FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/97ISR Number: 100000179Report Type:Expedited (15-DaCompany Report #10241997L001 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Literature Seroquel PS ORAL 10000.OO MG Initial or Prolonged Consciousness Health QD Required Overdose Professional Intervention to Pupillary Reflex Impaired Prevent Permanent Sinus Tachycardia Impairment/Damage Date:11/07/97ISR Number: 100000197Report Type:Expedited (15-DaCompany Report #10301997S001 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Foreign Seroquel PS ORAL 225.00 MG QD Initial or Prolonged Depressed Level Of Study PO 11 MON Consciousness Health Biperiden C Loss Of Consciousness Professional Ethyl Ester Of Pulse Pressure Decreased Cysteine C Flunitrazepam C Gamma-Oryzanol C Haloperidol C Osalmid C Pantethine C Phytonadione C Probucol C Promethazine C Ubidecarenone C Date:11/17/97ISR Number: 3001014-9Report Type:Expedited (15-DaCompany Report #11041997M026 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inappropriate Health Seroquel PS ORAL 150.00 MG Initial or Prolonged Antidiuretic Hormone Professional /QD/PO Secretion Carbamazepine C Date:11/20/97ISR Number: 3002147-3Report Type:Expedited (15-DaCompany Report #11071997M010 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Health Seroquel PS ORAL 25.00 Initial or Prolonged Platelet Count Decreased Professional MG/BID/PO 4 DAY Pneumonia Streptococcal Clozapine C Sepsis Thioridazine C White Blood Cell Count Decreased Date:12/01/97ISR Number: 3003501-6Report Type:Expedited (15-DaCompany Report #11071997M010 Age:31 YR Gender:Male I/FU:F Outcome PT Hospitalization - Neutropenia Initial or Prolonged Pneumonia Pneumococcal 22-Feb-2006 08:31 AM Page: 1 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS ORAL 25 MG TWICE A Professional DAY Date:12/11/97ISR Number: 3006484-8Report Type:Expedited (15-DaCompany Report #12011997S007 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dermatitis Foreign Seroquel PS ORAL 600.00MG/QD/P Drug Interaction Study O Face Oedema Health Clonazepam C Hypersensitivity Professional Diazepam C Lymphadenopathy Lamotrigine C Pyrexia Tongue Discolouration Date:12/15/97ISR Number: 3007184-0Report Type:Expedited (15-DaCompany Report #12051997M011 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenia Health Seroquel PS ORAL 100.00MG;QD; Mononeuritis Professional PO Nausea Weight Decreased Date:12/15/97ISR Number: 3008522-5Report Type:Expedited (15-DaCompany Report #12021997C001 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fall Study Seroquel PS ORAL 400.00MG QD Intervention to Rib Fracture Health Hydrochlorothiazide C Prevent Permanent Wrist Fracture Professional Oxycodone/Apirsin C Impairment/Damage Tylenol #3 C Date:12/15/97ISR Number: 3008525-0Report Type:Expedited (15-DaCompany Report #11041997M026 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Seroquel PS ORAL 100.00 MG HS Initial or Prolonged Inappropriate Professional PO Antidiuretic Hormone Beclomethasone Secretion Dipropionate C Carbamazepine C Clonazepam C Sertraline C Tetrabenazine C Date:12/16/97ISR Number: 3008339-1Report Type:Direct Company Report # Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Seroquel PS Zeneca Pharmaceuticals ORAL 100 MG PO BID 100MG QAM; 22-Feb-2006 08:31 AM Page: 2 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 200 MG QHS Trazodone C Glipizide C Haloperidol C Atrovent C Albuterol C Date:12/18/97ISR Number: 3009134-XReport Type:Expedited (15-DaCompany Report #11251997MO15 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Seroquel PS ORAL 25.00 MG BID Death Professional PO 5 DAY Myocardial Infarction Lorazepam C Sedation Sulfamethoxazole + Upper Respiratory Tract Trimethopri C Infection Thiothixene C Zyprexa C Date:12/19/97ISR Number: 3009617-2Report Type:Expedited (15-DaCompany Report #12111997M011 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Seroquel PS ORAL 300 MG QD PO Foreign Body Aspiration Professional Date:12/30/97ISR Number: 3014712-8Report Type:Expedited (15-DaCompany Report #M074454 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Serzone PS ORAL 200 MG QHS Initial or Prolonged Coma Professional ORAL 1 MON Respiratory Failure Seroquel SS ORAL 100 MG OD Sedation ORAL Date:12/31/97ISR Number: 3013387-1Report Type:Expedited (15-DaCompany Report #12221997M011 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Health Seroquel PS PO Initial or Prolonged Phosphatase Increased Professional Digoxin C Required Cholecystitis Olanzapine C Intervention to Cholelithiasis Warfarin C Prevent Permanent Jaundice Impairment/Damage Date:01/02/98ISR Number: 3013640-1Report Type:Expedited (15-DaCompany Report #12161997M010 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertension Health Seroquel PS ORAL DOSE:5000.00- Intervention to Lethargy Professional 5600.00 Prevent Permanent Overdose Other U/M:MG Impairment/Damage Sinus Tachycardia FREQ:NI Suicide Attempt ROUTE:PO Tachycardia Amtripyline Hydrochloride C 22-Feb-2006 08:31 AM Page: 3 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benztropine Mesylate C Date:01/02/98ISR Number: 3013643-7Report Type:Expedited (15-DaCompany Report #12051997M011 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Seroquel PS ORAL 100.00 MG QD Initial or Prolonged Mononeuritis Professional PO Disability Nausea Neuropathy Peripheral Peroneal Nerve Palsy Weight Decreased Date:01/07/98ISR Number: 3016163-9Report Type:Expedited (15-DaCompany Report #12291997S001 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Seroquel PS ORAL :75.00-150.00 Initial or Prolonged Aminotransferase Study , :MG, :QD, Increased Health :PO 4 WK Blood Alkaline Professional Ebastine C Phosphatase Increased Flunitrazepam C Blood Creatine Magnesium Oxide C Phosphokinase Increased Theophylline C Blood Lactate Dehydrogenase Increased Electrocardiogram St Segment Depression Electrocardiogram T Wave Inversion Myocardial Infarction Myocardial Ischaemia Date:01/09/98ISR Number: 3015691-XReport Type:Expedited (15-DaCompany Report #12241997M001 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Health Seroquel PS ORAL PO Intervention to Drug Toxicity Professional Fluvoxamine C Prevent Permanent Injury Company Impairment/Damage Psychotic Disorder Representative Date:01/09/98ISR Number: 3020754-9Report Type:Expedited (15-DaCompany Report #12311997C001 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Embolism Study Seroquel PS ORAL 300MG;QD;PO Initial or Prolonged Health Diazide C Professional Diphenhydramine Hydrochloride C Donepezil C 22-Feb-2006 08:31 AM Page: 4 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/98ISR Number: 3016981-7Report Type:Expedited (15-DaCompany Report #12161997M010 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Intentional Overdose Health Seroquel PS ORAL 5000-5600 MG Intervention to Lethargy Professional PO Prevent Permanent Suicide Attempt Company Amitriptyline C Impairment/Damage Tachycardia Representative Benzotropine Other Mesylate C Marijuana C Date:01/14/98ISR Number: 3016960-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Seroquel PS 400 MG Initial or Prolonged Grand Mal Convulsion Sedation Date:01/15/98ISR Number: 3016783-1Report Type:Expedited (15-DaCompany Report #12311997C001 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Embolism Study Seroquel PS ORAL 300 MG QD Initial or Prolonged Health Diazide C Professional Diphenhydramine C Donepezil C Date:01/15/98ISR Number: 3016784-3Report Type:Expedited (15-DaCompany Report #12241997M001 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Health Seroquel PS ORAL 25 MG PO Intervention to Agitation Professional Fluvoxamine C Prevent Permanent Condition Aggravated Company Impairment/Damage Drug Interaction Representative Hallucination Paranoia Psychotic Disorder Tendon Injury Date:01/16/98ISR Number: 3016946-5Report Type:Expedited (15-DaCompany Report #11251997M015 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Seroquel PS ORAL 25.00MG BID Feeling Abnormal Professional PO 6 DAY Myocardial Infarction Lorazepam C Sedation Sulfamethoxazole+Tri methopri C Thiothixene C Zyprexa C 22-Feb-2006 08:31 AM Page: 5 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/98ISR Number: 3016947-7Report Type:Expedited (15-DaCompany Report #12021997C001 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fall Study Seroquel PS ORAL 400.00 MG QD Intervention to Wrist Fracture Health PO Prevent Permanent Professional Hydrochlorothiazide C Impairment/Damage Oxycodone/Aspirin C Tylenol #3 C Date:01/22/98ISR Number: 3018349-6Report Type:Expedited (15-DaCompany Report #12011997S007 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dermatitis Foreign Seroquel PS ORAL 600.00 MG QD Drug Hypersensitivity Study PO 6 WK Drug Interaction Health Clonazepam C Face Oedema Professional Diazepam C Lymphadenopathy Lamotrigine C Pyrexia Tongue Discolouration Date:01/23/98ISR Number: 3018504-5Report Type:Expedited (15-DaCompany Report #01161998U003 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grandiosity Foreign Seroquel PS ORAL 400.00MG QD Initial or Prolonged Hypomania Study PO Irritability Health Na SS Professional Date:01/23/98ISR Number: 3018505-7Report Type:Expedited (15-DaCompany Report #01151998M012 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Health Seroquel PS ORAL 300.00MG QD Initial or Prolonged Hypotension Professional PO Required Respiratory Failure Hypoglycemics C Intervention to Sinus Bradycardia Lopazepam C Prevent Permanent .. C Impairment/Damage Date:01/23/98ISR Number: 3047798-5Report Type:Periodic Company Report #10211997M002 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Seroquel PS ORAL PO Joint Stiffness Date:01/23/98ISR Number: 3047799-7Report Type:Periodic Company Report #11031997M001 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Seroquel PS ORAL PO Compulsions Drug Ineffective Dry Mouth 22-Feb-2006 08:31 AM Page: 6 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/98ISR Number: 3047802-4Report Type:Periodic Company Report #11061997M006 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Consumer Seroquel PS ORAL 50.00 MG HS PO Clonazepam C Lithium C Date:01/23/98ISR Number: 3047804-8Report Type:Periodic Company Report #11071997M008 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Movement Disorder Consumer Seroquel PS ORAL 12.50 MG BID PO Clozapine C Phenobarbital C Date:01/23/98ISR Number: 3047807-3Report Type:Periodic Company Report #11121997M004 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Seroquel PS ORAL 25.00 MG BID Professional PO Company Risperidone C Representative Date:01/23/98ISR Number: 3047808-5Report Type:Periodic Company Report #11121997M012 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Seroquel PS ORAL 275.00 MG QD Inhibition Professional PO Divalproex Sodium C Date:01/23/98ISR Number: 3047811-5Report Type:Periodic Company Report #11141997M004 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Seroquel PS ORAL 700.00 MG QD PO 4 WK Clonazepam C Flurazepam C Elavil C Date:01/23/98ISR Number: 3047814-0Report Type:Periodic Company Report #11141997M006 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Health Seroquel PS ORAL 100.00 MG QD Professional PO 22-Feb-2006 08:31 AM Page: 7 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/98ISR Number: 3047816-4Report Type:Periodic Company Report #11181997M001 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Consumer Seroquel PS ORAL 500.00 MG BID Nausea PO 4 WK Tremor Lithium C Vomiting Date:01/23/98ISR Number: 3047818-8Report Type:Periodic Company Report #11181997M007 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Health Seroquel PS ORAL 100.00 MG BID Professional PO Date:01/23/98ISR Number: 3047820-6Report Type:Periodic Company Report #11201997M001 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Health Seroquel PS ORAL 350.00 MG QD Drug Interaction Professional PO Dysarthria Nefazodone Dysphagia Hydrochloride C Gait Disturbance Zyprexa C Posture Abnormal Sedation Date:01/23/98ISR Number: 3047823-1Report Type:Periodic Company Report #11211997M001 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Erythematous Health Seroquel PS ORAL 125.00-225.00 Skin Discolouration Professional MG BID PO Company Nefazodone Representative Hydrochloride C Date:01/23/98ISR Number: 3047825-5Report Type:Periodic Company Report #11251997M011 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Seroquel PS ORAL 25.00 - 50.00 Phosphokinase Increased Professional MS HS PO Body Temperature Increased Neuroleptic Malignant Syndrome Date:01/23/98ISR Number: 3047828-0Report Type:Periodic Company Report #11261997M002 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Seroquel PS ORAL 100.00 MG QD Sleep Disorder PO 22-Feb-2006 08:31 AM Page: 8 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/98ISR Number: 3047830-9Report Type:Periodic Company Report #12011997M004 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucinations, Mixed Consumer Seroquel PS ORAL 25.00 MG PO Muscle Disorder Nightmare Tremor Date:01/23/98ISR Number: 3047832-2Report Type:Periodic Company Report #12041997M008 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Seroquel PS ORAL 25.00 MG QD Initial or Prolonged Tremor Professional PO 3 WK Date:01/23/98ISR Number: 3047835-8Report Type:Periodic Company Report #12041997M011 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Orthostatic Hypotension Health Seroquel PS ORAL 25.00 MG QD Professional PO 3 WK Date:01/23/98ISR Number: 3047837-1Report Type:Periodic Company Report #12111997M012 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Seroquel PS ORAL PO Abnormal Professional Date:01/23/98ISR Number: 3047843-7Report Type:Periodic Company Report #12161997M011 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Seroquel PS ORAL 50.00 - Decreased Professional 100.00 MG BID PO Divalprex Sodium C Date:01/23/98ISR Number: 3047845-0Report Type:Periodic Company Report #12171997M003 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Erythematous Consumer Seroquel PS ORAL 50.00 MG QD Sedation PO Skin Chapped Date:01/23/98ISR Number: 3047849-8Report Type:Periodic Company Report #12171997M014 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Seroquel PS ORAL 100.00 - Inhibition Professional 150.00 MG BID PO Valproc Acid C 22-Feb-2006 08:31 AM Page: 9 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/98ISR Number: 3019380-7Report Type:Expedited (15-DaCompany Report #01121998M001 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Seroquel PS ORAL 300.00 MG QD Fall Professional PO Kussmaul Respiration Company Clarithromycin C Pneumonia Primary Representative Olanzapine C Atypical Pulmonary Embolism Pulse Absent Date:01/26/98ISR Number: 4657698-2Report Type:Direct Company Report #DQRS 125828 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Administration Error Seroquel Zeneca PS Zeneca Drug Dispensing Error Serzone Drug Prescribing Error Bristol-Myers Squibb SS Bristol -Myers Medication Error Squibb Date:01/29/98ISR Number: 3020949-4Report Type:Expedited (15-DaCompany Report #01201998M015 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Thrombotic Health Seroquel PS ORAL PO Hospitalization - Thrombocytopenic Purpura Professional Initial or Prolonged Date:01/30/98ISR Number: 3021534-0Report Type:Expedited (15-DaCompany Report #01201998M015 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Health Seroquel PS ORAL ORAL Hospitalization - Consciousness Professional Initial or Prolonged Ecchymosis Thrombotic Thrombocytopenic Purpura Date:02/02/98ISR Number: 3022798-XReport Type:Expedited (15-DaCompany Report #01261998S002 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Mood Foreign Seroquel PS ORAL PO Initial or Prolonged Suicidal Ideation Study Benztropine Mesylate C Health Lorazepam C Professional Date:02/02/98ISR Number: 3022800-5Report Type:Expedited (15-DaCompany Report #12291997S001 Age:63 YR Gender:Female I/FU:F Outcome PT Hospitalization - Aspartate Initial or Prolonged Aminotransferase Increased Blood Creatine Phosphokinase Increased 22-Feb-2006 08:31 AM Page: 10 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Lactate Dehydrogenase Increased Blood Urea Increased Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram St Foreign Seroquel PS ORAL 75-150 MG QD Segment Depression Study PO 4 WK Electrocardiogram T Wave Health Ebastine C Inversion Professional Flunitrazepam C Gamma-Glutamyltransferase Magnesium C Increased Theophylline C Date:02/03/98ISR Number: 3022706-1Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Other Quetiapine PS 200 MG 1 TID Initial or Prolonged Loss Of Consciousness Prozac C Serzone C Atiran C Bitalin C Indomethicin C Percocet C Tylenol #3 C Date:02/05/98ISR Number: 3023839-6Report Type:Expedited (15-DaCompany Report #01281998U001 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Seroquel PS ORAL 50.00 MG, QD, Hospitalization - Brain Hypoxia Health PO Initial or Prolonged Cardiac Arrest Professional Olanzapine C Dyspnoea Hypertension Leukocytosis Pneumonia Aspiration Tachycardia Date:02/10/98ISR Number: 3028382-6Report Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Discomfort Seroquel PS Zeneca ORAL 100MG PO BID Initial or Prolonged Penis Disorder Priapism Date:02/13/98ISR Number: 3030151-8Report Type:Expedited (15-DaCompany Report #01281998U001 Age:74 YR Gender:Female I/FU:F Outcome PT Death Anxiety Hospitalization - Brain Hypoxia Initial or Prolonged Cardiac Arrest Dyspnoea Heart Rate Increased Hypertension Hypoxia Leukocytosis Pneumonia Aspiration 22-Feb-2006 08:31 AM Page: 11 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 50.00 MG QD Health Olanzapine C Professional Date:02/17/98ISR Number: 3031296-9Report Type:Expedited (15-DaCompany Report #02061998M010 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myasthenic Syndrome Health Seroquel PS Initial or Prolonged Professional Prednisone C Date:02/17/98ISR Number: 3031297-0Report Type:Expedited (15-DaCompany Report #02101998U003 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Seroquel PS ORAL 25.00 MG PO Health QD 2 DAY Professional Haloperidol C Procyclidine Hydrochloride C Date:02/17/98ISR Number: 3031298-2Report Type:Expedited (15-DaCompany Report #01121998M001 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS ORAL 300.00 Cardiomegaly Professional MG,QD,PO 8 DAY Pulmonary Embolism Benztropine Mesylate C Syncope Clarithromycin C Lactulose C Olanzapine C Zyprexa C Date:02/18/98ISR Number: 3032354-5Report Type:Expedited (15-DaCompany Report #02101998M005 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Seroquel PS ORAL 400.00 MG Initial or Prolonged Agitation Divalproex C Hallucination Olanzapine C Hypertension Mania Mood Swings Date:02/24/98ISR Number: 3037936-2Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Seroquel PS ORAL 125 MG AM Intervention to 175MG P Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 12 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/98ISR Number: 3037151-2Report Type:Expedited (15-DaCompany Report #12111997M011 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Seroquel PS ORAL 300.00 MG QD Foreign Body Aspiration Professional PO Injury Asphyxiation Clonazepam C Date:03/02/98ISR Number: 3040845-6Report Type:Expedited (15-DaCompany Report #02191998M014 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Professional Date:03/02/98ISR Number: 3040849-3Report Type:Expedited (15-DaCompany Report #02231998M015 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Health Seroquel PS ORAL 325 MG QD PO Intervention to Professional Bisacodryl C Prevent Permanent Clozapine C Impairment/Damage Docusate Sodium C Psyllium Hydrophilic Butylacetate C Date:03/02/98ISR Number: 3146395-0Report Type:Periodic Company Report #01051998M004 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Seroquel PS ORAL 25 MG QD PO 3 WK Hospitalization - Professional Aspirin C Initial or Prolonged Donepezil C Required Furosemide C Intervention to Lisinopril C Prevent Permanent Trazodone C Impairment/Damage Date:03/02/98ISR Number: 3146397-4Report Type:Periodic Company Report #02131998M004 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel PS ORAL 300 MG QD PO Initial or Prolonged Syndrome Professional Company Representative Date:03/02/98ISR Number: 3146400-1Report Type:Periodic Company Report #03041998M014 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Seroquel PS ORAL 25- 50 MG QD Initial or Prolonged Professional PO 6 DAY Benztropine Mesylate C Clomipramine Hcl C Clonazepam C Risperidone C 22-Feb-2006 08:31 AM Page: 13 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/98ISR Number: 3050364-9Report Type:Expedited (15-DaCompany Report #02101998U003 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Seroquel PS ORAL 25 MG BID PO Health 3 DOSES Professional Haloperidol C Procyclidine Hydrochloride C Date:03/10/98ISR Number: 3049113-XReport Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Seroquel PS ORAL 25MG PO BID Date:03/10/98ISR Number: 3049343-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Disturbance In Attention Zyprexa PS ORAL Paramnesia Seroquil SS ORAL 5MG Schizophrenia TWICE/DAILY Verbigeration Date:03/11/98ISR Number: 3053194-7Report Type:Expedited (15-DaCompany Report #02061998MO10 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Expiratory Reserve Volume Health Seroquel PS ORAL PO 1 MON Initial or Prolonged Decreased Professional Prednisone C Hallucination Hypotonia Hypoventilation Inspiratory Capacity Decreased Myasthenic Syndrome Pulmonary Function Test Decreased Respiratory Acidosis Date:03/16/98ISR Number: 3055325-1Report Type:Expedited (15-DaCompany Report #02231998M015 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Health Seroquel PS ORAL 325 MG QD PO 45 DAY Intervention to Professional Bisacodryl C Prevent Permanent Clozapine C Impairment/Damage Docusate Sodium C Psyllium Hydrophilic Butylac C 22-Feb-2006 08:31 AM Page: 14 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/98ISR Number: 3060764-9Report Type:Expedited (15-DaCompany Report #02101998U003 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Seroquel PS ORAL 50 MG QD Condition Aggravated Health Haloperidol C Hallucination, Auditory Professional Procyclidine Paranoia Hydrochloride C Psychotic Disorder Schizophrenia Date:03/25/98ISR Number: 3062005-5Report Type:Expedited (15-DaCompany Report #03191998C001 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Study Seroquel PS ORAL 200.00 MG; Initial or Prolonged Disorientation Health QD; PO Encephalopathy Professional Benztropine Mesylate C Gait Disturbance Famotidine C Mental Impairment Perphenazine C Sedation Date:03/26/98ISR Number: 3062002-XReport Type:Expedited (15-DaCompany Report #02061998M010 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hallucination Health Seroquel PS ORAL PO 1 MON Hospitalization - Hypoventilation Professional Acetazolamide C Initial or Prolonged Inspiratory Capacity Albuterol C Decreased Clonazepam C Myasthenic Syndrome Fluticasone Psychotic Disorder Propionate C Pulmonary Function Test Gabapentin C Decreased Levothyroxine C Respiratory Acidosis Oxycodone C Prednisone C Risperidone C Sertraline Hydrochloride C Date:03/26/98ISR Number: 3062003-1Report Type:Expedited (15-DaCompany Report #03201998U002 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Leukaemia Foreign Seroquel PS ORAL 650.00 MG; Hospitalization - Pancytopenia Health QD;PO Initial or Prolonged Professional Date:03/26/98ISR Number: 3062007-9Report Type:Expedited (15-DaCompany Report #03181998M009 Age:73 YR Gender:Male I/FU:I Outcome PT Death Blood Creatine Phosphokinase Increased Influenza Muscle Rigidity Neuroleptic Malignant Syndrome 22-Feb-2006 08:31 AM Page: 15 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Aspiration Pyrexia Report Source Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 25.00-500 MG BID PO Carbamazepine C Date:03/30/98ISR Number: 3064844-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Seroquel PS Initial or Prolonged Pancytopenia Topomax C Depakote C Paxil C Date:03/31/98ISR Number: 3066483-7Report Type:Expedited (15-DaCompany Report #02101998U003 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Seroquel PS ORAL 50.00 MG QD Cardiomyopathy Health PO 3 DOSES Pharyngolaryngeal Pain Professional Haloperidol C Procyclidine Hydrochloride C Date:04/01/98ISR Number: 3058715-6Report Type:Expedited (15-DaCompany Report #03231998S001 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS ORAL PO 15 DAY Hospitalization - Increased Study Initial or Prolonged Aspartate Health Aminotransferase Professional Increased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Blood Triglycerides Increased Gamma-Glutamyltransferase Increased Jaundice Liver Disorder Portal Hypertension Date:04/02/98ISR Number: 3060035-0Report Type:Expedited (15-DaCompany Report #1998UW45297 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Seroquel PS Initial or Prolonged Professional 22-Feb-2006 08:31 AM Page: 16 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/03/98ISR Number: 3062677-5Report Type:Expedited (15-DaCompany Report #1998AP45167 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Seroquel PS ORAL 350 MG DAILY Health PO Professional Droperiodol C Other Clonazepam C Valproic Acid C Diazepam C Norethisterone C Clavulanic Acid C Amoxycillin C Date:04/03/98ISR Number: 3146247-6Report Type:Periodic Company Report #7394676 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urea Increased Health Abbott-Depakote PS Abbott ORAL PO Drug Interaction Professional Seroquel SS ORAL 400.000 MG PO QD Date:04/07/98ISR Number: 3071972-5Report Type:Direct Company Report # Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Seroquel PS ORAL 150 MG PO BID 4 WK Hospitalization - Dermatitis Initial or Prolonged Myoglobinuria Neuroleptic Malignant Syndrome Pyrexia Tremor Date:04/08/98ISR Number: 3061447-1Report Type:Expedited (15-DaCompany Report #1997AP3088 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS OPHTHALMIC 600 MG DALY Hospitalization - Increased Study PO Initial or Prolonged Aspartate Health Disability Aminotransferase Professional Increased Bilirubin Conjugated Increased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Blood Triglycerides Increased Gamma-Glutamyltransferase Increased Hepatomegaly Jaundice Liver Disorder Portal Hypertension Schizophrenia 22-Feb-2006 08:31 AM Page: 17 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/98ISR Number: 3062399-0Report Type:Expedited (15-DaCompany Report #1998AP45271 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Seroquel PS ORAL 300 MG QD PO Initial or Prolonged Convulsion Health Sodium Valproate SS Hyponatraemia Professional Loss Of Consciousness Polydipsia Rash Macular Date:04/10/98ISR Number: 3064498-6Report Type:Expedited (15-DaCompany Report #1998AP45322 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS ORAL 300 MG DAILY Hospitalization - Intentional Overdose Health PO Initial or Prolonged Suicide Attempt Professional Required Intervention to Prevent Permanent Impairment/Damage Date:04/14/98ISR Number: 3066333-9Report Type:Expedited (15-DaCompany Report #1998AP45308 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Hypoglycaemia Study PO Required Hypotension Health Seroquel SS ORAL 800 MG DAILY Intervention to Pharyngitis Professional PO Prevent Permanent Syncope Seroquel SS ORAL 600 MG DAILY Impairment/Damage PO Seroquel SS ORAL 100MG DAILY PO Seroquel SS ORAL 600MG DAILY PO Seroquel SS ORAL 200MG DAILY PO Pentoxyfylline C Date:04/14/98ISR Number: 3066335-2Report Type:Expedited (15-DaCompany Report #1998UW45378 Age:93 YR Gender:Female I/FU:I Outcome PT Death Blood Creatinine Increased Blood Potassium Increased Blood Urea Increased Hallucination Hypernatraemia Hypotension Hypoventilation Insomnia Leukocytosis Nasopharyngitis Paranoia Respiratory Acidosis Respiratory Rate 22-Feb-2006 08:31 AM Page: 18 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS 100 MG BID PO Professional Aricept C Gingko Biloba C Zoloft C Date:04/15/98ISR Number: 3065476-3Report Type:Expedited (15-DaCompany Report #1998AP45387 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Seroquel PS ORAL 300 MG BID PO Initial or Prolonged Respiratory Arrest Health Risperidone C Sedation Professional Chlorpromazine C Date:04/15/98ISR Number: 3065477-5Report Type:Expedited (15-DaCompany Report #1998AP45316 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Seroquel PS ORAL 800 MG QD PO Circulatory Collapse Study Weight Increased Health Professional Date:04/16/98ISR Number: 3070806-2Report Type:Expedited (15-DaCompany Report #1998AP44961 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Foreign Seroquel PS ORAL 200 MG DAILY Bronchopneumonia Health Lactulose C Cardiac Arrest Professional Brompheniramine Condition Aggravated Maleate C Coronary Artery Disease Temazepam C Myocardial Fibrosis Paracetamol C Date:04/16/98ISR Number: 3070808-6Report Type:Expedited (15-DaCompany Report #1998UW45416 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Health Seroquel PS Intervention to Thrombocytopenia Professional Depakote C Prevent Permanent Ativan C Impairment/Damage Neurontin C Date:04/17/98ISR Number: 3065188-6Report Type:Expedited (15-DaCompany Report #1998UW45455 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Arrest Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 19 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/98ISR Number: 3065939-0Report Type:Expedited (15-DaCompany Report #1998UW43653 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Discomfort Health Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Priapism Professional Vasotec C Required Ativan C Intervention to Mortin C Prevent Permanent Impairment/Damage Date:04/22/98ISR Number: 3071925-7Report Type:Direct Company Report # Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Seroquel PS 25MG BID Orthostatic Hypotension Seroquel SS 50MG BID Date:04/27/98ISR Number: 3070574-4Report Type:Expedited (15-DaCompany Report #1998AP45382 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Seroquel PS ORAL 400MG/QD/PO Initial or Prolonged Study Clomipramine C Required Health Intervention to Professional Prevent Permanent Impairment/Damage Date:04/28/98ISR Number: 3073287-8Report Type:Expedited (15-DaCompany Report #1998AP45271 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Seroquel PS ORAL 300 MG QD PO Initial or Prolonged Convulsion Health Sodium Valproate C Dermatitis Professional Hyponatraemia Loss Of Consciousness Date:04/29/98ISR Number: 3070540-9Report Type:Expedited (15-DaCompany Report #1998UW45634 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Seroquel PS ORAL 100 MG QD Initial or Prolonged Professional Valproic Acid C Date:04/30/98ISR Number: 3073199-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Health Seroquel PS ORAL 50 MG TID PO Hospitalization - Phosphokinase Increased Professional Ativan C Initial or Prolonged Confusional State Restoril C Required Mental Impairment Prozac C Intervention to Neuroleptic Malignant Lithobid C Prevent Permanent Syndrome Premarin C Impairment/Damage Pyrexia Synthroid C 22-Feb-2006 08:31 AM Page: 20 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Darvocet C Date:04/30/98ISR Number: 3075643-0Report Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akinesia Health Seroquel PS Zeneca ORAL 50 MG PO TID Extrapyramidal Disorder Professional Flat Affect Muscle Rigidity Parkinsonian Gait Restlessness Tremor Date:05/07/98ISR Number: 3074691-4Report Type:Expedited (15-DaCompany Report #1998AP45743 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Dizziness Health PO Other Hypoaesthesia Professional Droperidol C Malaise Pain Paraesthesia Tachycardia Date:05/11/98ISR Number: 3076703-0Report Type:Expedited (15-DaCompany Report #1998AP45570 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Seroquel PS ORAL 250 MG BID Phosphokinase Increased Health Sertraline C Loss Of Consciousness Professional Lithium Carbonate C Neuroleptic Malignant Syndrome Pyrexia White Blood Cell Count Increased Date:05/12/98ISR Number: 3077540-3Report Type:Expedited (15-DaCompany Report #1998UW46641 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Health Seroquel PS 150 MG PO Sedation Professional Depakote C Company Prolixin C Representative Date:05/13/98ISR Number: 3078938-XReport Type:Expedited (15-DaCompany Report #1998AP45796 Age:40 YR Gender:Male I/FU:I Outcome Disability Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 21 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Foreign Seroquel PS ORAL 650 MG PO Polycythaemia Health Chlorpromazine C Professional Olanzapine C Other Date:05/15/98ISR Number: 3079333-XReport Type:Expedited (15-DaCompany Report #1998UW 43653 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Discomfort Health Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Priapism Professional Vasotec C Required Ativan C Intervention to Motrin C Prevent Permanent Impairment/Damage Date:05/18/98ISR Number: 3080312-7Report Type:Expedited (15-DaCompany Report #1998AP45768 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Foreign Seroquel PS ORAL 200 MG PO Initial or Prolonged Depressed Level Of Health Procyclidine C Consciousness Professional Overdose Company Sedation Representative Date:05/21/98ISR Number: 3082350-7Report Type:Expedited (15-DaCompany Report #1998UW46805 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Seroquel PS ORAL 50 MG BID PO Initial or Prolonged Galactorrhoea Professional Paxil C Mood Swings Wellbutrin C Psychotic Disorder Lamictal C Suicide Attempt Date:05/28/98ISR Number: 3083395-3Report Type:Direct Company Report # Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Seroquel PS Zenneca 50 MG TWICE Other DAILY Date:05/29/98ISR Number: 3085428-7Report Type:Direct Company Report # Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Thrombocytopenia Seroquel PS UNCERTAIN-PRE Intervention to SCRIBED BY Prevent Permanent PSYCHIATRIST Impairment/Damage Enythomycin C 22-Feb-2006 08:31 AM Page: 22 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/98ISR Number: 3087896-3Report Type:Expedited (15-DaCompany Report #1998AP46009 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Seroquel PS ORAL 50 MG QD PO Pulmonary Embolism Other C0-Amoxiclav C Urinary Tract Infection Lofepramine C Sulpiride C Orphenadrine C Date:06/02/98ISR Number: 3087402-3Report Type:Expedited (15-DaCompany Report #1998AP45768 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Seroquel PS ORAL 400 MG QD PO Initial or Prolonged Consciousness Health Seroquel SS Electrocardiogram Professional Procyclidine C Abnormal Company Flupentixol C Heart Rate Increased Representative Pipotiazine C Myocardial Infarction Overdose Sedation Suicide Attempt Date:06/03/98ISR Number: 3090158-1Report Type:Expedited (15-DaCompany Report #1998AP46153 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS ORAL 350 MG QD PO Initial or Prolonged Condition Aggravated Other Date:06/09/98ISR Number: 3091196-5Report Type:Expedited (15-DaCompany Report #1998UW47030 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Seroquel PS ORAL 6 G PO Initial or Prolonged Brain Hypoxia Professional Prozac C Coma Lortab C Hypotension Xanax C Intentional Overdose Stupor Date:06/09/98ISR Number: 3091201-6Report Type:Expedited (15-DaCompany Report #1998UW47031 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Seroquel PS UNKNOWN UNKNOWN Hospitalization - Disseminated Professional Phenobarbital C Initial or Prolonged Intravascular Coagulation Ativan C Electrocardiogram St Dilantin C Segment Depression Hypotension Neuroleptic Malignant Syndrome Pyrexia Sinus Tachycardia 22-Feb-2006 08:31 AM Page: 23 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/98ISR Number: 3091809-8Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coma Seroquel PS 400MG/DAY IN Convulsion 2 DOSES Fall (FOLLOWING TITRATION FROM Date:06/09/98ISR Number: 3093531-0Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Seroquel PS 400 MG/DAY IN Fall 2 DOSES, Loss Of Consciousness FOLLOWING ...... FROM 100 MG / DAY Date:06/11/98ISR Number: 3093178-6Report Type:Expedited (15-DaCompany Report #1998UW47073 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Health Seroquel PS ORAL 75 MG QD PO 1 WK Initial or Prolonged Professional Chemotherapy C Date:06/12/98ISR Number: 3093605-4Report Type:Expedited (15-DaCompany Report #1998AP44509 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Seroquel PS ORAL 25 MG BID PO 2 DAY Pharyngolaryngeal Pain Health Haloperidol C Professional Procyclidine C Salbutamol C Date:06/17/98ISR Number: 3094873-5Report Type:Direct Company Report # Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Serzone PS 50 MG/100 MG Seroquel SS 50/100MG Date:06/17/98ISR Number: 3095266-7Report Type:Direct Company Report # Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Seroquel PS ORAL 550MG/DAY Therapeutic ORALLY Valproic Acid SS ORAL 1250/DAY ORALLY Lorazepam Prn C Clonazepam C Azmacort C Maxair C Minocycline C Ibuprofen Prn C 22-Feb-2006 08:31 AM Page: 24 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/98ISR Number: 3096963-XReport Type:Expedited (15-DaCompany Report #1998AP46403 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Seroquel PS Life-Threatening Health Professional Date:06/19/98ISR Number: 3096973-2Report Type:Expedited (15-DaCompany Report #1998AP46368 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aggression Foreign Seroquel PS ORAL 75 MG DAILY Required Lower Respiratory Tract Study PO Intervention to Infection Health Enalapril C Prevent Permanent Social Avoidant Behaviour Professional Lactulose C Impairment/Damage Company Pulmicort C Representative Trimethoprim C Date:06/19/98ISR Number: 3096974-4Report Type:Expedited (15-DaCompany Report #1998UW 47195 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Consumer Seroquel PS Initial or Prolonged Decreased Tegretol C Date:06/19/98ISR Number: 3096979-3Report Type:Expedited (15-DaCompany Report #1998AOP 46291 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Foreign Seroquel PS ORAL 750 MG DAILY Hospitalization - Lymphopenia Health PO Initial or Prolonged Neutropenia Professional Droperidol C Stelazine C Olanzapine C Diazepam C Date:06/19/98ISR Number: 3096980-XReport Type:Expedited (15-DaCompany Report #19984618 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Seroquel PS ORAL 25 MG QD PO Initial or Prolonged Hypotension Health Haloperidol C Required Orthostatic Hypotension Professional Chlorpromazine C Intervention to Respiratory Rate Clopixol Acuphse C Prevent Permanent Decreased Sulpiride C Impairment/Damage Clozapine C Date:06/19/98ISR Number: 3096981-1Report Type:Expedited (15-DaCompany Report #1998UW 47120 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Seroquel PS ORAL 300 MG QD PO Initial or Prolonged Health Zoloft C Professional Aspirin C Tums C 22-Feb-2006 08:31 AM Page: 25 