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 SS ORAL 20 MG DAILY Drug Abuser PO Haemodialysis Hypokalaemia Metabolic Acidosis Overdose Pneumonia Aspiration Renal Failure Acute Vomiting Date:12/05/00ISR Number: 3621776-7Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozapine PS 300MG HS Confusional State Seroquel SS 10MG HS Dysarthria Depakote C Gait Disturbance Lamocatil C Hyperglycaemia Lipitor C Memory Impairment Norvase C Tremor Inderal C Urinary Incontinence Vistaril C Vomiting Zoloft C Vasotec C Date:12/05/00ISR Number: 3623126-9Report Type:Expedited (15-DaCompany Report #2000AP05268 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Foreign Seroquel PS Astrazeneca Intervention to Second Degree Health Pharmaceuticals Lp 400 MG DAILY 4 MON Prevent Permanent Electrocardiogram Qt Professional Impairment/Damage Prolonged Other Date:12/07/00ISR Number: 3624257-XReport Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Seroquel PS 200 MG Q AM & Initial or Prolonged Non-Insulin-Dependent 400 MG QHS Haldol C Maalox C Tylenol C Cogentin C Mom C 22-Feb-2006 08:31 AM Page: 204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/00ISR Number: 3624447-6Report Type:Expedited (15-DaCompany Report #2000AP04493 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Flight Of Ideas Literature Seroquel PS Astrazeneca Initial or Prolonged Hallucination, Auditory Health Pharmaceuticals Lp 75 MG TID Insomnia Professional Quetiapine Fumarate SS 500 MG DAILY Irritability Quetiapine Fumarate SS 600 MG DAILY Mania Trifluoperazine SS 15 MG DAILY Paranoia Trifluoperazine SS 12 MG DAILY Pressure Of Speech Trifluoperazine SS 6 MG DAILY Psychomotor Hyperactivity Trigluoperazine SS 4 MG HS Psychosexual Disorder Valproic Acid SS 2000 MG DAILY Salivary Hypersecretion Valproic Acid SS 1500 MG DAILY Sedation Lithium Carbonate C Suicidal Ideation Thinking Abnormal Weight Decreased Date:12/08/00ISR Number: 3625631-8Report Type:Expedited (15-DaCompany Report #2000AP05441 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS Astrazeneca Hospitalization - Depressed Level Of Health Pharmaceuticals Lp Initial or Prolonged Consciousness Professional Prisdal C Required Metabolic Acidosis Other Neurontin C Intervention to Overdose Ranitidine C Prevent Permanent Respiratory Acidosis Idalprem C Impairment/Damage Respiratory Failure Suicide Attempt Date:12/11/00ISR Number: 3626317-6Report Type:Direct Company Report # Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Seroquel 200mg PS ORAL 200MG BID ORAL Date:12/12/00ISR Number: 3627126-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Urinary Retention Quetiapine 100 Mg Intervention to And 200 Mg Tabs Prevent Permanent Astra Zeneca PS Astra Zeneca ORAL 200/100/20 Impairment/Damage TID ORAL Clonidine 0.1mg Tablets SS Lederle ORAL 0.1MG TID ORAL Gabapentin C Vpa C 22-Feb-2006 08:31 AM Page: 205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/00ISR Number: 3627253-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Valproic Acid 250mg Hospitalization - White Blood Cell Count Tablets Generic PS ORAL 250MG BID Initial or Prolonged Decreased ORAL Quetiapine 25mg And 100mg Tabs Astrazeneca SS Astrazeneca ORAL 200/2SP BID ORAL Clonidine C Lithium C Date:12/14/00ISR Number: 3628924-3Report Type:Expedited (15-DaCompany Report #A0133478A Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Wellbutrin PS Glaxo Wellcome ORAL 38TAB Single Initial or Prolonged Dialysis dose Ileus Paralytic Tegretol SS ORAL 54TAB Single Overdose dose Oxygen Saturation Trazodone SS ORAL 12TAB Single Decreased dose Seroquel SS ORAL 38TAB Single dose Advil SS ORAL 1600MG Single dose Date:12/14/00ISR Number: 3630037-1Report Type:Expedited (15-DaCompany Report #2000UW04600 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aplastic Anaemia Health Seroquel PS Astrazeneca Intervention to Professional Pharmaceuticals Lp Prevent Permanent Chemotherapy C Impairment/Damage Date:12/14/00ISR Number: 3630040-1Report Type:Expedited (15-DaCompany Report #2000UW03984 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Seroquel PS Astrazeneca Hospitalization - Neuroleptic Malignant Professional Pharmaceuticals Lp ORAL 400 MG PO Initial or Prolonged Syndrome Colace C Required Vitamin C C Intervention to Asa C Prevent Permanent Impairment/Damage Date:12/18/00ISR Number: 3633289-7Report Type:Expedited (15-DaCompany Report #A0133478A Age:17 YR Gender:Female I/FU:I Outcome PT Hospitalization - Coma Initial or Prolonged Dialysis Ileus Paralytic Overdose 22-Feb-2006 08:31 AM Page: 206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxygen Saturation Decreased Sedation Report Source Product Role Manufacturer Route Dose Duration Health Wellbutrin PS Glaxo Wellcome Inc ORAL 38 TABLET/ Professional SINGLE DOSE/ ORAL Carbamazepine Tablet (Carbamazepine) SS ORAL 54 TABLET/ SINGLE DOSE/ ORAL Trazodone Tablet (Trazodone) SS ORAL 12 TABLET/ SINGLE DOSE/ ORAL Quetiapine Fumarate Tablet (Quetiapine Fumarate) SS ORAL 38 TABLET/SINGLE DOSE/ ORAL Ibuprofen Tablet (Ibuprofen) SS ORAL 1600 MG/ SINGLE DOSE/ ORAL Date:12/20/00ISR Number: 3635081-6Report Type:Expedited (15-DaCompany Report #2000TRE0088 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Revia PS Dupont Merck Professional Pharmaceutical Co ORAL PO Percocet (Oxycodone /Acetaminophen) SS ORAL PO Duragesic(Fentanyl) SS TRANSDERMAL 75 MCG/H ONCE TD (Seroquel) SS ORAL PO Neurontin (Gabapentin) SS ORAL PO (Trazodone) SS ORAL PO (Antidepressant-Unsp ecified) SS Depakote (Valproate Semisodium) SS ORAL PO Amitriptyline (Amitriptyline) SS ORAL PO Celexa (Citalopram Hydrobromide) SS ORAL PO (Fentanyl) SS INTRAVENOUS 0.05 MG/ML INJECTION ONCE IV Date:12/20/00ISR Number: 3635162-7Report Type:Expedited (15-DaCompany Report #2000UW04694 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Megacolon Health Seroquel PS Astrazeneca Initial or Prolonged Professional Pharmaceuticals Lp ORAL 1000 MG PO Olanzapine C 22-Feb-2006 08:31 AM Page: 207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/00ISR Number: 3635894-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Seroquel Required Astrazeneca PS Astrazeneca Intervention to Prevent Permanent Impairment/Damage Date:12/26/00ISR Number: 3636445-7Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Quetiapine PS ORAL 200MG QD PO Hospitalization - Confusional State Lansoprazole C Initial or Prolonged Dehydration Lithium C Disorientation Pancrease C Lethargy Divalproex C Sedation Date:12/26/00ISR Number: 3638899-9Report Type:Expedited (15-DaCompany Report #2000AP05712 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS Astrazeneca Initial or Prolonged Increased Health Pharmaceuticals Lp ORAL 75 MG BID PO Blood Albumin Decreased Professional Haloperidol C Cellulitis Other Procyclidine C Oedema Peripheral Frusemide C Skin Fissures Flucloxacillin C Co-Dydramol C Chlormethiazole C Diazepam C Date:12/28/00ISR Number: 3639022-7Report Type:Expedited (15-DaCompany Report #2000AP04281 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Seroquel PS Astrazeneca Hospitalization - Depression Health Pharmaceuticals Lp ORAL SEE IMAGE Initial or Prolonged Electroencephalogram Professional Abnormal Other Intentional Overdose Psychotic Disorder Sinus Tachycardia Suicide Attempt Date:12/28/00ISR Number: 3639042-2Report Type:Expedited (15-DaCompany Report #2000UW03884 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Consumer Seroquel PS Astrazeneca Initial or Prolonged Medication Error Pharmaceuticals Lp ORAL 400 MG DAILY Sedation PO Weight Increased Cogentin C Inderal C 22-Feb-2006 08:31 AM Page: 208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/01ISR Number: 3640908-8Report Type:Expedited (15-DaCompany Report #2000UW05233 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dysarthria Consumer Seroquel PS Astrazeneca Intervention to Feeling Abnormal Pharmaceuticals Lp Prevent Permanent Feeling Drunk Seroquel "Zeneca" SS ORAL 400 MG HS PO Impairment/Damage Lethargy Seroquel "Zeneca" SS ORAL 600 MG HS PO Throat Tightness Date:01/03/01ISR Number: 3641648-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000196 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Consumer Neurontin PS Parke Davis Initial or Prolonged Asthenia Pharmaceuticals Ltd ORAL 900 MG(300 MG Other Blood Potassium Decreased TID):2400MG(8 Carpal Tunnel Syndrome 00MG Cholelithiasis TID):2100MG(7 Cholestasis 00MG Decreased Activity Baclofen SS ORAL 80 MG PER Dental Caries ORAL Depression Ms Contin SS 1600 MG Difficulty In Walking Propulsid SS Dry Mouth Methadone SS 2500 MG Fall Percocet SS 1 OR 2 (Q 4 H Fatigue PRN) Gallbladder Disorder Valium SS 80 MG Gallbladder Pain Zanaflex SS ORAL 8 MG PER ORAL Headache Zoloft SS ORAL 200 MG PER Hypoaesthesia ORAL Hypothyroidism Hydrochlorothiazide SS ORAL 100 MG PER Joint Dislocation ORAL Lethargy Veetids SS ORAL 2000 MG PER Liver Function Test ORAL 1 WK Abnormal Synthroid SS Lymphadenopathy Oxy Ir (Oxycodone Malnutrition Hydrochloride) SS 8-10 DAILY Movement Disorder Lasix SS 80 MG Nervous System Disorder Ritalin SS 80 MG Oedema Peripheral K-Dur SS 20 MCG Osteoporosis Seroquel SS Ovarian Cyst Ketamine SS Pain In Extremity Klonopin SS Pruritus Corgard SS Skin Discolouration Relafen SS Skin Ulcer Celebrex SS 800 MG Tendon Disorder Carafate SS 4 MG Vomiting Dextromethorphan SS 200 MG Weight Decreased Nadolol SS Weight Increased Tegaderm SS Date:01/05/01ISR Number: 3642762-7Report Type:Expedited (15-DaCompany Report #2000AP05441 Age:31 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:31 AM Page: 209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Coma Foreign Seroquel PS Astrazeneca Intentional Overdose Health Pharmaceuticals Lp Metabolic Acidosis Professional Prisdal C Respiratory Acidosis Other Neurontin C Respiratory Failure Ranitidine C Suicide Attempt Idalprem C Date:01/05/01ISR Number: 3642846-3Report Type:Expedited (15-DaCompany Report #2000UW03450 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Seroquel PS Astrazeneca Initial or Prolonged Dermatitis Contact Professional Pharmaceuticals Lp ORAL 100 MG BID PO Drug Interaction Zyprexa SS 5 MG BID Dystonia Effexor SS Pruritus Weight Increased Date:01/08/01ISR Number: 3644429-8Report Type:Expedited (15-DaCompany Report #2000PK00541 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Electrolytes Foreign Seroquel PS Astrazeneca Abnormal Other Pharmaceuticals Lp ORAL 500 MG DAILY Cardiac Arrest PO Hypoglycaemia Respiratory Failure Date:01/08/01ISR Number: 3644430-4Report Type:Expedited (15-DaCompany Report #2000UW02863 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Foreign Seroquel PS Astrazeneca Health Pharmaceuticals Lp Professional Aricept C Other Benzodiacepina C Date:01/08/01ISR Number: 3644435-3Report Type:Expedited (15-DaCompany Report #2000AP05873 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS Astrazeneca Intervention to Neutropenia Literature Pharmaceuticals Lp 400 MG DAILY Prevent Permanent Health Impairment/Damage Professional Other Date:01/09/01ISR Number: 3644773-4Report Type:Expedited (15-DaCompany Report #00P-163-0100126-00 (1) Age:55 YR Gender:Female I/FU:F Outcome Death Hospitalization - 22-Feb-2006 08:31 AM Page: 210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Acute Respiratory Health Depakote PS Abbott Laboratories ORAL 750 MG, 1 IN Distress Syndrome Professional 1 D, PER ORAL Pancreatitis Haemorrhagic Seroquel (Seroquel) SS 500 MG, 1 IN 1 D, Fluphenazine Hydrohloride (Fluphenazine Hydrochloride) C Benzatropine Mesilate (Benzatropine Mesilate ) C Date:01/10/01ISR Number: 3645643-8Report Type:Expedited (15-DaCompany Report #2000UW03629 Age:76 YR Gender:Male I/FU:F 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:01/11/01ISR Number: 3646494-0Report Type:Expedited (15-DaCompany Report #2000UW05324 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Coordination Abnormal Health Seroquel PS Astrazeneca Difficulty In Walking Professional Pharmaceuticals Lp ORAL 800 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 500 MG DAILY PO Date:01/12/01ISR Number: 3646926-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Seroquel PS ORAL 400MG PO HS Muscular Weakness Date:01/16/01ISR Number: 3648235-XReport Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Jittery Quetiapine PS ORAL 200MG BID PO Muscle Rigidity Olanzapine SS ORAL 10 MG Q AM AND 15 MG Q HS PO Lorazepam C Benztropine C Mvi C Guiafenesin C Apap C 22-Feb-2006 08:31 AM Page: 211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/01ISR Number: 3649421-5Report Type:Expedited (15-DaCompany Report #2000AP05712 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS Astrazeneca Initial or Prolonged Increased Health Pharmaceuticals Lp ORAL 75 MG BID PO Blood Albumin Decreased Professional Haloperidol C Cellulitis Other Procyclidine C Oedema Peripheral Frusemide C Skin Fissures Flucloxacillin C Co-Dydramol C Chlormethiazole C Diazepam C Date:01/17/01ISR Number: 3649438-0Report Type:Expedited (15-DaCompany Report #2000UW03450 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Seroquel PS Astrazeneca Initial or Prolonged Dermatitis Contact Professional Pharmaceuticals Lp ORAL 100 MG BID PO Drug Interaction Zyprexa SS 5 MG BID Dystonia Effexor SS Pruritus Haloperidal SS INTRAMUSCULAR 10 MG IM Torticollis Vomiting Weight Increased Date:01/18/01ISR Number: 3650633-5Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Seroquel 200mg Zeneca PS Zeneca ORAL 3TTT PO HS Date:01/18/01ISR Number: 3650634-7Report Type:Direct Company Report # Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca ORAL 100MG 2TT HS Zoloft C Klonopin C Neurontin C Synthroid C Elavil C Zocor C Calcium Carbolate C Provera C Calan Sr C B12 C Date:01/19/01ISR Number: 3650553-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pancreatitis Acute Seroquel PS ORAL 200 MG BID PO Inderal C Depakote C Klonopin C 22-Feb-2006 08:31 AM Page: 212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/01ISR Number: 3652206-7Report Type:Expedited (15-DaCompany Report #02311 Age:67 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Literature Verapamil Hcl PS Purepac Overdose Pharmaceutical Co Div Purepac Inc ORAL ORAL Quetiapine SS ORAL ORAL Date:01/22/01ISR Number: 3652248-1Report Type:Expedited (15-DaCompany Report #02267 Age:45 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Trazodone Hcl PS Purepac Intentional Overdose Pharmaceutical Co Div Purepac Inc ORAL ORAL Quetiapine SS ORAL ORAL Venlafaxine SS ORAL ORAL Date:01/22/01ISR Number: 3652301-2Report Type:Expedited (15-DaCompany Report #02258 Age:72 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Trazodone Hcl PS Purepac Intentional Overdose Pharmaceutical Co Div Purepac Inc ORAL ORAL Acetaminophen SS ORAL ORAL Quetiapine SS ORAL ORAL Date:01/22/01ISR Number: 3652371-1Report Type:Expedited (15-DaCompany Report #2001AP00198 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Withdrawal Literature Seroquel PS Astrazeneca Syndrome Health Pharmaceuticals Lp 150 MG DAILY Convulsion Professional Tramadol SS 50 MG PRN Dehydration Venlafaxine SS 300 MG DAILY Drug Interaction ; 225 MG Ecchymosis DAILY Electrocardiogram St Trazodone SS 75 MG DAILY; Segment Elevation 100 MG DAILY Electrocardiogram T Wave Lorazepam C Peaked Metoclopramide C Excoriation Acetaminophen C Fall Folic Acid C Hyperhidrosis Lithium C Hyperkalaemia Promethazine C Insomnia Lansoprazole C Laceration Vitamin B Nos C Mouth Haemorrhage Benzonatate C Serotonin Syndrome Furosemide C Tremor Metoprolol C Enalapril C 22-Feb-2006 08:31 AM Page: 213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/01ISR Number: 3652372-3Report Type:Expedited (15-DaCompany Report #2000UW03992 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatitis Health Seroquel PS Astrazeneca Intervention to Prothrombin Time Professional Pharmaceuticals Lp ORAL 50 MG HS PO Prevent Permanent Prolonged Nevirapine SS ORAL 200 MG QD PO Impairment/Damage Combivir C Metoprolol C Leuprolide C Clonazepam C Enalapril C Date:01/23/01ISR Number: 3653735-2Report Type:Expedited (15-DaCompany Report #HQ5850112JAN2001 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Withdrawal Literature Effexor PS Wyeth Ayerst Hospitalization - Syndrome Laboratories 300 MG DAILY, Initial or Prolonged Asthenia 225 MG DAILY Convulsion Quetiapine Coronary Artery Disease (Quetiapine) SS ORAL 100 TO 150 MG Dehydration DAILY, ORAL Diarrhoea Tramadol (Tramadol) SS ORAL 50 MG, 1 OR 2 Ecchymosis TABLETS, Electrocardiogram St ORAL, AS Segment Elevation NEEDED Electrocardiogram T Wave Trazodone Peaked (Trazodone) SS ORAL 75MG DAILY, Emphysema ORAL, 100 MG Excoriation DAILY, ORAL Hepatic Steatosis Lithium (Lithium) C Hyperhidrosis Promethazine Hyperkalaemia (Promethazine) C Insomnia Acetaminophen Laceration (Paracetamol) C Renal Disorder Lansoprazole Tongue Haematoma (Lanzoprazole) C Toxicologic Test Abnormal Lorazepam Tremor (Lorazepam) C Vomiting Furosemide (Furosemide) C Metoprolol (Metoprolol) C Enalapril (Enalapril) C Folic Acid (Folic Acid) C Vitamin B (Vitamin B) C Benzonatate (Benzonatate) C Chlordiazepoxide (Chlordiazepoxide) C Ranitidine (Ranitidine) C Famotidine (Famotidine) C Metoclopramide (Metoclopramide Hydrochloride) C 22-Feb-2006 08:31 AM Page: 214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/01ISR Number: 3654124-7Report Type:Expedited (15-DaCompany Report #2000UW05002 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS Astrazeneca Professional Pharmaceuticals Lp ORAL 1200 MG DAILY PO Depakote C Neurontin C Adderall C Clonidine C Date:01/24/01ISR Number: 3654160-0Report Type:Expedited (15-DaCompany Report #NSADSS2001001169 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Literature Ultram PS Rw Johnson Convulsion Health Pharmaceutical Convulsive Threshold Professional Research Institute Lowered Trazodone Injury (Trazodone) SS Soft Tissue Injury Quetiapine Tongue Disorder (Quetiapine) SS Acetaminophen (Paracetamol) SS Promethazine (Promethazine) SS Venlafaxine (Venlafaxine) C Date:01/29/01ISR Number: 3656523-6Report Type:Expedited (15-DaCompany Report #NSADSS2001001169 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Literature Ultram PS Rw Johnson Convulsion Health Pharmaceutical Drug Interaction Professional Research Institute Venlafaxine (Venlafaxine) SS Trazodone (Trazodone) SS Quetiapine (Quetiapine) SS Promethazine (Promethazine) SS Acetaminophen (Paracetamol) SS Date:01/29/01ISR Number: 3656577-7Report Type:Expedited (15-DaCompany Report #2001UW00493 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Prolactin Increased Health Seroquel PS Astrazeneca Intervention to Pituitary Tumour Benign Professional Pharmaceuticals Lp ORAL 100 MG BID PO Prevent Permanent Bromocriptine C Impairment/Damage 22-Feb-2006 08:31 AM Page: 215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/01ISR Number: 3657375-0Report Type:Expedited (15-DaCompany Report #2001AP00559 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Decreased Foreign Seroquel PS Astrazeneca Intervention to Electrocardiogram Qt Health Pharmaceuticals Lp 200 MG BID Prevent Permanent Prolonged Professional Impairment/Damage Loss Of Consciousness Other Date:01/29/01ISR Number: 3657378-6Report Type:Expedited (15-DaCompany Report #2001AP00498 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS Astrazeneca Initial or Prolonged Fall Health Pharmaceuticals Lp ORAL 25 MG BID PO Lethargy Professional Procyclidine C Parkinsonism Other Senna C Cyproterone C Date:01/31/01ISR Number: 3657928-XReport Type:Expedited (15-DaCompany Report #2000PK00541 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Seroquel PS Astrazeneca Electrolyte Imbalance Health Pharmaceuticals Lp ORAL 500 MG DAILY Hypoglycaemia Professional PO Respiratory Failure Other Antra C Stilnox C Date:01/31/01ISR Number: 3658201-6Report Type:Expedited (15-DaCompany Report #2001UW00889 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Astrazeneca Professional Pharmaceuticals Lp Date:01/31/01ISR Number: 3658217-XReport Type:Expedited (15-DaCompany Report #2001UW00831 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Other Seroquel PS Astrazeneca Pharmaceuticals Lp ORAL 600 MG HS PO Remeron C Verapamil C Accupril C Date:01/31/01ISR Number: 3658218-1Report Type:Expedited (15-DaCompany Report #2001UW00854 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Urea Decreased Health Seroquel PS Astrazeneca Sudden Death Professional Pharmaceuticals Lp ORAL 200 MG DAILY PO Zoloft C Klonopin C Elavil C Calan C 22-Feb-2006 08:31 AM Page: 216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Provera C Neurontin C Synthroid C Oxa B12 Injection C Date:02/01/01ISR Number: 3660587-3Report Type:Expedited (15-DaCompany Report #2001UW00973 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Seroquel PS Astrazeneca Initial or Prolonged Heart Rate Irregular Health Pharmaceuticals Lp ORAL 100 MG DAILY Sinus Bradycardia Professional PO Other Risperidone C Apo-Benztropine C Date:02/02/01ISR Number: 3659750-7Report Type:Expedited (15-DaCompany Report #2001UW00897 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Astrazeneca Professional Pharmaceuticals Lp Date:02/02/01ISR Number: 3659751-9Report Type:Expedited (15-DaCompany Report #2001UW00831 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Seroquel PS Astrazeneca Pharmaceuticals Lp ORAL 600 MG HS PO Remeron C Verapamil C Accupril C Atenolol C Potassium C Prilosec C Zocor C Methocarbamol C Celexa C Vancenase Aq C Chlorpheniramine C Date:02/02/01ISR Number: 3660517-4Report Type:Expedited (15-DaCompany Report #2000UW03395 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS Astrazeneca Health Pharmaceuticals Lp ORAL 400 MG BID PO Professional Biperiden C Other Clonazepam C Date:02/05/01ISR Number: 3661280-3Report Type:Expedited (15-DaCompany Report #2001UW00985 Age:24 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Seroquel PS Astrazeneca Decreased Professional Pharmaceuticals Lp ORAL 200 MG TID PO Risperdal SS Depakote C Date:02/05/01ISR Number: 3663381-2Report Type:Expedited (15-DaCompany Report #2001UW00762 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Foreign Seroquel PS Astrazeneca Intervention to Eyelid Function Disorder Health Pharmaceuticals Lp ORAL 500 MG HS PO Prevent Permanent Nystagmus Professional Ventolin C Impairment/Damage Sinus Arrhythmia Other Tic Date:02/06/01ISR Number: 3661989-1Report Type:Periodic Company Report #10462612 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Serzone Tabs Red Blood Cell Count Professional (Nefazodone Hcl) PS ORAL ORAL Decreased Seroquel (Quetiapine) SS Date:02/08/01ISR Number: 3662291-4Report Type:Direct Company Report # Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gait Disturbance Seroquel Intervention to Parkinsonian Gait (Quetiapine) PS ORAL 300MG HS PO Prevent Permanent Impairment/Damage Date:02/08/01ISR Number: 3662705-XReport Type:Expedited (15-DaCompany Report #10683845 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Lactate Foreign Serzone PS Bristol Myers Squibb Dehydrogenase Increased Health Co Pharmaceutical Blood Sodium Decreased Professional Research Institute ORAL 400 Completed Suicide Other MILLIGRAM, 1 Depression DAY ORAL Schizophrenia Quetiapine SS ORAL 450 MILLIGRAM, 1 DAY ORAL Zopiclone C Alprazolam C 22-Feb-2006 08:31 AM Page: 218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/01ISR Number: 3664006-2Report Type:Expedited (15-DaCompany Report #2001UW00854 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Seroquel PS Astrazeneca Sudden Death Professional Pharmaceuticals Lp ORAL 200 MG DAILY Thinking Abnormal PO Zoloft C Klonopin C Elavil C Zocor C Calan - Slow Release C Provera C Neurontin C Synthroid C Oxa B12 Injection C Supplemental Iron C Date:02/12/01ISR Number: 3664007-4Report Type:Expedited (15-DaCompany Report #2001UW00831 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Health Seroquel PS Astrazeneca Cough Professional Pharmaceuticals Lp ORAL 600 MG HS PO Fatigue Remeron C Myocardial Infarction Verapamil C Accupril C Potassium C Prilosec C Zocor C Methocarbamol C Celexa C Vancenase Aq C Chlorpheniramine C Furosemide 'Aps" C Actos C Docusate Sodium C Date:02/12/01ISR Number: 3664104-3Report Type:Periodic Company Report #HQ0768708SEP2000 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Effexor PS Wyeth Ayerst Initial or Prolonged Professional Laboratories ORAL ORAL Other Quetiapine (Quetiapine) SS ORAL ORAL Pyrexa (Olanzapine) SS ORAL ORAL Date:02/12/01ISR Number: 3664132-8Report Type:Expedited (15-DaCompany Report #001-0902-M0100007 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Consumer Nardil PS Parke Davis Div Initial or Prolonged Drug Withdrawal Syndrome Warner Lambert Co ORAL SEE IMAGE Feeling Abnormal Seroquel Insomnia (Quentiapine) SS ORAL PER ORAL (Clonazepam) C Aspirin (Acetylsalicylic 22-Feb-2006 08:31 AM Page: 219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acid) C Date:02/12/01ISR Number: 3664469-2Report Type:Expedited (15-DaCompany Report #2001AP00733 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS Astrazeneca Hospitalization - Convulsion Health Pharmaceuticals Lp ORAL 200 MG DAILY Initial or Prolonged Hypotension Professional PO;25 MG Required Intentional Overdose Other DAILY PO Intervention to Respiratory Depression Eskazine C Prevent Permanent Suicide Attempt Tranxilium C Impairment/Damage Tachycardia Risperdale C Date:02/14/01ISR Number: 3667122-4Report Type:Expedited (15-DaCompany Report #2001UW00973 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Foreign Seroquel "Zeneca" PS Zeneca ORAL 100 MG DAILY Initial or Prolonged Heart Rate Irregular Health PO Myocardial Infarction Professional Risperidone C Sinus Arrhythmia Other Apo-Benztropine C Sinus Bradycardia Supraventricular Extrasystoles Date:02/15/01ISR Number: 3665998-8Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Irritability Quetiapine Fumarate PS Psychomotor Hyperactivity Date:02/15/01ISR Number: 3666476-2Report Type:Expedited (15-DaCompany Report #2001AP00830 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Seroquel "Zeneca" PS Zeneca Phosphokinase Increased Health Neurontin C Coma Professional Besitran C Hypotension Other Rivotril C Overdose Suicide Attempt Tachycardia Date:02/16/01ISR Number: 3666123-XReport Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Seroquel Initial or Prolonged Cholecystitis Acute (Quetiapime) PS 300 MG QD Pain Paxil (Paroxetine) SS 30 MG QHS Vomiting 22-Feb-2006 08:31 AM Page: 220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/01ISR Number: 3667415-0Report Type:Expedited (15-DaCompany Report #2001SE01240 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS Zeneca ORAL 500 MG DAILY Initial or Prolonged Drug Ineffective Health PO Iron Deficiency Professional Tranxilium C Leukocytosis Other Weight Decreased Date:02/20/01ISR Number: 3667417-4Report Type:Expedited (15-DaCompany Report #2001AP00922 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Foreign Seroquel PS Astrazeneca Initial or Prolonged Metabolic Acidosis Health Required Professional Intervention to Other Prevent Permanent Impairment/Damage Date:02/20/01ISR Number: 3667419-8Report Type:Expedited (15-DaCompany Report #2001PK00059 Age:49 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel Astrazeneca PS ORAL 75 MG DAILY Health PO Professional Other Date:02/20/01ISR Number: 3667436-8Report Type:Expedited (15-DaCompany Report #2001AP00700 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gastroenteritis Foreign Seroquel "Zeneca" PS Zeneca ORAL 200 MG BID PO Intervention to Salmonella Health Depakine SS ORAL 500 MG BID PO Prevent Permanent Leukopenia Professional Acetylsalicylic Acid C Impairment/Damage Monocyte Count Increased Other Dipiperon C Neutropenia Epipropane C Sectral "Akita" C Logastric C Date:02/20/01ISR Number: 3667810-XReport Type:Expedited (15-DaCompany Report #2001AP00888 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Nausea Foreign Seroquel "Zeneca" PS ORAL 200 MG BID PO Oesophageal Ulcer Health Temazepam C Professional Procyclidine C Other Inderal-La C Citalopram C Clonazepam C Chlorpromazine C Epilim Chrono C 22-Feb-2006 08:31 AM Page: 221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/01ISR Number: 3702772-8Report Type:Periodic Company Report #2000028100US Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Other Zyvox PS Pharmacia And Upjohn Drug Interaction Co INTRAVENOUS IV 14 DAY Hyperhidrosis Seroquel (Quetiapine) SS INTRAVENOUS 50 MG, QD, IV Date:02/21/01ISR Number: 3667931-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Quetiapine PS ORAL 40 MG PO Intervention to DAILY 3 MON Prevent Permanent Impairment/Damage Date:02/22/01ISR Number: 3669337-8Report Type:Expedited (15-DaCompany Report #2001AP01020 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS Astrazeneca Health Pharmaceuticals Lp Professional Other Date:02/23/01ISR Number: 3669826-6Report Type:Expedited (15-DaCompany Report #S00-UKI-00833-01 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Congenital Foreign Celexa PS Forest Laboratories Initial or Prolonged Hypotonia Health Inc TRANSPLACENTAL 20 MG QD Complications Of Maternal Professional TRANSPLACENTA Exposure To Therapeutic Other L Drugs Seroquel SS TRANSPLACENTAL 250 MG QD Eye Disorder TRANSPLACENTA Hypoventilation Neonatal L Neonatal Respiratory Trazodone SS TRANSPLACENTAL 150 MG QD Depression TRANSPLACENTA L Zopiclone SS TRANSPLACENTAL 7.5 MG QD TRANSPLACENTA L Lorazepam SS TRANSPLACENTAL 1 MG QD TRANSPLACENTA L Perphenazine SS TRANSPLACENTAL 4 MG QD TRANSPLACENTA L Methotrimeprazine SS 22-Feb-2006 08:31 AM Page: 222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/01ISR Number: 3670104-XReport Type:Expedited (15-DaCompany Report #S00-UKI-00592-01 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Congenital Foreign Celexa PS Forest Laboratories Initial or Prolonged Hypotonia Health Inc Congenital Anomaly Complications Of Maternal Professional Lorazepam SS TRANSPLACENTAL 1 MG QD Exposure To Therapeutic Other TRANSPLACENTA Drugs L Eye Disorder Perphenazine SS TRANSPLACENTAL 4 MG QD Hypoventilation Neonatal TRANSPLACENTA Neonatal Disorder L Neonatal Respiratory Trazodone SS TRANSPLACENTAL 150 MG QD Depression TRANSPLACENTA L Zopiclone SS TRANSPLACENTAL 7.5 MG QD TRANSPLACENTA L Seroquel SS TRANSPLACENTAL 250 MG TRANSPLACENTA L Methotrimeprazine SS Date:02/26/01ISR Number: 3670541-3Report Type:Expedited (15-DaCompany Report #2001UW01670 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cold Sweat Health Seroquel PS Astrazeneca Hospitalization - Cyanosis Professional Pharmaceuticals Lp ORAL 25 MG ONCE PO Initial or Prolonged Dermatitis Mellaril C Hypotension Inderal C Metabolic Acidosis Pyrexia Sepsis Shock Skin Discolouration Date:02/26/01ISR Number: 3670542-5Report Type:Expedited (15-DaCompany Report #2001UW01554 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Seroquel PS Astrazeneca Disorientation Pharmaceuticals Lp ORAL 400 MG BID PO Loss Of Consciousness Seroquel "Zeneca" SS Zeneca ORAL 500 MG BID PO Stupor Date:02/26/01ISR Number: 3670647-9Report Type:Expedited (15-DaCompany Report #2001AP00830 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Seroquel PS Astrazeneca Phosphokinase Increased Health Pharmaceuticals Lp Blood Pressure Decreased Professional Neurontin C Coma Other Besitran C Intentional Overdose Rivotril C Suicide Attempt Tachycardia 22-Feb-2006 08:31 AM Page: 223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/01ISR Number: 3670648-0Report Type:Expedited (15-DaCompany Report #2001UW00973 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Valve Disease Foreign Seroquel PS Astrazeneca Initial or Prolonged Bundle Branch Block Health Pharmaceuticals Lp ORAL 100 MG DAILY Endocarditis Bacterial Professional PO Heart Rate Irregular Other Seroquel "Zeneca" SS ORAL 325 MG DAILY Myocardial Infarction PO Sinus Arrhythmia Risperidone C Sinus Bradycardia Apo-Benztropine C Supraventricular Extrasystoles Date:02/27/01ISR Number: 3670425-0Report Type:Direct Company Report # Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Occult Blood Health Valproic Acid 250 Mg Required Petechiae Professional Tablets PS ORAL 250 MG BID Intervention to Thrombocytopenia User Facility 500MG HS ORAL Prevent Permanent Quetiapine 100 And Impairment/Damage 200 Mg Tablets Astra Zeneca SS Astra Zeneca ORAL 100 MG BID 200MG HS ORAL Penicillin Vk C 250 MG QID X 10 DAYS Date:02/27/01ISR Number: 3670993-9Report Type:Expedited (15-DaCompany Report #2001UW01663 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Haematuria Health Seroquel PS Astrazeneca Intervention to Proteinuria Professional Pharmaceuticals Lp Prevent Permanent Impairment/Damage Date:02/27/01ISR Number: 3670994-0Report Type:Expedited (15-DaCompany Report #2001UW01690 Age:0 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Complications Of Maternal Health Seroquel PS Astrazeneca Intervention to Exposure To Therapeutic Professional Pharmaceuticals Lp Prevent Permanent Drugs Klonopin SS 1 MG BID Impairment/Damage Drug Withdrawal Syndrome Paxil C Neonatal Hyperreflexia Date:02/28/01ISR Number: 3671616-5Report Type:Direct Company Report # Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Seroquel Initial or Prolonged Condition Aggravated (Quetiapine) PS ORAL 200 MG WAM Hallucination, Auditory /400 MG QD Pain Paxil C Klonopin C Remeron C 22-Feb-2006 08:31 AM Page: 224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3677814-9Report Type:Periodic Company Report #A040479 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Consumer Zoloft PS Pfizer Depression Pharmaceuticals Inc ORAL 250.00 Intentional Overdose TOTAL:TID:ORA Medication Error L Seroquel SS ORAL 100.00 MG TOTAL:DAILY:O RAL Depakote SS ORAL 1500.00 MG TOTAL:TID:ORA L Date:03/01/01ISR Number: 3672241-2Report Type:Expedited (15-DaCompany Report #2001045785US Age:67 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Exposure Health Calan PS Gd Searle And Co ORAL UNK, UNK, Professional ORAL Quetiapine(Quetiapin e) SS ORAL UNK, UNK, ORAL Date:03/01/01ISR Number: 3672497-6Report Type:Expedited (15-DaCompany Report #2001AP01131 Age:64 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS Astrazeneca Initial or Prolonged Other Pharmaceuticals Lp Date:03/02/01ISR Number: 3672820-2Report Type:Expedited (15-DaCompany Report #2001UW01844 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cystitis Interstitial Consumer Seroquel PS Astrazeneca Required Pharmaceuticals Lp ORAL 100 MG HS PO Intervention to Prevent Permanent Impairment/Damage Date:03/02/01ISR Number: 3672968-2Report Type:Expedited (15-DaCompany Report #2001AP01126 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Foreign Seroquel PS Astrazeneca Other Pharmaceuticals Lp 600 MG DAILY Zopiclone C Procyclidine C Date:03/05/01ISR Number: 3673813-1Report Type:Expedited (15-DaCompany Report #2001UW01852 Age: Gender: I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Seroquel PS Astrazeneca Professional Pharmaceuticals Lp Heparin C Date:03/05/01ISR Number: 3673814-3Report Type:Expedited (15-DaCompany Report #2001UW01813 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Seroquel PS Astrazeneca Initial or Prolonged Professional Pharmaceuticals Lp ORAL 100 MG BID PO Seroquel "Zeneca" SS Zeneca ORAL 150 MG Q12H PO Seroquel "Zeneca" SS ORAL 250 MG BID PO Seroquel "Zeneca" SS Zeneca ORAL 200 MG Q12H PO Seroquel "Zeneca" SS Zeneca Seroquel "Zeneca" SS Zeneca Niferex C Folic Acid C Zyprexa C Depakote C Eskalith C Date:03/05/01ISR Number: 3674134-3Report Type:Expedited (15-DaCompany Report #2001AP01209 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Oculogyration Foreign Seroquel PS Astrazeneca Health Pharmaceuticals Lp Professional Other Date:03/06/01ISR Number: 3674781-9Report Type:Expedited (15-DaCompany Report #US_010260115 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Quetiapine PS 400 MG/DAY Initial or Prolonged Anxiety Health Cardiac Disorder Professional Condition Aggravated Depression Heart Rate Increased Irritability Psychotic Disorder Date:03/09/01ISR Number: 3676433-8Report Type:Direct Company Report #USP 081363 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel 100 PS Zeneca Vomiting Serzone SS Bristol Myers Squibb 22-Feb-2006 08:31 AM Page: 226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/01ISR Number: 3678104-0Report Type:Expedited (15-DaCompany Report #2001PK00183 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG DAILY Health PO Professional Benperidol SS 10 MG DAILY Other Levomepromazine SS 25 MG DAILY Date:03/09/01ISR Number: 3678106-4Report Type:Expedited (15-DaCompany Report #2000AP05873 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS Astrazeneca Uk Ltd 400 MG DAILY Intervention to Neutropenia Literature Prevent Permanent Health Impairment/Damage Professional Other Date:03/09/01ISR Number: 3678111-8Report Type:Expedited (15-DaCompany Report #2001AP01126 Age:18 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Foreign Seroquel PS Astrazeneca Uk Ltd 600 MG DAILY Suicide Attempt Health Zopiclone C Professional Procyclidine C Other Date:03/09/01ISR Number: 3678201-XReport Type:Expedited (15-DaCompany Report #2001UW02243 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Crying Health Seroquel PS Astrazeneca Uk Ltd ORAL 500 MG DAILY Initial or Prolonged Loss Of Consciousness Professional PO Syncope Paxil C Date:03/12/01ISR Number: 3679603-8Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Seroquel Initial or Prolonged Insomnia (Quetiapine) PS 300MG Q Suicidal Ideation AM/500MG HS Depakote C Paxil C Klonopin C Remeron C Date:03/12/01ISR Number: 3680517-8Report Type:Expedited (15-DaCompany Report #2001UW02143 Age:48 YR Gender:Male 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 Professional Haldol C Ativan C Statin C 22-Feb-2006 08:31 AM Page: 227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/01ISR Number: 3680518-XReport Type:Expedited (15-DaCompany Report #2000UW01591 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS Astrazeneca Uk Ltd ORAL 250 MG HS PO 10 WK Intervention to Visual Acuity Reduced Professional Zyprexa SS Prevent Permanent Risperdal SS Impairment/Damage Date:03/13/01ISR Number: 3679854-2Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Quetiapine PS ORAL NOT A Initial or Prolonged Diabetes Mellitus RELIABLE PT Other Diabetic Ketoacidosis PO Disorientation Valproic Acid SS Thrombocytopenia Risperidone SS Haldol SS Benztropine SS Date:03/13/01ISR Number: 3679898-0Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Seroquel Intervention to Increased (Quitiapine) PS ORAL 8000 MG PO Prevent Permanent HS Impairment/Damage Date:03/14/01ISR Number: 3680969-3Report Type:Expedited (15-DaCompany Report #2001UW02117 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Seroquel PS Astrazeneca Uk Ltd Intervention to Professional Depakote C Prevent Permanent Impairment/Damage Date:03/14/01ISR Number: 3681705-7Report Type:Expedited (15-DaCompany Report #2001PK00187 Age:35 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Body Temperature Increased C-Reactive Protein Increased Condition Aggravated Electrocardiogram St Segment Elevation Grand Mal Convulsion Hyperthyroidism Influenza Like Illness Myocarditis Neuroleptic Malignant Syndrome 22-Feb-2006 08:31 AM Page: 228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pericarditis Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG DAILY Health PO Professional Other Date:03/14/01ISR Number: 3681707-0Report Type:Expedited (15-DaCompany Report #2001AP01209 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Oculogyration Foreign Seroquel PS Astrazeneca Uk Ltd Health Professional Other Date:03/14/01ISR Number: 3682891-5Report Type:Expedited (15-DaCompany Report #01P-144-0103996-00 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Attention Foreign Tranxene PS Abbott Laboratories Intervention to Deficit/Hyperactivity Health Pharmaceutical Prevent Permanent Disorder Professional Products Div ORAL 75 MG, 1 IN 1 Impairment/Damage Dyskinesia D, PER ORAL Extrapyramidal Disorder Seroquel (Seroquel) SS ORAL 600 MG, 1 IN 1 D, PER ORAL Date:03/15/01ISR Number: 3682262-1Report Type:Expedited (15-DaCompany Report #HQ7978305MAR2001 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Effexor PS Wyeth Ayerst Myocarditis Professional Laboratories ORAL 75 MG 1X PER 1 DAY ORAL 17 DAY Seroquel (Quetiapine) SS ORAL 150 MG 1X PER 1 DAY ORAL Tenormin (Atenolol) C Eutirox (Levothyroxine) C Date:03/16/01ISR Number: 3682974-XReport Type:Expedited (15-DaCompany Report #2000UW04333 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG BID PO Intervention to Maculopathy Professional Prozac C Prevent Permanent Risperdal C Impairment/Damage Neurontin C Insulin C Glucotrol C Lasix C Cardizem C Zestril C Lipitor C Lopid C 22-Feb-2006 08:31 AM Page: 229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ambien C Os-Cal C Accolate C Date:03/19/01ISR Number: 3684295-8Report Type:Expedited (15-DaCompany Report #2000UW03598 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 800 MG Asthenia DAILY;PO Body Temperature Seroquel "Zeneca" SS ORAL 600 MG;PO Increased Seroquel "Zeneca" SS ORAL 300 MG Bone Pain DAILY;PO Chills Seroquel "Zeneca" SS ORAL 400 MG Dehydration DAILY;PO Dysgeusia Clozaril C Feeling Cold Toprol Xl C Feeling Hot And Cold Valium C Heart Rate Increased Prilosec C Insomnia Zithromax "Pfizer" C Nausea Pneumonia Thirst White Blood Cell Count Decreased Date:03/19/01ISR Number: 3684695-6Report Type:Expedited (15-DaCompany Report #2000AP00920 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Immunoglobulin E Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 100 MG BID PO Increased Health Lactulose C Eosinophilia Professional Procyclidinec C Other Depo Provera C Zopiclone C Date:03/19/01ISR Number: 3684696-8Report Type:Expedited (15-DaCompany Report #2000AP05561 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 250 MG BID PO Health Clozapine SS ORAL 175 MG PO Professional Thyroxin C Other Date:03/19/01ISR Number: 3684697-XReport Type:Expedited (15-DaCompany Report #2000AP01195 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Albumin Increased Foreign Seroquel PS Astrazeneca Uk Ltd 300 MG DAILY Blood Alkaline Health Zyprexa SS ORAL 10 MG DAILY Phosphatase Increased Professional PO Polycythaemia Other Zyprexa SS ORAL 10 MG DAILY White Blood Cell Count PO Decreased 22-Feb-2006 08:31 AM Page: 230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/01ISR Number: 3684698-1Report Type:Expedited (15-DaCompany Report #2000AP01971 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 500 MG DAILY Health PO Professional Amisulpride C Other Date:03/19/01ISR Number: 3684699-3Report Type:Expedited (15-DaCompany Report #2000AP05619 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG DAILY Intervention to Body Temperature Health PO Prevent Permanent Increased Professional Leponex *Novartis* SS Novartis ORAL 100 MG TID PO Impairment/Damage Drug Level Below Other Zyprexa C Therapeutic Cisordinol C Leukopenia Lorazepam C Neuroleptic Malignant Syndrome Neutropenia Date:03/19/01ISR Number: 3684700-7Report Type:Expedited (15-DaCompany Report #2000AP02640 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Seroquel PS Astrazeneca Uk Ltd Health Lithium C Professional Other Date:03/21/01ISR Number: 3686821-1Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Seroquel (300 Mg Intervention to Daily) PS 300MG DAILY Prevent Permanent Zoloft C Impairment/Damage Date:03/21/01ISR Number: 3687576-7Report Type:Expedited (15-DaCompany Report #2001AP01209 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Oculogyration Foreign Seroquel PS Astrazeneca Uk Ltd Health Amilsulpride SS Professional Other Date:03/26/01ISR Number: 3689813-1Report Type:Expedited (15-DaCompany Report #2001UW02765 Age: Gender: I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Rhabdomyolysis Health Seroquel PS Astrazeneca Uk Ltd ORAL PO Professional Zocor SS Date:03/26/01ISR Number: 3689840-4Report Type:Expedited (15-DaCompany Report #2001UW02681 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG DIALY Initial or Prolonged Coma Professional PO Feeling Cold Proamatine C Movement Disorder Celexa C Sinemet C Mirapex "Pharmacia-Upjohn" C Date:03/26/01ISR Number: 3690355-8Report Type:Expedited (15-DaCompany Report #2001AP00922 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Fibrosing Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 750 MG DAILY Initial or Prolonged Blood Pressure Diastolic Health PO Required Decreased Professional Aspirin C Bayer Intervention to Dysarthria Other Losec C Prevent Permanent Hypothermia Cipramil C Impairment/Damage Metabolic Acidosis Date:03/26/01ISR Number: 3692792-4Report Type:Expedited (15-DaCompany Report #2001AP01491 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Deep Vein Thrombosis Other Seroquel PS Astrazeneca Uk Ltd ORAL 150 MG BID PO Pulmonary Embolism Quetiapine SS ORAL 200 MG BID PO Olanzapine C Droperidol C Haloperidol C Lorazepam C Date:03/29/01ISR Number: 3692325-2Report Type:Expedited (15-DaCompany Report #2001UW02939 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Respiratory Depression Health Seroquel PS Astrazeneca Uk Ltd Professional Date:03/29/01ISR Number: 3692327-6Report Type:Expedited (15-DaCompany Report #2000UW03156 Age:6 YR Gender: I/FU:F 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 Dexedrine "Medeva" C Respiratory Depression Valproate C Respiratory Distress 22-Feb-2006 08:31 AM Page: 232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/01ISR Number: 3692331-8Report Type:Expedited (15-DaCompany Report #2001UW02922 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Astrazeneca Uk Ltd Professional Alprazolam C Date:03/29/01ISR Number: 3692333-1Report Type:Expedited (15-DaCompany Report #2001UW02587 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bacterial Infection Health Seroquel PS Astrazeneca Uk Ltd ORAL 500 MG PRN PO Hospitalization - Blood Culture Positive Professional Mellaril C Initial or Prolonged Coma Veetids C Csf Test Abnormal Oxycontin C Csf White Blood Cell Maxalt C Count Positive Celexa C Electrocardiogram Qt Pamelor C Corrected Interval Maxzide C Prolonged Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Respiratory Disorder Sepsis Tooth Abscess Date:03/29/01ISR Number: 3692798-5Report Type:Expedited (15-DaCompany Report #2001SE02359 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cyanosis Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 6 GR DAILY PO Hospitalization - Overdose Health Dobupal C Initial or Prolonged Pallor Professional Tranxilium C Peripheral Coldness Other Stupor Date:03/29/01ISR Number: 3692799-7Report Type:Expedited (15-DaCompany Report #2001AP01524 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Uk Ltd 600 MG DAILY Rectal Haemorrhage Health White Blood Cell Count Professional Decreased Other Date:03/31/01ISR Number: 3693568-4Report Type:Expedited (15-DaCompany Report #NSADSS2001008399 Age:48 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Foreign Risperidone Throat Tightness Health (Unspecified) Professional (Risperidone) PS Janssen Research Fdn ORAL 0.5 MG, ORAL Quetiapine SS 22-Feb-2006 08:31 AM Page: 233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/01ISR Number: 3694411-XReport Type:Direct Company Report # Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Seroquel 75mg Psoriasis Zeneca Pharmaceuticals PS Zeneca Pharmaceuticals ORAL 75MG AT BEDTIME ORAL Dovonex Cream C Psorcon Cream C Dovonex Scalp Solution 1uxiq C Claritin C Atarax C Ssrna Cream C Pulva C Date:04/03/01ISR Number: 3695939-9Report Type:Expedited (15-DaCompany Report #2001SE02468 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cholestasis Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG DAILY Intervention to Hyperglycaemia Health PO Prevent Permanent Hypertriglyceridaemia Professional Rexer C Impairment/Damage Other Idalprem C Somnovit C Akineton C Date:04/03/01ISR Number: 3695946-6Report Type:Expedited (15-DaCompany Report #2001SE02599 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG DAILY Neutropenia Health PO Thrombocytopenia Professional Depakine SS ORAL 200 MG DAILY Other PO Eliten C Amaryl C Date:04/03/01ISR Number: 3695949-1Report Type:Expedited (15-DaCompany Report #2001SE02598 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 150 MG DAILY Shock Health PO Professional Efexor SS ORAL 75 MG DAILY Other PO Tenormin C Eutirox C Date:04/03/01ISR Number: 3695951-XReport Type:Expedited (15-DaCompany Report #2001AP01543 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Death Dyskinesia Foreign Dysphagia Health Foreign Body Aspiration Professional 22-Feb-2006 08:31 AM Page: 234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG DAILY PO Risperdal SS Rohypnol C Eurodin C Tasmolin C Date:04/03/01ISR Number: 3695955-7Report Type:Expedited (15-DaCompany Report #2001SE02734 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 750 MG DAILY Condition Aggravated Health PO Eating Disorder Professional Other Date:04/04/01ISR Number: 3697960-3Report Type:Expedited (15-DaCompany Report #2001AP01558 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Uk Ltd Health Seroquel "Zeneca" SS Professional Clozapine SS 1 WK Other Date:04/04/01ISR Number: 3698070-1Report Type:Expedited (15-DaCompany Report #001-0945-M0100345 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chondropathy Consumer Neurontin PS Parke Davis Initial or Prolonged Hypertrophy Breast Pharmaceuticals Ltd Knee Arthroplasty (Sertraline) SS ORAL 200 MG Weight Increased (DAILY), PER ORAL Lipitor (Atorvastatin Calcium) SS Celecoxib (Celecoxib) SS Clonazepam (Clonazepam) SS Desipramine (Desipramine) SS Quetiapine (Quentiapine) SS Date:04/10/01ISR Number: 3702239-7Report Type:Expedited (15-DaCompany Report #2001UW03403 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Computerised Tomogram Health Seroquel PS Astrazeneca Uk Ltd Initial or Prolonged Abnormal Professional Luvox C Cough Dyspnoea 22-Feb-2006 08:31 AM Page: 235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/01ISR Number: 3702244-0Report Type:Expedited (15-DaCompany Report #2001UW03379 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ascites Health Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG PO Intervention to Polydipsia Professional Lithium C Prevent Permanent Polyuria Impairment/Damage Date:04/10/01ISR Number: 3702247-6Report Type:Expedited (15-DaCompany Report #2001AP01551 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Literature Seroquel PS Astrazeneca Uk Ltd 100 MG BID Initial or Prolonged Blood Pressure Systolic Health Valproic Acid C Abnormal Professional Estradiol C Delusion Clonazepam C Hypothermia Fluphenazine C Hydroxyzine C Lisinopril C Levothyroxine C Folic Acid C Insulin C Nitroglycerin C Furosemide C Date:04/10/01ISR Number: 3702790-XReport Type:Expedited (15-DaCompany Report #2001AP01126 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Foreign Seroquel PS Astrazeneca Uk Ltd 600 MG DAILY Medication Error Health Zopiclone C Therapeutic Agent Professional Procyclidine C Toxicity Other Toxicologic Test Abnormal Date:04/10/01ISR Number: 3703663-9Report Type:Expedited (15-DaCompany Report #2001SE02359 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cyanosis Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 6 GR DAILY PO Hospitalization - Intentional Overdose Health Dobupal C Initial or Prolonged Pallor Professional Tranxilium C Peripheral Coldness Other Stupor Suicide Attempt Date:04/11/01ISR Number: 3702995-8Report Type:Direct Company Report # Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Quetiapine PS 25MG BID 22-Feb-2006 08:31 AM Page: 236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/01ISR Number: 3704169-3Report Type:Expedited (15-DaCompany Report #2001AP01131 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS Astrazeneca Uk Ltd Initial or Prolonged Drug Withdrawal Syndrome Health Professional Other Date:04/12/01ISR Number: 3704209-1Report Type:Expedited (15-DaCompany Report #2001AP01678 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pulmonary Embolism Foreign Seroquel PS Astrazeneca Uk Ltd Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:04/13/01ISR Number: 3704619-2Report Type:Expedited (15-DaCompany Report #2001SE02878 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel PS Astrazeneca Uk Ltd Initial or Prolonged Health Atarax C Professional Risolid C Other Ferrum C Harmonet C Date:04/13/01ISR Number: 3704623-4Report Type:Expedited (15-DaCompany Report #2001SE02734 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Seroquel PS Astrazeneca Uk Ltd Hospitalization - Choking Health Diamicron C Initial or Prolonged Condition Aggravated Professional Phenolid C Disinhibition Other Metformin C Eating Disorder Valium For Injection C Impulsive Behaviour Date:04/16/01ISR Number: 3704622-2Report Type:Expedited (15-DaCompany Report #2001SE02997 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG TID PO Intervention to Loss Of Consciousness Health Exelon C Prevent Permanent Professional Impairment/Damage Other Date:04/16/01ISR Number: 3705477-2Report Type:Expedited (15-DaCompany Report #2001AP01558 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Uk Ltd 300 MG DAILY Study Seroquel *Zeneca* SS Astrazeneca Health Clozapine SS 1 WK Professional Other 22-Feb-2006 08:31 AM Page: 237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/01ISR Number: 3705482-6Report Type:Expedited (15-DaCompany Report #2001AP01126 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Foreign Seroquel PS Astrazeneca Uk Ltd 600 MG DAILY Medication Error Health Zopiclone C Suicidal Ideation Professional Procyclidine C Toxicologic Test Abnormal Other Date:04/17/01ISR Number: 3705988-XReport Type:Direct Company Report #USP 53909 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Serzone PS Bristol-Myers Squibb Seroquel SS Astra Zenca Date:04/18/01ISR Number: 3707339-3Report Type:Expedited (15-DaCompany Report #2000UW03598 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Consumer Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG DAILY Aspiration PO Asthenia Seroquel "Zeneca" SS ORAL 800 MG DAILY Body Temperature PO Increased Seroquel "Zeneca" SS ORAL 300 MG DAILY Bone Pain PO Chills Seroquel "Zeneca" SS ORAL 400 MG DAILY Dehydration PO Dysgeusia Dyspnoea Heart Rate Increased Hyperhidrosis Insomnia Nasopharyngitis Nausea Pneumonia Thirst Viral Infection Weight Increased White Blood Cell Count Decreased Date:04/18/01ISR Number: 3707430-1Report Type:Expedited (15-DaCompany Report #2001UW03991 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Seroquel PS Astrazeneca Uk Ltd ORAL 900 MG DAILY Hospitalization - Professional PO 2 WK Initial or Prolonged Date:04/18/01ISR Number: 3707456-8Report Type:Expedited (15-DaCompany Report #2001AP01524 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel "Zeneca" PS Astrazeneca Uk Ltd 600 MG DAILY Rectal Haemorrhage Health White Blood Cell Count Professional Decreased Other 22-Feb-2006 08:31 AM Page: 238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/01ISR Number: 3707666-XReport Type:Expedited (15-DaCompany Report #2001UW03867 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Health Seroquel PS Astrazeneca Uk Ltd Haemoglobin Decreased Professional Date:04/19/01ISR Number: 3707906-7Report Type:Direct Company Report # Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Quetiapine 50 Mg Astrazeneca PS Astrazeneca ORAL 50 MG QHS ORAL Nefazadone 50 Mg Bristol-Myers Squibb SS Bristol-Myers Squibb ORAL 50 MG QHS ORAL Date:04/19/01ISR Number: 3708141-9Report Type:Expedited (15-DaCompany Report #2001AP01746 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gastric Ulcer Foreign Seroquel PS Astrazeneca Uk Ltd 300 MG DAILY 7 WK Intervention to Gastritis Health Salivix C Prevent Permanent Gastrointestinal Ulcer Professional Impairment/Damage Other Date:04/19/01ISR Number: 3708219-XReport Type:Expedited (15-DaCompany Report #2001SE02733 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Syncope Foreign Seroquel PS Astrazeneca Uk Ltd Study Seroquel "Zeneca" SS ORAL 200 MG BID PO Health Seroquel "Zeneca" SS ORAL 300 MG DAILY Professional PO Other Zoloft C Diapam C Date:04/19/01ISR Number: 3708220-6Report Type:Expedited (15-DaCompany Report #2001AP01543 Age:48 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 50 MG DAILY Hospitalization - Dysphagia Health PO Initial or Prolonged Injury Asphyxiation Professional Seroquel "Zeneca" SS ORAL 75 MG DAILY Tardive Dyskinesia Other PO Seroquel "Zeneca" SS ORAL 100 MG DAILY PO Seroquel "Zeneca" SS ORAL 200 MG DAILY PO Seroquel "Zeneca" SS ORAL 300 MG DAILY PO Seroquel "Zeneca" SS ORAL 400 MG DAILY PO Risperdal SS ORAL 6 MG DAILY PO Risperdal SS ORAL 4 MG DAILY PO Risperdal SS ORAL 3.5 MG DAILY PO 22-Feb-2006 08:31 AM Page: 239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal SS ORAL 3 MG DAILY PO Risperdal SS ORAL 2.5 MG DAILY PO Risperdal SS ORAL 2 MG DAILY PO Risperdal SS ORAL 1 MG DAILY PO Risperdal SS ORAL 0.5 MG DAILY PO Rohypnol C Eurodin C Tasmolin C Date:04/20/01ISR Number: 3708548-XReport Type:Expedited (15-DaCompany Report #2001SE02997 Age:50 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Other Seroquel PS Astrazeneca Uk Ltd ORAL 25 MG TID PO Loss Of Consciousness Exelon C Date:04/20/01ISR Number: 3708783-0Report Type:Expedited (15-DaCompany Report #01P-083-0105531-00 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Foreign Depakene PS Abbott Laboratories Hospitalization - Neutropenia Health Pharmaceutical Initial or Prolonged Thrombocytopenia Professional Products Div ORAL 600 MG, 1 IN 1 D, PER ORAL Seroquel (Seroquel) SS ORAL 200 MG 1 IN 1 D, PER ORAL Fosinopril Sodium (Fosinopril Sodium) C Glimepiride (Glimepiride) C Date:04/24/01ISR Number: 3709267-6Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Quetiapine 200mg Initial or Prolonged Tabs PS 400 MG AM, 200 MG HS Depakote C Stress Vitamin C Date:04/25/01ISR Number: 3711242-2Report Type:Expedited (15-DaCompany Report #2001SE02734 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Seroquel PS Astrazeneca Lp Hospitalization - Disinhibition Health Diamicron C Initial or Prolonged Impulsive Behaviour Professional Phenolid C Other Metformin C Valium For Injection C 22-Feb-2006 08:31 AM Page: 240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/01ISR Number: 3711244-6Report Type:Expedited (15-DaCompany Report #2001AP01543 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Foreign Seroquel PS Astrazeneca Lp ORAL SEE IMAGE Hospitalization - Dysphagia Health Risperdal SS ORAL SEE IMAGE Initial or Prolonged Injury Asphyxiation Professional Rohypnol C Required Tardive Dyskinesia Other Eurodin C Intervention to Tasmolin C Prevent Permanent Impairment/Damage Date:04/25/01ISR Number: 3711528-1Report Type:Expedited (15-DaCompany Report #2001AP01543 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Foreign Seroquel PS Astrazeneca Lp ORAL 50 MG DAILY Hospitalization - Dysphagia Health PO Initial or Prolonged Injury Asphyxiation Professional Seroquel "Zeneca" SS Zeneca ORAL 75 MG DAILY Required Tardive Dyskinesia Other PO Intervention to Seroquel "Zeneca" SS Zeneca ORAL 100 MG DAILY Prevent Permanent PO Impairment/Damage Seroquel "Zeneca" SS Zeneca ORAL 200 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 300 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 400 MG DAILY PO Risperdal SS ORAL 6 MG DAILY PO Risperdal SS ORAL 4 MG DAILY PO Risperdal SS ORAL 3.5 MG DAILY PO Risperdal SS ORAL 3 MG DAILY PO Risperdal SS ORAL 2.5 MG DAILY PO Risperdal SS ORAL 2 MG DAILY PO Risperdal SS ORAL 1 MG DAILY PO Risperdal SS ORAL 0.5 MG DAILY PO Rohypnol C Eurodin C Tasmolin C Date:04/26/01ISR Number: 3710667-9Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Seroquel PS Astra Zeneca Medication Error Serzone SS Bristol-Myers Squibb Date:04/26/01ISR Number: 3710947-7Report Type:Expedited (15-DaCompany Report #A0133478A Age:17 YR Gender:Female I/FU:F Outcome PT Life-Threatening Coma Hospitalization - Dialysis Initial or Prolonged Drug Level Above Other Therapeutic 22-Feb-2006 08:31 AM Page: 241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ileus Paralytic Overdose Oxygen Saturation Report Source Product Role Manufacturer Route Dose Duration Decreased Wellbutrin PS Glaxo Wellcome ORAL 38TAB Single Sedation dose Tegretol SS ORAL 54TAB Single dose Trazodone SS ORAL 12TAB Single dose Seroquel SS ORAL 38TAB Single dose Advil SS ORAL 1600MG Single dose Date:04/26/01ISR Number: 3711578-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Quetiapine 200mg PS ORAL 200MG QD ORAL Initial or Prolonged Quetiapine 100mg SS ORAL 100MG QD ORAL Required Divalproex C Intervention to Prazosin C Prevent Permanent Impairment/Damage Date:04/26/01ISR Number: 3711933-3Report Type:Expedited (15-DaCompany Report #2001UW04129 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Bone Pain Consumer Seroquel PS Astrazeneca Lp Calcinosis Foot Fracture Gait Disturbance Limb Deformity Date:04/30/01ISR Number: 3713865-3Report Type:Expedited (15-DaCompany Report #A0133478A Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Health Wellbutrin PS Glaxo Wellcome Inc ORAL 38 TABLET, Hospitalization - Overdose Professional SINGLE DOSE, Initial or Prolonged ORAL Required Carbamazepine Tablet Intervention to (Carbamazepine) SS ORAL 54 Prevent Permanent TABLET/SINGLE Impairment/Damage DOSE/ORAL Trazodone Tablet SS ORAL 12 TABLET/SINGLE DOSE/ORAL Quetiapine Fumarate Tablet (Quetiapine Fumarate) SS ORAL 38 TABLET/SINGLE DOSE/ORAL Ibuprofen Tablet (Ibuprofen) SS ORAL 1600 MG/SINGLE DOSE/ORAL 22-Feb-2006 08:31 AM Page: 242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/01ISR Number: 3714213-5Report Type:Expedited (15-DaCompany Report #2001UW04474 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Astrazeneca Lp Professional Date:05/01/01ISR Number: 3722785-XReport Type:Periodic Company Report #2001049457US Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Celebrex PS Gd Searle And Co ORAL ORAL Clonazepam SS ORAL ORAL Desipramine SS ORAL ORAL Seroquel SS ORAL ORAL Zoloft SS ORAL 200MG. QD. ORAL Neurontin SS ORAL ORAL Lipitor(Atorvastatin ) C Date:05/02/01ISR Number: 3715712-2Report Type:Expedited (15-DaCompany Report #2001AP01969 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Lp ORAL 200 MG BID PO 1 WK Literature Quetiapine SS ORAL 250 MG BID PO 4 WK Health Clozapine SS 400 MG DAILY 1 YR Professional Other Date:05/02/01ISR Number: 3715717-1Report Type:Expedited (15-DaCompany Report #2001AP01946 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Foreign Seroquel PS Astrazeneca Lp ORAL 600 MG DAILY Intervention to Decreased Health PO Prevent Permanent White Blood Cell Count Professional Impairment/Damage Decreased Other Date:05/02/01ISR Number: 3715831-0Report Type:Expedited (15-DaCompany Report #2001UW04476 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Unilateral Consumer Seroquel PS Astrazeneca Lp ORAL 100 MG QID PO 3 YR Intervention to Cataract Prevent Permanent Conjunctival Hyperaemia Impairment/Damage Eye Irritation Eyelid Oedema Intraocular Pressure Increased 22-Feb-2006 08:31 AM Page: 243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/01ISR Number: 3715853-XReport Type:Expedited (15-DaCompany Report #2001SE03367 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatitis Foreign Seroquel PS Astrazeneca Lp ORAL 400 MG DAILY Required Oedema Peripheral Health PO Intervention to Paraesthesia Professional Zyprexa SS ORAL 10 MG DAILY Prevent Permanent Vomiting Other PO Impairment/Damage Date:05/02/01ISR Number: 3715855-3Report Type:Expedited (15-DaCompany Report #2001AP01950 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Condition Aggravated Foreign Seroquel PS Astrazeneca Lp ORAL 50 MG PO 3 WK Obsessive-Compulsive Literature Moclobemide C Disorder Health Triiodothyronine C Professional Cetirizine C Other Date:05/07/01ISR Number: 3718241-5Report Type:Expedited (15-DaCompany Report #2001PK00392 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel PS Astrazeneca Lp ORAL 500 MG DAILY Intervention to Neutropenia Health PO Prevent Permanent Professional Impairment/Damage Other Date:05/07/01ISR Number: 3718876-XReport Type:Expedited (15-DaCompany Report #2000UW04390 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Seroquel PS Astrazeneca Lp ORAL SEE IMAGE Initial or Prolonged Dysphagia Lithium C Required Mental Disorder Lamotrigine C Intervention to Tardive Dyskinesia Prevent Permanent Tongue Disorder Impairment/Damage Date:05/07/01ISR Number: 3719046-1Report Type:Expedited (15-DaCompany Report #NSADSS2001008399 Age:48 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Risperdal PS Janssen Research Fdn ORAL ORAL 0.5 MG, Alanine Aminotransferase Health ORAL SEE Increased Professional IMAGE Aspartate Quetiapine Aminotransferase (Quetiapine) SS 400 MG Increased Biperiden Blood Lactate Hydrochloride Dehydrogenase Increased (Biperiden Cardio-Respiratory Arrest Hydrochloride) C Dyskinesia Flunitrazepam Foreign Body Aspiration (Flunitrazepam) C Hallucination, Auditory Estazolam Restlessness (Estazolam) C 22-Feb-2006 08:31 AM Page: 244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/01ISR Number: 3719394-5Report Type:Expedited (15-DaCompany Report #2001UW00762 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Foreign Seroquel PS Astrazeneca Lp ORAL 500 MG HS PO Intervention to Cataplexy Study Ventolin C Prevent Permanent Nystagmus Health Impairment/Damage Tic Professional Other Date:05/07/01ISR Number: 3719397-0Report Type:Expedited (15-DaCompany Report #2001AP02001 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Seroquel PS Astrazeneca Lp ORAL 400 MG QD PO Sudden Death Health Dogmatyl C Professional Solanax C Other Sedrena C Vegetamin A C Doral C Nivadil C Lochol C Acecol C Sulperazon C Insulin C Date:05/08/01ISR Number: 3719552-XReport Type:Periodic Company Report #2001UW00476 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Zomig PS Ipr Pharmaceuticals Inc Seroquel "Zeneca" SS Date:05/08/01ISR Number: 3720156-3Report Type:Expedited (15-DaCompany Report #2001UW04767 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleural Effusion Literature Seroquel PS Astrazeneca Lp ORAL 150 MG QD PO Initial or Prolonged Health Seroquel "Zeneca" SS Zeneca ORAL 150 MG QD PO Professional Clonidine C Prednisone C Lortab C Xanax C Paxil C Depakote C Pulmicort C Albuterol C Date:05/08/01ISR Number: 3720198-8Report Type:Expedited (15-DaCompany Report #A108646 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Irritability Consumer Geodon PS Pfizer Central Initial or Prolonged Mania Research ORAL 80.00 MG TOTAL BID ORAL Seroquel SS ORAL 300.00 MG 22-Feb-2006 08:31 AM Page: 245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TOTAL DAILY ORAL Depakote C Neurontin C Clonazepam C Date:05/09/01ISR Number: 3719852-3Report Type:Direct Company Report # Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Muscle Twitching Seroquel 100mg And Tic 25 Mg PS ORAL 125 MG BID ORAL Cogentin .5mg SS ORAL .5 MG BID ORAL Tegretol C Pertussis Vaccine C Haldol C Depakote C Risperidal C Ritalin C Date:05/09/01ISR Number: 3721001-2Report Type:Periodic Company Report #00P-163-0090728-00 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Depakote PS Abbott Laboratories ORAL PER ORAL Initial or Prolonged Professional Seroquel (Seroquel) SS Company Representative Date:05/10/01ISR Number: 3720123-XReport Type:Direct Company Report #USP 54029 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Serzone PS Bm Squibb Seroquel SS Astra Zeneca Date:05/11/01ISR Number: 3724376-3Report Type:Direct Company Report #USP 54065 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Serzone Tab PS Bristol-Myers-Squibb Seroquel SS Astra-Zeneca Date:05/14/01ISR Number: 3723851-5Report Type:Expedited (15-DaCompany Report #2001UW04839 Age: Gender:Female I/FU:I Outcome PT Life-Threatening Atrioventricular Block Hospitalization - Convulsion Initial or Prolonged Drug Interaction Hepatic Function Abnormal Neuroleptic Malignant Syndrome Overdose Pyrexia 22-Feb-2006 08:31 AM Page: 246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS Astrazeneca Lp Professional Citalopram SS Date:05/14/01ISR Number: 3723855-2Report Type:Expedited (15-DaCompany Report #2001AP02119 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Lp Health Professional Other Date:05/14/01ISR Number: 3723912-0Report Type:Expedited (15-DaCompany Report #2001UW04845 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Tolerance Decreased Health Seroquel PS Astrazeneca Lp ORAL 400 MG PO Initial or Prolonged Tardive Dyskinesia Professional Seroquel "Zeneca" SS Zeneca ORAL 25 MG PO Required Intervention to Prevent Permanent Impairment/Damage Date:05/14/01ISR Number: 3723913-2Report Type:Expedited (15-DaCompany Report #2001SE03377 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Circulatory Collapse Foreign Seroquel PS Astrazeneca Lp ORAL 100 MG DAILY Intervention to Coronary Artery Disease Study PO Prevent Permanent Hyperhidrosis Health Seroquel "Zeneca" SS ORAL 200 MG DAILY Impairment/Damage Hypokalaemia Professional PO Hypotension Other Seroquel "Zeneca" SS ORAL 150 MG DAILY Orthostatic Hypotension PO Pallor Teotard C Pulse Pressure Decreased Syncope Date:05/14/01ISR Number: 3723936-3Report Type:Expedited (15-DaCompany Report #2001UW01690 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Complications Of Maternal Health Seroquel PS Astrazeneca Lp TRANSPLACENTAL 50 MG BID TPL Intervention to Exposure To Therapeutic Professional Klonopin SS 1 MG BID Prevent Permanent Drugs Paxil C Impairment/Damage Drug Withdrawal Syndrome Neonatal Hyperreflexia Neonatal Asphyxia 22-Feb-2006 08:31 AM Page: 247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/01ISR Number: 3724742-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Seroquel PS ORAL PO Initial or Prolonged Coma Paxil C Required Hepatic Enzyme Increased Cogentin C Intervention to Muscle Twitching Ritalin C Prevent Permanent Oedema Oscal C Impairment/Damage Posturing Fibercon C Respiratory Arrest Date:05/18/01ISR Number: 3725946-9Report Type:Expedited (15-DaCompany Report #PHBS2001JP04795 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Tonsillitis Foreign Lescol PS Novartis Blood Glucose Increased Health Pharmaceuticals Corp ORAL 20 MG/D, ORAL C-Reactive Protein Professional Vegetamin Increased Other (Chlorpromazine Cardio-Respiratory Arrest Hydrochloride) SS ORAL 3 DF/D, ORAL Malaise Seroquel Odynophagia (Quetiapine) SS ORAL 4 DF/D, ORAL Sudden Death Doral (Quazepam) SS ORAL 2 DF/D, ORAL Urinary Incontinence Dogmatyl (Sulpiride) C White Blood Cell Count Solanax (Alprazolam) C Increased Nivadil (Nilvadipine) C Acecol (Temocapril Hydrochloride) C Sulperazon (Sulbactam Sodium, Cefoperazone Sodium) C Penfill R (Insulin Human) C Date:05/18/01ISR Number: 3726311-0Report Type:Expedited (15-DaCompany Report #2001UW05289 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anoxia Health Seroquel PS Astrazeneca Lp Intervention to Coma Professional Prevent Permanent Impairment/Damage Date:05/21/01ISR Number: 3726365-1Report Type:Expedited (15-DaCompany Report #2001UW05343 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ascites Health Seroquel PS Astrazeneca Lp Initial or Prolonged Hepatitis Professional Celexa SS Date:05/21/01ISR Number: 3726818-6Report Type:Expedited (15-DaCompany Report #NSADSS2001013504 Age: Gender: I/FU:F Outcome PT Report Source Death Diabetic Ketoacidosis Foreign Health 22-Feb-2006 08:31 AM Page: 248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal PS Janssen Research Fdn Seroquel (Seroquel) SS ORAL ORAL Date:05/22/01ISR Number: 3727156-8Report Type:Expedited (15-DaCompany Report #2001UW05480 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Health Seroquel PS Astrazeneca Lp ORAL 25 MG DAILY Intervention to Leukopenia Professional PO Prevent Permanent Neutropenia Valproic Acid SS Impairment/Damage Sertraline C Ativan C Date:05/22/01ISR Number: 3727239-2Report Type:Expedited (15-DaCompany Report #2001UW05309 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Disorder Health Seroquel PS Astrazeneca Lp Initial or Prolonged Faecaloma Professional Seroquel "Zeneca" SS ORAL 25 MG BID PO Renal Failure Acute Fleet Enema SS Renal Tubular Necrosis Dulcolax SS Milk Of Magnesia SS Fleet Mineral Oil Enema SS Golytely SS Magnesium Citrate SS Zoloft C Nifedipine Xl C Metamucil C Clonidine C Prilosec C Lorazepam C Percocet C Eulexin C Date:05/23/01ISR Number: 3727887-XReport Type:Expedited (15-DaCompany Report #A108646 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Consumer Geodon PS Pfizer Central Initial or Prolonged Medication Error Health Research ORAL ORAL Schizophrenia Professional Seroquel SS ORAL 300.00 MG TOTAL DAILY ORAL Neurontin (Gabapentin) SS 3600.00 MG TOTAL TID Beer SS ORAL ORAL Depakote C Clonazepam C 22-Feb-2006 08:31 AM Page: 249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/01ISR Number: 3727938-2Report Type:Expedited (15-DaCompany Report #2001AP02216 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Seroquel PS Astrazeneca Lp ORAL SEE IMAGE Health Slow-Fe C Professional Risumic C Other Hirnamin C Vegetamin A C Silece C Pyrethia C Akineton C Prolmon C Daiace C Date:05/25/01ISR Number: 3729018-9Report Type:Expedited (15-DaCompany Report #2001UW05597 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Thrombocytopenia Health Seroquel PS Astrazeneca Lp Intervention to Professional Prevent Permanent Impairment/Damage Date:05/25/01ISR Number: 3729019-0Report Type:Expedited (15-DaCompany Report #1999UW03089 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Literature Seroquel PS Astrazeneca Lp ORAL 50 MG QD PO Initial or Prolonged Medication Error Health Seroquel "Zeneca" SS ORAL 600 MG QD PO Required Neutropenia Professional Depakote C Intervention to Prevent Permanent Impairment/Damage Date:05/25/01ISR Number: 3729020-7Report Type:Expedited (15-DaCompany Report #2001UW05683 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Seroquel PS Astrazeneca Lp ORAL 500 MG DAILY Intervention to Weight Increased Professional PO Prevent Permanent Clozaril C Impairment/Damage Risperdal C Zyprexa C Date:05/25/01ISR Number: 3729345-5Report Type:Expedited (15-DaCompany Report #2001AP02212 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Seroquel PS Astrazeneca Lp ORAL 75 MG DAILY Health PO Professional Seroquel "Zeneca" SS ORAL 150 MG DAILY Other PO Seroquel "Zeneca" SS ORAL 225 MG DAILY PO Seroquel "Zeneca" SS ORAL 150 MG DAILY PO Perospirone 22-Feb-2006 08:31 AM Page: 250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride Hydrate SS ORAL 9 MG DAILY PO Silece C Rohypnol C Hiberna C Date:05/25/01ISR Number: 3729361-3Report Type:Expedited (15-DaCompany Report #2001AP02169 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Necrosis Foreign Seroquel PS Astrazeneca Lp Pancreatitis Haemorrhagic Health Professional Other Date:05/29/01ISR Number: 3729715-5Report Type:Expedited (15-DaCompany Report #2001UW05726 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Foreign Seroquel PS Astrazeneca Lp Health Risperdal C Professional Haldol C Other Clonidine C Tegretol C Clomipramine C Lithium C Ativan C Propranolol C Clonazepam C Pimozide C Zoladex C Chloral Hydrate C Tetrabenazine C Chlorpromazine C Date:05/29/01ISR Number: 3729717-9Report Type:Expedited (15-DaCompany Report #2001SE03881 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS Astrazeneca Lp ORAL 5 G DAILY PO Grand Mal Convulsion Health Intentional Overdose Professional Suicide Attempt Other Date:05/29/01ISR Number: 3730080-8Report Type:Expedited (15-DaCompany Report #2001UW05737 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arthritis Health Seroquel PS Astrazeneca Lp Intervention to Eosinophil Count Professional Prevent Permanent Increased Impairment/Damage Joint Swelling 22-Feb-2006 08:31 AM Page: 251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/01ISR Number: 3730699-4Report Type:Expedited (15-DaCompany Report #2001AP02001 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Tonsillitis Foreign Seroquel PS Astrazeneca Lp ORAL 400 MG DAILY Arrhythmia Health PO Blood Glucose Increased Professional Vegetamin A SS ORAL 3 UNK DAILY Electrocardiogram Qt Other PO Prolonged Doral SS ORAL 30 MG DAILY Myocardial Infarction PO Respiratory Arrest Dogmatyl C Sudden Death Solanax C Urinary Incontinence Sedrena C Nivadil C Lochol C Acecol C Sulperazon C Insulin C Date:05/29/01ISR Number: 3730702-1Report Type:Expedited (15-DaCompany Report #2001SE03413 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lethargy Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG ONCE PO Sedation Health Professional Company Representative Other Date:05/30/01ISR Number: 3730754-9Report Type:Expedited (15-DaCompany Report #2001AP01746 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Upper Health Seroquel PS Astrazeneca Lp 300 MG DAILY Intervention to Dyspnoea Professional Salivix C Prevent Permanent Gastric Ulcer Other Impairment/Damage Gastritis Intestinal Ulcer Oesophageal Ulcer Vomiting Date:05/31/01ISR Number: 3731228-1Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Quetiapine Fumarate PS Hospitalization - Pyridoxine Hcl C Initial or Prolonged Magnesium C Required Hydroxide C Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/31/01ISR Number: 3731300-6Report Type:Expedited (15-DaCompany Report #2001UW06000 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Seroquel PS Astrazeneca Lp ORAL 50 MG DAILY Professional PO Seroquel "Zeneca" SS ORAL 25 MG DAILY PO Digoxin C Coumadin "Dupont" C Remeron C Fentanyl Patch C Date:05/31/01ISR Number: 3731608-4Report Type:Expedited (15-DaCompany Report #2001AP02279 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Lp 1 MON Health Clozapine SS 8 MON Professional Other Date:06/01/01ISR Number: 3732192-1Report Type:Expedited (15-DaCompany Report #2001UW02391 Age:75 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Salivary Hypersecretion Health Seroquel PS Astrazeneca Lp ORAL 50 MG BID PO Initial or Prolonged Sepsis Professional Cogentin C Required Urinary Tract Infection Intervention to Prevent Permanent Impairment/Damage Date:06/01/01ISR Number: 3732660-2Report Type:Expedited (15-DaCompany Report #2001SE03983 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Discharge Foreign Seroquel PS Astrazeneca Lp ORAL 150 MG DAILY Initial or Prolonged Galactorrhoea Health PO Professional Other Date:06/04/01ISR Number: 3733143-6Report Type:Expedited (15-DaCompany Report #2001UW04839 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Seroquel PS Astrazeneca Lp ORAL 250 MG DAILY Hospitalization - Blood Creatine Other PO Initial or Prolonged Phosphokinase Increased Citalopram SS 40 MG DAILY Convulsion Procyclidine C Drug Interaction Hepatic Function Abnormal Neuroleptic Malignant Syndrome Overdose Pyrexia Rhabdomyolysis Thrombocytopenia 22-Feb-2006 08:31 AM Page: 253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733444-1Report Type:Periodic Company Report #A108233 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Consumer Geodon PS Pfizer Central Psychotic Disorder Research ORAL 40.00 MG Sedation TOTAL:BID:ORA L Seroquel SS Date:06/04/01ISR Number: 3733600-2Report Type:Periodic Company Report #A109488 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pollakiuria Health Geodon PS Pfizer Central Professional Research 60.00 MG TOTAL:BID Seroquel SS ORAL 300.00 MG TOTAL:DAILY:O RAL Anafranil C Effexor C Seroquel C Date:06/05/01ISR Number: 3733913-4Report Type:Expedited (15-DaCompany Report #2001UW05633 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypomania Consumer Seroquel PS Astrazeneca Lp ORAL 700 MG DAILY Initial or Prolonged Lethargy PO Platelet Count Decreased Seroquel "Zeneca" SS ORAL 600 MG DAILY Sedation PO Stress Risperdal C Depakote C Neurontin C Clonapin C Prevacid C Tapazole C Lasix C Date:06/05/01ISR Number: 3735360-8Report Type:Expedited (15-DaCompany Report #A111667 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Consumer Zoloft PS Pfizer Hospitalization - Convulsion Pharmaceuticals Inc UNKNOWN UNKNOWN Initial or Prolonged Depakote (Sodium Valproate) SS UNKNOWN UNKNOWN Seroquel (Quetiapine) SS UNKNOWN UNKNOWN Date:06/06/01ISR Number: 3734927-0Report Type:Expedited (15-DaCompany Report #A111667 Age: Gender:Female I/FU:F Outcome PT Life-Threatening Coma Hospitalization - Convulsion Initial or Prolonged Dyspnoea 22-Feb-2006 08:31 AM Page: 254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemorrhage Hallucination Report Source Product Role Manufacturer Route Dose Duration Consumer Zoloft PS Pfizer Pharmaceuticals Inc Depakote (Sodium Valproate) SS Seroquel (Quetiapine) SS Date:06/07/01ISR Number: 3735784-9Report Type:Expedited (15-DaCompany Report #2001UW06229 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cryptogenic Organizing Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG BID PO Initial or Prolonged Pneumonia Health Lorazepam C Required Neuroleptic Malignant Professional Sinemet C Intervention to Syndrome Other Vioxx C Prevent Permanent Zoloft C Impairment/Damage Requip C Synthroid C Catapres C Date:06/08/01ISR Number: 3737562-3Report Type:Expedited (15-DaCompany Report #US_010666894 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Quetiapine PS 300 MG/DAY Initial or Prolonged Agitation Health Condition Aggravated Professional Drug Ineffective Hallucination, Auditory Psychotic Disorder Date:06/08/01ISR Number: 3738881-7Report Type:Expedited (15-DaCompany Report #US_010666827 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Quetiapine PS 300 MG/DAY Initial or Prolonged Coma Health Irritability Professional Ketonuria Lethargy Nervousness Overdose Schizophrenia Sedation White Blood Cell Count Increased Date:06/11/01ISR Number: 3738127-XReport Type:Expedited (15-DaCompany Report #2001UW02391 Age:75 YR Gender: I/FU:F Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:31 AM Page: 255 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 Salivary Hypersecretion Health Seroquel PS Astrazeneca Lp ORAL 50 MG BID PO Sepsis Professional Cogentin C Urinary Tract Infection Date:06/12/01ISR Number: 3738482-0Report Type:Expedited (15-DaCompany Report #A109961 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon PS Pfizer Central Initial or Prolonged Blood Creatine Professional Research Phosphokinase Increased Lithium SS 1200.00 MG Coordination Abnormal TOTAL: Dystonia Seroquel Extrapyramidal Disorder (Quetiapine) SS 200.00 MG Hyperhidrosis TOTAL Hypomania Propranolol SS 60.00 MG Muscle Rigidity Paxil (Paroxetine) C Muscle Spasms Nortriptyline C Neuroleptic Malignant Syndrome Psychomotor Hyperactivity Pyrexia Restlessness Sleep Talking Tongue Disorder Urinary Incontinence Date:06/12/01ISR Number: 3738486-8Report Type:Expedited (15-DaCompany Report #2001UW06262 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Seroquel PS Astrazeneca Lp ORAL 300 MG DAILY Initial or Prolonged Nystagmus Health PO Required Professional Seroquel "Zeneca" SS ORAL 200 MG DAILY Intervention to Other PO Prevent Permanent Tegretol C Impairment/Damage Senokot C Lamotrigine C Ventolin C Colace C Date:06/12/01ISR Number: 3738767-8Report Type:Expedited (15-DaCompany Report #2001AP02661 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Seroquel PS Astrazeneca Lp ORAL 550 MG DAILY Initial or Prolonged Drug Interaction Health PO Disability Murder Professional Chloroquine SS ORAL 300 MG DAILY Required Other PO Intervention to Priadel SS ORAL 1200 MG DAILY Prevent Permanent PO Impairment/Damage 22-Feb-2006 08:31 AM Page: 256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/01ISR Number: 3739004-0Report Type:Expedited (15-DaCompany Report #2001UW06222 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Syncope Consumer Seroquel PS Astrazeneca Lp ORAL 25 MG DAILY Intervention to PO Prevent Permanent Impairment/Damage Date:06/13/01ISR Number: 3739085-4Report Type:Expedited (15-DaCompany Report #2001AP02216 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel PS Astrazeneca Lp ORAL 75 MG DAILY Cardiac Failure Health PO Sudden Death Professional Seroquel "Zeneca" SS ORAL 150 MG DAILY Other PO Slow-Fe C Risumic C Hirnamin C Vegetamin A C Silece C Pyrethia C Akineton C Prolmon C Daiace C Serenace C Lodopin C Date:06/13/01ISR Number: 3739895-3Report Type:Direct Company Report #USP 081445 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Serzone 100mg PS Bristol Myers Seroquel 100mg SS Astra-Zeneca Date:06/14/01ISR Number: 3739846-1Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Quetiapine - Intervention to Seroquel 100 Mg Prevent Permanent Zeneca PS Zeneca ORAL 100 MG BID Impairment/Damage ORAL Lithium C Oxazepam C Date:06/15/01ISR Number: 3741274-XReport Type:Expedited (15-DaCompany Report #2001AP02001 Age:68 YR Gender:Female I/FU:F Outcome PT Death Acute Tonsillitis Arrhythmia Blood Glucose Increased Electrocardiogram Qt Prolonged Myocardial Infarction Respiratory Arrest 22-Feb-2006 08:31 AM Page: 257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sudden Death Urinary Incontinence White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Seroquel PS Astrazeneca Lp ORAL 400 MG DAILY Health PO Professional Vegetamin A SS ORAL 3 DAILY PO Other Doral SS ORAL 30 MG DAILY PO Dogmatyl C Solanax C Sedrena C Nivadil C Lochol C Acecol C Sulperazon C Insulin C Date:06/18/01ISR Number: 3740695-9Report Type:Direct Company Report # Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - International Normalised Quetiapine PS Initial or Prolonged Ratio Increased Paroxetine Hcl C Required Quetiapine Fumarate C Intervention to Amiodarone Hcl C Prevent Permanent Levothyroxine Na C Impairment/Damage Lisinopril C Nitroglycerine C Carvedilol C Azithromycin C Nitroglycerin C Date:06/18/01ISR Number: 3741099-5Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Seroquel PS ORAL 50 MG BID PO Ultram SS ORAL 50 MG BID PO 6 MON Depakote C Ambien C Celexa C Zyprexa C Klonopin C Date:06/18/01ISR Number: 3741736-5Report Type:Expedited (15-DaCompany Report #2001UW06627 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Seroquel "Zeneca" PS Astrazeneca Lp Intervention to Neutropenia Clozapil SS Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3741762-6Report Type:Expedited (15-DaCompany Report #2001UW06623 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Consumer Seroquel PS Astrazeneca Lp ORAL 600 MG DAILY Amnesia Other PO Anxiety Disorder Seroqeuel "Zeneca" SS ORAL 300 MG DAILY Bereavement Reaction PO Bronchopneumonia Seroquel "Zeneca" SS ORAL 200 MG DAILY Cardiac Arrest PO Coma Seroquel "Zeneca" SS ORAL 150 MG DAILY Confusional State PO Disturbance In Attention Seroquel "Zeneca" SS Dyspnoea Metabolift SS Extrapyramidal Disorder Congentin C Hyperhidrosis Ativan C Hypotension Haldol C Insomnia Klonopin C Major Depression Ambien C Neuroleptic Malignant Paxil C Syndrome Panic Attack Paranoia Psychomotor Hyperactivity Psychotic Disorder Pyrexia Restlessness Schizophrenia Screaming Social Avoidant Behaviour Urinary Incontinence Date:06/18/01ISR Number: 3741946-7Report Type:Expedited (15-DaCompany Report #2001AP01543 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Foreign Seroquel PS Astrazeneca Lp ORAL 50 MG DAILY Hospitalization - Dyskinesia Health PO Initial or Prolonged Dysphagia Professional Seroquel "Zeneca" SS Zeneca ORAL 75 MG DAILY Required Injury Asphyxiation Other PO Intervention to Tardive Dyskinesia Seroquel "Zeneca" SS Zeneca ORAL 100 MG DAILY Prevent Permanent PO Impairment/Damage Seroquel "Zeneca" SS ORAL 200 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 300 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 400 MG DAILY PO Risperdal SS ORAL 6 MG DAILY PO Risperdal SS ORAL 4 MG DAILY PO Risperdal SS ORAL 3.5 MG DAILY PO Risperdal SS ORAL 3 MG DAILY PO Risperdal SS ORAL 2.5 MG DAILY PO Risperdal SS ORAL 2 MG DAILY PO Risperdal SS ORAL 1 MG DAILY PO Risperdal SS ORAL 0.5 MG DAILY PO Rohypnol C Eurodin C 22-Feb-2006 08:31 AM Page: 259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tasmolin C Date:06/18/01ISR Number: 3741960-1Report Type:Expedited (15-DaCompany Report #2001AP02668 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Disorder Foreign Seroquel PS Astrazeneca Lp ORAL 600 MG DAILY Initial or Prolonged Health PO Disability Professional Lithium Carbonate C Other Date:06/18/01ISR Number: 3743550-3Report Type:Periodic Company Report #LBID00201001555 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Health Lithobid PS Solvay Paranoia Professional Pharmaceuticals ORAL 900 MG DAILY Speech Disorder PO Seroquel (Seroquel) SS ORAL 600 MG DAILY PO Wellbutrin - Slow Release (Amfebutamone Hydrochloride) SS ORAL 150 MG DAILY PO Klonopin (Clonazepam) SS ORAL 2 MG DAILY PO Celebrex (Celecoxib) SS ORAL UNK DAILY PO Date:06/19/01ISR Number: 3742226-6Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Seroquel PS Initial or Prolonged Lethargy Gabapentin SS Other Overdose Date:06/19/01ISR Number: 3742384-3Report Type:Direct Company Report # Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Seroquel Intervention to (Quetiapine) PS Astra Zeneca ORAL 100 MG 2 TID Prevent Permanent PO Impairment/Damage Neurontin C Synthroid C Date:06/19/01ISR Number: 3742783-XReport Type:Expedited (15-DaCompany Report #2001AP02732 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Seroquel PS Astrazeneca Lp ORAL 37 G PO Initial or Prolonged Health Professional Other 22-Feb-2006 08:31 AM Page: 260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/01ISR Number: 3742784-1Report Type:Expedited (15-DaCompany Report #2001AP02857 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Imprisonment Foreign Seroquel PS Astrazeneca Lp Intervention to Murder Other Paxil C Prevent Permanent Evamyl C Impairment/Damage Date:06/19/01ISR Number: 3742785-3Report Type:Expedited (15-DaCompany Report #2001AP02861 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Seroquel PS Astrazeneca Lp ORAL 75 MG DAILY Coma Health PO Sudden Death Professional Seroquel "Zeneca" SS ORAL 150 MG DAILY Other PO Seroquel "Zeneca" SS ORAL 225 MG DAILY PO Serenace C Levotomin C Triphenidon C Adalat C Rohypnol C Tegretol C Anatensol C Date:06/19/01ISR Number: 3742786-5Report Type:Expedited (15-DaCompany Report #2001PK00558 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS Astrazeneca Lp ORAL 50 MG BID PO Neutropenia Health Professional Other Date:06/19/01ISR Number: 3742787-7Report Type:Expedited (15-DaCompany Report #2001SE04434 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grand Mal Convulsion Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG DAILY Intervention to Health PO Prevent Permanent Professional Zyprexa SS 20 MG DAILY Impairment/Damage Other Depakine C Dormicum "Roche" C Akineton C Date:06/19/01ISR Number: 3742788-9Report Type:Expedited (15-DaCompany Report #2001UW06492 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG TID PO Thrombocytopenia Health Acetaminophen C Professional Lasix C Other Zoloft C Combivent C Flovent C Potassium Chloride C 22-Feb-2006 08:31 AM Page: 261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Colace C Senokot C Date:06/19/01ISR Number: 3743217-1Report Type:Expedited (15-DaCompany Report #2001UW01663 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Haematuria Health Seroquel PS Astrazeneca Lp Intervention to Proteinuria Professional Prevent Permanent Renal Haemorrhage Impairment/Damage Date:06/21/01ISR Number: 3743531-XReport Type:Direct Company Report # Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Risperdal Janssen PS Janssen 4 MG BID PO Seroquel SS 200 MG TID PO Ferrous Sulfate C Reg Insulin C Chronulac C Multivitamin C Actos C Haldol C Date:06/21/01ISR Number: 3743533-3Report Type:Direct Company Report # Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS ORAL PO Celexa C Neurontin C Zyprexa C Psyllium C Desyrel C Maalox C Thorazine C Keflex C Date:06/21/01ISR Number: 3743980-XReport Type:Expedited (15-DaCompany Report #2001UW06624 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Study Seroquel PS Astrazeneca Lp Intervention to Distributor Clozaril C Prevent Permanent Impairment/Damage Date:06/21/01ISR Number: 3744880-1Report Type:Expedited (15-DaCompany Report #2001AP02216 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel "Zeneca" PS Astrazeneca Lp ORAL 75 MG DAILY Cardiac Failure Health PO Sudden Infant Death Professional Seroquel "Zeneca" SS ORAL 150 MG DAILY Syndrome Other PO 22-Feb-2006 08:31 AM Page: 262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Slow-Fe C Risumic C Hirnamin C Vegetamin A C Silece C Pyrethia C Akineton C Prolmon C Daiace C Serenace C Lodopin C Daiace C Mikelan C Dai-Kenchu-To C Halomonth C Date:06/21/01ISR Number: 3744883-7Report Type:Expedited (15-DaCompany Report #2001AP02841 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Seroquel "Zeneca" PS Astrazeneca Lp ORAL 225 MG DAILY Initial or Prolonged Health PO Professional Other Date:06/22/01ISR Number: 3745003-5Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bradyphrenia Zyprexa 5 Mg PS ORAL 5MG HS PO Intervention to Drug Withdrawal Syndrome Seroquel SS ORAL 50MG BID PO Prevent Permanent Fatigue Wellbutrin C Impairment/Damage Malaise Serzone C Vertigo Lamictal C Neurontin C Date:06/22/01ISR Number: 3745510-5Report Type:Expedited (15-DaCompany Report #A112695 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon PS Pfizer Central Sudden Death Professional Research Serentil (Mesoridazine) SS Seroquel (Quetiapine) SS Date:06/22/01ISR Number: 3745686-XReport Type:Expedited (15-DaCompany Report #2001UW06931 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Syncope Health Seroquel PS Astrazeneca Lp ORAL 25 MG DAILY Intervention to Professional PO Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/01ISR Number: 3745689-5Report Type:Expedited (15-DaCompany Report #2001UW06550 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS Astrazeneca Lp Intentional Overdose Professional Citalopram C Buspirone C Date:06/22/01ISR Number: 3745706-2Report Type:Expedited (15-DaCompany Report #2001UW06151 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrial Fibrillation Health Seroquel PS Astrazeneca Lp Intervention to Blood Magnesium Decreased Professional Prevent Permanent Electrocardiogram Qt Impairment/Damage Corrected Interval Prolonged Electrocardiogram Qt Prolonged Hypokalaemia Hypotension Hypovolaemia Ventricular Tachycardia Vomiting Date:06/22/01ISR Number: 3745712-8Report Type:Expedited (15-DaCompany Report #2001UW06625 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Other Seroquel PS Astrazeneca Lp Clozaril SS Date:06/25/01ISR Number: 3745783-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Seroquel PS ORAL 25MG TID ORAL Syndrome Seroquel 50 Mg SS ORAL 50 MG HS ORAL Clonopin C Lactulose C Claritin C Valproic Acid Syrup C Dulcolax Supp C Klonopin C Simethicone C Tylenol C Multivitamin C Date:06/25/01ISR Number: 3746664-7Report Type:Expedited (15-DaCompany Report #2001SE04424 Age:72 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fall Other Seroquel PS Astrazeneca Lp ORAL 25 MG BID PO Zyprexa SS 5 MG DAILY Remeron C Stilnox C Hygroton C Tenormin C 22-Feb-2006 08:31 AM Page: 264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/01ISR Number: 3748886-8Report Type:Periodic Company Report #2000SIN0149 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Sinemet PS Dupont Initial or Prolonged Gait Disturbance Professional Pharmaceuticals Co ORAL PO Sedation Other Seroquel (Quetiapine Fumarate) SS 25 MG QHS UNK Date:06/26/01ISR Number: 3747397-3Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Middle Insomnia Quetiapine PS Initial or Prolonged Sedation Date:06/27/01ISR Number: 3748787-5Report Type:Expedited (15-DaCompany Report #2001AP02956 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Lp ORAL 373 MG BID PO Other Clozaril C Sodium Valproate C Minocin C Lansoprazole C Date:06/27/01ISR Number: 3748788-7Report Type:Expedited (15-DaCompany Report #2001SE04627 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Seroquel PS Astrazeneca Lp Initial or Prolonged Condition Aggravated Other Insomnia Schizophrenia Date:06/27/01ISR Number: 3748789-9Report Type:Expedited (15-DaCompany Report #2001AP02001 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Tonsillitis Foreign Seroquel PS Astrazeneca Lp ORAL 400 MG DAILY Required Respiratory Arrest Other PO Intervention to Sudden Death Vegetamin A SS ORAL 3 DAILY PO Prevent Permanent Urinary Incontinence Doral SS ORAL 30 MG DAILY Impairment/Damage White Blood Cell Count PO Increased Dogmatyl C Solanax C Sedrena C Nivadil C Lochol C Acecol C Sulperazon C Insulin C 22-Feb-2006 08:31 AM Page: 265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/01ISR Number: 3749028-5Report Type:Expedited (15-DaCompany Report #2001AP02860 Age:51 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cellulitis Other Seroquel PS Astrazeneca Lp ORAL 750 MG DAILY Intervention to Oedema Peripheral PO Prevent Permanent Rash Maculo-Papular Lithium C Impairment/Damage Thyroxine C Lorazepam C Clozaril C Date:06/27/01ISR Number: 3749033-9Report Type:Expedited (15-DaCompany Report #2001UW06994 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG DAILY Intervention to Nervousness Health PO Prevent Permanent Neuroleptic Malignant Professional Buspirone SS Impairment/Damage Syndrome Other Moclobemide C Restlessness Serotonin Syndrome Tremor Date:06/28/01ISR Number: 3749873-6Report Type:Expedited (15-DaCompany Report #2001UW07140 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Platelet Count Decreased Health Seroquel PS Astrazeneca Lp Intervention to Professional Valproic Acid SS ORAL 1500 MG DAILY Prevent Permanent PO Impairment/Damage Date:06/28/01ISR Number: 3749955-9Report Type:Expedited (15-DaCompany Report #2001SE04696 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dystonia Foreign Seroquel PS Astrazeneca Lp ORAL 300 MG DAILY Mania Health PO Professional Other Date:06/28/01ISR Number: 3749956-0Report Type:Expedited (15-DaCompany Report #2001UW07276 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS Astrazeneca Lp Health Professional Other Date:06/28/01ISR Number: 3750468-9Report Type:Expedited (15-DaCompany Report #2001060018 Age:68 YR Gender:Female I/FU:I Outcome PT Death Acute Tonsillitis Hospitalization - Cardio-Respiratory Arrest Initial or Prolonged Sudden Death 22-Feb-2006 08:31 AM Page: 266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Foreign Doral PS Wallace Laboratories Health Div Carter Wallace Professional Inc ORAL 30 MG/D, PO Quetiapine Fumarate SS 400MG/D Chlorpromazine SS ORAL 3 TABLETS/D PO Temocapril Hcl C Nilvadipine C Alprazolam C Fluvastatin C Insulin C Date:06/29/01ISR Number: 3750652-4Report Type:Expedited (15-DaCompany Report #2000AP05007 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Loss Of Consciousness Foreign Seroquel PS Astrazeneca Lp 600 MG DAILY Hospitalization - Normal Delivery Health Initial or Prolonged Overdose Professional Required Other Intervention to Prevent Permanent Impairment/Damage Date:07/02/01ISR Number: 3750733-5Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Zyprexa PS ORAL 15MG AT HS PO Intervention to Seroquel SS ORAL 300 MG AT HS Prevent Permanent PO Impairment/Damage Date:07/02/01ISR Number: 3750750-5Report Type:Direct Company Report # Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel Label Read Serzone 200mg PS ORAL ORAL Date:07/04/01ISR Number: 3751933-0Report Type:Expedited (15-DaCompany Report #1998UW43680 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Eosinophil Count Health Seroquel PS Astrazeneca Lp ORAL 325 MG QD PO Intervention to Increased Professional Clozapine C Prevent Permanent Neutropenia Psyllium Hydrophilic Impairment/Damage Butylacetate C Bisacodryl C Docusate Sodium C 22-Feb-2006 08:31 AM Page: 267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/04/01ISR Number: 3751934-2Report 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 Astrazeneca Lp ORAL 200 MG BID PO Initial or Prolonged White Blood Cell Count Professional Haldol C Increased Cogentin C Date:07/04/01ISR Number: 3752296-7Report Type:Expedited (15-DaCompany Report #US_010666894 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Quetiapine PS 300 MG/DAY Initial or Prolonged Condition Aggravated Health Drug Ineffective Professional Hallucination, Auditory Psychotic Disorder Date:07/05/01ISR Number: 3753244-6Report Type:Expedited (15-DaCompany Report #2001AP03025 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Literature Seroquel PS Astrazeneca Lp ORAL 2000 MG DAILY Intervention to Drug Level Above Health PO Prevent Permanent Therapeutic Professional Risperidone SS Impairment/Damage Electrocardiogram Qt Clonazepam SS Corrected Interval Risperidone C Prolonged Venlafaxine C Electrocardiogram Qt Topiramate C Prolonged Overdose Sedation Date:07/05/01ISR Number: 3753618-3Report Type:Expedited (15-DaCompany Report #2000AP05540 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Oculogyration Foreign Seroquel PS Astrazeneca Lp ORAL 150 MG BID PO Intervention to Health Droperidol C Prevent Permanent Professional Lorazepam C Impairment/Damage Other Date:07/05/01ISR Number: 3753619-5Report Type:Expedited (15-DaCompany Report #2001SE04434 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grand Mal Convulsion Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG DAILY Intervention to Health PO Prevent Permanent Professional Zyprexa SS 20 MG DAILY Impairment/Damage Other Depakine C Dormicin "Roche" C Akineton C 22-Feb-2006 08:31 AM Page: 268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/01ISR Number: 3753621-3Report Type:Expedited (15-DaCompany Report #2001SE04424 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fall Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG BID PO Intervention to Health Zyprexa SS 5 MG DAILY Prevent Permanent Professional Remeron C Impairment/Damage Other Stilnox C Hygroton C Tenormin C Date:07/05/01ISR Number: 3753623-7Report Type:Expedited (15-DaCompany Report #2001SE02878 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel PS Astrazeneca Lp Initial or Prolonged Pyrexia Health Atarax C Professional Risolid C Other Ferrum C Harmonet C Date:07/05/01ISR Number: 3753624-9Report Type:Expedited (15-DaCompany Report #2001SE04627 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS Astrazeneca Lp Initial or Prolonged Condition Aggravated Health Delusion Of Reference Professional Insomnia Other Persecutory Delusion Date:07/06/01ISR Number: 3753570-0Report Type:Direct Company Report # Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Seroquel 300 Mg Bid Hospitalization - Cataract Po PS ORAL 300 MG BID PO 14 MON Initial or Prolonged Diabetes Mellitus Neurontin 300mg Qid Required Difficulty In Walking Po SS ORAL 300MG QID PO 16 MON Intervention to Faecal Incontinence Prevent Permanent Hypertension Impairment/Damage Obesity Urinary Incontinence Weight Increased Date:07/06/01ISR Number: 3753911-4Report Type:Expedited (15-DaCompany Report #2001UW07387 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abnormal Behaviour Consumer Seroquel PS Astrazeneca Lp ORAL 100 MG DAILY Aggression PO Alcohol Poisoning Seroquel "Zeneca" SS ORAL 275 MG DAILY Amnesia PO Disorientation Seroquel "Zeneca" SS ORAL 50 MG DAILY Feeling Abnormal PO Hallucination Methadone C Psychomotor Hyperactivity Theft 22-Feb-2006 08:31 AM Page: 269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/01ISR Number: 3753914-XReport Type:Expedited (15-DaCompany Report #2001UW07526 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Health Seroquel PS Astrazeneca Lp ORAL 100 MG BID PO Initial or Prolonged Professional Risperdal C Celexa C Amantadine C Verapamil C Date:07/06/01ISR Number: 3754349-6Report Type:Expedited (15-DaCompany Report #2001SE05078 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS Astrazeneca Lp ORAL 400 MG DAILY Intervention to Health PO Prevent Permanent Professional Fluoxetine C Impairment/Damage Other Date:07/09/01ISR Number: 3754892-XReport Type:Expedited (15-DaCompany Report #2001UW02243 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Seroquel PS Astrazeneca Lp ORAL 500 MG DAILY; Initial or Prolonged Condition Aggravated Professional PO Crying Paxil C Loss Of Consciousness Psychotic Disorder Syncope Date:07/10/01ISR Number: 3756279-2Report Type:Expedited (15-DaCompany Report #2001AP02861 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel PS Astrazeneca Lp ORAL SEE IMAGE Life-Threatening Hypotension Health Serenace C Loss Of Consciousness Professional Levotomin C Pallor Other Triphedinon C Polydipsia Adalat C Tachycardia Rohypnol C Ventricular Extrasystoles Tegretol C Anatensol C Pantosin C Marzulene C Cystanin C Daiokanzoto C Alesion C Laxoberon C Cysvon C Alosenn C Sunailin C Sennoside C 22-Feb-2006 08:31 AM Page: 270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/01ISR Number: 3756292-5Report Type:Expedited (15-DaCompany Report #A108646 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Geodon PS Pfizer Central Initial or Prolonged Drug Ineffective Health Research ORAL PO Mania Professional Seroquel SS ORAL 300.00 MG Medication Error TOTAL:DAILY:O Schizophrenia RAL Neurontin (Gabapentin) SS 3600.00 MG TOTAL:TID Beer SS ORAL ORAL Depakote C Clonazepam C Date:07/10/01ISR Number: 3756580-2Report Type:Expedited (15-DaCompany Report #2001AP03104 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Overdose Foreign Seroquel PS Astrazeneca Lp ORAL 150 MG BID PO Intervention to Peripheral Embolism Health Fluoxetine C Prevent Permanent Professional Impairment/Damage Other Date:07/10/01ISR Number: 3756948-4Report Type:Expedited (15-DaCompany Report #2001UW07739 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gastrointestinal Health Seroquel PS Astrazeneca Lp ORAL 800 MG DAILY Intervention to Haemorrhage Professional PO Prevent Permanent Impairment/Damage Date:07/11/01ISR Number: 3756547-4Report Type:Expedited (15-DaCompany Report #2001UW04767 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleural Effusion Health Seroquel PS Astrazeneca Lp ORAL 150MG QD PO Initial or Prolonged Scar Professional Seroquel "Zeneca" SS ORAL 150MG QD PO Clonidine C Prednisone C Lortab C Xanax C Paxil C Depakote C Pulmicort C Albuterol C Atrovent C Combivent C Date:07/11/01ISR Number: 3756760-6Report Type:Expedited (15-DaCompany Report #2001AP03274 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Other Neutropenia Foreign Literature Health 22-Feb-2006 08:31 AM Page: 271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Seroquel PS Astrazeneca Lp 200 MG BID 1 WK Quetiapine SS 250 MG BID 4 WK Clozapine SS 1 YR Date:07/11/01ISR Number: 3756761-8Report Type:Expedited (15-DaCompany Report #2001AP03205 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Lp Health Professional Other Date:07/12/01ISR Number: 3757080-6Report Type:Direct Company Report # Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bruxism Quetiapine Dyskinesia (Seroquel, Astra Zeneca) PS Astrazeneca ORAL 25 MG PO TID Adderall C Olanzapine C Date:07/16/01ISR Number: 3759468-6Report Type:Expedited (15-DaCompany Report #2001PK00582 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Seroquel PS Astrazeneca Lp ORAL 100 MG DAILY Leukopenia Health PO Neutropenia Professional Tagonis C Other Date:07/16/01ISR Number: 3759899-4Report Type:Expedited (15-DaCompany Report #2001UW08039 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Health Seroquel PS Astrazeneca Lp Intervention to Decreased Professional Prevent Permanent Impairment/Damage Date:07/17/01ISR Number: 3760348-0Report Type:Expedited (15-DaCompany Report #2001UW07926 Age:25 YR Gender:Male I/FU:I Outcome PT Required Aggression Intervention to Anxiety Prevent Permanent Delusion Of Reference Impairment/Damage Depressed Mood Hallucination, Auditory Imprisonment Murder Persecutory Delusion 22-Feb-2006 08:31 AM Page: 272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicidal Ideation Suspiciousness Theft Report Source Product Role Manufacturer Route Dose Duration Study Seroquel PS Astrazeneca Lp ORAL 300 MG DAILY Health PO Professional Dalmane C Seroquel "Zeneca" C Date:07/18/01ISR Number: 3760966-XReport Type:Expedited (15-DaCompany Report #2001UW07276 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS Astrazeneca Lp Health Multiple Drugs C Professional Other Date:07/18/01ISR Number: 3760987-7Report Type:Expedited (15-DaCompany Report #2001AP03419 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Foreign Seroquel PS Astrazeneca Lp ORAL 100 MG DAILY White Blood Cell Count Health PO Decreased Professional Impromen C Other Contomin C Pentona C Hirnamin C Doral C Halcion C Mucosta C Mucosolvan C Date:07/18/01ISR Number: 3761041-0Report Type:Expedited (15-DaCompany Report #2001SE05305 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS Astrazeneca Lp ORAL 400 MG BID PO Intervention to Health Tranxene C Prevent Permanent Professional Dalmadorm C Impairment/Damage Other Date:07/18/01ISR Number: 3761365-7Report Type:Expedited (15-DaCompany Report #2001UW08005 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Consumer Seroquel PS Astrazeneca Lp ORAL 175 MG DAILY Completed Suicide PO Overdose Lithium C Weight Increased Depakote C Lasix C 22-Feb-2006 08:31 AM Page: 273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/01ISR Number: 3761367-0Report Type:Expedited (15-DaCompany Report #2001UW07926 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Study Seroquel PS Astrazeneca Lp ORAL 300 MG DAILY Intervention to Drug Abuser Health PO Prevent Permanent Insomnia Professional Dalmane C Impairment/Damage Murder Seroquel C Nightmare Pressure Of Speech Psychotic Disorder Date:07/18/01ISR Number: 3761371-2Report Type:Expedited (15-DaCompany Report #2001UW05633 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Seroquel PS Astrazeneca Lp ORAL 700 MG DAILY Initial or Prolonged Fatigue PO Feeling Abnormal Seroquel "Zeneca" SS ORAL 100 MG BID Hypomania PO Lethargy Seroquel "Zeneca" SS ORAL 600 MG DAILY Platelet Count Decreased PO Sedation Risperdal C Sleep Disorder Depakote C Stress Neurontin C Prevacid C Tapazole C Lasix C Rhinocort Aqua C Zoloft C Date:07/19/01ISR Number: 3760976-2Report Type:Direct Company Report # Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Geodon-Use? PS GEODON 20 Hallucination, Tactile INCREASED TO Obsessive-Compulsive 80 Disorder Seroquel Withdrawal SS SEROQUEL 800 DECREASED 0 Klonopin C Prozac C Wellbutrin Sr C Topamax C Date:07/19/01ISR Number: 3761117-8Report Type:Direct Company Report # Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Valproic Acid 250mg Hospitalization - Scherer PS Scherer ORAL 250MG QAM Initial or Prolonged 500MG QHS ORAL Quetiapine 100mg Astra Zeneca SS Astra Zeneca ORAL 100MG BID ORAL Quetiapine C Concerta C 22-Feb-2006 08:31 AM Page: 274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/01ISR Number: 3762216-7Report Type:Expedited (15-DaCompany Report #2001PK00582 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Seroquel PS Astrazeneca Lp ORAL 100 MG DAILY Neutropenia Health PO White Blood Cell Count Professional Tagonis C Decreased Other Date:07/19/01ISR Number: 3762288-XReport Type:Expedited (15-DaCompany Report #2001AP03410 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Lp ORAL 400 MG DAILY Platelet Count Decreased Health PO White Blood Cell Count Professional Cercine C Decreased Other Levotomin C Benzalin C Date:07/23/01ISR Number: 3762591-3Report Type:Direct Company Report #USP 54170 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel PS Astra Zeneca Serzone SS Bristol-Myers Squibb Date:07/23/01ISR Number: 3764076-7Report Type:Expedited (15-DaCompany Report #2001AP02861 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel PS Astrazeneca Lp ORAL 75 MG DAILY Life-Threatening Cyanosis Health PO Hypotension Professional Seroquel "Zeneca" SS ORAL 150 MG DAILY Pallor Other PO Polydipsia Seroquel "Zeneca" SS ORAL 225 MG DAILY Tachycardia PO Ventricular Extrasystoles Alesion SS ORAL 20 MG DAILY PO Levotomin SS Adalat SS ORAL 20 MG DAILY PO Tegretol SS ORAL 200 MG DAILY PO Cysvon SS ORAL 10 MG DAILY PO Rohypnol SS ORAL 2 MG DAILY PO Serenace SS ORAL 9 MG DAILY PO Serenace SS ORAL 6 MG DAILY PO Serenace SS ORAL 3 MG DAILY PO Cystantin C Daiokanzoto C Laxoberon C Alosenn C Sunailin C Sennoside C Marzulene S C Triphedinon C Anatensol C Pantosin C 22-Feb-2006 08:31 AM Page: 275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/01ISR Number: 3764242-0Report Type:Expedited (15-DaCompany Report #2001AP03509 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Seroquel PS Astrazeneca Lp ORAL 50 MG DAILY Initial or Prolonged Condition Aggravated Health PO Drug Interaction Professional Quetiapine SS ORAL 75 MG DAILY Dyskinesia PO Dystonia Propranolol SS ORAL 10 MG BID PO Hallucination Levodopa-Carbiidopa C Heart Rate Decreased Hydrochlorothiazide/ Hypotension Triamterene C Jaw Disorder Date:07/24/01ISR Number: 3764276-6Report Type:Expedited (15-DaCompany Report #2001UW08306 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Health Seroquel PS Astrazeneca Lp ORAL 500 MG DAILY Intervention to Decreased Professional PO Prevent Permanent Risperdal C Impairment/Damage Date:07/24/01ISR Number: 3764277-8Report Type:Expedited (15-DaCompany Report #2001UW06435 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Seroquel PS Astrazeneca Lp ORAL 150 MG DAILY Initial or Prolonged Mania PO Speech Disorder Rsiperdal C Tardive Dyskinesia Lithium C Therapeutic Agent Depakote C Toxicity Date:07/26/01ISR Number: 3765462-1Report Type:Direct Company Report #USP 54186 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Serzone 100mg PS Bristol-Myers Squibb Seroquel 100mg SS Astra Zeneca Date:07/26/01ISR Number: 3766250-2Report Type:Expedited (15-DaCompany Report #2001AP02034 Age:57 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Glucose Increased Initial or Prolonged Convulsion Disability Cystitis Decubitus Ulcer Dehydration Delusion Hallucination Muscle Rigidity Neuroleptic Malignant Syndrome Oral Intake Reduced Pneumonia Sedation 22-Feb-2006 08:31 AM Page: 276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS Astrazeneca Lp ORAL 75 MG DAILY Health PO Professional Seroquel SS ORAL 150 MG DAILY Other PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 600 MG DAILY PO Serenace SS ORAL 45 MG DAILY PO Serenace SS 40.5 MG DAILY Serenace SS ORAL 36 MG DAILY PO Serenace SS ORAL 31.5 MG DAILY PO Serenace SS ORAL 27 MG DAILY PO Halomonth SS INTRAMUSCULAR 100 MG DAILY IM Levotomin SS 50 MG DAILY Artane C Solanax C Benzalin C Sennasid C Pantosin C Minzain C Date:07/27/01ISR Number: 3766712-8Report Type:Expedited (15-DaCompany Report #2001PK00711 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS Astrazeneca Lp ORAL 200 MG BID PO Thrombocytopenia Health Gladem C Professional Other Date:07/30/01ISR Number: 3768242-6Report Type:Expedited (15-DaCompany Report #2001UW01663 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Haematuria Health Seroquel "Zeneca" PS Astrazeneca Lp Intervention to Proteinuria Professional Neurontin C Prevent Permanent Renal Haemorrhage Depakote C Impairment/Damage Date:07/30/01ISR Number: 3768352-3Report Type:Expedited (15-DaCompany Report #2001PK00582 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Seroquel PS Astrazeneca Lp ORAL 100 MG DAILY Neutropenia Health PO White Blood Cell Count Professional Tagonis C Decreased Other 22-Feb-2006 08:31 AM Page: 277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/01ISR Number: 3768944-1Report Type:Expedited (15-DaCompany Report #2001AP03419 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS Astrazeneca Lp ORAL 100 MG DAILY Heart Rate Increased Health PO Pyrexia Professional Tienam SS 500 MG DAILY Other Tienam SS 1 G DAILY Tienam SS 500 MG DAILY Impromen C Contomin C Pentona C Hirnamin C Doral C Halcion C Mucosta C Mucosolvan C Date:07/30/01ISR Number: 3768945-3Report Type:Expedited (15-DaCompany Report #2001UW06994 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG DAILY Intervention to Nervousness Health PO Prevent Permanent Restlessness Professional Buspirone SS Impairment/Damage Tremor Other Moclobemide C Date:07/31/01ISR Number: 3767725-2Report Type:Expedited (15-DaCompany Report #A117270 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Zoloft PS Pfizer Drug Interaction Pharmaceuticals Inc ORAL ORAL Grand Mal Convulsion Diazepam SS Imprisonment Seroquel Injury (Quetiapine) SS Insomnia Oxycodone Medication Error Hydrochloride SS Physical Assault Date:07/31/01ISR Number: 3768618-7Report Type:Expedited (15-DaCompany Report #2001UW07276 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS Astrazeneca Lp ORAL 600 MG DAILY Chest Pain Health PO Myocardial Infarction Professional Risperdal SS ORAL 1 MG DAILY PO Pulmonary Embolism Other Effexor SS ORAL 225 MG DAILY PO Birth Control Pills C Date:07/31/01ISR Number: 3777716-3Report Type:Periodic Company Report #2001056168US Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Health Celebrex PS Gd Searle And Co ORAL ORAL Paranoia Professional Lithobid (Lithium Speech Disorder Carbonate) SS ORAL 900 MG, QD, 22-Feb-2006 08:31 AM Page: 278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Seroquel (Quetiapine) SS ORAL 600 MG, QD, ORAL Klonopin (Clonazepam) SS ORAL 2 MG, QD, ORAL Wellbutrin-Slow Release (Amfebutamone Hydrochloride) SS ORAL 150 MG, QD, ORAL Date:08/01/01ISR Number: 3769190-8Report Type:Expedited (15-DaCompany Report #2001UW06492 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ecchymosis Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG TID PO Leukopenia Health Acetaminophen C Thrombocytopenia Professional Lasix C White Blood Cell Count Other Zoloft C Decreased Combivent C Flovent C Potassium Chloride C Colace C Senokot C Hydrocortisone C Capoten C Selenium C Date:08/02/01ISR Number: 3770162-8Report Type:Expedited (15-DaCompany Report #A109961 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ecchymosis Health Geodon PS Pfizer Central Initial or Prolonged Fall Professional Research ORAL 40.00 Neuroleptic Malignant TOTAL:ORAL Syndrome Lithium SS 1200.00 MG TOTAL Seroquel (Quetiapine) SS 200.00 MG TOTAL Propranolol SS 60.00 MG TOTAL Paxil (Paroxetine) C Nortriptyline C Date:08/03/01ISR Number: 3771007-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02128 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Tegretol PS Novartis Initial or Prolonged Prolonged Health Pharmaceuticals Corp UNKNOWN 200 MG TID Overdose Professional UNKNOWN; 42 Other TABLETS/OVERD OSE Quetiapine (Quetiapine) SS UNKNOWN 200 MG TID UNKNOWN; 40 22-Feb-2006 08:31 AM Page: 279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TABLETS/OVERD OSE Venlafaxine (Venlafaxine) SS UNKNOWN 225 MG MANE UNKNOWN; 38 TABLETS/OVERD OSE Date:08/03/01ISR Number: 3771070-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100907 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Consumer Neurontin PS Pfizer Inc ORAL 1500 MG Initial or Prolonged Diarrhoea (QID), PER Drug Interaction ORAL Gastrointestinal Disorder Effexor (Venlafaxine Irritability Hydrochloride) SS Malaise Seroquel Nausea (Quetiapine) SS Pain Depakote (Valproate Semisodium) SS Date:08/03/01ISR Number: 3771176-4Report Type:Expedited (15-DaCompany Report #2001AP03410 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Lp ORAL 400 MG DAILY Platelet Count Decreased Health PO Professional Cercine C Other Levotomin C Benzalin C Serenace C Zotepine C Date:08/06/01ISR Number: 3771981-4Report Type:Expedited (15-DaCompany Report #2001UW09079 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Health Seroquel PS Astrazeneca Lp ORAL 100 MG TID PO 3 DAY Hospitalization - Pyrexia Professional Serzone C Initial or Prolonged Respiratory Arrest Antipsychotics C Depakote C Cogentin C Atrovent C Dilaudid C Clozaril C Date:08/07/01ISR Number: 3772189-9Report Type:Expedited (15-DaCompany Report #2001SE05711 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Thrombocytopenia Foreign Seroquel PS Astrazeneca 300 MG DAILY Intervention to Health Metoprolol Tartarate SS Astrazeneca Lp 100 MG DAILY Prevent Permanent Professional Valproate SS 2500 MG DAILY Impairment/Damage Other Tranxene C Tranylcypromne C 22-Feb-2006 08:31 AM Page: 280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/01ISR Number: 3772800-2Report Type:Expedited (15-DaCompany Report #2001AP03509 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Seroquel PS Astrazeneca Lp ORAL 50 MG DAILY Initial or Prolonged Bradycardia Health PO Drug Interaction Professional Quetiapine SS ORAL 75 MG DAILY Dyskinesia PO Dystonia Propranolol SS ORAL 10 MG BID PO Hallucination Levodopa-Carbidopa C Hypotension Hydrochlorothiazide/ Triamterene C Date:08/08/01ISR Number: 3773010-5Report Type:Expedited (15-DaCompany Report #2001SE05078 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS Astrazeneca Lp ORAL 400 MG DAILY Intervention to Health PO Prevent Permanent Professional Fluoxetine C Impairment/Damage Other Date:08/08/01ISR Number: 3773458-9Report Type:Expedited (15-DaCompany Report #2001UW09321 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Astrazeneca Lp ORAL 125 MG DAILY Professional PO Levothyroxine C Pepcid C Celebrex C Tylenol C Calcium C Colace C Date:08/08/01ISR Number: 3777694-7Report Type:Periodic Company Report #RS001816-USA Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastric Polyps Consumer Aciphex PS Eisai Inc ORAL 20 MG, PER Vomiting ORAL Seroquel (Quetiapine) SS ORAL PER ORAL Luvox (Fluvoxamine Maleate) C Entex (Entex) C Librax (Librax) C Zyrtec (Cetirizine Hydrochloride) C Date:08/09/01ISR Number: 3774105-2Report Type:Expedited (15-DaCompany Report #2001PK00765 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Leukopenia Foreign Initial or Prolonged Thrombocytopenia Study Health Professional 22-Feb-2006 08:31 AM Page: 281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel "Zeneca" PS Astrazeneca Lp ORAL 800 MG DAILY PO Tavor C Glianimon C Date:08/09/01ISR Number: 3774882-0Report Type:Expedited (15-DaCompany Report #A118670 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Vistaril PS Pfizer Laboratories Initial or Prolonged Fall Div Pfizer Inc 300.00 MG Required Fracture TOTAL:TID Intervention to Loss Of Consciousness Depakote SS Prevent Permanent Seroquel SS Impairment/Damage Buspar SS Prozac C Revia C Albuterol Inhaler C Flovent Inhaler C Date:08/13/01ISR Number: 3775885-2Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Quetiapine (25mg Intervention to Tremor Tab)(Astra/Zeneca) PS Astra/Zeneca ORAL 25 PO BID Prevent Permanent Impairment/Damage Date:08/14/01ISR Number: 3777340-2Report Type:Expedited (15-DaCompany Report #2001AP02861 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel PS Astrazeneca Lp ORAL 75 MG DAILY Life-Threatening Hypotension Health PO Polydipsia Professional Seroquel "Zeneca" SS Zeneca ORAL 150 MG DAILY Sudden Death Other PO Tachycardia Alesion SS ORAL 20 MG DAILY Ventricular Extrasystoles PO Seroquel "Zeneca" SS Zeneca ORAL 225 MG DAILY PO Levotomin SS Tegretol SS ORAL 200 MG DAILY PO Rohypnol SS ORAL 2 MG DAILY PO Serenace SS ORAL 6 MG DAILY PO Serenace SS ORAL 3 MG DAILY PO Serenace SS ORAL 9 MG DAILY PO Cysvon SS ORAL 10 MG DAILY PO Adalat SS ORAL 20 MG DAILY PO Triphedinon C Daiokanzoto C Alosenn C 22-Feb-2006 08:31 AM Page: 282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sennoside C Sunailin C Laxoberon C Cystanin C Anatensol C Marzulene C Pantosin C Date:08/14/01ISR Number: 3777360-8Report Type:Expedited (15-DaCompany Report #2001UW09272 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Headache Foreign Seroquel PS Astrazeneca Lp ORAL 25 MG DAILY Insomnia Health PO Paraesthesia Professional Seroquel "Zeneca" SS Zeneca ORAL 25 MG DAILY Serotonin Syndrome Other PO Vision Blurred Sertraline SS ORAL 100 MG PO Vitamin B12 Abnormal Lithium SS 900 MG HS Valproic Acid C Date:08/14/01ISR Number: 3777362-1Report Type:Expedited (15-DaCompany Report #2001AP02732 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Foreign Seroquel PS Astrazeneca Lp ORAL 37 G PO Hospitalization - Health Carbamazepine SS Initial or Prolonged Professional Procyclidine C Other Co-Proxamol C Date:08/14/01ISR Number: 3777364-5Report Type:Expedited (15-DaCompany Report #2001SE05968 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS Astrazeneca Lp ORAL 400 MG BID PO Intervention to Health Sodium Valproate C Prevent Permanent Professional Zuclopenthixol C Impairment/Damage Other Date:08/14/01ISR Number: 3777452-3Report Type:Expedited (15-DaCompany Report #2001UW01554 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Health Seroquel PS Astrazeneca Lp ORAL 400 MG DAILY Intervention to Disorientation Professional PO Prevent Permanent Headache Seroquel "Zeneca" SS ORAL 400 MG BID PO Impairment/Damage Loss Of Consciousness Seroquel "Zeneca" SS ORAL 500 MG BID PO Nausea Seroquel "Zeneca" SS ORAL 900 MG DAILY Stupor PO Syncope Urinary Retention 22-Feb-2006 08:31 AM Page: 283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/01ISR Number: 3777514-0Report Type:Expedited (15-DaCompany Report #2001UW09206 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel PS Astrazeneca Lp ORAL 900 MG DAILY Initial or Prolonged Health PO Professional Olanzapine C Date:08/15/01ISR Number: 3777408-0Report Type:Direct Company Report # Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram T Wave Quetiapine Fumarate PS SEE IMAGE Inversion Azithromycin C Aspirin C Enoxaparin C Furosemide C Lorazepam C Losartan C Kcl C Ntg C Morphine C Valsartan C Atrovent C Docusate C Divalproex C Albuterol C Acetaminophen C Date:08/16/01ISR Number: 3778370-7Report Type:Expedited (15-DaCompany Report #B0117185A Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Salbutamol PS Glaxo Wellcome RESPIRATORY (INHALATION) Depixol SS UNKNOWN 60MG Weekly Quetiapine SS ORAL 225MG per day Sandocal SS UNKNOWN 400MG Three times per day Ramipril SS UNKNOWN 1.25MG In the morning Alfacalcidol SS UNKNOWN 1MCG Per day Diazepam SS UNKNOWN 5MG Three times per day Procyclidine SS Glaxo Wellcome UNKNOWN 5MG Three times per day Date:08/16/01ISR Number: 3778817-6Report Type:Expedited (15-DaCompany Report #2001UWO9558 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Syncope Health Seroquel PS Astrazeneca Lp ORAL 300 MG DAILY Intervention to Professional PO Prevent Permanent Zyprexa C Impairment/Damage 22-Feb-2006 08:31 AM Page: 284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/01ISR Number: 3778917-0Report Type:Direct Company Report # Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Quetiapine PS 600 MG Initial or Prolonged Agitation Haldol SS 12 MG Condition Aggravated Irritability Date:08/17/01ISR Number: 3780105-9Report Type:Expedited (15-DaCompany Report #2001SE05987 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Seroquel PS Astrazeneca Lp ORAL 100 MG DAILY Condition Aggravated Health PO Delusion Of Grandeur Professional Seroquel SS ORAL 150 MG DAILY Mood Altered Other PO Myocardial Infarction Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Lithium C Clonazepam C Chloropromazine C Valproic Acid C Date:08/17/01ISR Number: 3780106-0Report Type:Expedited (15-DaCompany Report #2001AP02661 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Seroquel PS Astrazeneca Lp ORAL 550 MG DAILY Initial or Prolonged Drug Interaction Health PO Disability Murder Professional Chloroquine SS ORAL 300 MG DAILY Required Other PO Intervention to Priadel SS ORAL 1200 MG DAILY Prevent Permanent PO Impairment/Damage Date:08/17/01ISR Number: 3780134-5Report Type:Expedited (15-DaCompany Report #2001AP03845 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Seroquel PS Astrazeneca Lp ORAL 100 MG BID PO Neutropenia Health Sinemet-Plus C Professional Domperidone C Other Date:08/17/01ISR Number: 3780135-7Report Type:Expedited (15-DaCompany Report #2001AP03852 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Seroquel PS Astrazeneca Lp Health Professional Other 22-Feb-2006 08:31 AM Page: 285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/01ISR Number: 3780525-2Report Type:Expedited (15-DaCompany Report #B0117185A Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Ventolin PS Glaxo Wellcome Inc RESPIRATORY (INHALATION) INHALED Flupenthixol Hcl SS 60 MG / WEEKLY Quetiapine Tablet SS ORAL TWICE PER DAY / ORAL Sandocal SS 400 MG / THREE TIMES PER DAY Ramipril SS 1.25 MG / IN THE MORNING Alfacalcidol SS 1 MCG / PER DAY Diazepam SS 5 MG / THREE TIMES PER DAY Kemadrin (Procyclidine Hcl) SS 5 MG / THREE TIMES PER DAY Date:08/20/01ISR Number: 3780616-6Report Type:Expedited (15-DaCompany Report #2001UW09854 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Consumer Seroquel PS Astrazeneca Lp ORAL 600 MG DAILY Initial or Prolonged Hallucination, Auditory PO ; 800 MG Hypoaesthesia DAILY PO 1 YR Insomnia Lasix C Syncope Insulin C Coumadine C Celexa C Date:08/22/01ISR Number: 3782022-7Report Type:Expedited (15-DaCompany Report #2001-08-1173 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Salbulin Hfa Health (Salbutamol); Oral Professional Aerosol (Like Other Proventil Hfa) PS ORAL ORAL AER INH Depixol Injectable SS INTRAMUSCULAR 60 MG QWEEK INTRASMUSCULA R Ramipril Capsules SS ORAL 1.25 MG QAM ORAL Alfacalcidol Tablets SS ORAL 1 .25 MCG QD ORAL Diazepam Tabletes SS ORAL 5MG TID ORAL Procyclidine Tablets SS ORAL 5MG TID ORAL Quetiapine Fumurate SS 225MG QD Sandocal Tablets SS ORAL MG TID ORAL 22-Feb-2006 08:31 AM Page: 286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/22/01ISR Number: 3782265-2Report Type:Expedited (15-DaCompany Report #2001UW10044 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Arrest Health Seroquel "Zeneca" PS ORAL 200 MG BID PO Initial or Prolonged Respiratory Depression Professional Clozaril C Sedation Date:08/23/01ISR Number: 3782454-7Report Type:Expedited (15-DaCompany Report #2001UW10069 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Injury Health Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG BID PO Intervention to Orthostatic Hypotension Professional Seroquel "Zeneca" SS "Zeneca" ORAL 300 MG DAILY Prevent Permanent Syncope PO Impairment/Damage Therapeutic Response Seroquel "Zeneca" SS "Zeneca" ORAL 150 MG DAILY Decreased PO Clonazepam C Ritalin C Wellbutrin C Serzone C Date:08/23/01ISR Number: 3782460-2Report Type:Expedited (15-DaCompany Report #2001UW05683 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Health Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG BID PO Intervention to Leukopenia Professional Seroquel "Zeneca" SS "Zeneca" 400 MG HS Prevent Permanent Schizophrenia Seroquel "Zeneca" SS "Zeneca" ORAL 500 MG HS PO Impairment/Damage Weight Increased Clozaril SS 300 MG DAILY Zyprexa C Iron Supplement C Klonopin C Date:08/24/01ISR Number: 3782502-4Report Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Seroquel PS ORAL 800 MG QD ORAL Date:08/27/01ISR Number: 3782968-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperhidrosis Reserpine 0.1mg PS ORAL 0.1MG Initial or Prolonged Movement Disorder Quetiapine 100mg SS 2.5 TABS PO Nausea QD Pain Ibuprofen C Tardive Dyskinesia Clonazepam C Vomiting Oxycodone/Apap C Trazodone C 22-Feb-2006 08:31 AM Page: 287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/01ISR Number: 3784777-4Report Type:Periodic Company Report #S01-USA-01282-01 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Celexa (Citalopram Hydrobromide) PS ORAL 20 MG QD PO Remeron (Mitrazapine) SS ORAL 7.5 MG QHS PO Seroquel SS ORAL 25 MG QHS PO Date:08/29/01ISR Number: 3785054-8Report Type:Expedited (15-DaCompany Report #2000UW02762 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Seroquel "Zeneca" PS Zeneca ORAL 200 MG TID PO Hospitalization - Agitation Professional Parnate C Initial or Prolonged Bradyphrenia Pamelor C Required Brain Oedema Klonopin C Intervention to Convulsion Flomax C Prevent Permanent Hyperhidrosis Valium C Impairment/Damage Hypertension Dilantin C Hyperthermia Malignant Irritability Overdose Sleep Disorder Sleep Talking Tremor Date:08/29/01ISR Number: 3785146-3Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Seroquel (Astra Neuroleptic Malignant Zeneca) Quetiapine Syndrome Fumarate PS Astra Zeneca Rhabdomyolysis Zyprexa(Lilly) Thienobenzodiazepine SS Lilly PTA Date:08/29/01ISR Number: 3785276-6Report Type:Expedited (15-DaCompany Report #2001SE01514 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 ORAL 4 G DAILY PO Hospitalization - Miosis Health Lexotan SS ORAL 20 ML DAILY Initial or Prolonged Muscle Rigidity Professional PO Overdose Other Zoloft SS ORAL 250 MG DAILY Pneumonia Aspiration PO Suicide Attempt Antalgil SS ORAL 1200 MG DAILY Tachycardia PO Clopixol SS ORAL 4 DF DAILY PO Date:08/30/01ISR Number: 3785286-9Report Type:Direct Company Report # Age:17 YR Gender:Female I/FU:I Outcome PT Other Blood Triglycerides Increased Diabetes Mellitus 22-Feb-2006 08:31 AM Page: 288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Non-Insulin-Dependent Report Source Product Role Manufacturer Route Dose Duration Quetiapine PS ORAL 200MG TID PO Depakote C Paxil C Metformin C Date:08/30/01ISR Number: 3786114-8Report Type:Expedited (15-DaCompany Report #2001UW10357 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Palpitations Health Seroquel "Zeneca" PS ORAL 25 MG BID PO Intervention to Supraventricular Professional Seroquel "Zeneca" SS ORAL 200 MG HS PO Prevent Permanent Extrasystoles Seroquel "Zeneca SS ORAL 600 MG DAILY Impairment/Damage Supraventricular PO Tachycardia Prolixin C Vomiting Cogentin C Zoloft C Date:08/30/01ISR Number: 3786132-XReport Type:Expedited (15-DaCompany Report #K200100247 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Altace Capsules Health (Ramipril) Capsule, Professional 1.25 Mg PS ORAL 1.25 MG, QD, Other ORAL Diazepam (Diazepam) 5 Mg SS ORAL 5 MG, TID, ORAL Salbutamol (Salbutamol) SS ORAL ORAL Depixol (Flupentixol Decanoate) 60 Mg SS 60 MG, Q WEEK Quetiapine (Quetiapine) Tablet, 225 Mg SS ORAL 225 MG, QD, ORAL Sandocal "Novartis" (Calcium Carbonate, Colecalciferol, Sodium) 1200 Mg SS 400 MG, TID Alfacalcidol (Alfacalcidol) 1ug SS 1 UG Procyclidine (Procyclidine) 15 Mg SS 15 MG, QD Date:08/31/01ISR Number: 3786798-4Report Type:Expedited (15-DaCompany Report #2001SE01514 Age:32 YR Gender:Female I/FU:I Outcome PT Life-Threatening Coma Hospitalization - Miosis Initial or Prolonged Muscle Rigidity Overdose Pneumonia Aspiration Suicide Attempt 22-Feb-2006 08:31 AM Page: 289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel "Zeneca" PS ORAL 4 G DAILY PO Health Lexotan SS ORAL 20 ML DAILY Professional PO Other Zoloft SS ORAL 250 MG DAILY PO Antalgil SS ORAL 1200 MG DAILY PO Clopixol SS ORAL 4 DF DAILY PO Date:08/31/01ISR Number: 3786993-4Report Type:Expedited (15-DaCompany Report #2001UW10342 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Seroquel "Zeneca" PS Zeneca ORAL 25 MG BID PO Initial or Prolonged Neutropenia Professional Seroquel SS Zeneca ORAL 100 MG BID PO White Blood Cell Count Zyprexa C Decreased Haldol Decanoate C Navane C Cogentin C Date:08/31/01ISR Number: 3786995-8Report Type:Expedited (15-DaCompany Report #2001UW10548 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatic Failure Health Seroquel "Zeneca" PS Zeneca ORAL 25 MG PO Intervention to Professional Seroquel SS Zeneca ORAL 75 MG PO Prevent Permanent Aricept C Impairment/Damage Vistaril C Quinine C Buspar C Antivert C Ativan C Antibiotic Therapy C Date:08/31/01ISR Number: 3787182-XReport Type:Periodic Company Report #A110817 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Health Ziprasidone Po PS ORAL 120.00 MG Insomnia Professional TOTAL, BID, Intracranial Pressure ORAL Increased Quetiapine SS ORAL 200.00 MG Visual Disturbance TOTAL, DAILY, Vomiting ORAL Neurontin C Zoloft C Date:08/31/01ISR Number: 3787253-8Report Type:Periodic Company Report #A113144 Age:39 YR Gender:Male I/FU:I Outcome PT Other Arrhythmia Chest Pain Dyspnoea 22-Feb-2006 08:31 AM Page: 290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Twitching Schizophreniform Disorder Tooth Disorder Report Source Product Role Manufacturer Route Dose Duration Consumer Ziprasidone Po PS Pfizer Regulatory Safety ORAL 80.00 MG TOTAL:BID:ORA L Seroquel SS ORAL 600.00 MG TOTAL:BID:ORA L Aspirin C Retinol C Date:08/31/01ISR Number: 3787290-3Report Type:Periodic Company Report #A113282 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Ziprasidone Po PS 40.00 MG Asthenia TOTAL:BID Diarrhoea Seroquel SS Dyspnoea Tylenol Pm C Headache Prempro C Insomnia Ambien C Date:08/31/01ISR Number: 3787645-7Report Type:Periodic Company Report #A111636 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Ziprasidone Po PS ORAL 80.00 MG Dystonia Professional TOTAL:BID:ORA L Seroquel SS ORAL ORAL Lamictal C Neurontin C Demedex C Dexatrim C Effexor Xr C Topamax C Progestin C Date:08/31/01ISR Number: 3787750-5Report Type:Periodic Company Report #A117681 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Consumer Ziprasidone Po PS ORAL 40.00 MG Psychotic Disorder TOTAL Seroquel SS NOT SPECIFIED Lithium C Zoloft C Date:08/31/01ISR Number: 3788336-9Report Type:Periodic Company Report #A109488 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pollakiuria Health Ziprasidone Po PS 60.00 MG Professional TOTAL:BID Quetiapine SS ORAL 300.00 MG 22-Feb-2006 08:31 AM Page: 291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TOTAL:DAILY:O RAL Anafranil C Affexor C Seroquel C Date:08/31/01ISR Number: 3788824-5Report Type:Periodic Company Report #A107876 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hangover Consumer Ziprasidone Po PS ORAL 80.00 MG Insomnia Health TOTAL:BID:ORA Psychotic Disorder Professional L Diazepam SS Seroquel SS 100.00 TOTAL Prozac SS ORAL 20.00 MG TOTAL:ORAL Date:09/03/01ISR Number: 3787682-2Report Type:Expedited (15-DaCompany Report #2001SE06327 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Foreign Seroquel "Zeneca" PS ORAL 600 MG DAILY Hospitalization - Drug Interaction Health PO Initial or Prolonged Epilepsy Professional Lithium SS ORAL 800 MG DAILY Required Other PO Intervention to Depakine C Prevent Permanent Impairment/Damage Date:09/05/01ISR Number: 3788290-XReport Type:Expedited (15-DaCompany Report #2001UW10742 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Seroquel "Zeneca" PS ORAL 100 MG BID PO Initial or Prolonged Second Degree Professional Lipitor C Sinus Tachycardia Norvasc C Date:09/05/01ISR Number: 3788685-4Report Type:Expedited (15-DaCompany Report #2001SE06424 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anorexia Foreign Seroquel PS Zeneca 100 MG DAILY Intervention to Arthritis Health Noroxin SS Prevent Permanent Conjunctivitis Professional Pipamperon C Impairment/Damage Decreased Appetite Other Sulpiride C Hypoproteinaemia Lactulose C Pain Salbutamol C Weight Increased B Complex C Date:09/06/01ISR Number: 3788187-5Report Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Initial Insomnia Quetiapine PS ORAL 300MG/PM PO 2 WK Restlessness Thioridazine C Venlafaxine C 22-Feb-2006 08:31 AM Page: 292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonazepam C Date:09/06/01ISR Number: 3788795-1Report Type:Direct Company Report # Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Quetiapine PS ORAL 500 MG QD PO 5 MON Restlessness Benztropine C Quetiapine C Date:09/06/01ISR Number: 3789220-7Report Type:Expedited (15-DaCompany Report #2001SE06513 Age:58 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Seroquel "Zeneca" PS Zeneca Initial or Prolonged Dyspnoea Health Lipobay C Muscle Spasms Professional Rhabdomyolysis Other Date:09/06/01ISR Number: 3789231-1Report Type:Expedited (15-DaCompany Report #2001SE06486 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 500 MG DAILY Health PO Professional Other Date:09/06/01ISR Number: 3792646-9Report Type:Direct Company Report #USP 54368 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Serzone PS Bristol-Myers Squibb Medication Error Seroquel 200mg SS Zeneca Date:09/07/01ISR Number: 3789033-6Report Type:Direct Company Report #USP 54351 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Serzone (Nefazodone Initial or Prolonged Hcl) PS Bristol-Myers Squibb Seroquel(Quetiapine) SS Astra Zeneca Date:09/07/01ISR Number: 3789705-3Report Type:Expedited (15-DaCompany Report #2001UW10933 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel "Zeneca" PS Zeneca ORAL 150 MG BID PO Initial or Prolonged Health Provera C Professional Clonazepam C Benztropine C Tylenol C Ativan C Loxapine C Bisacodyl C 22-Feb-2006 08:31 AM Page: 293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/01ISR Number: 3789829-0Report Type:Expedited (15-DaCompany Report #2001PK00880 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Galactorrhoea Foreign Seroquel "Zeneca" PS Zeneca ORAL 600 MG DAILY Initial or Prolonged Study PO Health Tavor C Professional Other Date:09/11/01ISR Number: 3791450-5Report Type:Expedited (15-DaCompany Report #2001UW10699 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Epilepsy Foreign Seroquel PS Zeneca Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:09/11/01ISR Number: 3791529-8Report Type:Expedited (15-DaCompany Report #2001UW10757 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel "Zeneca" PS Zeneca ORAL 6.25 MG HS PO Initial or Prolonged Health Sinemet-Cr C Professional Conjugated Estrogens C Other Hydrochlorothiazide C Levothyroxine C Vitamin D2 C Benadryl C Ibuprofen C Ropinirole C Slow-K C Date:09/12/01ISR Number: 3791738-8Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Quetiapine PS ORAL 100 MG ORAL Intervention to Lithium C Prevent Permanent Oxaxepam C Impairment/Damage Date:09/12/01ISR Number: 3792507-5Report Type:Expedited (15-DaCompany Report #2001AP02091 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Seroquel "Zeneca" PS Zeneca 300 MG BID Sudden Death Health Inderal C Professional Cipramil C Other Prednisolone C Clopixol C 22-Feb-2006 08:31 AM Page: 294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/01ISR Number: 3792570-1Report Type:Direct Company Report # Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Quetiapine Intervention to (Seroquel) PS ORAL 25 MG PO BID Prevent Permanent + 300 MG PO Impairment/Damage BID/ STARTED PRIOR TO ADMISSION Lithium C Donnatal C Famotidine C Date:09/12/01ISR Number: 3793086-9Report Type:Expedited (15-DaCompany Report #200114909GDS Age:58 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Baycol PS Initial or Prolonged Health Seroquel SS Professional Other Date:09/13/01ISR Number: 3792987-5Report Type:Expedited (15-DaCompany Report #2001SE05711 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Thrombocytopenia Foreign Selokeen PS 100 MG DAILY Intervention to Health Quetiapine SS 300 MG DAILY Prevent Permanent Professional Valproate SS 2500 MG DAILY Impairment/Damage Other Tranylcypromine SS 70 MG DAILY Tranxene C Date:09/13/01ISR Number: 3792989-9Report Type:Expedited (15-DaCompany Report #2001AP03675 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Seroquel "Zeneca" PS ORAL 100 MG BID PO Lethargy Health Sinemet-Plus C Neutropenia Professional Domperidone C Sepsis Other Date:09/13/01ISR Number: 3793007-9Report Type:Expedited (15-DaCompany Report #2001AP02732 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Foreign Seroquel PS "Zeneca" ORAL 37 G PO Hospitalization - Pyrexia Health Carbamazepine SS 8 G Initial or Prolonged Professional Procyclidine C Other Co-Proxamol C Date:09/13/01ISR Number: 3793008-0Report Type:Expedited (15-DaCompany Report #2001AP03675 Age:68 YR Gender:Male I/FU:F Outcome PT Death Bronchopneumonia Lethargy 22-Feb-2006 08:31 AM Page: 295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutropenia Pyrexia Sepsis Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel "Zeneca" PS "Zeneca" ORAL 100 MG BID PO Health Sinemet-Plus C Professional Domperidone C Other Date:09/14/01ISR Number: 3793104-8Report Type:Periodic Company Report #PERCOCET2000-00428 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Percocet PS Endo ORAL PO Life-Threatening Overdose Professional Duragesic 25mcg/H Janssen SS Janssen TRANSDERMAL 75 MCG/H ONCE TRANSD Fentanyl Injection 0.05mg/Ml Janssen SS Janssen INTRAVENOUS ONCE IV Seroquel SS ORAL PO Revia Dupont SS Dupont ORAL PO Neurontin SS ORAL PO Trazodone SS ORAL PO Depakote SS ORAL PO Amitriptyline SS ORAL PO Date:09/14/01ISR Number: 3794270-0Report Type:Expedited (15-DaCompany Report #2001AP02857 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Foreign Seroquel "Zeneca" PS Zeneca Intervention to Aggression Other Risperidone SS Prevent Permanent Murder Paxil C Impairment/Damage Speech Disorder Evamyl C Toxicologic Test Abnormal Date:09/17/01ISR Number: 3795686-9Report Type:Expedited (15-DaCompany Report #2001PK00187 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Seroquel "Zeneca" PS ORAL 600 MG DAILY Initial or Prolonged Extrapyramidal Disorder Health PO Grand Mal Convulsion Professional Influenza Like Illness Other Leukopenia Muscle Rigidity Myocarditis Pericarditis Thrombocytopenia Tremor 22-Feb-2006 08:31 AM Page: 296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/01ISR Number: 3795287-2Report Type:Expedited (15-DaCompany Report #2001AP01746 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gastritis Foreign Seroquel "Zeneca" PS Zeneca 300 MG DAILY Intervention to Oesophageal Ulcer Health Seroquel "Zeneca" SS Zeneca 200 MG DAILY Prevent Permanent Professional Salivix C Impairment/Damage Other Date:09/19/01ISR Number: 3795090-3Report Type:Direct Company Report # Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grand Mal Convulsion Seroquel (200 Mg Intervention to Qid) (Astra/Zeneca) PS Aztra/Zeneca ORAL 200MG QID PO Prevent Permanent Seroquel (200mg Impairment/Damage Qid)(Aztra/Zeneca) SS Aztra/Zeneca ORAL 200MG QID PO Zoloft (100mg Hs) SS ORAL 100MG HS PO Date:09/19/01ISR Number: 3795097-6Report Type:Direct Company Report # Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Seroquel PS 200MG TID Initial or Prolonged Eskalith SS 450MG 2 Q 4PM Date:09/19/01ISR Number: 3796104-7Report Type:Expedited (15-DaCompany Report #2001SE06842 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Ineffective Foreign Seroquel "Zeneca" PS Oedema Health Seroquel "Zeneca" SS ORAL 400 MG DAILY Professional PO Other Seroquel "Zeneca" SS ORAL 600 MG DAILY PO Depakine C Seropram C Adiro C Vent-Retard C Insulated Nph Human C Date:09/19/01ISR Number: 3796106-0Report Type:Expedited (15-DaCompany Report #2001AP04193 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Seroquel "Zeneca" PS ORAL 200 MG BID PO Initial or Prolonged Akathisia Health Depixol C Blood Pressure Increased Professional Tachycardia Other Date:09/20/01ISR Number: 3796398-8Report Type:Expedited (15-DaCompany Report #2001AP02857 Age:37 YR Gender:Male I/FU:F Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Murder Foreign Seroquel "Zeneca" PS "Zeneca" Health Risperidone SS Professional Paxil C Other Evamyl C Date:09/24/01ISR Number: 3797367-4Report Type:Direct Company Report # Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Quetiapine PS Hydroxyzine C Aloh/Mgoh/Simth C Acetaminophen C Magnesium Hydroxide Susp, Oral C Date:09/24/01ISR Number: 3797574-0Report Type:Direct Company Report # Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - International Normalised Quetiapine PS Initial or Prolonged Ratio Increased Paroxetine Hcl C Required Quetiapine Fumarate C Intervention to Amiodarone Hcl C Prevent Permanent Levothyroxine Na C Impairment/Damage Lisinopril C Nitroglycerin C Carvedilol C Felodipine C Furosemide C ... C ... C Azithromycin C ... C Lisinopril C ... C ... C ... C ... C Date:09/24/01ISR Number: 3798206-8Report Type:Expedited (15-DaCompany Report #2001PK00765 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel "Zeneca" PS ORAL 300 MG TID PO Initial or Prolonged Thrombocytopenia Study Glianimon SS ORAL 8 MG QID PO Health Tavor C Professional L-Thyroxin C Other 22-Feb-2006 08:31 AM Page: 298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3799819-XReport Type:Expedited (15-DaCompany Report #2001SE06912 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Foreign Seroquel "Zeneca" PS ORAL 200 MG DAILY Hospitalization - Distress Syndrome Health PO Initial or Prolonged Coma Professional Buspar C Overdose Other Zoloft C Respiratory Failure Sedation Speech Disorder Date:09/26/01ISR Number: 3798910-1Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Olanzapine (10 Mg) PS ORAL 20 MG PO QHS Dizziness Quetiapine (100mg) SS ORAL 100 MG PO QHS Fatigue Citalopram C Hunger Quetiapine C Thirst Haldol Decanoate C Weight Increased Date:09/26/01ISR Number: 3799238-6Report Type:Expedited (15-DaCompany Report #2001UW11757 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Zeneca Professional Date:09/27/01ISR Number: 3801599-6Report Type:Expedited (15-DaCompany Report #2001UW08306 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Health Seroquel "Zeneca" PS ORAL 600 MG DAILY Intervention to Decreased Professional PO Prevent Permanent Risperdal C Impairment/Damage Prozac C Xanax C Buspar C Ditropan C Date:09/27/01ISR Number: 3801678-3Report Type:Expedited (15-DaCompany Report #2001UW09206 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel "Zeneca" PS ORAL 900 MG DAILY Initial or Prolonged Health PO Professional Olanzapine C Other Clonazepam C Divalproex Sodium C Docusate Calcium C 22-Feb-2006 08:31 AM Page: 299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802649-3Report Type:Periodic Company Report #2000UW03202 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ammonia Increased Health Seroquel "Zeneca" PS Zeneca Liver Function Test Professional Abnormal Date:09/28/01ISR Number: 3802654-7Report Type:Periodic Company Report #2000UW03186 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hair Disorder Health Seroquel "Zeneca" PS Zeneca Professional Date:09/28/01ISR Number: 3802660-2Report Type:Periodic Company Report #2000UW03177 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Seroquel "Zeneca" PS Zeneca ORAL 100 MG PO Drug Interaction Celebrex SS ORAL 100 MG PO Face Oedema Oxycodone SS Hyperhidrosis Wellbutrin SS 300 MG Hypoaesthesia Valium SS 10 MG PRN Influenza Like Illness Valium SS Oedema Peripheral Ambien SS Pain Ambien SS Toothache