO 3 MON Diabetes Mellitus Lorazepam C Date:01/30/98ISR Number: 3092121-3Report Type:Periodic Company Report #US97121342A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Health Zyprexa PS 40.00 MG Professional DAILY 24-Jun-2005 12:19 PM Page: 192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092126-2Report Type:Periodic Company Report #US97121345A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lethargy Health Zyprexa PS ORAL 25.00 MG Professional 3/WEEK PO Zoloft C Aricept C Date:01/30/98ISR Number: 3092131-6Report Type:Periodic Company Report #US97122098A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Health Zyprexa PS 40.00 MG Hyperbilirubinaemia Professional DAILY Intentional Misuse Company Representative Date:01/30/98ISR Number: 3092134-1Report Type:Periodic Company Report #US97122671A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Fall Professional DAILY PO 4 MON Lethargy Zoloft C Muscle Rigidity Pamelor C Mutism Ritalin C Neuroleptic Malignant Syndrome Pyrexia Date:01/30/98ISR Number: 3092137-7Report Type:Periodic Company Report #US97123277A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Health Zyprexa PS ORAL 15.00 MG Hospitalization - Muscle Rigidity Professional DAILY PO Initial or Prolonged Neuroleptic Malignant Inderal La C Syndrome Amantadine C Pyrexia Cardura C Cogentin C Antacid C Tylenol C Multivitamin C Ativan C Perphenazine C Date:01/30/98ISR Number: 3092140-7Report Type:Periodic Company Report #US97123682A Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Zyprexa PS 3 DAY Phosphokinase Increased Professional Wellbutrin C Delirium Trazodone C Neuroleptic Malignant Syndrome White Blood Cell Count Increased 24-Jun-2005 12:19 PM Page: 193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092143-2Report Type:Periodic Company Report #US97123727A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paraesthesia Consumer Zyprexa PS ORAL 25.00 MG Health DAILY PO Professional Cardura C Desyrel C Aspirin C Date:01/30/98ISR Number: 3092148-1Report Type:Periodic Company Report #US97124360A Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flushing Health Zyprexa PS ORAL 5.00 MG DAILY Psychomotor Hyperactivity Professional PO Retching Sedation Date:01/30/98ISR Number: 3092152-3Report Type:Periodic Company Report #US97124417A Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Syndrome Professional PO 1 WK Company Navane C Representative Date:01/30/98ISR Number: 3092157-2Report Type:Periodic Company Report #US97124423A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchospasm Health Zyprexa PS ORAL 40.00 MG Dysphagia Professional DAILY PO Pneumonia Aspiration Clozapine C Date:01/30/98ISR Number: 3092165-1Report Type:Periodic Company Report #US97124600A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Consumer Zyprexa PS ORAL 70.00 MG Vision Blurred Health DAILY PO Professional Depakote C Date:01/30/98ISR Number: 3092168-7Report Type:Periodic Company Report #US97100685A Age:80 YR Gender:Female I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Monocyte Count Increased Neutrophil Count 24-Jun-2005 12:19 PM Page: 194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Pulmonary Congestion Tachycardia White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Study Zyprexa PS ORAL 5.00 MG DAILY Health PO Professional Levothyroxine C Propulsid C Haldol C Zyprexa C Date:01/30/98ISR Number: 3092172-9Report Type:Periodic Company Report #US97101570A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Stress Disorder Study Zyprexa PS ORAL 15.00 MG Hospitalization - Suicidal Ideation Health DAILY PO Initial or Prolonged Professional Motrin C Tylenol C Date:01/30/98ISR Number: 3092175-4Report Type:Periodic Company Report #US97101897A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Eye Disorder Health DAILY PO Other Flat Affect Professional Trazodone C Hallucination Insomnia C Salivary Hypersecretion Risperidone C Suicidal Ideation Docusate Sodium C Levobunolol C Depakote C Tylenol C Date:01/30/98ISR Number: 3092180-8Report Type:Periodic Company Report #US97102089A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS ORAL 20.00 MG PO Initial or Prolonged Health Advil C Professional Date:01/30/98ISR Number: 3092183-3Report Type:Periodic Company Report #US97102356A Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Study Zyprexa PS ORAL 5.00 MG PO Initial or Prolonged Pyrexia Health Bactrim C Professional Date:01/30/98ISR