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/98ISR Number: 3096983-5Report Type:Expedited (15-DaCompany Report #1998 AP 46374 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Foreign Seroquel PS 150 MG BID Required Condition Aggravated Health Risperidone C Intervention to Dysarthria Professional Prevent Permanent Extrapyramidal Disorder Impairment/Damage Date:06/23/98ISR Number: 3097872-2Report Type:Expedited (15-DaCompany Report #1998AP46219 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Toothache Foreign Seroquel PS ORAL 150 MG BID PO Health Clomipramine C Professional Laxoberal C Procyclidine C Logynon C Date:06/23/98ISR Number: 3098141-7Report Type:Expedited (15-DaCompany Report #1998AP46398 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Foreign Clozapine PS 1 MON Life-Threatening Tachycardia Health Seroquel SS Professional Olanzapine SS Aspirin "Bayer" C Sodium Valproate C Digoxin C Fybogel C Date:06/26/98ISR Number: 3099814-2Report Type:Direct Company Report # Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Seroquel PS ORAL 25MG PO HS Extrapyramidal Disorder Professional Seroquel SS ORAL 25MG PO BID Date:06/29/98ISR Number: 3100463-8Report Type:Expedited (15-DaCompany Report #1998AP46521 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Seroquel PS Initial or Prolonged Hip Fracture Health Orthostatic Hypotension Professional Date:07/02/98ISR Number: 3101669-4Report Type:Expedited (15-DaCompany Report #1998AP46635 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS ORAL 200 MG QD PO Initial or Prolonged Disorientation Health Loss Of Consciousness Professional Medication Error Overdose 22-Feb-2006 08:31 AM Page: 26 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/98ISR Number: 3102257-6Report Type:Expedited (15-DaCompany Report #1998UW46805 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Health Seroquel PS ORAL 50 MG BID PO Initial or Prolonged Galactorrhoea Professional Paxil C Mood Swings Wellbutrin C Psychotic Disorder Lamictal C Suicide Attempt Mellaril C Weight Increased Tegretol C Haldol C Ativan C Desyrel C Date:07/06/98ISR Number: 3102260-6Report Type:Expedited (15-DaCompany Report #1998UW47073 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Health Seroquel PS ORAL 75 MG QD PO 1 WK Initial or Prolonged White Blood Cell Count Professional Chemotherapy C Decreased Date:07/06/98ISR Number: 3102317-XReport Type:Expedited (15-DaCompany Report #A0065505 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Wellbutrin PS ORAL 150 MG / PER Initial or Prolonged Mood Swings DAY / ORAL Platelet Count Decreased Lamictal SS ORAL 50 MG / TWICE Premenstrual Syndrome PER DAY / Pyrexia ORAL /TABLET White Blood Cell Count Quetiapine Fumarate SS ORAL ORAL/TABLET Decreased Carbamazepine SS ORAL ORAL/TABLET Paroxetine Hydrochloride C Lorazepam C Methysergide Maleate C Date:07/09/98ISR Number: 3103604-1Report Type:Expedited (15-DaCompany Report #1998UW47120 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Seroquel PS ORAL 300 MG QD PO Initial or Prolonged Health Zoloft C Professional Aspirin C Tums C Date:07/10/98ISR Number: 3103753-8Report Type:Expedited (15-DaCompany Report #1998AP46745 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Life-Threatening Drug Ineffective Health Amilsulpiride SS Professional 22-Feb-2006 08:31 AM Page: 27 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3104866-7Report Type:Expedited (15-DaCompany Report #1998UW45560 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Chest Pain Professional Seroquel SS ORAL 50 MG BID PO Required Confusional State Company Seroquel SS ORAL 300 MG QD PO Intervention to Delirium Representative Seroquel SS ORAL 100 MG BID PO Prevent Permanent Dysarthria Depakote C Impairment/Damage Dystonia Axid C Gait Disturbance Cogentin C Joint Stiffness Wellbutrin C Mental Impairment Lithium C Muscle Rigidity Ativan C Mydriasis Sedation Tremor Date:07/17/98ISR Number: 3106167-XReport Type:Expedited (15-DaCompany Report #1998AP46932 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pallor Foreign Seroquel PS Life-Threatening Health Professional Date:07/17/98ISR Number: 3188421-9Report Type:Periodic Company Report #A0065505 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Consumer Wellbutrin Initial or Prolonged Mood Altered Tablet-Controlled Platelet Count Decreased Release PS ORAL 150 MG/ PER Pyrexia DAY/ ORAL White Blood Cell Count Lamictal Tablet SS ORAL 50 MG/TWICE Decreased PER DAY/ ORAL Quetiapine Fumarate Tablet SS ORAL ORAL Carbamazepine Tablet SS ORAL ORAL Paroxetine Hydrochloride C Lorazepam C Methysergide Maleate C Date:07/20/98ISR Number: 3107075-0Report Type:Expedited (15-DaCompany Report #1998UW 47326 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Health Seroquel PS Intervention to Complications Of Maternal Professional Prevent Permanent Exposure To Therapeutic Impairment/Damage Drugs 22-Feb-2006 08:31 AM Page: 28 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/98ISR Number: 3107296-7Report Type:Expedited (15-DaCompany Report #GB/98/00834/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Clozaril PS 1 MON Seroquel SS 25 MG Date:07/21/98ISR Number: 3107458-9Report Type:Expedited (15-DaCompany Report #1998UW47797 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholangiogram Abnormal Health Seroquel PS ORAL 50 MG HS PO Initial or Prolonged Jaundice Professional Seroquel SS ORAL 50 MG BID PO Liver Function Test Haldol C Abnormal Remeron C Doxepin C Multivitamins C Paxil C Colace C Micronase C Synthroid C Tylenol C Date:07/23/98ISR Number: 3107995-7Report Type:Expedited (15-DaCompany Report #GB/98/00839/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Clozaril PS ORAL 450 MG ORAL Overdose Health Seroquel SS Professional Fluoxetine C Diazepam C Loratadine C Fybogel C Kwells C Date:07/23/98ISR Number: 3109230-2Report Type:Expedited (15-DaCompany Report #1998UW47828 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Seroquel PS ORAL 25 MG BID PO Aspiration Professional Thorazine C Circulatory Collapse Zoloft C Date:07/24/98ISR Number: 3109145-XReport Type:Expedited (15-DaCompany Report #1998UW47030 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Health Seroquel PS ORAL 6 G PO Hospitalization - Brain Hypoxia Professional Prozac C Initial or Prolonged Coma Lortab C Required Hypotension Xanax C Intervention to Intentional Overdose Prevent Permanent Stupor Impairment/Damage 22-Feb-2006 08:31 AM Page: 29 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/98ISR Number: 3111402-8Report Type:Expedited (15-DaCompany Report #1998AP46745 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Life-Threatening Drug Ineffective Health Amisulpiride SS Professional Date:08/03/98ISR Number: 3210022-4Report Type:Periodic Company Report #98154.01 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Haloperidol PS ORAL 1 MG QD THEN Fatigue 2 MG QD, ORAL Headache Seroquel Tablets Muscular Weakness Zeneca SS Zeneca ORAL 400 MG QD, Sedation ORAL MON Date:08/04/98ISR Number: 3113165-9Report Type:Expedited (15-DaCompany Report #1998AP46530 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Seroquel PS ORAL 700 MG QD PO Initial or Prolonged Aggression Health Haloperidol C Delusion Professional Carbamazepine C Delusion Of Grandeur Other Lorazepam C Drug Toxicity Piportil C Hallucination, Auditory Mania Mental Disorder Schizophrenia, Disorganised Type Date:08/05/98ISR Number: 3113466-4Report Type:Expedited (15-DaCompany Report #1998UW48027 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Health Seroquel PS ORAL 100 MG QAM PO Intervention to Heart Rate Irregular Professional Seroquel SS ORAL 200 MG HS PO Prevent Permanent Palpitations Effexor SS 37.5 MG QD Impairment/Damage Date:08/10/98ISR Number: 3114550-1Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Syncope Seroquel PS Zeneca ORAL 250MG PO HS; TITRATED UP FROM 25 MG BID Trazodone C Prolixin C 22-Feb-2006 08:31 AM Page: 30 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/10/98ISR Number: 3114852-9Report Type:Expedited (15-DaCompany Report #1998UW48084 Age:12 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Accidental Exposure Health Seroquel PS ORAL 25 MG PO Intervention to Coma Professional Prevent Permanent Leukocytosis Impairment/Damage Date:08/12/98ISR Number: 3116782-5Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Seroquel PS Zeneca Mental Impairment Pharmaceuticals Serzone SS Bristol-Myers Squibb Date:08/17/98ISR Number: 3243031-XReport Type:Periodic Company Report #1998UW47274 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Seroquel PS ORAL 25 MG QD PO, Initial or Prolonged Health 50 MG QD PO, Professional 100 MG, 200 MG, 300 MG PO Depakote C Acetaminophen C Milk Of Magnesia C Multivitamin C Haldol C Oxazepam C Date:08/17/98ISR Number: 3243034-5Report Type:Periodic Company Report #1998UW47258 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 300 MG QD PO Initial or Prolonged Psychotic Disorder Study Ambrotose Plus C Health Vitamin C C Professional Date:08/17/98ISR Number: 3243036-9Report Type:Periodic Company Report #1998UW47244 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delusional Disorder, Study Seroquel PS ORAL 25 MG, 50 MG Persecutory Type Health PO QD Professional Mellaril C Lithium C Prozac C Naprosyn C 22-Feb-2006 08:31 AM Page: 31 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/98ISR Number: 3243039-4Report Type:Periodic Company Report #1998UW47222 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Seroquel PS ORAL 75 MG, 100 Initial or Prolonged Health MG, 150 MG, Professional 200 MG, 300 MG QD PO Vistaril C Ativan C Date:08/17/98ISR Number: 3243044-8Report Type:Periodic Company Report #1998UW47033 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Seroquel PS Initial or Prolonged Professional Valium C Date:08/17/98ISR Number: 3243047-3Report Type:Periodic Company Report #1998UW47022 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Study Seroquel PS ORAL 50 MG, 62.5 Initial or Prolonged Health MG. 56.25 MG, Professional 75 MG, 25 MG PO Mirapex C Paxil C Prempro C Aspirin C Ambien C Date:08/17/98ISR Number: 3243050-3Report Type:Periodic Company Report #1998UW45462 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Seroquel PS ORAL 600 MG QD PO Initial or Prolonged Health Rivotril C Professional Haldol C Inderal C Date:08/17/98ISR Number: 3243053-9Report Type:Periodic Company Report #1998UW45457 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Study Seroquel PS ORAL 75 MG TID PO Initial or Prolonged Syncope Health Zoloft C Professional Zocor C Synthroid C Ativan C Date:08/17/98ISR Number: 3243056-4Report Type:Periodic Company Report #1998UW45378 Age:93 YR Gender:Female I/FU:I Outcome PT Death Blood Creatine Phosphokinase Increased 22-Feb-2006 08:31 AM Page: 32 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Pressure Decreased Leukocytosis Respiratory Acidosis Report Source Product Role Manufacturer Route Dose Duration Respiratory Rate Health Seroquel PS ORAL 100 MG BID PO Decreased Professional Aricept C Gingko C Zoloft C Date:08/17/98ISR Number: 3243060-6Report Type:Periodic Company Report #1998UW45345 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Seroquel PS ORAL 700 MG QD PO Initial or Prolonged Syndrome Health Haloperidol C Professional Lithium C Date:08/17/98ISR Number: 3243063-1Report Type:Periodic Company Report #1998UW45328 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Seroquel PS ORAL 25 MG, 450 MG Initial or Prolonged Professional QD PO Company Lithium C Representative Date:08/17/98ISR Number: 3243065-5Report Type:Periodic Company Report #1998UW45326 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Professional Depakote C Company Representative Date:08/17/98ISR Number: 3243067-9Report Type:Periodic Company Report #1997UW46536 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Seroquel PS ORAL 300 MG PO Initial or Prolonged Prolixin C Effexor C Cogentin C Parlodel C Multivitamins C Date:08/18/98ISR Number: 3118534-9Report Type:Expedited (15-DaCompany Report #1998AP47705 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis B Foreign Seroquel PS 5 WK Initial or Prolonged Jaundice Health Venlafaxine C Professional 22-Feb-2006 08:31 AM Page: 33 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/98ISR Number: 3118535-0Report Type:Expedited (15-DaCompany Report #1998AP47599 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Foreign Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Pulmonary Embolism Health Professional Date:08/18/98ISR Number: 3118536-2Report Type:Expedited (15-DaCompany Report #1998AP46932 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Seroquel PS ORAL 25 MG DAILY Life-Threatening Discomfort Health PO Malaise Professional Pallor Pulmonary Embolism Date:08/19/98ISR Number: 3118805-6Report Type:Expedited (15-DaCompany Report #1998UW48255 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Seroquel PS Initial or Prolonged Professional Lithium C Date:08/19/98ISR Number: 3119089-5Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Quetiapine PS ORAL 1500 MG BID Intervention to Gait Disturbance PO Prevent Permanent Clonidine Hci C Impairment/Damage Lorazepam C Bupropion C Multi-Vitamins C Date:08/19/98ISR Number: 3119090-1Report Type:Direct Company Report # Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pruritus Quetiapine PS ORAL 100 MG BID PO Intervention to Rash Maculo-Papular Diazepam C Prevent Permanent Divalproex Sodium C Impairment/Damage Doxepin C Date:08/24/98ISR Number: 3120904-XReport Type:Expedited (15-DaCompany Report #1998UW47956 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Professional Haldol C Cogentin C 22-Feb-2006 08:31 AM Page: 34 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/98ISR Number: 3121754-0Report Type:Expedited (15-DaCompany Report #1998AP45743 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Circulatory Collapse Health PO Other Condition Aggravated Professional Droperidol C Dizziness Hypoaesthesia Malaise Orthostatic Hypotension Pain In Extremity Paraesthesia Tachycardia Date:08/28/98ISR Number: 3124122-0Report Type:Expedited (15-DaCompany Report #1998AP48176 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Foreign Seroquel PS Initial or Prolonged Jaundice Other Muscle Rigidity Respiratory Rate Increased Date:08/31/98ISR Number: 3125056-8Report Type:Expedited (15-DaCompany Report #1998AP45743 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Circulatory Collapse Health PO Other Dizziness Professional Droperidol C Hypoaesthesia Olanzapine C Malaise Orthostatic Hypotension Pain In Extremity Paraesthesia Tachycardia Date:09/01/98ISR Number: 3124435-2Report Type:Direct Company Report # Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Quetiapine PS Zeneca ORAL 125 MG PO HS Initial or Prolonged Mania Thinking Abnormal Tic Date:09/02/98ISR Number: 3126362-3Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Seroquel PS ORAL 125 MG PO BID Required Lorazepam C Intervention to Terazosin C Prevent Permanent Divalproex C Impairment/Damage Choline Magsalicylate C 22-Feb-2006 08:31 AM Page: 35 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levothyroxine C Lactic Acid Lotion C Multivitamin C Date:09/03/98ISR Number: 3125700-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Seroquel PS ORAL 25 MG BID Klonopin C Depakote C Date:09/04/98ISR Number: 3127228-5Report Type:Direct Company Report # Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Seroquel PS ORAL 50MG PO X 1 Sedation Date:09/11/98ISR Number: 3128491-7Report Type:Expedited (15-DaCompany Report #1998UW48527 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Seroquel PS ORAL 100 MG QD PO Initial or Prolonged Phosphokinase Mb Professional Aspirin C Increased Ativan C Chest Pain Sorbitol C Vitamin E C Tylenol C Haldol C Date:09/14/98ISR Number: 3128253-0Report Type:Expedited (15-DaCompany Report #1998AP46403 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Seroquel PS ORAL 25 MG DAILY Health PO Professional Lofepramine C Frusemide C Date:09/16/98ISR Number: 3131029-1Report Type:Expedited (15-DaCompany Report #1997AP34171 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Seroquel PS Initial or Prolonged Confusional State Literature Fluoxetine C Heart Rate Increased Health Benzhexol C Overdose Professional Sedation Sinus Tachycardia 22-Feb-2006 08:31 AM Page: 36 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/98ISR Number: 3133039-7Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Seroquel PS ORAL 250 MG BID PO Initial or Prolonged Lithium C Milk Of Magnesia C Date:09/21/98ISR Number: 3133044-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS ORAL 250 MG BID PO 3 MON Lithium C Date:09/21/98ISR Number: 3133209-8Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Seroquel PS ORAL 200MG BID PO Hospitalization - Neutrophil Count Cogentin C Initial or Prolonged Decreased Date:09/21/98ISR Number: 3133213-XReport Type:Direct Company Report # Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Seroquel PS ORAL 300MG BID PO Initial or Prolonged Effexor C Ativan C Roditussin C Date:09/22/98ISR Number: 3133165-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS ORAL 200 MG BID PO Haldol C Cogentin C Date:09/22/98ISR Number: 3134351-8Report Type:Expedited (15-DaCompany Report #1998AP47036 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abnormal Behaviour Foreign Seroquel PS ORAL 150 MG BID PO Catatonia Health Lorazepam C Convulsion Professional Olanzapine C Flat Affect Other Poverty Of Speech Pupil Fixed Trance 22-Feb-2006 08:31 AM Page: 37 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/98ISR Number: 3134353-1Report Type:Expedited (15-DaCompany Report #1998UW47828 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Seroquel PS ORAL 25 MG BID PO Aspiration Professional Thorazine C Circulatory Collapse Zoloft C Klonopin C Date:09/23/98ISR Number: 3133993-3Report Type:Expedited (15-DaCompany Report #1998UW48724 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel PS Initial or Prolonged Neuroleptic Malignant Professional Syndrome Date:09/25/98ISR Number: 3135323-XReport Type:Expedited (15-DaCompany Report #1998AP47912 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Balance Disorder Health PO Chorea Professional Lorazepam C Dysuria Zopiclone C Fall Modopar C Insomnia Haloperidol C Movement Disorder Psychomotor Hyperactivity Sedation Skin Disorder Date:09/25/98ISR Number: 3135324-1Report Type:Expedited (15-DaCompany Report #1998AP46403 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Seroquel PS ORAL 25 MG DAILY Pulmonary Embolism Health PO Professional Lofepramine C Other Frusemide C Co-Amoxiclav C Sulpride C Orphenadrine C Date:10/01/98ISR Number: 3136834-3Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Seroquel PS Zeneca ORAL 150 MG PO Q Initial or Prolonged Phosphokinase Increased Professional AM ; 250 MG Blood Creatine PO QHS Phosphokinase Mb Ativan C Increased Vistaril C Chest Pain 22-Feb-2006 08:31 AM Page: 38 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/98ISR Number: 3137314-1Report Type:Expedited (15-DaCompany Report #1998UW48801 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Intentional Overdose Health Seroquel PS Intervention to Respiratory Depression Professional Prevent Permanent Impairment/Damage Date:10/02/98ISR Number: 3262109-8Report Type:Periodic Company Report #1998UW47766 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Seroquel PS Initial or Prolonged Hypersomnia Professional Overdose Date:10/02/98ISR Number: 3262112-8Report Type:Periodic Company Report #1998UW47679 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Insomnia PO 5 MON Tachycardia Date:10/02/98ISR Number: 3262115-3Report Type:Periodic Company Report #1998UW47567 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Consumer Seroquel PS Initial or Prolonged Hypertension Memory Impairment Thinking Abnormal Date:10/02/98ISR Number: 3262116-5Report Type:Periodic Company Report #1998UW47512 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Health Seroquel PS ORAL 100 MG QD PO Initial or Prolonged Overdose Professional Pyrexia Company Renal Failure Representative Date:10/02/98ISR Number: 3262119-0Report Type:Periodic Company Report #1998UW47447 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Seroquel PS Initial or Prolonged Electrocardiogram Qt Professional Depakote C Required Prolonged Lotensin C Intervention to Overdose Trazodone C Prevent Permanent Sedation Prozac C Impairment/Damage Tachycardia 22-Feb-2006 08:31 AM Page: 39 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/98ISR Number: 3266228-1Report Type:Periodic Company Report #7396091 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Abbott - Depakote PS Abbott Professional Seroquel SS 100.000 MG BID Micronase C Ativan C Trilafon C Date:10/05/98ISR Number: 3138044-2Report Type:Direct Company Report # Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Quetiapine PS ORAL 50MG PO BID 3 DAY Date:10/05/98ISR Number: 3138483-XReport Type:Expedited (15-DaCompany Report #1998AP48494 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Oedema Foreign Seroquel PS ORAL 800 MG DAILY Hospitalization - Coma Study PO Initial or Prolonged Haemorrhagic Stroke Health Disability Intentional Overdose Professional Required Liver Function Test Intervention to Abnormal Prevent Permanent Loss Of Consciousness Impairment/Damage Suicide Attempt White Blood Cell Count Increased Date:10/06/98ISR Number: 3138699-2Report Type:Expedited (15-DaCompany Report #1998UW48527 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Phosphokinase Increased Professional Seroquel SS ORAL 400 MG DAILY Blood Creatine PO Phosphokinase Mb Seroquel SS ORAL 250 MG DAILY Increased PO Chest Pain Aspirin C Neuroleptic Malignant Ativan C Syndrome Sorbitol C Tylenol C Haldol C Vistaril C Date:10/09/98ISR Number: 3140444-1Report Type:Direct Company Report # Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Q HS 25 MG Professional 22-Feb-2006 08:31 AM Page: 40 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/98ISR Number: 3142407-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Conjunctivitis Allergic Health Seroquel PS Zeneca ORAL PO 100 MG BID Lacrimation Increased Professional Date:10/13/98ISR Number: 3143121-6Report Type:Expedited (15-DaCompany Report #1998UW48445 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Health Seroquel PS ORAL 25 MG BID PO Hospitalization - Second Degree Professional Seroquel SS ORAL 100 MG Initial or Prolonged Bradycardia Other ;150;200;250; Required Hypotension BID PO Intervention to Syncope Trazodone C Prevent Permanent Prolixin C Impairment/Damage Zyprexa C Date:10/13/98ISR Number: 3143122-8Report Type:Expedited (15-DaCompany Report #1998AP45316 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Foreign Seroquel PS ORAL 800 MG QD PO Cardiac Disorder Study Circulatory Collapse Health Weight Increased Professional Date:10/14/98ISR Number: 3141378-9Report Type:Expedited (15-DaCompany Report #1998AP45316 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS ORAL 800 MG QD PO Atherosclerosis Study Blood Alcohol Increased Health Cardiac Disorder Professional Cardiomegaly Circulatory Collapse Coronary Artery Disease Hypertension Weight Increased Date:10/16/98ISR Number: 3142838-7Report Type:Expedited (15-DaCompany Report #1998AP45316 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Foreign Seroquel PS ORAL 800 MG QD PO Cardiomegaly Study Circulatory Collapse Health Coronary Artery Disease Professional Hypertension Sinus Tachycardia Weight Increased 22-Feb-2006 08:31 AM Page: 41 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/98ISR Number: 3143101-0Report Type:Expedited (15-DaCompany Report #1998UW49033 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Anencephaly Seroquel PS Complications Of Maternal Exposure To Therapeutic Drugs Date:10/19/98ISR Number: 3144270-9Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Seroquel PS Zeneca Pharm 50 MG 2 X DAY Intervention to Abnormal Prevent Permanent Impairment/Damage Date:10/20/98ISR Number: 3143871-1Report Type:Expedited (15-DaCompany Report #1998UW49055 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Health Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Liver Function Test Professional PO Abnormal Tegretol C Tylenol C Date:10/21/98ISR Number: 3144893-7Report Type:Expedited (15-DaCompany Report #1998UW48789 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Seroquel PS ORAL 200MG HS PO, Professional 100MG QD PO Loxitane C Deseril C Valium C Enalapril C Date:10/27/98ISR Number: 3147784-0Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Lower Seroquel PS Zeneca ORAL 100MG BID PO Arthralgia Morphine Pump C Back Pain Skelaxin C Neck Pain Dyazide C Pain In Jaw Voltaren C Trazodone C Flagyl C Vicodin C Klonopin C Sinemet C 22-Feb-2006 08:31 AM Page: 42 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/98ISR Number: 3148184-XReport Type:Expedited (15-DaCompany Report #1998AP49533 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Foreign Seroquel PS ORAL 300 MG QD PO Initial or Prolonged Complications Of Maternal Health Cipramil SS ORAL 20 MG QD PO Exposure To Therapeutic Professional Folic Acid C Drugs Other Chlorpheniramine C Loratadine` C Date:10/27/98ISR Number: 3149099-3Report Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Seroquel PS Zeneca ORAL 175 MG BID PO Professional Serzone SS Bristol Meyers-Squibb ORAL 175 MG BID PO Date:10/29/98ISR Number: 3149084-1Report Type:Expedited (15-DaCompany Report #1998AP49716 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Foreign Seroquel PS ORAL 150 MG BID PO 10 MON Hospitalization - Pulse Absent Health Phenytoin C Initial or Prolonged Respiratory Arrest Professional Fluoxetine C Torsade De Pointes Date:10/29/98ISR Number: 3149085-3Report Type:Expedited (15-DaCompany Report #1998UW47195 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Seroquel PS ORAL 200 MG POL; Initial or Prolonged Professional 200 MG QD PO Tegretol C Date:10/30/98ISR Number: 3150291-2Report Type:Expedited (15-DaCompany Report #S98-UKI-00725-01(-0) Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Citalopram PS ORAL 20 MG DAILY, Health PO Professional Seroquel SS Folic Acid C Loratidine C Date:11/02/98ISR Number: 3151644-9Report Type:Expedited (15-DaCompany Report #1998UW49216 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Increased Health Seroquel PS ORAL 12.5 MG BID Initial or Prolonged Hypernatraemia Professional PO Hyperventilation Metabolic Acidosis Pco2 Decreased 22-Feb-2006 08:31 AM Page: 43 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/98ISR Number: 3151686-3Report Type:Expedited (15-DaCompany Report #1998UW48970 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Insufficiency Health Seroquel PS ORAL 300 MG PO Initial or Prolonged Blood Alkaline Professional Tegretol SS ORAL 600 MG QD PO Required Phosphatase Increased Cogentin C Intervention to Blood Chloride Increased Trilafon C Prevent Permanent Drug Interaction Impairment/Damage Electrolyte Imbalance Hyperkalaemia Hyponatraemia Date:11/09/98ISR Number: 3153662-3Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lenticular Opacities Seroquel PS Zeneca ORAL 300 MG QD PO Date:11/09/98ISR Number: 3154349-3Report Type:Expedited (15-DaCompany Report #1998UW48724 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Health Seroquel PS ORAL 25 MG QD PO Hospitalization - Coma Professional Prolixin SS INTRAMUSCULAR 37. 5 MG IM Initial or Prolonged Dermatitis Antabuse C Required Mental Impairment Intervention to Muscle Rigidity Prevent Permanent Neuroleptic Malignant Impairment/Damage Syndrome Date:11/10/98ISR Number: 3155861-3Report Type:Expedited (15-DaCompany Report #1998AP48494 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Oedema Foreign Seroquel PS ORAL 800 MG DAILY, Hospitalization - Coma Study PO Initial or Prolonged Electrocardiogram Health Disability Abnormal Professional Required Haemorrhagic Stroke Intervention to Hypotension Prevent Permanent Intentional Overdose Impairment/Damage Sedation Suicide Attempt Tachycardia Date:11/12/98ISR Number: 3156942-0Report Type:Expedited (15-DaCompany Report #1998AP49716 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Foreign Seroquel PS ORAL 150MG BID PO Required Pulse Absent Health Phenytoin C Intervention to Respiratory Arrest Professional Fluoxetine C Prevent Permanent Torsade De Pointes Other Madapar C Impairment/Damage Co-Amilofruse C Lactulose C 22-Feb-2006 08:31 AM Page: 44 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/98ISR Number: 3156955-9Report Type:Expedited (15-DaCompany Report #1998AP49961 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Foreign Seroquel PS Initial or Prolonged Sedation Study Chlormethiazole C Health Co-Codamol C Professional Dothiepin C Piroxicam C Date:11/13/98ISR Number: 3157420-5Report Type:Expedited (15-DaCompany Report #1998AP49997 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angina Pectoris Foreign Seroquel PS Cardiac Disorder Health Aspirin C Professional Oxprenolol C Other Amlodipine C Isosorbide Dinitrate C Date:11/13/98ISR Number: 3157422-9Report Type:Expedited (15-DaCompany Report #1998UW49274 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Seroquel PS ORAL 50 MG PO Initial or Prolonged Disturbance In Attention Health Warfarin Sodium C Dysphasia Professional Cyanocobalamin C Judgement Impaired Diltiazem Lethargy Hydrochloride C Sedation Digoxin C Timolol Maleate C Acetazolamide C Date:11/16/98ISR Number: 3270273-XReport Type:Periodic Company Report #19980800014 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Prilosec PS ORAL QD PO Drug Interaction Professional Seroquel SS 250 MG QD Risperdal C Klonopin C Cogentin C Depakote C Lescol C Calcium C Folate Sodium C Date:11/17/98ISR Number: 3158877-6Report Type:Expedited (15-DaCompany Report #1998AP49944 Age:39 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Disability Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 45 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Seroquel PS 800 MG DAILY Cardiac Failure Study PO Constipation Health Centrum C Cyanosis Professional Ileus Paralytic Liver Function Test Abnormal Oedema Peripheral Pericardial Effusion Pleural Effusion Tachycardia Viral Infection Weight Decreased Date:11/23/98ISR Number: 3161503-3Report Type:Expedited (15-DaCompany Report #1998UW49384 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Hyperchloraemic Study Seroquel PS ORAL 125 MG QD PO Hospitalization - Blood Pressure Decreased Health Acetysalicylic Acid C Initial or Prolonged Blood Urea Increased Professional Acetazolamide C Hypernatraemia Timolol Maleate C Lethargy Bisacodyl C Oliguria Artificial Tears C Oxygen Saturation Senna C Decreased Pneumonia Pneumonia Aspiration Date:11/23/98ISR Number: 3161507-0Report Type:Expedited (15-DaCompany Report #1998AP49997 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Seroquel PS ORAL 100 MG DAILY Health PO Professional Aspirin "Bayer" C Oxprenolol C Amlodipine C Isosorbide Dinitrate C Ibuprofen C Frusemide C Date:11/23/98ISR Number: 3161508-2Report Type:Expedited (15-DaCompany Report #1998UW49478 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Seroquel PS ORAL 50 MG QD PO; Initial or Prolonged Professional 100 MG QD PO Clozaril C Colace C Cold Capsules C 22-Feb-2006 08:31 AM Page: 46 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3162071-2Report Type:Direct Company Report # Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Seroquel PS ORAL 1 TAB PO Q HS Dry Mouth Hallucination, Visual Date:11/24/98ISR Number: 3162118-3Report Type:Direct Company Report # Age:16 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Seroquel PS Zeneca ORAL PO HS Intervention to Dyskinesia Nicoderm Patch 21 SS Alza INTRAVENOUS Prevent Permanent Eyelid Ptosis DRIP ONCE DAILY Impairment/Damage Headache Effexor C Hypertonia Depakote C Paranoia Date:11/24/98ISR Number: 3162344-3Report Type:Expedited (15-DaCompany Report #1998UW49478 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Seroquel PS ORAL 50 MG QD PO / Initial or Prolonged White Blood Cell Count Professional 100 MG QD PO Decreased Clozaril C Colace C Cold Capsules C Date:11/25/98ISR Number: 3163366-9Report Type:Expedited (15-DaCompany Report #1998UW49520 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Complete Professional Sinemet C Required Intervention to Prevent Permanent Impairment/Damage Date:11/25/98ISR Number: 3163367-0Report Type:Expedited (15-DaCompany Report #1998UW49515 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Seroquel PS ORAL 150 MG QD PO Initial or Prolonged Arthritis ; 200 MG QD Bone Pain PO Constipation Convulsion Dermatitis Dyskinesia Ear Pain Gastrointestinal Haemorrhage Neck Pain Renal Colic 22-Feb-2006 08:31 AM Page: 47 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/98ISR Number: 3165775-0Report Type:Expedited (15-DaCompany Report #1998UW49554 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Seroquel PS ORAL 800 MG QD PO Circulatory Collapse Professional Gabapentin C Coma Diabetic Ketoacidosis Transient Ischaemic Attack Date:12/07/98ISR Number: 3167300-7Report Type:Expedited (15-DaCompany Report #1998AP49944 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Seroquel PS ORAL 800 MG DAILY Hospitalization - Cardiac Failure Study PO Initial or Prolonged Constipation Health Centrum C Disability Cyanosis Professional Required Ileus Paralytic Intervention to Liver Function Test Prevent Permanent Abnormal Impairment/Damage Myocarditis Oedema Peripheral Pericardial Disease Pleural Disorder Tachycardia Viral Infection Weight Decreased Date:12/07/98ISR Number: 3168263-0Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Quetiapine PS ORAL 450 MG / QD /PO Docusate Sodium C Olanzapine C Depakote C Diazepam C Psyllium C Date:12/07/98ISR Number: 3168264-2Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Quetiapine PS ORAL 650 MG / QD / Decreased PO Multivitamins C Valproic Acid C Docusate Sodium C Olanzapine C Diazepam C Gabapentin C Docuate Sodium C 22-Feb-2006 08:31 AM Page: 48 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/98ISR Number: 3168266-6Report Type:Direct Company Report # Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Abnormal Quetiapine PS ORAL 300 MG / BID Thrombocytopenia / PO White Blood Cell Count Valproic Acid C Decreased Diphenhydramine Hcl C Date:12/09/98ISR Number: 3169506-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Impairment Clozapine PS ORAL 100MG PO BID Initial or Prolonged Neutropenia Quetiapine SS ORAL 25MG PO Other Pyrexia Streptococcal Sepsis Date:12/09/98ISR Number: 3169847-6Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Quetiapine PS ORAL 25 MG PO BID Initial or Prolonged Neutropenia Professional Clozaril SS ORAL 100 MG PO TID Other Pyrexia Date:12/10/98ISR Number: 3169450-8Report Type:Direct Company Report # Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Seroquel PS TOOK Faecaloma COMBINATION Priapism 2 WEEKS 2 WK Serzone SS TOOK COMBINATION 2 WEEKS 2 WK Ativan SS 2MG;1MG NOON 2MG HS 2 WK Date:12/11/98ISR Number: 3169675-1Report Type:Expedited (15-DaCompany Report #1998UW49520 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Health Seroquel PS ORAL 25 MG BID PO Hospitalization - Complete Professional Sinemet-Cr C Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:12/14/98ISR Number: 3286622-2Report Type:Periodic Company Report #1998UW47558 Age:27 YR Gender:Male I/FU:I Outcome PT Hospitalization - Overdose Initial or Prolonged Sedation 22-Feb-2006 08:31 AM Page: 49 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS Health Professional Other Date:12/14/98ISR Number: 3286624-6Report Type:Periodic Company Report #1998UW48225 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Foreign Seroquel PS ORAL 700 MG QD PO Initial or Prolonged Study Zopiclone C Health Cogentin C Professional Zyprexa C Other Date:12/14/98ISR Number: 3286625-8Report Type:Periodic Company Report #1998UW48134 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Foreign Seroquel PS ORAL 25 MG PO Initial or Prolonged Study Rivotril C Health Artane C Professional Other Date:12/14/98ISR Number: 3286627-1Report Type:Periodic Company Report #1998UW48108 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Foreign Seroquel PS ORAL 600 MG QD PO Initial or Prolonged Study Seroquel SS ORAL 700 MG QD PO Health Lorazepam C Professional Temazepam C Other Cisapride C Ranitidine C Date:12/14/98ISR Number: 3286628-3Report Type:Periodic Company Report #1998UW48082 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Decreased Professional Cogentin C Date:12/14/98ISR Number: 3286629-5Report Type:Periodic Company Report #1998UW48080 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Seroquel PS ORAL 300 MG BID PO Initial or Prolonged Decreased Professional Effexor C Ativan C Robitussin C Vitamin E C Peri-Colace C 22-Feb-2006 08:31 AM Page: 50 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/98ISR Number: 3286631-3Report Type:Periodic Company Report #1998UW48072 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Seroquel PS ORAL 250 MG BID PO Initial or Prolonged Decreased Professional Lithium C Milk Of Magnesia C Date:12/14/98ISR Number: 3286633-7Report Type:Periodic Company Report #1998UW47887 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Drug Ineffective PO Emotional Disorder Seroquel SS ORAL 400 MG DAILY Suicidal Ideation PO Clozaril C Depakote C Ativan C Date:12/14/98ISR Number: 3286634-9Report Type:Periodic Company Report #1998UW48170 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Seroquel PS Initial or Prolonged Irritability Date:12/14/98ISR Number: 3286636-2Report Type:Periodic Company Report #1998UW48526 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Seroquel PS ORAL 12000 MG PO Initial or Prolonged Coma Professional Required Electrocardiogram Qt Intervention to Corrected Interval Prevent Permanent Prolonged Impairment/Damage Overdose Tachycardia Date:12/14/98ISR Number: 3286638-6Report Type:Periodic Company Report #1998UW48644 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Seroquel PS ORAL 200 MGQD PO Initial or Prolonged Health Depakote C Professional Captopril C Date:12/14/98ISR Number: 3286640-4Report Type:Periodic Company Report #1998UW48859 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Health Seroquel PS ORAL 100 MG QD PO Professional Trazodone C Eskalith C Prozac C Depakote C Herbal Thoid 22-Feb-2006 08:31 AM Page: 51 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medication C Date:12/14/98ISR Number: 3286642-8Report Type:Periodic Company Report #1998UW48956 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Seroquel PS ORAL 9 G PO Initial or Prolonged Increased Professional Klonopin C Required Aspartate Intervention to Aminotransferase Prevent Permanent Increased Impairment/Damage Blood Creatine Phosphokinase Increased Chromaturia Overdose Date:12/14/98ISR Number: 3286644-1Report Type:Periodic