Tremor Date:09/28/01ISR Number: 3802669-9Report Type:Periodic Company Report #2000UW03172 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Seroquel "Zeneca" PS Zeneca 300 MG Blood Pressure Increased Professional Prozac SS 80 MG QD Confusional State Interferon C Heart Rate Increased Mental Impairment Date:09/28/01ISR Number: 3802670-5Report Type:Periodic Company Report #2000UW03157 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Seroquel "Zeneca" PS Zeneca ORAL 200 MG QD PO Initial or Prolonged Phosphokinase Increased Professional Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Date:09/28/01ISR Number: 3802671-7Report Type:Periodic Company Report #2000UW03120 Age:10 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Priapism Health Seroquel PS ORAL 50 MG QAM PO Professional Seroquel SS ORAL 25 MG PO Seroquel SS ORAL 75 MG HS PO Seroquel SS ORAL 50 MG QAM PO Ritalin SS 10 MG QID Ritalin SS 30 MG BID Ritalin SS 20 MG BID Lithium C Date:09/28/01ISR Number: 3802673-0Report Type:Periodic Company Report #2000UW03084 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Seroquel PS Professional Lithium C Date:09/28/01ISR Number: 3802675-4Report Type:Periodic Company Report #2000UW03061 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blepharospasm Consumer Seroquel PS ORAL 100 MG PO Dizziness Seroquel SS ORAL 400 MG PO Hallucination, Auditory Seroquel SS ORAL 500 MG PO Pruritus Somnolence Syncope Tachycardia Date:09/28/01ISR Number: 3802677-8Report Type:Periodic Company Report #2000UW03034 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhinorrhoea Consumer Seroquel PS ORAL 150 MG BID PO Date:09/28/01ISR Number: 3802680-8Report Type:Periodic Company Report #2000UW02998 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Consumer Seroquel "Zeneca" PS Zeneca Increased Chest Pain Chest Wall Pain Diarrhoea Malaise Nausea Palpitations Rhinitis Somnolence 22-Feb-2006 08:31 AM Page: 301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802691-2Report Type:Periodic Company Report #2000UW03427 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Health Seroquel "Zeneca" PS "Zeneca" ORAL 75 MG QD PO Syncope Professional Hydrochlorothiazide C Calcium C Norvasc C Accupril C Depakote C Date:09/28/01ISR Number: 3802693-6Report Type:Periodic Company Report #2000UW03401 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Seroquel "Zeneca" PS "Zeneca" ORAL 300 MG DAILY Confusional State Professional PO Hyperreflexia Prozac C Hypertension Tachycardia Date:09/28/01ISR Number: 3802695-XReport Type:Periodic Company Report #2000UW03355 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Seroquel "Zeneca" PS "Zeneca" ORAL 3000 MG ONCE Initial or Prolonged Professional PO Date:09/28/01ISR Number: 3802697-3Report Type:Periodic Company Report #2000UW03340 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel "Zeneca" PS "Zeneca" ORAL MG PO Professional Date:09/28/01ISR Number: 3802699-7Report Type:Periodic Company Report #2000UW03339 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel "Zeneca" PS "Zeneca" ORAL 75 MG QD PO Intervention to Professional Valproic Acid C Prevent Permanent Dilantin C Impairment/Damage Aricept C Terazosin Hydrochloride C Milk Of Magnesia C Acetaminophen C Date:09/28/01ISR Number: 3802701-2Report Type:Periodic Company Report #2000UW03333 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 400 MG QD PO Nausea Zoloft C Paraesthesia 22-Feb-2006 08:31 AM Page: 302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802703-6Report Type:Periodic Company Report #2000UW03296 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Auditory Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 100 MG DAILY Musculoskeletal Pain PO Thinking Abnormal Seroquel "Zeneca" SS "Zeneca" ORAL 50 MG DAILY PO Seroquel "Zeneca" SS "Zeneca" ORAL 25 MG DAILY PO Depakote C Date:09/28/01ISR Number: 3802705-XReport Type:Periodic Company Report #2000UW3254 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Enuresis Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 150 MG PO Irritability Seroquel "Zeneca" SS "Zeneca" ORAL 100 MG DAILY Thinking Abnormal PO Celexa C Date:09/28/01ISR Number: 3802708-5Report Type:Periodic Company Report #2000UW03219 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrasystoles Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 100 MG QD PO Fatigue Seroquel "Zeneca" SS "Zeneca" ORAL 550 MG HS PO Heart Rate Increased Ativan C Heart Rate Irregular Digoxin C Artane C Date:09/28/01ISR Number: 3802710-3Report Type:Periodic Company Report #2000UW03208 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Health Seroquel "Zeneca" PS "Zeneca" ORAL 100 MG HS PO Sleep Disorder Professional Seroquel "Zeneca" SS "Zeneca" ORAL 25 MG PRN PO Mellaril C Date:09/28/01ISR Number: 3802713-9Report Type:Periodic Company Report #2000UW03630 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Seroquel "Zeneca" PS "Zeneca" ORAL 100 MG BID PO Professional Date:09/28/01ISR Number: 3802716-4Report Type:Periodic Company Report #2000UW03607 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel "Zeneca" PS ORAL MG PO Professional 22-Feb-2006 08:31 AM Page: 303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802718-8Report Type:Periodic Company Report #2000UW03598 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 600 MG DAILY Asthenia PO Bone Pain Seroquel "Zeneca" SS "Zeneca" ORAL 800 MG DAILY Chills PO Dehydration Seroquel "Zeneca" SS "Zeneca" ORAL 300 MG DAILY Dysgeusia PO Dyspnoea Seroquel "Zeneca" SS "Zeneca" ORAL 400 MG DAILY Feeling Cold PO Feeling Hot Clozaril C Insomnia Toprol Xl C Leukopenia Valium C Nausea Prilosec C Pneumonia Zithromax "Pfizer" C Pyrexia Tachycardia Thirst Date:09/28/01ISR Number: 3802719-XReport Type:Periodic Company Report #2000UW03562 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Prostatic Specific Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 350 MG DAILY Antigen Increased PO Date:09/28/01ISR Number: 3802721-8Report Type:Periodic Company Report #2000UW3532 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Seroquel "Zeneca" PS "Zeneca" ORAL 400 MG QD PO Professional Trazodone C Flovent C Albuterol C Zoloft C Risperdal C Claritin-D C Colace C Multivitamins C Minerals Nos C Date:09/28/01ISR Number: 3802723-1Report Type:Periodic Company Report #2000UW03514 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Drunk Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG BID PO Obsessive-Compulsive Disorder Date:09/28/01ISR Number: 3802725-5Report Type:Periodic Company Report #2000UW03504 Age:57 YR Gender:Male I/FU:I Outcome PT Other Drug Interaction Fatigue Movement Disorder 22-Feb-2006 08:31 AM Page: 304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Restlessness Report Source Product Role Manufacturer Route Dose Duration Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 500 MG PO Lithium C Date:09/28/01ISR Number: 3802727-9Report Type:Periodic Company Report #2000UW03503 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Hypersensitivity Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG BID PO Rash Erythematous Rash Papular Date:09/28/01ISR Number: 3802729-2Report Type:Periodic Company Report #2000UW03500 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG QD PO Nervousness Seroquel "Zeneca" SS "Zeneca" ORAL 100 MG QD PO Syncope Klonopin C Prevacid C Potassium Chloride C Date:09/28/01ISR Number: 3802731-0Report Type:Periodic Company Report #2000UW03461 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 300 MG HS PO Dyspnoea Seroquel "Zeneca" SS "Zeneca" ORAL 100 MG HS PO Feeling Jittery Zoloft C Irritability Date:09/28/01ISR Number: 3802736-XReport Type:Periodic Company Report #2000UW03761 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastritis Health Seroquel "Zeneca" PS ORAL 100 MG DAILY Pain Professional PO Date:09/28/01ISR Number: 3802738-3Report Type:Periodic Company Report #2000UW03739 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Seroquel "Zeneca" PS ORAL 300 MG QD PO Professional Coumadin "Dupont" SS Heparin C Date:09/28/01ISR Number: 3802742-5Report Type:Periodic Company Report #2000UW03730 Age:40 YR Gender:Female I/FU:I Outcome PT Other Blood Cholesterol Increased Drug Ineffective 22-Feb-2006 08:31 AM Page: 305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ill-Defined Disorder Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Seroquel "Zeneca" PS Date:09/28/01ISR Number: 3802744-9Report Type:Periodic Company Report #2000UW03700 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Seroquel "Zeneca" PS Professional Date:09/28/01ISR Number: 3802747-4Report Type:Periodic Company Report #2000UW03692 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Thyroid Stimulating Health Seroquel "Zeneca" PS Hormone Increased Professional Menorrhagia Date:09/28/01ISR Number: 3802749-8Report Type:Periodic Company Report #2000UW03685 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Seroquel "Zeneca" PS ORAL 800 MG DAILY Professional PO Date:09/28/01ISR Number: 3802750-4Report Type:Periodic Company Report #2000UW05333 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Seroquel "Zeneca" PS "Zeneca" Professional Date:09/28/01ISR Number: 3802751-6Report Type:Periodic Company Report #2000UW05296 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Seroquel "Zeneca" PS "Zeneca" ORAL 125 MG DAILY Vision Blurred Professional PO Zyprexa SS ORAL 20 MG DAILY PO Navane C Date:09/28/01ISR Number: 3802752-8Report Type:Periodic Company Report #2000UW05140 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Candidiasis Health Seroquel "Zeneca" PS "Zeneca" ORAL 500 MG QD PO Initial or Prolonged Face Oedema Professional Depakote C Swelling Trazodone C Clonapin C Benzatropine C Neurontin C Zyprexa C 22-Feb-2006 08:31 AM Page: 306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802753-XReport Type:Periodic Company Report #2000UW05134 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Impairment Health Seroquel "Zeneca" PS "Zeneca" 100 MG QAM Professional ODT Seroquel "Zeneca" SS "Zeneca" ORAL 300 MG HS PO Zyprexa C Date:09/28/01ISR Number: 3802754-1Report Type:Periodic Company Report #2000UW05091 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pregnancy Health Seroquel "Zeneca" PS "Zeneca" Professional Date:09/28/01ISR Number: 3802755-3Report Type:Periodic Company Report #2000UW05061 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Field Defect Health Seroquel "Zeneca" PS "Zeneca" ORAL 400 MG QD PO Professional Seroquel "Zeneca" SS "Zeneca" ORAL 1000 MG QD PO Date:09/28/01ISR Number: 3802756-5Report Type:Periodic Company Report #2000UW05004 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Miosis Health Seroquel "Zeneca" PS "Zeneca" ORAL 200 MG QD PO Professional Date:09/28/01ISR Number: 3802757-7Report Type:Periodic Company Report #2000UW04985 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel "Zeneca" PS "Zeneca" ORAL 200 MG TID PO Intervention to Professional Ativan C Prevent Permanent Nitro C Impairment/Damage Depakote C Multivitamins C Flexeril C Dilantin C Date:09/28/01ISR Number: 3802758-9Report Type:Periodic Company Report #2000UW04878 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 300 MG QD PO Choking Sensation Valium C Flushing Clozaril C Hyperhidrosis Nausea Temperature Intolerance Thirst 22-Feb-2006 08:31 AM Page: 307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802759-0Report Type:Periodic Company Report #2000UW04801 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Seroquel "Zeneca" PS Zeneca Professional Zyprexa C Celexa C Risperdal C Date:09/28/01ISR Number: 3802770-XReport Type:Periodic Company Report #2000UW03677 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nervousness Consumer Seroquel "Zeneca" PS 25 MG QD Nightmare Palpitations Somnolence Date:09/28/01ISR Number: 3802771-1Report Type:Periodic Company Report #2000UW03672 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Sleep-Related Health Seroquel "Zeneca" PS ORAL 50 MG HS PO Event Professional Seroquel "Zeneca" SS ORAL 25 MG QAM PO Nightmare Seroquel "Zeneca" SS ORAL 75 MG HS PO Sleep Talking Buspar C Weight Increased Celexa C Date:09/28/01ISR Number: 3802772-3Report Type:Periodic Company Report #2000UW03657 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradyphrenia Health Seroquel "Zeneca" PS ORAL 100 MG QD PO Peripheral Coldness Professional Speech Disorder Date:09/28/01ISR Number: 3802774-7Report Type:Periodic Company Report #2000UW03632 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Seroquel "Zeneca" PS ORAL 300 MG QD PO Face Oedema Professional Coumadin "Dupont" C Hyposthenuria Vicodin C Prothrombin Time Abnormal Thorazine C Date:09/28/01ISR Number: 3802777-2Report Type:Periodic Company Report #2000UW03909 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Seroquel "Zeneca" PS ORAL 200 MG QAM PO Deficit/Hyperactivity Professional Seroquel "Zeneca" SS ORAL 400 MG HS PO Disorder Hallucination, Auditory Impulsive Behaviour 22-Feb-2006 08:31 AM Page: 308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802780-2Report Type:Periodic Company Report #2000UW03906 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Seroquel "Zeneca" PS ORAL 200 MG BID PO Initial or Prolonged Chest Pain Professional Levaquin C Coordination Abnormal Depression Dizziness Feeling Abnormal Medication Error Muscle Spasms Tremor Date:09/28/01ISR Number: 3802783-8Report Type:Periodic Company Report #2000UW03904 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Consumer Seroquel "Zeneca" PS ORAL 100 MG PO Somnolence Vomiting Date:09/28/01ISR Number: 3802785-1Report Type:Periodic Company Report #2000UW03897 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Seroquel "Zeneca" PS ORAL 500 MG QD PO Disturbance In Attention Professional Luvox SS Restlessness Ativan SS Date:09/28/01ISR Number: 3802787-5Report Type:Periodic Company Report #2000UW03891 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Toxicity Health Seroquel "Zeneca" PS Hospitalization - Overdose Professional Initial or Prolonged Date:09/28/01ISR Number: 3802789-9Report Type:Periodic Company Report #2000UW03879 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Pigmentation Health Seroquel "Zeneca" PS ORAL 600 MG QD PO Professional Date:09/28/01ISR Number: 3802793-0Report Type:Periodic Company Report #2000UW03807 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Deafness Health Seroquel "Zeneca" PS ORAL 150 MG HS PO Professional 22-Feb-2006 08:31 AM Page: 309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802796-6Report Type:Periodic Company Report #2000UW03794 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Consumer Seroquel "Zeneca" PS ORAL 400 MG HS PO Wellbutrin C Date:09/28/01ISR Number: 3802799-1Report Type:Periodic Company Report #2000UW03779 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Seroquel "Zeneca" PS Ativan C Date:09/28/01ISR Number: 3802800-5Report Type:Periodic Company Report #2000UW03772 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grand Mal Convulsion Health Seroquel "Zeneca" PS ORAL 25 MG BID PO Intervention to Professional Seroquel "Zeneca" SS ORAL 75 MG DAILY Prevent Permanent PO Impairment/Damage Seroquel "Zeneca" SS ORAL 50 MG BID PO Seroquel "Zeneca" SS ORAL 50 MG TID PO Zyprexa C Depakote C Ativan C Tylenol C Date:09/28/01ISR Number: 3802801-7Report Type:Periodic Company Report #2000UW04109 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coeliac Disease Health Seroquel "Zeneca" PS Zeneca ORAL 50 MG HS PO Professional Seroquel "Zeneca' SS Zeneca ORAL 100 MG QD PO Zyprexa C Zestril C Wellbutrin - Slow Release C Luvox C Humalog C Humulin N C Date:09/28/01ISR Number: 3802802-9Report Type:Periodic Company Report #2000UW04102 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Health Seroquel "Zeneca" PS Zeneca Intervention to Syndrome Professional Prevent Permanent Impairment/Damage Date:09/28/01ISR Number: 3802803-0Report Type:Periodic Company Report #2000UW04093 Age:50 YR Gender:Male I/FU:I Outcome PT Other Balance Disorder Eye Rolling 22-Feb-2006 08:31 AM Page: 310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Tremor Report Source Product Role Manufacturer Route Dose Duration Health Seroquel "Zeneca" PS Zeneca ORAL 100 MG HS PO Professional Mellaril C Date:09/28/01ISR Number: 3802804-2Report Type:Periodic Company Report #2000UW04089 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cerebellar Ataxia Health Seroquel "Zeneca" PS Zeneca Intervention to Drug Interaction Professional Fluoxetine SS Prevent Permanent Dystonia Dilantin SS Impairment/Damage Nystagmus Date:09/28/01ISR Number: 3802806-6Report Type:Periodic Company Report #2000UW04081 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Seroquel "Zeneca" PS Zeneca ORAL 750 MG DAILY Initial or Prolonged Professional PO Inderal C Depakote C Date:09/28/01ISR Number: 3802810-8Report Type:Periodic Company Report #2000UW04018 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Health Seroquel "Zeneca" PS Zeneca Dystonia Professional Date:09/28/01ISR Number: 3802812-1Report Type:Periodic Company Report #2000UW03968 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Memory Impairment Consumer Seroquel "Zeneca" PS Zeneca Prozac C Sleeping Pills C Relaxing Pills C Date:09/28/01ISR Number: 3802814-5Report Type:Periodic Company Report #2000UW03945 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Consumer Seroquel "Zeneca" PS Zeneca ORAL 25 MG HS PO Myalgia Prevacid C Pain Proscar C Pain In Extremity Hytrin C Paxil C 22-Feb-2006 08:31 AM Page: 311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802815-7Report Type:Periodic Company Report #2000UW03923 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Emotional Disorder Consumer Seroquel "Zeneca" PS Zeneca ORAL 50 MG HS PO Headache Seroquel "Zeneca" SS Zeneca ORAL 25 MG DAILY Musculoskeletal Stiffness PO Tachycardia Lithium C Tremor Clonapin C Visual Disturbance Date:09/28/01ISR Number: 3802818-2Report Type:Periodic Company Report #2000UW03919 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel "Zeneca" PS Zeneca Intervention to Professional Lithium C Prevent Permanent Navane C Impairment/Damage Hydrochlorothiazide C Date:09/28/01ISR Number: 3802819-4Report Type:Periodic Company Report #2000UW04354 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Consumer Seroquel "Zeneca PS ORAL 1000 MG DAILY PO Date:09/28/01ISR Number: 3802820-0Report Type:Periodic Company Report #2000UW04353 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restless Legs Syndrome Health Seroquel "Zeneca" PS Professional Date:09/28/01ISR Number: 3802821-2Report Type:Periodic Company Report #2000UW04352 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Seroquel "Zeneca" PS Blood Prolactin Increased Professional Date:09/28/01ISR Number: 3802822-4Report Type:Periodic Company Report #2000UW04346 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Health Seroquel "Zeneca" PS Intervention to Professional Prevent Permanent Impairment/Damage Date:09/28/01ISR Number: 3802823-6Report Type:Periodic Company Report #2000UW04336 Age: Gender: I/FU:I Outcome PT Other Conjunctivitis Eye Pain 22-Feb-2006 08:31 AM Page: 312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eyelid Oedema Report Source Product Role Manufacturer Route Dose Duration Health Seroquel "Zeneca" PS ORAL 200 MG QE PO Professional Seroquel "Zeneca" SS ORAL 100 MG QD PO Date:09/28/01ISR Number: 3802824-8Report Type:Periodic Company Report #2000UW04331 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Seroquel "Zeneca" PS ORAL 200 MG PO Initial or Prolonged Seroquel "Zeneca" SS ORAL 300 MG PO Date:09/28/01ISR Number: 3802825-XReport Type:Periodic Company Report #2000UW04323 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Seroquel "Zeneca" PS ORAL 100 MG HS PO Date:09/28/01ISR Number: 3802826-1Report Type:Periodic Company Report #2000UW04304 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Seroquel "Zeneca" PS Initial or Prolonged Depression Serzone C Insomnia Date:09/28/01ISR Number: 3802827-3Report Type:Periodic Company Report #2000UW04300 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Seroquel "Zeneca" PS Unevaluable Event Depakote C Lipitor C Detrol C Pepcid C Nolvadex "Zeneca" C Aspirin "Bayer" C Metoprolol C Verapamil C Triamterene C Zaroxolyn C Klc C Date:09/28/01ISR Number: 3802828-5Report Type:Periodic Company Report #2000UW04272 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel "Zeneca" PS ORAL 200 MG BID PO Initial or Prolonged Syndrome Professional Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802837-6Report Type:Periodic Company Report #2000UW04270 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Oestrogen Increased Health Seroquel "Zeneca" PS Professional Date:09/28/01ISR Number: 3802839-XReport Type:Periodic Company Report #2000UW04269 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Changed Health Seroquel "Zeneca" PS Professional Date:09/28/01ISR Number: 3802843-1Report Type:Periodic Company Report #2000UW04224 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Disorder Health Seroquel "Zeneca" PS ORAL 600 MG DAILY Sleep Walking Professional PO Date:09/28/01ISR Number: 3802844-3Report Type:Periodic Company Report #2000UW04218 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Seroquel "Zeneca" PS ORAL 8000 MG QD PO Initial or Prolonged Insomnia Zoloft C Nausea Depakote C Schizoaffective Disorder Thyroid C Vitreous Floaters Vitamin E C Benadryl C Date:09/28/01ISR Number: 3802845-5Report Type:Periodic Company Report #2000UW04155 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Health Seroquel "Zeneca" PS ORAL 100 MG BID PO Professional Wellbutrin -Slow Release C Zyprexa C Paxil C Date:09/28/01ISR Number: 3802847-9Report Type:Periodic Company Report #2000UW04142 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Consumer Seroquel "Zeneca" PS 700 MG QD DE Intervention to Blood Pressure Increased Seroquel "Zeneca" SS ORAL 800 MG QD PO Prevent Permanent Dyspnoea Lorazepam C Impairment/Damage Feeling Abnormal Trilafon C Hallucination, Auditory Depakote C Heart Rate Increased Libido Increased Palpitations 22-Feb-2006 08:31 AM Page: 314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802849-2Report Type:Periodic Company Report #2000UW04135 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Seroquel "Zeneca" PS ORAL 300 MG QD PO Drug Interaction Professional Tegretol SS ORAL 200 MG BID PO Hostility Date:09/28/01ISR Number: 3802852-2Report Type:Periodic Company Report #2000UW04125 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Seroquel "Zeneca" PS Hostility Professional Tegretol C Date:09/28/01ISR Number: 3802853-4Report Type:Periodic Company Report #2000UW04117 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Seroquel "Zeneca" PS ORAL 200 MG BID PO Drug Level Changed Professional Depakote SS 1500 MG QD Depakote SS ORAL 1000 MG BID PO Depakote C 750 MG BID Date:09/28/01ISR Number: 3802854-6Report Type:Periodic Company Report #2000UW04116 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Seroquel "Zeneca" PS ORAL 300 MG BID PO Dyspnoea Professional Zantac C Pain In Extremity Gabapentin C Palpitations Date:09/28/01ISR Number: 3802855-8Report Type:Periodic Company Report #2000UW04621 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel "Zeneca" PS Zeneca Intervention to Professional Depakote C Prevent Permanent Impairment/Damage Date:09/28/01ISR Number: 3802856-XReport Type:Periodic Company Report #2000UW04533 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Health Seroquel "Zeneca" PS Zeneca Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802857-1Report Type:Periodic Company Report #2000UW04479 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Seroquel "Zeneca" PS Zeneca ORAL 200 MG DAILY Hallucination, Auditory Professional PO Migraine Seroquel "Zeneca" SS Zeneca ORAL 250 MG DAILY Muscle Rigidity PO Nausea Seroquel "Zeneca" SS Zeneca ORAL 300 MG HS PO Tremor Seroquel "Zeneca" SS Zeneca ORAL 150 MG DAILY PO Wellbutrin C Benadryl C Zoloft C Risperdal C Date:09/28/01ISR Number: 3802858-3Report Type:Periodic Company Report #2000UW04478 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myalgia Health Seroquel "Zeneca" PS Zeneca Professional Date:09/28/01ISR Number: 3802859-5Report Type:Periodic Company Report #2000UW044507 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Seroquel "Zeneca" PS Zeneca ORAL 12.5 MG HS PO Intervention to Inadequate Control Health Insulin Humulin-N C Prevent Permanent Professional Nortriptyline C Impairment/Damage Sinemet C Date:09/28/01ISR Number: 3802860-1Report Type:Periodic Company Report #2000UW04419 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Consumer Seroquel "Zeneca" PS Zeneca ORAL 200 MG BID PO Initial or Prolonged Clozaril C Paxil C Artane C Depakote C Respirin C Restoril C Date:09/28/01ISR Number: 3802861-3Report Type:Periodic Company Report #2000UW04412 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinson'S Disease Consumer Seroquel "Zeneca" PS Zeneca ORAL 175 MG QD PO Somnolence Seroquel "Zeneca" SS Zeneca ORAL 25 MG HS PO Temazepam C Amantadine C Xanax C Mirapex "Boehringer Ingelheim" C Boehringer Ingelheim Sinemet C 22-Feb-2006 08:31 AM Page: 316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802862-5Report Type:Periodic Company Report #2000UW04379 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Health Seroquel "Zeneca" PS Zeneca Red Blood Cell Professional Lithium C Sedimentation Rate Increased Date:09/28/01ISR Number: 3802863-7Report Type:Periodic Company Report #2000UW04377 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel "Zeneca" PS Zeneca Professional Date:09/28/01ISR Number: 3802864-9Report Type:Periodic Company Report #2000UW04361 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Auditory Consumer Seroquel "Zeneca" PS Zeneca ORAL 300 MG QD PO Date:09/28/01ISR Number: 3802865-0Report Type:Periodic Company Report #2000UW02960 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel "Zeneca" PS Zeneca ORAL MG PO Professional Date:09/28/01ISR Number: 3802866-2Report Type:Periodic Company Report #2000UW02914 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pregnancy Health Seroquel "Zeneca" PS Professional Date:09/28/01ISR Number: 3802867-4Report Type:Periodic Company Report #2000UW02904 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Health Seroquel "Zeneca" PS Zenica Initial or Prolonged Professional Neurontin C Paxil C Date:09/28/01ISR Number: 3802868-6Report Type:Periodic Company Report #2000UW02872 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Seroquel "Zeneca" PS ORAL 25 MG QD PO, Chest Pain 300 MG QD PO, Dizziness 600 MG QD PO, Joint Stiffness 800 MG DAILY Muscle Rigidity PO 1 WK Muscle Spasms 22-Feb-2006 08:31 AM Page: 317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802869-8Report Type:Periodic Company Report #2000UW02860 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Consumer Seroquel"Zeneca" PS ORAL 300 MG PO Sluggishness Zyprexa C Somnolence Date:09/28/01ISR Number: 3802870-4Report Type:Periodic Company Report #2000UW02843 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrooesophageal Reflux Consumer Seroquel "Zeneca" PS ORAL 500 MG QD PO, Disease 50 MG TID PO Hypertonia Muscle Rigidity Sedation Therapeutic Response Unexpected Date:09/28/01ISR Number: 3802871-6Report Type:Periodic Company Report #2000UW02823 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Consumer Seroquel "Zeneca" PS ORAL 125 MG DAILY Unexpected PO, 100 MG DAILY PO, 75 MG DAILY PO Date:09/28/01ISR Number: 3802872-8Report Type:Periodic Company Report #2000UW02789 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Consumer Seroquel PS Zeneca ORAL 125 MG QAM PO, 25 MG HS PO Date:09/28/01ISR Number: 3802873-XReport Type:Periodic Company Report #2000UW02763 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pregnancy Health Seroquel "Zeneca" PS Zeneca Professional Date:09/28/01ISR Number: 3802874-1Report Type:Periodic Company Report #2000UW02760 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Seroquel "Zeneca" PS ORAL 25 MG HS PO, Dizziness 12.5 MG HS PO Feeling Abnormal Serzone C Insomnia Nausea Somnolence 22-Feb-2006 08:31 AM Page: 318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802875-3Report Type:Periodic Company Report #2000UW04773 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Seroquel "Zeneca" PS Initial or Prolonged Professional Date:09/28/01ISR Number: 3802876-5Report Type:Periodic Company Report #2000UW04758 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Seroquel "Zeneca" PS ORAL 25 MG BID PO Fatigue Date:09/28/01ISR Number: 3802877-7Report Type:Periodic Company Report #2000UW04751 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Disorder Health Seroquel "Zeneca" PS Professional Date:09/28/01ISR Number: 3802878-9Report Type:Periodic Company Report #2000UW04737 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pigmentation Disorder Health Seroquel "Zeneca" PS Zeneca ORAL 100 MG HS PO Professional Risperdal C Date:09/28/01ISR Number: 3802879-0Report Type:Periodic Company Report #2000UW04706 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gingival Hyperplasia Other Seroquel "Zeneca" PS Date:09/28/01ISR Number: 3802880-7Report Type:Periodic Company Report #2000UW04692 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Health Seroquel "Zeneca" PS Zeneca ORAL 25 MG TID PO Consciousness Professional Difficulty In Walking Lethargy Somnolence Date:09/28/01ISR Number: 3802881-9Report Type:Periodic Company Report #2000UW04683 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Otitis Media Health Seroquel "Zeneca" PS Zeneca Sinusitis Professional 22-Feb-2006 08:31 AM Page: 319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802882-0Report Type:Periodic Company Report #2000UW04653 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lenticular Opacities Health Seroquel "Zeneca" PS ORAL 800 MG PO Professional Date:09/28/01ISR Number: 3802883-2Report Type:Periodic Company Report #2000UW04636 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Consumer Seroquel "Zeneca" PS ORAL 100 MG QAM PO Lip Dry 200 MG HS PO Date:09/28/01ISR Number: 3802884-4Report Type:Periodic Company Report #2000UW04635 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Seroquel "Zeneca" PS Zeneca ORAL 25 MG BID PO Hypothermia Professional Olanzapine SS Gabapentin SS Reglan SS Date:09/28/01ISR Number: 3802885-6Report Type:Periodic Company Report #2000UW02759 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tongue Paralysis Health Seroquel "Zeneca" PS ORAL 200 MG QD PO Professional Date:09/28/01ISR Number: 3802886-8Report Type:Periodic Company Report #2000UW02752 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Seroquel "Zeneca" PS 200 MG; 600 Professional MG Date:09/28/01ISR Number: 3802887-XReport Type:Periodic Company Report #2000UW02686 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Seroquel "Zeneca" PS Insomnia Professional Irritability Date:09/28/01ISR Number: 3802888-1Report Type:Periodic Company Report #2000UW02665 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Livedo Reticularis Other Seroquel PS ORAL 100 MG TID PO Muscle Spasms Lorazepam C Urticaria Lithium C Clonopin C Cogentin C Tylenol C Milk Of Magnesia C 22-Feb-2006 08:31 AM Page: 320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802889-3Report Type:Periodic Company Report #2000UW02591 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Seroquel PS ORAL 500 MG PO Eye Disorder Lithium C Fatigue Mellaril C Date:09/28/01ISR Number: 3802890-XReport Type:Periodic Company Report #2000UW02380 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Seroquel "Zeneca" PS Agitation Hostility Malaise Screaming Date:09/28/01ISR Number: 3802891-1Report Type:Periodic Company Report #2000UW02064 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel "Zeneca" PS ORAL 50 MG DAILY Intervention to Professional PO; 100 MG Prevent Permanent BID PO; 400 Impairment/Damage MG QD PO Effexor C Lithium C Klonopin C Depakote C Ssri'S C Nneurontin C Date:09/28/01ISR Number: 3802892-3Report Type:Periodic Company Report #2000UW01923 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Seroquel "Zeneca" PS ORAL 400 MG QD PO; Extrapyramidal Disorder Professional 300 MG QD PO Date:09/28/01ISR Number: 3802893-5Report Type:Periodic Company Report #2000UW01749 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel "Zeneca" PS ORAL 200 MG DAILY Intervention to Professional PO Prevent Permanent Impairment/Damage Date:09/28/01ISR Number: 3802894-7Report Type:Periodic Company Report #2000AP04799 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Literature Quetiapine PS Health Verapamil SS Professional 22-Feb-2006 08:31 AM Page: 321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3804676-9Report Type:Periodic Company Report #2000AP04464 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Increased Literature Quetiapine Fumarate PS 300 MG Intervention to Dizziness Health Benztropine C Prevent Permanent Hyperhidrosis Professional Haloperidol C Impairment/Damage Nausea Fluoxetine C Nervousness Risperidone C Orthostatic Hypotension Lorazepam C Tachycardia Paroxetine C Vomiting Venlafaxine C Date:09/28/01ISR Number: 3804678-2Report Type:Periodic Company Report #2000AP04264 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Literature Olanzapine PS 10 MG Intervention to Inadequate Control Health Quetiapine Fumarate SS 100 MG TID Prevent Permanent Professional Sertraline C Impairment/Damage Haloperidol Decanoate C Fluoxetine C Glipizide C Metformin C Venlafaxine C Date:09/28/01ISR Number: 3804685-XReport Type:Periodic Company Report #1999UW03089 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Literature Seroquel "Zeneca" PS "Zeneca" ORAL 50 MG QD PO Initial or Prolonged Neutropenia Health Seroquel "Zeneca" SS "Zeneca" ORAL 600 MG QD PO Required Professional Depakote C Intervention to Prevent Permanent Impairment/Damage Date:09/28/01ISR Number: 3804687-3Report Type:Periodic Company Report #1998UW48083 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Seroquel PS Initial or Prolonged Professional Seroquel SS ORAL 100 MG BID PO Dulcolax C Peri-Colace C Metamucil C Glycerin C Clonapin C Depakote C Date:09/28/01ISR Number: 3804688-5Report Type:Periodic Company Report #1998UW48080 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Seroquel PS ORAL 300 MG BID PO Initial or Prolonged Professional Effexor C Ativan C 22-Feb-2006 08:31 AM Page: 322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Robitussin C Vitamin E C Peri-Colace C Date:09/28/01ISR Number: 3804689-7Report Type:Periodic Company Report #1998UW48072 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Seroquel PS ORAL 250 MG BID PO Initial or Prolonged Professional Lithium C Milk Of Magnesia C Date:09/28/01ISR Number: 3804690-3Report Type:Periodic Company Report #2001UW00476 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel "Zeneca" PS Zeneca Professional Zomig SS Date:09/28/01ISR Number: 3804691-5Report Type:Periodic Company Report #2001UW00375 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paraesthesia Consumer Seroquel "Zeneca" PS Zeneca ORAL 200 MG HS PO 2 YR Date:09/28/01ISR Number: 3804692-7Report Type:Periodic Company Report #2001UW00367 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Disorder Consumer Seroquel "Zeneca" PS Zeneca ORAL 250 MG DAILY PO 18 MON Date:09/28/01ISR Number: 3804693-9Report Type:Periodic Company Report #2001UW00363 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Seroquel "Zeneca" PS Zeneca ORAL 12.5 MG HS PO Initial or Prolonged Insulin-Dependent Professional Seroquel "Zeneca" SS Zeneca ORAL 25 MG HS PO Seroquel "Zeneca" SS Zeneca ORAL 37.5 MG HS PO Seroquel "Zeneca" SS Zeneca ORAL 12.5 MG QAM PO Seroquel "Zeneca" SS Zeneca ORAL 37.5 MG HS PO Ritalin C Date:09/28/01ISR Number: 3804694-0Report Type:Periodic Company Report #2001UW00360 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pregnancy Health Seroquel "Zeneca" PS Zeneca Professional 22-Feb-2006 08:31 AM Page: 323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3804695-2Report Type:Periodic Company Report #2001UW00234 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Seroquel "Zeneca" PS Zeneca ORAL 50 MG HS PO Palpitations Professional Seroquel "Zeneca" SS Zeneca ORAL 100 MG QAM PO Seroquel "Zeneca" SS Zeneca ORAL 200 MG HS PO Remeron SS Depakote C Date:09/28/01ISR Number: 3804696-4Report Type:Periodic Company Report #2001UW00231 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Health Seroquel "Zeneca" PS Zeneca ORAL 50 MG TID PO Intervention to Weight Increased Professional Seroquel "Zeneca" SS Zeneca ORAL 200 MG BID PO Prevent Permanent Seroquel "Zeneca" SS ORAL 200 MG TID PO Impairment/Damage Effexor C Avapro C Remeron C Multivitamins C Depo Provera C Ativan C Droperidol C Humulin Nph C Humalog C Humalog Sliding Scale C Chlortrimeton C Anaprox C Amoxicillin C Fedahist C Date:09/28/01ISR Number: 3804697-6Report Type:Periodic Company Report #2001UW00175 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel "Zeneca" PS Zeneca ORAL 400 MG BID PO Initial or Prolonged Syndrome Professional Depakote C Allopurinol C Tegretol C Clonazepam C Lorazepam C Azithromycin C Date:09/28/01ISR Number: 3804698-8Report Type:Periodic Company Report #2001UW00083 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Seroquel "Zeneca" PS Zeneca ORAL 50 MG HS PO Initial or Prolonged Professional Seroquel "Zeneca" SS Zeneca ORAL 450 MG HS PO Date:09/28/01ISR Number: 3804699-XReport Type:Periodic Company Report #2001AP02705 Age:44 YR Gender:Male I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cataract Literature Seroquel "Zeneca" PS Zeneca 700 MG DAILY Health Risperidone C Professional Date:10/01/01ISR Number: 3802808-XReport Type:Expedited (15-DaCompany Report #2001UW12078 Age:57 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Foreign Seroquel "Zeneca" PS Other Risperdal SS Date:10/01/01ISR Number: 3802809-1Report Type:Expedited (15-DaCompany Report #2001PK00971 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Foreign Seroquel "Zeneca" PS ORAL 375 MG DAILY Initial or Prolonged Thromboplastin Time Health PO Prolonged Professional Seroquel "Zeneca" SS ORAL 6 G DAILY PO Aspartate Other Gladem C Aminotransferase Saroten "Bayer Increased Vital" C Atrioventricular Block First Degree Blood Amylase Increased C-Reactive Protein Increased Electrocardiogram Qt Prolonged Overdose Rhabdomyolysis Sedation Ventricular Tachycardia White Blood Cell Count Increased Date:10/03/01ISR Number: 3803376-9Report Type:Expedited (15-DaCompany Report #B0121705A Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Salbutamol PS Glaxo Wellcome RESPIRATORY Arrhythmia (INHALATION) Bipolar I Disorder Procyclidine SS Glaxo Wellcome UNKNOWN 5MG Three Blood Phosphorus times per day Increased Flupenthixol SS UNKNOWN 60MG Weekly Confusional State Quetiapine SS UNKNOWN 225MG See Coronary Artery Disease text Delusion Sandocal SS UNKNOWN 400MG Three Drug Level Above times per day Therapeutic Ramipril SS UNKNOWN 1.25MG In the Irritability morning Speech Disorder Alfacalcidol SS UNKNOWN 1MCG Per day Sudden Death Diazepam SS UNKNOWN 5MG Three times per day Chlorpromazine Hydrochloride SS Glaxo Wellcome UNKNOWN 22-Feb-2006 08:31 AM Page: 325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam SS PARENTERAL Lithium SS UNKNOWN 15 DAY Date:10/03/01ISR Number: 3803570-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Valproic Acid PS ORAL 500 MG PO BID Intervention to Pancytopenia Quetiapine SS ORAL 200 MG PO Prevent Permanent Thrombocytopenia BID, PTA Impairment/Damage Urinary Tract Infection Levothyroxine C Lansoprazole C Iron C Folic Acid C Bupropion C Benztropine C Date:10/03/01ISR Number: 3804532-6Report Type:Expedited (15-DaCompany Report #2001AP04069 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Literature Quetiapine PS 25 MG BID 4 DAY White Blood Cell Count Health Decreased Professional Date:10/03/01ISR Number: 3804535-1Report Type:Expedited (15-DaCompany Report #2001AP04631 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Literature Quetiapine PS ORAL 200 MG DAILY Neutropenia Health PO Thrombocytopenia Professional Quetiapine SS ORAL 200 MG BID PO 30 DAY Date:10/03/01ISR Number: 3806177-0Report Type:Expedited (15-DaCompany Report #2001UW12059 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphasia Foreign Seroquel "Zeneca" PS ORAL 12.5 MG QD PO 9 WK Cerebrovascular Disorder Other Coumadin "Dupont" SS 2 DAY Paralysis Heparin SS 3 DAY Zopiclone SS ORAL 7.5 MG QD PO 3 DAY Acetaminophen C Furosemide C Levodopa-Carbidopa C Metronidazole C Miconazole C Date:10/03/01ISR Number: 3806363-XReport Type:Expedited (15-DaCompany Report #2001UW12073 Age:4 YR Gender:Male I/FU:I Outcome PT Death Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Blood Urea Increased 22-Feb-2006 08:31 AM Page: 326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bronchospasm Confusional State Cough Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Foreign Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG PO 1 DAY Consciousness Other Zuclopenthixol SS INTRAMUSCULAR 200 MG INT Fall IM 9 DAY Flushing Flunisolide Nasal Gait Disturbance Spray C Hyperhidrosis Insulin Isophane Bw C Movement Disorder Insulin Regular C Muscle Rigidity Lisinopril C Pyrexia Nitroglycerin "A.L." C Restlessness Pravastatin Sodium C Sinus Tachycardia Salbutamol C Speech Disorder Septra C Tremor Zopiclone C Date:10/03/01ISR Number: 3806807-3Report Type:Expedited (15-DaCompany Report #2001SE07248 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Seroquel "Zeneca" PS ORAL 200 MG DAILY Initial or Prolonged Grand Mal Convulsion Health PO Professional Besitran C Other Noctamid C Idalprem C Date:10/04/01ISR Number: 3805349-9Report Type:Expedited (15-DaCompany Report #2001UW12218 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Other Seroquel "Zeneca" PS 15 DAY Intervention to Cardiac Failure Clozaril SS 15 DAY Prevent Permanent Congestive Impairment/Damage Cardiomyopathy Leukocytosis Oedema Peripheral Phlebitis Date:10/05/01ISR Number: 3807391-0Report Type:Expedited (15-DaCompany Report #2001AP04714 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel "Zeneca" PS Zeneca Decreased Health Clozapine C Professional Haloperidol C Other Amlodipine C Zopiclone C Date:10/05/01ISR Number: 3807393-4Report Type:Expedited (15-DaCompany Report #2001UW12261 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Foreign Seroquel "Zeneca" PS ORAL 12.5 MG BID Intervention to Laryngospasm Other PO Prevent Permanent Zyprexa SS ORAL 5 MG TID PO 5 DAY Impairment/Damage Sinemet C 22-Feb-2006 08:31 AM Page: 327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/01ISR Number: 3807401-0Report Type:Expedited (15-DaCompany Report #2001SE06842 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Ineffective Foreign Seroquel "Zeneca" PS Zeneca Intervention to Oedema Health Seroquel "Zeneca" SS Zeneca ORAL 400 MG DAILY Prevent Permanent Professional PO Impairment/Damage Other Seroquel "Zeneca" SS Zeneca ORAL 600 MG DAILY PO Depakine C Seropram C Adiro C Vent-Retard C Insulatard Nph Human C Date:10/05/01ISR Number: 3807415-0Report Type:Expedited (15-DaCompany Report #2001UW12244 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Urea Increased Foreign Seroquel "Zeneca" PS ORAL 50 MG DAILY Intervention to Confusional State Other PO 8 DAY Prevent Permanent Coordination Abnormal Lithium SS ORAL 750 MG DAILY Impairment/Damage Delirium PO 5 YR Delusion Diovan SS ORAL 80 MG DAILY Drug Level Above PO 2 WK Therapeutic Lorazepam C Mania Ciproflaxacin C Sedation Conjugated Estrogens C Glyburide C L-Typtophan C Zopiclone C Date:10/05/01ISR Number: 3807416-2Report Type:Expedited (15-DaCompany Report #2001UW12263 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Foreign Seroquel "Zeneca" PS 300 MG DAILY Intervention to Diabetic Ketoacidosis Other Olanzapine C Prevent Permanent Hyperglycaemia Impairment/Damage Polydipsia Polyuria Date:10/05/01ISR Number: 3808948-3Report Type:Expedited (15-DaCompany Report #2001UW12251 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Complications Of Maternal Foreign Seroquel "Zeneca" PS TRANSPLACENTAL 300 MG DAILY Intervention to Exposure To Therapeutic Other TPL Prevent Permanent Drugs Fluvoxamine SS ORAL 200 MG DAILY Impairment/Damage Gastrointestinal PO Malformation Date:10/05/01ISR Number: 3808949-5Report Type:Expedited (15-DaCompany Report #2001UW12266 Age:44 YR Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Arrhythmia Foreign Seroquel "Zeneca" PS ORAL 50 MG TID PO Blood Magnesium Decreased Other Levaquin SS ORAL 250 MG DAILY Drug Level Above PO 10 DAY Therapeutic Citalopram C Electrocardiogram Imovane C Abnormal Levomepromazine C Electrocardiogram Qt Magnesium C Prolonged Nefazodone C Torsade De Pointes Nozinan C Ventricular Tachycardia Propranolol C Theophylline C Ventolin C Zopiclone C Date:10/08/01ISR Number: 3806780-8Report Type:Expedited (15-DaCompany Report #2001AP04726 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Foreign Seroquel "Zeneca" PS Intervention to Complications Of Maternal Health Prevent Permanent Exposure To Therapeutic Professional Impairment/Damage Drugs Other Pregnancy Date:10/08/01ISR Number: 3806781-XReport Type:Expedited (15-DaCompany Report #2001UW12243 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Seroquel "Zeneca" PS Intervention to Neutropenia Other Clonazepam SS Prevent Permanent Clozaril SS 148 DAY Impairment/Damage Estrogen SS Levothyroxine SS Singulair SS Date:10/08/01ISR Number: 3806782-1Report Type:Expedited (15-DaCompany Report #2001UW12264 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depressed Level Of Foreign Seroquel "Zeneca PS ORAL 50 MG QD PO Intervention to Consciousness Other Pce SS 333 MG TID Prevent Permanent Clonazepam C Impairment/Damage Epival C Flovent C Percocet C Tylenol Extra-Strength C Date:10/08/01ISR Number: 3806882-6Report Type:Expedited (15-DaCompany Report #1633292A Age:47 YR Gender:Female I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:31 AM Page: 329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Cardiac Arrest Literature Aspirin PS ORAL PO LESS Dialysis Health THAN 8 HOURS Haematemesis Professional Unspecified Hypotension Acetaminophen Intentional Self-Injury Product SS ORAL PO Metabolic Acidosis LESS THAN 8 Respiratory Alkalosis HOURS Quetiapine SS Date:10/08/01ISR Number: 3807685-9Report Type:Expedited (15-DaCompany Report #2001UW11757 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel "Zeneca" PS Zeneca ORAL 100 MG HS PO Professional Seroquel "Zeneca" SS Zeneca ORAL 150 MG HS PO Date:10/10/01ISR Number: 3807672-0Report Type:Expedited (15-DaCompany Report #K200100470 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Kemadrin Health (Procyclidine) Professional Tablet, 5mg PS 5 MG, TID Other Altace Capsules (Ramipril) Capsule, 1.25 Mg SS 1.25 MCG, QD Ventolin (Salbutamol) SS RESPIRATORY (INHALATION) RESPIRATORY Flupentixol (Flupentixol) SS 60 MG Quetiapine (Quetiapine) Tablet SS ORAL BID, ORAL Sandocal "Novartis"(Calcium Carbonate, Colecalciferol, Sodium) SS 400 MG, TID Alfacalcidol (Alfacalcidol) SS 1 MCG, QD Diazepam (Diazepam) SS 5 MG, TID Date:10/10/01ISR Number: 3807854-8Report Type:Expedited (15-DaCompany Report #2001UW12256 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Mental Disorder Foreign Seroquel PS ORAL 500 MG PO Intervention to Sedation Health Lithium C Prevent Permanent Professional Impairment/Damage Other 22-Feb-2006 08:31 AM Page: 330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/01ISR Number: 3808101-3Report Type:Expedited (15-DaCompany Report #2001UW12260 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Health Seroquel "Zeneca" PS Zeneca ORAL 800 MG DAILY Initial or Prolonged Difficulty In Walking Professional PO Disability Dizziness Seroquel "Zeneca" SS ORAL 700 MG DAILY Joint Stiffness PO Pyrexia Risperdal C Rhabdomyolysis Date:10/10/01ISR Number: 3809492-XReport Type:Expedited (15-DaCompany Report #1998UW47645 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Ineffective Literature Seroquel PS ORAL 200 MG BID PO Intervention to Hepatitis C Health Seroquel SS ORAL 200 MG DAILY Prevent Permanent Leukopenia Professional PO Impairment/Damage Platelet Count Decreased Olanzapine SS 10 MG DAILY Psychotic Disorder Risperdal C Date:10/10/01ISR Number: 3810020-3Report Type:Expedited (15-DaCompany Report #2001AP03838 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Salbutamol PS Astrazeneca Arrhythmia Health Pharmaceuticals Bipolar I Disorder Professional Ramipril SS ORAL 1.25 MG DAILY Blood Phosphorus Other PO Increased Quetiapine SS ORAL 75 MG HS PO Chest Pain Quetiapine SS ORAL 150 MG HS PO Confusional State Depixol SS 60 MG WEEK Coronary Artery Disease Sandocal "Novartis" SS ORAL 400 MG TID PO Delusion Alfacalcidol SS ORAL 1 UG DAILY PO Drug Level Above Diazepam SS ORAL 5 MG TID PO Therapeutic Procyclidine SS 5 MG TID Dyspnoea Chlorpromazine SS Emotional Distress Lorazepam SS Irritability Lithium SS Left Ventricular Failure Mania Respiratory Failure Speech Disorder Sudden Death Date:10/10/01ISR Number: 3810507-3Report Type:Expedited (15-DaCompany Report #B0121705A Age:55 YR Gender:Male I/FU:I Outcome PT Death Agitation Arrhythmia Bipolar I Disorder Blood Phosphorus Increased Confusional State Coronary Artery Disease Delusion Irritability Speech Disorder 22-Feb-2006 08:31 AM Page: 331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sudden Death Report Source Product Role Manufacturer Route Dose Duration Foreign Ventolin Unspecified Inhaler Device (Albuterol Sulfate) PS RESPIRATORY (INHALATION) INHALED Kemadrin (Formulation Unknown) (Procyclidine Hcl) SS 5 MG / THREE TIMES PER DAY / Flupenthixol (Formulation Unknown) (Flupenthixol) SS 60 MG / WEEKLY Quetiapine (Formulation Unknown) (Quetiapine) SS 225 MG / SEE TEXT Sandocal (Formulation Unknown) (Sandocal) SS 400 MG / THREE TIMES PER DAY Ramipril (Formulation Unknown) (Ramipril) SS 1.25 MG / IN THE MORNING / Alfacalcidol (Formulation Unknown) (Alfacalcidol) SS 1 MCG / PER DAY Diazepam (Formulation Unknown) (Diazepam) SS 5 MG / THREE TIMES PER DAY Lorazepam (Formulation Unknown) (Lorazepam) SS PARENTERAL PARENTERAL Lithium Salt (Formulation Unknown) (Lithium Salt) SS Chlorpromazine Hcl (Formulation Unknown) (Chlorpromazine Hcl) SS Date:10/12/01ISR Number: 3808641-7Report Type:Expedited (15-DaCompany Report #2001AP04758 Age:65 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Sodium Decreased Initial or Prolonged Confusional State Convulsion 22-Feb-2006 08:31 AM Page: 332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel "Zeneca" PS 600 MG DAILY Health Oxybutinin SS 2.5 MG BID Professional Ibuprofen C Other Lactulose C Paracetamol C Temazepam C Quinine Sulphate C Vitamin E C Date:10/12/01ISR Number: 3808643-0Report Type:Expedited (15-DaCompany Report #2001AP04415 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Seroquel "Zeneca" PS ORAL 400 MG DAILY Increased Health PO Aspartate Professional Seroquel "Zeneca" SS ORAL 500 MG DAILY Aminotransferase Other PO Increased Vegetamin C Hepatic Function Abnormal Silece C Leukocytosis Date:10/12/01ISR Number: 3808849-0Report Type:Expedited (15-DaCompany Report #2001UW12260 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Health Seroquel "Zeneca" PS ORAL 800 MG DAILY Initial or Prolonged Difficulty In Walking Professional PO Disability Dizziness Seroquel "Zeneca" SS ORAL 700 MG DAILY Pain In Extremity PO Pyrexia Risperdal C Rhabdomyolysis Date:10/15/01ISR Number: 3809579-1Report Type:Expedited (15-DaCompany Report #2001UW12559 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Consumer Seroquel "Zeneca" PS Zeneca ORAL 25 MG DAILY Initial or Prolonged White Blood Cell Count PO Decreased Seroquel "Zeneca" SS Zeneca ORAL 250 MG DAILY PO Depakote C Risperdal C Adderall C Date:10/15/01ISR Number: 3809724-8Report Type:Expedited (15-DaCompany Report #2001AP04834 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Lactate Foreign Seroquel "Zeneca" PS Initial or Prolonged Dehydrogenase Increased Health Rohypnol C Pyrexia Professional Zyprexa C Rhabdomyolysis Other Halcion C 22-Feb-2006 08:31 AM Page: 333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/01ISR Number: 3809753-4Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Dreams Seroquel PS 2 X DAY 100 Disability Bone Disorder MG Required Confusional State Intervention to Constipation Prevent Permanent Dizziness Impairment/Damage Dry Mouth Dyskinesia Dysphemia Face Oedema Gingival Bleeding Haematemesis Heart Rate Increased Libido Increased Oedema Photosensitivity Reaction Rectal Haemorrhage Sedation Skin Discolouration Swelling Tremor Vein Disorder Weight Increased Date:10/16/01ISR Number: 3809913-2Report Type:Expedited (15-DaCompany Report #2001-08-1173 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Salbulin Hfa Hospitalization - Arrhythmia Health (Salbutamol) Oral Initial or Prolonged Blood Phosphorus Professional Aerosol PS RESPIRATORY Increased Other (INHALATION) ORAL AER INH Delusion Depixol Injectable SS INTRAMUSCULAR 60MG QWEEK* Irritability INTRAMUCULAR Mania Ramipril Capsules SS ORAL 1.25 MG QAM Speech Disorder ORAL Sudden Death Alfacalcidol Tablets SS ORAL 1MCG QD ORAL Diazepam Tablets SS ORAL 15MG TID ORAL Procyclidine Tablets SS ORAL 15MG TID ORAL Quetiapine Fumurate SS 225MG QD Sandocal Tablets SS ORAL 400MG TID ORAL Lorazepam Injectable SS Lithium SS ORAL ORAL .... C INTRAMUSCULAR 60MG QWEEK INTRAMUSCULAR Date:10/16/01ISR Number: 3809982-XReport Type:Expedited (15-DaCompany Report #2001UW12953 Age:44 YR Gender:Female I/FU:I Outcome PT Death Cardiac Disorder Drug Level Above Therapeutic Hypokinesia Mitral Valve Incompetence Myocarditis 22-Feb-2006 08:31 AM Page: 334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tricuspid Valve Incompetence Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS Zeneca ORAL 800 MG Professional Seroquel SS Zeneca ORAL 900 MG DAILY PO Olanzapine C Topamax C Remeron C Date:10/16/01ISR Number: 3810221-4Report Type:Expedited (15-DaCompany Report #2001PK00971 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Seroquel "Zeneca" PS Zeneca ORAL 375 MG DAILY Initial or Prolonged Activated Partial Health PO Thromboplastin Time Professional Seroquel "Zeneca" SS ORAL 6 G DAILY PO Prolonged Other Gladem C Aspartate Saroten "Bayer Aminotransferase Vital" C Increased Elobact C Blood Amylase Increased Blood Lactate Dehydrogenase Increased C-Reactive Protein Increased Electrocardiogram Qt Prolonged Laboratory Test Abnormal Myoglobin Blood Increased Rhabdomyolysis Sedation Ventricular Tachycardia White Blood Cell Count Increased Date:10/17/01ISR Number: 3810618-2Report Type:Expedited (15-DaCompany Report #2001AP04055 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Foreign Seroquel "Zeneca" PS Zeneca 150 MG BID Drug Ineffective Health Sulpiride C Fatigue Professional Sedation Other Date:10/17/01ISR Number: 3811072-7Report Type:Expedited (15-DaCompany Report #2001UW12724 Age:45 YR Gender:Female I/FU:I Outcome PT Death Abdominal Distension Required Bladder Disorder Intervention to Blood Albumin Decreased Prevent Permanent Blood Calcium Decreased Impairment/Damage Blood Chloride Decreased Blood Potassium Decreased Cardiomegaly Coma Electrocardiogram St 22-Feb-2006 08:31 AM Page: 335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Segment Depression Hepatic Steatosis Oedema Oedema Peripheral Report Source Product Role Manufacturer Route Dose Duration Pathological Fracture Health Seroquel "Zeneca" PS ORAL 800 MG DAILY Pneumonia Aspiration Professional PO Thirst Clonidine C Oxycontin C Loxapine C Klonopin C Lasix C Prilosec C Iron C Senokot C Percocet C Date:10/17/01ISR Number: 3811082-XReport Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Quetiapine Fumarate PS Hospitalization - Buprenorphine C Initial or Prolonged Oxycodone Required 5mg/Acetaminophen C Intervention to Pseudoephedrine C Prevent Permanent Mirtazepine C Impairment/Damage Tramadol C Diazepam C Gabapentin C Trazodone C Multivitamins /Zinc (Centrum) C Aspirin C Phenylephrine Hcl C Date:10/17/01ISR Number: 3811091-0Report Type:Direct Company Report # Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cataract Seroquel PS ORAL 25 MG QD PO Initial or Prolonged Pepcid C Mvi C Buspar C Metamucil C Tylenol Prn C Zoloft C Date:10/18/01ISR Number: 3811248-9Report Type:Direct Company Report # Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Rigidity (Astra Zeneca) Seroquel (100 Mg Tabs) PS Astra Zeneca 100MG TABS Seroquel (Astra Zeneca) (200mg Tabs) SS Astra Zeneca Effexor C 22-Feb-2006 08:31 AM Page: 336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/01ISR Number: 3811572-XReport Type:Expedited (15-DaCompany Report #HQ6829008OCT2001 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Ativan (Lorazepam, Arrhythmia Professional Injection) PS PARENTERAL PARENTERAL Coronary Artery Other Chlorpromazine Atherosclerosis (Chlorpromazine) SS Delusion Depixol (Flupentixol Drug Level Above Decanoate) SS 60 MG 1 X PER Therapeutic 1 WK Irritability Diazepam (Diazepam) SS 5 MG 3 X PER Medication Error 1 DAY Mental Impairment Lithium (Lithium) SS 15 DAY Speech Disorder Procyclidine Sudden Death (Procyclidine) SS 5 MG 3 X PER 1 DAY Quetiapine (Quetiapine) SS 225 MG 1 X PER 1 DAY Salbutamol (Salbutamol) SS RESPIRATORY (INHALATION) INHALATION Sandocal (Calcium Glubionate) SS 400 MG 3 X PER 1 DAY Date:10/18/01ISR Number: 3811600-1Report Type:Expedited (15-DaCompany Report #2001UW12717 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Seroquel "Zeneca" PS Initial or Prolonged Aggression Antidepressants C Foot Fracture Risperdal C Suicide Attempt Neurontin C Date:10/18/01ISR Number: 3811732-8Report Type:Expedited (15-DaCompany Report #11017209 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Literature Nefazodone Hcl PS 300 MILLIGRAM, 1/1 DAY Quetiapine SS 75 MILLIGRAM, 1/1 DAY Divalproex Sodium (Valporic Acid) SS 500 MILLIGRAM, 1/1 DAY Date:10/19/01ISR Number: 3812574-XReport Type:Expedited (15-DaCompany Report #K200100247 Age:55 YR Gender:Male I/FU:F Outcome PT Death Abnormal Behaviour Agitation Arrhythmia Bipolar I Disorder Condition Aggravated 22-Feb-2006 08:31 AM Page: 337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coronary Artery Disease Drug Level Above Therapeutic Report Source Product Role Manufacturer Route Dose Duration Irritability Foreign Altace (Ramipril) PS ORAL 1.25 MG, QD, Medication Error Health ORAL Speech Disorder Professional Diazepam SS ORAL 5 MG, TID, Other ORAL Salbutamol SS ORAL ORAL Depixol (Flupentixol Decanoate) SS 60 MG, Q WEEK Quetiapine SS ORAL 225 MG, QD, ORAL Sandocal (Calcium Carbonate, Colecaliferol) SS Novartis 400 MG, TID Alfacalidol SS 1 UG Procyclidine SS 15 MG, QD Chlorpromazine SS Lorazepam SS Lithium SS Date:10/23/01ISR Number: 3813600-4Report Type:Expedited (15-DaCompany Report #2001SE07362 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aggression Foreign Seroquel "Zeneca" PS Required Hostility Study Intervention to Obsessive-Compulsive Health Prevent Permanent Disorder Professional Impairment/Damage Date:10/23/01ISR Number: 3813633-8Report Type:Expedited (15-DaCompany Report #2001AP04743 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Engorgement Foreign Seroquel PS Zeneca 700 MG DAILY Intervention to Breast Pain Health Methodone C Prevent Permanent Breast Tenderness Professional Mirtazapine C Impairment/Damage Other Date:10/23/01ISR Number: 3814378-0Report Type:Expedited (15-DaCompany Report #HQ7370619OCT2001 Age:50 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Hydroxyzine Hcl Intentional Overdose (I.M.) (Hydroxyzine Hydrochloride, Injection) PS OVERDOSE AMOUNT UNKNOWN Paroxetine (Paroxetine,) SS OVERDOSE AMOUNT UNKNOWN Quetiapine (Quetiapine,) SS OVERDOSE AMOUNT UNKNOWN 22-Feb-2006 08:31 AM Page: 338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/01ISR Number: 3814558-4Report Type:Expedited (15-DaCompany Report #2001SE07707 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel "Zeneca" PS ORAL 150 MG BID PO Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:10/24/01ISR Number: 3814559-6Report Type:Expedited (15-DaCompany Report #2001PK01008 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Seroquel "Zeneca" PS ORAL 150 MG DAILY Leukopenia Health PO Neutropenia Professional Leponex "Novartis" C Other Date:10/25/01ISR Number: 3815459-8Report Type:Expedited (15-DaCompany Report #2001SE07749 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel Medication Error Health "Zeneca" PS Zeneca 400 MG DAILY Professional Valium C Other Nozinan C Tegretol C Haldol C Seroxat C Ciba-Geigy Dominal C Kemadrin C Date:10/25/01ISR Number: 3815483-5Report Type:Expedited (15-DaCompany Report #2001SE06513 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Seroquel "Zeneca" PS ORAL 200 MG DAILY Initial or Prolonged Dyspnoea Health PO Muscle Spasms Professional Lipobay SS ORAL 0.4 MG DAILY Rhabdomyolysis Other PO Zoloft C Date:10/25/01ISR Number: 3815484-7Report Type:Expedited (15-DaCompany Report #2001UW12266 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Foreign Seroquel "Zeneca" PS ORAL 50 MG TID PO Intervention to Blood Magnesium Decreased Other Seroquel "Zeneca" SS ORAL 200 MG HS PO Prevent Permanent Drug Level Above Levaquin SS ORAL 250 MG DAILY Impairment/Damage Therapeutic PO Electrocardiogram Qt Citalopram C Prolonged Imovane C Syncope Levomepromazine C Torsade De Pointes Magnesium C Ventricular Tachycardia Nefazodone C Nozinan C Propranolol C Theophylline C 22-Feb-2006 08:31 AM Page: 339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventolin C Zopiclone C Date:10/29/01ISR Number: 3816643-XReport Type:Expedited (15-DaCompany Report #2001PK00941 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Seroquel PS Zeneca ORAL 800 MG DAILY Erythema Other PO Leukopenia Pruritus Date:10/29/01ISR Number: 3817144-5Report Type:Expedited (15-DaCompany Report #2001PK00879 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel "Zeneca" PS Astrazeneca Hospitalization - Drug Toxicity Study Pharmaceuticals 50 MG DAILY Initial or Prolonged Leukopenia Health Seroquel "Zeneca" SS 75 MG DAILY Professional Seroquel "Zeneca" SS 100 MG DAILY Other Seroquel "Zeneca" SS 200 MG DAILY Seroquel "Zeneca" SS 400 MG DAILY Seroquel "Zeneca" SS 1000 MG DAILY Leponex "Sandoz" SS Leponex "Sandoz" SS 162.5 MG DAILY Leponex "Sandoz" SS 200 MG DAILY Leponex "Sandoz" SS 150 MG DAILY Leponex "Sandoz" SS 100 MG DAILY Lyogen C Akineton C Truxal C Date:10/29/01ISR Number: 3817149-4Report Type:Expedited (15-DaCompany Report #APCDSS2001001371 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL 6 MG, DAILY, Professional ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL 150 MG, DAILY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL 300 MG, DAILY, ORAL Olanzapine (Olanzapine) SS ORAL 5 MG, DAILY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Biperiden Hydrochloride 22-Feb-2006 08:31 AM Page: 340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Biperiden Hydrochloride) C Teprenone (Teprenone) C Date:10/29/01ISR Number: 3817153-6Report Type:Expedited (15-DaCompany Report #2001SE07712 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel "Zeneca" PS ORAL 200 MG BID PO Intervention to Health Vallergan C Prevent Permanent Professional Impairment/Damage Other Date:10/29/01ISR Number: 3817156-1Report Type:Expedited (15-DaCompany Report #2001UW13564 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Foreign Seroquel "Zeneca" PS ORAL 550 MG DAILY Reading Disorder Health PO Professional Seroquel "Zeneca" SS ORAL 200 MG HS PO Other Seroquel "Zeneca" SS ORAL 25 MG QD PO Olanzapine C Date:11/02/01ISR Number: 3819696-8Report Type:Expedited (15-DaCompany Report #2001AP05201 Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Quetiapine PS Health Gabapentin SS Professional Indinavir SS Date:11/02/01ISR Number: 3819942-0Report Type:Expedited (15-DaCompany Report #2001PK00941 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Seroquel "Zeneca" PS ORAL 800 MG DAILY Erythema Other PO Leukopenia Pruritus Date:11/02/01ISR Number: 3820105-3Report Type:Direct Company Report # Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Geodon PS Hospitalization - Electrocardiogram Seroquel SS Initial or Prolonged Abnormal Tegretal C Pulse Absent Cogentin C Ativan C Glucotrol C 22-Feb-2006 08:31 AM Page: 341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/01ISR Number: 3820238-1Report Type:Expedited (15-DaCompany Report #2001SE06941 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Foreign Seroquel "Zeneca" PS ORAL 400 MG DAILY Required Study PO Intervention to Health Prozac C Prevent Permanent Professional Clopixol C Impairment/Damage Other Kemadrin C Valium C Date:11/02/01ISR Number: 3820239-3Report Type:Expedited (15-DaCompany Report #2001UW13786 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel "Zeneca" PS Decreased Health Professional Other Date:11/02/01ISR Number: 3820242-3Report Type:Expedited (15-DaCompany Report #2001UW12264 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Decreased Foreign Seroquel "Zeneca" PS ORAL 50 MG QD PO Intervention to Depressed Level Of Other Pce SS 333 MG TID Prevent Permanent Consciousness Clonazepam C Impairment/Damage Pco2 Decreased Epival C Po2 Increased Flovent C Percocet C Tylenol Extra-Strength C Date:11/02/01ISR Number: 3820244-7Report Type:Expedited (15-DaCompany Report #2001SE07874 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Dissection Foreign Seroquel "Zeneca" PS Zeneca 400 MG DAILY Myocardial Infarction Health Amlor C Sudden Death Professional Dipiperon C Other Stilnoct C Akineton C Loortan C Nozinan C Risperdal C Date:11/05/01ISR Number: 3820855-9Report Type:Expedited (15-DaCompany Report #02610 Age:30 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Trazodone PS Intentional Overdose Amitriptyline SS Quetiapine SS 22-Feb-2006 08:31 AM Page: 342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/01ISR Number: 3821882-8Report Type:Expedited (15-DaCompany Report #2001AP05295 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Seroquel PS ORAL 50 MG DAILY Sudden Death Health PO Professional Symmetrel C Other Gramalil C Depas C Date:11/05/01ISR Number: 3821959-7Report Type:Expedited (15-DaCompany Report #2001SE05879 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Foreign Seroquel "Zeneca" PS ORAL 800 MG DAILY Life-Threatening Cardio-Respiratory Arrest Study PO Dehydration Health Metformin C Dialysis Professional Carvediol C Diarrhoea Other Ramipril C Dizziness Indapamide C Hypotension Hypoventilation Muscle Twitching Pulse Pressure Decreased Pupillary Reflex Impaired Pyrexia Renal Failure Viral Infection Date:11/05/01ISR Number: 3821961-5Report Type:Expedited (15-DaCompany Report #2001UW13713 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Rhabdomyolysis Foreign Seroquel "Zeneca" PS ORAL 200 MG HS PO 2 WK Intervention to Health Seroquel "Zeneca" SS ORAL 100 MG QD PO 8 MON Prevent Permanent Professional Epival C 250 MG 1 YR Impairment/Damage Other Effexor C ORAL 225 MG PO 1 YR Date:11/05/01ISR Number: 3822289-XReport Type:Expedited (15-DaCompany Report #2001AP03675 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Seroquel "Zeneca" PS ORAL 100 MG BID PO Dementia Health Simemet-Plus C Neutropenia Professional Domperidone C Sepsis Other Date:11/06/01ISR Number: 3820747-5Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Seroquel (200mg) PS ORAL 200MG BID PO Required Syndrome Navane SS ORAL 20MG BID PO Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/01ISR Number: 3821430-2Report Type:Expedited (15-DaCompany Report #2001GB00028 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Flutter Foreign Quetiapine PS ORAL 25 MG BID PO Hospitalization - Health Aspirin "Bayer" C Initial or Prolonged Professional Isosorbide Required Other Mononitrate C Intervention to Frusemide C Prevent Permanent Simvastatin C Impairment/Damage Lansoprazole C Thyroxine C Beclomethasone C Date:11/06/01ISR Number: 3821439-9Report Type:Expedited (15-DaCompany Report #2001AP02732 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Disorder Foreign Seroquel "Zeneca" PS Zeneca ORAL 37 G PO Hospitalization - Hypothermia Health Carbamazepine SS 8 G Initial or Prolonged Loss Of Consciousness Professional Procyclidine C Lower Respiratory Tract Other Co-Proxamol C Infection Overdose Pyrexia Suicide Attempt Date:11/07/01ISR Number: 3823251-3Report Type:Expedited (15-DaCompany Report #2001UW10757 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Marrow Hyperplasia Foreign Seroquel "Zeneca" PS Zeneca ORAL 6.25 MG HS PO Initial or Prolonged Neutropenia Health Sinemet-Cr C Neutrophilia Professional Conjugated Estrogens C Other Hydrochlorothiazide C Levothyroxine C Vitamin D2 C Benadryl C Ibuprofen C Ropinirole C Slow-K C Date:11/07/01ISR Number: 3824301-0Report Type:Expedited (15-DaCompany Report #2001UW12243 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Seroquel "Zeneca" PS Zeneca Intervention to Neutropenia Other Clonazepam SS Prevent Permanent Clozaril SS Impairment/Damage Estrogen SS Levothyroxine C Singulair C 22-Feb-2006 08:31 AM Page: 344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/01ISR Number: 3822371-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chromaturia Seroquel Disability Electrolyte Imbalance (Quetiapine) PS Required Ulcer Intervention to Weight Decreased Prevent Permanent Impairment/Damage Date:11/08/01ISR Number: 3822373-0Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Palpitations Pravastatin PS PREADMISSION Initial or Prolonged Rhabdomyolysis Stelazine SS Seroquel SS Metoprolol C Glyburide C Acetaminophen C Date:11/08/01ISR Number: 3824160-6Report Type:Expedited (15-DaCompany Report #2001AP05295 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Seroquel PS ORAL 50 MG DAILY Health PO Professional Symmetrical C Other Gramalil C Depas C Date:11/12/01ISR Number: 3825187-0Report Type:Expedited (15-DaCompany Report #2001SE06912 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Foreign Seroquel "Zeneca" PS ORAL 200 MG DAILY Hospitalization - Distress Syndrome Health PO Initial or Prolonged Overdose Professional Buspar C Respiratory Failure Other Zoloft C Sedation Speech Disorder Date:11/12/01ISR Number: 3825188-2Report Type:Expedited (15-DaCompany Report #2001SE07248 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Seroquel "Zeneca" PS ORAL 200 MG DAILY Initial or Prolonged Insomnia Health PO Status Epilepticus Professional Besitran C Other Noctamid C Idalprem C 22-Feb-2006 08:31 AM Page: 345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/01ISR Number: 3825190-0Report Type:Expedited (15-DaCompany Report #2001GB00048 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depressed Level Of Foreign Quetiapine PS ORAL 25 MG DAILY Intervention to Consciousness Health PO Prevent Permanent Professional Betahistine C Impairment/Damage Other Sinemet C Date:11/13/01ISR Number: 3826058-6Report Type:Expedited (15-DaCompany Report #EMADSS2001006354 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal (2 Mg Initial or Prolonged Health Tablet) Other Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 DAILY, ORAL Seroquel (Seroquel) SS ORAL 100 MG, 2 IN 1 DAILY, ORAL Date:11/13/01ISR Number: 3826186-5Report Type:Expedited (15-DaCompany Report #2001UW14349 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel "Zeneca" PS Intervention to Health Epival C Prevent Permanent Professional Impairment/Damage Other Date:11/13/01ISR Number: 3826188-9Report Type:Expedited (15-DaCompany Report #2001AP05344 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 75 MG DAILY Initial or Prolonged Increased Health PO Aspartate Professional Seroquel SS ORAL 150 MG DAILY Aminotransferase Other PO Increased Contomin SS ORAL 25 MG DAILY Blood Creatine PO Phosphokinase Increased Diazepam C C-Reactive Protein Celmanil C Increased Date:11/14/01ISR Number: 3823673-0Report Type:Periodic Company Report #C2001-1063.01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets 25 Other Neutropenia Professional Mg Mylan PS ORAL 525 MG/DAY, Other ORAL Depakote Abbott SS ORAL 1750 MG/DAY, ORAL Seroquel Astra Zeneca SS Astra Zeneca ORAL 700 MG/DAY, ORAL Levothyroxine C Lithium C 22-Feb-2006 08:31 AM Page: 346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/01ISR Number: 3824258-2Report Type:Direct Company Report #USP 54584 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel 200mg (Quetiapine) PS Astra Zeneca Serzone 200mg (Nefazodone Hcl) SS Bristol-Myers Squibb Date:11/16/01ISR Number: 3825370-4Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Clozaril (Novartis) Haematemesis 500-800 Mg/D X 6yr PS Novartis 500-800 MG/D Sudden Death X 6YR 6 YR Seroquel 800-600mg/D X 3 Years SS 800-600MG/D X 3 YEARS 3 YR Effexor Xr 300-450mg/D X 5 Mo SS 300-450MG/D X 5 MO 5 MON Depakote 1000mg Hs X 5mo SS 1000MG HS X 5MO 5 MON Lipitor C Cozaar C Lung Inhaler C Date:11/16/01ISR Number: 3825529-6Report Type:Direct Company Report #USP 54547 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Serzone PS Bristol-Myers Squibb Seroquel SS Astra Zeneca Date:11/16/01ISR Number: 3825531-4Report Type:Direct Company Report #USP 54549 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Seroquel PS Astra Zeneca Serzone SS Bristol-Myers Squibb Seroquel SS Astra Zeneca Serzone SS Bristol-Myers Squibb Date:11/16/01ISR Number: 3825833-1Report Type:Expedited (15-DaCompany Report #2001AP05426 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Literature Quetiapine PS Decreased Health Platelet Count Decreased Professional 22-Feb-2006 08:31 AM Page: 347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/01ISR Number: 3825918-XReport Type:Expedited (15-DaCompany Report #2001UW12724 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Seroquel "Zeneca" PS "Zeneca" ORAL 800 MG HS PO Required Aspartate Professional Seroquel "Zeneca" SS "Zeneca" ORAL 800 MG DAILY Intervention to Aminotransferase PO Prevent Permanent Increased Seroquel "Zeneca" SS "Zeneca" ORAL 800 MG DAILY Impairment/Damage Aspiration PO Belligerence Clonidine C Bladder Disorder Oxycontin C Blood Albumin Decreased Loxitane C Blood Alkaline Klonopin C Phosphatase Increased Lasix C Blood Calcium Decreased Prilosec C Blood Chloride Decreased Iron C Blood Potassium Decreased Senokot C Blood Sodium Decreased Percocet C Coma Haldol C Electrocardiogram Depakote C Abnormal Dramamine C Haematocrit Decreased Haemoglobin Decreased Hepatic Steatosis Mania Oedema Oedema Peripheral Pathological Fracture Pneumonia Aspiration Thirst Date:11/16/01ISR Number: 3826594-2Report Type:Expedited (15-DaCompany Report #2001PK01065 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel "Zeneca" PS Zeneca ORAL 250 MG DAILY Initial or Prolonged Health PO Professional Seroquel "Zeneca" SS Zeneca ORAL 500 MG DAILY Other PO Seroquel "Zeneca" SS Zeneca ORAL 600 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 500 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 450 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 450 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 200 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 300 MG DAILY PO Date:11/16/01ISR Number: 3826849-1Report Type:Expedited (15-DaCompany Report #2001UW14675 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other 22-Feb-2006 08:31 AM Page: 348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/01ISR Number: 3826852-1Report Type:Expedited (15-DaCompany Report #2001SE08411 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS 600 MG DAILY Health Sodium Valproate C Professional Other Date:11/16/01ISR Number: 3826860-0Report Type:Expedited (15-DaCompany Report #2001PK01090 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Seroquel "Zeneca" PS ORAL 75 MG DAILY Initial or Prolonged Emotional Distress Health PO Restlessness Professional Seroquel "Zeneca" SS ORAL 100 MG DAILY Other PO Seroquel "Zeneca" SS ORAL 75 MG DAILY PO Seroquel "Zeneca" SS ORAL 100 MG DAILY PO Seroquel "Zeneca" SS ORAL 125 MG DAILY PO Seroquel "Zeneca" SS ORAL 150 MG DAILY PO Tavor C Date:11/16/01ISR Number: 3826865-XReport Type:Expedited (15-DaCompany Report #2001AP05471 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Foreign Seroquel "Zeneca" PS ORAL 300 MG DAILY Haemorrhage Health PO Neuroleptic Malignant Professional Zotepine C Syndrome Other Haloperidol C Renal Failure Acute Akineton C Sepsis Artane C Anafranil C Hiberna C Rohypnol C Date:11/16/01ISR Number: 3827309-4Report Type:Expedited (15-DaCompany Report #2001AP05429 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Seroquel PS ORAL 50 MG DAILY Dehydration Health PO Epilepsy Professional Seroquel SS ORAL 100 MG DAILY Loss Of Consciousness Other PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Risperdal C Gasmotin C Selbex C Nitorol C Amoban C Sediel C 22-Feb-2006 08:31 AM Page: 349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Frandol C Date:11/16/01ISR Number: 3827366-5Report Type:Expedited (15-DaCompany Report #2001PK01065 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel "Zeneca" PS Astrazeneca Lp ORAL 250 MG DAILY Initial or Prolonged Health PO Professional Seroquel "Zeneca" SS ORAL 500 MG DAILY Other PO Seroquel "Zeneca" SS ORAL 600 MG DAILY PO Seroquel "Zeneca" SS ORAL 500 MG DAILY PO Seroquel "Zeneca" SS ORAL 450 MG DAILY PO Seroquel "Zeneca" SS ORAL 450 MG DAILY PO Seroquel "Zeneca" SS ORAL 200 MG DAILY PO Seroquel "Zeneca" SS ORAL 300 MG DAILY PO Date:11/16/01ISR Number: 3827380-XReport Type:Expedited (15-DaCompany Report #2001PK01070 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Seroquel "Zeneca" PS ORAL 150 MG DAILY Initial or Prolonged Anxiety Health PO Confusional State Professional Seroquel "Zeneca" SS ORAL 200 MG DAILY Delirium Other PO Disorientation Seroquel "Zeneca" SS ORAL 250 MG DAILY Dizziness PO Drug Interaction Seroquel "Zeneca" SS ORAL 300 MG DAILY Drug Level Above PO Therapeutic Leponex "Novartis" SS ORAL 225 MG DAILY Drug Level Below PO Therapeutic Leponex "Novartis" SS ORAL 275 MG DAILAY Vomiting PO Leponex "Novartis" SS ORAL 300 MG DAILY PO Leponex "Novartis" SS ORAL 350 MG DAILY PO Leponex "Novartis" SS ORAL 400 MG DAILY PO Leponex "Novartis" SS ORAL 450 MG DAILY PO Leponex "Novartis" SS ORAL 500 MG DAILY PO Leponex "Novartis" SS ORAL 550 MG DAILY PO Leponex "Novartis" SS ORAL 650 MG DAILY PO Leponex "Novartis" SS ORAL 700 MG DAILY PO Leponex "Novartis" SS ORAL 500 MG DAILY PO Leponex "Novartis" SS ORAL 400 MG DAILY PO 22-Feb-2006 08:31 AM Page: 350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stilnox C Tavor C Pirenzepin C Date:11/16/01ISR Number: 3827549-4Report Type:Expedited (15-DaCompany Report #2001PK00187 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Seroquel "Zeneca" PS "Zeneca" ORAL 600 MG DAILY Initial or Prolonged Hyperthyroidism Health PO Influenza Like Illness Professional Leukopenia Other Myocarditis Thrombocytopenia Date:11/16/01ISR Number: 3827550-0Report Type:Expedited (15-DaCompany Report #2001PK01076 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Foreign Seroquel PS Zeneca ORAL 100 MG DAILY Initial or Prolonged Drug Interaction Health PO Hypoaesthesia Professional Seroquel SS Zeneca ORAL 200 MG DAILY PO Seroquel SS Zeneca ORAL 600 MG DAILY PO Leponex SS Novartis ORAL 200 MG DAILY PO Leponex SS Novartis ORAL 250 MG DAILY PO Leponex SS Novartis ORAL 300 MG DAILY PO Leponex SS Novartis ORAL 350 MG DAILY PO Leponex SS Novartis ORAL 400 MG DAILY PO Leponex SS Novartis ORAL 200 MG DAILY PO L-Thyroxin C Dociton C Date:11/16/01ISR Number: 3827580-9Report Type:Expedited (15-DaCompany Report #2001GB00067 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Toxicologic Test Abnormal Foreign Seroquel PS Health Epilim C Professional Clopixol (Decanoate) C Other Date:11/16/01ISR Number: 3827974-1Report Type:Expedited (15-DaCompany Report #2001UW05633 Age: Gender:Male I/FU:F Outcome PT Hospitalization - Arthralgia Initial or Prolonged Condition Aggravated Confusional State Depression 22-Feb-2006 08:31 AM Page: 351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Hypomania Insomnia Report Source Product Role Manufacturer Route Dose Duration Lethargy Consumer Seroquel "Zeneca" PS ORAL 700 MG DAILY Paranoia PO Platelet Count Decreased Seroquel "Zeneca" SS ORAL 100 MG BID PO Sedation Seroquel "Zeneca" SS ORAL 600 MG DAILY Stress PO Seroquel "Zeneca" SS ORAL 500 MG QD PO Risperdal C Depakote C Neurontin C Clonapin C Prevacid C Tapazole C Lasix C Rhinocort Aqua C Zoloft C Celebrex C Date:11/19/01ISR Number: 3825858-6Report Type:Expedited (15-DaCompany Report #WAES 01112380 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Crixivan PS Merck & Co., Inc ORAL Gabapentin SS ORAL Quetiapine Fumarate SS ORAL [Composition Unspecified] SS ORAL Date:11/19/01ISR Number: 3827508-1Report Type:Expedited (15-DaCompany Report #2001UW14447 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Seroquel "Zeneca' PS ORAL 300 MG DAILY Initial or Prolonged Diabetic Ketoacidosis Professional PO Required Myocardial Ischaemia Depakote C Intervention to Prevent Permanent Impairment/Damage Date:11/20/01ISR Number: 3827828-0Report Type:Expedited (15-DaCompany Report #2001GB00059 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Health Professional Other Date:11/21/01ISR Number: 3829116-5Report Type:Expedited (15-DaCompany Report #2001GB00059 Age: Gender: I/FU:I Outcome PT Report Source Other Neutropenia Foreign Health Professional 22-Feb-2006 08:31 AM Page: 352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel PS Date:11/21/01ISR Number: 3829383-8Report Type:Expedited (15-DaCompany Report #US_011176963 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Quetiapine PS 300 MG/DAY Initial or Prolonged Health Professional Date:11/21/01ISR Number: 3829556-4Report Type:Expedited (15-DaCompany Report #2001AP04714 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel "Zeneca" PS Zeneca Intervention to Health Clozapine C Prevent Permanent Professional Haloperidol C Impairment/Damage Other Amlodipine C Zopiclone C Date:11/21/01ISR Number: 3829558-8Report Type:Expedited (15-DaCompany Report #2001GB00095 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Increased Foreign Seroquel PS 150 MG DAILY Intervention to Drug Interaction Health Paroxetine C Prevent Permanent Serotonin Syndrome Professional Impairment/Damage Other Date:11/21/01ISR Number: 3829559-XReport Type:Expedited (15-DaCompany Report #2001SE08455 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 550 MG DAILY Health PO Professional Na Valproate C Other Date:11/21/01ISR Number: 3829561-8Report Type:Expedited (15-DaCompany Report #2001SE07749 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel "Zeneca" PS Zeneca 400 MG DAILY Health Valium C Professional Nozinan C Other Tegretol C Haldol C Seroxat "Ciba-Geigy" C Dominal Forte C Kemadrin C 22-Feb-2006 08:31 AM Page: 353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/01ISR Number: 3829563-1Report Type:Expedited (15-DaCompany Report #2001AP04905 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Face Oedema Foreign Seroquel "Zeneca" PS Zeneca 300 MG DAILY Health Lithium C Professional Paroxetine C Other Thyroxine "Aps" C Aps Date:11/21/01ISR Number: 3829784-8Report Type:Expedited (15-DaCompany Report #001-0945-M0101195 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Neurontin PS ORAL 1200 MG (600 Initial or Prolonged Anxiety MG, BID), PER Other Cognitive Disorder ORAL Condition Aggravated Seroquel Convulsion (Quetiapine) SS Drug Ineffective Klonopin Extrapyramidal Disorder (Clonazepam) SS ORAL 1.5 MG (BID), Mania PER ORAL Medication Error Nightmare Panic Attack Sedation Thinking Abnormal Tremor Weight Increased Date:11/21/01ISR Number: 3830144-4Report Type:Expedited (15-DaCompany Report #2001AP05295 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Seroquel "Zeneca" PS ORAL 50 MG DAILY Cardio-Respiratory Arrest Health PO Diarrhoea Professional Symmetrel C Malnutrition Other Anatensol C Pneumonia Akineton C Productive Cough Impromen C Sudden Death Hiberna C Doral C Unasyn For Injection C Tienam C Gramalil C Depas C Date:11/21/01ISR Number: 3830147-XReport Type:Expedited (15-DaCompany Report #2001UW14682 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel "Zeneca" PS ORAL 100 MG QD PO Intervention to International Normalised Health Seroquel "Zeneca" SS ORAL 25 MG QD PO Prevent Permanent Ratio Increased Professional Impairment/Damage Other 22-Feb-2006 08:31 AM Page: 354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/01ISR Number: 3830149-3Report Type:Expedited (15-DaCompany Report #2001UW14674 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Loss Of Consciousness Foreign Seroquel "Zeneca" PS Intervention to Syncope Health Prevent Permanent Professional Impairment/Damage Other Date:11/23/01ISR Number: 3828671-9Report Type:Expedited (15-DaCompany Report #HQ8398513NOV2001 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alkaline Health Effexor Xr Phosphatase Increased Professional (Venlafaxine Circulatory Collapse Hydrochloride, Electrocardiogram St Capsule, Extended Segment Abnormal Release) PS 450 MG 1X PER Haematemesis 1 DAY 5 MON Influenza Like Illness Clozaril (Clozapine, Mitral Valve Incompetence ) SS 800 MG 1X PER Sudden Death 1 DAY 6 YR Ventricular Hypertrophy Depakote (Valproate White Blood Cell Count Semisodium, ) SS 1000 MG AT Increased BEDTIME 5 MON Seroquel (Quetiapine) SS 600 MG 1X PER 1 DAY 3 YR Lipitor (Atorvastatin) C Cozaar (Losartan Potassium) C Unspecified Inhaler (Unspecified Inhaler) C Date:11/26/01ISR Number: 3829678-8Report Type:Expedited (15-DaCompany Report #WAES 01112380 Age:35 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Literature Cap Crixivan PS ORAL PO Health Gabapentin SS ORAL PO Professional Quetiapine Fumarate SS ORAL PO [Composition Unspecified] SS ORAL PO Date:11/26/01ISR Number: 3829684-3Report Type:Expedited (15-DaCompany Report #2001UW14720 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Haemorrhagic Stroke Consumer Seroquel PS ORAL 400 MG PO Intervention to Myocardial Infarction Seroquel SS ORAL 200 MG PO Prevent Permanent Weight Increased Impairment/Damage 22-Feb-2006 08:31 AM Page: 355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/01ISR Number: 3830018-9Report Type:Expedited (15-DaCompany Report #2001UW14880 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Seroquel PS ORAL 150 MG BID PO Initial or Prolonged Full Blood Count Professional Decreased Neuroleptic Malignant Syndrome Vomiting Date:11/27/01ISR Number: 3830573-9Report Type:Expedited (15-DaCompany Report #PHEH2001US08891 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Health Clozaril Abnormal Professional (Clozapine)Tablet PS ORAL 800MG DAILY, Gastrointestinal ORAL Infection Seroquel Haematemesis (Quetiapine) SS Ventricular Hypertrophy Effexor(Venlafaxine Hydrochloride) SS Depakote(Valproate Semisodium) SS Lipitor (Atorvastatin) C Cozaar(Losartan Potassium) C Lung Surfactants C Date:11/27/01ISR Number: 3830649-6Report Type:Expedited (15-DaCompany Report #S01-USA-02259-01 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Celexa (Citalopram Initial or Prolonged Ileus Paralytic Professional Hydrobromide) PS ORAL 1200 MG ONCE Intentional Overdose Company PO Nausea Representative Celexa (Citalopram Tremor Hydrobromide) SS ORAL 40 MG QD PO Seroquel SS ORAL 1200 MG ONCE PO Seroquel SS ORAL 200 MG QD PO Clozaril (Clozapine)` C Date:11/27/01ISR Number: 3831031-8Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Seroquel 200 Mg Initial or Prolonged Fall Zeneca PS ORAL 600 MG ONCE ORAL Asa C Atenolol C Insulin C Lisinopril C Vitamin E C 22-Feb-2006 08:31 AM Page: 356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/01ISR Number: 3831161-0Report Type:Expedited (15-DaCompany Report #2001AP05344 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 75 MG DIALY Initial or Prolonged Increased Study PO Aspartate Health Seroquel SS ORAL 150 MG DAILY Aminotransferase Professional PO Increased Other Contomin SS ORAL 25 MG DAILY Blood Chloride Increased PO Blood Creatine Cefocef SS 2 G DAILY Phosphokinase Increased Diazepam C C-Reactive Protein Celmanil C Increased Pneumonia Date:11/27/01ISR Number: 3831353-0Report Type:Expedited (15-DaCompany Report #2001SE07874 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Dissection Foreign Seroquel "Zeneca" PS Zeneca 400 MG DAILY Myocardial Infarction Health Amlor C Sudden Death Professional Dipiperon C Other Stilnoct C Akineton C Loortan C Nozinan C Risperdal C No Match C Omic C Date:11/28/01ISR Number: 3831403-1Report Type:Expedited (15-DaCompany Report #2001UW10775 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersomnia Health Seroquel PS ORAL 25 MG ONCE PO Initial or Prolonged Syncope Professional Date:11/28/01ISR Number: 3831408-0Report Type:Expedited (15-DaCompany Report #2001UW15100 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS Life-Threatening Cardiac Disorder Professional Date:11/28/01ISR Number: 3831410-9Report Type:Expedited (15-DaCompany Report #2001UW14742 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS Life-Threatening Cardiac Disorder Professional 22-Feb-2006 08:31 AM Page: 357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/01ISR Number: 3831419-5Report Type:Expedited (15-DaCompany Report #2001UW14835 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Other Seroquel PS ORAL 50 MG BID PO Initial or Prolonged Blood Creatine A FEW YEARS Phosphokinase Increased Seroquel SS ORAL 500 MG HS PO Blood Creatine A FEW YEARS Phosphokinase Mb Gabitril SS ORAL 14 MG QD PO Increased Paxil SS ORAL 30 MG QD PO Complex Partial Seizures Ritalin SS ORAL 20 MG QID PO Delirium Lamictal C Faecal Incontinence Biaxin C Grand Mal Convulsion Neurontin C Leukocytosis Zomig C Major Depression Imitrex Mental Impairment "Glaxo-Wellcome" C Migraine Ranitidine C Urinary Incontinence Remeron C White Blood Cell Count Synthroid C Increased Date:11/28/01ISR Number: 3831770-9Report Type:Expedited (15-DaCompany Report #2001UW14977 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS Overdose Professional Alprazolam C Mirtazapine C Date:11/28/01ISR Number: 3832063-6Report Type:Expedited (15-DaCompany Report #2000AP05873 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Lethargy Foreign Seroquel "Zeneca" PS 400 MG DAILY Intervention to Leukopenia Literature Seroquel "Zeneca" SS 750 MG DAILY 1 MON Prevent Permanent Neutropenia Health Impairment/Damage Tardive Dyskinesia Professional Other Date:11/28/01ISR Number: 3832461-0Report Type:Expedited (15-DaCompany Report #2001SE08727 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Foreign Quetiapine PS 50 MG DAILY Intervention to Dystonia Health Prevent Permanent Joint Stiffness Professional Impairment/Damage Pain Other Tongue Spasm Torticollis Vision Blurred Date:11/29/01ISR Number: 3832534-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB03207 Age:29 YR Gender:Male I/FU:I Outcome PT Hospitalization - Cardiac Disorder Initial or Prolonged Hypothermia 22-Feb-2006 08:31 AM Page: 358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Lower Respiratory Tract Infection Report Source Product Role Manufacturer Route Dose Duration Overdose Foreign Carbamazepine Suicide Attempt Health (Carbamazepine) PS Professional Seroquel Other (Quetiapine) SS ORAL ORAL Procyclidine (Procyclidine) C Co-Proxamol (Dextropropoxyphene Hydrochloride, Paracetamol) C Date:11/29/01ISR Number: 3833122-4Report Type:Expedited (15-DaCompany Report #2001AP05295 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Valve Stenosis Foreign Seroquel "Zeneca" PS ORAL 50 MG DAILY Aspiration Health PO Cardiac Failure Professional Gramalil SS ORAL 75 MG DAILY Cardio-Respiratory Arrest Other PO Oral Intake Reduced Gramalil SS ORAL 50 MG DAILY Sudden Death PO Depas SS ORAL 1 MG DAILY PO Symmetrel C Anatensol C Akineton C Impromen C Hiberna C Doral C Unasyn For Injection C Tienam C Date:11/29/01ISR Number: 3836125-9Report Type:Periodic Company Report #US_010260340 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Study Quetiapine PS 400 MG/DAY Initial or Prolonged Health Olanzapine SS 15 MG/DAY Professional Olanzapine SS 20 MG/DAY Xanax (Alprazolam) C Albuterol C Date:11/29/01ISR Number: 3837056-0Report Type:Periodic Company Report #US009033 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Gabitril PS ORAL 2 MG QD ORAL Initial or Prolonged Complex Partial Seizures Professional Gabitril SS ORAL 16 MG QD ORAL Faecal Incontinence Company Gabitril SS ORAL 16 MG QD ORAL Urinary Incontinence Representative Seroquel SS ORAL 50 MG BID ORAL A FEW YEARS Seroquel SS ORAL 500 MG QHS ORAL A FEW YEARS Ritalin SS ORAL 20 MG QID 22-Feb-2006 08:31 AM Page: 359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Paxil SS ORAL 30 MG DAILY ORAL Lamictal C Biaxin C Neurontin C Zomig C Imitrex C Glaxo-Welcome Ranitidine C Remeron C Synthroid C Date:11/29/01ISR Number: 3839623-7Report Type:Periodic Company Report #US_010566539 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Study Quetiapine PS 300 MG/DAY Initial or Prolonged Health Quetiapine SS 400 MG/DAY Professional Olanzapine SS 15 MG/IN THE EVENING Valium (Diazepam) C Date:11/30/01ISR Number: 3833177-7Report Type:Expedited (15-DaCompany Report #2001SE08765 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Mass Foreign Seroquel PS 300 MG DAILY Intervention to Gynaecomastia Health Canabis C Prevent Permanent Hepatic Enzyme Increased Professional Alcohol C Impairment/Damage Injury Other Date:11/30/01ISR Number: 3833361-2Report Type:Expedited (15-DaCompany Report #2001UW12260 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Seroquel "Zeneca" PS ORAL 800 MG DAILY Initial or Prolonged Pyrexia Professional PO Required Rhabdomyolysis Seroquel "Zeneca" SS ORAL 700 MG DAILY Intervention to PO Prevent Permanent Risperdal C Impairment/Damage Date:12/03/01ISR Number: 3833905-0Report Type:Expedited (15-DaCompany Report #2001UW13564 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Foreign Seroquel "Zeneca" PS Zeneca ORAL 550 MG DAILY Health PO Professional Seroquel "Zeneca" SS Zeneca ORAL 200 MG HS PO Other Seroquel "Zeneca" SS Zeneca ORAL 25 MG QD PO Olanzapine C 22-Feb-2006 08:31 AM Page: 360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/01ISR Number: 3833057-7Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Quetapine (200mg) Qd Increased Orally PS ORAL 200MG QD Gamma-Glutamyltransferase ORALLY Increased Clonazepam C Intentional Overdose ... C Date:12/04/01ISR Number: 3833066-8Report Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Seroquel (25mg) PS 25 MG PO Hospitalization - Body Temperature (DAILY AS Initial or Prolonged Increased BID) Required Dehydration Prednisone (20 Mg) SS ORAL 20 MG PO (8 Intervention to Haematemesis PILLS Prevent Permanent Urine Ketone Body Present DISPENSED) Impairment/Damage White Blood Cell Count Prolixin Deconate Increased 50mg SS INTRAMUSCULAR 50 MG IM Q MONTH Zyprexa Zydis 5 Mg SS INTRAVENOUS 5 MG PO IVP Insulin C Liquid Prozac C Liquid Depakene C Depakote C Zanax C Klonopin C Date:12/04/01ISR Number: 3833860-3Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Quetiapine PS 200 MG QHS Cogwheel Rigidity AND 100 MG Tremor BID Fluoxetine Hcl C Ibuprofen C Lorazepam C Multivitamin/Mineral s C Thiamine Hcl C Trazodone Hcl C Valproic Acid C Zolpidem Tartrate C Date:12/04/01ISR Number: 3834709-5Report Type:Expedited (15-DaCompany Report #2000AP02316 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel "Zeneca" PS Zeneca ORAL 400 MG DAILY Neutrophil Count Literature PO Decreased Health Seroquel "Zeneca" SS Zeneca ORAL 600 MG DAILY Professional PO Other Olanzapine C Clozapine C Flupentixol-Decanoat 22-Feb-2006 08:31 AM Page: 361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report e C Date:12/04/01ISR Number: 3834867-2Report Type:Expedited (15-DaCompany Report #01P-163-01113250-00 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haematemesis Health Depakote (Divalproex Influenza Professional Sodium) (Divalproex Sudden Death Sodium) PS 1000 MG, 1 IN 1 D Clozapine SS 800 MG, 1 IN 1 D Venlafaxine Hydrochloride SS 450 MG, 1 IN 1 D Seroquel SS 600 MG, 1 IN 1 D Atorvastatin C Losartan Potassium C Lung Inhaler C Date:12/05/01ISR Number: 3833998-0Report Type:Direct Company Report # Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Seraquel PS ORAL 100MG PO TID Torsade De Pointes Date:12/05/01ISR Number: 3835951-XReport 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 "Zeneca" PS Zeneca ORAL 400 MG DAILY Hospitalization - Escherichia Sepsis Literature PO Initial or Prolonged Haemoglobin Decreased Health Seroquel "Zeneca" SS Zeneca ORAL 200 MG DAILY Leukopenia Professional PO Pharyngitis Other Olanzapine C Pneumonia Lithium Carbonate C Thrombocytopenia Normison C Tonsillitis Fluimucil C Lorazepam C Tremblex C Date:12/05/01ISR Number: 3836045-XReport Type:Expedited (15-DaCompany Report #2001UW14675 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 1400 MG DAILY Intervention to Neutrophil Count Health PO Prevent Permanent Decreased Professional Seroquel SS ORAL 1300 MG DAILY Impairment/Damage Other PO 22-Feb-2006 08:31 AM Page: 362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/01ISR Number: 3836046-1Report Type:Expedited (15-DaCompany Report #2001GB00152 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS Zeneca Decreased Health Professional Other Date:12/06/01ISR Number: 3836524-5Report Type:Expedited (15-DaCompany Report #2001UW15230 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Health Seroquel "Zeneca" PS ORAL 700 MG DAILY Intervention to Syncope Professional PO Prevent Permanent Cogentin C Impairment/Damage Date:12/06/01ISR Number: 3836525-7Report Type:Expedited (15-DaCompany Report #2001UW15231 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Adrenal Disorder Health Seroquel "Zeneca" PS ORAL 24000 MG Hospitalization - Coma Professional DAILY PO Initial or Prolonged Dialysis Disability Lung Disorder Overdose Date:12/06/01ISR Number: 3837223-6Report Type:Expedited (15-DaCompany Report #2001UW05633 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Foreign Seroquel "Zeneca" PS ORAL 700 MG DAILY Initial or Prolonged Asthenia Consumer PO Confusional State Other Seroquel "Zeneca" SS ORAL 100 MG BID PO Depression Seroquel "Zeneca" SS ORAL 600 MG DAILY Fatigue PO Feeling Abnormal Seroquel "Zeneca" SS ORAL 200 MG TID PO Hypomania Hypothyroidism Insomnia Malaise Paranoia Photosensitivity Reaction Platelet Count Decreased Sedation Stress Weight Increased Date:12/06/01ISR Number: 3837333-3Report Type:Expedited (15-DaCompany Report #2001SE07749 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel "Zeneca" PS 400 MG DAILY Health Valium C Professional Nozinan C Other Tegretol C Haldol C 22-Feb-2006 08:31 AM Page: 363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroxat "Ciba-Geigy" C Dominal Forte C Kemadrin C Date:12/06/01ISR Number: 3837338-2Report Type:Expedited (15-DaCompany Report #2001AP05471 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Seroquel"Zeneca" PS ORAL 300 MG DAILY Hospitalization - Phosphokinase Increased Health PO Initial or Prolonged Blood Pressure Decreased Professional Zotepine C Required Gastric Haemorrhage Other Haloperidol C Intervention to Gastrointestinal Akineton C Prevent Permanent Haemorrhage Artane C Impairment/Damage Gastrointestinal Necrosis Anafranil C Hyperthermia Malignant Hiberna C Loss Of Consciousness Rohypnol C Mesenteric Artery Embolism Metabolic Acidosis Neuroleptic Malignant Syndrome Oesophageal Haemorrhage Pyrexia Renal Failure Acute Septic Shock Tongue Biting Tongue Disorder Date:12/06/01ISR Number: 3837339-4Report Type:Expedited (15-DaCompany Report #2001UW14682 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel "Zeneca" PS ORAL 100 MG QD PO Intervention to International Normalised Health Seroquel "Zeneca" SS ORAL 25 MG QD PO Prevent Permanent Ratio Increased Professional Serzone C Impairment/Damage Other Risperidone C Clonazepam C Neurontin C Nortriptyline C Date:12/06/01ISR Number: 3837340-0Report Type:Expedited (15-DaCompany Report #2001UW14977 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS ORAL 200 MG DAILY Intentional Overdose Professional PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 800 MG DAILY PO Seroquel SS ORAL 1000 MG DAILY PO Seroquel SS ORAL 1200 MG DAILY PO Alprazolam C Mirtazapine C 22-Feb-2006 08:31 AM Page: 364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/01ISR Number: 3837343-6Report Type:Expedited (15-DaCompany Report #2001UW05243 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Seroquel "Zeneca" PS Zeneca ORAL 25 MG DAILY Initial or Prolonged Convulsion Professional PO Depression Seroquel "Zeneca" SS Zeneca ORAL 200 MG DAILY Drug Abuser PO Drug Withdrawal Syndrome Klonopin SS Medication Error Celexa C Memory Impairment Nortriptyline C Allegra C Lotensin C Prilosec C Date:12/06/01ISR Number: 3837345-XReport Type:Expedited (15-DaCompany Report #2001UW04115 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Consumer Seroquel "Zeneca" PS Zeneca ORAL 200 MG BID PO Initial or Prolonged Medication Error Serzone SS 200 MG BID Palpitations Date:12/06/01ISR Number: 3837425-9Report Type:Expedited (15-DaCompany Report #2001UW15248 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Seroquel "Zeneca" PS Zeneca ORAL 100 MG BID PO Professional Propanolol C Date:12/10/01ISR Number: 3837524-1Report Type:Expedited (15-DaCompany Report #2001UW05633 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Foreign Seroquel "Zeneca" PS ORAL 700 MG DAILY Initial or Prolonged Asthenia Consumer PO Confusional State Other Seroquel "Zeneca" SS ORAL 100 MG BID PO Depression Seroquel "Zeneca" SS ORAL 600 MG DAILY Fatigue PO Hypomania Seroquel "Zeneca" SS ORAL 500 MG QD PO Hypothyroidism Seroquel "Zeneca" SS ORAL 200 MG TID PO Insomnia Risperdal C Malaise Depakote C Myalgia Neurontin C Paranoia Clonapin C Photosensitivity Reaction Prevacid C Platelet Count Decreased Tapazole C Sedation Lasix C Stress Rhinocort Aqua C Weight Increased Zoloft C Celebrex C Wellbutrin C 22-Feb-2006 08:31 AM Page: 365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/01ISR Number: 3837889-0Report Type:Expedited (15-DaCompany Report #2001UW15494 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ventricular Tachycardia Health Seroquel "Zeneca" PS Zeneca ORAL 800 MG PO Initial or Prolonged Professional Seroquel "Zeneca" SS Zeneca ORAL 400 MG PO Date:12/10/01ISR Number: 3837891-9Report Type:Expedited (15-DaCompany Report #2001UW15330 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Seroquel "Zeneca" PS Zeneca ORAL 1200 MG ONCE Initial or Prolonged Ileus Paralytic Professional PO Intentional Overdose Seroquel "Zeneca" SS Zeneca ORAL 200 MG QD PO Nausea Celexa SS ORAL 1200 MG ONCE Tremor PO Celexa SS ORAL 40 MG QD PO Clozaril C Date:12/11/01ISR Number: 3838468-1Report Type:Expedited (15-DaCompany Report #2001AP05471 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Seroquel "Zeneca" PS ORAL 300 MG DAILY Hospitalization - Phosphokinase Increased Health PO Initial or Prolonged Blood Pressure Decreased Professional Zotepine C Required Computerised Tomogram Other Haloperidol C Intervention to Abnormal Akineton C Prevent Permanent Gastric Haemorrhage Artane C Impairment/Damage Gastrointestinal Anafranil C Haemorrhage Hiberna C Gastrointestinal Necrosis Rohypnol C Heart Rate Increased Hyperthermia Malignant Loss Of Consciousness Mesenteric Artery Embolism Metabolic Acidosis Neuroleptic Malignant Syndrome Oesophageal Haemorrhage Renal Failure Acute Respiratory Rate Increased Septic Shock Shock Ultrasound Scan Abnormal Date:12/12/01ISR Number: 3839420-2Report Type:Expedited (15-DaCompany Report #2001UW14675 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 1400 MG DAILY Intervention to Neutrophil Count Health PO Prevent Permanent Decreased Professional Seroquel SS ORAL 1300 MG DAILY Impairment/Damage PO Clozapine SS 22-Feb-2006 08:31 AM Page: 366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/01ISR Number: 3839995-3Report Type:Expedited (15-DaCompany Report #2001AP05795 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Seroquel PS ORAL 750 MG DAILY Corrected Interval Study PO Prolonged Health Seroquel SS ORAL 675 MG DAILY Hypokalaemia Professional PO Leukopenia Other Seroquel SS ORAL 600 MG DAILY Sinus Bradycardia PO Somnolence Seroquel SS ORAL 500 MG DAILY Vertigo PO White Blood Cell Count Seroquel SS ORAL 400 MG DAILY Decreased PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 150 MG DAILY PO Seroquel SS ORAL 75 MG DAILY PO Risperdal C Tasmolin C Solon C Tinelac C Doral C Goodmin C Date:12/12/01ISR Number: 3840282-8Report Type:Expedited (15-DaCompany Report #S01-USA-02257-01 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Celexa (Citalopram Intentional Overdose Professional Hydrobromide) PS Company Quetiapine Representative (Quetiapine Fumarate) SS Neurontin (Gabapentin) SS Desyrel (Trazodone Hydrochloride) SS Date:12/12/01ISR Number: 3849705-1Report Type:Periodic Company Report #C2001-2182.01 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine Tablets Other Leukopenia Professional Mylan PS ORAL 25MG QD (X 1 Neutrophil Count Other DAY), 25MG Decreased BID (X 1DAY), ORAL Seroquel Astra Zeneca SS ORAL 200MG, ORAL Date:12/13/01ISR Number: 3839805-4Report Type:Expedited (15-DaCompany Report #2001SE09174 Age:30 YR Gender:Male I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Foreign Seroquel PS ORAL 100 MG DAILY Disorientation Health PO Hypotonia Professional Seroquel SS ORAL 6G DAILY PO Overdose Other Trihexyphenidil C Flufenazine Decanoate C Date:12/13/01ISR Number: 3839814-5Report Type:Expedited (15-DaCompany Report #2001UW15708 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 600 MG PO Decreased Professional Date:12/13/01ISR Number: 3839815-7Report Type:Expedited (15-DaCompany Report #2001UW14890 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conversion Disorder Health Seroquel "Zeneca" PS Zeneca ORAL 150 MG DAILY Initial or Prolonged Extrapyramidal Disorder Professional PO Sedation Seroquel "Zeneca" SS Zeneca ORAL 125 MG DAILY Somnolence PO Depakote C Klonopin C Celexa C Date:12/14/01ISR Number: 3839485-8Report Type:Expedited (15-DaCompany Report #2001PK01189 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Seroquel PS 600 MG DAILY Drowning Health Haldol C Professional Tavor C Other Date:12/14/01ISR Number: 3839487-1Report Type:Expedited (15-DaCompany Report #2001SE09170 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Acute Foreign Seroquel PS 100 MG DAILY Initial or Prolonged Health PO Professional Gardenale C Other Date:12/17/01ISR Number: 3839884-4Report Type:Direct Company Report # Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Seroquel Required (Quetiapine) PS 50 MG BID Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/01ISR Number: 3841247-2Report Type:Expedited (15-DaCompany Report #2001UW15951 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Professional Date:12/18/01ISR Number: 3841415-XReport Type:Expedited (15-DaCompany Report #2001GB00213 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Red Blood Cell Count Foreign Seroquel "Zeneca" PS ORAL 75 MG BID PO Increased Health Professional Other Date:12/18/01ISR Number: 3841416-1Report Type:Expedited (15-DaCompany Report #2001SE07362 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aggression Foreign Seroquel "Zeneca" PS ORAL 600 MG DAILY Required Hostility Study PO Intervention to Obsessive-Compulsive Health Prevent Permanent Disorder Professional Impairment/Damage Other Date:12/18/01ISR Number: 3841417-3Report Type:Expedited (15-DaCompany Report #2001AP05429 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Systolic Foreign Seroquel PS ORAL 50 MG DAILY Intervention to Decreased Health PO Prevent Permanent Depressed Level Of Professional Seroquel SS ORAL 100 MG DAILY Impairment/Damage Consciousness Other PO Syncope Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Risperdal C Gasmotin C Selbex C Nitorol C Sediel C Frandol C Date:12/18/01ISR Number: 3841805-5Report Type:Expedited (15-DaCompany Report #2015042 Age:73 YR Gender:Male I/FU:I Outcome PT Death Brain Oedema Cardiomegaly Completed Suicide Gun Shot Wound Hepatomegaly Intentional Self-Injury Oedema Peripheral Pulmonary Congestion Renal Hypertrophy 22-Feb-2006 08:31 AM Page: 369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Splenomegaly Subarachnoid Haemorrhage Tooth Disorder Report Source Product Role Manufacturer Route Dose Duration Toxicologic Test Abnormal Health Oxycodone Professional Hydrochloride PS ORAL PO Other Hydrocodone Bitartrate SS ORAL PO Quetiapine SS ORAL PO Carisoprodol SS ORAL PO Meprobamate SS ORAL PO Doxepin SS ORAL PO Nicotine SS ORAL PO Date:12/19/01ISR Number: 3842505-8Report Type:Expedited (15-DaCompany Report #2001UW16100 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alkaline Health Seroquel PS 800-600 MG QD 3 YR Required Phosphatase Increased Professional Clozaril SS 500-800 MG QD 6 YR Intervention to Circulatory Collapse Effexor SS 300-450 MG Prevent Permanent Electrocardiogram QD 5 MON Impairment/Damage Abnormal Depakote SS 1000 MG HS 5 MON Gastrointestinal Lipitor C Infection Cozaar C Haematemesis Unspecified C Influenza Mitral Valve Incompetence Sudden Death Ventricular Hypertrophy White Blood Cell Count Increased Date:12/19/01ISR Number: 3842542-3Report Type:Expedited (15-DaCompany Report #2001SE09087 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Seroquel "Zeneca" PS ORAL 400 MG DAILY Initial or Prolonged Epilepsy Study PO Health Professional Other Date:12/20/01ISR Number: 3843324-9Report Type:Expedited (15-DaCompany Report #A129766 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Consumer Zoloft Tablets PS Fall Seroquel SS Hip Fracture Paranoia Stress 22-Feb-2006 08:31 AM Page: 370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/01ISR Number: 3843712-0Report Type:Direct Company Report # Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Olanzapine PS Syndrome Quetiapine SS Date:12/24/01ISR Number: 3844400-7Report Type:Expedited (15-DaCompany Report #NSADSS2001038538 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Haldol (Haloperidol) PS Initial or Prolonged Electrocardiogram Qt Professional Seroquel (Seroquel) SS ORAL ORAL Prolonged Paxil (Paroxetine Hydrochloride) C Date:12/26/01ISR Number: 3844496-2Report Type:Expedited (15-DaCompany Report #2001UW16178 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Seroquel "Zeneca" PS "Zeneca" Initial or Prolonged Health Topiramide SS Professional Other Date:12/27/01ISR Number: 3845147-3Report Type:Expedited (15-DaCompany Report #2001UW16342 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Seroquel PS ORAL 125 MG DAILY Platelet Count Decreased Study PO Red Blood Cell Count Other Vioxx C Decreased Amitriptyline C Sertraline C Clonazepam C Valproic Acid C Levothyroxine C Mineral Oil-Ear Drops C Lactulose C Ciprofloxacin C Zuclopenthixol C Date:12/27/01ISR Number: 3845743-3Report Type:Expedited (15-DaCompany Report #2001UW15248 Age:32 YR Gender:Female I/FU:F Outcome PT Death Alcohol Poisoning Body Temperature Decreased Cardiac Arrest Coma Completed Suicide Heart Rate Increased Hypotension Hypothermia Overdose Respiratory Rate 22-Feb-2006 08:31 AM Page: 371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS Zeneca ORAL 60 DF ONCE PO Professional Seroquel SS Zeneca ORAL 100 MG BID PO Inderal SS 30 DF ONCE Nsaid SS Propranolol SS ORAL 20 MG BID PO Date:12/28/01ISR Number: 3846822-7Report Type:Expedited (15-DaCompany Report #2001UW16191 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Seroquel "Zeneca" PS Zeneca Initial or Prolonged Blood Pressure Decreased Health Required Loss Of Consciousness Professional Intervention to Neuroleptic Malignant Other Prevent Permanent Syndrome Impairment/Damage Date:12/28/01ISR Number: 3846824-0Report Type:Expedited (15-DaCompany Report #2001GB00231 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Seroquel "Zeneca" PS ORAL 400 MG DAILY Intervention to Hypoglycaemia Health PO Prevent Permanent Professional Clopixol (Decanoate) C Impairment/Damage Other Lustral C Filair C Fluticasone C Metformin C Glibenclamide C Date:12/28/01ISR Number: 3846967-1Report Type:Expedited (15-DaCompany Report #2001UW08893 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Seroquel "Zeneca" PS "Zeneca" Professional Atenolol C Date:01/02/02ISR Number: 3847389-XReport Type:Expedited (15-DaCompany Report #2001UW16417 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Other Seroquel PS Intervention to Electrocardiogram Qt Haldol SS Prevent Permanent Prolonged Paxil C Impairment/Damage Date:01/02/02ISR Number: 3847390-6Report Type:Expedited (15-DaCompany Report #2001UW16395 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel PS ORAL 900 MG DAILY Initial or Prolonged Overdose Professional PO Seroquel SS ORAL 600 MG DAILY 22-Feb-2006 08:31 AM Page: 372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Date:01/02/02ISR Number: 3847401-8Report Type:Expedited (15-DaCompany Report #2001UW13042 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Chromaturia Health Seroquel "Zeneca" PS Zeneca ORAL 50 MG BID PO Intervention to Dysuria Professional Seroquel "Zeneca" SS Zeneca ORAL 25 MG BID PO 1 DAY Prevent Permanent Wellbutrin - Slow Impairment/Damage Release C Risperdal C Date:01/02/02ISR Number: 3847402-XReport Type:Expedited (15-DaCompany Report #2001UW16478 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Seroquel "Zeneca" PS Zeneca ORAL 800 MG QD PO Initial or Prolonged Confusional State Professional Risperdal C Diabetes Mellitus Serentil C Diabetic Ketoacidosis Depakote C Dizziness Ativan C Heart Rate Abnormal Respiratory Disorder Urinary Incontinence Date:01/02/02ISR Number: 3847403-1Report Type:Expedited (15-DaCompany Report #2001UW16400 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Decreased Health Seroquel PS ORAL 50 MG PO Intervention to Drug Interaction Professional Biaxin SS Prevent Permanent Impairment/Damage Date:01/02/02ISR Number: 3847434-1Report Type:Expedited (15-DaCompany Report #2001AP05963 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Seroquel PS ORAL 300 MG DAILY Health PO Professional Risperdal C Other Contomin C Levotomin C Zyprexa C Date:01/02/02ISR Number: 3847435-3Report Type:Expedited (15-DaCompany Report #2001GB00032 Age:44 YR Gender:Male I/FU:I Outcome PT Life-Threatening Blood Creatinine Decreased Blood Urea Decreased Circulatory Collapse Fall Grand Mal Convulsion Hyponatraemia Incontinence 22-Feb-2006 08:31 AM Page: 373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Meningitis Meningococcal Sepsis Neutrophil Count Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Seroquel "Zeneca" PS Astrazenica Petechiae Health Pharmaceuticals 300 MG BID White Blood Cell Count Professional Lorazepam SS Increased Other Date:01/02/02ISR Number: 3847463-8Report Type:Expedited (15-DaCompany Report #2001SE05879 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Foreign Seroquel "Zeneca" PS ORAL 800 MG DAILY Life-Threatening Cardio-Respiratory Arrest Study PO Dehydration Health Metformin C Dialysis Professional Carvediol C Diarrhoea Other Ramipril C Hypotension Indapamide C Hypoventilation Muscle Twitching Orthostatic Hypotension Pulse Pressure Decreased Pupillary Reflex Impaired Pyrexia Renal Failure Viral Infection Date:01/03/02ISR Number: 3847839-9Report Type:Expedited (15-DaCompany Report #2001AP05471 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Seroquel "Zeneca" PS ORAL 400 MG DAILY Life-Threatening Computerised Tomogram Health PO Hospitalization - Abnormal Professional Seroquel "Zeneca" SS ORAL 300 MG DAILY Initial or Prolonged Gastric Haemorrhage Other PO Required Gastrointestinal Lodopin SS ORAL 150 MG DAILY Intervention to Haemorrhage PO Prevent Permanent Gastrointestinal Necrosis Lodopin SS ORAL 100 MG DAILY Impairment/Damage Hyperthermia Malignant PO Loss Of Consciousness Levotomin SS ORAL 100 MG DAILY Mesenteric Artery PO Embolism Levotomin SS ORAL 50 MG DAILY Metabolic Acidosis PO Neuroleptic Malignant Cosminal SS ORAL 5 MG DAILY PO Syndrome Anafranil SS ORAL 75 MG DAILY Oesophageal Haemorrhage PO Psychomotor Hyperactivity Akineton C Respiratory Rate Artane C Increased Hiberna C Sepsis Rohypnol C Septic Shock Forsenid C Shock Stress Ulcer Tachycardia Tongue Biting 22-Feb-2006 08:31 AM Page: 374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/02ISR Number: 3847869-7Report Type:Expedited (15-DaCompany Report #2001SE09514 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS ORAL 300 MG DAILY Asthenia Health PO Liver Function Test Professional Leponex SS ORAL 500 MG DAILY Abnormal Other PO Pyrexia Date:01/03/02ISR Number: 3847942-3Report Type:Expedited (15-DaCompany Report #EMADSS2001006354 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal (2 Mg Initial or Prolonged Study Tablet) Health (Risperidone) PS ORAL 2 MG, 2 IN 1 Professional DAILY, ORAL Seroquel (Seroquel) SS ORAL 100 MG, 2 IN 1 DAILY, ORAL Hypnorex (Lithium Carbonate) C Date:01/03/02ISR Number: 3848148-4Report Type:Expedited (15-DaCompany Report #2001AP04342 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Foreign Seroquel "Zeneca" PS Zeneca ORAL 75 MG DAILY Intervention to Duodenal Ulcer Health PO Prevent Permanent Professional Seroquel "Zeneca" SS Zeneca ORAL 150 MG DAILY Impairment/Damage Other PO Seroquel "Zeneca" SS Zeneca ORAL 300 MG DAILY PO Serenace C Akineton C Benzalin C Pursennid C Selbex C Magnesium Oxide C Date:01/07/02ISR Number: 3849403-4Report Type:Expedited (15-DaCompany Report #2002UW00021 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Required Professional Intervention to Prevent Permanent Impairment/Damage Date:01/07/02ISR Number: 3849599-4Report Type:Expedited (15-DaCompany Report #2001SE09514 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS ORAL 300 MG DAILY Health PO Professional Leponex SS ORAL 500 MG DAILY Other PO 22-Feb-2006 08:31 AM Page: 375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/02ISR Number: 3849916-5Report Type:Expedited (15-DaCompany Report #2001AP06012 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Seroquel PS ORAL 300 MG QD PO Health Melleril C Professional Limas C Other Silence C Isomytal C Pursennid C Date:01/08/02ISR Number: 3849883-4Report Type:Expedited (15-DaCompany Report #A200184 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Ziprasidone Po PS ORAL BID:ORAL Initial or Prolonged Hallucination Professional Zoloft SS ORAL ORAL Required Uveitis Seroquel SS ORAL ORAL Intervention to Remeron Prevent Permanent (Mirtazapine) C Impairment/Damage Depakote (Divalproex) C Combivent Inhaler C Ativan (Lorazepam) C Theodur (Theophylline) C Humibid (Guaifenesin) C Date:01/08/02ISR Number: 3849888-3Report Type:Expedited (15-DaCompany Report #2001UW09640 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Bradykinesia Health Nexium PS ORAL 40 MG DAILY Choking Professional PO Cogwheel Rigidity Seroquel SS ORAL 200 MG DAILY Drooling PO Dysphagia Clozaril C Dystonia Depakote C Oesophageal Disorder Date:01/08/02ISR Number: 3850556-2Report Type:Direct Company Report #CTU 158694 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Doxepin PS Initial or Prolonged Small Intestinal Quetiapine SS Obstruction Date:01/09/02ISR Number: 3850802-5Report Type:Expedited (15-DaCompany Report #2001UW14890 Age:24 YR Gender:Male I/FU:F Outcome PT Hospitalization - Conversion Disorder Initial or Prolonged Extrapyramidal Disorder Grand Mal Convulsion Sedation Somnolence 22-Feb-2006 08:31 AM Page: 376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tardive Dyskinesia Tremor Report Source Product Role Manufacturer Route Dose Duration Health Seroquel "Zeneca" PS ORAL 150 MG DAILY Professional PO Seroquel "Zeneca" SS ORAL 125 MG DAILY PO Depakote C Klonopin C Celexa C Date:01/10/02ISR Number: 3850653-1Report Type:Direct Company Report #CTU 158819 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coordination Abnormal Health Quetiapine Fumarate PS Intervention to Drooling Professional Carbidopa Prevent Permanent 25/Levodopa 100mg C Impairment/Damage Donepezil C Fluoxetine C Date:01/10/02ISR Number: 3851162-6Report Type:Expedited (15-DaCompany Report #2002GB00014 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Foreign Seroquel Disability Health "Zeneca" PS Zeneca ORAL 150 MG BID PO Required Professional Clozaril C Intervention to Other Prevent Permanent Impairment/Damage Date:01/11/02ISR Number: 3851799-4Report Type:Expedited (15-DaCompany Report #2001UW08893 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Health Seroquel "Zeneca" PS Zeneca Intervention to Professional Atenolol C Prevent Permanent Impairment/Damage Date:01/11/02ISR Number: 3851837-9Report Type:Expedited (15-DaCompany Report #2015459 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Oxycodone Cardiac Arrest Professional Hydrochloride Cardiomegaly Other (Similar To Nda Coma 20-533) PS Respiratory Arrest Quetiapine SS Ventricular Hypertrophy Verapamil Hcl SS Temazepam SS Hydrocodone Bitartrate SS Ibuprofen SS Caffeine Anhydride SS D/L Methorphan SS 22-Feb-2006 08:31 AM Page: 377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diphenhydramine Hcl SS Dihydrocodeine (Similar To Anda 88-584) SS Hycomine C Duragesic (Fentanyl) Patch C Keflex (Cephalexin) C Date:01/14/02ISR Number: 3852225-1Report Type:Expedited (15-DaCompany Report #2001SE09514 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS ORAL 300 MG DAILY Asthenia Health PO Liver Function Test Professional Leponex SS ORAL 500 MG DAILY Abnormal Other PO Pyrexia Date:01/14/02ISR Number: 3852950-2Report Type:Expedited (15-DaCompany Report #2002UW00297 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Seroquel PS ORAL 250 MG DAILY Decreased Professional PO Clozapine SS ORAL 700 MG DAILY PO Divalproex Sodium SS ORAL 500 MG TID PO Divalproex Sodium C ORAL 1000 MG BID PO Chlorpromazine C Date:01/15/02ISR Number: 3853458-0Report Type:Expedited (15-DaCompany Report #GB8886707JAN2002 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Abnormal Health Ativan (Lorazepam) PS Blood Urea Decreased Professional Seroquel Grand Mal Convulsion Other (Quetiapine, , 0) SS 600 MG 1X PER Hyponatraemia 1 DAY Meningitis Meningococcal Sepsis Neutrophil Count Abnormal Petechiae White Blood Cell Count Abnormal Date:01/15/02ISR Number: 3853522-6Report Type:Expedited (15-DaCompany Report #2002GB00013 Age:95 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Circulatory Collapse Foreign Quetiapine PS ORAL 25 MG DAILY Intervention to Coma Health PO Prevent Permanent Professional Donepezil C Impairment/Damage Other Detrusitol C 22-Feb-2006 08:31 AM Page: 378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/15/02ISR Number: 3853524-XReport Type:Expedited (15-DaCompany Report #2001PK01189 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Foreign Seroquel PS ORAL 500 MG DAILY Life-Threatening Sudden Cardiac Death Health PO Professional Haldol C Other Quilonum C Tegretal C Diazepam C Date:01/15/02ISR Number: 3853527-5Report 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 Agranulocytosis Foreign Seroquel "Zeneca" PS Zeneca ORAL 500 MG QD PO Intervention to Granulocytopenia Health Clozapine C Prevent Permanent Professional Lorazepam C Impairment/Damage Other Date:01/16/02ISR Number: 3853536-6Report Type:Direct Company Report #CTU 159241 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Seroquel (200mg Initial or Prolonged Hypotension Tablet) PS 200MG BID Other Lethargy Seroquel (300mg Tablet) SS 600MG QHS Depakene C Neurontin C Cogentin C Adalat Cc C Lisinopril C Mvi C Feso4 C Date:01/16/02ISR Number: 3853569-XReport Type:Direct Company Report #CTU 159236 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Seroquel (100 Mg) PS ORAL 100MG PO BID Dyspnoea Risperdal C Depakote C Seroquel C Date:01/16/02ISR Number: 3855109-8Report Type:Expedited (15-DaCompany Report #2001AP06012 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Seroquel PS ORAL 300 MG QD PO Loss Of Consciousness Health Melleril C Myocardial Infarction Professional Limas C Other Silece C Isomytal C Pursennid C 22-Feb-2006 08:31 AM Page: 379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/02ISR Number: 3855110-4Report Type:Expedited (15-DaCompany Report #2002PK00009 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Disorder Foreign Seroquel "Zeneca" PS "Zeneca" ORAL 400 MG DAILY Granulocytopenia Other PO Leukopenia Dapotum D For Injection C Date:01/16/02ISR Number: 3855334-6Report Type:Expedited (15-DaCompany Report #GB8886707JAN2002 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Foreign Ativan (Lorazepam, Decreased Health Unspec,0) PS Blood Urea Decreased Professional Seroquel Circulatory Collapse Other (Quetiapine, 0) SS 600 MG 1X PER Grand Mal Convulsion 1 DAY Hyponatraemia Meningitis Meningococcal Sepsis Neutrophil Count Increased Petechiae White Blood Cell Count Increased Date:01/18/02ISR Number: 3856005-2Report Type:Expedited (15-DaCompany Report #2001GB00095 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertension Foreign Quetiapine PS ORAL 25 MG BID PO Intervention to Tachycardia Health Quetiapine SS ORAL 200 MG BID PO Prevent Permanent Professional Paroxetine C Impairment/Damage Other Date:01/18/02ISR Number: 3856012-XReport Type:Expedited (15-DaCompany Report #2002GB00068 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Foreign Quetiapine PS ORAL 150 MG QAM PO Life-Threatening Atherosclerosis Health Quetiapine SS ORAL 200 MG HS PO Coronary Artery Professional Inderal SS ORAL 80 MG QAM PO Thrombosis Other Drug Interaction Myocardial Infarction Date:01/20/02ISR Number: 3858081-XReport Type:Expedited (15-DaCompany Report #2002AP00047 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Health PO Professional Other 22-Feb-2006 08:31 AM Page: 380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/02ISR Number: 3857949-8Report Type:Expedited (15-DaCompany Report #2001SE09170 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Acute Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Health PO Professional Gardenale C Other Date:01/22/02ISR Number: 3858082-1Report Type:Expedited (15-DaCompany Report #2001GB00296 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Screen False Foreign Seroquel "Zeneca" PS Zeneca ORAL 200 MG BID PO Initial or Prolonged Positive Health Trazodone C Professional Minocin C Other Date:01/22/02ISR Number: 3858093-6Report Type:Expedited (15-DaCompany Report #2002UW00667 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blister Foreign Seroquel "Zeneca" PS Zeneca 100 - 150 MG Difficulty In Walking Health DAILY Rash Generalised Professional Other Date:01/22/02ISR Number: 3858234-0Report Type:Expedited (15-DaCompany Report #A201061 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Navane Capsules PS ORAL 7.00 MG Initial or Prolonged Blood Sodium Decreased Professional TOTAL:DAILY:O Required Convulsion RAL Intervention to Diarrhoea Sertraline SS ORAL ORAL Prevent Permanent Weight Decreased Seroquel SS 200.00 MG Impairment/Damage TOTAL:DAILY Synthroid C Lipitor C Calcium C Zyrtec C Date:01/22/02ISR Number: 3858295-9Report Type:Expedited (15-DaCompany Report #2002UW00443 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cyanosis Health Seroquel "Zeneca" PS ORAL 25 MG PO Intervention to Hypotension Professional Prevent Permanent Pulse Absent Impairment/Damage Date:01/23/02ISR Number: 3857648-2Report Type:Expedited (15-DaCompany Report #2002PK00022 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Other Leukopenia Foreign Health 22-Feb-2006 08:31 AM Page: 381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Seroquel "Zeneca" PS Zeneca ORAL 50 MG DAILY PO Akineton Retard C Ximovan "Rhone-Poulenc" C Date:01/24/02ISR Number: 3858882-8Report Type:Direct Company Report #CTU 160072 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Quetiapine PS 1200MG/DAY 2 Initial or Prolonged Coordination Abnormal WEEKS AT THIS Dizziness DOSE 2 WK Medication Error Accupril C Ventricular Extrasystoles Seroquel C Cogentin C Date:01/24/02ISR Number: 3859030-0Report Type:Expedited (15-DaCompany Report #01P-163-0113250-00 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Depakote (Divalproex Gastrointestinal Disorder Professional Sodium) (Divalproex Haematemesis Sodium) PS 1000 MG, 1 IN Influenza 1 D Sudden Death Clozapine SS 800 MG, 1 IN 1 D Venlafaxine Hydrochloride SS 450 MG, 1 IN 1 D Seroquel SS 600 MG, 1 IN 1 D Atorvastatin C Losartan Potassium C Lung Inhaler C Date:01/25/02ISR Number: 3860346-2Report Type:Expedited (15-DaCompany Report #2001PK01189 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Foreign Seroquel PS ORAL 500 MG DAILY Life-Threatening Electrocardiogram Qt Health PO Prolonged Professional Haldol C Sudden Cardiac Death Other Quilonum C Tegretal C Diazepam C Date:01/25/02ISR Number: 3860714-9Report Type:Expedited (15-DaCompany Report #2002AP00158 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Quetiapine PS Toxicologic Test Abnormal Health Sertraline SS Professional Olanzapine SS 22-Feb-2006 08:31 AM Page: 382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ephedrine C Pseudoephedrine C Date:01/25/02ISR Number: 3860946-XReport Type:Expedited (15-DaCompany Report #2002AP00161 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Literature Quetiapine PS Drug Toxicity Health Professional Date:01/25/02ISR Number: 3860951-3Report Type:Expedited (15-DaCompany Report #2002AP00160 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bipolar I Disorder Literature Quetiapine PS Completed Suicide Health Propoxyphene SS Overdose Professional Diphenhydramine C Acetaminophen C Sertraline C Date:01/28/02ISR Number: 3859815-0Report Type:Expedited (15-DaCompany Report #S01-USA-02259-01 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Celexa(Citalopram Initial or Prolonged Condition Aggravated Professional Hydrobromide) PS ORAL 1200 MG ONCE Crohn'S Disease Company PO Diarrhoea Representative Celexa (Citalopram Ileus Paralytic Hydrobromide) SS ORAL 40 MG QD PO Intentional Overdose Celexa (Citalopram Nausea Hydrobromide) SS ORAL 60 MG QD PO Obsessive-Compulsive Seroquel SS ORAL 1200 MG ONCE Disorder PO Tremor Seroquel SS ORAL 200 MG QD PO Clozaril (Clozapine) C Date:01/28/02ISR Number: 3860975-6Report Type:Expedited (15-DaCompany Report #2002UW00669 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoaesthesia Foreign Seroquel PS Initial or Prolonged Speech Disorder Other Tv-1203/Carbidopa SS ORAL 7 DAILY PO Syncope Quinapril SS Transient Ischaemic Lorazepam C Attack Plavix C Sinemet C Oxazepam C Simvastatin C Vitamin B12 C Vitamin E C Amantadine C 22-Feb-2006 08:31 AM Page: 383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/02ISR Number: 3860916-1Report Type:Direct Company Report #CTU 160386 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Serzone 100mg PS ORAL 200 MG ONCE PER ORAL Seroquel 100 Mg SS Date:01/29/02ISR Number: 3862038-2Report Type:Expedited (15-DaCompany Report #2002AP00047 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplasia Pure Red Cell Foreign Seroquel PS ORAL 750 MG DAILY; Initial or Prolonged Health PO Professional Tasmolin C Other Gasmotin C Selbex C Rohypnol C Levotomin C Metligine C Methycobal C Date:01/29/02ISR Number: 3862040-0Report Type:Expedited (15-DaCompany Report #2002GB00156 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gamma-Glutamyltransferase Foreign Seroquel "Zeneca" PS Zeneca ORAL 750 MG DAILY Abnormal Health PO Professional Lorazepam C Other Date:01/29/02ISR Number: 3862311-8Report Type:Direct Company Report #CTU 160318 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cataract Seroquel PS Astra Zeneca ORAL 25MG-200MG BEDTIME ORALLY Seroquel 50mg Astra Zeneca SS Astra Zeneca ORAL 25MG-200MG BEDTIME ORALLY Seroquel 100mg Astra Zeneca SS Astra Zeneca ORAL 25MG-200MG BEDTIME ORALLY Seroquel 200mg Astra Zeneca SS Astra Zeneca ORAL 25MG-200MG BEDTIME ORALLY Klonopin C Lamictal C Premarin C Provera C Sectral C Zocor C Aspirin C Lamisil Tablets C 22-Feb-2006 08:31 AM Page: 384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/02ISR Number: 3863622-2Report Type:Periodic Company Report #PHEH2001US08877 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Ritalin(Methylphenid Initial or Prolonged Faecal Incontinence Professional ate Hydrochloride) Grand Mal Convulsion Tablet, 20mg PS ORAL 20 MG, QID, Mental Status Changes ORAL Urinary Incontinence Gabitril(Tiagabine Hydrochloride) SS ORAL 2 MG, QD, ORAL; 16 MG, QD, ORAL; 32 MG, QD Seroquel(Quetiapine) SS ORAL 50 MG, BID, ORAL; 500 MG, QHS, ORAL Paxil (Paroxetine Hydrochloride) SS ORAL 30 MG, QD, ORAL Lamictal C Biaxin (Clarithromycin) C Neurontin (Gabapentin) C Imitrex "Glaxo" (Sumatriptan) C Ranitidine (Mirtazapine) C Synthroid C Date:01/31/02ISR Number: 3861543-2Report Type:Direct Company Report #CTU 160501 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Seroquel (200 Mg) PS 200 MG BID Initial or Prolonged Oral Intake Reduced Celexa C Regurgitation Of Food Zyprexa C Sedation Cogentin C Depakene C Risperdal C Seroquel C Haldol Decanoate C Date:01/31/02ISR Number: 3863043-2Report Type:Expedited (15-DaCompany Report #2002SE00624 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS 300-400 MG Viral Infection Health Remeron SS ORAL 30 MG DAILY Professional PO Other Subutex SS 6-16 MG Date:01/31/02ISR Number: 3863045-6Report Type:Expedited (15-DaCompany Report #2001AP04758 Age:64 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Osmolarity Initial or Prolonged Decreased Confusional State 22-Feb-2006 08:31 AM Page: 385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Convulsion Grand Mal Convulsion Hyponatraemia Report Source Product Role Manufacturer Route Dose Duration Incontinence Foreign Seroquel "Zeneca" PS ORAL 600 MG DAILY Loss Of Consciousness Health PO Professional Oxybutinin SS 2.5 MG BID Other Ibuprofen C Lactulose C Paracetamol C Temazepam C Quinine Sulphate C Vitamin E C Date:01/31/02ISR Number: 3863048-1Report Type:Expedited (15-DaCompany Report #2001PK01189 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Foreign Seroquel PS ORAL 500 MG DAILY Life-Threatening Drowning Health PO Dyskinesia Professional Haldol C Electrocardiogram Qt Other Quilonum C Prolonged Tegretal C Loss Of Consciousness Diazepam C Sudden Cardiac Death Date:01/31/02ISR Number: 3863139-5Report Type:Expedited (15-DaCompany Report #2002SE00662 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Seroquel PS 50-300 MG Hospitalization - Decreased Activity Health DAILY Initial or Prolonged Depressed Level Of Professional Zoloft SS ORAL 25 MG DAILY Consciousness PO Fatigue Lasix C Pneumonia Aspiration Reniten Mite Rpd C Somnolence Folvite C Speech Disorder Distraneurin C Date:01/31/02ISR Number: 3863140-1Report Type:Expedited (15-DaCompany Report #2002SE00611 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Seroquel PS 400-600 MG Neutropenia Health Remeron SS 30 MG Professional Haldol C Dipiperon C Akineton C Valium C Date:01/31/02ISR Number: 3863141-3Report Type:Expedited (15-DaCompany Report #2001AP06012 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Seroquel PS ORAL 300 MG QD PO Health Melleril C Professional Limas C Silece C 22-Feb-2006 08:31 AM Page: 386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Isomytal C Pursennid C Date:01/31/02ISR Number: 3863142-5Report Type:Expedited (15-DaCompany Report #2002UW00667 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blister Foreign Seroquel "Zeneca" PS Zeneca 100 - 150 MG Dermatitis Exfoliative Health DAILY Difficulty In Walking Professional Seroquel "Zeneca" SS Zeneca Rash Effexor C Date:01/31/02ISR Number: 3865189-1Report Type:Expedited (15-DaCompany Report #2002UW00949 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel "Zeneca" PS Zeneca Professional Date:01/31/02ISR Number: 3865211-2Report Type:Expedited (15-DaCompany Report #2002UW01073 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Consumer Seroquel "Zeneca" PS Zeneca 80-100 OF 200 Intervention to Bundle Branch Block Left MG TABLETS Prevent Permanent Cardiac Failure Fentanyl C Impairment/Damage Congestive Ativan C Coma Deep Vein Thrombosis Heart Rate Increased Overdose Pyrexia Date:02/01/02ISR Number: 3863907-XReport Type:Expedited (15-DaCompany Report #2001AP05963 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Seroquel PS ORAL 300 MG DAILY Health PO Professional Risperdal SS ORAL 12 MG DAILY Other PO Contomin SS ORAL 300 MG DAILY PO Zyprexa SS ORAL 5 MG DAILY PO Zyprexa SS ORAL 10 MG DAILY PO Levotomin C Artane C Tasmolin C Selbex C Rohypnol C 22-Feb-2006 08:31 AM Page: 387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/02ISR Number: 3863796-3Report Type:Expedited (15-DaCompany Report #2002SE00662 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Seroquel PS 50-300 MG Hospitalization - Depressed Level Of Health DAILY Initial or Prolonged Consciousness Professional Zoloft SS ORAL 25 MG DAILY Difficulty In Walking Other PO Drug Interaction Lasix C Fatigue Reniten Mite Rpd C Haemorrhagic Stroke Folvite C Pneumonia Aspiration Distraneurin C Sedation Sepsis Speech Disorder Tachypnoea Date:02/04/02ISR Number: 3865052-6Report Type:Expedited (15-DaCompany Report #01P-163-0112960-00 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Depakote 500mg Initial or Prolonged Increased Appetite Professional (Depakote) Myocardial Ischaemia (Divalproex Sodium) Weight Increased (Divalproex Sodium) PS ORAL 500 MG, 2 IN 1 D, PER ORAL Quetiapine SS ORAL 100 MG, 3 IN 1 D, PER ORAL Date:02/04/02ISR Number: 3865081-2Report Type:Expedited (15-DaCompany Report #2001UW16100 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alkaline Health Seroquel PS 800-600 MG QD 3 YR Required Phosphatase Increased Professional Clozaril SS 500-800 MG QD 6 YR Intervention to Circulatory Collapse Effexor SS 300-450 MG QD 5 MON Prevent Permanent Electrocardiogram Depakote SS 1000 MG HS 5 MON Impairment/Damage Abnormal Lipitor C Gamma-Glutamyltransferase Cozaar C Increased Unspecified C Haematemesis Heart Rate Increased Influenza Mitral Valve Incompetence Sudden Death Ventricular Hypertrophy White Blood Cell Disorder Date:02/05/02ISR Number: 3863204-2Report Type:Expedited (15-DaCompany Report #B0117185A Age:55 YR Gender:Male I/FU:F Outcome PT Death Agitation Arrhythmia Atherosclerosis Bipolar I Disorder Blood Phosphorus Increased Confusional State 22-Feb-2006 08:31 AM Page: 388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Delusion Drug Level Above Therapeutic Report Source Product Role Manufacturer Route Dose Duration Incoherent Salbutamol PS Glaxo Wellcome RESPIRATORY Irritability (INHALATION) Sudden Death Depixol SS UNKNOWN 60MG Weekly Quetiapine SS ORAL 225MG per day Sandocal SS UNKNOWN 400MG Three times per day Ramipril SS UNKNOWN 1.25MG In the morning Alfacalcidol SS UNKNOWN 1MCG Per day Diazepam SS UNKNOWN 5MG Three times per day Procyclidine SS Glaxo Wellcome UNKNOWN 5MG Three times per day Chlorpromazine Hydrochloride SS Glaxo Wellcome UNKNOWN Lorazepam SS PARENTERAL Lithium SS UNKNOWN 15 DAY Date:02/05/02ISR Number: 3863207-8Report Type:Expedited (15-DaCompany Report #B0121705A Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Salbutamol PS Glaxo Wellcome RESPIRATORY Arrhythmia (INHALATION) Atherosclerosis Procyclidine SS Glaxo Wellcome UNKNOWN 5MG Three Bipolar I Disorder times per day Confusional State Flupenthixol SS UNKNOWN 60MG Weekly Incoherent Quetiapine SS UNKNOWN 225MG See Irritability dosage text Sudden Death Sandocal SS UNKNOWN 400MG Three times per day Ramipril SS UNKNOWN 1.25MG In the morning Alfacalcidol SS UNKNOWN 1MCG Per day Diazepam SS UNKNOWN 5MG Three times per day Chlorpromazine Hydrochloride SS Glaxo Wellcome UNKNOWN Lorazepam SS PARENTERAL Lithium SS UNKNOWN 15 DAY Date:02/05/02ISR Number: 3866018-2Report Type:Expedited (15-DaCompany Report #2002UW01441 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Professional Date:02/06/02ISR Number: 3865723-1Report Type:Expedited (15-DaCompany Report #A129766 Age: Gender:Female I/FU:F Outcome PT Death Aphasia Dysphagia Fall 22-Feb-2006 08:31 AM Page: 389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hip Fracture Oral Intake Reduced Paranoia Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Consumer Zoloft Tablets PS Stress Seroquel SS Date:02/06/02ISR Number: 3866265-XReport Type:Expedited (15-DaCompany Report #2002AP00047 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplasia Pure Red Cell Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Condition Aggravated Health PO Malaise Professional Tasmolin C Other Gasmotin C Selbex C Rohypnol C Levotomin C Metligine C Methycobal C Date:02/06/02ISR Number: 3866335-6Report Type:Expedited (15-DaCompany Report #2002AP00255 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Other Seroquel PS Intervention to Syndrome Haloperidol C Prevent Permanent Speech Disorder Risperdal C Impairment/Damage Developmental Tardive Dyskinesia Date:02/06/02ISR Number: 3866359-9Report Type:Expedited (15-DaCompany Report #2001AP05795 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Seroquel PS ORAL 750 MG DAILY Corrected Interval Study PO Prolonged Health Seroquel SS ORAL 675 MG DAILY Hypokalaemia Professional PO Leukopenia Other Seroquel SS ORAL 600 MG DAILY Sinus Bradycardia PO Somnolence Seroquel SS ORAL 500 MG DAILY Vertigo PO White Blood Cell Count Seroquel SS ORAL 400 MG DAILY Decreased PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 150 MG DAILY PO Seroquel SS ORAL 75 MG DAILY PO Risperdal C Tasmolin C Solon C Tinelac C Doral C Goodmin C 22-Feb-2006 08:31 AM Page: 390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/02ISR Number: 3866983-3Report Type:Expedited (15-DaCompany Report #2001PK00582 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Foreign Seroquel "Zeneca" PS Zeneca ORAL 100 MG DAILY Neutropenia Health PO Weight Increased Professional Tagonis C White Blood Cell Count Other Decreased Date:02/07/02ISR Number: 3867010-4Report Type:Expedited (15-DaCompany Report #200210403GDS Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Foreign Ciproxin Syndrome Health (Ciprofloxacin) PS ORAL 500 MG/BID; Professional ORAL Other Seroquel SS ORAL 200 MG/DAILY; ORAL Elopram SS ORAL 20 MG/DAILY; ORAL Sinemet C Requip C Date:02/07/02ISR Number: 3867071-2Report Type:Expedited (15-DaCompany Report #2002UW01512 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Other Seroquel PS Depakote C Cogentin C Clozaril C Date:02/07/02ISR Number: 3867750-7Report Type:Expedited (15-DaCompany Report #2002SE00762 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 600 MG DAILY Overdose Health PO Professional Zyprexa SS LONG TERM Other TREATMENT Akineton SS Prozac SS Orfidal SS Trankimazin SS Date:02/07/02ISR Number: 3867770-2Report Type:Expedited (15-DaCompany Report #2001SE08765 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Mass Foreign Seroquel PS 300 MG DAILY Intervention to Gynaecomastia Health Canabis C Prevent Permanent Injury Professional Alcohol C Impairment/Damage Liver Function Test Other Abnormal 22-Feb-2006 08:31 AM Page: 391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/02ISR Number: 3868023-9Report Type:Expedited (15-DaCompany Report #2002UW01733 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS Health Professional Other Date:02/11/02ISR Number: 3868025-2Report Type:Expedited (15-DaCompany Report #2002UW01569 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Disorder Foreign Seroquel PS Intervention to Oedema Health Prevent Permanent Professional Impairment/Damage Other Date:02/12/02ISR Number: 3869129-0Report Type:Expedited (15-DaCompany Report #2002AP00307 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Seroquel PS ORAL 150 MG DAILY Health PO Professional Lusyton C Other Tasmolin C Abovis C Eurodin C Tetramide C Date:02/13/02ISR Number: 3869033-8Report Type:Direct Company Report #CTU 161566 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Seroquel 25mg PS ORAL 50 MG TID Initial or Prolonged ORAL Paxil C Date:02/13/02ISR Number: 3869770-5Report Type:Expedited (15-DaCompany Report #2002AP00287 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Health PO Professional Other Date:02/13/02ISR Number: 3869771-7Report Type:Expedited (15-DaCompany Report #2001AP06012 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Foreign Seroquel PS ORAL 300 MG QD PO Loss Of Consciousness Health Melleril C Professional Limas C Other Silece C Isomytal C Pursennid C 22-Feb-2006 08:31 AM Page: 392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/02ISR Number: 3870678-XReport Type:Expedited (15-DaCompany Report #2001UW15857 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hepatic Pain Health Seroquel PS ORAL 300 MG DAILY Hepatomegaly Professional PO Oedema Wellbutrin Sr C Pitting Oedema Neurontin C Weight Increased Xanax C Date:02/13/02ISR Number: 3889610-8Report Type:Periodic Company Report #C2001-1063.01 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets 25 Other Neutropenia Professional Mg Mylan PS Mylan ORAL 525 MG/DAY, Other ORAL Depakote Abbott SS Abbott ORAL 1750 MG/DAY, ORAL Seroquel Astrazeneca SS Astrazeneca ORAL 700 MG/DAY, ORAL Levothyroxine C Lithium C Date:02/14/02ISR Number: 3870382-8Report Type:Expedited (15-DaCompany Report #A201061 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Navane Capsules PS ORAL 7.00 MG Initial or Prolonged Agitation Professional TOTAL:BID:ORA Required Coma L Intervention to Convulsion Zoloft SS ORAL ORAL Prevent Permanent Diarrhoea Seroquel SS 200.00 MG Impairment/Damage Hyponatraemia TOTAL:DAILY Inappropriate Synthroid C Antidiuretic Hormone Lipitor C Secretion Calcium C Weight Decreased Zyrtec C Miacalcin C Date:02/14/02ISR Number: 3870453-6Report Type:Expedited (15-DaCompany Report #2002GB00282 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Foreign Seroquel PS Required Health Intervention to Professional Prevent Permanent Other Impairment/Damage Date:02/14/02ISR Number: 3870455-XReport Type:Expedited (15-DaCompany Report #2002SE01036 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel "Zeneca" PS 700 MG QD Health Stelazine SS ORAL 5 MG QD PO Professional Roaccutane SS Other 22-Feb-2006 08:31 AM Page: 393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/15/02ISR Number: 3870909-6Report Type:Expedited (15-DaCompany Report #2002UW01877 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 500 MG DAILY Decreased Professional PO Company Seroquel SS ORAL 300 MG DAILY Representative PO Seroquel SS Date:02/15/02ISR Number: 3870968-0Report Type:Expedited (15-DaCompany Report #2002GB00277 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Circulatory Collapse Foreign Seroquel "Zeneca" PS "Zeneca" ORAL 700 MG DAILY Intervention to Hypotension Health PO Prevent Permanent Professional Impairment/Damage Other Date:02/15/02ISR Number: 3870969-2Report Type:Expedited (15-DaCompany Report #2001UW14720 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Dreams Consumer Seroquel PS ORAL 400 MG PO Intervention to Cerebral Haemorrhage Seroquel SS ORAL 200 MG PO Prevent Permanent Muscular Weakness Impairment/Damage Myocardial Infarction Oedema Peripheral Weight Increased Date:02/15/02ISR Number: 3871306-XReport Type:Expedited (15-DaCompany Report #2002AP00047 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplasia Pure Red Cell Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Health PO Professional Seroquel SS ORAL 500 MG DAILY Other PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 750 MG DAILY PO Tasmolin C Gasmotin C Selbex C Rohypnol C Levotomin C Metligine C Methycobal C Date:02/19/02ISR Number: 3872476-XReport Type:Expedited (15-DaCompany Report #2002UW01569 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Foreign Seroquel PS Health Professional Other 22-Feb-2006 08:31 AM Page: 394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/02ISR Number: 3872477-1Report Type:Expedited (15-DaCompany Report #2002GB00361 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Quetiapine PS ORAL 400 MG DAILY Intervention to Mania Health PO Prevent Permanent Paranoia Professional Quetiapine SS ORAL 600 MG DAILY Impairment/Damage Other PO Clomipramine C Date:02/19/02ISR Number: 3872478-3Report Type:Expedited (15-DaCompany Report #1999AP06595 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel "Zeneca" PS ORAL 600 MG DAILY Neutropenia Health PO Professional Fluoxetine C Other Sulpiride C Date:02/19/02ISR Number: 3872493-XReport Type:Expedited (15-DaCompany Report #2001AP05328 Age:60 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Seroquel "Zeneca" PS Zeneca 200 MG BID 3 YR Initial or Prolonged Fatigue Health Seroquel "Zeneca" SS Zeneca 150 MG BID 4 WK Required Professional Antibiotics C Intervention to Company Prevent Permanent Representative Impairment/Damage Other Date:02/19/02ISR Number: 3872527-2Report Type:Expedited (15-DaCompany Report #2002UW02144 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coma Health Seroquel PS Intervention to Professional Topamax C Prevent Permanent Lithium C Impairment/Damage Date:02/20/02ISR Number: 3873704-7Report Type:Expedited (15-DaCompany Report #2002AP00379 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Study Quetiapine PS ORAL 800 MG DAILY Intervention to Electrocardiogram Qt Health PO Prevent Permanent Corrected Interval Professional Lovastatin SS 10 MG DAILY Impairment/Damage Prolonged Lovastatin SS 5 MG DAILY Lipids Increased Sertraline C Date:02/20/02ISR Number: 3873759-XReport Type:Expedited (15-DaCompany Report #2001UW10757 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Seroquel "Zeneca" PS ORAL 6.25 MG HS PO Initial or Prolonged Marrow Hyperplasia Health Sinemet-Cr C Neutropenia Professional Conjugated Estrogens C Other Hydrochlorothiazide C 22-Feb-2006 08:31 AM Page: 395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levothyroxine C Vitamin D2 C Benadryl C Ibuprofen C Ropinirole C Slow-K C Date:02/21/02ISR Number: 3872794-5Report Type:Direct Company Report #CTU 162070 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Torticollis Quetiapine PS Initial or Prolonged Risperidone SS Date:02/21/02ISR Number: 3872903-8Report Type:Expedited (15-DaCompany