Number: 3092186-9Report Type:Periodic Company Report #US97102407A Age:89 YR Gender:Male I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Pneumonia Aspiration Pulmonary Congestion 24-Jun-2005 12:19 PM Page: 195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Tachycardia Vomiting Report Source Product Role Manufacturer Route Dose Duration Study Zyprexa PS ORAL 5.00 MG DAILY Health PO Professional Zantac C Ativan C Demerol C Date:01/30/98ISR Number: 3092189-4Report Type:Periodic Company Report #US97103394A Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Study Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Condition Aggravated Health PO Dehydration Professional Allegra C Hypernatraemia Synthroid C Pneumonia Lorazepam C Pulmonary Congestion Pyrexia Sepsis Date:01/30/98ISR Number: 3092193-6Report Type:Periodic Company Report #US97104534A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Study Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Health PO Professional Prolixin C Atarax C Date:01/30/98ISR Number: 3092195-XReport Type:Periodic Company Report #US97105395A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Flat Affect Study Zyprexa PS ORAL 20.00 MG Initial or Prolonged Hallucination, Auditory Health DAILY PO Insomnia Professional Lithobid C Mania Pressure Of Speech Date:01/30/98ISR Number: 3092209-7Report Type:Periodic Company Report #US97105779A Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Study Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Hip Fracture Health PO Disability Professional Aspirin C Isoptin-Slow Release C Multivitamin C 24-Jun-2005 12:19 PM Page: 196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092210-3Report Type:Periodic Company Report #US97112344A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oral Intake Reduced Study Zyprexa PS ORAL 5.00 MG PO Respiratory Failure Health Professional Date:01/30/98ISR Number: 3092211-5Report Type:Periodic Company Report #US97112422A Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Zyprexa PS ORAL 10.00 MG Life-Threatening Heart Rate Decreased Health DAILY PO Hypotension Professional Lorazepam C Oral Intake Reduced Buspirone C Levothyroxine Sodium C Digoxin C Trazodone C Tylenol C Bacitracin C Date:01/30/98ISR Number: 3092212-7Report Type:Periodic Company Report #US97112731A Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clavicle Fracture Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Fall Health DAILY PO Professional Phazyme C Docusate C Nortriptyline C Lanoxin C Aspirin C Buspar C Hydroxyzine C Enulose C Vitamin E C Ibuprofen C Acetaminophen C Milk Of Magnesia C Zithromax C Cipro C Xanax C Date:01/30/98ISR Number: 3092213-9Report Type:Periodic Company Report #US97121015A Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Study Zyprexa PS ORAL 10.00 MG PO Hospitalization - Dehydration Health Aspirin C Initial or Prolonged Ecchymosis Professional Cyanocobalamin C Excoriation Propanolol C Fall Vicon Forte C Oral Intake Reduced Docusate Sodium C Urinary Tract Infection Zantac C Ativan C Vistaril C 24-Jun-2005 12:19 PM Page: 197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092214-0Report Type:Periodic Company Report #US97121063A Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Study Zyprexa PS ORAL 10.00 MG Hospitalization - Abdominal Pain Upper Health DAILY PO Initial or Prolonged Pneumonia Professional Magnesium Citrate C Bisacodyl C Milk Of Magnesia C Demerol C Phenergan C Date:01/30/98ISR Number: 3092215-2Report Type:Periodic Company Report #US97122884A Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lung Infiltration Study Zyprexa PS ORAL 10.00 MG Hospitalization - Pneumonia Aspiration Health DAILY PO Initial or Prolonged Pyrexia Professional Ceftriaxone C Trihexyphenidyl C Diltiazem C Metronidazole C Date:01/30/98ISR Number: 3092216-4Report Type:Periodic Company Report #US97124444A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Study Zyprexa PS ORAL 20.00 MG Fatigue Health DAILY PO Hepatitis Professional Influenza Like Illness Lethargy Pain Pyrexia Date:01/30/98ISR Number: 3092217-6Report Type:Periodic Company Report #US97125038A Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Zyprexa PS ORAL 10.00 MG PO Initial or Prolonged Health Professional Date:01/30/98ISR Number: 3092218-8Report Type:Periodic Company Report #US97125710A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affect Lability Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Aggression