Company Report #1998UW49037 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Seroquel PS ORAL 1200 MG PO Initial or Prolonged Corrected Interval Professional Prolonged Company Overdose Representative Date:12/14/98ISR Number: 3286646-5Report Type:Periodic Company Report #1998UW49078 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Study Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Health PO Required Professional Vitamin E C Intervention to Sertraline Prevent Permanent Hydrochloride C Impairment/Damage Multivitamins C Alprazolam C Ambesol C Hydrocortisone C Date:12/14/98ISR Number: 3286648-9Report Type:Periodic Company Report #1998UW48943 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Seroquel PS Initial or Prolonged Date:12/15/98ISR Number: 3170463-0Report Type:Direct Company Report # Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Seroquel PS ORAL 150MG PO Q AM Rash Erythematous & HS Proliocin C Cogentin C Aenolol C 22-Feb-2006 08:31 AM Page: 52 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/98ISR Number: 3171002-0Report Type:Expedited (15-DaCompany Report #1998UW49478 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Seroquel PS ORAL 50 MG QD PO Hospitalization - Sepsis Professional Seroquel SS ORAL 100 MG QD PO Initial or Prolonged Clozaril C Colace C Cold Capsules C Date:12/16/98ISR Number: 3171006-8Report Type:Expedited (15-DaCompany Report #1998UW49679 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alopecia Foreign Seroquel PS Intervention to Dyskinesia Study Prevent Permanent Eye Infection Health Impairment/Damage Logorrhoea Professional Date:12/17/98ISR Number: 3170805-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Seroquel PS ORAL PO 300MG QD Depakote C Benztropine Mesylate C Paxil C Haldol C Date:12/17/98ISR Number: 3171733-2Report Type:Expedited (15-DaCompany Report #1998AP48494 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Oedema Foreign Seroquel PS ORAL 800MG DAILY Hospitalization - Coma Study PO Initial or Prolonged Electrocardiogram Qt Health Disability Corrected Interval Professional Required Prolonged Other Intervention to Electrocardiogram St Prevent Permanent Segment Abnormal Impairment/Damage Hypotension Intentional Overdose Liver Function Test Abnormal Loss Of Consciousness Sedation Suicide Attempt Tachycardia White Blood Cell Count Increased Date:12/17/98ISR Number: 3171993-8Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Quetiapine PS 1 QID & HS Initial or Prolonged Fall Orthostatic Hypotension 22-Feb-2006 08:31 AM Page: 53 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/98ISR Number: 3171656-9Report Type:Expedited (15-DaCompany Report #981001-107013759 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Haldol PS 10 DAY Confusional State Professional Risperidone SS ORAL .5 MG, BID Depressed Level Of ORAL Consciousness Quetiapine Fumarate SS ORAL 12.5 MG, BID Haematuria ORAL Joint Stiffness Neuroleptic Malignant Syndrome Pyrexia Date:12/21/98ISR Number: 3172360-3Report Type:Expedited (15-DaCompany Report #1998UW49826 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Seroquel PS Initial or Prolonged Dermatitis Professional Nephritis Interstitial Company Representative Date:12/21/98ISR Number: 3173093-XReport Type:Direct Company Report # Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Paroxetine PS ORAL 20 MG PO QHS Ileus Paralytic Seroquel SS 600 MG / DAY Tylenol C Depakote C Metamocil C Dulcolax C Colace C Premarin C Aspirin C Vit E C Mylanta C Date:12/21/98ISR Number: 3173162-4Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Seroquel PS Zenica 100MG Q AM; 400MG Q HS; INCREASED ON 10/26/98 Buspar C Benadryl C Date:12/22/98ISR Number: 3173489-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Anaemia Bipolar I Disorder Cataract Operation Hypothyroidism 22-Feb-2006 08:31 AM Page: 54 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impulse-Control Disorder Leukopenia Neutropenia Report Source Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 200 MG PO BID Drojepsion SS 10 MG PER DAY Depakote Tablet SS 1250 MG PER DAY Date:12/23/98ISR Number: 3173702-5Report Type:Expedited (15-DaCompany Report #1998AP50640 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Seroquel PS Health Chlorpromazine C Professional Diazepam C Heminevrin C Date:12/24/98ISR Number: 3173345-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neutropenia Clozapine PS ORAL 300 MG PO QD Oxygen Saturation Quetiapine SS ORAL 50 MG PO QD Decreased Norplant Insertion C Pneumonia Nyquil C Sepsis Theraflu C Shock Iburprofen C White Blood Cell Count Decreased Date:12/28/98ISR Number: 3176185-4Report Type:Expedited (15-DaCompany Report #1998UW48859 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Seroquel PS ORAL 100MG QD PO Chest Pain Professional Trazodone C Condition Aggravated Eskalith C Drug Abuser Prozac C Drug Toxicity Depakote C Fluid Retention Herbal Thyroid Hepatomegaly Medication C Myocardial Infarction Overdose Pulmonary Oedema Splenomegaly Date:12/28/98ISR Number: 3176645-6Report Type:Expedited (15-DaCompany Report #1998UW49885 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Seroquel PS ORAL 300 MG TID PO Initial or Prolonged Professional Risperdal C Celexa C 22-Feb-2006 08:31 AM Page: 55 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/98ISR Number: 3176406-8Report Type:Expedited (15-DaCompany Report #1998AP50769 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Seroquel PS ORAL 50 MG DAILY Cardiac Failure Health PO Clostridium Colitis Professional Seroquel SS ORAL 25 MG DAILY Dehydration Other PO Depressed Level Of Co-Beneldopa C Consciousness Amitriptyline C Diarrhoea Senna C Enterocolitis Amoxycillin C Haemorrhagic Haloperidol C Intestinal Ischaemia Bisacodyl C Lactic Acidosis Domperidone C Malaise Paracetamol C Megacolon Selegiline C Shock Co-Danthrusate C White Blood Cell Count Tolcapone C Increased X-Ray Gastrointestinal Tract Abnormal Date:12/29/98ISR Number: 3176407-XReport Type:Expedited (15-DaCompany Report #1998AP50776 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Seroquel PS ORAL 200 MG QD PO Initial or Prolonged Phosphokinase Increased Health Cephalexin C Hyperthermia Malignant Professional Metronidazole C Other Paracetamol C Thioridazine C Terfenadine C Lactulose C Methysergide C Date:12/29/98ISR Number: 3176408-1Report Type:Expedited (15-DaCompany Report #1998UW49802 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Accidental Exposure Consumer Seroquel PS ORAL 100 MG QD PO Intervention to Amnesia Alprazolam C Prevent Permanent Medication Error Serzone C Impairment/Damage Date:12/29/98ISR Number: 3177443-XReport Type:Expedited (15-DaCompany Report #USA/98/02754/LEX Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Hospitalization - Drug Interaction Professional Seroquel SS Initial or Prolonged Infection Colace (Docusate Influenza Like Illness Sodium) C Leukopenia 22-Feb-2006 08:31 AM Page: 56 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/98ISR Number: 3176662-6Report Type:Expedited (15-DaCompany Report #1998UW49911 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Seroquel PS ORAL 500 MG QD PO Initial or Prolonged Condition Aggravated Study Clozapine C Hallucination Health Nefazodone C Professional Clanzapine C Other Penicillin C Nefazodone C Date:12/31/98ISR Number: 3176181-7Report Type:Direct Company Report # Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Seroquel PS Initial or Prolonged Lethargy Date:01/04/99ISR Number: 3177452-0Report Type:Expedited (15-DaCompany Report #1998AP50790 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Cardiac Failure Study PO; 600 MG Cardiac Murmur Health DIALY PO Congestive Cardiomyopathy Professional Lactulose C Dyspnoea Exertional Ejection Fraction Abnormal Gallop Rhythm Present Low Cardiac Output Syndrome Necrosis Oedema Peripheral Pulmonary Hypertension Rales Sinus Tachycardia Venous Pressure Jugular Increased Date:01/04/99ISR Number: 3177453-2Report Type:Expedited (15-DaCompany Report #1998UW49826 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Seroquel PS Initial or Prolonged Dermatitis Professional Prednisone C Nephritis Interstitial Company Representative Date:01/05/99ISR Number: 3178093-1Report Type:Expedited (15-DaCompany Report #1998UW49216 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Increased Health Seroquel PS ORAL 12.5 MG BID Initial or Prolonged Hyperventilation Professional PO Metabolic Acidosis Lorazepam C Glyburide C Synthroid C 22-Feb-2006 08:31 AM Page: 57 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prinivil C Colchicine C Diflucan C Date:01/07/99ISR Number: 3179033-1Report Type:Direct Company Report # Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Seroquel PS Zeneca 25 Q AM ; 25 Initial or Prolonged Q PM ; 50 Q HS Date:01/08/99ISR Number: 3178690-3Report Type:Direct Company Report # Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Seroquel PS Zeneca ORAL 100 BID ORAL Initial or Prolonged Fluvoxamine C Lorazepam C Zolpidem C Levothyroxine C Naltrexone C Clonazepam C Date:01/12/99ISR Number: 3179776-XReport Type:Expedited (15-DaCompany Report #1999UW00073 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel PS ORAL 25 MG QD PO Initial or Prolonged Heart Rate Abnormal Professional Darvocet C Neurological Symptom Date:01/19/99ISR Number: 3181917-5Report Type:Expedited (15-DaCompany Report #1998UW49478 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Seroquel PS ORAL 50 MG QD Hospitalization - Bacterial Sepsis Professional Seroquel SS ORAL 100 MG QD Initial or Prolonged Megakaryocytes Increased Clozaril SS ORAL 300 MG QD Neutropenia Colace C Pneumonia Cold Capsules C Sepsis White Blood Cell Count Decreased Date:01/19/99ISR Number: 3182146-1Report Type:Expedited (15-DaCompany Report #1998UW49826 Age:29 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Blood Creatinine Increased Computerised Tomogram Abnormal Eosinophil Count Increased 22-Feb-2006 08:31 AM Page: 58 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Erythema Erythema Multiforme Nephritis Interstitial Report Source Product Role Manufacturer Route Dose Duration Proteinuria Health Seroquel PS ORAL 25 MG BID PO Vomiting Professional Seroquel SS ORAL 50 MG BID PO Company Atarax C Representative Lithobid C Navane C Tegretol C Date:01/25/99ISR Number: 3185739-0Report Type:Expedited (15-DaCompany Report #1998UW47956 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Professional Haldol C Cogentin C Date:01/26/99ISR Number: 3185424-5Report Type:Direct Company Report # Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apnoea Quetiapine PS 25 MG X 1 Blood Pressure Decreased DOSE Coma Cyanosis Pulse Pressure Decreased Date:01/26/99ISR Number: 3186275-8Report Type:Expedited (15-DaCompany Report #1998UW45416 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Health Seroquel PS Intervention to Drug Ineffective Professional Depokate C Prevent Permanent Neutropenia Ativan C Impairment/Damage Thrombocytopenia Neurontin C Date:01/28/99ISR Number: 3187239-0Report Type:Periodic Company Report #1999AP00448 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Seroquel PS ORAL 400 MG BID PO Initial or Prolonged Nausea Study Ranitidine C Disability Sedation Health Clonazepam C Professional Date:01/28/99ISR Number: 3187240-7Report Type:Expedited (15-DaCompany Report #1998UW49478 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Seroquel PS ORAL 50 MG QD PO; Hospitalization - Bone Marrow Depression Professional 100 MG QD PO Initial or Prolonged Gram Stain Negative Clozaril SS ORAL 300 MG QD PO Neutropenia Colace C Pneumonia Cold Capsules C Sepsis 22-Feb-2006 08:31 AM Page: 59 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/99ISR Number: 3189548-8Report Type:Expedited (15-DaCompany Report #USA/98/02754/LEX Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril (Clozapine) PS ORAL 300MG ORAL Hospitalization - Bacterial Sepsis Professional Seroquel SS 100MG Initial or Prolonged Drug Interaction Colace C Required Infection Intervention to Influenza Like Illness Prevent Permanent Leukopenia Impairment/Damage Neutropenia Pneumonia Date:02/02/99ISR Number: 3190132-0Report Type:Expedited (15-DaCompany Report #1998UW49885 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Seroquel PS ORAL 300 MG TID PO Initial or Prolonged Agranulocytosis Professional Risperdal C Neutrophil Count Celexa C Decreased Zyprexa C Pyrexia Date:02/02/99ISR Number: 3190135-6Report Type:Expedited (15-DaCompany Report #1999UW00073 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel PS ORAL 25 MG QD PO Initial or Prolonged Heart Rate Irregular Professional Darvocet C Neurological Symptom Tylenol C Colace C Date:02/04/99ISR Number: 3298331-4Report Type:Periodic Company Report #M085541 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Health Serzone Tabs PS ORAL 300 MG BID Visual Disturbance Professional ORAL 2 WK Seroquel SS 50 MG TID 2 WK Ativan C Date:02/04/99ISR Number: 3301248-XReport Type:Periodic Company Report #M076193 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Serzone Tabs PS ORAL SMALL DOSE(S) Professional PO Seroquel SS SMALL DOSE(S) Date:02/04/99ISR Number: 3303172-5Report Type:Periodic Company Report #M074752 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Serzone Tabs PS ORAL ORAL Sedation Professional Seroquel SS 22-Feb-2006 08:31 AM Page: 60 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/99ISR Number: 3194426-4Report Type:Expedited (15-DaCompany Report #1996AP20763 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Seroquel PS Initial or Prolonged Clonic Convulsion Study Delirium Health Disorientation Professional Dry Mouth Haematuria Restlessness Sedation Urinary Incontinence Urinary Retention Date:02/09/99ISR Number: 3194428-8Report Type:Expedited (15-DaCompany Report #1998AP46291 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Seroquel PS ORAL 750 MG DAILY Hospitalization - Leukopenia Health PO Initial or Prolonged Lymphopenia Professional Droperidol C Neutropenia Stelazine C Olanzapine C Diazepam C Date:02/12/99ISR Number: 3197854-6Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Seroquel PS ORAL 50 MG PO 4 DAY Dyskinesia Professional Effexor C Eyelid Ptosis Depakote C Headache Nicoderm Patch C Hypertonia Injury Tongue Disorder Date:02/12/99ISR Number: 3198169-2Report Type:Expedited (15-DaCompany Report #1999UW00377 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Study Seroquel PS ORAL 800 MG QD PO Initial or Prolonged Headache Health Seroquel SS ORAL 400 MG QD PO Influenza Professional Seroquel SS ORAL 700 MG QD PO Migraine Seroquel SS ORAL 600 MG QD PO Pyrexia Seroquel SS ORAL 500 MG QD PO Vision Blurred Seroquel SS ORAL 300 MG QD PO Vomiting Lithium C Ibuprofin C Tylenol C Benzoyl Peroxide C 22-Feb-2006 08:31 AM Page: 61 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/99ISR Number: 3198172-2Report Type:Expedited (15-DaCompany Report #1999AP00771 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Health PO 1 MON Professional Chlorpromazine C Date:02/16/99ISR Number: 3199759-3Report Type:Expedited (15-DaCompany Report #1998UW45634 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Clostridium Colitis Foreign Seroquel PS ORAL 100 MG QD PO Hospitalization - Leukopenia Health Valproic Acid C Initial or Prolonged Professional Required Other Intervention to Prevent Permanent Impairment/Damage Date:02/16/99ISR Number: 3199809-4Report Type:Expedited (15-DaCompany Report #1998UW47195 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Seroquel PS ORAL 200 MG PO Initial or Prolonged Neutrophil Count Professional Seroquel SS ORAL 200 MG QD PO Decreased Seroquel SS Date:02/17/99ISR Number: 3200523-7Report Type:Expedited (15-DaCompany Report #1999UW00528 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Seroquel PS 600 MG DAILY Initial or Prolonged Blood Creatine Professional Risperdal SS ORAL 4.5 MG QD PO; Phosphokinase Increased 3 MG BID PO Coma Thorazine SS ORAL 3 MG BID PO Confusional State Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Tachycardia Tremor Date:02/22/99ISR Number: 3205535-5Report Type:Periodic Company Report #8-98365-079A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Consumer Effexor Xr Capsules PS ORAL 75 MG THREE Dyspepsia TIMES DAILY Nausea ORAL Adderall (Dextroamphetamine/ Amphetamine Mixture) Tablets SS ORAL ORAL Seroquel (Quetiapine) Tablets SS ORAL ORAL Xanax C 22-Feb-2006 08:31 AM Page: 62 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/99ISR Number: 3204467-6Report Type:Expedited (15-DaCompany Report #1998UW48789 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Health Seroquel PS ORAL 200 MG HS Disability Decreased Activity Professional PO-100 MG QD Pulmonary Embolism PO Venous Thrombosis Limb Loxitane C Deseril C Valium C Enalapril C Date:02/23/99ISR Number: 3204619-5Report Type:Expedited (15-DaCompany Report #1999UW00339 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Seroquel PS ORAL 25 MG QID PO Initial or Prolonged Phosphokinase Increased Professional Delirium Fall Haemorrhagic Stroke Neuroleptic Malignant Syndrome Pyrexia Date:02/24/99ISR Number: 3206730-1Report Type:Expedited (15-DaCompany Report #1999AP00935 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Blood Creatine Health PO Phosphokinase Increased Professional Aspirin C Blood Lactate Pergolide C Dehydrogenase Increased Madopar C Electrocardiogram Gaviscon C Abnormal Fall Loss Of Consciousness Upper Respiratory Tract Infection Date:02/24/99ISR Number: 3206731-3Report Type:Expedited (15-DaCompany Report #1999AP00931 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Seroquel PS Hospitalization - Consciousness Study Seroquel SS ORAL 200 MG BID PO Initial or Prolonged Overdose Health Seroquel SS ORAL 600 MG DAILY Required Sedation Professional PO Intervention to Temazepam C Prevent Permanent Lorazepam C Impairment/Damage 22-Feb-2006 08:31 AM Page: 63 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3207977-0Report Type:Expedited (15-DaCompany Report #1998UW45634 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Clostridium Colitis Foreign Seroquel PS ORAL 100 MG QD PO Hospitalization - Condition Aggravated Health Valproic Acid C Initial or Prolonged Leukopenia Professional Primaxin C Required Other Intervention to Prevent Permanent Impairment/Damage Date:02/26/99ISR Number: 3208492-0Report Type:Expedited (15-DaCompany Report #1998AP50790 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Cardiac Failure Study PO; 600 MG Cardiac Murmur Health DAILY PO Congestive Cardiomyopathy Professional Lactulose C Drug Toxicity Other Dyspnoea Exertional Ejection Fraction Abnormal Gallop Rhythm Present Necrosis Oedema Oedema Peripheral Pulmonary Hypertension Rales Sinus Tachycardia Sinusitis Vein Disorder Date:02/26/99ISR Number: 3208493-2Report Type:Expedited (15-DaCompany Report #1999AP01074 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cold Sweat Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Coma Health PO Pallor Professional Aspirin "Bayer" C Sedation Other Chlormethiazole C Vomiting Temazepam C Co-Beneldopa C Date:02/26/99ISR Number: 3208966-2Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Parkinson'S Disease Quetiapine PS ORAL 200MG BID Intervention to ORAL Prevent Permanent Clotrimazole C Impairment/Damage Alum Hydrox/Mag Hydrox/Simeth Xtra C Albuterol Inhalant C Oxazepam C Acetaminophen C Magnesium Hydroxide C Lorazepam C 22-Feb-2006 08:31 AM Page: 64 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Guaifenesin C Albuterol Soln C Thiothixene C Sodium Chloride Soln C Loperamide C Felodipine C Date:03/01/99ISR Number: 3209512-XReport Type:Expedited (15-DaCompany Report #1998UW49826 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Abdominal Pain Upper Professional Seroquel SS ORAL 50 MG BID PO Blood Creatinine Company Atarax C Increased Representative Lithobid C Computerised Tomogram Navane C Abnormal Tegretol C Dermatitis Eosinophil Count Increased Erythema Multiforme Nephritis Interstitial Proteinuria Vomiting Date:03/02/99ISR Number: 3210244-2Report Type:Expedited (15-DaCompany Report #1998AP50640 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Seroquel PS Health Chlorpromazine C Professional Diazepam C Other Heminevrin C Date:03/02/99ISR Number: 3212171-3Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Quetiapine PS ORAL 300MG/QD/PO Dyskinesia Bupropion C Dysphagia Clonidon C Gait Disturbance Mult/Vitamins C Benztopline Mersylate C Date:03/05/99ISR Number: 3214274-6Report Type:Expedited (15-DaCompany Report #1999AP01214 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Impulsive Behaviour Foreign Seroquel PS ORAL 300 MG DAILY Irritability Health PO Professional Olanzapine C 22-Feb-2006 08:31 AM Page: 65 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/99ISR Number: 3219714-4Report Type:Periodic Company Report #1998UW49165 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Health Seroquel PS ORAL 50 MG BID PO Intervention to Abnormal Professional Mv C Prevent Permanent Oyst-Cal C Impairment/Damage Provera C Premarin C Date:03/08/99ISR Number: 3219718-1Report Type:Periodic Company Report #1998UW49078 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Study Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Health PO Required Professional Vitamin E C Intervention to Sertraline Prevent Permanent Hydrochloride C Impairment/Damage Multivitamins C Alprazolam C Ambesol C Hydrocortisone C Date:03/08/99ISR Number: 3219722-3Report Type:Periodic Company Report #1998UW49325 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Skin Disorder Health Seroquel PS Initial or Prolonged Professional Date:03/08/99ISR Number: 3219730-2Report Type:Periodic Company Report #1998UW49467 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Seroquel PS ORAL 25 MG HS PO; Initial or Prolonged Decreased Professional 75 MG HS PO Alprazolam C Calcium Carbonate C Ceftriaxone C Lactulose C Nefazodone C Sular C Selegiline C Levodopa-Carbidopa C Date:03/08/99ISR Number: 3219732-6Report Type:Periodic Company Report #1998UW49459 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Study Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Health Docusate Sodium C Professional Isosorbide C Aspirin C Levofloxacin C Famotidine C 22-Feb-2006 08:31 AM Page: 66 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/99ISR Number: 3219734-XReport Type:Periodic Company Report #1998UW49507 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel PS ORAL 100 MG BID PO Intervention to Professional Prevent Permanent Impairment/Damage Date:03/08/99ISR Number: 3219737-5Report Type:Periodic Company Report #1998UW49604 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Overdose Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:03/08/99ISR Number: 3219740-5Report Type:Periodic Company Report #1998UW49829 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Health Seroquel PS Initial or Prolonged Professional Dilantin C Company Representative Date:03/08/99ISR Number: 3219742-9Report Type:Periodic Company Report #1998UW49823 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS Intervention to Professional Haldol Decanoate C Prevent Permanent Haldol C Impairment/Damage Depakote C Paxil C Cogentin C Furosemide C Zestril C Levoxyl C Zyprexa C Date:03/08/99ISR Number: 3219745-4Report Type:Periodic Company Report #1998UW49777 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Seroquel PS Initial or Prolonged Prolonged Health Olanzapine SS Overdose Professional Divalproex C Date:03/08/99ISR Number: 3219747-8Report Type:Periodic Company Report #1998UW49889 Age:20 MON Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 67 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Health Seroquel PS 100 MG Tachycardia Professional Date:03/08/99ISR Number: 3219750-8Report Type:Periodic Company Report #1998UW49887 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Seroquel PS ORAL 25 MG QD PO; Initial or Prolonged Agitation Professional 375 MG PO Date:03/08/99ISR Number: 3219753-3Report Type:Periodic Company Report #1999UW00245 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Study Seroquel PS ORAL 200 MG QD PO Initial or Prolonged Health Professional Date:03/08/99ISR Number: 3219754-5Report Type:Periodic Company Report #1999UW00267 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Seroquel PS Initial or Prolonged Professional Date:03/08/99ISR Number: 3219755-7Report Type:Periodic Company Report #1999UW00313 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Foreign Seroquel PS Initial or Prolonged Study Clonazepam C Health Professional Other Date:03/08/99ISR Number: 3326018-8Report Type:Periodic Company Report #1999UW00283 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Consumer Seroquel PS ORAL 12.5 MG QD PO Hypersomnia Seroquel SS ORAL 25 MG QD PO Vasodilatation Date:03/08/99ISR Number: 3326021-8Report Type:Periodic Company Report #1999UW00279 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Seroquel PS ORAL 50 MG QD PO Decreased Professional Seroquel SS ORAL 100 MG QD PO Seroquel SS ORAL 200 MG QD PO Seroquel SS ORAL 300 MG QD PO Seroquel SS ORAL 400 MG QD PO 22-Feb-2006 08:31 AM Page: 68 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS ORAL 600 MG QD PO Depakote C Date:03/08/99ISR Number: 3326023-1Report Type:Periodic Company Report #1999UW00248 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Health Seroquel PS ORAL 50 MG BID PO Dyskinesia Professional Klonopin C Restlessness Remeron C Weight Decreased Depakote C Xanax C Date:03/08/99ISR Number: 3326025-5Report Type:Periodic Company Report #1999UW00173 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Consumer Seroquel PS ORAL 200 MG QD PO Date:03/08/99ISR Number: 3326027-9Report Type:Periodic Company Report #1999UW00131 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Visual Field Defect Health Seroquel PS ORAL 100 MG QAM PO Professional Seroquel SS ORAL 200 MG HS PO Haldol C Moban C Risperdal C Loxitane C Date:03/08/99ISR Number: 3326029-2Report Type:Periodic Company Report #1999UW00062 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Macular Degeneration Health Seroquel PS Professional Date:03/08/99ISR Number: 3326031-0Report Type:Periodic Company Report #1999UW00010 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Consumer Seroquel PS ORAL 200 MG HS PO Abnormal Dreams Effexor C Ambien C Adderall C Xanax C Date:03/08/99ISR Number: 3326032-2Report Type:Periodic Company Report #1998UW49954 Age:46 YR Gender:Male I/FU:I Outcome PT Dermatitis Dyshidrosis Eye Pain Flushing 22-Feb-2006 08:31 AM Page: 69 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Stomatitis Tongue Oedema Report Source Product Role Manufacturer Route Dose Duration Ulcer Health Seroquel PS ORAL 200 MG BID PO Professional Seroquel SS ORAL 25 MG HS PO Risperdal C Moban C Effexor C Date:03/08/99ISR Number: 3326035-8Report Type:Periodic Company Report #1998UW49943 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Seroquel PS White Blood Cell Count Professional Tegretol C Decreased Company Representative Date:03/08/99ISR Number: 3326036-XReport Type:Periodic Company Report #1998UW49851 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Seroquel PS ORAL 200 MG QD PO Dyskinesia Seroquel SS ORAL 25 MG QD PO Sedation Weight Increased Date:03/08/99ISR Number: 3326039-5Report Type:Periodic Company Report #1998UW49743 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Seroquel PS ORAL 400 MG QD PO Bipolar I Disorder Professional Clozaril SS 100 MG QD Confusional State Drug Interaction Intermittent Explosive Disorder Mania Date:03/08/99ISR Number: 3326041-3Report Type:Periodic Company Report #1998UW49690 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Seroquel PS Ecchymosis Professional Date:03/08/99ISR Number: 3326043-7Report Type:Periodic Company Report #1998UW49594 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Health Seroquel PS ORAL 25 MG QD PO Fatigue Professional Trilafon C Iron Deficiency Anaemia Cogentin C Depakote C Ativan C 22-Feb-2006 08:31 AM Page: 70 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/99ISR Number: 3326058-9Report Type:Periodic Company Report #1998UW49576 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Pain Consumer Seroquel PS ORAL 100 MG QD PO Oedema Restlessness Date:03/08/99ISR Number: 3326059-0Report Type:Periodic Company Report #1998UW49555 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coma Health Seroquel PS ORAL 300 MG QD PO Professional Gabapentin C Prolixin C Date:03/08/99ISR Number: 3326083-8Report Type:Periodic Company Report #1998UW49490 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Seroquel PS ORAL 100 MG BID PO Movement Disorder Risperdal C Date:03/08/99ISR Number: 3326085-1Report Type:Periodic Company Report #1998UW49475 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Seroquel PS ORAL 12.5 MG QD PO Anorexia Seroquel SS ORAL 50 MG QD PO Coma Hallucination Date:03/08/99ISR Number: 3326088-7Report Type:Periodic Company Report #1998UW49455 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paraesthesia Consumer Seroquel PS ORAL 25 MG QD PO Restlessness Xanax C Effexor C Date:03/08/99ISR Number: 3326090-5Report Type:Periodic Company Report #1998UW49445 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Erythematous Health Seroquel PS ORAL 55 MG QD PO Vasculitis Professional Date:03/08/99ISR Number: 3326092-9Report Type:Periodic Company Report #1998UW49403 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Consumer Seroquel PS ORAL 25 MG QD PO Neck Pain Tension 22-Feb-2006 08:31 AM Page: 71 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/99ISR Number: 3326093-0Report Type:Periodic Company Report #1998UW49371 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Memory Impairment Health Seroquel PS ORAL 150 MG QD PO Mental Impairment Professional Roxicet C Serzone C Date:03/08/99ISR Number: 3326094-2Report Type:Periodic Company Report #1998UW49353 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Seroquel PS ORAL 100 MG QD PO Oedema Peripheral Professional Zoloft C Skin Disorder Company Pepcid C Representative Date:03/08/99ISR Number: 3326095-4Report Type:Periodic Company Report #1998UW49352 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Seroquel PS ORAL 300 MG QD PO Joint Swelling Professional Muscle Spasms Company Oedema Peripheral Representative Date:03/08/99ISR Number: 3326096-6Report Type:Periodic Company Report #1998UW49255 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Health Seroquel PS Malaise Professional Date:03/08/99ISR Number: 3326097-8Report Type:Periodic Company Report #1998UW46628 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Health Seroquel PS ORAL 50 MG TID PO 2 WK Priapism Professional Serzone C Visual Disturbance Company Ativan C Representative Date:03/15/99ISR Number: 3222237-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Seroquel PS Zeneca 50 MG HS, Intervention to Cholelithiasis THEN Prevent Permanent Cholestasis INCREASED TO Impairment/Damage Hepatitis 100 MG HS, Lethargy THEN 50 MG Liver Function Test Abnormal 22-Feb-2006 08:31 AM Page: 72 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/99ISR Number: 3222573-7Report Type:Expedited (15-DaCompany Report #1998AP50790 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged C-Reactive Protein Study PO Required Increased Health Seroquel SS ORAL 600 MG DAILY Intervention to Cardiac Failure Professional PO Prevent Permanent Cardiac Murmur Lactulose C Impairment/Damage Cardiac Output Decreased Congestive Cardiomyopathy Drug Toxicity Dyspnoea Exertional Ejection Fraction Abnormal Gallop Rhythm Present Gamma-Glutamyltransferase Increased Heart Rate Increased Oedema Peripheral Pulmonary Hypertension Rales Sinus Tachycardia Sinusitis Date:03/18/99ISR Number: 3222250-2Report Type:Expedited (15-DaCompany Report #1998UW43888 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Seroquel PS ORAL 50 MG BID PO Phosphokinase Increased Professional Carbamazepine C Influenza Laxative C Muscle Rigidity Haloperidol C Neuroleptic Malignant Sertraline Syndrome Hydrochloride C Pneumonia Aspiration Clomazepam C Pyrexia Date:03/22/99ISR Number: 3223966-4Report Type:Expedited (15-DaCompany Report #1999UW00945 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Consciousness Health Epival C Diplopia Professional Chloral Hydrate C Hypotension Other Clonazepam C Intentional Overdose Tachycardia Date:03/23/99ISR Number: 3225639-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cholelithiasis Health Seroquel PS Zeneca 50 MG HS THE Intervention to Hepatitis Professional INCREASED 100 Prevent Permanent Lethargy MG HS THEN Impairment/Damage Liver Function Test 50MG BID + Abnormal 150 MG HS 6 DAY 22-Feb-2006 08:31 AM Page: 73 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/99ISR Number: 3226559-8Report Type:Expedited (15-DaCompany Report #1999UW00377 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Csf Pressure Abnormal Study Seroquel PS ORAL 800 MG QD PO; Initial or Prolonged Encephalopathy Health 400 MG QD Headache Professional PO;800 MG QD Influenza Like Illness PO; 700MG QD Migraine PO;500 MG QD Post Viral Fatigue Lithium C Syndrome Ibuprofin C Pyrexia Tylenol C Viral Infection Vision Blurred Vomiting Date:04/05/99ISR Number: 3232775-1Report Type:Expedited (15-DaCompany Report #1998UW49274 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Study Seroquel PS ORAL 50 MG PO Initial or Prolonged Confusional State Health Warfarin Sodium C Disturbance In Attention Professional Cyanocobalamin C Dysphasia Diltiazem Heart Rate Decreased Hydrochloride C Lethargy Donepezil C Sedation Digoxin C Timolol Maleate C Acetazolamide C Date:04/12/99ISR Number: 3238075-8Report Type:Expedited (15-DaCompany Report #1999UW00740 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blepharospasm Health Seroquel PS ORAL 25 MG QD PO Intervention to Condition Aggravated Professional Paxil C Prevent Permanent Eyelid Oedema Impairment/Damage Psychotic Disorder Date:04/13/99ISR Number: 3239174-7Report Type:Expedited (15-DaCompany Report #1999UW01246 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Seroquel PS ORAL 200 MG HS PO Professional Date:04/13/99ISR Number: 3239176-0Report Type:Expedited (15-DaCompany Report #001-0945-990134 Age:20 YR Gender:Male I/FU:I Outcome PT Hospitalization - Bipolar Disorder Initial or Prolonged Convulsion Dizziness Drug Interaction Drug Level Below Therapeutic Headache Lethargy 22-Feb-2006 08:31 AM Page: 74 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mania Status Epilepticus Report Source Product Role Manufacturer Route Dose Duration Health Neurontin Capsules Professional 300 Mg (Gabapentin) PS ORAL 2700 MG (900 MG, TID), PER ORAL (Lithium) SS (Seroquel) SS Ambien (Zolpidem Tartrate C Date:04/15/99ISR Number: 3239987-1Report Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Seroquel PS ORAL REFER TO Initial or Prolonged Diabetic Ketoacidosis CHART PO Date:04/16/99ISR Number: 3241399-1Report Type:Expedited (15-DaCompany Report #1999UW01310 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Seroquel PS Initial or Prolonged Discomfort Synthroid C Gastric Ulcer Perforation Xanax C Peritonitis Date:04/22/99ISR Number: 3244542-3Report Type:Direct Company Report # Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Quetiapine PS 100/200/200 Required Cogwheel Rigidity Klonopin SS 1MG HD Intervention to Drug Ineffective Depakote SS 1MG HD Prevent Permanent Joint Stiffness Impairment/Damage Date:04/23/99ISR Number: 3244702-1Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Pseudoephedrine PS 30MG TID QD Intentional Self-Injury Seroquel SS 25MG QM/50MG PRN Tegretal C Mild Of Magnessa C Cisapride C Vitamin E C Moprazule C 22-Feb-2006 08:31 AM Page: 75 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/99ISR Number: 3245806-XReport Type:Expedited (15-DaCompany Report #9900837 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Zoloft Tablets PS ORAL 100.00 MG Intervention to Electroencephalogram Professional TOTAL;DAILY;O Prevent Permanent Abnormal RAL Impairment/Damage Growth Retardation Luvox SS ORAL 100.00 MG TOTAL;BID;ORA L Seroquel SS ORAL 75.00 MG TOTAL;DAILY;O RAL Date:04/23/99ISR Number: 3246026-5Report Type:Expedited (15-DaCompany Report #1999UW01419 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conversion Disorder Consumer Seroquel PS Initial or Prolonged Dissociation Klonopin C Medication Error Paranoia Personality Disorder Date:04/27/99ISR Number: 3247359-9Report Type:Expedited (15-DaCompany Report #1999AP02235 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lower Respiratory Tract Foreign Seroquel PS ORAL 250 MG BID PO Infection Health Finasteride C Neutropenia Professional Frusemide C White Blood Cell Count Other Decreased Date:04/29/99ISR Number: 3249988-5Report Type:Expedited (15-DaCompany Report #001-0945-990134 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Neurontin Capsules Initial or Prolonged Convulsion Professional 300 Mg (Gabapentin) PS ORAL 2700 MG (900 Dizziness MG, TID) PER Drug Interaction ORAL Headache Eskalith (Lithium Lethargy Carbonate) SS Status Epilepticus Seroquel SS Ambien C Date:04/30/99ISR Number: 3251611-0Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Parkinson'S Disease Quetiapine PS ORAL 200MG , BID, Intervention to ORAL Prevent Permanent Clotrimazole C Impairment/Damage Alum Hydrox C Mag Hydrox C Simeth C Albuterol C 22-Feb-2006 08:31 AM Page: 76 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/99ISR Number: 3253035-9Report Type:Expedited (15-DaCompany Report #1999UW01246 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Seroquel PS ORAL 200 MG HS PO Professional Restoril C Wellbutrin C Zyprexa C Prempro C Dyazide C Motrin C Inhalers C Date:05/06/99ISR Number: 3255249-0Report Type:Direct Company Report # Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Health Seroquel PS Zeneca ORAL 100MG BID Intervention to Professional ORAL Prevent Permanent Pepcid C Impairment/Damage Predniisone C Neurontin C Synthroid C Date:05/10/99ISR Number: 3258086-6Report Type:Expedited (15-DaCompany Report #1999UW01583 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Seroquel PS ORAL 200 MG QD PO Initial or Prolonged Phosphokinase Increased Health Seroquel SS ORAL 50 MG QD PO Ecchymosis Professional Paxil SS ORAL 20MG QD PO Electrocardiogram Other Dalmane SS ORAL 30 MG QD PO Abnormal Intentional Overdose Liver Function Test Abnormal Date:05/10/99ISR Number: 3258089-1Report Type:Expedited (15-DaCompany Report #1999AP01737 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Seroquel PS ORAL 900 MG DAILY Initial or Prolonged Coma Health PO Condition Aggravated Professional Seroquel SS Depressed Level Of Other Carbamazepine C Consciousness Procyclidine C Heart Rate Increased Staring Date:05/11/99ISR Number: 3259183-1Report Type:Expedited (15-DaCompany Report #1999UW00969 Age:28 YR Gender:Male I/FU:I Outcome PT Death Acidosis Arrhythmia Asthenia Asthma Blood