Report #HQ0747219FEB2002 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Health Efexor (Venlafaxine Initial or Prolonged Dyspnoea Professional Hydrochloride, Other Other Tablet) PS ORAL SEE IMAGE Quetiapine (Quetiapine) SS ORAL SEE IMAGE Valproate Sodium (Valproate Sodium, ) SS ORAL 3 G 1X PER 1 DAY Date:02/21/02ISR Number: 3872930-0Report Type:Expedited (15-DaCompany Report #2002UW00669 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Foreign Seroquel PS Initial or Prolonged Transient Ischaemic Other Tv-1203/Carbidopa SS ORAL 7 DAILY PO Attack Quinapril SS Lorazepam C Plavix C Sinemet - Slow Release C Oxazepam C Simvastatin C Vitamin B12 C Vitamin E C Amantadine C Date:02/21/02ISR Number: 3873329-3Report Type:Expedited (15-DaCompany Report #2001AP05328 Age:60 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Seroquel "Zeneca" PS Zeneca 200 MG BID 3 YR Initial or Prolonged Health Seroquel "Zeneca" SS Zeneca 150 MG BID 4 WK Required Professional Antibiotics C Intervention to Company Prevent Permanent Representative Impairment/Damage Other 22-Feb-2006 08:31 AM Page: 396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/02ISR Number: 3873334-7Report Type:Expedited (15-DaCompany Report #2002AP00353 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cystitis Foreign Seroquel PS ORAL 150 MG DAILY Intervention to Hepatitis Study PO Prevent Permanent Health Seroquel SS ORAL 225 MG DAILY Impairment/Damage Professional PO Other Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Loxoprofen Sodium SS ORAL 60 MG DAILY PO Haloperidol C Sulpiride C Promethazine Hydrochloride C Flunitrazepam C Sennoside C Date:02/22/02ISR Number: 3874063-6Report Type:Expedited (15-DaCompany Report #02-0191 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Clonazepam Tablets Aggression Other (0.5 Mg) PS Watson Laboratories Crying Inc ORAL 1 PO TID Head Banging Seroquel Tablets 25 Homicidal Ideation Mg (Astrazeneca Mania Pharmaceuticals) SS Astrazeneca Suicidal Ideation Pharmaceuticals ORAL 1 PO Q3 PM Neurontin C Topamax C Date:02/25/02ISR Number: 3873939-3Report Type:Expedited (15-DaCompany Report #2002UW02223 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Seroquel PS ORAL 700 MG DAILY Liver Function Test Professional PO Abnormal Clozapine SS ORAL 525 MG QD PO Neutropenia Depakote SS ORAL 1750 MG QD PO Levothyroxine C Lithium C Interferon C Date:02/25/02ISR Number: 3873941-1Report Type:Expedited (15-DaCompany Report #2002UW00021 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Valve Stenosis Health Seroquel PS ORAL 800 MG DAILY Asthma Professional PO Cardiomegaly Citalopram SS Drug Toxicity Propoxyphene SS Mitral Valve Prolapse Topiramate SS Pancreatic Pseudocyst Triazolam SS Diphenhydramine C Propoxyphene 22-Feb-2006 08:31 AM Page: 397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Compound C Acetaminophen C Bupropion C Caffeine C Date:02/25/02ISR Number: 3874647-5Report Type:Expedited (15-DaCompany Report #NSADSS2001039330 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Topamax Cardiac Disorder Professional (Unspecified) Drug Toxicity (Topiramate) PS ORAL ORAL Risperdal (2 Mg Tablet) (Risperidone) SS ORAL 2 MG, 2 IN DAILY, ORAL Citalopram (Citalopram) SS Propoxyphene (Dextropropoxyphene) SS Quetiapine (Quetiapine) SS Triazolam (Triazolam) SS Diphenhydramine (Diphenhydramine) C Acetaminophen (Paracetamol) C Bupropion (Amfebutamone) C Date:02/25/02ISR Number: 3874967-4Report Type:Direct Company Report #CTU 162219 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Serzone All Strengths Bristol Meyers Squibb PS Bristol Meyers Squibb ORAL 300 TO DAILY ORAL Seroquel All Streghths Astra Zeneca SS Astra Zeneca ORAL 50 TO DAILY ORAL Date:02/26/02ISR Number: 3875760-9Report Type:Expedited (15-DaCompany Report #2002UW02418 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 100 MG PO Decreased Professional Date:02/26/02ISR Number: 3875790-7Report Type:Expedited (15-DaCompany Report #NSADSS2001039330 Age:43 YR Gender:Male I/FU:F Outcome PT Death Asthma Cardiac Disorder 22-Feb-2006 08:31 AM Page: 398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Toxicity Report Source Product Role Manufacturer Route Dose Duration Health Risperdal Professional (Risperidone) PS ORAL 2 MG, 2 IN DAILY, ORAL Topamax (Unspecified) (Topiramate) SS ORAL ORAL Propoxyphene (Dextropropoxyphene) SS Citalopram (Citalopram) SS Quetiapine (Quetiapine) SS Triazolam (Triazolam) SS Diphenhydramine (Diphenhydramine) C Acetaminophen (Paracetamol) C Bupropion (Amfebutamone) C Date:02/26/02ISR Number: 3875987-6Report Type:Expedited (15-DaCompany Report #2002AP00385 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS Health Seroquel SS ORAL 300 MG DAILY Professional PO Other Minomycin SS ORAL 100 MG DAILY PO Serenace SS INTRAVENOUS 5 MG DAILY IV Halcion C Lendormin C Alosenn C Date:02/26/02ISR Number: 3875989-XReport Type:Expedited (15-DaCompany Report #2002UW01363 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Feeling Abnormal Foreign Seroquel PS ORAL 25 MG BID PO Health Seroquel SS ORAL 12.5 MG BID Professional PO Other Risperidone C Aspirin Enteric Coated K.P. C Metformin C Glyburide C Synthroid C Alphagan C 22-Feb-2006 08:31 AM Page: 399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/02ISR Number: 3875990-6Report Type:Expedited (15-DaCompany Report #2002GB00282 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Foreign Seroquel "Zeneca" PS Zeneca Required Non-Insulin-Dependent Health Intervention to Professional Prevent Permanent Other Impairment/Damage Date:02/26/02ISR Number: 3876307-3Report Type:Expedited (15-DaCompany Report #2002AP00047 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplasia Pure Red Cell Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Malaise Health PO Professional Seroquel SS ORAL 500 MG DAILY Other PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 750 MG DAILY PO Tasmolin C Gasmotin C Selbex C Rohypnol C Levotomin C Metligine C Methycobal C Date:02/27/02ISR Number: 3874852-8Report Type:Direct Company Report #CTU 162428 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anoxic Encephalopathy Quietiapine PS 100-120 TABS Hospitalization - Aspiration X 1 DOSE Initial or Prolonged Hypotension Lithium C Required Pulmonary Oedema Diltiazem C Intervention to Pulse Absent Gabapentin C Prevent Permanent Pyrexia Topiramate C Impairment/Damage Risperidal C Lisinopril C Ceftriaxone C Date:02/27/02ISR Number: 3875962-1Report Type:Direct Company Report #CTU 162457 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Seroquel PS 100MG QA + Initial or Prolonged Insulin-Dependent 400 MG HS Celexa C Catapres C Periactin C Benadryl C Procardia C Dilantin C 22-Feb-2006 08:31 AM Page: 400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/02ISR Number: 3876041-XReport Type:Expedited (15-DaCompany Report #GB8913119FEB2002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congenital Anomaly Health Ativan (Lorazepam, Initial or Prolonged Drug Exposure During Professional Tablet, 0) PS TRANSPLACENTAL Pregnancy Other Cipramil (Citalopram Eye Disorder Hydrobromide, ,0) SS TRANSPLACENTAL Hypotonia Neonatal Methotrimeprazine Hypoventilation Neonatal (Levomepromazine, , Maternal Drugs Affecting 0) SS TRANSPLACENTAL Foetus Perphenazine Neonatal Disorder (Perphenazine, , 0) SS TRANSPLACENTAL Seroquel (Quetiapine, , 0) SS TRANSPLACENTAL Trazodone (Trazodone, , 0) SS TRANSPLACENTAL Zopiclone (Zopiclone, , 0) SS TRANSPLACENTAL Date:02/27/02ISR Number: 3877076-3Report Type:Expedited (15-DaCompany Report #02P-163-0188315-00 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Depakote (Divalproex Neutropenia Professional Sodium) Platelet Count Decreased Other (Divalproex Sodium) PS ORAL 1750 MG, 1 IN 1 D, PER ORAL Clozapine SS ORAL 525 MG, 1 IN 1 D, PER ORAL Quetiapine Fumarate SS ORAL 700 MG, 1 IN 1 D, PER ORAL Levothyroxine C Lithium C Date:02/28/02ISR Number: 3877620-6Report Type:Expedited (15-DaCompany Report #2002AP00307 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Foreign Seroquel PS ORAL 75 MG DAILY Face Oedema Health PO Muscle Strain Professional Seroquel SS ORAL 150 MG DAILY Sudden Death Other PO Lusyton C Tasmolin C Abovis C Eurodin C Tetramide C Date:02/28/02ISR Number: 3877651-6Report Type:Expedited (15-DaCompany Report #2002PK00157 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glossodynia Foreign Seroquel "Zeneca" PS Zeneca ORAL 300 MG DAILY Initial or Prolonged Pancytopenia Health PO Professional Nexium SS ORAL 20 MG DAILY Other PO Trileptal SS ORAL 1500 MG DAILY PO 22-Feb-2006 08:31 AM Page: 401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nozinan SS ORAL 100 MG DAILY PO Voltaren "Novartis" SS Novartis ORAL 200 MG DAILY PO Effectin C Trittico C Praxiten C Date:02/28/02ISR Number: 3877652-8Report Type:Expedited (15-DaCompany Report #2002UW01733 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS Health Professional Other Date:02/28/02ISR Number: 3878178-8Report Type:Expedited (15-DaCompany Report #2002UW01080 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coma Health Seroquel PS ORAL 25 MG BID PO Intervention to Professional Prevent Permanent Impairment/Damage Date:02/28/02ISR Number: 3878180-6Report Type:Expedited (15-DaCompany Report #2002UW02450 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatic Steatosis Consumer Seroquel PS ORAL 300 MG DAILY Intervention to Liver Disorder PO Prevent Permanent Weight Increased Armour Thyroid C Impairment/Damage Date:02/28/02ISR Number: 3878182-XReport Type:Expedited (15-DaCompany Report #2002UW02674 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel "Zeneca" PS Zeneca 900 MG DAILY Professional Date:02/28/02ISR Number: 3878548-8Report Type:Expedited (15-DaCompany Report #A202921 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Ziprasidone Po PS 80.00 MG Initial or Prolonged Drug Interaction Professional TOTAL:DAILY Required Dyspnoea Seroquel SS ORAL 350.00 MG Intervention to Heart Rate Increased TOTAL:DAILY:O Prevent Permanent Nausea RAL Impairment/Damage Neuroleptic Malignant Ambien (Zolpidem) C Syndrome Tetracycline C Vomiting 22-Feb-2006 08:31 AM Page: 402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/02ISR Number: 3889424-9Report Type:Periodic Company Report #001-0945-M0100596 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Neurontin Initial or Prolonged Mania Professional (Gabapentin) PS 3600 MG (TID) Overdose Seroquel SS 900 MG Schizophrenia (DAILY) / SEE IMAGE Geodon SS ORAL 40 MG (BID), PER ORAL / SEE IMAGE Beer SS Date:02/28/02ISR Number: 3889429-8Report Type:Periodic Company Report #001-0945-M0100461 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Neurontin Overdose Professional (Gabapentin) PS ORAL 2700 MG TID PER ORAL Seroquel (Quentiapine) SS 650 MG DAILY Aspirin (Acetylsalicylic Acid) C Multivitamin (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, C Vitamin E (Tocopherol) C Buspar (Buspirone Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Insulin (Insulin) C Date:03/01/02ISR Number: 3877875-8Report Type:Expedited (15-DaCompany Report #2002GB00452 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS 100 MG BID Intervention to Sedation Health Venlafaxine SS Prevent Permanent Professional Impairment/Damage Other Date:03/01/02ISR Number: 3877876-XReport Type:Expedited (15-DaCompany Report #2001SE03377 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Circulatory Collapse Foreign Seroquel "Zeneca" PS ORAL 100 MG DAILY Intervention to Hyperhidrosis Study PO Prevent Permanent Orthostatic Hypotension Health Seroquel "Zeneca" SS ORAL 200 MG DAILY Impairment/Damage Pallor Professional PO Pulse Pressure Decreased Other Seroquel "Zeneca" SS ORAL 150 MG DAILY Syncope PO 22-Feb-2006 08:31 AM Page: 403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Teotard C Date:03/01/02ISR Number: 3878586-5Report Type:Expedited (15-DaCompany Report #S02-UKI-00324-02 Age:0 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congenital Anomaly Foreign Cipramil (Citalopram Initial or Prolonged Eye Disorder Health Hydrobromide) PS Congenital Anomaly Hypotonia Neonatal Professional Lorazepam SS Hypoventilation Other Perphenazine SS Maternal Drugs Affecting Trazodone SS Foetus Zopiclone SS Neonatal Respiratory Seroquel SS Depression Methotrimeprazine SS Date:03/04/02ISR Number: 3879030-4Report Type:Expedited (15-DaCompany Report #2002GB00363 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Essential Hypertension Foreign Seroquel "Zeneca" PS Zeneca ORAL 600 MG DAILY Initial or Prolonged Hypertensive Crisis Health PO Professional Unspecified C Other Date:03/04/02ISR Number: 3879034-1Report Type:Expedited (15-DaCompany Report #2002AP00385 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS Pyrexia Health Seroquel SS ORAL 300 MG DAILY Professional PO Minomycin SS ORAL 100 MG DAILY PO Serenace SS INTRAVENOUS 5 MG DAILY IV Halcion C Lendormin C Alosenn C Date:03/04/02ISR Number: 3879770-7Report Type:Direct Company Report #CTU 162738 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Risperdal 2 Mg Qhs PS 2MG QHS Initial or Prolonged Confusional State Seroquel 100mg Po Q Parkinsonism 6h SS ORAL 100MG PO Q 6H Lotensin C Zantac C Folate C Atarax C Tylenol C Maalox C Remeron C Cardura C Sinemet C Aricept C Cogentin C Depakote C 22-Feb-2006 08:31 AM Page: 404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lasix C Lopressor C Pepcid C Seroquel C Date:03/05/02ISR Number: 3879336-9Report Type:Expedited (15-DaCompany Report #2002UW02648 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Health Seroquel "Zeneca" PS Intervention to Phosphokinase Increased Professional Prevent Permanent Impairment/Damage Date:03/05/02ISR Number: 3880870-6Report Type:Expedited (15-DaCompany Report #2002PK00183 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Seroquel PS Initial or Prolonged Sedation Health Seroquel SS ORAL 3000 MG DAILY Suicide Attempt Professional PO Other Date:03/05/02ISR Number: 3880871-8Report Type:Expedited (15-DaCompany Report #2001AP03934 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Disorientation Foreign Seroquel "Zeneca" PS Zeneca ORAL 75 MG DAILY Hospitalization - Loss Of Consciousness Health PO Initial or Prolonged Neuroleptic Malignant Professional Seroquel "Zeneca" SS Zeneca ORAL 52 U ONCE PO Syndrome Other Contomin SS ORAL 75 MG DAILY Overdose PO Pyrexia Contomin SS ORAL 25 MG ONCE PO Suicide Attempt Lexotan SS ORAL 24 MG DAILY Urinary Incontinence PO Lexotan SS ORAL 2 MG ONCE PO Date:03/06/02ISR Number: 3879689-1Report Type:Expedited (15-DaCompany Report #2002UW02841 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Health Seroquel PS ORAL 300 MG DAILY Professional PO 2 MON Date:03/06/02ISR Number: 3880006-1Report Type:Expedited (15-DaCompany Report #2002AP00473 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Extrasystoles Study PO Prevent Permanent Health Seroquel SS ORAL 75 MG DAILY Impairment/Damage Professional PO Other Seroquel SS ORAL 500 MG DAILY PO Risperdal C Myslee C 22-Feb-2006 08:31 AM Page: 405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benzalin C Pantosin C Shuprase C Cennaride C Date:03/06/02ISR Number: 3880007-3Report Type:Expedited (15-DaCompany Report #2000AP01959 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Congenital Anomaly Foreign Seroquel PS Zeneca MOTHER TOOK Hospitalization - Eye Disorder Health 250 MG DAILY Initial or Prolonged Hypotonia Neonatal Professional Lorazepam SS MOTHER TOOK 1 Congenital Anomaly Hypoventilation Other MG DAILY Maternal Drugs Affecting Zopiclone SS MOTHER TOOK Foetus 7.5 MG DAILY Neonatal Respiratory Perphenazine SS MOTHER 4 MG Depression DAILY Trazodone SS MOTHER TOOK 150 MG DAILY Cipramil SS MOTHER TOOK 20 MG DAILY Methotrimeprazine SS Date:03/06/02ISR Number: 3880485-XReport Type:Expedited (15-DaCompany Report #HQ0747219FEB2002 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Efexor (Venlafaxine Initial or Prolonged Depersonalisation Professional Hydrochloride, Other Drug Withdrawal Syndrome Other Tablet) PS ORAL 300 MG 1X PER Dyspnoea 1 DAY ORAL Hallucination, Auditory Efexor (Venlafaxine Sleep Disorder Hydrochloride, Tablet) SS ORAL "RAPID RETITIRATION OVER 36 HOURS TO USUAL DOSE" Quetiapine (Quetiapine, ) SS ORAL 800 MG 1X PER 1 DAY ORAL Quetiapine (Quetiapine, ) SS ORAL TITRATION ORAL Valproate Sodium (Valproate Sodium, ) SS ORAL 3 G 1X PER 1 DAY ORAL Valproate Sodium (Valproate Sodium, ) SS ORAL ORAL Date:03/07/02ISR Number: 3879555-1Report Type:Direct Company Report #CTU 162906 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Difficulty In Walking Seroquel 100mg Aztra Intervention to Oedema Zenicha PS Aztra Zenicha ORAL 2000 MG DAILY Prevent Permanent Pain In Extremity ORAL Impairment/Damage Psychotic Disorder Depakote C 22-Feb-2006 08:31 AM Page: 406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Kcl C Simethacone C Glyburide C Glucophage C Benzapril C Asa C Prevacid C Lipitor C Risperdal C Date:03/08/02ISR Number: 3881661-2Report Type:Expedited (15-DaCompany Report #GB8920204MAR2002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Efexor (Venlafaxine Sedation Professional Hydrochloride, Unspec, 0) PS ORAL ORAL Seroquel (Quetiapine, 0) SS ORAL 100 MG 2X PER 1 DAY, ORAL Date:03/12/02ISR Number: 3882137-9Report Type:Direct Company Report #USP 54584 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel 200mg (Quetiapine) PS Astra Zeneca Serzone 200mg( Nefazodone Hcl) SS Bristol-Myers Squibb Date:03/12/02ISR Number: 3882909-0Report Type:Expedited (15-DaCompany Report #2001UW05633 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Consumer Seroquel "Zeneca" PS ORAL 700 MG DAILY Initial or Prolonged Asthenia PO Confusional State Seroquel "Zeneca" SS ORAL 100 MG BID PO Delusion Seroquel "Zeneca" SS ORAL 600 MG DAILY Depression PO Fatigue Seroquel "Zeneca" SS ORAL 500 MG QD PO Hypomania Seroquel "Zeneca" SS ORAL 200 MG TID PO Hypothyroidism Seroquel "Zeneca" SS ORAL 800 MG DAILY Insomnia PO Malaise Risperdal C Paranoia Depakote C Photosensitivity Reaction Neurontin C Platelet Count Decreased Clonapin C Sedation Prevacid C Stress Tapazole C Weight Increased Lasix C Rhinocort Aqua C Zoloft C Celebrex C Wellbutrin C 22-Feb-2006 08:31 AM Page: 407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/02ISR Number: 3882934-XReport Type:Expedited (15-DaCompany Report #2002UW02766 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Health Seroquel PS Zeneca ORAL 300 MG DAILY Hospitalization - Coma Professional PO Initial or Prolonged Overdose Seroquel SS Zeneca ORAL 100 MG PO Suicide Attempt Depakote SS Date:03/12/02ISR Number: 3882951-XReport Type:Expedited (15-DaCompany Report #2002SE00624 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Zeneca ORAL 300 MG DAILY Viral Infection Health PO Professional Remeron C Other Zoloft C Subutex C Date:03/12/02ISR Number: 3882953-3Report Type:Expedited (15-DaCompany Report #2001SE09087 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Seroquel "Zeneca" PS Zeneca ORAL 400 MG DAILY Initial or Prolonged Petit Mal Epilepsy Study PO Health Serlain SS ORAL 50 MG QD PO Professional Lormetazepam C Other Lysanxia C Date:03/12/02ISR Number: 3883053-9Report Type:Expedited (15-DaCompany Report #2000AP01959 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Congenital Anomaly Foreign Seroquel "Zeneca" PS MOTHER TOOK Hospitalization - Hypotonia Neonatal Health 250 MG DAILY Initial or Prolonged Hypoventilation Professional Lorazepam SS MOTHER TOOK 1 Congenital Anomaly Maternal Drugs Affecting Other MG DAILY Foetus Zopiclone SS MOTTHER TOOK Neonatal Disorder 7.5 MG DAILY Neonatal Respiratory Perphenazine SS MOTHER TOOK 4 Depression MG DAILY Respiratory Depression Trazodone SS MOTHER TOOK 150 MG DAILY Cipramil SS MOTHER TOOK 20 MG DAILY Methotrimeprazine SS Date:03/13/02ISR Number: 3883431-8Report Type:Expedited (15-DaCompany Report #2002AP00482 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Seroquel PS ORAL 50 MG DAILY Hypothermia Study PO Ileus Paralytic Health Seroquel SS ORAL 300 MG DAILY Pneumonia Professional PO Other Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 600 MG DAILY 22-Feb-2006 08:31 AM Page: 408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Linton C Zyprexa C Artane C Metligine C Rohypnol C Gaster C Date:03/13/02ISR Number: 3883432-XReport Type:Expedited (15-DaCompany Report #2002AP00497 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 700 MG DAILY Health PO Professional Seroquel SS ORAL 200 MG DAILY Other PO Wypax C Date:03/14/02ISR Number: 3882730-3Report Type:Direct Company Report #CTU 163381 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Seroquel PS ORAL PO Zyprexa SS ORAL PO Prolixin C Cogentin C Date:03/15/02ISR Number: 3884334-5Report Type:Expedited (15-DaCompany Report #2001PK00083 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Seroquel "Zeneca" PS ORAL 600 MG DAILY Health PO Professional Orfiril "Desitin" C Other Atosil C Thiamazol C Delix C Date:03/15/02ISR Number: 3884337-0Report Type:Expedited (15-DaCompany Report #2001PK00531 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Seroquel "Zeneca" PS ORAL 750 MG DAILY Neutrophil Count Health PO Decreased Professional Ergenyl SS ORAL 450 MG DAILY White Blood Cell Count Other PO Decreased Haloperidol C Tavor C Date:03/15/02ISR Number: 3884338-2Report Type:Expedited (15-DaCompany Report #2000AP03966 Age:16 YR Gender:Female I/FU:I Outcome PT Other Aspartate Aminotransferase Increased Epistaxis 22-Feb-2006 08:31 AM Page: 409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gamma-Glutamyltransferase Increased Headache Report Source Product Role Manufacturer Route Dose Duration Lymphocytosis Foreign Seroquel "Zeneca" PS Health Professional Other Date:03/15/02ISR Number: 3884340-0Report Type:Expedited (15-DaCompany Report #2001AP02119 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel "Zeneca" PS Initial or Prolonged Health Diazepam C Required Professional Intervention to Other Prevent Permanent Impairment/Damage Date:03/15/02ISR Number: 3884342-4Report Type:Expedited (15-DaCompany Report #2001AP02279 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel "Zeneca" PS ORAL 375 MG BID PO Health Minocin C Professional Sodium Valproate C Other Lansoprazole C Fortisip C Clozaril C Date:03/15/02ISR Number: 3884343-6Report Type:Expedited (15-DaCompany Report #2001SE07712 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel "Zeneca" PS ORAL 200 MG BID PO Intervention to Health Vallergan C Prevent Permanent Professional Impairment/Damage Other Date:03/15/02ISR Number: 3884367-9Report Type:Expedited (15-DaCompany Report #APCDSS2001001371 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Risperdal (Tablet) Sudden Death Health (Risperidone) PS SEE IMAGE FOR Professional DOSAGE TEXT & THERAPY DATES Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS VARING DOSES FROM 25 TO 300 MG DAILY Quetiapine Fumarate (Quetiapine Fumarate) SS VARING DOSES FROM 50 TO 22-Feb-2006 08:31 AM Page: 410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 600 MG DAILY Olanzapine (Olanzapine) SS VARING DOSES FROM 5 TO 10 MG DAILY Flunitrazepam (Flunitrazepam) SS VARING DOSE FROM 2 MG TO 4 MG Levomepromazine (Levomepromazine) SS VARING DOSE FROM 10 MG TO 25 MG Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Teprenone (Teprenone) C Date:03/15/02ISR Number: 3884966-4Report Type:Expedited (15-DaCompany Report #2001UW08959 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Seroquel PS Zeneca ORAL 450 MG DAILY Temperature Intolerance PO Activelle C Ativan C Neurontin C Zyprexa C Date:03/15/02ISR Number: 3884968-8Report Type:Expedited (15-DaCompany Report #2001UW09452 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Seroquel PS Zeneca ORAL 50 MG HS PO Deficit/Hyperactivity Professional Serzone C Disorder Lamictal C Bone Pain Ejaculation Disorder Leukopenia Muscle Spasms Pelvic Pain Thirst Urinary Retention Date:03/15/02ISR Number: 3884971-8Report Type:Expedited (15-DaCompany Report #2001UW13414 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Cardiac Failure Congestive Diabetes Mellitus Oedema Peripheral 22-Feb-2006 08:31 AM Page: 411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Visual Disturbance Report Source Product Role Manufacturer Route Dose Duration Consumer Seroquel PS Zeneca Date:03/15/02ISR Number: 3884973-1Report Type:Expedited (15-DaCompany Report #2000UW04299 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Zeneca ORAL 300 MG DAILY Professional PO Seroquel SS Zeneca ORAL 400 MG DAILY PO Seroquel SS Zeneca Prolixin C Cogentin C Ativan C Date:03/18/02ISR Number: 3885046-4Report Type:Expedited (15-DaCompany Report #2002UW03307 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel "Zeneca" PS ORAL 1100 MG DAILY Decreased Consumer PO Other Cogentin C Fluanxol"Lundbeck" C Date:03/18/02ISR Number: 3885096-8Report Type:Expedited (15-DaCompany Report #2002US03382 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Consumer Seroquel "Zeneca" PS ORAL 150 MG DAILY Intervention to Clonic Convulsion PO Prevent Permanent Glaucoma Xanax C Impairment/Damage Headache Loxapine C Heart Rate Increased Risperdal C Macular Degeneration Zyprexa C Paralysis Visual Acuity Reduced Date:03/18/02ISR Number: 3885097-XReport Type:Expedited (15-DaCompany Report #2002UW03090 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Rhabdomyolysis Other Seroquel "Zeneca" PS ORAL 300 MG DAILY Intervention to PO Prevent Permanent Seroquel "Zeneca" SS ORAL 100 MG BID PO Impairment/Damage Zocor "Dieckmann" C Lopid C Date:03/18/02ISR Number: 3885109-3Report Type:Expedited (15-DaCompany Report #2002UW03403 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG DAILY Initial or Prolonged PO 22-Feb-2006 08:31 AM Page: 412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal SS Date:03/18/02ISR Number: 3885110-XReport Type:Expedited (15-DaCompany Report #2002UW03339 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG DAILY Initial or Prolonged Professional PO Date:03/18/02ISR Number: 3885111-1Report Type:Expedited (15-DaCompany Report #2002UW02956 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choking Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 300 MG BID PO Initial or Prolonged Dysphagia Seroquel "Zeneca" SS "Zeneca" ORAL 500 MG DAILY Tremor PO Seroquel "Zeneca" SS "Zeneca" ORAL 600 MG DAILY PO Depakote C Cogentin C Date:03/18/02ISR Number: 3885169-XReport Type:Expedited (15-DaCompany Report #2001UW09206 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel "Zeneca" PS Zeneca ORAL 700 MG DAILY Initial or Prolonged Health PO Professional Seroquel "Zeneca" SS Zeneca ORAL 400 MG HS PO Other Seroquel "Zeneca" SS Zeneca ORAL 600 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 800 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 900 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 600 MG HS DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 200 MG BID PO Olanzapine C Clonazepam C Divalproex Sodium C Docusate Calcium C Date:03/18/02ISR Number: 3885170-6Report Type:Expedited (15-DaCompany Report #2002UW03475 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Foreign Seroquel PS ORAL 25 MG PO Initial or Prolonged Health Clopixol Professional (Hydrochoride) C Other 22-Feb-2006 08:31 AM Page: 413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/02ISR Number: 3884779-3Report Type:Direct Company Report #CTU 163694 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Penile Pain Seroquel PS 7 MON Initial or Prolonged Priapism Other Required Intervention to Prevent Permanent Impairment/Damage Date:03/19/02ISR Number: 3885453-XReport Type:Expedited (15-DaCompany Report #2002AP00556 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Distension Foreign Seroquel PS ORAL 75 MG DAILY Intervention to Constipation Health PO Prevent Permanent Gastrointestinal Motility Professional Seroquel SS ORAL 150 MG DAILY Impairment/Damage Disorder Other PO Somnolence Seroquel SS ORAL 75 MG DAILY Vomiting PO Risperdal C Pantosin C Gascon C Magnesium Oxide C No Match C Sennoside C Tasmolin C Levotomin C Date:03/19/02ISR Number: 3885454-1Report Type:Expedited (15-DaCompany Report #2002GB00687 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Foreign Quetiapine PS ORAL 200 MG BID PO Neutropenia Health Prednisolone C Osteoporosis Professional Enalapril C Other Xalatan C Digoxin C Venlafaxine C Oilatum Emollient C Fosamax C Calcichew C Donepezil C Bendrofluazide C Date:03/19/02ISR Number: 3885457-7Report Type:Expedited (15-DaCompany Report #2002AP00473 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Supraventricular Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Extrasystoles Study PO Prevent Permanent Health Seroquel SS ORAL 75 MG DAILY Impairment/Damage Professional PO Other Seroquel SS ORAL 500 MG DAILY PO Risperdal C Myslee C 22-Feb-2006 08:31 AM Page: 414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benzalin C Pantosin C Shuprase C Cennaride C Date:03/19/02ISR Number: 3885539-XReport Type:Expedited (15-DaCompany Report #NSADSS2002007512 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Dependence Consumer Duragesic (75 Mcg/Hr Hospitalization - Patch ) (Fentanyl) PS TRANSDERMAL 75 MCG/H, 1 Initial or Prolonged IN 48 HOUR(S), TRANSD Neurontin (Gabapentin) SS ORAL 3000 , 3 IN 24 HOUR(S), ORAL Trazodone (Trazadone) SS ORAL 100, 1 IN 24 HOUR(S), ORAL Seroquel (Seroquel) SS ORAL 100 MG, 2 IN 24 HOUR(S), ORAL Effexor (Venlafaxine Hydrochloride) SS ORAL ORAL Pepcid (Famotidine) C Darvocet (Carvocet) C Ambien (Zolpidem Tartrate) C Zofran (Ondansetron Hydrochloride) C Provera (Medroxyprogesterone Acetate) C Date:03/19/02ISR Number: 3886250-1Report Type:Direct Company Report #CTU 163755 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Quetiapine PS 25MG 4TTTT OR Initial or Prolonged PLACEBO Sinemet C Mirapex C Anapril C Proscar C Date:03/19/02ISR Number: 3886251-3Report Type:Direct Company Report #CTU 163756 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pain In Extremity Quetiapine PS 25MG 4TTTT Initial or Prolonged BID OR PLACEBO Mirapex C Proprianolol C Sinemet C Aspirin C 22-Feb-2006 08:31 AM Page: 415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aricept C Date:03/21/02ISR Number: 3887012-1Report Type:Expedited (15-DaCompany Report #2002GB00156 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel "Zeneca" PS ORAL 750 MG DAILY Health PO Professional Lorazepam C Other Date:03/21/02ISR Number: 3887055-8Report Type:Expedited (15-DaCompany Report #2002AP00385 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Seroquel PS Initial or Prolonged Pyrexia Health Seroquel SS ORAL 300 MG DAILY Required Professional PO Intervention to Other Minomycin SS ORAL 100 MG DAILY Prevent Permanent PO Impairment/Damage Serenace SS INTRAVENOUS 5 MG DAILY IV Halcion C Lendormin C Alosenn C Date:03/21/02ISR Number: 3887095-9Report Type:Expedited (15-DaCompany Report #2002GB00277 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypotension Foreign Seroquel "Zeneca" PS ORAL 350 MG BID PO Intervention to Impaired Driving Ability Health Prevent Permanent Loss Of Consciousness Professional Impairment/Damage Other Date:03/21/02ISR Number: 3887418-0Report Type:Expedited (15-DaCompany Report #2002UW03767 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Seroquel PS ORAL 800 MG DAILY Decreased Professional PO White Blood Cell Count Seroquel SS ORAL 900 MG DAILY Decreased PO Depakote C Pamelor C Date:03/22/02ISR Number: 3887657-9Report Type:Expedited (15-DaCompany Report #2002UW03827 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Embolism Health Seroquel PS ORAL 500 MG DAILY Professional PO Risperdal C Multiple Medications C 22-Feb-2006 08:31 AM Page: 416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/22/02ISR Number: 3887695-6Report Type:Expedited (15-DaCompany Report #02P-163-0188315-00 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Depakote (Divalproex Neutropenia Professional Sodium) (Divalproex Other Sodium) PS ORAL 1750 MG, 1 IN 1 D, PER ORAL Clozapine SS ORAL 525 MG, 1 IN 1 D, PER ORAL Quetiapine Fumarate SS ORAL 700 MG, 1 IN 1 D, PER ORAL Levothyroxine C Lithium C Date:03/22/02ISR Number: 3887807-4Report Type:Expedited (15-DaCompany Report #2002SE00611 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Seroquel PS 400-600 MG Neutropenia Health Remeron SS 30 MG Professional Haldol C Other Dipiperon C Akineton Retard C Valium C Date:03/25/02ISR Number: 3888256-5Report Type:Expedited (15-DaCompany Report #2002UW03119 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 600 MG DAILY Intervention to Visual Acuity Reduced Professional PO Prevent Permanent Paxil C Impairment/Damage Neurontin C Date:03/25/02ISR Number: 3888739-8Report Type:Expedited (15-DaCompany Report #2002GB00696 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Foreign Quetiapine PS ORAL 100MG BID PO Intervention to Abnormal Health Quetiapine SS ORAL 150MG BID PO Prevent Permanent Pericardial Effusion Professional Mirtazapine C Impairment/Damage Other Ranitidine C Date:03/27/02ISR Number: 3890741-7Report Type:Expedited (15-DaCompany Report #2002GB00232 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bundle Branch Block Right Foreign Seroquel "Zeneca" PS ORAL 150 MG TID PO Intervention to Dyspnoea Health Depixol C Prevent Permanent Electrocardiogram Professional Paroxetine C Impairment/Damage Abnormal Other Procyclidine C Headache Zopiclone C Sinus Tachycardia Ventricular Hypertrophy Weight Increased 22-Feb-2006 08:31 AM Page: 417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/02ISR Number: 3890790-9Report Type:Expedited (15-DaCompany Report #2001UW03379 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ascites Health Seroquel "Zeneca" PS ORAL 600 MG PO Intervention to Polydipsia Professional Lithium SS 1050 MG DAILY Prevent Permanent Polyuria Impairment/Damage Date:03/27/02ISR Number: 3890791-0Report Type:Expedited (15-DaCompany Report #2002UW03981 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 25 MG HS PO Decreased Professional Date:03/27/02ISR Number: 3890904-0Report Type:Expedited (15-DaCompany Report #2002UW03993 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Cancer Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:03/29/02ISR Number: 3892519-7Report Type:Expedited (15-DaCompany Report #2002AP00563 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colitis Ischaemic Foreign Seroquel PS ORAL 25 MG DAILY Disability Gastric Ulcer Health PO Required Melaena Professional Tiaprim SS ORAL 48 MG DAILY Intervention to Rhabdomyolysis Other PO Prevent Permanent Tiaprim SS ORAL 120 MG DAILY Impairment/Damage PO Depas C Sermion C Bufferin C Brovarin C Date:03/29/02ISR Number: 3892725-1Report Type:Expedited (15-DaCompany Report #2002AP00620 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Literature Quetiapine PS ORAL 100 MG DAILY Intervention to Convulsion Health PO 1 DAY Prevent Permanent Disorientation Professional Olanzapine SS ORAL 15 MG DAILY Impairment/Damage Drug Interaction PO Fall Benztropine C Tongue Biting Sertraline C Tremor Clonazepam C 22-Feb-2006 08:31 AM Page: 418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/02ISR Number: 3892094-7Report Type:Expedited (15-DaCompany Report #NSADSS2001008399 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Risperdal PS ORAL 25 DAY Alanine Aminotransferase Quetiapine SS ORAL 1 DAY Increased Risperdal C ORAL 503 DAY Aspartate Risperdal C ORAL 38 DAY Aminotransferase Risperdal C ORAL 7 DAY Increased Risperdal C ORAL 7 DAY Blood Lactate Quetiapine C ORAL 2 DAY Dehydrogenase Increased Quetiapine C ORAL 3 DAY Cardio-Respiratory Arrest Quetiapine C ORAL 2 DAY Choking Estazolam C ORAL 559 DAY Dyskinesia Flunitrazepam C ORAL 609 DAY Hallucination, Auditory Biperiden Hypoaesthesia Hydrochloride C ORAL 69 DAY Nasopharyngeal Disorder Quetiapine C ORAL 1 DAY Neck Pain Quetiapine C ORAL 1 DAY Obstruction Quetiapine C ORAL 1 DAY Restlessness Risperdal C ORAL 4 DAY Tremor Risperdal C ORAL 3 DAY Risperdal C ORAL 4 DAY Risperdal C ORAL 10 DAY Risperdal C ORAL 4 DAY Date:04/01/02ISR Number: 3893290-5Report Type:Expedited (15-DaCompany Report #2002AP00690 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Loss Of Consciousness Foreign Quetiapine PS ORAL 300 MG BID PO Hospitalization - Renal Failure Acute Health Mirtazapine SS ORAL 30 MG DAILY Initial or Prolonged Professional PO Other Sertraline SS ORAL 100 MG DAILY PO Gliclazide C Metformin C Date:04/01/02ISR Number: 3893292-9Report Type:Expedited (15-DaCompany Report #2002AP00632 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Seroquel PS ORAL 400 MG DAILY Sudden Death Health PO Professional Seroquel SS ORAL 200 MG DAILY Other PO Wintermin C Akineton C Benzalin C Rohypnol C Vegetamin A C Flomox C Pl. Gran. C Dasen C 22-Feb-2006 08:31 AM Page: 419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/02ISR Number: 3893314-5Report Type:Expedited (15-DaCompany Report #2002GB00747 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Parotid Gland Enlargement Foreign Seroquel PS ORAL 250 MG BID PO Intervention to White Blood Cell Count Health Seroquel SS ORAL 200 MG BID PO Prevent Permanent Decreased Professional Impairment/Damage Other Date:04/01/02ISR Number: 3893412-6Report Type:Expedited (15-DaCompany Report #2001GB00067 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Seroquel PS Therapeutic Health Epilim C Professional Clopixol C Other Date:04/02/02ISR Number: 3893845-8Report Type:Expedited (15-DaCompany Report #2002UW04377 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Health Seroquel PS Required Cardiac Arrest Professional Intervention to Cardio-Respiratory Arrest Prevent Permanent Impairment/Damage Date:04/02/02ISR Number: 3894199-3Report Type:Expedited (15-DaCompany Report #NSADSS2001008399 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Risperdal (Tablet) Increased Health (Risperidone) PS ORAL SEE IMAGE Aspartate Professional Quetiapine Aminotransferase (Quetiapine) SS ORAL SEE IMAGE Increased Biperiden Blood Lactate Hydrochloride Dehydrogenase Increased (Biperiden Cardio-Respiratory Arrest Hydrochloride) C Choking Flunitrazepam Dyskinesia (Flunitrazepam) C Hallucination, Auditory Estazolam Hypoaesthesia (Estazolam) C Neck Pain Restlessness Tremor Date:04/03/02ISR Number: 3894365-7Report Type:Expedited (15-DaCompany Report #2002UW02674 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Health Seroquel "Zeneca" PS ORAL 900 MG DAILY Required Loss Of Consciousness Professional PO Intervention to Seroquel "Zeneca" SS ORAL 600 MG DAILY Prevent Permanent PO Impairment/Damage Loxapine C Lamictal C 22-Feb-2006 08:31 AM Page: 420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonazepam C Gabapentin C Date:04/04/02ISR Number: 3895627-XReport Type:Expedited (15-DaCompany Report #2002UW04531 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Health Seroquel PS Professional Date:04/04/02ISR Number: 3896051-6Report Type:Expedited (15-DaCompany Report #2002UW04457 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Seroquel PS ORAL 200 MG DAILY Haematocrit Decreased Professional PO Lymphocyte Count Increased White Blood Cell Count Increased Date:04/04/02ISR Number: 3896053-XReport Type:Expedited (15-DaCompany Report #2002UW04300 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaphylactic Shock Health Seroquel PS ORAL 200 MG PO Intervention to Professional Prevent Permanent Impairment/Damage Date:04/05/02ISR Number: 3896202-3Report Type:Expedited (15-DaCompany Report #GB8913119FEB2002 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eye Disorder Health Ativan (Lorazepam, Initial or Prolonged Hypotonia Neonatal Professional Tablet, 0) PS TRANSPLACENTAL 1 MG Hypoventilation Neonatal Other [FREQUENCY Maternal Drugs Affecting UNSPEC] Foetus TRANSPLACENTA Neonatal Disorder L Pregnancy Cipramil (Citalopram Hydrobromide, , 0) SS TRANSPLACENTAL 20 MG TRANSPLACENTA L Methotrimeprazine (Levomepromazine, , 0) SS TRANSPLACENTAL 12.5MG TRANSPLACENTA L Perphenazine (Pherphenazine, , 0) SS TRANSPLACENTAL 4MG TRANSPLACENTA L Seroquel (Quetiapine, , 0) SS TRANSPLACENTAL 250MG TRANSPLACENTA L 22-Feb-2006 08:31 AM Page: 421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone (Trazodone, , 0) SS TRANSPLACENTAL 150MG TRANSPLACENTA L Zopiclone (Zopiclone, , 0) SS TRANSPLACENTAL 7.5MG TRANSPLACENTA L Date:04/05/02ISR Number: 3896915-3Report Type:Expedited (15-DaCompany Report #2002AP00620 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Literature Quetiapine PS ORAL 100 MG DAILY Intervention to Convulsion Health PO 1 DAY Prevent Permanent Disorientation Professional Olanzapine SS ORAL 15 MG DAILY Impairment/Damage Drug Interaction PO Fall Benztropine C Memory Impairment Sertraline C Clonazepam C Date:04/08/02ISR Number: 3897029-9Report Type:Direct Company Report #CTU 165231 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Palpitations Seroquel 100mg Astra Initial or Prolonged Zeneca PS Astra Zeneca ORAL 1-2 PO BID Other Beconase Ag C Azlprazolam C Amoxicillin C Metragel(Vaginal) C Date:04/08/02ISR Number: 3897330-9Report Type:Expedited (15-DaCompany Report #2002AP00497 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 700 MG DAILY Health PO Professional Seroquel SS ORAL 400 MG DAILY Other PO Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Wypax C Date:04/09/02ISR Number: 3897933-1Report Type:Expedited (15-DaCompany Report #2002AP00482 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Life-Threatening Condition Aggravated Foreign Hypothermia Study Ileus Paralytic Health 22-Feb-2006 08:31 AM Page: 422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 50 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 600 MG DAILY PO Linton C Zyprexa C Artane C Metligine C Rohypnol C Gaster C Date:04/09/02ISR Number: 3897934-3Report Type:Expedited (15-DaCompany Report #2002AP00556 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Distension Foreign Seroquel PS ORAL 75 MG DAILY Intervention to Flatulence Health PO Prevent Permanent Gastrointestinal Motility Professional Seroquel SS ORAL 150 MG DAILY Impairment/Damage Disorder Other PO Intestinal Dilatation Seroquel SS ORAL 75 MG DAILY Nausea PO Somnolence Risperdal SS ORAL 3 MG DAILY PO Vomiting Tasmolin SS ORAL 3 MG DAILY PO Zyprexa SS ORAL 10 MG DAILY PO Levotomin SS ORAL 20 MG DAILY PO Depas C Sennoside C Pantosin C No Match C Gascon C Magnesium Oxide C Date:04/09/02ISR Number: 3897936-7Report Type:Expedited (15-DaCompany Report #2002AP00563 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colitis Ischaemic Foreign Seroquel PS ORAL 25 MG DAILY Disability Condition Aggravated Health PO Required Gastric Ulcer Professional Tiaprim SS ORAL 48 MG DAILY Intervention to Melaena Other PO Prevent Permanent Posture Abnormal Tiaprim SS ORAL 120 MG DAILY Impairment/Damage Rhabdomyolysis PO Depas C Sermion C Bufferin C Brovarin C 22-Feb-2006 08:31 AM Page: 423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/02ISR Number: 3897239-0Report Type:Expedited (15-DaCompany Report #WAES 0204USA01083 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Zocor PS Merck & Co., Inc ORAL Initial or Prolonged Memory Impairment Seroquel SS Date:04/10/02ISR Number: 3898441-4Report Type:Expedited (15-DaCompany Report #2002GB00363 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Essential Hypertension Foreign Seroquel "Zeneca" PS Zeneca ORAL 600 MG DAILY Initial or Prolonged Hypertensive Crisis Health PO Professional Other Date:04/10/02ISR Number: 3898628-0Report Type:Expedited (15-DaCompany Report #2001GB00213 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fatigue Foreign Seroquel PS INCREASING Intervention to Red Blood Cell Count Health Seroquel SS ORAL 200 MD BID PO Prevent Permanent Increased Professional Ventolin C Impairment/Damage Restless Legs Syndrome Other Date:04/10/02ISR Number: 3898831-XReport Type:Direct Company Report #CTU 165356 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Seroquel PS 100 MG AM & Neutropenia 200 MG HS PO Neurontin SS ORAL 800 MG TID PO Clonidine C Hemocyte Plus C Date:04/11/02ISR Number: 3897446-7Report Type:Expedited (15-DaCompany Report #APCDSS2001001371 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Risperdal PS ORAL 14 DAY Schizophrenia Chlorpromazine Hydrochloride SS ORAL 916 DAY Quetiapine Fumarate SS ORAL 237 DAY Trihexyphenidyl Hydrochloride SS ORAL 916 DAY Flunitrazepam SS ORAL 916 DAY Teprenone SS ORAL 185 DAY Biperiden Hydrochloride SS ORAL 916 DAY Olanzapine SS ORAL 41 DAY Levomepromazine Maleate SS ORAL 721 DAY Diazepam SS ORAL 14 DAY Promethazine SS ORAL 83 DAY Nitrazepam SS ORAL 47 DAY Lorazepam SS ORAL 376 DAY L-Cysteine Ethylester 22-Feb-2006 08:31 AM Page: 424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrocholoride SS ORAL 14 DAY Mosapramine SS ORAL 23 DAY Etizolam SS ORAL 93 DAY Impromen SS ORAL 501 DAY Risperdal C ORAL 28 DAY Risperdal C ORAL 14 DAY Risperdal C ORAL 14 DAY Risperdal C ORAL 9 DAY Risperdal C ORAL 306 DAY Risperdal C ORAL 28 DAY Risperdal C ORAL 14 DAY Risperdal C ORAL 14 DAY Levomepromazine Maleate C ORAL Flunitrazepam C ORAL Teprenone C ORAL Biperiden Hydrochloride C ORAL Trihexyphenidyl Hydrochloride C ORAL Olanzapine C ORAL Quetiapine Fumarate C ORAL Chlorpromazine Hydrochloride C ORAL Risperdal C ORAL 14 DAY Risperdal C ORAL 49 DAY Risperdal C ORAL 35 DAY Risperdal C ORAL 126 DAY Risperdal C ORAL 63 DAY Risperdal C ORAL 174 DAY Risperdal C ORAL Date:04/11/02ISR Number: 3899528-2Report Type:Expedited (15-DaCompany Report #2002AP00779 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Alanine Aminotransferase Foreign Seroquel PS ORAL 300 MG DAILY Increased Study PO Aspartate Health Seroquel SS ORAL 400 MG DAILY Aminotransferase Professional PO Increased Other Rohypnol C Blood Cholesterol Pyrethia C Increased Vegetamin A C Hepatic Function Abnormal Hepatic Steatosis Hyperlipidaemia Date:04/12/02ISR Number: 3899925-5Report Type:Expedited (15-DaCompany Report #2002AP00589 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Convulsion Health PO Required Insomnia Professional Wypax C Intervention to Irritability Other Rohypnol C Prevent Permanent Loss Of Consciousness Benzalin C Impairment/Damage Pursennid C 22-Feb-2006 08:31 AM Page: 425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/02ISR Number: 3900144-4Report Type:Expedited (15-DaCompany Report #APCDSS2001001371 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Risperdal Fall Health (Risperidone) PS SEE IMAGE Schizophrenia Professional Impromen (Unspecified) (Bromperidol) SS VARYING DOSES FROM 6 TO 24 MG DAILY Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS VARYING DOSES FROM 25 TO 300 MG DAILY Biperiden Hydrochloride (Biperiden Hydrochloride) SS VARYING DOSES FROM 3 TO 6 MG DAILY Levomepromazine Maleate (Levomepromazine Maleate) SS ORAL VARYING DOSE FROM 5 MG TO 50 MG DAILY, PO Olanzapine (Olanzapine) SS ORAL MG, DAILY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS VARYING DOSES FROM 50 TO 600 MG DAILY Lorazepam (Lorazepam) SS VARYING DOSES FROM 0.5 WHEN NECESSARY TO 3 MG DAILY Promethazine (Promethazine) SS ORAL MG, DAILY, ORAL Diazepam (Diazepam) SS ORAL MG, PRN, ORAL Nitrazepam (Nitrazepam) SS ORAL MG, DAILY, ORAL L-Cysteine Ethylester Hydrocholoride (L-Cysteine Ethylester, SS ORAL MG, DAILY, ORAL Flunitrazepam (Flunitrazepam) SS ORAL VARYING DOSE FROM 1 MG TO 4 MG DAILY, PO Trihexyphenidyl 22-Feb-2006 08:31 AM Page: 426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride (Trihexyphenidyl Hydrochloride) SS VARYING DOSES FROM 4 TO 12 MG DAILY Teprenone (Teprenone) C VARYING DOSES FROM 150 TO 300 MG DAILY Etizolam (Etizolam) C ORAL MG, DAILY, ORAL Mosapramine (Mosapramine) C VARYING DOSES FROM 50 TO 150 MG DAILY Date:04/15/02ISR Number: 3900821-5Report Type:Expedited (15-DaCompany Report #2002UW05015 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Seroquel PS ORAL 100 MG HS PO Professional Luvox SS 50 MG BID Neurontin SS 300 MG TID Xanax SS 0.25 MG TID PRN Date:04/15/02ISR Number: 3900934-8Report Type:Expedited (15-DaCompany Report #WAES 0204USA01083 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Tab Zocor Unk PS ORAL PO Initial or Prolonged Memory Impairment Professional Seroquel Unk SS Date:04/16/02ISR Number: 3901740-0Report Type:Expedited (15-DaCompany Report #2002UW04568 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Health Seroquel PS 25-50 MG QD Intervention to Hepatitis Professional Seroquel SS 100-200 MG AT Prevent Permanent Liver Disorder NIGHT Impairment/Damage Seroquel SS 300-400 MG QD AT NIGHT Amitriptyline C Atenolol C Baclofen C Docusate C Hydrochlorothiazide C Levetiracetam C Lisinopril C Oxycodone C Percocet C Simvastatin C Vitamin E C 22-Feb-2006 08:31 AM Page: 427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/02ISR Number: 3902215-5Report Type:Expedited (15-DaCompany Report #2001SE06912 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Foreign Seroquel "Zeneca" PS Zeneca ORAL 200 MG DAILY Hospitalization - Distress Syndrome Health PO Initial or Prolonged Overdose Professional Buspar C Respiratory Failure No Match C Somnolence Zoloft C No Match C Date:04/16/02ISR Number: 3902216-7Report Type:Expedited (15-DaCompany Report #2002UW04875 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 50 MG BID PO Intervention to Drug Level Increased Health Seroquel SS ORAL 25 MG BID PO Prevent Permanent Professional Epival C Impairment/Damage Clobazem C Date:04/17/02ISR Number: 3902201-5Report Type:Expedited (15-DaCompany Report #2002AP00855 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Literature Quetiapine PS 100 MG TID Intervention to Inadequate Control Health Olanzapine SS 10 MG Prevent Permanent Weight Increased Professional Sertraline C Impairment/Damage Haloperidol Decanoate C Fluoxetine C Venlafaxine C Date:04/17/02ISR Number: 3902205-2Report Type:Expedited (15-DaCompany Report #2002UW04903 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Seroquel PS ORAL 100 MG QID PO Initial or Prolonged Drooling Professional Seroquel SS ORAL 200 MG TID PO Drug Level Increased Serentil SS 100 MG BID Stupor Serentil SS 150 MG DAILY Congentin C Zoloft C Date:04/17/02ISR