Health DAILY PO Condition Aggravated Professional Grandiosity Insomnia Irritability Judgement Impaired Medication Error Pressure Of Speech 24-Jun-2005 12:19 PM Page: 198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092219-XReport Type:Periodic Company Report #US98010145A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Study Zyprexa PS ORAL 20.00 MG Initial or Prolonged Health DAILY PO Professional Prozac C Famotidine C Ultram C Valium C Motrin C Date:01/30/98ISR Number: 3092220-6Report Type:Periodic Company Report #US97082461A Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Paranoia Health DAILY PO Professional Date:01/30/98ISR Number: 3092221-8Report Type:Periodic Company Report #US97085023A Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Study Zyprexa PS ORAL 5.00 MG DAILY Other Coma Health PO Hypotension Professional Cipro C Mental Impairment Ferrous Sulfate C Prilosec C Peri-Colace C Albuterol C Alprazolam C Date:01/30/98ISR Number: 3092222-XReport Type:Periodic Company Report #US97092296A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Hallucination Health DAILY PO Professional Date:01/30/98ISR Number: 3092223-1Report Type:Periodic Company Report #US97092452A Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa PS ORAL 15.00 MG Initial or Prolonged Depression Health DAILY Hepatitis C Professional Valium C Prozac C Salsalate C Benazepril Hydrochloride C 24-Jun-2005 12:19 PM Page: 199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092224-3Report Type:Periodic Company Report #US97083151A Age:94 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Study Zyprexa PS ORAL 15.00 MG Infection Health DAILY Professional Date:01/30/98ISR Number: 3092225-5Report Type:Periodic Company Report #US97120121A Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Disorder Study Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Pneumonia Health PO Tachycardia Professional Zantac C Heartburn C Date:01/30/98ISR Number: 3092441-2Report Type:Periodic Company Report #US97012404A Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unintended Pregnancy Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Lithium C Paroxetine C Insulin C Date:01/30/98ISR Number: 3092444-8Report Type:Periodic Company Report #US97031720A Age: Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Inappropriate Health Zyprexa PS Eli Lilly And Co Antidiuretic Hormone Professional Secretion Date:01/30/98ISR Number: 3092446-1Report Type:Periodic Company Report #US97040373A Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Hypertension Professional DAILY PO Nervousness Entex La C Sedation Trimox C Speech Disorder Tremor Date:01/30/98ISR Number: 3092450-3Report Type:Periodic Company Report #US97051819A Age:34 YR Gender:Female I/FU:F Outcome PT Amblyopia Amnesia Anxiety Depression Dizziness Glaucoma Headache 24-Jun-2005 12:19 PM Page: 200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Nausea Sedation Report Source Product Role Manufacturer Route Dose Duration Tachycardia Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Thinking Abnormal Health DAILY PO Tremor Professional Prednisone C Vomiting Other Asthma C Nasacort C Date:01/30/98ISR Number: 3092453-9Report Type:Periodic Company Report #US97052131A Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Deep Vein Thrombosis Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Date:01/30/98ISR Number: 3092455-2Report Type:Periodic Company Report #US97054228A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS Eli Lilly And Co 10.00 MG Phosphokinase Increased Professional DAILY Weight Increased Depakote C ... C Multivitamin C Zantac C Clonidine C Date:01/30/98ISR Number: 3092458-8Report Type:Periodic Company Report #US97060937A Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Phosphokinase Increased Professional 2/DAY PO Weight Increased Haldol C Klonopin C Date:01/30/98ISR Number: 3092460-6Report Type:Periodic Company Report #US97061063A Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Professional DAILY PO Depakote C Date:01/30/98ISR Number: 3092463-1Report Type:Periodic Company Report #US97062269A Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Grand Mal Convulsion Health Zyprexa PS Eli Lilly And Co Professional Luvox C Company Wellbutrin C Representative 24-Jun-2005 12:19 PM Page: 201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092467-9Report Type:Periodic Company Report #US97063280A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Above Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Therapeutic Professional DAILY PO Lithium C Depakote C Mellaril C Date:01/30/98ISR Number: 3092471-0Report Type:Periodic Company Report #US97063289A Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Leukopenia Professional PO Liver Function Test Klonopin C Abnormal Tegretol C Malaise Premarin C Date:01/30/98ISR Number: 3092476-XReport Type:Periodic Company Report #US97064045A Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Professional PO 4 DAY Prozac C Lorazepam C Date:01/30/98ISR Number: 3092479-5Report Type:Periodic Company Report #US97065155A Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Iritis Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Professional DAILY PO Date:01/30/98ISR Number: 3092483-7Report Type:Periodic Company Report #US97065410A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS Eli Lilly And Co ORAL 5.00 MG DAILY Insomnia Professional PO Oedema Company Effexor C Representative Date:01/30/98ISR Number: 3092487-4Report Type:Periodic Company Report #US97070484A Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Pamelor C Trazodone C 24-Jun-2005 12:19 PM Page: 202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3092490-4Report Type:Periodic Company Report #US97072005A Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Haldol C Ativan C Diazepam C Apap C Maalox C Milk Of Magnesia C Date:01/30/98ISR Number: 3092493-XReport Type:Periodic Company Report #US97072020A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Increased Professional DAILY PO Vitamins C Date:01/30/98ISR Number: 3092496-5Report Type:Periodic Company Report #US97073277A Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Blood Creatine Professional DAILY PO Phosphokinase Increased Prozac C Confusional State Cogentin C Coordination Abnormal Lorazepam C Dyskinesia Hyperhidrosis Hypertonia Intentional Misuse Muscle Rigidity Musculoskeletal Stiffness Pyrexia Tachycardia Tremor Date:01/30/98ISR Number: 3092499-0Report Type:Periodic Company Report #US97075173A Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Choreoathetosis Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Delusion Professional DAILY PO Company Nifedipine C Representative Nicotine Dermal Patch C Date:01/30/98ISR Number: 3092503-XReport Type:Periodic Company Report #US97076211A Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Facial Palsy Health Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Professional DAILY PO Depakote C Risperdal C 24-Jun-2005 12:19 PM Page: 203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tranxene C Vistaril C Date:01/30/98ISR Number: 3092511-9Report Type:Periodic Company Report #US97082272A Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Eli Lilly And Co ORAL 7.50 MG DAILY Drug Interaction Professional PO Anafranil C Klonopin C Date:01/30/98ISR Number: 3092517-XReport Type:Periodic Company Report #US97082284A Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antinuclear Antibody Health Zyprexa PS Eli Lilly And Co Positive Professional Buspar C Arthritis Oedema Pain Date:01/30/98ISR Number: 3092520-XReport Type:Periodic Company Report #US97082446A Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Consumer Zyprexa PS Eli Lilly And Co ORAL 20.00 MG Sedation Health DAILY PO Weight Increased Professional Date:01/30/98ISR Number: 3092526-0Report Type:Periodic Company Report #US97083877A Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa PS Eli Lilly And Co 5.00 MG 2 MON Professional Company Representative Date:01/30/98ISR Number: 3092534-XReport Type:Periodic Company Report #US97084228A Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Weight Increased Professional DAILY PO Date:01/30/98ISR Number: 3092549-1Report Type:Periodic Company Report #US97085029A Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Zyprexa PS Eli Lilly And Co ORAL 10.00 MG Myalgia Health DAILY PO Tendon Disorder Professional Nadolol C Weight Increased Estrogen Nos C Medroxyprogesterone C 24-Jun-2005 12:19 PM Page: 204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trihexyphenidyl C Fluoxetine C Date:01/30/98ISR Number: 3092552-1Report Type:Periodic Company Report #US97085041A Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Health Zyprexa PS Eli Lilly And Co ORAL 15.00 MG Oedema Professional DAILY PO Papilloedema Propranol C Weight Increased