Potassium Decreased 22-Feb-2006 08:31 AM Page: 77 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disseminated Intravascular Coagulation Epistaxis Report Source Product Role Manufacturer Route Dose Duration Eye Haemorrhage Health Seroquel PS Hyperglycaemia Professional Lithium C Hyperpyrexia Company Hypertonia Representative Infection Influenza Like Illness Liver Function Test Abnormal Muscle Twitching Ventricular Fibrillation Weight Decreased Date:05/11/99ISR Number: 3259185-5Report Type:Expedited (15-DaCompany Report #1999UW01583 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Seroquel PS ORAL 200 , 50, MG Initial or Prolonged Phosphokinase Increased Health QD PO Ecchymosis Professional Paxil SS ORAL 20 MG QD PO Electrocardiogram Dalmane SS ORAL 30 MG QD PO Abnormal Intentional Overdose Liver Function Test Abnormal Suicide Attempt Date:05/12/99ISR Number: 3260021-1Report Type:Expedited (15-DaCompany Report #1999AP02538 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Foreign Seroquel PS ORAL 500MG QD PO 1 YR Jaundice Health Professional Other Date:05/13/99ISR Number: 3261273-4Report Type:Expedited (15-DaCompany Report #1999AP02517 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Coordination Abnormal Foreign Seroquel PS ORAL 200MG BID PO Fall Health Olanzapine C Nystagmus Professional Date:05/13/99ISR Number: 3261275-8Report Type:Expedited (15-DaCompany Report #1999UW00945 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Consciousness Health Epival C Diplopia Professional Chloral Hydrate C Hypotension Clonazepam C Intentional Overdose Suicide Attempt Tachycardia 22-Feb-2006 08:31 AM Page: 78 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/99ISR Number: 3262875-1Report Type:Expedited (15-DaCompany Report #1999AP02516 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coagulopathy Foreign Seroquel PS 1 WK Initial or Prolonged Psychotic Disorder Health Pulmonary Embolism Professional Transient Ischaemic Attack Date:05/17/99ISR Number: 3264600-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Seroquel PS 200MG BID Intervention to Tardive Dyskinesia Ativan C Prevent Permanent Artane C Impairment/Damage Zoloft C Trazadone C Fibercon C Multivitamin C Inderal C Depakote C Tegretol C Date:05/18/99ISR Number: 3264137-5Report Type:Expedited (15-DaCompany Report #1998AP49716 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Foreign Seroquel PS ORAL 150 MG BID PO Required Abnormal Health Phenytoin C Intervention to Grand Mal Convulsion Professional Fluoxetine C Prevent Permanent Hypoxia Madopar C Impairment/Damage Pulse Absent Co-Amilofruse C Respiratory Arrest Lactulose C Torsade De Pointes Amitryptiline C Transient Ischaemic Bendrofluazide C Attack Ventricular Extrasystoles Date:05/19/99ISR Number: 3265651-9Report Type:Expedited (15-DaCompany Report #1998UW49696 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Overdose Health Morphine C Professional Other Date:05/24/99ISR Number: 3268745-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Other Blast Cell Proliferation Laboratory Test Abnormal Leukaemia Neutrophil Count Decreased 22-Feb-2006 08:31 AM Page: 79 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Seroquel 25mg, 100 Mg (Zeneca) PS Zenica ORAL 150MG PO BID(4/15/99 AT THIS DOSE) Creat C Carborate C Multvit C Metamoli C Benzol C Retin A C Kebcomazole C Date:05/24/99ISR Number: 3269315-7Report Type:Expedited (15-DaCompany Report #1998UW49515 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Seroquel PS ORAL 150 MG QD PO; Initial or Prolonged Back Pain 200 MG QD PO Cataract Constipation Convulsion Dehydration Dermatitis Dyskinesia Ear Pain Gastric Haemorrhage Gastrointestinal Disorder Haematemesis Monarthritis Mouth Ulceration Nausea Neck Pain Nephrolithiasis Renal Colic Urine Analysis Abnormal Date:05/24/99ISR Number: 3269317-0Report Type:Expedited (15-DaCompany Report #1999UW01902 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel "Zeneca" PS Initial or Prolonged Intentional Overdose Professional Required Intervention to Prevent Permanent Impairment/Damage Date:05/25/99ISR Number: 3268721-4Report Type:Direct Company Report # Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Subcapsular Health Seroquel 400mg PS ORAL 400MG PO Professional Thioidazine C Depakote C Levoxyl C 22-Feb-2006 08:31 AM Page: 80 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/99ISR Number: 3269503-XReport Type:Expedited (15-DaCompany Report #1999AP02717 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Torsade De Pointes Foreign Seroquel "Zeneca" PS Zeneca ORAL 75 MG QD PO Initial or Prolonged Ventricular Tachycardia Health Nifedipine C Other Professional Thyroxine C Other Co-Danthrameer C Date:05/25/99ISR Number: 3269881-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Seroquel PS 350 X 400MG Professional QD 7 MON Date:05/28/99ISR Number: 3272614-6Report Type:Expedited (15-DaCompany Report #1998AP48494 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Oedema Foreign Seroquel PS ORAL 800 MG DAILY Hospitalization - Coma Study Initial or Prolonged Liver Function Test Health Disability Abnormal Professional Required Loss Of Consciousness Other Intervention to Overdose Prevent Permanent Suicide Attempt Impairment/Damage Tachycardia White Blood Cell Count Increased Date:06/01/99ISR Number: 3275230-5Report Type:Expedited (15-DaCompany Report #1999UW01989 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Seroquel "Zeneca" PS ORAL 50 MG BID PO Initial or Prolonged Leukopenia Professional Seroquel "Zeneca" SS ORAL 100 MG BID PO Seroquel "Zeneca" SS ORAL 150 MG BID PO Lithium C Olanzapine C Multivitamins C Metamucil C Benzoyl C Retin A C Ketoconazole C Hydroxyzine C Date:06/02/99ISR Number: 3283737-XReport Type:Periodic Company Report #98USA11354 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Health Tegretol Tablet 200 Initial or Prolonged Jaundice Professional Mg (Carbamazepine) PS ORAL 200 MG, BID, ORAL Alcohol Unknown (Ethanol) SS ORAL ORAL Tylenol Unknown 325 Mg (Paracetamol) SS ORAL 1300 MG, 22-Feb-2006 08:31 AM Page: 81 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY, ORAL Seroquel Unknown (Quetiapine Fumarate) SS UNKNOWN Date:06/03/99ISR Number: 3281385-9Report Type:Periodic Company Report #1995AP13360 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Study Seroquel PS Initial or Prolonged Prolonged Health Professional Date:06/03/99ISR Number: 3281386-0Report Type:Periodic Company Report #1998UW46755 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Study Seroquel PS ORAL 150 MG BID PO Initial or Prolonged Orthostatic Hypotension Health Sinemet C Required Syncope Professional Diabeta C Intervention to Prevent Permanent Impairment/Damage Date:06/03/99ISR Number: 3281387-2Report Type:Periodic Company Report #1998UW49037 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Seroquel PS ORAL 1200 MG PO Initial or Prolonged Prolonged Professional Overdose Company Representative Date:06/03/99ISR Number: 3281388-4Report Type:Periodic Company Report #1998UW49242 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Syncope Professional Acetaminophen C Albuterol C Kefzol C Lovenox C Pepcid C Amaril Vaccine C Insulin C Nicoderm C Prednisone C Zoloft C Theophylline C Date:06/03/99ISR Number: 3281389-6Report Type:Periodic Company Report #1998UW49829 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Liver Function Test Health Initial or Prolonged Abnormal Professional Company 22-Feb-2006 08:31 AM Page: 82 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Seroquel PS 300 MG DAILY Dilantin C Tegretol C Date:06/03/99ISR Number: 3281390-2Report Type:Periodic Company Report #1999UW00245 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Study Seroquel PS ORAL 200 MG QD PO Initial or Prolonged Syncope Health Acetaminophen C Professional Lorazepam C Aspirin C Date:06/03/99ISR Number: 3281391-4Report Type:Periodic Company Report #1999UW00400 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Seroquel PS Initial or Prolonged Consciousness Professional Fatigue Date:06/03/99ISR Number: 3281392-6Report Type:Periodic Company Report #1999UW00571 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS ORAL 100 MG PO Professional Date:06/03/99ISR Number: 3281393-8Report Type:Periodic Company Report #1999UW00535 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Seroquel PS ORAL 100 MG QAM PO Initial or Prolonged Professional Seroquel SS ORAL 150 MG HS PO Disability Required Intervention to Prevent Permanent Impairment/Damage Date:06/03/99ISR Number: 3281394-XReport Type:Periodic Company Report #1999UW00887 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Seroquel PS ORAL 100 MG HS PO Initial or Prolonged Decreased Professional 22-Feb-2006 08:31 AM Page: 83 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/99ISR Number: 3281395-1Report Type:Periodic Company Report #1999UW00885 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthyroidism Health Seroquel PS ORAL 300 MG QD PO Initial or Prolonged Professional Syntrhoid C Company Theragran C Representative Vitamin C C Detrol C Antivert C Lasix C Date:06/03/99ISR Number: 3281396-3Report Type:Periodic Company Report #1999UW00802 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Seroquel PS ORAL 200 MG QD PO Initial or Prolonged Decreased Professional Seroquel SS ORAL 400 MG QD PO Effexor C Depakote C Date:06/03/99ISR Number: 3281397-5Report Type:Periodic Company Report #1999UW01165 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Seroquel PS ORAL 100 MG ONCE Initial or Prolonged Sedation Professional PO Xanax C Serzone C Date:06/03/99ISR Number: 3281398-7Report Type:Periodic Company Report #1999UW01095 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel PS ORAL 75 MG QD PO Initial or Prolonged Syndrome Professional Clonazepam C Required Ovral C Intervention to Epival C Prevent Permanent Impairment/Damage Date:06/03/99ISR Number: 3281399-9Report Type:Periodic Company Report #1999UW01472 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Seroquel PS Initial or Prolonged Fatigue Professional Required Overdose Intervention to Suicide Attempt Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 84 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/99ISR Number: 3335619-2Report Type:Periodic Company Report #1999UW01448 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Seroquel PS Drug Interaction Professional Sudafed SS Date:06/03/99ISR Number: 3335629-5Report Type:Periodic Company Report #1999UW01344 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Seroquel PS Professional Date:06/03/99ISR Number: 3335632-5Report Type:Periodic Company Report #1999UW01321 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatitis Health Seroquel PS Professional Lithium C Date:06/03/99ISR Number: 3335635-0Report Type:Periodic Company Report #1999UW01308 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Health Seroquel PS ORAL 150 MG DAILY Myalgia Professional PO Nausea Company Zyprexa C Representative Tegretol C Paxil C Date:06/03/99ISR Number: 3335638-6Report Type:Periodic Company Report #1999UW01086 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intermittent Explosive Health Seroquel PS ORAL 200 MG TID PO Disorder Professional Seroquel SS ORAL 50 MG HS PO Seroquel SS ORAL 200 MG TID PO Prolixin C Ativan C Date:06/03/99ISR Number: 3335642-8Report Type:Periodic Company Report #1999UW01021 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Health Seroquel PS ORAL 25 MG BID PO Professional Date:06/03/99ISR Number: 3335648-9Report Type:Periodic Company Report #1999UW01002 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Seroquel PS ORAL 200 MG QD PO Hypersomnia Seroquel SS ORAL 400 MG QD PO Insomnia Lithium C Restlessness 22-Feb-2006 08:31 AM Page: 85 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/99ISR Number: 3335650-7Report Type:Periodic Company Report #1999UW00967 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Seroquel PS ORAL 100 MG PO Professional Paxil C Depakote C Date:06/03/99ISR Number: 3335652-0Report Type:Periodic Company Report #1999UW00934 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Peripheral Sensory Health Seroquel PS ORAL 25 MG QD PO Neuropathy Professional Seroquel SS ORAL 75 MG QD PO Haldol C Date:06/03/99ISR Number: 3335655-6Report Type:Periodic Company Report #1999UW00920 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Malaise Consumer Seroquel PS Sedation Date:06/03/99ISR Number: 3335658-1Report Type:Periodic Company Report #1999UW00800 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysuria Health Seroquel PS ORAL 800 MG QD PO Professional Date:06/03/99ISR Number: 3335660-XReport Type:Periodic Company Report #1999UW00777 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Seroquel PS ORAL 800 MG QD PO Phosphokinase Increased Professional Chest Pain Company Representative Date:06/03/99ISR Number: 3335661-1Report Type:Periodic Company Report #1999UW00756 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Seroquel PS ORAL 50 MG HS PO Paranoia Professional Aleve C Zoloft C Thyroid C Date:06/03/99ISR Number: 3335663-5Report Type:Periodic Company Report #1999UW00696 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Malaise Consumer Seroquel PS 12.5 MG HS Skin Disorder 22-Feb-2006 08:31 AM Page: 86 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/99ISR Number: 3335664-7Report Type:Periodic Company Report #1999UW00677 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Consumer Seroquel PS Anxiety Navane C Attention Cogentin C Deficit/Hyperactivity Disorder Burning Sensation Fatigue Feeling Cold Flushing Headache Insomnia Intestinal Functional Disorder Mental Impairment Nausea Pain In Extremity Palpitations Panic Reaction Restlessness Date:06/03/99ISR Number: 3335666-0Report Type:Periodic Company Report #1999UW00659 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Consumer Seroquel PS ORAL 300 MG QD PO Pain In Extremity Prozac C Effexor C Date:06/03/99ISR Number: 3335667-2Report Type:Periodic Company Report #1999UW00611 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Seroquel PS ORAL 100 MG QD PO Professional Date:06/03/99ISR Number: 3335670-2Report Type:Periodic Company Report #1999UW00596 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataract Health Seroquel PS ORAL 300 MG BID PO Eye Disorder Professional Seroquel SS ORAL 200 MG BID PO Depakote C Date:06/03/99ISR Number: 3335671-4Report Type:Periodic Company Report #1999UW00574 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Consumer Seroquel PS ORAL 50 MG DAILY Muscle Twitching PO Seroquel SS ORAL 400 MG DAILY PO Zyprexa C 22-Feb-2006 08:31 AM Page: 87 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/99ISR Number: 3335673-8Report Type:Periodic Company Report #1999UW00527 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Seroquel PS ORAL 25 MG QD PO Eye Rolling Professional Muscle Twitching Company Representative Date:06/03/99ISR Number: 3335712-4Report Type:Periodic Company Report #1999UW01157 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Consumer Seroquel PS Intervention to Convulsion Prevent Permanent Impairment/Damage Date:06/03/99ISR Number: 3335748-3Report Type:Periodic Company Report #1999UW00778 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 600 MG QD PO Intervention to Professional Prevent Permanent Impairment/Damage Date:06/03/99ISR Number: 3335778-1Report Type:Periodic Company Report #1999UW00525 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Seroquel PS ORAL 200 MG QD PO Eye Rolling Professional Muscle Twitching Company Representative Date:06/03/99ISR Number: 3335821-XReport Type:Periodic Company Report #1999UW00517 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Seroquel PS ORAL 150 MG QD PO Seroquel SS ORAL 500 MG QD PO Date:06/03/99ISR Number: 3335823-3Report Type:Periodic Company Report #1999UW00488 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Seroquel PS Irritability Zoloft C Sinemet C Permax C Klonopin C 22-Feb-2006 08:31 AM Page: 88 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/99ISR Number: 3335827-0Report Type:Periodic Company Report #1999UW00466 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Consumer Seroquel PS Muscular Weakness Nausea Date:06/03/99ISR Number: 3335844-0Report Type:Periodic Company Report #1999UW00450 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot And Cold Health Seroquel PS Flushing Professional Premarin C Date:06/03/99ISR Number: 3335845-2Report Type:Periodic Company Report #1999UW00449 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot And Cold Health Seroquel PS Flushing Professional Haldol C Glucophage C Date:06/03/99ISR Number: 3335850-6Report Type:Periodic Company Report #1999UW00385 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Testicular Disorder Health Seroquel PS Professional Date:06/03/99ISR Number: 3335860-9Report Type:Periodic Company Report #1999UW00344 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Urinary Retention Health Seroquel PS ORAL 600 MG QD PO Intervention to Professional Seroquel SS ORAL 300 MG QD PO Prevent Permanent Company Luvox C Impairment/Damage Representative Ativan C Date:06/03/99ISR Number: 3335863-4Report Type:Periodic Company Report #1999UW00324 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 100 MG TID PO 15 MON Intervention to Professional Steroid C Prevent Permanent Relafen C Impairment/Damage Effexor C Paxil C Prilosec C Darvocet-N C Ambien C Maxalt C Neurontin C Urecholine C Vistaril C Diazepam C 22-Feb-2006 08:31 AM Page: 89 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/99ISR Number: 3335867-1Report Type:Periodic Company Report #1999UW00304 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Seroquel PS ORAL 400 MG QD PO Tremor Professional Mellaril C Neurontin C Depakote C Tegretol C Date:06/03/99ISR Number: 3335871-3Report Type:Periodic Company Report #1999UW00279 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Seroquel PS ORAL 50 MG QD PO Decreased Professional Seroquel SS ORAL 100 MG QD PO Seroquel SS ORAL 200 MG QD PO Seroquel SS ORAL 300 MG QD PO Seroquel SS ORAL 400 MG QD PO Seroquel SS ORAL 600 MG QD PO Depakote C Date:06/03/99ISR Number: 3335877-4Report Type:Periodic Company Report #1999UW00265 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscular Weakness Health Seroquel PS ORAL 75 MG QD PO Professional Risperdal C Date:06/03/99ISR Number: 3335881-6Report Type:Periodic Company Report #1999UW00213 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Health Seroquel PS ORAL 12.5 MG QD PO Professional Desogen "Ciba-Geigy" C Company Macrobid C Representative Chronactin C Klonopin C Nardil C Date:06/03/99ISR Number: 3335886-5Report Type:Periodic Company Report #1999UW00010 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Consumer Seroquel PS ORAL 200 MG HS PO Abnormal Dreams Effexor C Diarrhoea Ambien C Nausea Adderall C Xanax C Date:06/03/99ISR Number: 3335890-7Report Type:Periodic Company Report #1998UW49823 Age:41 YR Gender:Female I/FU:F Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 90 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cataract Health Seroquel PS ORAL 300 MG PO Professional Haldol Decanoate C Haldol C Depakote C Paxil C Cogentin C Furosemide C Zestril C Levoxyl C Zyprexa C Date:06/03/99ISR Number: 3335893-2Report Type:Periodic Company Report #1998UW49084 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Seroquel PS ORAL 600 MG QD PO Professional Date:06/03/99ISR Number: 3335896-8Report Type:Periodic Company Report #1998UW48733 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Peripheral Vascular Health Seroquel PS ORAL 125 MG TID PO Disorder Professional Seroquel SS ORAL 200 MG TID PO Pyrexia Company Seroquel SS ORAL 150 MG TID PO Representative Klonopin C Depakote C Date:06/03/99ISR Number: 3335900-7Report Type:Periodic Company Report #1998UW47346 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Seroquel PS ORAL 100 MG TID PO Loss Of Consciousness Date:06/03/99ISR Number: 3335904-4Report Type:Periodic Company Report #1998UW46392 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Seroquel PS ORAL 100 MG BID PO Oedema Professional Depakote SS 250 MG Telangiectasia Depakote SS 1500 MG Weight Increased Triphasil C Effexor C Propanolol C Date:06/03/99ISR Number: 3337288-4Report Type:Periodic Company Report #1999UW00125 Age:20 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Agitation Bipolar I Disorder 22-Feb-2006 08:31 AM Page: 91 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Choreoathetosis Irritability Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS ORAL 25 MG QD PO Professional Seroquel SS ORAL 50 MG BID PO Company Seroquel SS ORAL 300 MG HS PO Representative Seroquel SS ORAL 100 MG PRN PO Risperdal C Lithium C Prozac C Cogentin C Benadryl C Date:06/04/99ISR Number: 3276359-8Report Type:Expedited (15-DaCompany Report #1999UW02013 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Health Seroquel "Zeneca" PS Initial or Prolonged Professional Paxil C Date:06/08/99ISR Number: 3278951-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Quetiapine (Zeneca) PS Zeneca ORAL 25MG PO TID; 25 MG PO BID Date:06/14/99ISR Number: 3282595-7Report Type:Expedited (15-DaCompany Report #1999PK00252 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel "Zeneca" PS Zeneca ORAL 800 MG DAILY Initial or Prolonged Neutropenia Health PO Professional Ciatyl C Sepram C Akineton C Date:06/14/99ISR Number: 3282597-0Report Type:Expedited (15-DaCompany Report #1999AP02516 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coagulopathy Foreign Seroquel PS 1 WK Initial or Prolonged Psychotic Disorder Health Pulmonary Embolism Professional Transient Ischaemic Other Attack Date:06/15/99ISR Number: 3283914-8Report Type:Expedited (15-DaCompany Report #1999AP03017 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blepharospasm Foreign Seroquel "Zeneca" PS Zeneca ORAL 100 MG BID PO Posture Abnormal Health Seroquel "Zeneca" SS Zeneca ORAL 50 MG BID PO 3 WK Vocal Cord Disorder Professional Seroquel "Zeneca" SS Zeneca ORAL 25 MG BID PO 3 WK Other Procyclidine C Clopixol C 22-Feb-2006 08:31 AM Page: 92 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlorpromazine C Olanzapine C Risperidone C Clopixol C Date:06/18/99ISR Number: 3286446-6Report Type:Expedited (15-DaCompany Report #1999AP02973 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agitation Foreign Seroquel "Zeneca" PS ORAL 200 MG DAILY Confusional State Health PO Convulsion Professional Seroquel "Zeneca" SS ORAL 150 MG PO Zuclopenthixol C Olanzapine C Risperidone C Date:06/21/99ISR Number: 3288189-1Report Type:Expedited (15-DaCompany Report #1999UW01448 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Health Seroquel PS Intervention to Agitation Professional Seroquel SS ORAL 50 MG HS PO Prevent Permanent Anorexia Seroquel SS ORAL 25 MG QAM PO Impairment/Damage Drug Interaction Seroquel SS ORAL 50 MG HS PO Ecchymosis Sudafed SS 30 MG TID Excoriation Tegretol C Insomnia Prilosec C Intentional Self-Injury Propulsid C Scratch Milk Of Magnesia C Upper Respiratory Tract Multivitamins And Infection Iron C Vitamin E C Date:06/22/99ISR Number: 3289087-XReport Type:Expedited (15-DaCompany Report #1999AP03154 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Myalgia Foreign Seroquel "Zeneca" PS Zeneca ORAL 200 MG DAILY Health PO Professional Paroxetine C Other Procyclidine C Date:06/25/99ISR Number: 3291787-2Report Type:Expedited (15-DaCompany Report #1998UW47326 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Health Seroquel PS ORAL 200 MG BID PO Intervention to Malaise Professional Prevent Permanent Nausea Impairment/Damage Vaginal Haemorrhage 22-Feb-2006 08:31 AM Page: 93 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/99ISR Number: 3293370-1Report Type:Expedited (15-DaCompany Report #1999UW02013 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Health Seroquel "Zeneca" PS Zeneca Initial or Prolonged Professional Paxil C Date:06/29/99ISR Number: 3294769-XReport Type:Expedited (15-DaCompany Report #1999AP02991 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Left Ventricular Failure Foreign Seroquel "Zeneca" PS Zeneca ORAL 500 MG DAILY Initial or Prolonged Health PO 4 MON Professional Other Date:07/01/99ISR Number: 3294913-4Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Seroquel 200 Mg PS 200MG BID Depakote C Klonopin C Date:07/07/99ISR Number: 3297507-XReport Type:Direct Company Report # Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Body Temperature Seroquel Increased (Quetiapine) 25 Mg PS 12.5MG AM & Muscle Rigidity 25MG HS Neuroleptic Malignant Syndrome Date:07/07/99ISR Number: 3298878-0Report Type:Expedited (15-DaCompany Report #1999UW01989 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Seroquel "Zeneca" PS ORAL 50 MG BID PO Initial or Prolonged Leukopenia Professional Seroquel "Zeneca" SS ORAL 100 MG BID PO Neutrophil Count Seroquel "Zeneca" SS ORAL 150 MG BID PO Decreased Lithium C Olanzapine C Multivitamins C Metamucil C Benzoyl Peroxide C Retin A C Ketoconazole C Hydroxyzine C Date:07/09/99ISR Number: 3300441-XReport Type:Expedited (15-DaCompany Report #1998AP50790 Age:61 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:31 AM Page: 94 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Bundle Branch Block Left Foreign Seroquel PS ORAL 200 MG DAILY C-Reactive Protein Study PO Increased Health Seroquel SS ORAL 600 MG DAILY Cardiac Failure Professional PO Cardiac Murmur Lactulose C Cardiomyopathy Congestive Cardiomyopathy Dyspnoea Exertional Ejection Fraction Abnormal Gallop Rhythm Present Gamma-Glutamyltransferase Increased Hyponatraemia Low Cardiac Output Syndrome Oedema Peripheral Pulmonary Hypertension Rales Venous Pressure Jugular Increased Weight Decreased Date:07/12/99ISR Number: 3301786-XReport Type:Expedited (15-DaCompany Report #1999UW00611 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tuberculosis Health Seroquel PS ORAL 100 MG QD PO Initial or Prolonged Professional Date:07/20/99ISR Number: 3306802-7Report Type:Direct Company Report # Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Seroquel 25mghs PS ORAL 25MG HS ORAL Initial or Prolonged Consciousness Gammahydroxybutrate Other Diarrhoea (Ghb) SS ORAL 32.5MG/KG HS Vomiting ORAL REPEAT 3 HRS LATER Provigil C Atenolol C Date:07/21/99ISR Number: 3308342-8Report Type:Expedited (15-DaCompany Report #1999UW02451 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel "Zeneca" PS Zeneca ORAL 300 MG QD PO 2 WK Initial or Prolonged Loss Of Consciousness Professional Seroquel "Zeneca" SS Zeneca ORAL 400 MG QD PO Neuroleptic Malignant Company Lithium C Syndrome Representative Depakote C Pyrexia White Blood Cell Count Increased 22-Feb-2006 08:31 AM Page: 95 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/22/99ISR Number: 3308759-1Report Type:Expedited (15-DaCompany Report #1999AP03788 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cold Sweat Foreign Seroquel "Zeneca" PS Zeneca 500 MG QD PO WK Initial or Prolonged Coma Health Dipyridamole C Feeling Cold Professional Zopiclone C Date:07/23/99ISR Number: 3309984-6Report Type:Direct Company Report #52441 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Serentil (Mesoridazine Besylate) PS Boehringer Ingelheim Seroquel (Quetiapine Fumarate) SS Zeneca Pharmaceuticals Date:07/23/99ISR Number: 3310437-XReport Type:Direct Company Report # Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Erectile Dysfunction Quetiapine PS ORAL 400 MG BID ORAL Haloperidol SS ORAL 10 MG Q HS ORAL Date:07/27/99ISR Number: 3311563-1Report Type:Expedited (15-DaCompany Report #1999AP04033 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hiatus Hernia Foreign Seroquel "Zeneca" PS Zeneca ORAL 200 MG BID PO Intervention to Nausea Health Ranitidine C Prevent Permanent Oesophageal Ulcer Professional Prozac C Impairment/Damage Oesophagitis Pericarditis Retching Weight Increased Date:07/27/99ISR Number: 3311564-3Report Type:Expedited (15-DaCompany Report #1999AP02991 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Left Ventricular Failure Foreign Seroquel "Zeneca" PS Zeneca ORAL 500 MG QD PO 4 MON Initial or Prolonged Health Professional Date:07/28/99ISR Number: 3312792-3Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other International Normalised Health Seroquel Quetiapine PS 9 DAY Ratio Decreased Professional Thrombocytopenia Vasculitis 22-Feb-2006 08:31 AM Page: 96 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/99ISR Number: 3314142-5Report Type:Expedited (15-DaCompany Report #1999UW02688 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Seroquel "Zeneca" PS Zeneca Initial or Prolonged Difficulty In Walking Professional Nardil SS Disability Drug Interaction Listless Social Avoidant Behaviour Date:08/02/99ISR Number: 3316145-3Report Type:Expedited (15-DaCompany Report #1999AP04326 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Feeling Hot Foreign Seroquel "Zeneca" PS ORAL 100 MG BID PO Oedema Peripheral Health Nifedipine C Pain In Extremity Professional Tolbutamide C Rash Erythematous Other Aspirin "Bayer" C Fluoxetine C Date:08/04/99ISR Number: 3319171-3Report Type:Expedited (15-DaCompany Report #1999AP04367 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Choking Sensation Foreign Seroquel "Zeneca" PS Hyperhidrosis Health Hypersensitivity Professional Lymphadenopathy Other Muscle Rigidity Pruritus Tongue Oedema Date:08/05/99ISR Number: 3319467-5Report Type:Expedited (15-DaCompany Report #1999AP04033 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hiatus Hernia Foreign Seroquel "Zeneca" PS "Zeneca" ORAL 200 MG BID PO Intervention to Ill-Defined Disorder Health Ranitidine C Prevent Permanent Oesophageal Ulcer Professional Prozac C Impairment/Damage Oesophagitis Other Pericarditis Retching Weight Increased Date:08/10/99ISR Number: 3322756-1Report Type:Expedited (15-DaCompany Report #1999UW02930 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Health Seroquel "Zeneca" PS Zeneca Initial or Prolonged Professional Pharmaceuticals ORAL 25 MG BID PO 2 WK Dilantin C Serzone C Lithium C 22-Feb-2006 08:31 AM Page: 97 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/99ISR Number: 3325559-7Report Type:Expedited (15-DaCompany Report #1999AP02777 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Seroquel "Zeneca" PS ORAL 150 MG BID Initial or Prolonged Haematoma Health Professional Date:08/17/99ISR Number: 3329308-8Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Lithium 300mg PS ORAL 300MG BID Initial or Prolonged Dysphagia ORAL Disability Heart Rate Increased Seroquel 300mg SS ORAL 300MG HS ORAL Required Hypertension Ambien C Intervention to Muscle Twitching Depakote C Prevent Permanent Muscular Weakness Paxil C Impairment/Damage Paralysis Synthroid C Tremor Tenormin C Zestril C Date:08/19/99ISR Number: 3329450-1Report Type:Direct Company Report # Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Seroquel PS 100 BID Intervention to Blood Prolactin Increased Haloperidol SS 5 BID 4-26-99 Prevent Permanent Dyskinesia DECREASE 5 Impairment/Damage Feeling Abnormal QHS 5-3-99 Galactorrhoea D/C Psychomotor Hyperactivity Date:08/20/99ISR Number: 3330905-4Report Type:Expedited (15-DaCompany Report #1999UW02451 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Seroquel "Zeneca" PS ORAL 400 MG QD PO 2 WK Hospitalization - Dermatitis Professional Seroquel "Zeneca" SS ORAL 400 MG QD PO Initial or Prolonged Lethargy Company Lithium C Required Leukocytosis Representative Depakote C Intervention to Loss Of Consciousness Prevent Permanent Neuroleptic Malignant Impairment/Damage Syndrome Pyrexia Date:08/24/99ISR Number: 3333271-3Report Type:Expedited (15-DaCompany Report #1999UW03127 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Seroquel "Zeneca" PS ORAL 600 MG BID Initial or Prolonged Muscular Weakness Professional Seroquel "Zeneca" SS ORAL 300 MG BID Tremor Lithium C 22-Feb-2006 08:31 AM Page: 98 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/99ISR Number: 3336323-7Report Type:Expedited (15-DaCompany Report #1998UW49033 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Anencephaly Seroquel PS Complications Of Maternal Paxil C Exposure To Therapeutic Synthroid C Drugs Date:08/30/99ISR Number: 3336551-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coagulopathy Health Seroquel PS TWO TIMES Required Haemorrhage Professional DAILY 5 WK Intervention to International Normalised Prevent Permanent Ratio Increased Impairment/Damage Laceration Date:08/31/99ISR Number: 3337233-1Report Type:Direct Company Report # Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Valproic Acid PS ORAL 750MG BID Hospitalization - ORAL Initial or Prolonged Quetiapine SS ORAL 150MG BID ORAL Guanfacine C Sertraline C Date:09/01/99ISR Number: 3338890-6Report Type:Expedited (15-DaCompany Report #1999UW02817 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Health Seroquel "Zeneca" PS Zeneca ORAL 300 MG DAILY Initial or Prolonged Flushing Professional PO Influenza Like Illness Company Trazodone C Malaise Representative Prozac C Myalgia Klonopin C Pyrexia Ativan C Serotonin Syndrome Viral Infection Date:09/03/99ISR Number: 3341028-2Report Type:Expedited (15-DaCompany Report #1999UW03212 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Seroquel "Zeneca" PS Zeneca ORAL 12.5 MG QD PO Initial or Prolonged Haemorrhage Professional Seroquel "Zeneca" SS Zeneca ORAL 12.5 MG BID Required International Normalised PO Intervention to Ratio Increased Seroquel "Zeneca" SS Zeneca ORAL 25 MG BID PO Prevent Permanent Laceration Coumadin SS Impairment/Damage Lip Disorder Carbidopa C Levodopa C Fludrocortisone C Pepcid C Multivitamins C Levothyroxine C 22-Feb-2006 08:31 AM Page: 99 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Propoxyphene C Lactulose C Acetaminophen C Date:09/07/99ISR Number: 3342157-XReport Type:Expedited (15-DaCompany Report #1999UW02930 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Health Seroquel "Zeneca" PS ORAL 50MG BID PO Initial or Prolonged Pyrexia Professional Seroquel "Zeneca" SS ORAL 75MG HS PO Rash Erythematous Dilantin C Stevens-Johnson Syndrome Serzone C Urticaria Lithium C Date:09/07/99ISR Number: 3344081-5Report Type:Periodic Company Report #1998UW49037 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Seroquel PS ORAL 1200 MG PO Initial or Prolonged Prolonged Professional Overdose Company Representative Date:09/07/99ISR Number: 3344085-2Report Type:Periodic Company Report #1999UW01090 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Health Seroquel PS ORAL 50 MG HS Initial or Prolonged Psychotic Disorder Professional PO Company Zyprexa C Representative Depakote C Date:09/07/99ISR Number: 3344088-8Report Type:Periodic Company Report #1999UW01095 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel PS ORAL 75 MG QD Initial or Prolonged Syndrome Professional PO Required Clonazepam C Intervention to Ovral C Prevent Permanent Epival C Impairment/Damage Date:09/07/99ISR Number: 3344091-8Report Type:Periodic Company Report #1999UW01530 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Seroquel PS ORAL 500 MG PO 10 DAY Initial or Prolonged Attention Deficit/Hyperactivity Disorder Delusion Thinking Abnormal 22-Feb-2006 08:31 AM Page: 100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/99ISR Number: 3344095-5Report Type:Periodic Company Report #1999UW02154 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Seroquel PS ORAL 50 MG QD Initial or Prolonged Health PO Professional Lanoxin C Hydrochlorothiazide C Paroxetine Hydrochloride C Lisinopril C Haloperidol C Date:09/07/99ISR Number: 3344100-6Report Type:Periodic Company Report #1999UW02356 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Palpitations Consumer Seroquel "Zeneca" PS Zeneca ORAL 800 MG QD Initial or Prolonged PO Neurontin C Synthroid C Erythromycin C Date:09/07/99ISR Number: 3344102-XReport Type:Periodic Company Report #1999UW02422 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Deafness Health Seroquel "Zeneca" PS Zeneca ORAL 75 MG QD Professional PO Seroquel "Zeneca" SS Zeneca ORAL 50 MG QD PO Depakote C Ritalin C Date:09/07/99ISR Number: 3344104-3Report Type:Periodic Company Report #1999UW02423 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Seroquel "Zeneca" PS Zeneca ORAL 100 MG BID Initial or Prolonged Professional PO Disability Seroquel "Zeneca" SS Zeneca ORAL 200 MG BID Required PO Intervention to Seroquel "Zeneca" SS ORAL 200 MG TID Prevent Permanent PO Impairment/Damage Depakote C Klonopin C Date:09/07/99ISR Number: 3360357-XReport Type:Periodic Company Report #1999UW02658 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Seroquel "Zeneca" PS 22-Feb-2006 08:31 AM Page: 101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/99ISR Number: 3360359-3Report Type:Periodic Company Report #1999UW02657 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Seroquel "Zeneca" PS Date:09/07/99ISR Number: 3360360-XReport Type:Periodic Company Report #1999UW02656 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Consumer Seroquel "Zeneca" PS ORAL 100 MG QD PO Dysuria Date:09/07/99ISR Number: 3360361-1Report Type:Periodic Company Report #1999UW02629 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Retention Health Seroquel PS ORAL 600 MG QD PO Professional Seroquel SS ORAL 300 MG QD PO Celexa C Date:09/07/99ISR Number: 3360362-3Report Type:Periodic Company Report #1999UW02628 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Health Seroquel "Zeneca" PS ORAL 25 MG QD PO Intervention to Syndrome Professional Zyprexa C Prevent Permanent Impairment/Damage Date:09/07/99ISR Number: 3360363-5Report Type:Periodic Company Report #1999UW02578 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Consumer Seroquel PS Date:09/07/99ISR Number: 3360365-9Report Type:Periodic Company Report #1999UW02573 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Health Seroquel "Zeneca" PS ORAL 250 MG QD PO Professional Date:09/07/99ISR Number: 3360366-0Report Type:Periodic Company Report #1999UW02488 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Health Seroquel "Zeneca" PS ORAL 50 MG QD PO Intervention to Professional Risperdal C Prevent Permanent Company Welibutrin C Impairment/Damage Representative 22-Feb-2006 08:31 AM Page: 102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/99ISR Number: 3360367-2Report Type:Periodic Company Report #1999UW02375 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Consumer Seroquel "Zeneca" PS Drug Interaction Tums C Date:09/07/99ISR Number: 3360368-4Report Type:Periodic Company Report #1999UW02372 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aphasia Health Seroquel "Zeneca" PS Intervention to Dysphagia Professional Haldol C Prevent Permanent Mental Impairment Impairment/Damage Muscle Rigidity Neuroleptic Malignant Syndrome Salivary Hypersecretion Tachypnoea Date:09/07/99ISR Number: 3360370-2Report Type:Periodic Company Report #1999UW02362 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Restlessness Health Seroquel PS ORAL 50 MG BID PO Tongue Oedema Professional Prilosec C Vasotec C Date:09/07/99ISR Number: 3360373-8Report Type:Periodic Company Report #1999UW02333 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Consumer Seroquel PS ORAL 12.5 MG QD PO Dizziness Ativan C Malaise Inderal C Pyrexia Synthroid C Toprol C Date:09/07/99ISR Number: 3360386-6Report Type:Periodic Company Report #1999UW02329 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mental Impairment Consumer Seroquel "Zeneca" PS Date:09/07/99ISR Number: 3360388-XReport Type:Periodic Company Report #1999UW02276 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Function Abnormal Health Seroquel "Zeneca" PS Professional 22-Feb-2006 08:31 AM Page: 103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/99ISR Number: 3360389-1Report Type:Periodic Company Report #1999UW02249 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Balance Disorder Consumer Seroquel "Zeneca" PS ORAL 600 MG PO Bone Pain Seroquel "Zeneca" SS ORAL 200 MG PO Catatonia Dysgraphia Ecchymosis Gingival Pain Memory Impairment Toothache Tremor Date:09/07/99ISR Number: 3360391-XReport Type:Periodic Company Report #1999UW02029 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Health Seroquel PS Pharyngitis Professional Date:09/07/99ISR Number: 3360393-3Report Type:Periodic Company Report #1999UW01973 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Seroquel PS ORAL 25 MG QD PO Nervous System Disorder Professional Date:09/07/99ISR Number: 3360396-9Report Type:Periodic Company Report #1999UW01925 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Seroquel "Zeneca" PS ORAL 200 MG QD PO Professional Trazodone C Vistaril C Lorazepam C Trapanal C Date:09/07/99ISR Number: 3360399-4Report Type:Periodic Company Report #1999UW01919 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Health Seroquel "Zeneca" PS ORAL 25 MG QD PO Intervention to Professional Seroquel "Zeneca" SS ORAL 50 MG QD PO Prevent Permanent Impairment/Damage Date:09/07/99ISR Number: 3360401-XReport Type:Periodic Company Report #1999UW01796 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Consumer Seroquel PS ORAL 600 MG QD PO 2 MON Palpitations Seroquel SS ORAL 200 MG QD PO Vaginal Infection Seroquel SS ORAL 300 MG PO Tegretol C Monostat C 22-Feb-2006 08:31 AM Page: 104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/99ISR Number: 3371748-5Report Type:Periodic Company Report #1999UW01793 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Seroquel PS ORAL 200 MG QD PO Tic Professional Seroquel SS ORAL 150 MG QD PO Seroquel SS ORAL 100 MG QD PO Lithium C Risperdal C Date:09/07/99ISR Number: 3371751-5Report Type:Periodic Company Report #1999UW01777 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Consumer Seroquel PS ORAL 200 MG QD PO Seroquel SS ORAL 600 MG QD PO Date:09/07/99ISR Number: 3371753-9Report Type:Periodic Company Report #1999UW01776 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Health Seroquel PS ORAL 300 MG PO Professional Company Representative Date:09/07/99ISR Number: 3371754-0Report Type:Periodic Company Report #1999UW01769 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Health Seroquel PS ORAL 125 MG DAILY Loss Of Consciousness Professional PO Company Risperdal C Representative Zoloft C Cogentin C Ativan C Omeprazole C Date:09/07/99ISR Number: 3371757-6Report Type:Periodic Company Report #1999UW01718 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gingivitis Health Seroquel PS ORAL 400 MG QD PO Professional Seroquel SS ORAL 250 MG QD PO Lithium C Date:09/07/99ISR Number: 3371759-XReport Type:Periodic Company Report #1999UW01531 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Seroquel PS ORAL 500 MG QD PO Professional 22-Feb-2006 08:31 AM Page: 105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/99ISR Number: 3371760-6Report Type:Periodic Company Report #1999UW01515 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Jaundice Consumer Seroquel PS Date:09/07/99ISR Number: 3371762-XReport Type:Periodic Company Report #1999UW01418 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 25 MG QD PO Intervention to Professional Seroquel SS ORAL 50 MG QD PO Prevent Permanent Remeron C Impairment/Damage Klonopin C Date:09/07/99ISR Number: 3371763-1Report Type:Periodic Company Report #1999UW01308 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Health Seroquel PS ORAL 150 MG DAILY Myalgia Professional PO Nausea Company Zyprexa C Representative Tegretol C Paxil C Date:09/07/99ISR Number: 3371765-5Report Type:Periodic Company Report #1999UW00596 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataract Health Seroquel PS ORAL 300 MG BID PO Professional Seroquel SS ORAL 200 MG BID PO Zyprexa C Depakote C Magnum C Date:09/08/99ISR Number: 3342931-XReport Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Seroquel 25 Mg PS 25MG Q HS Anxiety Professional Zyprexa C Insomnia Date:09/08/99ISR Number: 3343433-7Report Type:Expedited (15-DaCompany Report #1999AP04818 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Seroquel "Zeneca" PS Zeneca ORAL 25 MG DAILY Initial or Prolonged Muscle Twitching Health PO Syncope Professional Folic Acid C Urinary Incontinence Other Calcipotriol C Co-Codamol C Aspirin "Bayer" C Bendrofluazide C Diprobase Cream C 22-Feb-2006 08:31 AM Page: 106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/99ISR Number: 3343760-3Report Type:Expedited (15-DaCompany Report #1999UW03287 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Seroquel "Zeneca" PS Life-Threatening Intentional Overdose Zoloft SS Hospitalization - Serotonin Syndrome Thorazine SS Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:09/10/99ISR Number: 3344678-2Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Seroquel 25 Mg PS ORAL 25 MG PO BID Disturbance In Attention Plendil C Dizziness Hydrochlorothiazide C Feeling Abnormal Lithium C Feeling Hot Tegretol C Memory Impairment Pyrexia Sedation Date:09/15/99ISR Number: 3347978-5Report Type:Expedited (15-DaCompany Report #9938220 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Navane Capsules PS ORAL ORAL Initial or Prolonged Heart Rate Increased Professional Seroquel SS Insomnia Chloral Hydrate SS Tension Date:09/20/99ISR Number: 3351906-6Report Type:Periodic Company Report #1995AP13360 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Study Seroquel PS Initial or Prolonged Prolonged Health Professional Date:09/20/99ISR Number: 3351911-XReport Type:Periodic Company Report #1998UW46755 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Study Seroquel PS ORAL 150 MG BID PO Initial or Prolonged Orthostatic Hypotension Health Sinemet C Required Syncope Professional Diabeta C Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3351914-5Report Type:Periodic Company Report #1998UW49037 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Seroquel PS ORAL 1200 MG PO Initial or Prolonged Prolonged Professional Overdose Company Representative Date:09/20/99ISR Number: 3351916-9Report Type:Periodic Company Report #1998UW49829 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Health Seroquel PS 300 MG DAILY Initial or Prolonged Professional Dilantin C Company Tegretol C Representative Date:09/20/99ISR Number: 3351920-0Report Type:Periodic Company Report #1998UW49823 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 300 MG PO Intervention to Professional Haldol Decanoate C Prevent Permanent Haldol C Impairment/Damage Depakote C Paxil C Cogentin C Furosemide C Zestril C Levoxyl C Zyprexa C Date:09/20/99ISR Number: 3351923-6Report Type:Periodic Company Report #1998UW49242 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Syncope Professional Acetaminophen C Albuterol C Kefzol C Lovenox C Pepcid C Amaril Vaccine "Pasteur" C Insulin C Nicoderm C Prednisone C Zoloft C Theophylline C Date:09/20/99ISR Number: 3351925-XReport Type:Periodic Company Report #1999UW00125 Age:20 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Agitation Bipolar I Disorder 22-Feb-2006 08:31 AM Page: 108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Choreoathetosis Irritability Mania Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Health Seroquel PS ORAL 25 MG QD PO Professional Seroquel SS ORAL 50 MG BID PO Company Seroquel SS ORAL 300 MG HS PO Representative Seroquel SS ORAL 100 MG PRN PO Risperdal C Lithium C Prozac C Cogentin C Benadryl C Date:09/20/99ISR Number: 3351929-7Report Type:Periodic Company Report #1999UW00245 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Study Seroquel PS ORAL 200 MG QD PO Initial or Prolonged Syncope Health Acetaminophen C Professional Lorazepam C Aspirin C Multivitamins C Furosemide C Temazepam C Docusate Sodium C Date:09/20/99ISR Number: 3351932-7Report Type:Periodic Company Report #1999UW00344 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Urinary Retention Health Seroquel PS ORAL 600 MG QD PO Intervention to Professional Seroquel SS ORAL 300 MG QD PO Prevent Permanent Company Luvox C Impairment/Damage Representative Ativan C Date:09/20/99ISR Number: 3351936-4Report Type:Periodic Company Report #1999UW00324 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 100 MG TID PO 3 MON Intervention to Professional Steroid C Prevent Permanent Relafen C Impairment/Damage Effexor C Paxil C Prilosec C Darvocet-N C Ambien C Maxalt C Neurontin C Urecholine C Vistaril C Diazepam C 22-Feb-2006 08:31 AM Page: 109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3351939-XReport Type:Periodic Company Report #1999UW00400 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Seroquel PS Initial or Prolonged Consciousness Professional Fatigue Date:09/20/99ISR Number: 3351943-1Report Type:Periodic Company Report #1999UW00571 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS ORAL 100 MG PO Professional Date:09/20/99ISR Number: 3351945-5Report Type:Periodic Company Report #1999UW00562 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Muscle Twitching Health Seroquel PS Intervention to Professional Mellaril SS ORAL 200 MG DAILY Prevent Permanent PO Impairment/Damage Haldol SS Depakote C Tegretol C Neurontin C Date:09/20/99ISR Number: 3351949-2Report Type:Periodic Company Report #1999UW00535 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Seroquel PS ORAL 100 MG QAM PO Initial or Prolonged Professional Seroquel SS ORAL 150 MG HS PO Disability Required Intervention to Prevent Permanent Impairment/Damage Date:09/20/99ISR Number: 3351952-2Report Type:Periodic Company Report #1999UW00887 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Seroquel PS ORAL 100 MG HS PO Initial or Prolonged Decreased Professional Date:09/20/99ISR Number: 3351955-8Report Type:Periodic Company Report #1999UW00885 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthyroidism Health Seroquel PS ORAL 300 MG QD PO Initial or Prolonged Professional Synthroid C Company Theragran C Representative Vitamin C C Detrol C Antivert C Lasix C 22-Feb-2006 08:31 AM Page: 110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3351959-5Report Type:Periodic Company Report #1999UW00802 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Seroquel PS ORAL 200 MG QD PO Initial or Prolonged Decreased Professional Seroquel SS ORAL 400 MG QD PO Effexor C Depakote C Date:09/20/99ISR Number: 3351961-3Report Type:Periodic Company Report #1999UW00983 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Health Seroquel PS ORAL 50 MG QD PO Intervention to Professional Lithium C Prevent Permanent Company Impairment/Damage Representative Date:09/20/99ISR Number: 3351967-4Report Type:Periodic Company Report #1999UW01197 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Petit Mal Epilepsy Health Seroquel PS Intervention to Professional Neutrontin C Prevent Permanent Company Impairment/Damage Representative Date:09/20/99ISR Number: 3351969-8Report Type:Periodic Company Report #1999UW01165 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Seroquel PS ORAL 100 MG ONCE Initial or Prolonged Sedation Professional PO Xanax C Serzone C Date:09/20/99ISR Number: 3351972-8Report Type:Periodic Company Report #1999UW01157 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Consumer Seroquel PS Intervention to Convulsion Prevent Permanent Impairment/Damage Date:09/20/99ISR Number: 3351974-1Report Type:Periodic Company Report #1999UW01095 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel PS ORAL 75 MG QD PO Initial or Prolonged Syndrome Professional Clonazepam C Required Ovral C Intervention to Epival C Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3351977-7Report Type:Periodic Company Report #1999UW01418 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 25 MG QD PO Intervention to Professional Seroquel SS ORAL 50 MG QD PO Prevent Permanent Remeron C Impairment/Damage Klonopin C Date:09/20/99ISR Number: 3351980-7Report Type:Periodic Company Report #1999UW01472 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Seroquel PS Initial or Prolonged Arrhythmia Professional Required Fatigue Intervention to Suicide Attempt Prevent Permanent Impairment/Damage Date:09/20/99ISR Number: 3352431-9Report Type:Expedited (15-DaCompany Report #1999UW03212 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Health Seroquel "Zeneca" PS ORAL 12.5 MG QD PO Hospitalization - Haemorrhage Professional Seroquel "Zenceca" SS ORAL 12.5 MG BID Initial or Prolonged International Normalised PO Required Ratio Increased Seroquel "Zeneca" SS ORAL 25 MG BID PO Intervention to Urinary Tract Infection Coumadin SS ORAL 47.5 MG WEEK Prevent Permanent PO Impairment/Damage Coumadin SS ORAL 45 MG WEEK PO Coumadin SS ORAL 35 MG WEEK PO Tylenol SS ORAL 650 MG TID PO Carbidopa C Levodopa C Fludrocortisone C Date:09/20/99ISR Number: 3364358-7Report Type:Periodic Company Report #1999UW00778 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 600 MG QD PO Intervention to Professional Prevent Permanent Impairment/Damage Date:09/20/99ISR Number: 3364927-4Report Type:Periodic Company Report #1998UW46392 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Seroquel PS ORAL 100 MG BID PO Oedema Professional Depakote SS 250 MG Spider Naevus Depakote SS 1500 MG Weight Increased Triphasil C Effexor C Propanolol C Mellaril C 22-Feb-2006 08:31 AM Page: 112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3364928-6Report Type:Periodic Company Report #1999UW00010 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Consumer Seroquel PS ORAL 200 MG HS PO Abnormal Dreams Effexor C Diarrhoea Ambien C Nausea Adderall C Xanax C Date:09/20/99ISR Number: 3364932-8Report Type:Periodic Company Report #1999UW01448 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Seroquel PS Drug Interaction Professional Sudafed SS Date:09/20/99ISR Number: 3364936-5Report Type:Periodic Company Report #1999UW01344 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Health Seroquel PS Professional Date:09/20/99ISR Number: 3365065-7Report Type:Periodic Company Report #1999UW00800 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysuria Health Seroquel PS ORAL 800 MG QD PO Professional Date:09/20/99ISR Number: 3365068-2Report Type:Periodic Company Report #1999UW00659 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Consumer Seroquel PS ORAL 300MG QD PO Pain In Extremity Prozac C Effexor C Date:09/20/99ISR Number: 3365071-2Report Type:Periodic Company Report #1999UW00611 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Health Seroquel PS ORAL 100MG QD PO Professional Date:09/20/99ISR Number: 3365128-6Report Type:Periodic Company Report #1999UW00596 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataract Health Seroquel PS ORAL 300MG BID PO; Eye Disorder Professional 200MG BID PO Depakote C 22-Feb-2006 08:31 AM Page: 113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3365130-4Report Type:Periodic Company Report #1999UW00574 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Consumer Seroquel PS ORAL 50MG DAILY Muscle Twitching PO, 400MG DAILY PO Zyprexa C Date:09/20/99ISR Number: 3365134-1Report Type:Periodic Company Report #1999UW00527 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Seroquel PS ORAL 25MG QD PO Eye Rolling Professional Muscle Twitching Company Representative Date:09/20/99ISR Number: 3365136-5Report Type:Periodic Company Report #1999UW00525 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Seroquel PS ORAL 200MG QD PO Eye Rolling Professional Muscle Twitching Company Representative Date:09/20/99ISR Number: 3365138-9Report Type:Periodic Company Report #1999UW00517 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Seroquel PS ORAL 150MG QD PO; 500MG QD PO Date:09/20/99ISR Number: 3365140-7Report Type:Periodic Company Report #1999UW00488 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Seroquel PS Irritability Zoloft C Sinemet C Permax C Klonopin C Date:09/20/99ISR Number: 3365143-2Report Type:Periodic Company Report #1999UW00466 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Consumer Seroquel PS Muscular Weakness Nausea 22-Feb-2006 08:31 AM Page: 114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3365146-8Report Type:Periodic Company Report #1999UW00450 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Flushing Health Seroquel PS Professional Premarin C Date:09/20/99ISR Number: 3365150-XReport Type:Periodic Company Report #1999UW00449 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Flushing Health Seroquel PS Hyperhidrosis Professional Haldol C Glucophage C Date:09/20/99ISR Number: 3365155-9Report Type:Periodic Company Report #1999UW00385 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Testicular Pain Health Seroquel PS Professional Date:09/20/99ISR Number: 3365157-2Report Type:Periodic Company Report #1999UW00304 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Seroquel PS ORAL 400 MG QD PO Tremor Professional Haldol Decanoate SS Mellaril C Neurontin C Depakote C Tegretol C Date:09/20/99ISR Number: 3365161-4Report Type:Periodic Company Report #1999UW00279 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Seroquel PS 50MG QD PO, Decreased Professional 100MG QD PO, 200MG QD PO, 300MG QD PO, 400MG QD PO, Depakote C Date:09/20/99ISR Number: 3365165-1Report Type:Periodic Company Report #1999UW00265 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscular Weakness Health Seroquel PS ORAL 75MG QD PO Professional Risperdal C 22-Feb-2006 08:31 AM Page: 115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3365168-7Report Type:Periodic Company Report #1999UW00213 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Health Seroquel PS ORAL 12.5MG QD PO Professional Desogen C Company Macrobid C Representative Chronactin C Klonopin C Nardil C Date:09/22/99ISR Number: 3354591-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Health Seroquel PS ORAL 100 BID PO 5 DAY Urticaria Professional Seroquel SS ORAL 200 QHS PO Kaopectate C Date:09/22/99ISR Number: 3354877-1Report Type:Expedited (15-DaCompany Report #1999AP04977 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG BID PO Corrected Interval Health Seroquel "Zeneca" SS "Zeneca" ORAL 75 MG QD PO Prolonged Professional Seroquel "Zeneca" SS "Zeneca" ORAL 50 MG BID PO Other Losartan C Aspirin "Bayer" C Sertraline C Frusemide C Venlafaxine C Stelazine C Date:10/08/99ISR Number: 3368569-6Report Type:Expedited (15-DaCompany Report #1999AP05466 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Foreign Seroquel "Zeneca" PS Zeneca ORAL 200 MG BID PO Initial or Prolonged Health Olanzapine C Professional Cipramil C Other Date:10/12/99ISR Number: 3370666-6Report Type:Expedited (15-DaCompany Report #9938220 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Navane Capsules PS ORAL ORAL Initial or Prolonged Heart Rate Increased Professional Seroquel SS Insomnia Chloral Hydrate SS Medication Error Tension 22-Feb-2006 08:31 AM Page: 116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/99ISR Number: 3371525-5Report Type:Expedited (15-DaCompany Report #1999AP04977 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Seroquel "Zeneca" PS ORAL 25 MG BID Electrocardiogram Qt Health PO Prolonged Professional Seroquel "Zeneca" SS ORAL 75 MG Electrocardiogram St DAILY Segment Abnormal PO Supraventricular Seroquel "Zeneca" SS ORAL 25 MG Extrasystoles BID PO Losartan C Aspirin "Bayer" C Sertraline C Frusemide C Venlafaxine C Stelazine C Enalapril C Diazepam C Lormetazepam C Paracetamol C Gaviscon "Smith Kline Beecham" C Date:10/13/99ISR Number: 3371560-7Report Type:Expedited (15-DaCompany Report #1999AP05378 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cold Sweat Foreign Seroquel "Zeneca" PS ORAL 150 MG DAILY Feeling Hot Health PO Hyperaesthesia Professional Prozac C Hyperhidrosis Date:10/13/99ISR Number: 3371563-2Report Type:Expedited (15-DaCompany Report #1999AP05466 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Seroquel "Zeneca" PS ORAL 200 MG BID PO Initial or Prolonged Drug Hypersensitivity Health Olanzapine C Dyspnoea Professional Cipramil C Face Oedema Date:10/13/99ISR Number: 3371566-8Report Type:Expedited (15-DaCompany Report #1999AP04367 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Choking Sensation Foreign Seroquel "Zeneca" PS ORAL 25 MG BID PO Drug Hypersensitivity Health Thyroxine C Face Oedema Professional Nabumetone C Hyperhidrosis Zopiclone C Lymphadenopathy Olanzapine C Malaise Muscle Rigidity Myalgia Pruritus Swelling Tongue Oedema 22-Feb-2006 08:31 AM Page: 117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/14/99ISR Number: 3372877-2Report Type:Expedited (15-DaCompany Report #1999AP04541 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antibody Test Abnormal Foreign Seroquel "Zeneca" PS ORAL 200 MG DAILY Initial or Prolonged Antinuclear Antibody Health PO Required Positive Professional Seroquel "Zeneca" SS ORAL 100 MG BID PO Intervention to Arthralgia Other Prozac C Prevent Permanent Blood Thyroid Stimulating Fluoxetine C Impairment/Damage Hormone Increased Risperidone C Dyskinesia Myalgia Oculogyration Rash Erythematous Rash Macular Red Blood Cell Sedimentation Rate Increased Skin Lesion Systemic Lupus Erythematosus White Blood Cell Count Increased Date:10/15/99ISR Number: 3372037-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening International Normalised Seroquel 25 Mg PS TWO TIMES Required Ratio Increased DAILY Intervention to Mouth Haemorrhage Prevent Permanent Urinary Tract Infection Impairment/Damage Date:10/18/99ISR Number: 3375713-3Report Type:Expedited (15-DaCompany Report #1999UW03215 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel "Zeneca" PS Zeneca Drug Toxicity Professional Bupropion SS Intentional Overdose Olanzapine SS Carbamazepine SS Pramoxine SS Date:10/20/99ISR Number: 3377337-0Report Type:Expedited (15-DaCompany Report #1999UW03784 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Seroquel "Zeneca" PS ORAL 300 MG PO Initial or Prolonged Movement Disorder Professional Risperdal C Muscle Twitching Company Buspar C Serotonin Syndrome Representative Prozac C Tremor Loxapine C 22-Feb-2006 08:31 AM Page: 118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/99ISR Number: 3377356-4Report Type:Expedited (15-DaCompany Report #1999AP00931 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Seroquel PS Hospitalization - Consciousness Study Seroquel SS ORAL 200 MG BID PO Initial or Prolonged Overdose Health Seroquel SS ORAL 600 MG DAILY Required Sedation Professional PO Intervention to Other Temazepam C Prevent Permanent Lorazepam C Impairment/Damage Date:10/22/99ISR Number: 3379578-5Report Type:Expedited (15-DaCompany Report #JAUSA35881 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Health Risperdal (3 Mg Initial or Prolonged Binocular Eye Movement Professional Tablet) Required Disorder (Risperidone) PS ORAL 9 MG, DAILY, Intervention to Blood Creatine ORAL: 3 MG, 1 Prevent Permanent Phosphokinase Increased IN 1 DAY(S), Impairment/Damage Clonic Convulsion ORAL: 3MG, 2 Coma IN 1 DAY(S), Confusional State Seroquel Dementia (Quetiapine) SS ORAL 600 MG , Dysarthria DAILY, ORAL Encephalopathy Thorazine (Tablet) Extensor Plantar Response (Chlorpromazine) SS ORAL 200 MG, 1 IN Eye Rolling 1 DAY(S), Hypoxia ORAL Muscle Rigidity Phencyclidine Neuroleptic Malignant (Phencyclidine) SS Syndrome Klonopin (Tablet) Pyrexia (Clonazepam) C Respiratory Failure Prolixin Stupor (Fluphenazine Tachycardia Hydrochloride) C Tremor Olanzapine Vomiting (Olanzapine C Date:10/25/99ISR Number: 3381424-0Report Type:Expedited (15-DaCompany Report #1999AP04907 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Seroquel "Zeneca" PS Zeneca ORAL 750 MG DAILY Initial or Prolonged Eosinophilia Health PO Gastrointestinal Professional Sertraline C Infection Other Chlorpromazine C Date:10/26/99ISR Number: 3382730-6Report Type:Expedited (15-DaCompany Report #1999AP05466 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Seroquel "Zeneca" PS Zeneca ORAL 150 MG BID PO Initial or Prolonged Drug Hypersensitivity Health Olanzapine C Dyspnoea Professional Cipramil C Face Oedema Oedema Mouth Tongue Oedema 22-Feb-2006 08:31 AM Page: 119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/99ISR Number: 3382732-XReport Type:Expedited (15-DaCompany Report #1999AP04541 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Seroquel "Zeneca" PS Zeneca ORAL 200 MG DAILY Initial or Prolonged Positive Health PO Required Arthralgia Professional Prozac C Intervention to Autoantibody Positive Fluoxetine C Prevent Permanent Blood Cholesterol Risperidone C Impairment/Damage Increased Blood Thyroid Stimulating Hormone Increased Dna Antibody Positive Erythema Movement Disorder Myalgia Oculogyration Red Blood Cell Sedimentation Rate Increased Skin Lesion Systemic Lupus Erythematosus White Blood Cell Count Increased Date:10/27/99ISR Number: 3383104-4Report Type:Expedited (15-DaCompany Report #9935038 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ageusia Health Navane Capsules PS ORAL 6.00 MG TOTAL Initial or Prolonged Drug Ineffective Professional DAILY ORAL Required Heart Rate Increased Seroquel SS UNKNOWN NOT SPECIFIED Intervention to Insomnia Chloral Hydrate SS UNKNOWN NOT SPECIFIED Prevent Permanent Tension Impairment/Damage Thinking Abnormal Date:10/27/99ISR Number: 3383111-1Report Type:Expedited (15-DaCompany Report #1999UW03784 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Seroquel "Zeneca" PS Zeneca ORAL 300 MG PO Initial or Prolonged Coma Professional Risperdal C Convulsion Company Buspar C Depressed Level Of Representative Prozac C Consciousness Loxapine C Loss Of Consciousness Muscle Contractions Involuntary Muscle Twitching Neuroleptic Malignant Syndrome Serotonin Syndrome Tremor 22-Feb-2006 08:31 AM Page: 120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/99ISR Number: 3389671-9Report Type:Expedited (15-DaCompany Report #1999AP05466 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Seroquel PS Zeneca ORAL 150 MG BID PO Initial or Prolonged Dyspnoea Health Olanzapine C Face Oedema Professional Cipramil C Hypersensitivity Other Date:11/08/99ISR Number: 3391186-9Report Type:Expedited (15-DaCompany Report #9935038 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ageusia Health Navane Capsules PS ORAL 6.00 MG Initial or Prolonged Drug Effect Decreased Professional TOTAL: DAILY: Required Drug Ineffective ORAL Intervention to Heart Rate Increased Seroquel SS Prevent Permanent Insomnia Chloral Hydrate SS Impairment/Damage Medication Error Tension Thinking Abnormal Date:11/09/99ISR Number: 3391458-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Seroquel PS ORAL 400MG PO DAILY 1 MON Zyprexa SS ORAL 10MG PO DAILY (SERVERAL MONTHS) Depakene C Clonidine C Cogentin C Anafranil C Vistaril C Date:11/10/99ISR Number: 3394212-6Report Type:Expedited (15-DaCompany Report #1999AP06076 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Seroquel "Zeneca" PS ORAL 225 MG BID PO Exposure To Therapeutic Health Seroquel "Zeneca" SS ORAL 220 MG BID PO Drugs Professional Muscle Twitching Pregnancy Premature Baby Date:11/12/99ISR Number: 3399691-6Report Type:Periodic Company Report #19981200141 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Prilosec Cap PS Professional Quetiapine SS Depakote SS 22-Feb-2006 08:31 AM Page: 121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/99ISR Number: 3397422-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glossitis Health Quetiapine PS 100MG HS Tardive Dyskinesia Professional Diltiorem C Tongue Disorder Buspirone C Prazosin C Salsalate C Metformin C Glipiride C Cyprosheptadine C Lanesprazole C Diazepam C Asa C Sertraline C Felodipine C Date:11/16/99ISR Number: 3399339-0Report Type:Expedited (15-DaCompany Report #1999AP06148 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Seroquel "Zeneca" PS ORAL 25 MG DAILY Initial or Prolonged Complete Health PO Myocardial Infarction Professional Haloperidol C Other Date:11/22/99ISR Number: 3405716-1Report Type:Expedited (15-DaCompany Report #1999AP06204 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Seroquel "Zeneca" PS "Zeneca" ORAL 300 MG DAILY Health PO Professional Prozac C Other Procyclidine C Date:11/23/99ISR Number: 3405394-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Seroquel PS 700MG QD Increased Professional Blood Triglycerides Increased Low Density Lipoprotein Increased Date:11/23/99ISR Number: 3406737-5Report Type:Periodic Company Report #USA/98/02337/LEX Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Health Clozaril (Clozapine) PS ORAL 200 MG, ORAL Initial or Prolonged Professional Seroquel SS Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/99ISR Number: 3408953-5Report Type:Expedited (15-DaCompany Report #1998AP50790 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Foreign Seroquel PS ORAL 200 MG DAILY Life-Threatening Bundle Branch Block Left Study PO Hospitalization - C-Reactive Protein Health Seroquel SS ORAL 600 MG DAILY Initial or Prolonged Increased Professional PO Required Cardiac Failure Lactulose C Intervention to Cardiac Murmur Lasilix C Prevent Permanent Cardio-Respiratory Arrest Zestril C Impairment/Damage Congestive Cardiomyopathy Digoxine C Dyspnoea Solian C Dyspnoea Exertional Seresta C Ejection Fraction Abnormal Gallop Rhythm Present Gamma-Glutamyltransferase Increased Hyponatraemia Myocardial Infarction Necrosis Oedema Peripheral Pulmonary Hypertension Rales Sinus Tachycardia Sinusitis Venous Pressure Jugular Increased Date:11/24/99ISR Number: 3408955-9Report Type:Expedited (15-DaCompany Report #1999UW04185 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Seroquel "Zeneca" PS Intervention to Neutrophil Count Professional Clorazil SS ORAL 250 MG PO Prevent Permanent Decreased Prozac C Impairment/Damage White Blood Cell Count Risperdal C Decreased Neurontin C Vitamin E C Ambien C Aspirin C Niferex C Vitamin C C Date:11/29/99ISR Number: 3409395-9Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akinesia Seroquel 25mg Zeneca Amnesia (Sample) PS Zeneca ORAL 50MG 1 HR Asthenia ORAL Loss Of Consciousness Albuterol C Memory Impairment Beclomethasone C Motor Dysfunction Eskalith C Aspirin C Vitamins C&E C Codeine C Levothyroxine C Lamotrigine C 22-Feb-2006 08:31 AM Page: 123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Topomax C Captopril C Allopurinol C Flax Seed Oil C Date:11/29/99ISR Number: 3409879-3Report Type:Expedited (15-DaCompany Report #1999UW04185 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Seroquel "Zeneca" PS Zeneca Intervention to Neutropenia Professional Clorazil SS ORAL 250 MG PO Prevent Permanent Prozac C Impairment/Damage Risperdal C Neurontin C Ambien C Aspirin "Bayer" C Niferex C Vitamin C C Date:11/29/99ISR Number: 3409881-1Report Type:Expedited (15-DaCompany Report #1999UW04196 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Health Seroquel "Zeneca" PS Zeneca Initial or Prolonged Blood Bilirubin Increased Professional Depakote C Hepatitis Lithium Carbonate C Liver Function Test Thyroid Medication C Abnormal Proton Pump Inhibitor C Pancrease C Insulin C Date:11/30/99ISR Number: 3411086-5Report Type:Expedited (15-DaCompany Report #1999UW04196 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Health Seroquel "Zeneca" PS Zeneca ORAL 100 MG QD PO Initial or Prolonged Blood Bilirubin Increased Professional Depakote C Hepatitis Lithium Carbonate C International Normalised Thyroid Medication C Ratio Increased Proton Pump Liver Function Test Inhibitor C Abnormal Pancrease C Insulin C Date:11/30/99ISR Number: 3412646-8Report Type:Periodic Company Report #1998UW48512 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Literature Seroquel PS ORAL 200 MG QD PO Initial or Prolonged Lithium C Gabapentin C Clonazepam C Venlafaxine C 22-Feb-2006 08:31 AM Page: 124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/99ISR Number: 3412649-3Report Type:Periodic Company Report #1999AP05419 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Literature Seroquel "Zeneca" PS Zeneca ORAL 350 MH DAILT Health PO 4 WK Professional Risperidone C Diphenhydramine C Date:11/30/99ISR Number: 3412651-1Report Type:Periodic Company Report #1999UW01472 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Seroquel PS Initial or Prolonged Suicide Attempt Professional Required Ventricular Extrasystoles Intervention to Prevent Permanent Impairment/Damage Date:11/30/99ISR Number: 3412652-3Report Type:Periodic Company Report #1999UW01990 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel "Zeneca" PS Zeneca ORAL 200 MG QAM PO Hospitalization - Convulsion Professional Seroquel "Zeneca" SS Zeneca ORAL 300 MG HS PO Initial or Prolonged Fluid Overload Company Lithium C Required Representative Vitamin C Intervention to Synthroid C Prevent Permanent Impairment/Damage Date:11/30/99ISR Number: 3412654-7Report Type:Periodic Company Report #1999UW02154 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Seroquel PS ORAL 50 MG QD PO Initial or Prolonged Health Lanoxin C Professional Hydrochlorothiazide C Paroxetine Hydrochloride C Lisinopril C Haloperidol C Date:11/30/99ISR Number: 3412657-2Report Type:Periodic Company Report #1999UW02914 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Study Seroquel "Zeneca" PS Zeneca Initial or Prolonged Pneumonia Health Seroquel "Zeneca" SS Zeneca Professional Potassium C Hydrocortizone C Paroxetine C Senna C Amoxicillin C Guafenesin C Lacticare C 22-Feb-2006 08:31 AM Page: 125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/99ISR Number: 3412658-4Report Type:Periodic Company Report #1999UW03023 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Study Seroquel "Zeneca" PS Zeneca ORAL 100 MG QD PO Initial or Prolonged Syncope Health Verapamil C Professional Certagen C Atenolol C Acetaminophen C Diltiazem C Fml-S C Serzone C Simethicone C Date:11/30/99ISR Number: 3412659-6Report Type:Periodic Company Report #1999UW03193 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Seroquel "Zeneca" PS Zeneca Initial or Prolonged Professional Date:11/30/99ISR Number: 3412660-2Report Type:Periodic Company Report #1999UW03248 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel "Zeneca" PS Zeneca Initial or Prolonged Syndrome Professional Overdose Date:11/30/99ISR Number: 3412661-4Report Type:Periodic Company Report #1999UW03304 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Seroquel "Zeneca" PS Zeneca Initial or Prolonged Professional Date:11/30/99ISR Number: 3412663-8Report Type:Periodic Company Report #1999UW03532 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Seroquel "Zeneca" PS ORAL 600 MG QD PO 1 YR Initial or Prolonged Weight Increased Professional Klonopin C Benadryl C Date:11/30/99ISR Number: 3412665-1Report Type:Periodic Company Report #1999UW03770 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Seroquel "Zeneca" PS Zeneca ORAL 100 MG QD PO Initial or Prolonged Hypersomnia Professional Required Overdose Intervention to Sedation Prevent Permanent Suicide Attempt Impairment/Damage 22-Feb-2006 08:31 AM Page: 126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/99ISR Number: 3412831-5Report Type:Expedited (15-DaCompany Report #1998UW45634 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Seroquel PS ORAL 100 MG QD PO Hospitalization - Clostridium Colitis Health Valproic Acid C Initial or Prolonged Leukopenia Professional Primaxin C Required White Blood Cell Count Other Intervention to Increased Prevent Permanent Impairment/Damage Date:12/03/99ISR Number: 3413445-3Report Type:Expedited (15-DaCompany Report #1999AP06076 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Seroquel "Zeneca" PS ORAL 225 MG BID PO Exposure To Therapeutic Health Seroquel "Zeneca" SS ORAL 200 MG BID PO Drugs Professional Droperidol SS Muscle Twitching Chlorpromazine SS Premature Baby Date:12/08/99ISR Number: 3416437-3Report Type:Expedited (15-DaCompany Report #1999AP06498 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cerebellar Ataxia Foreign Seroquel "Zeneca" PS ORAL 250 MG BID Condition Aggravated Health Droperidol C Professional Date:12/09/99ISR Number: 3417770-1Report Type:Expedited (15-DaCompany Report #1999UW02680 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Seroquel PS ORAL 150 MG QD PO 5 MON Cataract Cortical Professional Prilosec C Cataract Nuclear Company Reglan C Representative Prozac C Date:12/10/99ISR Number: 3417884-6Report Type:Direct Company Report # Age:22.8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Health Seroquel PS 150MG QHS Initial or Prolonged Professional Risperdal SS 3MG QHS Date:12/10/99ISR Number: 3417908-6Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Quetiapine 100mg Initial or Prolonged Tablets PS ORAL 100MG QAM 700MG HS ORAL Gabapentin 400mg Capsules SS ORAL 800MG TID ORAL Fluphenazine C 22-Feb-2006 08:31 AM Page: 127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluvastatin C Date:12/10/99ISR Number: 3418567-9Report Type:Expedited (15-DaCompany Report #1999AP06579 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Foreign Seroquel "Zeneca" PS Zeneca ORAL 200 MG DAILY Initial or Prolonged Grand Mal Convulsion Health PO 66 DAY Hyponatraemia Professional Seroquel "Zeneca" SS Zeneca ORAL 750 MG DAILY Inappropriate Other PO 66 DAY Antidiuretic Hormone Venlafaxine SS Secretion Lithium Carbonate C Date:12/13/99ISR Number: 3420621-2Report Type:Expedited (15-DaCompany Report #1999UW04378 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Health Seroquel "Zeneca" PS Initial or Prolonged Jaundice Professional Depakote C Tegretol C Clonopin C Date:12/13/99ISR Number: 3421124-1Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Seroquel /25 Mg Loss Of Consciousness /Zeneca (Sample) PS Zeneca ORAL 50MG 1 HR Memory Impairment ORAL Motor Dysfunction Albuterol C Beclomethasone C Eskalith C Aspirin C Vitamins C & E C Codeine C Levothyroxine C Lamotrigine C Topomax C Captopril C Date:12/20/99ISR Number: 3426044-4Report Type:Direct Company Report # Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Seroquel 100mg- Zeneca PS Zeneca 1T QAM 2T QHS Risperdal 3mg SS 1T QID Depakene C Ativan C Date:12/29/99ISR Number: 3433551-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Other Condition Aggravated Neutropenia 22-Feb-2006 08:31 AM Page: 128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Health Seroquel 100mg Tabs PS 250MG BID Professional THEN 200 MG BID 6 DAY Clozaril C Date:01/03/00ISR Number: 3435186-9Report Type:Expedited (15-DaCompany Report #WAES 99121450 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Tab Vioxx 25 Mg PS ORAL 25 Initial or Prolonged Attention Professional MG/DAILY/PO Deficit/Hyperactivity Tab Vioxx 25 Mg SS ORAL 500 MG/1X/PO Disorder Tab Parnate SS ORAL 10 Confusional State TABLET/1X/PO Hepatic Function Abnormal Tab Seroquel 200 Mg SS ORAL 4000 MG/1X/PO Intentional Overdose Tab Propecia 1 Mg SS ORAL 20 MG/1X/PO Pneumonia Tab Propecia 1 Mg SS ORAL 1 MG/DAILY/PO Suicide Attempt Thrombocythaemia Date:01/03/00ISR Number: 3435198-5Report Type:Expedited (15-DaCompany Report #WAES 99121450 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Tab Vioxx 25 Mg PS ORAL 500 MG/1X/PO Initial or Prolonged Attention Professional Tab Parnate SS ORAL 10 Deficit/Hyperactivity TABLET/1X/PO Disorder Tab Seroquel 200 Mg SS ORAL 4000 MG/1X/PO Confusional State Intentional Overdose Date:01/04/00ISR Number: 3436536-XReport Type:Expedited (15-DaCompany Report #1999AP06800 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Foreign Quetiapine PS ORAL 75 MG DAILY Initial or Prolonged Blood Creatine Health PO Required Phosphokinase Increased Professional Misoprostol C Intervention to C-Reactive Protein Other Losartan C Prevent Permanent Increased Nifedipine C Impairment/Damage Fall Olanzapine C Hypokalaemia Increased Bronchial Secretion Lymphocytosis Pneumonia Pyrexia Red Blood Cell Sedimentation Rate Increased Sedation Transient Ischaemic Attack 22-Feb-2006 08:31 AM Page: 129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/00ISR Number: 3436574-7Report Type:Expedited (15-DaCompany Report #1999AP04907 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Seroquel "Zeneca" PS ORAL 750 MG DAILY Initial or Prolonged Diarrhoea Other PO Dysgeusia Sertraline C Eosinophilia Chlorpromazine C Date:01/04/00ISR Number: 3436577-2Report Type:Expedited (15-DaCompany Report #1999AP06235 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Seroquel "Zeneca" PS ORAL 100 MG PO Initial or Prolonged Hepatocellular Damage Health Promethazine C Liver Function Test Professional Akineton C Abnormal Other Date:01/05/00ISR Number: 3437688-8Report Type:Direct Company Report # Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neurotoxicity Health Seroquel PS SEE IMAGE Initial or Prolonged Professional Lithobid SS SEE IMAGE Depakote C Ativan C Hytrin C Maxzide C Vioxx C Prozac C Prilosec C Ogen C Albuterol Inh C Date:01/10/00ISR Number: 3441775-8Report Type:Expedited (15-DaCompany Report #1999AP06530 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dry Mouth Foreign Seroquel "Zeneca" PS ORAL 250 MG DAILY Dysarthria Health PO Motor Dysfunction Professional Salbutamol C Muscle Rigidity Other Muscle Twitching Sedation Date:01/10/00ISR Number: 3441815-6Report Type:Expedited (15-DaCompany Report #1999UW04502 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel "Zeneca" PS Intervention to Health Clozapine C Prevent Permanent Professional Impairment/Damage 22-Feb-2006 08:31 AM Page: 130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/00ISR Number: 3442642-6Report Type:Expedited (15-DaCompany Report #1999AP05757 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Seroquel "Zeneca" PS Zeneca ORAL 750 MG DAILY Initial or Prolonged Diabetic Ketoacidosis Health PO Weight Increased Professional Priadel C Other Depixol C Acamprosate C Date:01/11/00ISR Number: 3442643-8Report Type:Expedited (15-DaCompany Report #2000AP00056 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Reaction Foreign Seroquel "Zeneca" PS Zeneca ORAL 50 MG DAILY Initial or Prolonged Delirium Health PO Face Oedema Professional Other Date:01/13/00ISR Number: 3443644-6Report Type:Expedited (15-DaCompany Report #2000UW00031 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Health Seroquel PS ORAL 50 MG BID PO Initial or Prolonged Eosinophilic Pneumonia Professional Prinivil C White Blood Cell Count Potassium C Decreased Furosemide C Paxil C Xanax C Date:01/14/00ISR Number: 3443813-5Report Type:Direct Company Report # Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Seroquel PS 25MG HS Initial or Prolonged Difficulty In Walking Sinemet 25/100 SS 1 7AM, 1/2 Sedation 10AM, 1/2 2PM Date:01/14/00ISR Number: 3443819-6Report Type:Direct Company Report # Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Sinemet 25/100 PS QID Initial or Prolonged Dyskinesia Seroquel SS QD OR TID Hyperhidrosis Zydis C Hypotension Requip C Pallor Remeron C Date:01/19/00ISR Number: 3446317-9Report Type:Expedited (15-DaCompany Report #1999UW04378 Age:41 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Encephalopathy Health Seroquel "Zeneca" PS Hepatitis C Professional Tegretol SS Jaundice Depakote SS Liver Function Test Klonopin C Abnormal Date:01/19/00ISR Number: 3446329-5Report Type:Expedited (15-DaCompany Report #1999UW04196 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ammonia Increased Health Seroquel "Zeneca" PS ORAL 100 MG QD PO; Hospitalization - Asthenia Professional 200 MG QD PO Initial or Prolonged Blood Bilirubin Increased Tylenol W/Codeine Required Chromaturia No. 3 SS Intervention to Hepatitis Tylenol SS Prevent Permanent International Normalised Depakote C Impairment/Damage Ratio Increased Lithium Carbonate C Liver Function Test Thyroid Medication C Abnormal Lansoprazole C Mental Impairment Pancrease C Overdose Nph Insulin C Sedation Date:01/19/00ISR Number: 3446347-7Report Type:Expedited (15-DaCompany Report #1999AP06800 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Quetiapine PS ORAL 75 MG DAILY Initial or Prolonged Phosphokinase Increased Health PO Required Blood Potassium Decreased Professional Misoprostol C Intervention to Body Temperature Other Losartan C Prevent Permanent Increased Nifedipine C Impairment/Damage Fall Olanzapine C Increased Bronchial Secretion Pneumonia Pyrexia Red Blood Cell Sedimentation Rate Increased Sedation Transient Ischaemic Attack Date:01/20/00ISR Number: 3445654-1Report Type:Expedited (15-DaCompany Report #1999UW02680 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Seroquel PS ORAL 150 MG QD PO Professional Seroquel SS Company Prilosec C Representative Reglan C Prozac C 22-Feb-2006 08:31 AM Page: 132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/00ISR Number: 3447243-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000000200 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Autonomic Nervous System Health Risperdal (Tablet) Imbalance Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Blood Creatine DAY(S) ORAL Phosphokinase Increased Seroquel (Seroquel) SS ORAL 600 MG, DAILY Conjunctivitis ORAL Dehydration Loxitane (Loxapine Drug Level Above Succinate) SS ORAL ORAL Therapeutic Lithium (Lithium) SS ORAL ORAL Drug Toxicity Synthroid Hypertension (Levothyroxine Leukopenia Sodium) C Mental Impairment Depakote (Valproate Muscle Rigidity Semisodium) C Neuroleptic Malignant Syndrome Pyrexia Date:02/02/00ISR Number: 3449875-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Lens Disorder Seroquel Intervention to (Quetiapine) PS 300MG Q Prevent Permanent AM/450MG Q HS Impairment/Damage Risperidone C Valproic Acid C Clonazepam C Propanolol C Date:02/02/00ISR Number: 3450253-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Seroquel Initial or Prolonged Dyskinesia (Quetiapine) PS 300 MG Q AM/ 450 MG Q HS FROM 2ND QTR. 1998 Risperidone C Valproic Acid C Clonazepam C Propranolol C Date:02/02/00ISR Number: 3450537-7Report Type:Expedited (15-DaCompany Report #18588-021 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Communication Disorder Health Lithium Carbonate Initial or Prolonged Distractibility Professional Tablets Usp, 300mg Other Drug Interaction Roxane Laboratories, Mental Status Changes Inc. PS Roxane Laboratories, Inc. ORAL 450MG QAM & 600MG QPM, PO Seroquel (Quetiapine Fumarate) 200mg 22-Feb-2006 08:31 AM Page: 133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zeneca Pharmaceuticals, Inc. SS Zeneca Pharmaceuticals, Inc. ORAL 400MG QHS, PO Gabitril C Ambien (Zolpidem Tartrate) C Mysoline (Primidone) C Prometrium(Progester one) C Vitamin B6 C Calcium Supplements C Date:02/02/00ISR Number: 3450542-0Report Type:Expedited (15-DaCompany Report #1999AP06493 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel "Zeneca" PS Zeneca ORAL 300 MG BID PO Initial or Prolonged Disinhibition Health Injury Professional Libido Increased Other Sexual Abuse Date:02/02/00ISR Number: 3450544-4Report Type:Expedited (15-DaCompany Report #2000UW00205 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Health Seroquel "Zeneca" PS Zeneca ORAL 25 MG BID PO Initial or Prolonged Thromboplastin Time Professional Seroquel "Zeneca" SS Zeneca ORAL 400 MG BID PO Required Prolonged Company Depakote C Intervention to Alanine Aminotransferase Representative Topamax C Prevent Permanent Increased Remeron C Impairment/Damage Ammonia Increased Aspartate Aminotransferase Increased Blood Ph Decreased Brain Herniation Brain Oedema Coma Condition Aggravated Depression Facial Bones Fracture Head Banging Hepatitis Hypokalaemia Insomnia Intracranial Pressure Increased Metabolic Acidosis Pupil Fixed Pyrexia Status Epilepticus 22-Feb-2006 08:31 AM Page: 134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/00ISR Number: 3450612-7Report Type:Expedited (15-DaCompany Report #2000AP00356 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS Zeneca Aspiration Health Thioridazine C Vomiting Professional Other Date:02/02/00ISR Number: 3450646-2Report Type:Direct Company Report # Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Seroquel PS 100MG Q AM/ Abdominal Pain 200MG HS 3 MON Dysphagia Gastrointestinal Motility Disorder Hyperhidrosis Muscle Spasms Nasopharyngeal Disorder Nephrolithiasis Oesophageal Spasm Renal Colic Salivary Gland Disorder Salivary Hypersecretion Tachycardia Date:02/07/00ISR Number: 3453984-2Report Type:Expedited (15-DaCompany Report #2000UW00318 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Seroquel "Zeneca" PS Zeneca ORAL 125 MG QD PO Initial or Prolonged Professional Zyprexa C Date:02/08/00ISR Number: 3454716-4Report Type:Expedited (15-DaCompany Report #M0042-2000 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Remeron PS ORAL 30 MG/DAY, PO Pneumonia Health Seroquel SS ORAL 300 MG/DAY, Professional PO Other Amitriptyline C Temazepam C Date:02/09/00ISR Number: 3455561-6Report Type:Expedited (15-DaCompany Report #2000UW00143 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatitis Health Seroquel "Zeneca" PS Zeneca Intervention to Liver Function Test Professional Prevent Permanent Abnormal Impairment/Damage 22-Feb-2006 08:31 AM Page: 135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/15/00ISR Number: 3457423-7Report Type:Direct Company Report # Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Seroquel Initial or Prolonged Neutropenia (Quetiapine) PS ORAL 150 MG TID PO Omeprazole C Bactrim C Caco3 C Enoxaparin C Benztropine C Ibuprofen C Hydroxyzine C Haloperidol C Trazodone C Date:02/15/00ISR Number: 3457471-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Health Seroquel 25mg PS ORAL 25MG PO AM & Convulsion Professional 50 MG PO HS Status Epilepticus Sinemet 25/250 C Apap C Lisinopril C Cardizem Cd C Trazadone C Date:02/15/00ISR Number: 3458222-2Report Type:Expedited (15-DaCompany Report #1999UW04502 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel "Zeneca" PS ORAL 50 MG QD PO Intervention to Neutropenia Health Clozapine C Prevent Permanent Professional Lorazepam C Impairment/Damage Date:02/15/00ISR Number: 3458573-1Report Type:Periodic Company Report #10006203 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Sodium Decreased Health Serzone Tabs Convulsion Professional (Nefazodone Hcl) PS ORAL 600 MILLIGRAM, 1/1 DAY ORAL Seroquel (Quetiapine) SS 800 MILLIGRAM Date:02/16/00ISR Number: 3458464-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Twitching Seroquel 100 Mg And Tic 200 Mg. Zeneca PS Zeneca ORAL 100 MG 1 AM/NOON ORAL Multiple Vitamins C Hydroxyzine C Clonidine C 22-Feb-2006 08:31 AM Page: 136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/00ISR Number: 3458879-6Report Type:Expedited (15-DaCompany Report #2000UW00149 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Seroquel "Zeneca" PS Zeneca Initial or Prolonged Anaemia Professional Depakote C Condition Aggravated Company Antibiotics C Coordination Abnormal Representative Hydrocephalus Tremor Date:02/17/00ISR Number: 3459422-8Report Type:Expedited (15-DaCompany Report #2000UW00488 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Seroquel PS Zeneca ORAL 400 MG HS PO Initial or Prolonged Mental Impairment Professional Lithium Carbonate Tablets SS ORAL 450 MG QD PO Lithium Carbonate Tablets SS ORAL 600 MG HS PO Gabitril C Ambien C Mysoline C Prometrium C Multiple Vitamins C Vitamin B6 C Calcium C Date:02/18/00ISR Number: 3460384-8Report Type:Expedited (15-DaCompany Report #HQ0890403FEB2000 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cellulitis Health Effexor PS ORAL ORAL 1 WK Dermatitis Professional Lithium SS Oedema Seroquel "Zeneca" SS Zeneca ORAL ORAL Pyrexia Weight Increased Date:02/23/00ISR Number: 3462045-8Report Type:Expedited (15-DaCompany Report #2000UW00553 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Seroquel "Zeneca" PS ORAL 500 MG PO Neutropenia Health Lithium C Professional Clonazepam C Other Iron Sulfate C Docusate C Date:02/23/00ISR Number: 3467974-7Report Type:Periodic Company Report #9915490 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Zoloft Tablets PS ORAL ORAL Initial or Prolonged Delusion Professional Seroquel SS ORAL ORAL Required Hallucination Depakote SS ORAL ORAL Intervention to Paranoia Haldol C Prevent Permanent Cogentin C Impairment/Damage 22-Feb-2006 08:31 AM Page: 137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3468277-7Report Type:Periodic Company Report #JAUSA35570 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choreoathetosis Health Risperdal (Tablet) Initial or Prolonged Condition Aggravated Professional (Risperidone) PS SEE IMAGE Dyskinesia Seroquel Gynaecomastia (Quetiapine) SS (08-NOV-98): Weight Decreased ESTIMATED STOP DATE Lithium C Prozac C Date:02/23/00ISR Number: 3470523-0Report Type:Periodic Company Report #A0105838A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Health Lamictal Tablet Initial or Prolonged Professional (Lamotrigine) PS ORAL 100 MG / TWICE PER DAY / ORAL Quetiapine Fumarate Tablet (Quetiapine Fumarate) SS ORAL 100 MG / TWICE PER DAY / ORAL Bupropion Hydrochloride C Citalopram Hydrobromide C Clonazepam C Date:02/24/00ISR Number: 3462590-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000139 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coombs Direct Test Health Neurontin Initial or Prolonged Positive Professional (Gabapentin) PS Haematocrit Decreased Seroquel Haemoglobin Decreased (Quentiapine) SS 600 MG Haemolytic Anaemia Psychotic Disorder Date:02/24/00ISR Number: 3463237-4Report Type:Expedited (15-DaCompany Report #00P-163-0087101-00 (0) Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Gabitril (Gabitril) Initial or Prolonged Akathisia Professional (Tiagabine Hcl) PS ORAL 24 MG 1 IN 1 Communication Disorder D PER ORAL Crying Lithium Carbonate Drug Interaction (Lithium Carbonate) SS ORAL 1050 MG 1 IN Dyskinesia 1 D PER ORAL Dyspnoea Seroquel (Seroquel) SS ORAL PER ORAL Fear Mtv(Vitamins Nos) C Mental Impairment Calcium (Calcium) C Muscle Contractions Pyridoxine Involuntary Hydrochloride Muscle Twitching (Pyridoxine 22-Feb-2006 08:31 AM Page: 138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Progesterone (Progesterone) C Primidone (Primidone) C Date:02/28/00ISR Number: 3471283-XReport Type:Periodic Company Report #99USA11042 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Anafranil Capsule Drug Interaction Professional (Clomipramine Hydrochloride) PS ORAL 150 MG,DAILY,ORAL Klonopin Tablet (Clonazepam) SS ORAL 4 MG,DAILY,ORAL Seroquel Tablet (Quetiapine Fumarate) SS ORAL 150 MG,DAILY,ORAL Date:03/01/00ISR Number: 3465964-1Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Health Seroquel PS PO ? DOSE Initial or Prolonged Professional Date:03/01/00ISR Number: 3467190-9Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Health Quetiapine PS ORAL 50 MG QHS Hospitalization - Renal Failure Professional ORAL Initial or Prolonged Risperidone SS ORAL 1MG QHS ORAL Disability Date:03/03/00ISR Number: 3469070-1Report Type:Expedited (15-DaCompany Report #2000UW00663 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Health Seroquel "Zeneca" PS Zeneca White Blood Cell Count Professional Decreased Date:03/06/00ISR Number: 3470186-4Report Type:Periodic Company Report #2000UW00266 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Seroquel "Zeneca" PS "Zeneca" ORAL 300 MG QD PO Initial or Prolonged Professional Zoloft C Klonopin C Haldol C Depakote C 22-Feb-2006 08:31 AM Page: 139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/00ISR Number: 3470187-6Report Type:Periodic Company Report #2000UW00047 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Date:03/06/00ISR Number: 3470189-XReport Type:Periodic Company Report #2000UW00023 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Seroquel "Zeneca" PS "Zeneca" Initial or Prolonged Professional Depakote C Date:03/06/00ISR Number: 3470191-8Report Type:Periodic Company Report #2000UW00004 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 200 MG QD PO Initial or Prolonged Haldol C Date:03/06/00ISR Number: 3470192-XReport Type:Periodic Company Report #1999UW04330 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Seroquel "Zeneca" PS "Zeneca" ORAL 125 MG QD PO 30 DAY Hospitalization - Syndrome Professional Seroquel "Zeneca" SS ORAL 150 MG QD PO 30 DAY Initial or Prolonged Company Haldol C Representative Date:03/06/00ISR Number: 3470194-3Report Type:Periodic Company Report #1999UW04215 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Seroquel "Zeneca" PS "Zeneca" ORAL 275 MG BID PO Initial or Prolonged Professional Risperidal C Date:03/06/00ISR Number: 3470196-7Report Type:Periodic Company Report #1999UW04166 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Failure Acute Health Seroquel "Zeneca" PS "Zeneca" ORAL 100 MG QD PO Hospitalization - Professional Humulin 30/70 C Initial or Prolonged Company Lasix C Required Representative Aldactone C Intervention to Diabeta C Prevent Permanent Vitamin B1 C Impairment/Damage Synthroid C Levaquin C Haldol C Ativan C 22-Feb-2006 08:31 AM Page: 140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/00ISR Number: 3470198-0Report Type:Periodic Company Report #1999UW04109 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Seroquel "Zeneca" PS "Zeneca" ORAL 180 MG QD PO Initial or Prolonged Overdose Professional Required Intervention to Prevent Permanent Impairment/Damage Date:03/06/00ISR Number: 3470199-2Report Type:Periodic Company Report #1999UW03931 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Consumer Seroquel "Zeneca" PS "Zeneca" Initial or Prolonged Syndrome Haldol C Date:03/06/00ISR Number: 3470202-XReport Type:Periodic Company Report #1999UW03770 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Seroquel "Zeneca" PS "Zeneca" ORAL 100 MG QD PO Initial or Prolonged Hypersomnia Professional Required Overdose Intervention to Sedation Prevent Permanent Suicide Attempt Impairment/Damage Date:03/06/00ISR Number: 3470206-7Report Type:Periodic Company Report #1999UW03532 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Seroquel "Zeneca" PS "Zeneca" ORAL 600 MG QD PO 1 YR Initial or Prolonged Weight Increased Professional Klonopin C Company Benadryl C Representative Date:03/06/00ISR Number: 3470209-2Report Type:Periodic Company Report #1998UW49078 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Study Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Health PO Required Professional Vitamin E C Intervention to Sertraline Prevent Permanent Hydrochloride C Impairment/Damage Multivitamins C Alprazolam C Ambesol C Hydrocortisone C 22-Feb-2006 08:31 AM Page: 141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/00ISR Number: 3470217-1Report Type:Periodic Company Report #1999UW03355 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Seroquel "Zeneca" PS "Zeneca" 100 MG DAILY Initial or Prolonged Prolonged Professional Paxil C Syncope Company Zithromax C Representative Neurontin C Date:03/06/00ISR Number: 3470221-3Report Type:Periodic Company Report #1999UW03023 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Study Seroquel "Zeneca" PS "Zeneca" ORAL 100 MG QD PO Initial or Prolonged Syncope Health Verapamil C Professional Certagen, Oral Liquid C Ranitidine C Atenolol C Acetaminophen C Diltiazem Hydrochloride C Fml-S C Serzone C Simethicone C Date:03/06/00ISR Number: 3552802-1Report Type:Periodic Company Report #2000UW00147 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscular Weakness Health Seroquel PS Astrazeneca Uk Ltd ORAL 50 MG HS PO ; Myalgia Professional 100 MG HS PO Zoloft C Revia C Ibuprofen C Date:03/06/00ISR Number: 3552803-3Report Type:Periodic Company Report #2000UW00146 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diaphragmatic Hernia Consumer Seroquel PS Astrazeneca Uk Ltd Ear Disorder Headache Hypertension Rhinitis Date:03/06/00ISR Number: 3552804-5Report Type:Periodic Company Report #2000UW00122 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 300 MG HS PO Arthritis Back Pain Renal Colic 22-Feb-2006 08:31 AM Page: 142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/00ISR Number: 3552805-7Report Type:Periodic Company Report #2000UW00110 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Seroquel PS Astrazeneca Uk Ltd Professional Date:03/06/00ISR Number: 3552806-9Report Type:Periodic Company Report #2000UW00098 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG QD PO Restlessness Professional Depakote C Date:03/06/00ISR Number: 3552807-0Report Type:Periodic Company Report #2000UW00092 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG DAILY Intervention to Malaise PO; 250 MG Prevent Permanent DAILY PO Impairment/Damage Date:03/06/00ISR Number: 3552808-2Report Type:Periodic Company Report #2000UW00084 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cranial Nerve Palsies Health Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG QD PO Multiple Professional Effexor C Tetracycline C Benzoyl Peroxide C Date:03/06/00ISR Number: 3552809-4Report Type:Periodic Company Report #2000UW00081 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Seroquel PS Astrazeneca Uk Ltd ORAL 300 MG QD PO Professional Date:03/06/00ISR Number: 3552810-0Report Type:Periodic Company Report #1999UW04559 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Health Seroquel PS Astrazeneca Uk Ltd ORAL 12.5 MG QD Sedation Professional PO; 6.25 MG QD PO Neurontin C Date:03/06/00ISR Number: 3552811-2Report Type:Periodic Company Report #1999UW04406 Age:31 YR Gender:Female I/FU:I Outcome PT Movement Disorder Muscle Rigidity Peripheral Sensory Neuropathy 22-Feb-2006 08:31 AM Page: 143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG HS PO; 50 MG QAM PO; 400 MG HS PO Neurontin SS 1500 MG DAILY Ambien C Lamictal C Effexor C Zoloft C Date:03/06/00ISR Number: 3552812-4Report Type:Periodic Company Report #1999UW04401 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Health Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG HS PO; Blood Pressure Diastolic Professional 100 MG HS PO Increased Risperdal C Confusional State Zoloft C Feeling Cold Muscle Twitching Tachycardia Date:03/06/00ISR Number: 3552813-6Report Type:Periodic Company Report #1999UW04393 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mental Impairment Health Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG BID PO Professional Date:03/06/00ISR Number: 3552814-8Report Type:Periodic Company Report #1999UW04391 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Trismus Health Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG HS PO Professional ; 25 MG TID Company PO Representative Depakote C Remeron C Date:03/06/00ISR Number: 3552815-XReport Type:Periodic Company Report #1999UW04374 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 12.5 MG QD PO; 25 MG QD PO Clonidine C Dexedrine C 22-Feb-2006 08:31 AM Page: 144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/00ISR Number: 3552816-1Report Type:Periodic Company Report #1999UW04371 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eating Disorder Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG QD PO ; 50 MG HS PO Risperdal C Date:03/06/00ISR Number: 3552817-3Report Type:Periodic Company Report #1999UW04360 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 800 MG QD PO Zyprexa C Date:03/06/00ISR Number: 3552818-5Report Type:Periodic Company Report #1999UW04339 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG QD PO; Sleep Attacks Professional 800 MG QD PO Prozac SS ORAL 60 MG QD PO Date:03/06/00ISR Number: 3552819-7Report Type:Periodic Company Report #1999UW04334 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Health Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG QD PO Professional Sinequan C Albuterol C Atarax C Date:03/06/00ISR Number: 3552820-3Report Type:Periodic Company Report #1999UW04329 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Health Seroquel PS Astrazeneca Uk Ltd ORAL 300 MG BID Dyspnoea Professional PO; 100 MG Hyperhidrosis TID PO Pallor Klonopin C Peripheral Coldness Adderall C Tachycardia Neurontin C Date:03/06/00ISR Number: 3552821-5Report Type:Periodic Company Report #1999UW04305 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Dreams Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG QD PO Hypersomnia Date:03/06/00ISR Number: 3552838-0Report Type:Periodic Company Report #1999UW04230 Age:40 YR Gender:Female I/FU:I Outcome PT Dyspnoea Fatigue 22-Feb-2006 08:31 AM Page: 145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Influenza Myalgia Nausea Report Source Product Role Manufacturer Route Dose Duration Sensation Of Heaviness Health Seroquel PS Astrazeneca Uk Ltd ORAL 50 MG HS PO Tachycardia Professional Seroquell "Zeneca" SS Zeneca ORAL 100 MG HS PO Neurontin C Wellbutrin C Hormone Replacement C Clonazepam C Prilosec C Date:03/06/00ISR Number: 3552839-2Report Type:Periodic Company Report #1999UW04138 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG BID PO Tremor Professional Cytomel SS Antabuse C Date:03/06/00ISR Number: 3552840-9Report Type:Periodic Company Report #1999UW04114 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG BID PO Phosphokinase Increased Professional Dystonia Company Hepatic Function Abnormal Representative Muscle Rigidity Musculoskeletal Stiffness Date:03/06/00ISR Number: 3552841-0Report Type:Periodic Company Report #1999UW04079 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eating Disorder Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG TID PO Feeling Abnormal Hypersomnia Sleep Walking Tremor Date:03/06/00ISR Number: 3552842-2Report Type:Periodic Company Report #1999UW04063 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Seroquel PS Astrazeneca Uk Ltd Tongue Disorder Professional Date:03/06/00ISR Number: 3552843-4Report Type:Periodic Company Report #1999UW04050 Age:70 YR Gender:Male I/FU:I Outcome PT Dizziness Feeling Abnormal Flushing Hypercholesterolaemia Hyperhidrosis 22-Feb-2006 08:31 AM Page: 146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertriglyceridaemia Insomnia Report Source Product Role Manufacturer Route Dose Duration Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG HS PO FEW MONTHS Xanax C Date:03/06/00ISR Number: 3552844-6Report Type:Periodic Company Report #1999UW04044 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Health Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG BID PO Increased Professional Luvox C Date:03/06/00ISR Number: 3552845-8Report Type:Periodic Company Report #1999UW04021 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Seroquel PS Astrazeneca Uk Ltd Zoloft C Luvox C Depakote C Neurontin C Clonapin C Prevacid C Date:03/06/00ISR Number: 3552846-XReport Type:Periodic Company Report #1999UW03977 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Colour Vision Tests Health Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG HS PO Abnormal Professional Ambien C Company Prilosec C Representative Date:03/06/00ISR Number: 3552847-1Report Type:Periodic Company Report #1999UW03963 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Seroquel PS Astrazeneca Uk Ltd Aphonia Fall Date:03/06/00ISR Number: 3552848-3Report Type:Periodic Company Report #1999UW03947 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paraesthesia Health Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG QD PO Professional Company Representative 22-Feb-2006 08:31 AM Page: 147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/00ISR Number: 3552849-5Report Type:Periodic Company Report #1999UW03878 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Seroquel PS Astrazeneca Uk Ltd Fatigue Date:03/06/00ISR Number: 3552850-1Report Type:Periodic Company Report #1999UW03776 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG BID PO Dyspnoea Seroquel "Zeneca" SS Zeneca ORAL 100 MG QD PO Sinusitis Syncope Date:03/06/00ISR Number: 3552851-3Report Type:Periodic Company Report #1999UW03491 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataract Health Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG QAM PO Feeling Abnormal Professional Seroquel "Zeneca" SS Zeneca ORAL 200 MG HS PO Suicidal Ideation Klonopin C Lithium C Synthroid C Premarin C Insulin C Date:03/06/00ISR Number: 3552852-5Report Type:Periodic Company Report #1999UW01777 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG QD PO Seroquel SS ORAL 600 MG QD PO Lithium C Klonopin C Date:03/06/00ISR Number: 3552853-7Report Type:Periodic Company Report #1999UW01769 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Literature Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG BID PO Confusional State Health Risperdal C Delirium Professional Zoloft C Labile Blood Pressure Company Cogentin C Loss Of Consciousness Representative Ativan C Speech Disorder Omeprazole C Olanzapine C Date:03/08/00ISR Number: 3472125-9Report Type:Expedited (15-DaCompany Report #00-02-0070 Age:50 YR Gender:Female I/FU:I Outcome PT Hospitalization - Delirium Initial or Prolonged Hyponatraemia Leukocytosis Lower Limb Fracture 22-Feb-2006 08:31 AM Page: 148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Aspiration Respiratory Distress Report Source Product Role Manufacturer Route Dose Duration Health Clozapine -Zenith Professional Goldline PS ORAL 125MG ORAL Seroquel Tablets SS Risperdal Tablets SS ORAL ORAL Date:03/10/00ISR Number: 3473545-9Report Type:Expedited (15-DaCompany Report #JAUSA36761 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accommodation Disorder Health Risperdal (4 Mg Initial or Prolonged Asthenia Professional Tablet) Cataract (Risperidone) PS ORAL 4 MG, 2 IN 1 Chest Discomfort DAY (S), ORAL Condition Aggravated Seroquel (Seroquel) SS ORAL 100 MG, 3 IN Depression 1 DAY (S), Disturbance In Attention ORAL Eye Disorder Seroquel (Seroquel) SS ORAL 300 MG, 3 IN Face Oedema 1 DAY(S), Pain ORAL Photosensitivity Reaction Artane (Tablet 2 Mg) Psychotic Disorder (Trihexyphenidyl) C Sensation Of Heaviness Paxil (Paroxetine Vision Blurred Hydrochloride) C Visual Disturbance Cogentin Weight Increased (Benzatropine Mesilate) C Date:03/14/00ISR Number: 3475666-3Report Type:Expedited (15-DaCompany Report #1999AP06204 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Seroquel "Zeneca" PS Zeneca ORAL 300 MG DAILY Pregnancy Health PO Professional Prozac C Other Procyclidine C Depixol C Date:03/16/00ISR Number: 3476973-0Report Type:Expedited (15-DaCompany Report #2000UW00767 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Study Seroquel PS Zeneca ORAL 700 MG DAILY Drug Interaction Health PO Leukopenia Professional Seroquel SS Zeneca ORAL 600 MG DAILY Neutropenia PO Schizophrenia Depakote C Zantac C Date:03/21/00ISR Number: 3477744-1Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Seroquel Zeneca Pharmaceuticals PS Zeneca 22-Feb-2006 08:31 AM Page: 149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals 600MG HS 047 2 YR Date:03/22/00ISR Number: 3479056-9Report Type:Expedited (15-DaCompany Report #2000UW00920 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Seroquel "Zeneca" PS 5 G Initial or Prolonged Consciousness Required Loss Of Consciousness Intervention to Sinus Tachycardia Prevent Permanent Suicide Attempt Impairment/Damage Date:03/22/00ISR Number: 3479057-0Report Type:Expedited (15-DaCompany Report #2000UW00910 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Necrotising Foreign Seroquel "Zeneca" PS ORAL 200 MG BID PO 6 MON Other Epival SS ORAL 1250 MG BID PO Cisapride C Clozaril C Haldol C Losec C Paxil C Date:03/24/00ISR Number: 3480106-4Report Type:Expedited (15-DaCompany Report #2000UW00926 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Seroquel "Zeneca" PS Zeneca ORAL 600 MG QD PO Phosphokinase Increased Professional Seroquel "Zeneca" SS Zeneca ORAL 400 MG BID PO Conjunctivitis Risperdal SS ORAL 1 MG BID PO Dehydration Risperdal SS ORAL 3 MG QD PO Drug Toxicity Risperdal SS ORAL 4 MG QD PO Leukopenia Loxitane SS Mental Impairment Lithium SS Muscle Rigidity Synthroid C Neuroleptic Malignant Depakote C Syndrome Pyrexia Date:03/24/00ISR Number: 3480127-1Report Type:Expedited (15-DaCompany Report #1999UW03089 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Seroquel "Zeneca" PS Zeneca ORAL 25 MG QD PO Initial or Prolonged Neutropenia Professional Seroquel "Zeneca" SS Zeneca ORAL 600 MG QD PO Required Company Depakote C Intervention to Representative Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/00ISR Number: 3480212-4Report Type:Expedited (15-DaCompany Report #1997UW40230 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Literature Seroquel PS ORAL 10000 MG QD Initial or Prolonged Consciousness Health PO Required Overdose Professional Propranolol C Intervention to Pupillary Reflex Impaired Prevent Permanent Sinus Tachycardia Impairment/Damage Date:03/24/00ISR Number: 3480691-2Report Type:Expedited (15-DaCompany Report #JRFUSA2000002001 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Risperdal (Tablet) Initial or Prolonged Hyponatraemia Professional (Risperidone) PS ORAL ORAL Required Leukocytosis Clozapine Intervention to Lower Limb Fracture (Clozapine) SS ORAL ORAL Prevent Permanent Pneumonia Aspiration Seroquel (Seroquel) SS ORAL ORAL Impairment/Damage Respiratory Distress Respiratory Failure Date:03/27/00ISR Number: 3480500-1Report Type:Expedited (15-DaCompany Report #JAUSA36761 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Risperdal (4 Mg Initial or Prolonged Cataract Tablet) Chest Discomfort (Risperidone) PS ORAL 4 MG, 2 IN 1 Condition Aggravated DAY (S), ORAL Depression Seroquel (Seroquel) SS ORAL 100 MG; 300 Disturbance In Attention MG, 3 IN 1 Face Oedema DAY (S), ORAL Intraocular Pressure .. C Increased Artane Pain (Trihexyphenidyl) C Photosensitivity Reaction Paxil (Paroxetine Psychotic Disorder Hydrochloride) C Vision Blurred Cogentin Visual Acuity Reduced (Benzatropine Weight Increased Mesilate) C Date:03/28/00ISR Number: 3481351-4Report Type:Expedited (15-DaCompany Report #00P-163-0087101-00 (1) Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Gabitril (Gabitril) Initial or Prolonged Akathisia Professional (Tiagabine Hcl) PS ORAL 24 MG, 1 IN 1 Amnesia D, PER ORAL Anxiety Lithium Carbonate Crying (Lithium Carbonate) SS ORAL 1050 MG 1 IN Drug Interaction 1 D PER ORAL Fear Seroquel (Seroquel) SS ORAL PER ORAL Mental Impairment Mtv (Vitamins Nos) C Movement Disorder Calcium (Calcium) C Muscle Twitching Pyridoxine Psychomotor Hyperactivity Hydrochloride (Pyridoxine 22-Feb-2006 08:31 AM Page: 151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Progesterone (Progesterone) C Primidone (Primidone) C Date:03/29/00ISR Number: 3481522-7Report Type:Direct Company Report # Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Penis Disorder Health Seroquel 25 Mg PS 25 MG BID-TID Professional Celexa 30mg C Restoril 30mg C Date:03/29/00ISR Number: 3481597-5Report Type:Expedited (15-DaCompany Report #2000UW00657 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Liver Function Test Health Seroquel "Zeneca" PS Zeneca ORAL 25 MG HS PO Intervention to Abnormal Professional Serentil C Prevent Permanent Premarin C Impairment/Damage Date:03/30/00ISR Number: 3482157-2Report Type:Expedited (15-DaCompany Report #231898 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coronary Artery Occlusion Consumer Klonopin Tablets Initial or Prolonged Oxygen Saturation (Clonazepam) 2 Mg PS ORAL 2 MG 1 PER Decreased PRN ORAL 4384 DAY Quadruple Vessel Bypass Norvasc (Amlodipine Graft Besylate) C Sinemet (Carbidopa/Levodopa) C Propulsid (Cisapride) C Lozol (Indapamide) C Proscar (Finasteride) C Aspirin (Aspirin) C Multivitamin (Multivitamin Nos) C Vitamin E (Vitamin E) C Cardura (Doxazosin Mesylate) C Vasotec (Enalapril Maleate) C Potassium (Potassium Nos) C Celexa (Citalopram) C Seroquel (Quetapine Fumarate) I 22-Feb-2006 08:31 AM Page: 152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/00ISR Number: 3484378-1Report Type:Expedited (15-DaCompany Report #1996AP23169 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Seroquel PS Initial or Prolonged Blood Glucose Increased Literature Inderal C Blood Sodium Decreased Health Ativan C Blood Urea Decreased Professional Desyrel C Coma Condition Aggravated Intentional Overdose Loss Of Consciousness Lung Infiltration Mydriasis Paralysis Pco2 Decreased Po2 Increased Pupillary Reflex Impaired Respiratory Rate Increased Sedation Sinus Tachycardia Social Avoidant Behaviour Suicide Attempt Date:04/05/00ISR Number: 3484454-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000000200 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal (1 Mg Initial or Prolonged Phosphokinase Increased Professional Tablet) Conjunctivitis (Risperidone) PS ORAL SEE IMAGE Dehydration Seroquel (Seroquel) SS ORAL SEE IMAGE Diabetes Mellitus Loxitane (Loxitane Drug Level Above Succinate) SS ORAL SEE IMAGE Therapeutic Lithium (Lithium) SS ORAL SEE IMAGE Drug Toxicity Depakote (Valproate Hypertension Semisodium) SS ORAL SEE IMAGE Lethargy Fiber Lax Leukopenia (Polycarbophl Mental Impairment Calcium) C Muscle Rigidity Synthroid Neuroleptic Malignant (Levothyroxine Syndrome Sodium) C Neutropenia Trazodone Polyuria (Trazodone) C Pyrexia Cogentin Tachycardia (Benzatropine Tremor Mesilate) C Colace (Docusate Sodium) C Ddavrp (Desmopressin) C Zoloft (Sertraline Hydrochloride) C Lactaid (Tilactase) C Erythromycin (Erythromycin) C Lac-Hydrin (Ammonium Lactate) C 22-Feb-2006 08:31 AM Page: 153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/00ISR Number: 3484475-0Report Type:Expedited (15-DaCompany Report #2000AP01466 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Seroquel "Zeneca" PS ORAL 175 MG BID PO White Blood Cell Count Health Clozaril C Decreased Professional Date:04/05/00ISR Number: 3484479-8Report Type:Expedited (15-DaCompany Report #2000AP01382 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Seroquel "Zeneca" PS Health Professional Date:04/05/00ISR Number: 3484491-9Report Type:Expedited (15-DaCompany Report #2000AP00958 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancreatic Pseudocyst Foreign Seroquel "Zeneca" PS ORAL 400 MG BID PO Pancreatitis Health Lofepramine C Professional Dihydrocodeine C Omeprazole C Antipsychotics C Haloperidol C Zuclopenthixol C Date:04/07/00ISR Number: 3485273-4Report Type:Expedited (15-DaCompany Report #00P-163-0087101-00 (2) Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Gabitril (Gabitril) Initial or Prolonged Akathisia Professional (Tiagabine Hcl) PS ORAL 24 MG, 1 IN 1 Amnesia D, PER ORAL Anxiety Lithium Carbonate Communication Disorder (Lithium Carbonate) SS ORAL 1050 MG, 1 IN Drug Interaction 1 D, PER ORAL Dyspnoea Seroquel (Seroquel) SS ORAL PER ORAL Electroencephalogram Mtv (Vitamins Nos) C Abnormal Calcium (Calcium) C Fear Pyridoxine Mental Disorder Hydrochloride Movement Disorder (Pyridoxine Muscle Twitching Hydrochloride) C Serotonin Syndrome Progesterone Upper Respiratory Tract (Progesterone) C Infection Primidone (Primidone) C Date:04/10/00ISR Number: 3485936-0Report Type:Expedited (15-DaCompany Report #2000UW01164 Age:43 YR Gender:Male I/FU:I Outcome PT Hospitalization - Diabetes Mellitus Initial or Prolonged Hyperglycaemia Ketoacidosis Polydipsia 22-Feb-2006 08:31 AM Page: 154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polyuria Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Health Seroquel "Zeneca" PS ORAL 200 MG HS PO Professional Venlafaxine C Company Representative Date:04/11/00ISR Number: 3486801-5Report Type:Expedited (15-DaCompany Report #2000UW01097 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Study Seroquel "Zeneca" PS ORAL 50 MG DAILY Initial or Prolonged Aggression Health PO; 600 MG Agitation Professional DAILY PO Condition Aggravated Loxapine C Drug Ineffective Hallucination, Auditory Stress Date:04/13/00ISR Number: 3488077-1Report Type:Expedited (15-DaCompany Report #HQ2684111APR2000 Age:0 MON Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Congenital Health Ativan Tablet Initial or Prolonged Hypotonia Professional (Lorazepam) PS TRANSPLACENTAL Complications Of Maternal Citalopram Exposure To Therapeutic (Citalopram) SS TRANSPLACENTAL Drugs Perphenazine Congenital Eye Disorder (Perphenazine) SS Neonatal Respiratory Quetiapine Fumarate Distress Syndrome (Quetiapine Fumarate) SS TRANSPLACENTAL Trazodone (Trazodone0 SS TRANSPLACENTAL Zopiclone(Zopiclone) SS TRANSPLACENTAL Date:04/13/00ISR Number: 3488118-1Report Type:Expedited (15-DaCompany Report #2000UW00990 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Hypersensitivity Health Seroquel "Zeneca" PS ORAL 25 MG HS PO Intervention to Dry Throat Professional Celex C Prevent Permanent Rash Erythematous Ritalin C Impairment/Damage Rash Pruritic Zyprexa C Throat Tightness Date:04/17/00ISR Number: 3489109-7Report Type:Expedited (15-DaCompany Report #00-02-0070 Age:50 YR Gender:Female I/FU:F Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Convulsion Delirium Hyponatraemia Leukocytosis Lower Limb Fracture 22-Feb-2006 08:31 AM Page: 155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxygen Saturation Decreased Pneumonia Aspiration Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Health Clozapine - Zenith Respiratory Distress Professional Goldline Pharm. Respiratory Failure Tablets PS Zenith Goldline Respiratory Rate Pharm. ORAL 125MG ORAL Increased Seroquel Tablets SS ORAL ORAL Risperdal Tablets SS ORAL ORAL Prozac C Date:04/17/00ISR Number: 3489224-8Report Type:Expedited (15-DaCompany Report #2000AP01543 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Foreign Seroquel "Zeneca" PS ORAL 200 MG BID PO Initial or Prolonged Convulsion Health Seroquel "Zeneca" SS ORAL 100 MG BID PO 1 DAY Electroencephalogram Professional Seroquel "Zeneca" SS ORAL 50 MG BID PO 1 DAY Abnormal Other Seroquel "Zeneca" SS ORAL 25 MG BID PO 1 DAY Injury Asphyxiation Sedation Date:04/18/00ISR Number: 3489493-4Report Type:Expedited (15-DaCompany Report #2000UW01311 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Health Seroquel "Zeneca" PS ORAL 300 MG DAILY Initial or Prolonged Condition Aggravated Professional PO Drug Abuser Seroquel "Zeneca" SS ORAL 900 MG DAILY Hallucination, Auditory PO Overdose Dalmane SS Sedation Zyprexa C Speech Disorder Depakote C Lamictal C Risperdal C Zestoretic "Zeneca" C Lipitor C Covera-Hs C Date:04/18/00ISR Number: 3489615-5Report Type:Expedited (15-DaCompany Report #1999AP06076 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Congenital Foreign Seroquel "Zeneca" PS Zeneca 225 MG BID Hypotonia Health Seroquel "Zeneca" SS Zeneca TRANSPLACENTAL 200 MG BID Clonic Convulsion Professional Droperidol SS SUBCUTANEOUS 20 MG DAILY Complications Of Maternal Other SQ Exposure To Therapeutic Chlorpromazine SS TRANSPLACENTAL 200 MG DAILY Drugs Prozac SS TRANSPLACENTAL 60 MG DAILY Convulsion Neonatal Procyclidine SS TRANSPLACENTAL 10 MG DAILY Electroencephalogram Abnormal Feeding Disorder Neonatal Muscle Twitching Neonatal Disorder Premature Baby Sepsis Neonatal 22-Feb-2006 08:31 AM Page: 156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/00ISR Number: 3490211-4Report Type:Expedited (15-DaCompany Report #00P-163-0087101-00 (3) Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Gabitril (Gabitril) Initial or Prolonged Akathisia Professional (Tiagabine Hcl) PS ORAL 24 MG, 1 IN 1 Amnesia D, PER ORAL Anxiety Lithium Carbonate Communication Disorder (Lithium Carbonate) SS ORAL 1050 MG, 1 IN Crying 1 D, PER ORAL Drug Interaction Seroquel (Seroquel) SS ORAL PER ORAL Dyspnoea Mtv (Vitamins Nos) C Electroencephalogram Calcium (Calcium) C Abnormal Pyridoxine Fear Hydrochloride Mental Impairment (Pyridoxine) C Movement Disorder Progesterone Muscle Twitching (Progesterone) C Restlessness Primidone Tremor (Primidone) C Upper Respiratory Tract Infection Date:04/20/00ISR Number: 3490641-0Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Seroquel 100 Mg Constipation (Zeneca Pharm) PS Zeneca Pharm 300 MG PO Q Liver Function Test HS Abnormal Premarin C Prilosec C Zoloft C Alprazolam C Thioridazine C Imipramine C Date:04/21/00ISR Number: 3491344-9Report Type:Expedited (15-DaCompany Report #2000AP01886 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel "Zeneca" PS Zeneca 400 MG DAILY Electrocardiogram Qt Health Depakine SS 500 MG DAILY Corrected Interval Professional Prozac SS 20 MG DAILY Prolonged Other Overdose Date:04/25/00ISR Number: 3492330-5Report Type:Expedited (15-DaCompany Report #2000UW00663 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Health Seroquel "Zeneca" PS Zeneca ORAL 50 MG QD PO Intervention to Lethargy Professional Seroquel "Zeneca" SS Zeneca ORAL 60 MG QD PO Prevent Permanent Leukopenia Seroquel "Zeneca" SS Zeneca ORAL 200 MG QAM PO Impairment/Damage Neutropenia Seroquel "Zeneca" SS Zeneca ORAL 300 MG HS PO Depakote C Luvox C Alprazolam C 22-Feb-2006 08:31 AM Page: 157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/00ISR Number: 3493745-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coagulopathy Seraquel 25 Mg PS ORAL 25 MG AM Intervention to Dysmenorrhoea ORAL; 50 MG. Prevent Permanent Menorrhagia P.M. ORAL Impairment/Damage Date:05/01/00ISR Number: 3494785-9Report Type:Expedited (15-DaCompany Report #2000AP01886 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Foreign Seroquel "Zeneca" PS 400 MG DAILY Decreased Health Depakine SS 500 MG DAILY Blood Potassium Decreased Professional Cardiac Disorder Other Coma Eosinophil Count Decreased Haematocrit Decreased Haemoglobin Decreased Hyporeflexia Miosis Overdose Platelet Count Decreased Red Blood Cell Count Decreased White Blood Cell Count Decreased Date:05/01/00ISR Number: 3495314-6Report Type:Expedited (15-DaCompany Report #S00-USA-00571-01 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Celexa (Citalopram Pulmonary Congestion Professional Hydrobromide) PS Pulmonary Oedema Clonazepam SS Toxicologic Test Abnormal Zolpidem SS Amitriptyline SS Mirtazepine SS Quetiapine (Quetiapine Fumarate) SS Amphetamine SS Cannabinoids SS Ethanol SS Date:05/02/00ISR Number: 3495455-3Report Type:Expedited (15-DaCompany Report #2000AP01970 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel "Zeneca" PS "Zeneca" ORAL 200 MG BID PO Initial or Prolonged Neutropenia Health Chlorpromazine C Professional Depixol C Other Duphaston C Zopiclone C Pyridoxine C Procyclidine C 22-Feb-2006 08:31 AM Page: 158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/00ISR Number: 3495457-7Report Type:Expedited (15-DaCompany Report #2000AP01959 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Congenital Foreign Seroquel "Zeneca" PS "Zeneca" Initial or Prolonged Hypotonia Health Lorazepam SS Complications Of Maternal Professional Zopiclone SS Exposure To Therapeutic Other Perphenazine SS Drugs Trazodone SS Congenital Eye Disorder Cipramil SS Neonatal Respiratory Methotrimeprazine SS Depression Date:05/03/00ISR Number: 3495631-XReport Type:Direct Company Report # Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chorea Quietipine 100mg Qd PS ORAL 100MG PO QHS 30 DAY Initial or Prolonged Condition Aggravated Psychiatric Symptom Date:05/04/00ISR Number: 3496568-2Report Type:Expedited (15-DaCompany Report #2000AP02002 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel "Zeneca" PS Zeneca ORAL 600 MG DAILY Hospitalization - Leukopenia Health PO Initial or Prolonged Pneumonia Professional Clozapine C Other Lithium Carbonate C Normison C Fluimucil C Lorazepam C Tremblex C Date:05/04/00ISR Number: 3496572-4Report Type:Expedited (15-DaCompany Report #2000AP01972 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Literature Quetiapine Fumarate PS ORAL 50 MG QD PO; Initial or Prolonged Blood Pressure Decreased Health 50 MG BID PO Drug Interaction Professional Haloperidol C Dyspnoea Sertraline C Heart Rate Decreased Benztropine C Hyperventilation Miconazole C Respiratory Alkalosis Metronidazole C Respiratory Rate Sorbitol C Increased Tachycardia Tachypnoea Vaginal Candidiasis Vaginitis Bacterial Ventricular Extrasystoles 22-Feb-2006 08:31 AM Page: 159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/00ISR Number: 3497130-8Report Type:Expedited (15-DaCompany Report #2000UW01524 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel "Zeneca" PS ORAL 25 MG QD PO Initial or Prolonged Depressed Level Of Professional Seroquel "Zeneca" SS ORAL 25 MG ONCE PO Consciousness Aricept C Drug Hypersensitivity Pallor Pulse Absent Respiratory Failure Date:05/05/00ISR Number: 3497218-1Report Type:Expedited (15-DaCompany Report #00P-163-0089497-00 (0) Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Autonomic Nervous System Health Depakote (Depakote) Intervention to Imbalance Professional (Divalproex Sodium) PS ORAL 1500 MG, 1 IN Prevent Permanent Blood Creatine Other 1 D, PER ORAL Impairment/Damage Phosphokinase Increased (SEE IMAGE) Conjunctivitis Risperidone Dehydration (Risperidone) SS ORAL 1 MG, 2 IN 1 Diabetes Mellitus D, PER ORAL Drug Level Above (SEE IMAGE) Therapeutic Seroquel (Seroquel) SS ORAL 600 MG, 1 IN Drug Toxicity 1 D, PER ORAL Enuresis (SEE IMAGE) Feeling Abnormal Loxapine Succinate Hypertension (Loxapine Succinate) SS ORAL 10 MG, 1 IN 1 Lethargy D, PER ORAL Leukopenia (SEE IMAGE) Mental Impairment Lithium (Lithium) SS ORAL 300 MG, 2 IN Muscle Rigidity 1 D, PER ORAL Neuroleptic Malignant (SEE IMAGE) Syndrome Polycarbophil Neutropenia Calcium Pyrexia (Polycarbophil Tachycardia Calcium) C Tremor Levothyroxine Sodium (Levothyroxine Sodium) C Trazodone (Trazodone) C Benzatropine Mesilate (Benzatropine Mesilate) C Docusate Sodium (Docusate Sodium) C Desmopressin (Desmopressin) C Sertraline Hydrochloride (Sertraline Hydrochloride) C Tilactase (Tilactase) C Erythromycin (Erythromycin) (Erythromycin) C Ammonium Lactate 22-Feb-2006 08:31 AM Page: 160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Ammonium Lactate) C Date:05/09/00ISR Number: 3497964-XReport Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Liver Function Test Seroquel PS 50MG QD Intervention to Abnormal Trazodone C Prevent Permanent Gabapentin C Impairment/Damage Date:05/11/00ISR Number: 3499570-XReport Type:Expedited (15-DaCompany Report #2000UW01557 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Health Seroquel PS Astrazeneca Uk Ltd Hospitalization - Delirium Professional Risperdal SS Initial or Prolonged Fracture Clozapine SS Required Hyponatraemia Intervention to Leukocytosis Prevent Permanent Pneumonia Aspiration Impairment/Damage Respiratory Failure Date:05/15/00ISR Number: 3499997-6Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Seroquel PS 400MG DAILY, Breast Engorgement AS 200MG Chest Discomfort 2X/DAY 3 MON Chest Pain Lithium C Dyskinesia Dyspnoea Exostosis Muscle Spasms Palpitations Sinus Congestion Tremor Date:05/15/00ISR Number: 3501350-3Report Type:Expedited (15-DaCompany Report #2000UW01578 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Seroquel PS Zeneca Uk Ltd ORAL 250 MG QD PO Hypoventilation Professional Depakote C Sudden Death Ativan C Date:05/15/00ISR Number: 3501355-2Report Type:Expedited (15-DaCompany Report #2000AP02052 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS Astrazeneca Uk Ltd Hospitalization - Intentional Overdose Health Initial or Prolonged Professional 22-Feb-2006 08:31 AM Page: 161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/00ISR Number: 3501361-8Report Type:Expedited (15-DaCompany Report #2000UW01590 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Health Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG QD PO Professional Seroquel "Zeneca" SS Zeneca ORAL 225 MG QD PO Company Valproic C Representative Levothyroxine C Premarin C Ibuprofen C Multivitamins C Docusate C Folic Acid C Vitamin B12 C Date:05/18/00ISR Number: 3502201-3Report Type:Expedited (15-DaCompany Report #2000AP02002 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel "Zeneca" PS Astrazeneca Uk Ltd ORAL 600 MG DAILY Hospitalization - Condition Aggravated Health PO Initial or Prolonged Pneumonia Professional Clozapine C Lithium Carbonate C Normison C Fluimucil C Lorazepam C Tremblex C Date:05/19/00ISR Number: 3502483-8Report Type:Expedited (15-DaCompany Report #2000UW01688 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Interstitial Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 300 MG QD PO Initial or Prolonged Health Lamotrigine C Professional Sertraline C Other Calcitrol C Lorazepam C Date:05/22/00ISR Number: 3503149-0Report Type:Expedited (15-DaCompany Report #00P-163-0087101-00 (4) Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Gabitril PS Abbott Laboratories Initial or Prolonged Akathisia Professional Pharmaceutical Amnesia Products Div ORAL 24MG, 1 IN 1 Anxiety D, PER ORAL Communication Disorder Lithium Carbonate Crying (Lithium Carbonate) SS ORAL 1050 MG, 1 IN Drug Interaction 1 D, PER ORAL Dyskinesia Seroquel (Seroquel) SS ORAL PER ORAL Fear Mtv C Mental Impairment Calcium C Movement Disorder Pyridoxine Muscle Twitching Hydrochloride C Tremor Progesterone C Upper Respiratory Tract Primidone C Infection 22-Feb-2006 08:31 AM Page: 162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/00ISR Number: 3503624-9Report Type:Expedited (15-DaCompany Report #2000UW01711 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Red Blood Cell Count Health Seroquel PS Astrazeneca Uk Ltd Decreased Professional Company Representative Date:05/23/00ISR Number: 3503625-0Report Type:Expedited (15-DaCompany Report #2000AP00356 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 175 MG DAILY Atherosclerosis Health PO Cardiac Arrest Professional Thioridazine C Overdose Other Fluoxetine C Pneumonia Aspiration Zopiclone C Pulmonary Haemorrhage Diclofenac C Pulmonary Oedema Sudden Death Date:05/23/00ISR Number: 3503626-2Report Type:Expedited (15-DaCompany Report #2000AP02052 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 300 MG BID PO Hospitalization - Overdose Health Initial or Prolonged Professional Required Other Intervention to Prevent Permanent Impairment/Damage Date:05/26/00ISR Number: 3505286-3Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Androgens Decreased Seroquel PS 400 MG DAILY Balance Disorder AS 200MG Breast Engorgement 2X/DAY 3 MON Chest Discomfort Lithium C Chest Pain Dyskinesia Exostosis Medication Error Muscle Spasms Palpitations Respiratory Disorder Sinus Congestion Tremor Date:05/26/00ISR Number: 3505632-0Report Type:Periodic Company Report #18558-015 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Lithium Carbonate PS Roxane Laboratories Inc 1 MON 22-Feb-2006 08:31 AM Page: 163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel Tablets SS Zeneca Laboratories Diazepam Tablets C Date:05/31/00ISR Number: 3506767-9Report Type:Expedited (15-DaCompany Report #2000AP02002 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG DAILY Hospitalization - Biopsy Bone Marrow Health PO Initial or Prolonged Abnormal Professional Olanzapine C Haemoglobin Decreased Other Lithium Carbonate C Leukopenia Normison C Lymphocyte Count Lorazepam C Increased Tremblex C Monocyte Count Decreased Pneumonia Pyrexia Thrombocytopenia Date:06/01/00ISR Number: 3506927-7Report Type:Expedited (15-DaCompany Report #2000UW01842 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coombs Positive Health Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG QD PO Haemolytic Anaemia Professional Lipitor C Prozac C Wellbutrin C Vasotec C Humulin 30/70 C Lopid C Prempro C Date:06/01/00ISR Number: 3506928-9Report Type:Expedited (15-DaCompany Report #2000UW01840 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Seroquel PS Astrazeneca Uk Ltd Professional Zyprexa C Date:06/05/00ISR Number: 3507521-4Report Type:Direct Company Report #USP 53066 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel (Quetiapine Fumarale) PS Zeneca Date:06/05/00ISR Number: 3508073-5Report Type:Direct Company Report # Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Seroquel 25mg/Tab Zeneca PS Zeneca ORAL 50MG QHS ORAL Bactrim Ds C Maxzide C Calcitonin C 22-Feb-2006 08:31 AM Page: 164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/00ISR Number: 3508086-3Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Seroquel 25mg/Tab Zeneca PS Zeneca ORAL 100MG QHS ORAL Lisinopril C Atorvastatin C Carbamazepine C Olanzapine C Lithium C Metformin C Date:06/06/00ISR Number: 3508714-2Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysuria Health Quetiapine 200mg & Initial or Prolonged Priapism Professional 100mg (Zeneca) PS Zeneca ORAL 300MG PO BID Date:06/06/00ISR Number: 3508766-XReport Type:Direct Company Report # Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fatigue Quetiapine PS ORAL 100 MG HS PO Required Loss Of Consciousness Intervention to Renal Failure Acute Prevent Permanent Rhabdomyolysis Impairment/Damage Date:06/07/00ISR Number: 3509580-1Report Type:Expedited (15-DaCompany Report #2000UW01593 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Disturbance In Attention Health Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG DAILY Dizziness Professional PO Fall Company Seroquel "Zeneca" SS Zeneca ORAL 300 MG DAILY Gait Disturbance Representative PO Loss Of Consciousness Claritin-D C Syncope Allegra C Amtex C Paxil C Cogentin C Date:06/08/00ISR Number: 3510687-3Report Type:Expedited (15-DaCompany Report #2000UW01557 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Health Seroquel PS Astrazeneca Uk Ltd Hospitalization - Convulsion Professional Risperdal SS 4 MG QD Initial or Prolonged Delirium Clozapine SS ORAL 125 MG QD Required Hyponatraemia Intervention to Leukocytosis Prevent Permanent Lower Limb Fracture Impairment/Damage Pneumonia Aspiration Po2 Decreased Respiratory Failure 22-Feb-2006 08:31 AM Page: 165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/00ISR Number: 3510689-7Report Type:Expedited (15-DaCompany Report #2000AP02316 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG DAILY Leukopenia Health PO Professional Seroquel "Zeneca" SS ORAL 400 MG DAILY Other PO Fluanxol "Bayer" C Date:06/08/00ISR Number: 3510690-3Report Type:Expedited (15-DaCompany Report #2000UW01579 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Health Seroquel PS Astrazeneca Uk Ltd Initial or Prolonged Overdose Professional Required Syncope Company Intervention to Representative Prevent Permanent Impairment/Damage Date:06/08/00ISR Number: 3517076-6Report Type:Periodic Company Report #2000UW01291 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choking Sensation Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 300 MG QD PO Initial or Prolonged Dry Mouth Seroquel "Zeneca" SS Zeneca ORAL 600 MG QD PO Dysphagia Hypokalaemia Tic Date:06/08/00ISR Number: 3517079-1Report Type:Periodic Company Report #2000UW00624 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Sensation Health Seroquel PS Astrazeneca Uk Ltd Hospitalization - Dysphagia Professional Seroquel "Zeneca" SS Zeneca ORAL 400 MG PO Initial or Prolonged Neuroleptic Malignant Zyprexa C Disability Syndrome Depakote C Pneumonia Retching Date:06/08/00ISR Number: 3517083-3Report Type:Periodic Company Report #2000UW00319 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Health Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG QD PO Initial or Prolonged Condition Aggravated Professional Seroquel "Zeneca" SS Zeneca ORAL 700 MG QD PO Convulsion Insomnia Date:06/08/00ISR Number: 3517086-9Report Type:Periodic Company Report #2000UW00213 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG PO Overdose Professional Venlafaxine C 22-Feb-2006 08:31 AM Page: 166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Effexor C Alprazolam C Ambien C Zoloft C Synthroid C Neurontin C Etodolac C Atenolol C Zyprexa C Date:06/08/00ISR Number: 3517088-2Report Type:Periodic Company Report #2000UW00282 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 50 MG BID PO Initial or Prolonged Deficit/Hyperactivity Xanax C Disorder Estrotest C Depression Ptu C Hyperthyroidism Inderal C Palpitations Provera C Panic Disorder Date:06/08/00ISR Number: 3517090-0Report Type:Periodic Company Report #1996AP23169 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Study Seroquel PS Astrazeneca Uk Ltd Initial or Prolonged Overdose Literature Inderal C Suicide Attempt Health Ativan C Tachycardia Professional Desyrel C Date:06/08/00ISR Number: 3517094-8Report Type:Periodic Company Report #1998UW49037 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Literature Seroquel PS Astrazeneca Uk Ltd Initial or Prolonged Chest Pain Health Required Coma Professional Intervention to Electrocardiogram Qt Company Prevent Permanent Prolonged Representative Impairment/Damage Hyperglycaemia Hypokalaemia Overdose Tachycardia Date:06/08/00ISR Number: 3517095-XReport Type:Periodic Company Report #1999UW03089 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG QD PO Initial or Prolonged White Blood Cell Count Professional Seroquel "Zeneca" SS ORAL 600 MG QD PO Required Decreased Company Depakote C Intervention to Representative Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/00ISR Number: 3564773-2Report Type:Periodic Company Report #2000UW01303 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertrophy Breast Health Seroquel PS Astrazeneca Uk Ltd Professional Date:06/08/00ISR Number: 3564776-8Report Type:Periodic Company Report #2000UW00701 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fibrocystic Breast Health Seroquel PS Astrazeneca Uk Ltd Disease Professional Date:06/08/00ISR Number: 3564777-XReport Type:Periodic Company Report #2000UW00745 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Consumer Seroquel PS Astrazeneca Uk Ltd Skin Disorder Weight Increased Date:06/08/00ISR Number: 3564778-1Report Type:Periodic Company Report #2000UW00771 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tic Consumer Seroquel PS Astrazeneca Uk Ltd Company Representative Date:06/08/00ISR Number: 3564779-3Report Type:Periodic Company Report #2000UW00798 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Health Seroquel PS Astrazeneca Uk Ltd ORAL 50 MG HS PO Ear Infection Professional Prozac C Flushing Tigan C Hyperhidrosis Antivert C Nausea Oedema Tremor Vertigo Date:06/08/00ISR Number: 3564780-XReport Type:Periodic Company Report #2000UW00831 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthritis Consumer Seroquel PS Astrazeneca Uk Ltd Jaw Disorder Celebrex C Celexa C Hydrocodone C Cogentin C 22-Feb-2006 08:31 AM Page: 168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/00ISR Number: 3564781-1Report Type:Periodic Company Report #2000UW00899 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Palpitations Health Seroquel PS Astrazeneca Uk Ltd ORAL 250 MG QD PO Professional Date:06/08/00ISR Number: 3564782-3Report Type:Periodic Company Report #2000UW00926 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Conjunctivitis Health Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG QD PO Dehydration Professional Seroquel SS ORAL 600 MG QD PO Drug Toxicity Risperdal SS ORAL 1 MG BID PO Neuroleptic Malignant Risperdal SS ORAL 3 MG PO Syndrome Risperdal SS ORAL 4 MG QD PO White Blood Cell Count Loxitane SS Decreased Lithium SS Synthroid C Depakote C Date:06/08/00ISR Number: 3564783-5Report Type:Periodic Company Report #2000UW00930 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG PO Hypersomnia Risperdal C Sedation Date:06/08/00ISR Number: 3564784-7Report Type:Periodic Company Report #2000UW01017 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG DAILY Fatigue PO / Insomnia 400 MG DAILY PO Luvox C Clozaril C Date:06/08/00ISR Number: 3564785-9Report Type:Periodic Company Report #2000UW01047 Age:47 YR Gender:Female I/FU:I Outcome PT Asthma Condition Aggravated Constipation Cough Delayed Recovery From Anaesthesia Emotional Disorder Endometriosis Excitability Hypercholesterolaemia Hyperglycaemia Muscle Spasms Myalgia Neck Pain 22-Feb-2006 08:31 AM Page: 169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Osteoarthritis Sexual Dysfunction Tension Report Source Product Role Manufacturer Route Dose Duration Urine Abnormality Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 150 MG PO Weight Increased Date:06/08/00ISR Number: 3564786-0Report Type:Periodic Company Report #2000UW01080 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Uterine Haemorrhage Consumer Seroquel PS Astrazeneca Uk Ltd Date:06/08/00ISR Number: 3564787-2Report Type:Periodic Company Report #2000UW01110 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lichen Planus Health Seroquel PS Astrazeneca Uk Ltd Professional Date:06/08/00ISR Number: 3564788-4Report Type:Periodic Company Report #2000UW01103 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG PO Hypersomnia Neurontin C Motor Dysfunction Gabitrial C Neuropathy Peripheral Speech Disorder Date:06/08/00ISR Number: 3564789-6Report Type:Periodic Company Report #2000UW01132 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain Consumer Seroquel PS Astrazeneca Uk Ltd Depakote C Ibuprofen C Date:06/08/00ISR Number: 3564790-2Report Type:Periodic Company Report #2000UW01272 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG PO Depression Feeling Jittery Hyperhidrosis Medication Error Pyrexia Sedation Temperature Intolerance Vomiting 22-Feb-2006 08:31 AM Page: 170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/00ISR Number: 3564791-4Report Type:Periodic Company Report #2000UW00503 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Walking Health Seroquel PS Astrazeneca Uk Ltd Speech Disorder Professional Company Representative Date:06/08/00ISR Number: 3566148-9Report Type:Periodic Company Report #2000UW00521 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Limb Injury Consumer Seroquel PS Astrazeneca Uk Ltd Weight Increased Date:06/08/00ISR Number: 3566149-0Report Type:Periodic Company Report #2000UW00530 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 50 MG QD PO Date:06/08/00ISR Number: 3566151-9Report Type:Periodic Company Report #2000UW00559 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bruxism Consumer Seroquel PS Astrazeneca Uk Ltd Dry Mouth Lacrimation Increased Skin Disorder Skin Odour Abnormal Speech Disorder Visual Disturbance Date:06/08/00ISR Number: 3566153-2Report Type:Periodic Company Report #2000UW00583 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Consumer Seroquel PS Astrazeneca Uk Ltd Date:06/08/00ISR Number: 3566155-6Report Type:Periodic Company Report #2000UW00495 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Penis Disorder Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 300 MG PO Date:06/08/00ISR Number: 3566156-8Report Type:Periodic Company Report #2000UW00479 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Seroquel PS Astrazeneca Uk Ltd 50 MG DAILY Drug Level Above Professional Seroquel "Zeneca" SS 200 MG DAILY Therapeutic Clomipramine SS 50 MG DAILY Luvox C Inositol C 22-Feb-2006 08:31 AM Page: 171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/00ISR Number: 3566158-1Report Type:Periodic Company Report #2000UW00375 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Motor Dysfunction Health Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG DAILY Neuropathy Peripheral Professional PO Cogentin C Date:06/08/00ISR Number: 3566160-XReport Type:Periodic Company Report #2000UW00291 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG BID PO Lithium C Zyprexa C Klonopin C Levoxyl C Neurontin C Date:06/08/00ISR Number: 3566163-5Report Type:Periodic Company Report #1998UW46612 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataract Health Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG BID PO Professional Paxil C Company Zyprexa C Representative Risperdal C Date:06/08/00ISR Number: 3566166-0Report Type:Periodic Company Report #1999UW03491 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataract Health Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG QAM PO Feeling Abnormal Professional Seroquel "Zeneca" SS ORAL 200 MG HS PO Pain Klonopin C Suicidal Ideation Lithium C Synthroid C Premarin C Insulin C Date:06/08/00ISR Number: 3566169-6Report Type:Periodic Company Report #1999UW04391 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG HS PO Professional Seroquel "Zeneca" SS ORAL 25 MG TID PO Company Depakote C Representative Remeron C Date:06/08/00ISR Number: 3566174-XReport Type:Periodic Company Report #2000UW00146 Age:77 YR Gender:Female I/FU:I Outcome PT Diaphragmatic Hernia Ear Disorder Headache Hypertension 22-Feb-2006 08:31 AM Page: 172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rhinitis Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG QD PO Professional Paxil C Remeron C Date:06/09/00ISR Number: 3510916-6Report Type:Expedited (15-DaCompany Report #2000AP02540 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Central-Alveolar Foreign Seroquel PS Astrazeneca Uk Ltd INTRA-UTERINE 250 MG DAILY Hospitalization - Hypoventilation Health IU Initial or Prolonged Complications Of Maternal Professional Citalopram SS INTRA-UTERINE 20 MG DAILY Exposure To Therapeutic Other IU Drugs Trazodone SS 150 MG DAILY Neonatal Disorder IU Neonatal Respiratory Zopiclone SS INTRA-UTERINE 7.5 MG DAILY Depression IU Lorazepam SS INTRA-UTERINE 1 MG DAILY IU Perphenazine SS 4 MG DAILY IU Date:06/12/00ISR Number: 3511978-2Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Androgens Abnormal Seroquel PS 400MG DAILY Balance Disorder AS (CONT Breast Oedema )200MG 2X Chest Discomfort /DAY 2 DAY Chest Pain Lithium C Dyskinesia Exostosis Eye Irritation Medication Error Muscle Spasms Palpitations Respiratory Disorder Sinus Congestion Tremor Date:06/13/00ISR Number: 3513146-7Report Type:Direct Company Report # Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Twitching Seroquel (Astra Initial or Prolonged Zeneca) PS Astra Zencea Amantadine C Remeron C Ntg C Seroquel C Cogentin C Lanoxin C Aricept C Fiorinal C 22-Feb-2006 08:31 AM Page: 173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/00ISR Number: 3513447-2Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Serroquel 50 Mg PS ORAL 50MG PO DAILY Initial or Prolonged Anxiety Neurontin C Confusional State Remeron C Disorientation Dyskinesia Flushing Hyperhidrosis Memory Impairment Myalgia Oedema Pyrexia Sleep Disorder Date:06/15/00ISR Number: 3515538-9Report Type:Expedited (15-DaCompany Report #10409993 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Congenital Foreign Desyrel PS Apothecon Inc Div Initial or Prolonged Hypotonia Health Bristol Myers Squibb TRANSPLACENTAL T-PLAC Complications Of Maternal Professional Lorazepam SS TRANSPLACENTAL T-PLAC Exposure To Therapeutic Other Perphenazine SS TRANSPLACENTAL T-PLAC Drugs Zopiclone SS TRANSPLACENTAL T-PLAC Eye Disorder Cipramil (Citalopram Neonatal Disorder Hydrobromide) SS TRANSPLACENTAL T-PLAC Neonatal Respiratory Seroquel Depression (Quetiapine) SS TRANSPLACENTAL T-PLAC Methotrimeprazine SS TRANSPLACENTAL T-PLAC Date:06/21/00ISR Number: 3516334-9Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Orthostatic Hypotension Seroquel / 100 Mg PS ORAL 100 MG QHS PO Seroquel 25mg SS ORAL 25MG/QAM/PO Colace C Miacalcin C Citracal C Ntg C Imdur C Date:06/21/00ISR Number: 3517440-5Report Type:Expedited (15-DaCompany Report #2000AP02002 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG DAILY Hospitalization - Bone Marrow Depression Health PO Initial or Prolonged Condition Aggravated Professional Seroquel SS ORAL 200 MG DAILY Haemoglobin Decreased Other PO Leukopenia Olanzapine C Pharyngitis Lithium C Pneumonia Normison C Pyrexia Fluimucil C Red Blood Cell Lorazepam C Sedimentation Rate Tremblex C Increased 22-Feb-2006 08:31 AM Page: 174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/00ISR Number: 3517856-7Report Type:Expedited (15-DaCompany Report #S00-UKI-00833-01 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Central-Alveolar Foreign Citalopram PS Forest Laboratories Initial or Prolonged Hypoventilation Health Inc TRANSPLACENTAL 20 MG QD Complications Of Maternal Professional TRANSPLACENTA Exposure To Therapeutic Other L Drugs Seroquel SS TRANSPLACENTAL MG UNK Neonatal Respiratory TRANSPLACENTA Depression L Trazodone SS TRANSPLACENTAL MG UNK TRANSPLACENTA L Zopiclone SS TRANSPLACENTAL MG UNK TRANSPLACENTA L Lorazepam SS TRANSPLACENTAL MG UNK TRANSPLACENTA L Perphenazine SS TRANSPLACENTAL MG UNK TRANSPLACENTA L Date:06/22/00ISR Number: 3517875-0Report Type:Expedited (15-DaCompany Report #2000PK00227 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG DAILY Initial or Prolonged Leukopenia Health PO Liver Function Test Professional Seroquel "Zeneca" SS ORAL 200 MG DAILY Abnormal Other PO Pyrexia Jarsin C Bronchoretard C Date:06/27/00ISR Number: 3520924-7Report Type:Expedited (15-DaCompany Report #1381412A Age:72 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Tylenol PS Mcneil Consumer Drug Level Above Health Products Co Div Therapeutic Professional Mcneilab Inc ORAL UNKNOWN DOSE, Suicide Attempt PO Quetiapine SS ORAL UNKNOWN DOSE, PO Trazodone SS ORAL UNKNOWN AMOUNT, PO Date:06/29/00ISR Number: 3522241-8Report Type:Expedited (15-DaCompany Report #2000UW02238 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG DAILY Initial or Prolonged Medication Error Professional PO Seroquel "Zeneca" SS ORAL 700 MG DAILY PO Risperdal C Depakote C Neurontin C 22-Feb-2006 08:31 AM Page: 175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Celexa C Date:06/30/00ISR Number: 3522766-5Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Quetiapine Intervention to (Seroquel) PS ORAL 50MG PO AM Prevent Permanent Quetiapine Impairment/Damage (Seroquel) SS ORAL 100MG PO HS Date:06/30/00ISR Number: 3522865-8Report Type:Direct Company Report # Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Quetiapine 250 Mg PS ORAL 250 MG BID Intervention to ORAL Prevent Permanent Clozapine 100 Mg SS ORAL 400 ONCE A Impairment/Damage DAY ORAL Lorazepan C Date:07/05/00ISR Number: 3524415-9Report Type:Direct Company Report # Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Sinemet 25/100 PS 2 TID & 1 HS Confusional State Seroquel SS 250MG HS Sedation Propulsid C Fiberlax C Docusate C Xalatan C Betoptic St C Prevacid C Glucosamine/Chondroi tin C ... C Relafen C Date:07/05/00ISR Number: 3524802-9Report Type:Expedited (15-DaCompany Report #2000UW02160 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Health Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG QD PO Decreased Professional Seroquel "Zeneca" SS Zeneca ORAL 300 MG QD PO White Blood Cell Count Depakote C Decreased Imipramine C Date:07/06/00ISR Number: 3525573-2Report Type:Expedited (15-DaCompany Report #S00-USA-00749-01 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Accommodation Disorder Health Celexa PS Forest Laboratories Apathy Professional Inc ORAL 10 MG QD PO Colour Blindness Celexa (Citalopram) SS ORAL 20 MG QD PO Visual Field Defect Celexa (Citalopram SS ORAL 10 MG QD PO Seroquel SS ORAL 300 MG QD PO 22-Feb-2006 08:31 AM Page: 176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa (Olanzapine) SS ORAL 2.5 MG QD PO Date:07/10/00ISR Number: 3526765-9Report Type:Expedited (15-DaCompany Report #2000AP03092 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Foreign Seroquel PS Astrazeneca Uk Ltd Phosphokinase Increased Health Neuroleptic Malignant Professional Syndrome Other Date:07/11/00ISR Number: 3527183-XReport Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erection Increased Seroquel 50 Mg Qhs PS ORAL PO QHS Celexa 40mg Qd SS ORAL PO QAM Date:07/13/00ISR Number: 3528411-7Report Type:Direct Company Report # Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Seroquel PS 25MG BID Movement Disorder ;25MG AM 50HS Muscle Twitching ; 50MG BID ;100MG QHS; 50MG BID; Luvox C Cogentin C Neutrontin C Stelazine C Date:07/13/00ISR Number: 3528990-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000002001 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal PS Janssen Research Fdn Initial or Prolonged Delirium Professional Div Johnson And Required Fibula Fracture Johnson ORAL 9 MG, DAILY, Intervention to Hyponatraemia ORAL Prevent Permanent Leukocytosis Clozapine Impairment/Damage Lower Limb Fracture (Clozapine) SS ORAL ORAL Pneumonia Aspiration Seroquel (Seroquel) SS ORAL ORAL Respiratory Distress Respiratory Failure Tibia Fracture Date:07/17/00ISR Number: 3530951-1Report Type:Expedited (15-DaCompany Report #2000PK00269 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Affect Lability Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 300 MG DAILY Crying Health PO Eyelid Oedema Professional Leukocytosis Other 22-Feb-2006 08:31 AM Page: 177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/00ISR Number: 3530560-4Report Type:Direct Company Report # Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Depakote Brand Name Hospitalization - Thrombocytopenia 250mg And 500mg Tabs Initial or Prolonged Abbott PS Abbott ORAL 250/2 50/50 Required TID ORAL Intervention to Quetiapine 200mg And Prevent Permanent 100mg Tabs Zeneca SS Zeneca ORAL 200MG BID Impairment/Damage ORAL Date:07/19/00ISR Number: 3532044-6Report Type:Expedited (15-DaCompany Report #2000AP03084 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Prothrombin Time Foreign Seroquel PS Astrazeneca Uk Ltd Prolonged Health Droperidol C Professional Procyclidine C Other Date:07/19/00ISR Number: 3532502-4Report Type:Expedited (15-DaCompany Report #2000AP03332 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Literature Seroquel PS Astrazeneca Uk Ltd Coma Health Tramadol SS Drug Level Above Professional Cocaine SS Therapeutic Benzoylecgonine SS Hepatic Congestion Hepatic Steatosis Date:07/19/00ISR Number: 3532503-6Report Type:Expedited (15-DaCompany Report #2000AP03331 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Literature Quetiapine PS Astrazeneca Uk Ltd Cardiomegaly Health Lorazepam SS Coma Professional Valproic Acid SS Drug Level Above Phentermine SS Therapeutic Phenytoin SS Hypertrophic Obstructive Propoxyphene SS Cardiomyopathy Nefazodone C Overdose Verapamil C Pulmonary Congestion Pulmonary Oedema Ventricular Hypertrophy Date:07/21/00ISR Number: 3533594-9Report Type:Expedited (15-DaCompany Report #2000AP03226 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 75 MG DAILY Initial or Prolonged Health PO Required Professional Leponex SS Novartis Intervention to Other Pharmaceuticals ORAL 100 MG DAILY Prevent Permanent PO Impairment/Damage Aspirin C Bayer 22-Feb-2006 08:31 AM Page: 178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sorbidilat C Diamicron C Seropram C Date:07/25/00ISR Number: 3534546-5Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Seroquel 200mg PS ORAL 200MG QD PO Weight Increased Amlodipine C Lorazepam C Insulin C Vitamin E C Rosiglitazone C Paroxetine C Simvastatin C Asa C Glyburide C Date:07/25/00ISR Number: 3534902-5Report Type:Expedited (15-DaCompany Report #2000UW01590 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG QD PO Neutropenia Professional Seroquel "Zeneca" SS ORAL 225 MG QD PO Red Blood Cell Count Valproic Acid C Decreased Levothyroxine C Premarin C Ibuprofen C Multivitamins C Docusate C Folic Acid C Vitamin B12 C Date:07/26/00ISR Number: 3536218-XReport Type:Expedited (15-DaCompany Report #A025655 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Foreign Lithane PS Pfizer Inc ORAL 750.00 MG Initial or Prolonged Confusional State Literature TOTAL:DAILY:O Coordination Abnormal Health RAL Delirium Professional Valsartan SS ORAL 80.00 MG Drug Interaction TOTAL:DAILY:O Drug Level Above RAL Therapeutic Quetiapine SS ORAL 50.00 MG Grandiosity TOTAL:DAILY:O Mania RAL Medication Error L-Tryptophan C Sedation Lorazepam C Glyburide C Conjugated Estrogens C 22-Feb-2006 08:31 AM Page: 179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/00ISR Number: 3537854-7Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Seroquel PS 400 MG DAILY, Breast Engorgement AS (CONT) Chest Discomfort 200MG 2X/DAY Chest Pain ~ 3 MONTHS Dyskinesia Lithium C Exostosis Eye Irritation Medication Error Muscle Spasms Palpitations Respiratory Disorder Sinus Congestion Tremor Date:08/01/00ISR Number: 3538219-4Report Type:Direct Company Report # Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Quetiapine PS Initial or Prolonged Dizziness Drug Hypersensitivity Hypotension Orthostatic Hypotension Syncope Date:08/01/00ISR Number: 3538344-8Report Type:Expedited (15-DaCompany Report #2000AP03521 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chorea Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG BID PO Initial or Prolonged Drug Interaction Health Risperdal SS ORAL 8 MG DAILY PO Tardive Dyskinesia Professional Artane C Other Valium C Date:08/02/00ISR Number: 3540057-3Report Type:Expedited (15-DaCompany Report #2000AP03486 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Uk Ltd Health Professional Other Date:08/03/00ISR Number: 3541348-2Report Type:Expedited (15-DaCompany Report #2000UW02685 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG DAILY Professional PO 22-Feb-2006 08:31 AM Page: 180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/03/00ISR Number: 3541353-6Report Type:Expedited (15-DaCompany Report #2000UW01578 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Seroquel PS Astrazeneca Uk Ltd ORAL 250 MG QD PO Coma Professional Depakote C Condition Aggravated Ativan C Hypoventilation Date:08/04/00ISR Number: 3542546-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Quetiapine Fumarate Intervention to Neutropenia Professional 100mg Tablets Prevent Permanent Astra-Zeneca PS Astra-Zeneca ORAL 300MG BID Impairment/Damage ORAL Valproic Acid C Date:08/07/00ISR Number: 3544189-5Report Type:Expedited (15-DaCompany Report #2000AP03589 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 300 MG DAILY Health PO Professional Risperidone C Other Quilonum C Date:08/07/00ISR Number: 3544578-9Report Type:Expedited (15-DaCompany Report #2000AP03612 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Literature Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG DAILY; Initial or Prolonged Diabetic Ketoacidosis Health PO Required Professional Seroquel "Zeneca" SS ORAL 300 MG DAILY; Intervention to PO Prevent Permanent Risperidone C Impairment/Damage Propanolol C Date:08/11/00ISR Number: 3549100-9Report Type:Expedited (15-DaCompany Report #2000AP03666 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Distension Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 300 MG BID PO Intervention to Bladder Disorder Health Depixol SS Prevent Permanent Drug Interaction Professional Benztropine SS Impairment/Damage Urinary Retention Other Modecate "Sanofi Winthrop" C Temazepam C Senna C Nicotine C 22-Feb-2006 08:31 AM Page: 181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/00ISR Number: 3549103-4Report Type:Expedited (15-DaCompany Report #2000AP03092 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Foreign Seroquel PS Astrazeneca Uk Ltd Intervention to Phosphokinase Increased Health Prevent Permanent Professional Impairment/Damage Other Date:08/14/00ISR Number: 3550690-0Report Type:Expedited (15-DaCompany Report #A010796 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Consumer Navane PS Roerig Div Pfizer Intervention to Dry Mouth Inc Prevent Permanent Dysuria Stelazine SS Impairment/Damage Neurogenic Bladder Seroquel SS Nightmare Olanzapine SS Tardive Dyskinesia Urinary Retention Date:08/18/00ISR Number: 3553423-7Report Type:Expedited (15-DaCompany Report #2000AP03422 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG DAILY Initial or Prolonged Blood Uric Acid Increased Health PO Required Caesarean Section Professional Intervention to Cholelithiasis Other Prevent Permanent Hepatic Steatosis Impairment/Damage Liver Function Test Abnormal Pregnancy Vomiting Date:08/18/00ISR Number: 3553439-0Report Type:Expedited (15-DaCompany Report #2000UW02863 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Foreign Seroquel PS Astrazeneca Uk Ltd Health Professional Other Date:08/18/00ISR Number: 3553853-3Report Type:Expedited (15-DaCompany Report #2000UW02905 Age:18 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Seroquel PS Astrazeneca Uk Ltd Initial or Prolonged Hyperglycaemia Professional Sertraline C Lipids Increased Pancreatitis Acute 22-Feb-2006 08:31 AM Page: 182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/00ISR Number: 3553854-5Report Type:Expedited (15-DaCompany Report #2000UW02848 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Astrazeneca Uk Ltd ORAL 750 MG PO; Professional 500 MG PO ... SS Date:08/18/00ISR Number: 3553855-7Report Type:Expedited (15-DaCompany Report #2000UW02861 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Abuser Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG TID PO Intervention to Prevent Permanent Impairment/Damage Date:08/18/00ISR Number: 3553856-9Report Type:Expedited (15-DaCompany Report #2000AP03769 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 350 MG BID PO Initial or Prolonged Hyperglycaemia Health Priadel C Inappropriate Professional Benztropine C Antidiuretic Hormone Other Secretion Renal Failure Acute Date:08/21/00ISR Number: 3554505-6Report Type:Expedited (15-DaCompany Report #2000UW01590 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG QD PO Red Blood Cell Count Professional Seroquel "Zeneca" SS ORAL 225 MG QD PO Decreased Valproic Acid C Levothyroxine C Premarin C Multivitamins C Docusate C Folic Acid C Vitamin B12 C Date:08/21/00ISR Number: 3554508-1Report Type:Expedited (15-DaCompany Report #2000UW02942 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Astrazeneca Uk Ltd ORAL 1200 MG DAILY Professional PO Zyprexa C Carbatrol C Klonopin C Haldol C 22-Feb-2006 08:31 AM Page: 183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/21/00ISR Number: 3554510-XReport Type:Expedited (15-DaCompany Report #2000AP03765 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Psychotic Disorder Health PO Professional Cyproterone Acetate C Other Date:08/22/00ISR Number: 3555658-6Report Type:Expedited (15-DaCompany Report #2000AP03846 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Foreign Seroquel PS Astrazeneca Uk Ltd Intervention to Phosphokinase Increased Literature Risperidone C Prevent Permanent Liver Function Test Health Olanzapine C Impairment/Damage Abnormal Professional Clozapine C Neutrophil Count Other Decreased Date:08/24/00ISR Number: 3557218-XReport Type:Direct Company Report # Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Trazodone 100mg PS ORAL 100MG HS ORAL Seroquel 50mg Astrazeneca SS Astrazeneca ORAL 50MG BID ORAL Date:08/24/00ISR Number: 3566371-3Report Type:Direct Company Report # Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Thyroid Stimulating Health Lithium PS ORAL 600 MG PO BID Hormone Increased Professional Thorazine SS ORAL 200 MG PO QID Condition Aggravated Depakote SS ORAL 500 MG PO BID Hypercholesterolaemia Seroquel SS ORAL 200 MG PO BID Hypertriglyceridaemia Depakote SS ORAL 250-750 MG PO Zyprexa SS ORAL 5MG PO HS Ritalin SS 20 MG PO TID Tenex C Date:08/28/00ISR Number: 3559627-1Report Type:Direct Company Report # Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Zyprexa PS Coordination Abnormal Seroquel SS Dyscalculia Paxil SS Hyperglycaemia Major Depression Mood Disorder Due To A General Medical Condition Movement Disorder Psychotic Disorder Tremor 22-Feb-2006 08:31 AM Page: 184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/00ISR Number: 3560240-0Report Type:Expedited (15-DaCompany Report #2000PK00327 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG DAILY Initial or Prolonged Depressed Level Of Health PO Disability Consciousness Professional Required Disorientation Other Intervention to Grand Mal Convulsion Prevent Permanent Impairment/Damage Date:09/05/00ISR Number: 3565450-4Report Type:Direct Company Report # Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Choreoathetosis Seroquel 200mg PS 1T Q HS Date:09/11/00ISR Number: 3569168-3Report Type:Expedited (15-DaCompany Report #2000UW03156 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Seroquel PS Astrazeneca Uk Ltd ORAL 1500 MG ONCE Hospitalization - Lethargy Professional PO Initial or Prolonged Overdose Required Respiratory Distress Intervention to Prevent Permanent Impairment/Damage Date:09/11/00ISR Number: 3569269-XReport Type:Expedited (15-DaCompany Report #2000SIN0142 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Sinemet PS Dupont Initial or Prolonged Gait Disturbance Professional Pharmaceuticals Co ORAL QID PO Hypotension Other Seroquel (Quetiapine Pallor Fumarate) SS Sweat Gland Disorder Remeron (Mirtazapine) C Requip (Ropinirole Hydrochloride) C Unspecified C Date:09/12/00ISR Number: 3573823-9Report Type:Periodic Company Report #2000UW02471 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG PO Increased Appetite Glucophage C Lethargy Altace C Vision Blurred 22-Feb-2006 08:31 AM Page: 185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/00ISR Number: 3573824-0Report Type:Periodic Company Report #2000UW02352 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG QD PO Zoloft C Propecia C Trazodone C Date:09/12/00ISR Number: 3573825-2Report Type:Periodic Company Report #2000UW02297 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 75 MG QD PO ; 25 MG QD PO Lithium C Tofranil C Vicodin C Oxycontin C Coumadin C Vitamins C Date:09/12/00ISR Number: 3573826-4Report Type:Periodic Company Report #2000UW02266 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Seroquel PS Astrazeneca Uk Ltd Hair Growth Abnormal Psoriasis Seborrhoea Date:09/12/00ISR Number: 3573827-6Report Type:Periodic Company Report #2000UW02187 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Astrazeneca Uk Ltd ORAL MG PO Professional Date:09/12/00ISR Number: 3573828-8Report Type:Periodic Company Report #2000UW02145 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysuria Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 50 MG HS PO ; Night Sweats 25 MG HS PO Date:09/12/00ISR Number: 3573829-XReport Type:Periodic Company Report #2000UW02108 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Health Seroquel PS Astrazeneca Uk Ltd Professional 22-Feb-2006 08:31 AM Page: 186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/00ISR Number: 3573830-6Report Type:Periodic Company Report #2000UW02034 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG QD PO Date:09/12/00ISR Number: 3573831-8Report Type:Periodic Company Report #2000UW01889 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Clonic Convulsion Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 50 MG QD PO Health Professional Other Date:09/12/00ISR Number: 3573832-XReport Type:Periodic Company Report #2000UW01813 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 800 MG DAILY PO ; 1000 MG DAILY PO Wellbutrin C Depakote C Date:09/12/00ISR Number: 3573833-1Report Type:Periodic Company Report #2000UW01690 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Consumer Seroquel PS Astrazeneca Uk Ltd Pharyngolaryngeal Pain Date:09/12/00ISR Number: 3573834-3Report Type:Periodic Company Report #2000UW01638 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 75 MG QD PO Photophobia Aldactone C Wellbutrin C Date:09/12/00ISR Number: 3573835-5Report Type:Periodic Company Report #2000UW01619 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Seroquel PS Astrazeneca Uk Ltd Initial or Prolonged Professional Zoloft C Trilafon C Date:09/12/00ISR Number: 3573836-7Report Type:Periodic Company Report #2000UW01489 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Seroquel PS Astrazeneca Uk Ltd Initial or Prolonged Professional Tofranil C 22-Feb-2006 08:31 AM Page: 187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/00ISR Number: 3573837-9Report Type:Periodic Company Report #2000UW01441 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Seroquel PS Astrazeneca Uk Ltd 25 MG Agitation Constipation Dermatitis Electroencephalogram Abnormal Eye Discharge Muscle Spasms Nausea Weight Increased Date:09/12/00ISR Number: 3573838-0Report Type:Periodic Company Report #2000UW01439 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Movement Disorder Health Seroquel PS Astrazeneca Uk Ltd Oral Soft Tissue Disorder Professional Date:09/12/00ISR Number: 3573839-2Report Type:Periodic Company Report #2000UW01425 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Consumer Seroquel PS Astrazeneca Uk Ltd Depakote C Paxil C Haloperidol C Imipramine C Klonopin C Date:09/12/00ISR Number: 3573840-9Report Type:Periodic Company Report #2000UW01383 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG BID PO Dizziness Paxil C Feeling Abnormal Loss Of Consciousness Palpitations Date:09/12/00ISR Number: 3573841-0Report Type:Periodic Company Report #2000UW01380 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Open Angle Glaucoma Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 125 MG QD PO Urinary Tract Infection Date:09/12/00ISR Number: 3573842-2Report Type:Periodic Company Report #2000UW01286 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Seroquel PS Astrazeneca Uk Ltd Luvox C 22-Feb-2006 08:31 AM Page: 188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/00ISR Number: 3573843-4Report Type:Periodic Company Report #2000UW00852 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Health Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG BID PO Professional : 200 MG BID PO : 550 MG DAILY PO Risperdal C Navane C Haldol C Date:09/14/00ISR Number: 3571635-3Report Type:Expedited (15-DaCompany Report #2000PK00373 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 800 MG DAILY Health PO Professional Other Date:09/14/00ISR Number: 3571657-2Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Quetiapine PS Therapeutic Carbamazepine Xr SS Date:09/15/00ISR Number: 3571943-6Report Type:Direct Company Report # Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Quetiapine PS 50MG / 100MG Intervention to Priapism / 400MG Prevent Permanent Haloperidol SS 10 MG; 1 DOSE Impairment/Damage Mesoridazine SS 50 MG; 1 DOSE Date:09/18/00ISR Number: 3573425-4Report Type:Periodic Company Report #9933986 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Navane PS Roerig Div Pfizer Professional Inc 2MG TOTAL/DAILY/O RAL Thiothixene SS ORAL ORAL Seroquel SS ORAL ORAL Date:09/18/00ISR Number: 3575010-7Report Type:Expedited (15-DaCompany Report #2000UW03300 Age:72 YR Gender:Female I/FU:I Outcome Death Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:31 AM Page: 189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Analgesic Drug Level Health Seroquel PS Astrazeneca Uk Ltd UNKNOWN UNKNOWN Above Therapeutic Professional Trazodone SS UNKNOWN UNKNOWN Aspartate Tylenol Aminotransferase Extra-Strength SS Increased Warfarin C Blood Bicarbonate Mirtazapine C Decreased Blood Osmolarity Increased Blood Ph Decreased Coma Completed Suicide Hypocalcaemia Hypotension Metabolic Acidosis Respiratory Failure Date:09/19/00ISR Number: 3573333-9Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Quetiapine PS Therapeutic Carbamazapine Xr SS Date:09/20/00ISR Number: 3575936-4Report Type:Expedited (15-DaCompany Report #2000UW03315 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Astrazeneca Uk Ltd ORAL 900 MG DAILY Professional PO Depakote C Neurontin C Date:09/21/00ISR Number: 3576822-6Report Type:Expedited (15-DaCompany Report #2000UW03395 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG BID PO Health Biperiden C Professional Clonazepam C Other Date:09/22/00ISR Number: 3577048-2Report Type:Direct Company Report # Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Simvastatin 20mg PS ORAL 20MG QD PO Initial or Prolonged Phosphokinase Increased Professional Haloperidol Muscle Rigidity Decanoate SS INTRAMUSCULAR 100 MG Q MO Pyrexia IM Tremor Seroquel 100 Mg Astra Zeneca SS Astra Zeneca ORAL 300MG/D ORAL Asa C Apap C 22-Feb-2006 08:31 AM Page: 190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benztropine C Clonazepam C Docusate C Lansoprazole C Paroxetine C Vit E C Date:09/25/00ISR Number: 3578375-5Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Health Quetiapine Fumarate PS Decreased Appetite Professional Tremor Date:09/26/00ISR Number: 3580488-9Report Type:Expedited (15-DaCompany Report #2000AP04144 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG DAILY Intervention to Drug Effect Decreased Health PO Prevent Permanent Drug Withdrawal Syndrome Professional Carbamazepine C Impairment/Damage Nausea Other Amisulpride C Vomiting Clonazepam C Date:09/26/00ISR Number: 3580537-8Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Decreased Appetite Quetiapine Fumarate PS Lethargy Tardive Dyskinesia Tremor Date:09/26/00ISR Number: 3580548-2Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Quetiapine Fumarate PS Tardive Dyskinesia Date:09/26/00ISR Number: 3580676-1Report Type:Expedited (15-DaCompany Report #HQ7822826JUN2000 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Crying Consumer Effexor Xr PS Wyeth Ayerst Fatigue Laboratories Inc ORAL 75 MG DAILY Road Traffic Accident TITRATED UP Sedation IN Tearfulness INCREMENTS; ORAL Klonopin (Clonazepam, 0) Extended Release SS ORAL ORAL IS LESS THAN HALF OF WHAT IT WAS 22-Feb-2006 08:31 AM Page: 191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report IN NOV-1999 Seroquel (Quetiapine, , 0) SS ORAL ORAL 1 DOSE Xanax (Alprazolam, , 0) SS ORAL ORAL, DOSE IS LESS THAN HALF OF WHAT IT WAS IN NOV,1999 Xanax (Alprazolam, , 0) SS ORAL "IS LESS THAN HALF OF WHAT IT WAS IN NOV-1999; ORAL Topamax (Topiramate) C Synthroid (Levonthyroxine Sodium) C Cozaar (Losartan Potassium) C Prilosec (Omeprazole) C Adipex-P (Phentermine Hydrochloride) C Carisoprodol (Carisoprodol) C Bontril Pdm (Phendimetrazine Tartrate) C Date:09/27/00ISR Number: 3581712-9Report Type:Expedited (15-DaCompany Report #2000UW03450 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Seroquel PS Astrazeneca Uk Ltd Initial or Prolonged Dystonia Professional Zyprexa SS Effexor SS Date:10/03/00ISR Number: 3586705-3Report Type:Expedited (15-DaCompany Report #1999UW00945 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Hyperchloraemic Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG BID PO Initial or Prolonged Depressed Level Of Literature Epival C Consciousness Health Chloral Hydrate C Diplopia Professional Clonazepam C Drug Effect Prolonged Other Drug Level Above Therapeutic Hypernatraemia Hypotension Intentional Overdose Lethargy Suicide Attempt Tachycardia 22-Feb-2006 08:31 AM Page: 192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/00ISR Number: 3587065-4Report Type:Expedited (15-DaCompany Report #2000AP04281 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG PO Hospitalization - Depression Health Initial or Prolonged Electroencephalogram Professional Abnormal Other Overdose Psychotic Disorder Sinus Tachycardia Suicide Attempt Toxicologic Test Abnormal Date:10/05/00ISR Number: 3588613-0Report Type:Direct Company Report #USP 53327 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Seroquel PS Astra Zeneca Serzone SS Bristol Myers Squibb Date:10/06/00ISR Number: 3589222-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Seroquel PS Date:10/06/00ISR Number: 3589223-1Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Joint Stiffness Seroquel PS Date:10/10/00ISR Number: 3592222-7Report Type:Expedited (15-DaCompany Report #2000AP04344 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Seroquel PS Astrazeneca Uk Ltd Health Olanzapine C Professional Dothiepin C Other Date:10/17/00ISR Number: 3596151-4Report Type:Periodic Company Report #990765.01 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Fluphenazine Hcl PS Mylan Professional Pharmaceuticals Inc ORAL 5 MG QD ORAL Seroquel Zeneca SS Zeneca ORAL 350MG QD, ORAL Ativan C Cogentin C Depakote C Fluphenazine Decanoate C Klonopin C Lithium C 22-Feb-2006 08:31 AM Page: 193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/00ISR Number: 3597577-5Report Type:Expedited (15-DaCompany Report #A033556 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Increased Literature Zoloft PS Pfizer Initial or Prolonged Blood Pressure Decreased Health Pharmaceuticals Inc ORAL 50.00 MG Condition Aggravated Professional TOTAL: DAILY: Delusional Disorder, ORAL Persecutory Type Quetiapine SS ORAL 100.00 MG Difficulty In Walking TOTAL: BID: Dyspnoea ORAL Extrapyramidal Disorder Haloperidol SS ORAL 2.00 MG Flat Affect TOTAL: DAILY: Formication ORAL Gait Disturbance Hallucination Heart Rate Decreased Hyperventilation Joint Stiffness Mental Impairment Metabolic Acidosis Movement Disorder Pco2 Decreased Psychotic Disorder Respiratory Alkalosis Sinus Tachycardia Tachypnoea Vaginal Candidiasis Vaginitis Bacterial Ventricular Extrasystoles Date:10/19/00ISR Number: 3598451-0Report Type:Expedited (15-DaCompany Report #2000UW03738 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukaemia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 300 MG QD PO Initial or Prolonged Pancytopenia Health Bupropion Professional Hydrochloride C Other Gabapentin C Azithromycin C Clonazepam C Date:10/20/00ISR Number: 3598901-XReport Type:Direct Company Report # Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Quetiapine 100 And 25 Mg Tabs Zeneca PS Zeneca ORAL 75 MG QAM ORAL Olanzapine C Benztropine C Date:10/25/00ISR Number: 3601264-4Report Type:Direct Company Report # Age:71 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Grand Mal Convulsion Seroquel 25mg PS ORAL 50MG PO TID Celexa C Tylenol C Ativan C Date:10/25/00ISR Number: 3601548-XReport Type:Expedited (15-DaCompany Report #2000UW03875 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 700 MG DAILY Initial or Prolonged Fatigue PO Required Leukopenia Seroquel "Zeneca" SS Intervention to Seroquel "Zeneca" SS ORAL 600 MG DAILY Prevent Permanent PO Impairment/Damage Celexa C Date:10/25/00ISR Number: 3601822-7Report Type:Expedited (15-DaCompany Report #2000UW03884 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG DAILY Initial or Prolonged Medication Error PO Sedation Cogentin C Weight Increased Inderal C Date:10/25/00ISR Number: 3601960-9Report Type:Expedited (15-DaCompany Report #1996AP23835 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 300 MG DAILY Neutropenia Study PO Health Professional Other Date:10/25/00ISR Number: 3601962-2Report Type:Expedited (15-DaCompany Report #2000PK00409 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG DAILY Health PO Professional Seroquel "Zeneca" SS "Zeneca" ORAL 600 MG DAILY Other PO Seroquel "Zeneca" SS "Zeneca" ORAL 900 MG DAILY PO Seroquel "Zeneca" SS "Zeneca" ORAL 600 MG DAILY PO 22-Feb-2006 08:31 AM Page: 195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/00ISR Number: 3603501-9Report Type:Expedited (15-DaCompany Report #2000AP04616 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 125 MG DAILY Initial or Prolonged Hyperhidrosis Health PO Melaena Professional Prozac SS ORAL 20 MG DAILY Pyrexia Other PO Rofecoxib SS 25 MG DAILY Aspirin SS Regulan C Madopar C Zimovane C Zacin C Radioactive Iodine C Date:10/27/00ISR Number: 3603503-2Report Type:Expedited (15-DaCompany Report #2000AP04688 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 150 MG BID PO Hospitalization - Diabetic Ketoacidosis Health Ecstasy SS ORAL 5 PO Initial or Prolonged Drug Abuser Professional Alcohol SS Haemodialysis Other Paroxetine C Hypokalaemia Anti-Diabetic Overdose Therapy C Date:10/31/00ISR Number: 3605300-0Report Type:Expedited (15-DaCompany Report #10572881 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Serzone PS Bristol Myers Squibb Initial or Prolonged Consciousness Professional Co Pharmaceutical Ill-Defined Disorder Research Institute ORAL 200 Overdose MILLIGRAM, 2/1 DAY ORAL 2 MON Seroquel (Quetiapine) SS Lithium C Tegretol C Klonopin C Synthroid C Date:11/01/00ISR Number: 3605232-8Report Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Seroquil 100mg Ud PS 100MG QHS Liver Function Test Abnormal Date:11/01/00ISR Number: 3605810-6Report Type:Expedited (15-DaCompany Report #2000AP04737 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Dysarthria Foreign Initial or Prolonged Hemiparesis Health Tremor Professional 22-Feb-2006 08:31 AM Page: 196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG BID PO Carbamazepine C Aspirin "Bayer" C Metformin C Doxepin C Dipyridamole C Date:11/01/00ISR Number: 3605864-7Report Type:Expedited (15-DaCompany Report #2000AP02544 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cerebrovascular Accident Foreign Seroquel PS Astrazeneca Uk Ltd Intervention to Malaise Other Prevent Permanent Myocardial Infarction Impairment/Damage Date:11/06/00ISR Number: 3607377-5Report Type:Direct Company Report # Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Seroquel By Zeneca Therapeutic Pharmaceuticals PS 100 MG ORALLY BID Depakote C Date:11/06/00ISR Number: 3607404-5Report Type:Direct Company Report # Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Seroquel 200 Mg PS ORAL 200 MG BID Intervention to ORAL Prevent Permanent Clonazepam C Impairment/Damage Diphenhydramine C Divalproex C Gabapentin C Docusate C Ibuprofen C Metoprolol C Minocycline C Nelova 1/35-E C Omeprazole C Perphenazine C Vitamin E C Date:11/06/00ISR Number: 3607885-7Report Type:Expedited (15-DaCompany Report #2000UW03962 Age:17 YR Gender:Female I/FU:I Outcome PT Death Aggression Agitation Arrhythmia Cardiac Disorder Condition Aggravated Drug Level Below 22-Feb-2006 08:31 AM Page: 197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Pulmonary Congestion Pulmonary Oedema Rhinorrhoea Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Health Seroquel PS Astrazeneca Uk Ltd ORAL 75 MG QD PO Tachycardia Professional Seroquel "Zeneca" SS ORAL 150 MG QD PO Seroquel "Zeneca" SS ORAL 200 MG HS PO Paxil C Haldol C Inderal C Cogentin C Date:11/09/00ISR Number: 3610298-5Report Type:Expedited (15-DaCompany Report #2000UW03855 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukocytoclastic Foreign Seroquel PS Astrazeneca Uk Ltd Intervention to Vasculitis Health Prevent Permanent Professional Impairment/Damage Other Date:11/13/00ISR Number: 3610852-0Report Type:Expedited (15-DaCompany Report #2000PK00430 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchitis Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 50 MG DAILY Cough Health PO Neutropenia Professional Seroquel "Zeneca" SS ORAL 100 MG DAILY Pyrexia Other PO Seroquel "Zeneca" SS ORAL 125 MG DAILY PO Seroquel "Zeneca" SS ORAL 175 MG DAILY PO Seroquel "Zeneca" SS ORAL 250 MG DAILY PO Seroquel "Zeneca" SS ORAL 325 MG DAILY PO Seroquel "Zeneca" SS ORAL 400 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Seroquel "Zeneca" SS 0 MG DAILY Seroquel "Zeneca" SS ORAL 200 MG DAILY PO Seroquel "Zeneca" SS ORAL 250 MG DAILY PO Seroquel "Zeneca" SS ORAL 175 MG DAILY PO Trevilor C Paspertin C Date:11/13/00ISR Number: 3610892-1Report Type:Expedited (15-DaCompany Report #2000PK00104 Age:35 YR Gender:Female I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Cold Sweat Dizziness Hypertension 22-Feb-2006 08:31 AM Page: 198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Pain In Extremity Sensation Of Pressure Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS Astrazeneca Uk Ltd Health Seroquel SS ORAL 700 MG DAILY Professional PO Other Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 350 MG DAILY PO Seroquel SS ORAL 100 MG DAILY PO Seroquel SS ORAL 450 DAILY PO Tavor C Date:11/13/00ISR Number: 3610895-7Report Type:Expedited (15-DaCompany Report #2000AP04808 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aspartate Foreign Seroquel PS Astrazeneca Uk Ltd 800 MG DAILY 1 YR Intervention to Aminotransferase Health Citalopram C Prevent Permanent Increased Professional Impairment/Damage Blood Creatine Other Phosphokinase Increased Date:11/13/00ISR Number: 3611120-3Report Type:Expedited (15-DaCompany Report #2000UW04189 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Seroquel PS Astrazeneca Uk Ltd Initial or Prolonged Professional Depakote C Required Intervention to Prevent Permanent Impairment/Damage Date:11/13/00ISR Number: 3611160-4Report Type:Periodic Company Report #FLUV00299000290 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Health Luvox PS Solvay Professional Pharmaceuticals ORAL 100 MG BID PO Seroquel (Quetiapine Fumarate) SS ORAL 100 MG TID PO Date:11/14/00ISR Number: 3611446-3Report Type:Direct Company Report # Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Discolouration Quetiapine (25, 50, Skin Disorder 100 Mg Tabs, Zeneca) PS Zeneca ORAL 25,50,100 MG Urticaria TABS SEE IMAGE Beconase Aq Nasal Spray C 22-Feb-2006 08:31 AM Page: 199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/00ISR Number: 3613302-3Report Type:Periodic Company Report #A027306 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Health Sinequan PS Pfizer Laboratories Professional Div Pfizer Inc ORAL 75.00 MG TOTAL:DAILY:O RAL Depakote SS 1500.00 MG TOTAL:BID Lithobid SS 600 MG TOTAL BID Seroquel SS 25MG TOTAL DAILY Date:11/15/00ISR Number: 3612113-2Report Type:Expedited (15-DaCompany Report #2000PK00438 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 50 MG DAILY Health PO Professional Seroquel "Zeneca" SS ORAL 100 MG DAILY Other PO Tavor C Date:11/15/00ISR Number: 3612114-4Report Type:Expedited (15-DaCompany Report #2000AP04963 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Face Oedema Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 50 MG BID PO Intervention to Hypersensitivity Health Flupentixol C Prevent Permanent Speech Disorder Professional Lofepramine C Impairment/Damage Other Date:11/15/00ISR Number: 3612161-2Report Type:Expedited (15-DaCompany Report #2000UW04053 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG BID PO Initial or Prolonged Syncope Professional Lamictal C Paxil C Date:11/17/00ISR Number: 3613500-9Report Type:Expedited (15-DaCompany Report #2000UW03098 Age:37 YR Gender:Female I/FU:I Outcome PT Required Anaemia Megaloblastic Intervention to Gastrointestinal Pain Prevent Permanent Haematocrit Decreased Impairment/Damage Haemoglobin Decreased Leukopenia Mean Cell Volume Increased Medication Error Muscular Weakness Pco2 Decreased Red Blood Cell Count Decreased 22-Feb-2006 08:31 AM Page: 200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG PO Professional Premarin C Ativan C Intron C Rebetol C Date:11/17/00ISR Number: 3613565-4Report Type:Expedited (15-DaCompany Report #2000AP05007 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Complications Of Maternal Foreign Seroquel PS Astrazeneca Uk Ltd 600 MG DAILY Hospitalization - Exposure To Therapeutic Health Initial or Prolonged Drugs Professional Loss Of Consciousness Other Overdose Date:11/21/00ISR Number: 3615333-6Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Quetiapine PS ORAL 200MG Q AM, 400MG Q HS PO Sertraline C Date:11/22/00ISR Number: 3616803-7Report Type:Expedited (15-DaCompany Report #2000AP05032 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS Astrazeneca Intervention to Health Pharmaceuticals Lp 150 MG BID Prevent Permanent Professional Seroquel "Zeneca" SS Zeneca 200 MG BID Impairment/Damage Other Date:11/22/00ISR Number: 3617915-4Report Type:Expedited (15-DaCompany Report #2000UW04299 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Other Seroquel PS Astrazeneca Pharmaceuticals Lp ORAL 300 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 400 MG DAILY PO Seroquel "Zeneca" SS Zeneca Prolixin C Cogentin C Ativan C Date:11/27/00ISR Number: 3617320-0Report Type:Expedited (15-DaCompany Report #2000AP05123 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Aggression Foreign Initial or Prolonged Health 22-Feb-2006 08:31 AM Page: 201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Seroquel PS Astrazeneca Pharmaceuticals Lp ORAL 300 MG DAILY PO Date:11/27/00ISR Number: 3617321-2Report Type:Expedited (15-DaCompany Report #2000PK00462 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Foreign Seroquel PS Astrazeneca Intervention to Dizziness Study Pharmaceuticals Lp ORAL 300 MG DAILY Prevent Permanent Tachycardia Health PO Impairment/Damage Vertigo Professional Quilonum - Slow Other Release C Date:11/27/00ISR Number: 3622929-4Report Type:Periodic Company Report #PHEH1999US04132 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 250 MG, OT, ORAL Seroquel (Seroquel) SS Prozac (Fluoxetine Hydrochloride) C Risperdal (Risperidone) C Neurontin (Gabapentin) C Vitamin E (Tocopherol) C Ambien (Zolpidem Tartrate) C Aspirin (Acetylsalicylic Acid) C Niferex (Polysaccharide-Iron Complex) C Vitamin C (Ascorbic Acid) C Date:11/28/00ISR Number: 3618322-0Report Type:Expedited (15-DaCompany Report #S00-UKI-01881-01 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Celexa PS Forest Laboratories Phosphokinase Increased Health Inc ORAL 40 MG QD PO Liver Function Test Professional Seroquel SS Abnormal Other Seroquel SS ORAL 800 MG QD PO Paracetamol C Ibuprofen C 22-Feb-2006 08:31 AM Page: 202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3618981-2Report Type:Expedited (15-DaCompany Report #2000UW03629 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Mass Health Seroquel PS Astrazeneca Intervention to Gynaecomastia Professional Pharmaceuticals Lp ORAL 25 MG TID PO Prevent Permanent Sinemet C Impairment/Damage Date:11/29/00ISR Number: 3619050-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000009351 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Duragesic PS Alza Corp TRANSDERMAL 75 MCG/H, 1 Medication Error Professional IN 1 TIME(S), TRANSD Percocet (Oxycodone) SS ORAL ORAL Seroquel (Seroquel) SS ORAL ORAL Revia (Naltrexone) SS ORAL ORAL Neurontin (Gabapentin) SS ORAL ORAL Trazodone (Trazodone) SS ORAL ORAL Depakote (Valproate Semisodium) SS ORAL ORAL Amitriptyline (Amitriptyline0 SS ORAL ORAL Celexa (Citalopram Hydrobromie) SS ORAL ORAL Anti-Depressants (Nos) Antideppressants) SS Fentanyl (0,05 Mg/Ml Injection) (Fentanyl) SS INTRAVENOUS 1 IN 1 TIME(S), IV Date:11/29/00ISR Number: 3619232-5Report Type:Expedited (15-DaCompany Report #2000AP04808 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aspartate Foreign Seroquel PS Astrazeneca Intervention to Aminotransferase Health Pharmaceuticals Lp ORAL (2)800 MG Prevent Permanent Increased Professional DAILY PO Impairment/Damage Blood Creatine Other Cipramil SS ORAL 40 MG DAILY Phosphokinase Increased PO Paracetamol C Ibuprofen C Date:11/29/00ISR Number: 3619233-7Report Type:Expedited (15-DaCompany Report #2000PK00463 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Seroquel PS Astrazeneca Initial or Prolonged Diverticulitis Health Pharmaceuticals Lp ORAL 125 MG DAILY Leukocytosis Professional PO Other 22-Feb-2006 08:31 AM Page: 203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/00ISR Number: 3620035-6Report Type:Expedited (15-DaCompany Report #2000AP04688 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Foreign Seroquel PS Astrazeneca Hospitalization - Aspiration Health Pharmaceuticals Lp ORAL 150 MG BID PO Initial or Prolonged Blood Electrolytes Professional Ecstasy SS ORAL 5 PO Abnormal Other Alcohol SS Diabetic Ketoacidosis Paroxetine