Number: 3902207-6Report Type:Expedited (15-DaCompany Report #2002UW05002 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Health Seroquel PS Initial or Prolonged Professional Date:04/18/02ISR Number: 3903015-2Report Type:Expedited (15-DaCompany Report #2002GB00919 Age:40 YR Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Foreign Quetiapine Fumarate PS ORAL 300 MG DAILY Psychiatric Symptom Health PO Professional Venlfaxine C Other Risperidone C Chlorpromazine C Zopiclone C Date:04/18/02ISR Number: 3903072-3Report Type:Direct Company Report #CTU 166071 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Valproic Acid 250mg Hospitalization - Thrombocytopenia Capsules PS ORAL 500MG BID Initial or Prolonged ORAL Quetiapine 100mg And 200mg Tabs Oral SS Astra Zeneca ORAL 100MG QAM 200MG QHS ORAL Date:04/18/02ISR Number: 3903236-9Report Type:Expedited (15-DaCompany Report #2001UW09452 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Attention Health Seroquel "Zeneca" PS ORAL 50 MG HS PO Intervention to Deficit/Hyperactivity Professional Seroquel "Zeneca" SS ORAL 400 MG DAILY Prevent Permanent Disorder PO Impairment/Damage Bone Pain Serzone C Difficulty In Walking Lamictal C Ejaculation Disorder Levaquin C Leukopenia Muscle Spasms Pelvic Pain Thirst Urinary Retention Date:04/18/02ISR Number: 3903237-0Report Type:Expedited (15-DaCompany Report #2002UW05142 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Seroquel PS Insulin C Zyprexa C Date:04/22/02ISR Number: 3904710-1Report Type:Expedited (15-DaCompany Report #2002UW04998 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Health Seroquel PS ORAL 200 MG TID PO Initial or Prolonged Decreased Professional Seroquel SS ORAL 300 MG DAILY PO Neurontin C Clonidine C Hemocyte Plus C 22-Feb-2006 08:31 AM Page: 429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/02ISR Number: 3904974-4Report Type:Expedited (15-DaCompany Report #2002AP00917 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Seroquel PS ORAL 75 MG DAILY Initial or Prolonged Petit Mal Epilepsy Health PO Professional Seroquel SS ORAL 150 MG DAILY Other PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Serenace C Levotomin C Akineton C Halcion C Rohypnol C Benzalin C Date:04/23/02ISR Number: 3905979-XReport Type:Expedited (15-DaCompany Report #2001GB00213 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fatigue Foreign Seroquel PS INCREASING Intervention to Red Blood Cell Count Health Seroquel SS ORAL 200 MG BID PO Prevent Permanent Increased Professional Ventolin C Impairment/Damage Restless Legs Syndrome Other Date:04/23/02ISR Number: 3906066-7Report Type:Expedited (15-DaCompany Report #2002UW05374 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Neutropenia Professional Prozac C Date:04/23/02ISR Number: 3906067-9Report Type:Expedited (15-DaCompany Report #2002UW05003 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Health Seroquel PS Initial or Prolonged Hepatitis Professional Psychotic Disorder Renal Failure Acute Rhabdomyolysis Date:04/26/02ISR Number: 3908068-3Report Type:Expedited (15-DaCompany Report #2002UW05415 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Seroquel PS ORAL 1200 MG DAILY Decreased Professional PO Clozapine C 22-Feb-2006 08:31 AM Page: 430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/02ISR Number: 3908069-5Report Type:Expedited (15-DaCompany Report #2001UW14720 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Consumer Seroquel PS ORAL 400 MG DAILY Disability Cerebral Haemorrhage PO Myocardial Infarction Seroquel SS ORAL 200 MG DAILY Oedema Peripheral PO Sleep Disorder Seroquel SS Vein Disorder Metamucil C Vision Blurred Cogentin C Weight Increased Klonopin C Date:04/26/02ISR Number: 3908174-3Report Type:Expedited (15-DaCompany Report #2002UW04568 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Health Seroquel PS 25-50 MG QD Intervention to Hepatitis Professional Seroquel SS 100-200 MG AT Prevent Permanent Liver Disorder NIGHT Impairment/Damage Seroquel SS 300-400 MG QD AT NIGHT Amitriptyline C Atenolol C Baclofen C Docusate C Hydrochlorothiazide C Levetiracetam C Lisinopril C Oxycodone C Percocet C Simvastatin C Vitamin E C Date:04/26/02ISR Number: 3908176-7Report Type:Expedited (15-DaCompany Report #2001UW03379 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required No Adverse Drug Effect Health Seroquel "Zeneca" PS ORAL 600 MG PO Intervention to Professional Lithium SS 1050 MG DAILY Prevent Permanent Impairment/Damage Date:04/26/02ISR Number: 3908248-7Report Type:Expedited (15-DaCompany Report #2002GB01001 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS ORAL 750 MG DAILY Intervention to Head Banging Consumer PO Prevent Permanent Impatience Other Impairment/Damage Date:04/26/02ISR Number: 3908249-9Report Type:Expedited (15-DaCompany Report #2002AP00690 Age:61 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:31 AM Page: 431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Foreign Quetiapine PS ORAL 300 MG BID PO Circulatory Collapse Health Mirtazapine SS ORAL 30 MG DAILY Confusional State Professional PO Eye Movement Disorder Other Sertraline SS ORAL 100 MG DAILY Loss Of Consciousness PO Malaise Gliclazide C Muscle Rigidity Metformin C Neuroleptic Malignant Syndrome Oliguria Po2 Decreased Renal Failure Acute Restlessness Date:04/26/02ISR Number: 3908256-6Report Type:Expedited (15-DaCompany Report #2002GB00973 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Oedema Foreign Quetiapine PS ORAL 150 MG DAILY Hospitalization - Convulsion Health PO Initial or Prolonged Hyponatraemia Professional Quetiapine SS DOSE Other INCREASED Date:04/26/02ISR Number: 3908257-8Report Type:Expedited (15-DaCompany Report #2002AP00901 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS ORAL 400 MG DAILY C-Reactive Protein Health PO Increased Professional Lexin C Cellulitis Other Contomin C Pyrexia Serenace C Rash Levotomin C Vegetamin B C Selbex C Kamag G C Date:04/26/02ISR Number: 3908524-8Report Type:Expedited (15-DaCompany Report #2002UW03993 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Seroquel PS Professional Date:04/26/02ISR Number: 3908567-4Report Type:Expedited (15-DaCompany Report #2002PK00359 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 600 MG DAILY, Health PO Professional Seroquel SS ORAL 400 MG DAILY Other PO Mirtazapin C Zolpidem C 22-Feb-2006 08:31 AM Page: 432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Omeprazol C Date:04/26/02ISR Number: 3908740-5Report Type:Expedited (15-DaCompany Report #2002UW04457 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Health Seroquel PS ORAL 200 MG DAILY Intervention to Lymphocyte Count Professional PO Prevent Permanent Increased Zoloft C Impairment/Damage White Blood Cell Count Increased Date:04/26/02ISR Number: 3908961-1Report Type:Expedited (15-DaCompany Report #2002UW05536 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Seroquel PS Decreased Professional Depakote C White Blood Cell Count Anti-Psychotics C Decreased Date:04/29/02ISR Number: 3909708-5Report Type:Expedited (15-DaCompany Report #2002GB01003 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Health Professional Other Date:04/29/02ISR Number: 3909710-3Report Type:Expedited (15-DaCompany Report #2002SE02800 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 400 MG DAILY Health PO Professional Depakine C Other Temesta C Date:04/29/02ISR Number: 3909712-7Report Type:Expedited (15-DaCompany Report #2002SE00624 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel Zeneca" PS ORAL 300 MG DAILY Intervention to Viral Infection Health PO Prevent Permanent Professional Remeron C Impairment/Damage Other Zoloft C Subutex C Date:04/30/02ISR Number: 3910798-4Report Type:Expedited (15-DaCompany Report #APCDSS2002000366 Age:27 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Dystonia Foreign Risperidone Fall Health (Risperidone) PS MAXIMUM DOSE Tardive Dyskinesia Professional WAS 12 MG/DAY Treatment Noncompliance Haloperidol (Haloperidol) SS MAXIMUM DOSE WAS 16 MG/DAY 6 YR Quetiapine (Quetiapine) SS ORAL MG, DAILY, ORAL Diazepam (Diazepam) C Chlorpromazine (Chlorpromazine) C Clonazepam (Clonazepam) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Date:04/30/02ISR Number: 3910968-5Report Type:Expedited (15-DaCompany Report #2002UW05548 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 500 MG DAILY Intervention to Neutropenia Health PO Prevent Permanent Professional Haldol Janssen-Cilag C Impairment/Damage Other Date:04/30/02ISR Number: 3910988-0Report Type:Expedited (15-DaCompany Report #2002PK00009 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Foreign Seroquel Zeneca PS 50 MG DAILY Leukopenia Other Seroquel Zeneca SS 100 MG DAILY Seroquel Zeneca SS 200 MG DAILY Seroquel Zeneca SS 300 MG DAILY Seroquel Zeneca SS 400 MG DAILY Seroquel Zeneca SS 500 MG DAILY Seroquel Zeneca SS 600 MG DAILY Seroquel Zeneca SS 400 MG DAILY Dapotum D C Zyprexa C Haldol Janssen C Date:05/01/02ISR Number: 3910518-3Report Type:Direct Company Report #CTU 167098 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Seroquel PS Fluctuation Neurontin C Dizziness Roxicet C Fall Prilosec C Ambien C Synthroid C 22-Feb-2006 08:31 AM Page: 434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prozac C Date:05/01/02ISR Number: 3911022-9Report Type:Expedited (15-DaCompany Report #2001AP04758 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel "Zeneca" PS ORAL 300 MG BID PO Initial or Prolonged Blood Osmolarity Health Oxybutinin SS 2.5 MG BID Decreased Professional Ibuprofen C Brain Damage Other Lactulose C Grand Mal Convulsion Paracetamol C Hyponatraemia Temazepam C Incontinence Quinine Sulphate C Loss Of Consciousness Vitamin E C Obsessive-Compulsive Malic Acid C Disorder Glandosane C Polydipsia Benzhexol Thirst Hyrochloride C Olanzapine C Date:05/01/02ISR Number: 3911532-4Report Type:Direct Company Report #CTU 167174 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Seroquel 100mg PS ORAL 100MG QHS Dysarthria ORAL Lethargy Depakote Er C Lorazepam C Date:05/02/02ISR Number: 3911428-8Report Type:Direct Company Report #CTU 167198 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Wellbutrin Sr 150mg Initial or Prolonged Fall (Glaxo Wellcome) PS Glaxo Wellcome ORAL 150MG PO QD Required Gaze Palsy Seroquel 25mg (Astra Intervention to Grand Mal Convulsion Zeneca) SS Astra Zeneca ORAL 50MG PO Q 1HR Prevent Permanent Lethargy PRN Impairment/Damage Birth Control Pills (Necon 0.5/35) C Lorazepam C Date:05/02/02ISR Number: 3911650-0Report Type:Expedited (15-DaCompany Report #2002UW05565 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS ORAL 425 MG DAILY Neutropenia Professional PO Red Blood Cell Count Decreased Thrombocytopenia 22-Feb-2006 08:31 AM Page: 435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/02ISR Number: 3911651-2Report Type:Expedited (15-DaCompany Report #2002UW05852 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Thrombosis Health Seroquel PS ORAL 300 MG DAILY Hospitalization - Professional PO Initial or Prolonged Seroquel SS Aspirin "Smith Kline Beecham" C Lamictal C Xanax C Date:05/02/02ISR Number: 3911887-0Report Type:Expedited (15-DaCompany Report #2002GB01032 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Lower Respiratory Tract Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Infection Health PO Prevent Permanent Neutropenia Professional Seroquel SS ORAL 50 MG PRN PO Impairment/Damage Other Date:05/03/02ISR Number: 3912004-3Report Type:Expedited (15-DaCompany Report #2002UW05916 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Health Seroquel PS ORAL 200 MG TID PO Required Diabetic Coma Professional Celexa C Intervention to Malaise Ditropan C Prevent Permanent Ddavp C Impairment/Damage Date:05/03/02ISR Number: 3912005-5Report Type:Expedited (15-DaCompany Report #2002UW05802 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Crying Other Seroquel PS Mania Serzone SS Medication Error Screaming Suicidal Ideation Date:05/03/02ISR Number: 3912006-7Report Type:Expedited (15-DaCompany Report #2002UW05782 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Macular Oedema Health Seroquel PS ORAL 300 MG HS PO Intervention to Professional Topamax C Prevent Permanent Hypolipidemic Agent C Impairment/Damage Date:05/03/02ISR Number: 3912213-3Report Type:Expedited (15-DaCompany Report #2002GB01030 Age: Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Overdose Foreign Initial or Prolonged Health Professional 22-Feb-2006 08:31 AM Page: 436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 40 DF PO Propanolol SS Date:05/03/02ISR Number: 3912237-6Report Type:Expedited (15-DaCompany Report #2002GB00703 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Foreign Seroquel PS 25 MG BID Intervention to Second Degree Health Seroquel SS 300 MG BID Prevent Permanent Sinus Tachycardia Professional Prozac C Impairment/Damage Other Priadel C Senna C Lorazepam C Welldorm C Chlorpheniramine C Date:05/03/02ISR Number: 3912252-2Report Type:Expedited (15-DaCompany Report #2001AP04758 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel "Zeneca" PS ORAL 300 MG BID PO Initial or Prolonged Brain Damage Health Oxybutinin SS 2.5 MG BID Grand Mal Convulsion Professional Lactulose C Hyponatraemia Other Paracetamol C Obsessive-Compulsive Temazepam C Disorder Quinine Sulphate C Polydipsia Vitamin E C Thirst Malic Acid C Glandosane C Benzhexol Hydrochloride C Olanzapine C Ibuprofen C Date:05/03/02ISR Number: 3912389-8Report Type:Expedited (15-DaCompany Report #2002AP00901 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS ORAL 400 MG DAILY Required C-Reactive Protein Health PO Intervention to Increased Professional Lexin SS ORAL 400 MG DAILY Prevent Permanent Cellulitis Other PO Impairment/Damage Drug Interaction Contomin C Eczema Infected Serenace C Fungal Infection Levotomin C Hepatocellular Damage Vegetamin-B C Pyrexia Selbex C Kamag G C 22-Feb-2006 08:31 AM Page: 437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/02ISR Number: 3912221-2Report Type:Expedited (15-DaCompany Report #A209807 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nightmare Consumer Zoloft Tablets PS Initial or Prolonged Ziprasidone SS 120.00 MG TOTAL:TID Quetiapine SS Aspirin C Date:05/06/02ISR Number: 3912573-3Report Type:Expedited (15-DaCompany Report #2001GB00304 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Complications Of Maternal Foreign Seroquel "Zeneca" PS ORAL 150 MG DAILY Intervention to Exposure To Therapeutic Health PO Prevent Permanent Drugs Professional Impairment/Damage Haemorrhage Other Premature Separation Of Placenta Date:05/06/02ISR Number: 3912574-5Report Type:Expedited (15-DaCompany Report #2002GB01069 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Foreign Seroquel PS Hospitalization - Inappropriate Health Initial or Prolonged Antidiuretic Hormone Professional Secretion Other Date:05/07/02ISR Number: 3913481-4Report Type:Expedited (15-DaCompany Report #2002SE01984 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS INTAKE OF Completed Suicide Health APPROXIMATELY Intentional Overdose Professional 12 GRAM Other Date:05/07/02ISR Number: 3913747-8Report Type:Expedited (15-DaCompany Report #2002AP01037 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS Decreased Health Lithium Carbonate C Professional Clonazepam C Other Levomepromazine Maleate C Date:05/08/02ISR Number: 3914906-0Report Type:Expedited (15-DaCompany Report #2002GB01084 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Foreign Quetiapine PS ORAL 150 MG BID PO Neutropenia Health Haloperidol C Professional Lorazepam C Other Zopiclone C 22-Feb-2006 08:31 AM Page: 438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Salbutamol C Diazepam C Date:05/09/02ISR Number: 3915289-2Report Type:Expedited (15-DaCompany Report #2002UW06116 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fatigue Health Seroquel PS ORAL 50 MG HS PO Intervention to Gastrointestinal Professional Prevent Permanent Haemorrhage Impairment/Damage Hepatitis Kidney Infection Date:05/09/02ISR Number: 3915290-9Report Type:Expedited (15-DaCompany Report #2002AP01072 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Literature Quetiapine Fumarate PS ORAL 100 MG DAILY Initial or Prolonged Drug Ineffective Health PO 4 MON Schizophrenia Professional Quetiapine Fumarate SS ORAL 300 MG DAILY Treatment Noncompliance PO Weight Decreased Quetiapine Fumarate SS ORAL 600 MG DAILY PO Date:05/09/02ISR Number: 3915291-0Report Type:Expedited (15-DaCompany Report #2002AP01068 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Literature Quetiapine Fumarate PS ORAL 700 MG DAILY Initial or Prolonged Fat Redistribution Health PO 1 YR Schizophrenia Professional Quetiapine Fumarate SS ORAL 800 MG DAILY Suicidal Ideation PO Clozapine C Date:05/10/02ISR Number: 3914932-1Report Type:Expedited (15-DaCompany Report #2002UW06117 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Seroquel PS ORAL 300 MG PO Hepatic Failure Professional Ace Inhibitor C Date:05/10/02ISR Number: 3915554-9Report Type:Expedited (15-DaCompany Report #2002AP01077 Age:29 YR Gender:Female I/FU:I Outcome PT Death Blood Potassium Decreased Required Brain Herniation Intervention to Brain Oedema Prevent Permanent Cerebral Ischaemia Impairment/Damage Coma Contusion Drug Level Below Therapeutic Dry Mouth Emotional Distress Hypersensitivity 22-Feb-2006 08:31 AM Page: 439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyponatraemia Hypothalamo-Pituitary Disorders Report Source Product Role Manufacturer Route Dose Duration Oedema Mouth Foreign Seroquel PS ORAL 25 MG BID PO Polydipsia Psychogenic Health Seroquel SS ORAL 50 MG DAILY Polyuria Professional PO Postictal State Other Risperidone C Skin Discolouration Lithium C Tongue Discolouration Tongue Oedema Water Intoxication Date:05/10/02ISR Number: 3915556-2Report Type:Expedited (15-DaCompany Report #2002PK00423 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Granulocytopenia Foreign Seroquel PS ORAL 200 MG BID PO Intervention to Hyperbilirubinaemia Health Prevent Permanent Leukopenia Professional Impairment/Damage Nausea Other Psychotic Disorder Date:05/13/02ISR Number: 3915776-7Report Type:Expedited (15-DaCompany Report #2002UW06388 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Screen Positive Health Seroquel PS ORAL 200 MG BID PO Professional Topamax C Wellbutrin - Slow Release C Date:05/13/02ISR Number: 3916205-XReport Type:Expedited (15-DaCompany Report #2002UW06165 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthyroidism Foreign Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Suicidal Ideation Study PO Health Ranitidine C Professional Tricyclen C Other Propanolol C Tapazole C Flonase C Date:05/13/02ISR Number: 3916209-7Report Type:Expedited (15-DaCompany Report #2002SE03020 Age:74 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Apraxia Atrial Fibrillation Dysphagia Hallucination Headache Hypercholesterolaemia Hypertension International Normalised Ratio Increased 22-Feb-2006 08:31 AM Page: 440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oral Intake Reduced Prothrombin Time Prolonged Report Source Product Role Manufacturer Route Dose Duration Renal Impairment Foreign Seroquel PS ORAL 50 MG DAILY Speech Disorder Health PO Professional Haldol "Janssen" C Other Marcoumar C Plavix C Tenormin C Date:05/13/02ISR Number: 3916210-3Report Type:Expedited (15-DaCompany Report #2002SE03030 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Seroquel PS ORAL 400 MG DAILY Decreased Health PO Professional Absenor C Other Temesta C Date:05/13/02ISR Number: 3916211-5Report Type:Expedited (15-DaCompany Report #2002GB01086 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Foreign Seroquel PS Intervention to Cardiac Disorder Health Erythromycin SS Prevent Permanent Drug Interaction Professional Impairment/Damage Electrocardiogram Qt Other Prolonged Feeling Abnormal Heart Rate Increased Malaise Date:05/13/02ISR Number: 3924242-4Report Type:Periodic Company Report #PHEH2002US03526 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Trileptal(Oxcarbazep Drug Interaction Professional ine) PS ORAL ORAL Company Seroquel Representative (Quetiapine) SS Date:05/14/02ISR Number: 3916931-2Report Type:Expedited (15-DaCompany Report #2002-05-0145 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Loratadine Like Complications Of Maternal Health Claritin PS ORAL ORAL Exposure To Therapeutic Professional Quetiapine Fumurate SS Drugs Citalopram SS Maternal Drugs Affecting Fucidin SS TOPICAL TOPICAL 12 WK Foetus 22-Feb-2006 08:31 AM Page: 441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/02ISR Number: 3917022-7Report Type:Direct Company Report #CTU 168090 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Neurontin PS Hospitalization - Aggression Seroquel SS Initial or Prolonged Anger Serevent C Other Condition Aggravated Singulair C Required Drug Effect Decreased Zyrtec C Intervention to Suicidal Ideation Albuterol C Prevent Permanent Weight Increased Impairment/Damage Date:05/15/02ISR Number: 3917230-5Report Type:Direct Company Report #CTU 168099 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Seroquel 25mg PS ORAL 25MG Q AM Q White Blood Cell Count PM ORAL Decreased Pericolace C Date:05/17/02ISR Number: 3918539-1Report Type:Direct Company Report #CTU 168379 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Seroquel Quetiapine PS ORAL 600MG 3X Initial or Prolonged Myocarditis 200MG ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:05/17/02ISR Number: 3918822-XReport Type:Expedited (15-DaCompany Report #2002UW05916 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Seroquel PS ORAL 200 MG TID PO Hospitalization - Blood Creatinine Professional Seroquel SS ORAL 400 MG DAILY Initial or Prolonged Increased PO Blood Pressure Increased Celexa C Blood Urea Increased Ditropan C Diabetes Mellitus Ddavp C Diabetic Hyperosmolar Albuterol C Coma Hyperpyrexia Leukocytosis Loss Of Consciousness Mental Status Changes Nausea Pharyngolaryngeal Pain Renal Failure Acute Vomiting White Blood Cell Count Increased 22-Feb-2006 08:31 AM Page: 442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/02ISR Number: 3918824-3Report Type:Expedited (15-DaCompany Report #2002UW06467 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cataract Subcapsular Health Seroquel PS ORAL 200 MG QID PO Initial or Prolonged Psychotic Disorder Professional Seroquel SS Required Vision Blurred Depakote C Intervention to Cogentin C Prevent Permanent Klonopin C Impairment/Damage Synthroid C Berocca C Date:05/17/02ISR Number: 3918867-XReport Type:Expedited (15-DaCompany Report #A210743 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Ziprasidone Po PS ORAL 140.00 MG Initial or Prolonged Drug Interaction TOTAL:DAILY:O Electrocardiogram Qt RAL Prolonged Quetiapine SS 500.00 MG Stress TOTAL:DAILY Urinary Tract Infection Neurontin C Buspar C Klonopin (Clonazepam) C Date:05/17/02ISR Number: 3919144-3Report Type:Expedited (15-DaCompany Report #2002AP00690 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Quetiapine PS ORAL 300 MG BID PO Hospitalization - Communication Disorder Health Mirtazapine SS ORAL 30 MG DAILY Initial or Prolonged Loss Of Consciousness Professional PO Neuroleptic Malignant Other Sertraline SS ORAL 100 MG DAILY Syndrome PO Oxygen Saturation Gliclazide C Decreased Metformin C Renal Failure Acute Date:05/20/02ISR Number: 3919371-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE01612 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Leponex / Clozaril Initial or Prolonged Liver Function Test Health (Clozapine) Other Abnormal Professional (Clozapine) Tablet PS ORAL 250 MG/DAY, Rhabdomyolysis Other ORAL Seroquel (Quetiapine) SS ORAL 800 MG/DAY, ORAL Date:05/20/02ISR Number: 3919457-5Report Type:Expedited (15-DaCompany Report #2002UW06625 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Seroquel PS ORAL 125 MG DAILY PO Clonopin C 22-Feb-2006 08:31 AM Page: 443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin E C Vitamin C C Date:05/20/02ISR Number: 3919717-8Report Type:Expedited (15-DaCompany Report #2002UW04875 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 50 MG BID PO Intervention to Drug Level Increased Health Seroquel SS ORAL 25 MG BID PO Prevent Permanent Professional Epival C Impairment/Damage Other Clobazem C Date:05/20/02ISR Number: 3919834-2Report Type:Expedited (15-DaCompany Report #NSADSS2002016032 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Monistat Hospitalization - Concomitant Disease Literature (Unspecified)(Micona Initial or Prolonged Progression Health zole Nitrate) PS CUTANEOUS CUTANE Facial Palsy Professional Coumadin (Warfarin Hemiplegia Sodium) SS ORAL ORAL Mutism Heparin (Heparin) SS Zopiclone (Zopiclone) SS INTRAVENOUS IV Quetiapine Fumarate (Quetiapine Fumarate) SS Acetaminophen (Paracetamol) C Carbidopa/Levodopa (Sinemet) C Metronidazole (Metronidazole) C Furosemide (Furosemide) C Date:05/22/02ISR Number: 3920920-1Report Type:Expedited (15-DaCompany Report #2002UW04998 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Health Seroquel PS ORAL 200 MG TID PO Initial or Prolonged Decreased Professional Seroquel SS ORAL 550 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Clonidine C Neurontin C Hemocyte C Date:05/22/02ISR Number: 3920926-2Report Type:Expedited (15-DaCompany Report #2002UW06742 Age:23 YR Gender:Female I/FU:I Outcome PT Life-Threatening Acidosis Hospitalization - Cardiotoxicity Initial or Prolonged Grand Mal Convulsion Hypotension 22-Feb-2006 08:31 AM Page: 444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurotoxicity Overdose Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS ORAL 100 MG TID PO Professional Neurontin SS Thyroid Medication C Celexa C Date:05/22/02ISR Number: 3922562-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE01612 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Leponex / Clozaril Initial or Prolonged Increased Health (Clozapine) Other Aspartate Professional (Clozapine) Tablet PS ORAL 250 MG/DAY, Aminotransferase Other ORAL Increased Seroquel Blood Alkaline (Quetiapine) Phosphatase Increased Film-Coated Tablet SS ORAL 800MG/DAY, Blood Creatine ORAL Phosphokinase Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Contusion Fall Gamma-Glutamyltransferase Increased Pyrexia Rhabdomyolysis Date:05/23/02ISR Number: 3921185-7Report Type:Direct Company Report #CTU 168733 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Seroquel 100 Mg Initial or Prolonged Physical Examination Astra Zeneca PS Astra Zeneca ORAL 150MG BID Abnormal ORAL Serzone 100 Mg Bristol Myers Squibb SS Bristol Myers Squibb ORAL 150 MG BID ORAL Date:05/23/02ISR Number: 3921926-9Report Type:Expedited (15-DaCompany Report #PHBS2002CA05923 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Carbamazepine(Carbam Drug Level Decreased Literature azepine) Unknown PS 1400 MG/DAY, Drug Level Increased Health Quetiapine(Quetiapin Professional e) SS 800 MG/DAY Other 22-Feb-2006 08:31 AM Page: 445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/02ISR Number: 3922180-4Report Type:Expedited (15-DaCompany Report #2002AP01163 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Prerenal Failure Foreign Seroquel PS ORAL 75 MG DAILY Required Blood Pressure Decreased Health PO Intervention to Candidiasis Professional Clofekton C Prevent Permanent Diabetes Mellitus Other Akineton C Impairment/Damage Diabetic Coma Sennoside C Diabetic Ketoacidosis Disseminated Intravascular Coagulation Gastrointestinal Haemorrhage Haemophilus Infection Heart Rate Increased Hypercapnia Nervous System Disorder Neuroleptic Malignant Syndrome Pupils Unequal Pyrexia Renal Failure Acute Shock Sputum Culture Positive Streptococcal Infection Date:05/23/02ISR Number: 3922181-6Report Type:Expedited (15-DaCompany Report #2002AP01162 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Foreign Seroquel PS ORAL 225 MG DAILY Hospitalization - Renal Failure Acute Health PO Initial or Prolonged Rhabdomyolysis Professional Risperdal C Required Other Akineton C Intervention to Hiberna C Prevent Permanent Rohypnol C Impairment/Damage Date:05/23/02ISR Number: 3922241-XReport Type:Expedited (15-DaCompany Report #2002UW05536 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Seroquel PS ORAL 500 MG DAILY Professional PO Depakote C Anti-Psychotics C Risperdal C Lithium C Date:05/23/02ISR Number: 3922289-5Report Type:Expedited (15-DaCompany Report #2002AP01160 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Health Professional Other 22-Feb-2006 08:31 AM Page: 446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/02ISR Number: 3922502-4Report Type:Direct Company Report #CTU 168876 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Seroquel (Quetiapine Initial or Prolonged Blindness Fumorate) PS Astrazeneca Group 25MG 4 X DAY Required Blood Pressure Increased AT BEDTIME Intervention to Muscle Spasms Prevent Permanent Impairment/Damage Date:05/28/02ISR Number: 3924167-4Report Type:Expedited (15-DaCompany Report #2002AP00917 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Petit Mal Epilepsy Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Health PO Professional Seroquel SS ORAL 300 MG DAILY Other PO Serenace C Levotomin C Akineton C Halcion C Rohypnol C Benzalin C Bromvalerylurea C Date:05/28/02ISR Number: 3924172-8Report Type:Expedited (15-DaCompany Report #2002UW06165 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthyroidism Foreign Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Suicidal Ideation Study PO Health Ranitidine C Professional Tricyclen C Other Propanolol C Tapazole C Flonase C Date:05/28/02ISR Number: 3924411-3Report Type:Expedited (15-DaCompany Report #2002UW07034 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Date:05/28/02ISR Number: 3925115-3Report Type:Expedited (15-DaCompany Report #2002UW05916 Age:12 YR Gender:Female I/FU:F Outcome PT Death Abdominal Pain Hospitalization - Blood Pressure Increased Initial or Prolonged Body Temperature Decreased Diabetes Mellitus Diabetic Hyperosmolar Coma Hyperpyrexia 22-Feb-2006 08:31 AM Page: 447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Leukocytosis Mental Status Changes Report Source Product Role Manufacturer Route Dose Duration Nausea Health Seroquel PS ORAL 200 MG TID; Pharyngolaryngeal Pain Professional PO; 400 MG Renal Failure Acute DAILY; PO Vomiting Celexa C Ditropan C Ddavp C Albuterol C Date:05/28/02ISR Number: 3925281-XReport Type:Expedited (15-DaCompany Report #2002AP01226 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Literature Quetiapine PS ORAL 15 G ONCE PO Initial or Prolonged Depressed Level Of Health Consciousness Professional Drug Screen Positive Electrocardiogram Qt Prolonged Hypotension Overdose Tachycardia Date:05/29/02ISR Number: 3926026-XReport Type:Expedited (15-DaCompany Report #2002UW07048 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Professional Date:05/29/02ISR Number: 3926128-8Report Type:Expedited (15-DaCompany Report #2002UW07219 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS ORAL 800 MG PO 2 YR Professional Date:05/29/02ISR Number: 3926183-5Report Type:Expedited (15-DaCompany Report #2002PK00499 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel "Zeneca" PS Pyrexia Health Thrombocytopenia Professional Other Date:05/29/02ISR Number: 3926184-7Report Type:Expedited (15-DaCompany Report #2002GB01254 Age: Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:31 AM Page: 448 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 Acidosis Foreign Quetiapine PS ORAL 150 MG BID PO Dehydration Health Zyprexa SS ORAL 20 MG HS PO Diabetic Ketoacidosis Professional Clozapine C Glycosylated Haemoglobin Other Increased Weight Increased Date:05/30/02ISR Number: 3926411-6Report Type:Direct Company Report #CTU 169203 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Seroquel 25mg PS ORAL 25MG BID ORAL Initial or Prolonged Dehydration Apap C Heart Rate Increased Bupropoin C Pneumonia Citalopram C Combivent C Lisinopril C Date:05/30/02ISR Number: 3927590-7Report Type:Expedited (15-DaCompany Report #S02-UKI-00324-02 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congenital Anomaly Foreign Cipramil (Citalopram Initial or Prolonged Eye Disorder Health Hydrobromide) PS Congenital Anomaly Hypotonia Neonatal Professional Lorazepam SS Hypoventilation Neonatal Other Perphenazine SS Maternal Drugs Affecting Trazodone SS Foetus Zopiclone SS Neonatal Respiratory Seroquel SS Depression Methotrimeprazine SS Date:05/30/02ISR Number: 3927614-7Report Type:Expedited (15-DaCompany Report #S00-UKI-00592-01 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congenital Anomaly Foreign Cipramil (Citalopram Initial or Prolonged Eye Disorder Health Hydrobromide) PS Congenital Anomaly Hypotonia Neonatal Professional Lorazepam SS TRANSPLACENTAL 1 MG QD Hypoventilation Neonatal Other TRANSPLACENTA Maternal Drugs Affecting L Foetus Perphenazine SS TRANSPLACENTAL 4 MG QD Neonatal Respiratory TRANSPLACENTA Depression L Trazodone SS TRANSPLACENTAL 150 MG QD TRANSPLACENTA L Zopiclone SS TRANSPLACENTAL 7.5 MG QD TRANSPLACENTA L Seroquel SS TRANSPLACENTAL 250 MG TRANSPLACENTA L Methotrimepazine SS 22-Feb-2006 08:31 AM Page: 449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/02ISR Number: 3927881-XReport Type:Expedited (15-DaCompany Report #2002GB01226 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ill-Defined Disorder Foreign Seroquel PS ORAL 25 MG PO Intervention to Health Zopiclone SS Prevent Permanent Professional Impairment/Damage Other Date:05/31/02ISR Number: 3927108-9Report Type:Expedited (15-DaCompany Report #2002GB01255 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Quetiapine PS ORAL 200 MG BID PO Intervention to White Blood Cell Count Health Prevent Permanent Decreased Professional Impairment/Damage Other Date:05/31/02ISR Number: 3927109-0Report Type:Expedited (15-DaCompany Report #2002GB01262 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Stevens-Johnson Syndrome Foreign Seroquel PS Intervention to Health Seroquel SS HIGHER DOSE Prevent Permanent Professional Depakote SS Impairment/Damage Other Date:05/31/02ISR Number: 3927110-7Report Type:Expedited (15-DaCompany Report #2002AP01160 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Seroquel PS ORAL 600 MG DAILY Blood Pressure Increased Health PO Cardiac Failure Professional Seroquel SS ORAL 500 MG DAILY Dystonia Other PO Emotional Disorder Seroquel SS ORAL 600 MG DAILY Movement Disorder PO Muscle Rigidity Doral C Osteoarthritis Rohypnol C Restlessness Akineton C Somnolence Alosenn C Pursennid C Adalat C Date:05/31/02ISR Number: 3927566-XReport Type:Expedited (15-DaCompany Report #2002AP01163 Age:36 YR Gender:Male I/FU:F Outcome PT Death Acute Prerenal Failure Required Anorexia Intervention to Blood Pressure Decreased Prevent Permanent Candidiasis Impairment/Damage Circulatory Collapse Dehydration Diabetes Mellitus Diabetic Coma Diabetic Hyperosmolar Coma 22-Feb-2006 08:31 AM Page: 450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetic Ketoacidosis Disseminated Intravascular Coagulation Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Foreign Seroquel PS ORAL 75 MG DAILY Abnormal Health PO Gastrointestinal Professional Seroquel SS ORAL 25 MG DAILY Haemorrhage Other PO Glucose Urine Present Seroquel SS ORAL 75 MG DAILY Glycosylated Haemoglobin PO Increased Seroquel SS ORAL 150 MG DAILY Haemophilus Infection PO Heart Rate Increased Seroquel SS ORAL 50 MG DAILY Hypercapnia PO Hypotension Seroquel SS ORAL 25 MG DAILY Infection PO Malaise Clofekton C Mouth Haemorrhage Akineton C Myoglobin Blood Increased Sennoside C Nervous System Disorder Neuroleptic Malignant Syndrome Pupils Unequal Pyrexia Renal Failure Acute Respiratory Failure Respiratory Rate Decreased Rhabdomyolysis Shock Streptococcal Infection Stupor Weight Decreased Weight Increased Date:06/03/02ISR Number: 3928533-2Report Type:Expedited (15-DaCompany Report #2002UW07411 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaphylactoid Reaction Health Seroquel PS Hospitalization - Laryngospasm Professional Initial or Prolonged Date:06/03/02ISR Number: 3928544-7Report Type:Expedited (15-DaCompany Report #2002UW07234 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Seroquel PS ORAL 2500 MG ONCE Initial or Prolonged Muscle Rigidity Professional PO Overdose Date:06/04/02ISR Number: 3928283-2Report Type:Expedited (15-DaCompany Report #02P-167-0193305-00 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Disorder Foreign Erythromycin Intervention to Drug Interaction Health (Erythromycin) Prevent Permanent Malaise Professional (Erythromycin) PS Impairment/Damage Palpitations Seroquel 22-Feb-2006 08:31 AM Page: 451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Quetiapine) SS ORAL PER ORAL Date:06/04/02ISR Number: 3928945-7Report Type:Expedited (15-DaCompany Report #2002AP01162 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Foreign Seroquel PS ORAL 225 MG DAILY Hospitalization - Renal Failure Acute Health PO Initial or Prolonged Rhabdomyolysis Professional Risperdal C Required Other Akineton C Intervention to Hiberna C Prevent Permanent Rohypnol C Impairment/Damage Cercine C Pyrethia C Date:06/04/02ISR Number: 3928953-6Report Type:Expedited (15-DaCompany Report #2002SE03443 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Foreign Seroquel PS Health Professional Other Date:06/04/02ISR Number: 3928954-8Report Type:Expedited (15-DaCompany Report #2002SE03448 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Foreign Seroquel PS Health Professional Other Date:06/04/02ISR Number: 3928955-XReport Type:Expedited (15-DaCompany Report #2002PK00510 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 600 MG DAILY Health PO Professional Promethazin C Other Benperidol C Date:06/04/02ISR Number: 3929251-7Report Type:Expedited (15-DaCompany Report #2002PK00507 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 500 MG DAILY Neutrophil Count Health PO Decreased Professional Mirtazapin C Other Venlafaxin C 22-Feb-2006 08:31 AM Page: 452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/02ISR Number: 3929253-0Report Type:Expedited (15-DaCompany Report #2002PK00509 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 600 MG DAILY Neutrophil Count Health PO Decreased Professional Promethazin C Other Date:06/05/02ISR Number: 3930197-9Report Type:Expedited (15-DaCompany Report #2002SE03265 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytopenia Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Influenza Like Illness Health PO Pyrexia Professional Seroquel SS ORAL 50 MG DAILY Thrombocytopenia Other PO Cipramil C Rivotril C Vallergan C Zyprexa C Date:06/05/02ISR Number: 3930489-3Report Type:Expedited (15-DaCompany Report #2002UW06165 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Foreign Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Hyperthyroidism Study PO Required Suicidal Ideation Other Ranitidine C Intervention to Syncope Tricyclen C Prevent Permanent Vomiting Flonase C Impairment/Damage Weight Decreased Date:06/05/02ISR Number: 3930491-1Report Type:Expedited (15-DaCompany Report #2002AP00385 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Seroquel PS UNKNOWN Initial or Prolonged Pyrexia Health DOSAGE Required Professional Seroquel SS ORAL 300 MG DAILY Intervention to Other PO Prevent Permanent Minomycin SS ORAL 100 MG DAILY Impairment/Damage PO Serenace SS INTRAVENOUS 5 MG DAILY IV Halcion C Lendormin C Alosenn C Date:06/05/02ISR Number: 3930495-9Report Type:Expedited (15-DaCompany Report #2002GB01324 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram R On T Foreign Seroquel PS ORAL 450 MG DAILY Intervention to Phenomenon Health PO Prevent Permanent Sinus Tachycardia Professional Paroxetine C Impairment/Damage Other Lofepramine C Lactulose C 22-Feb-2006 08:31 AM Page: 453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/02ISR Number: 3930497-2Report Type:Expedited (15-DaCompany Report #2002PK00498 Age:0 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Neonatal Foreign Seroquel PS 400 MG DAILY Intervention to Hypotonia Neonatal Health TPL Prevent Permanent Maternal Drugs Affecting Professional Stilnox C Impairment/Damage Foetus Other Ferro-Folgamma C Neonatal Respiratory Failure Date:06/05/02ISR Number: 3930656-9Report Type:Expedited (15-DaCompany Report #2002108733CH Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Pressure Increased Health Xanax (Alprazolam) Other Body Temperature Professional Tablet, 0.25 Mg PS ORAL 0.5 MG/DAY, Increased ORAL Hyporeflexia Seroquel Lethargy (Quetiapine) Tablet, Respiration Abnormal 100 Mg SS ORAL 75 MG, ORAL Respiratory Failure Depakine (Valproate Sleep Apnoea Syndrome Sodium) Tablet, 500 Tachycardia Mg SS ORAL 2000 MG/DAY, ORAL Seroquel SS ORAL 150 MG/DAY, ORAL Tramal (Tramadol Hydrochloride) 100 Mg SS Seroquel SS ORAL 175 MG/DAY, ORAL Temesta (Lorazepam) Tablet, 2.5 Mg SS ORAL 2.5 MG/DAY, ORAL Haldol C Date:06/05/02ISR Number: 3930751-4Report Type:Expedited (15-DaCompany Report #2001UW14720 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Seroquel PS ORAL 400 MG DAILY Cerebral Haemorrhage PO Delusion Seroquel SS ORAL 200 MG DAILY Myocardial Infarction PO Oedema Peripheral Seroquel SS Psychotic Disorder Metamucil C Schizophrenia Cogentin C Treatment Noncompliance Klonopin C Vein Disorder Vision Blurred Weight Increased Date:06/05/02ISR Number: 3930798-8Report Type:Expedited (15-DaCompany Report #2002GB01305 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Life-Threatening Neutropenia Foreign Health 22-Feb-2006 08:31 AM Page: 454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Quetiapine PS ORAL 50 MG BID PO Date:06/07/02ISR Number: 3929441-3Report Type:Direct Company Report #CTU 169676 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Depakote PS 1000 MG BID Initial or Prolonged Lethargy Risperidone SS ORAL 1 MG PO BID Stupor Lithium SS 450 MG BID Vision Blurred Quetiapine SS 200 MG BID Hydroxyzine C Naproxen C Citalopram C Lorazepam C Date:06/07/02ISR Number: 3930740-XReport Type:Expedited (15-DaCompany Report #2002GB01030 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Seroquel PS ORAL 550 MG DAILY Coma Health PO Overdose Professional Seroquel SS OVERDOSE Pulse Absent Other Seroquel SS Propranolol SS 30 TABLETS TAKEN AT ONCE Procyclidine SS TOOK IN EXCESS Date:06/07/02ISR Number: 3930919-7Report Type:Expedited (15-DaCompany Report #S02-UKI-00324-02 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eye Disorder Foreign Cipramil (Citalopram Initial or Prolonged Hypotonia Neonatal Health Hydrobromide) PS Congenital Anomaly Hypoventilation Neonatal Professional Lorazepam SS Maternal Drugs Affecting Other Perphenazine SS Foetus Trazodone SS Respiratory Depression Zopiclone SS Respiratory Tract Seroquel SS Malformation Methotrimeprazine SS Date:06/07/02ISR Number: 3931035-0Report Type:Expedited (15-DaCompany Report #2002UW07145 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Liver Disorder Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/02ISR Number: 3931051-9Report Type:Expedited (15-DaCompany Report #2002UW07648 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ulcerative Health Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Professional PO Depakote C Haldol "Janssen" C Date:06/07/02ISR Number: 3931082-9Report Type:Expedited (15-DaCompany Report #S00-UKI-00592-01 Age:0 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Central-Alveolar Foreign Cipramil (Citalopram Initial or Prolonged Hypoventilation Health Hydrobromide) PS Congenital Anomaly Congenital Anomaly Professional Lorazepam SS TRANSPLACENTAL 1 MG QD Eye Disorder Other TRANSPLACENTA Hypotonia Neonatal L Hypoventilation Neonatal Perphenazine SS TRANSPLACENTAL 4 MG QD Maternal Drugs Affecting TRANSPLACENTA Foetus L Neonatal Disorder Trazodone SS TRANSPLACENTAL 150 MG QD Neonatal Respiratory TRANSPLACENTA Depression L Zopiclone SS TRANSPLACENTAL 7.5 MG QD TRANSPLACENTA L Seroquel SS TRANSPLACENTAL 250 MG TRANSPLACENTA L Methotrimeprazine SS Date:06/10/02ISR Number: 3930851-9Report Type:Direct Company Report #CTU 169791 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Discomfort Divalproex Solvay Hospitalization - Depression Pharmaceuticals PS ORAL 3500 MG ORAL Initial or Prolonged Nausea Seroquel Required Pancreatitis Astra-Zeneca Intervention to Vomiting Pharmaceuticals SS Astra-Zeneca Prevent Permanent Pharmaceuticals ORAL 50MG QHS ORAL Impairment/Damage Atenolol C Carbamazepine C Clotrimazole Cream C Lansoprazole C Levothyroxine C Lisinopril C Simvastatin C Spironolactone C Triamcinolone Ointment C Date:06/10/02ISR Number: 3931202-6Report Type:Expedited (15-DaCompany Report #2002UW07639 Age: Gender: I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Benign Intracranial Health Seroquel PS ORAL 500 MG PO Hypertension Professional Wellbutrin C Brain Oedema Date:06/10/02ISR Number: 3931349-4Report Type:Expedited (15-DaCompany Report #PHBS2002AT02719 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Trileptal(Oxcarbazep Initial or Prolonged Pyrexia Study ine) PS ORAL SEE IMAGE Tonsillitis Health Seroquel(Quetiapine) SS ORAL SEE IMAGE Professional Effectin(Bitolterol Other Mesilate) SS ORAL SEE IMAGE Trittico(Trazodone Hydrochloride) SS ORAL 300 MG/DAY, ORAL Nozinan(Levomepromaz ine) SS ORAL SEE IMAGE Nexium(Esomeprazole) SS ORAL 20 NG/DAY, ORAL Voltaren (Diclofenac Sodium) C Venlafaxine (Venlafaxine) C Date:06/10/02ISR Number: 3931400-1Report Type:Expedited (15-DaCompany Report #HQ2551703JUN2002 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Health Temesta (Lorazepam, Consciousness Professional Tablet) PS ORAL 2.5 MG 1X PER Drug Interaction 1 DAY 2 DAY Extensor Plantar Response Depakine (Valproate Heart Rate Increased Sodium, ) SS ORAL 2000 MG 1X Hyperreflexia PER 1 DAY Malaise Seroquel Sleep Apnoea Syndrome (Quetiapine, ) SS ORAL SEE IMAGE 2 DAY Somnolence Tramal (Tramadol Tachycardia Hydrochloride, ) SS ORAL 12.5 MG 1X PER 1 DAY 2 DAY Xanax (Alprazolam, ) SS ORAL 0.5 MG 1X PER 1 DAY Haldol (Haloperidol) C Date:06/11/02ISR Number: 3933990-1Report Type:Expedited (15-DaCompany Report #2002AP00632 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Seroquel PS ORAL 200 MG DAILY Nasopharyngitis Health PO Sudden Death Professional Seroquel SS ORAL 400 MG DAILY Other PO Wintermin C Akineton C Benzalin C 22-Feb-2006 08:31 AM Page: 457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rohypnol C Vegetamin A C Flomox C Pl Gran. C Dasen C Date:06/11/02ISR Number: 3934224-4Report Type:Expedited (15-DaCompany Report #2002SE03492 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Epistaxis Foreign Seroquel PS ORAL 600 MG DAILY Intervention to Thrombocytopenia Health PO Prevent Permanent Professional Efexor SS ORAL 75 MG DAILY Impairment/Damage Other PO Surmontil SS ORAL 100 MG DAILY PO Temesta C Date:06/11/02ISR Number: 3934226-8Report Type:Expedited (15-DaCompany Report #2002PK00157 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glossodynia Foreign Seroquel "Zeneca" PS Zeneca BELOW 300 Initial or Prolonged Pancytopenia Health MG/DAY Pyrexia Professional Seroquel "Zeneca" SS Zeneca ORAL 300 MG DAILY Other PO Nexium SS ORAL 20 MG DAILY PO Trileptal SS BELOW 1500 MG Trileptal SS 1500 MG DAILY PO Nozinan SS BELOW 100 MG/DAY Nozinan SS ORAL 100 MG DAILY PO Trittico SS ORAL 300 MG DAILY PO Voltaren "Novartis" SS Novartis ORAL 200 MG DAILY PO Effectin C Date:06/12/02ISR Number: 3932796-7Report Type:Expedited (15-DaCompany Report #2002AP01561 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Seroquel PS ORAL 600 MG DAILY Drug Withdrawal Syndrome Health PO Psychiatric Symptom Professional Linton SS 6 MG DAILY Sudden Death Other Linton SS 12 MG DAILY Contomin SS 150 MG DAILY Tasmolin C Depas C Risumic C Benzalin C Rohypnol C 22-Feb-2006 08:31 AM Page: 458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/02ISR Number: 3932821-3Report Type:Expedited (15-DaCompany Report #2002SE03541 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 175 MG DAILY Intervention to Extensor Plantar Response Other PO Prevent Permanent Hyporeflexia Valproate Sodium SS ORAL 200 MG DAILY Impairment/Damage Lethargy PO Pain Alprazolam SS ORAL 0.5 MG DAILY Respiration Abnormal PO Sleep Apnoea Syndrome Lorazepam SS ORAL 2.5 MG DAILY Snoring PO Somnolence Tramadol SS ORAL 12.5 MG DAILY Tachycardia PO Haloperidol C Date:06/12/02ISR Number: 3932825-0Report Type:Expedited (15-DaCompany Report #2002GB01336 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Seroquel PS Initial or Prolonged Health Unspecified C Professional Other Date:06/12/02ISR Number: 3933428-4Report Type:Expedited (15-DaCompany Report #HQ2551703JUN2002 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Health Temesta (Lorazepam, Body Temperature Professional Tablet) PS ORAL 2.5 MG 1X PER Increased 1 DAY ORAL 2 DAY Depressed Level Of Depakine (Valproate Consciousness Sodium, ) SS ORAL 2000 MG 1X Drug Interaction PER 1 DAY Extensor Plantar Response ORAL Hyporeflexia Seroquel Malaise (Quetiapine, ) SS ORAL SEE IMAGE 2 DAY Sleep Apnoea Syndrome Tramal (Tramadol Sleep Disorder Hydrochloride, ) SS ORAL 12.5 MG 1X Somnolence PER 1 DAY Tachycardia ORAL 2 DAY Xanax (Alprazolam, ) SS ORAL 0.5 MG 1X PER 1 DAY ORAL ... C Haldol (Haloperidol) C ... C Date:06/17/02ISR Number: 3935510-4Report Type:Expedited (15-DaCompany Report #2002UW07805 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Seroquel PS ORAL 150 MG BID PO Initial or Prolonged Physical Examination Serzone SS ORAL 150 MG BID PO Abnormal 22-Feb-2006 08:31 AM Page: 459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/02ISR Number: 3935512-8Report Type:Expedited (15-DaCompany Report #2002UW07934 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Seroquel PS ORAL 600 MG HS PO Professional Clozaril SS 800 MG QD Cogentin SS 2 MG BID Paxil SS 30 MG Risperidone C Date:06/17/02ISR Number: 3935525-6Report Type:Expedited (15-DaCompany Report #2002UW01819 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Seroquel "Zeneca" PS Zeneca ORAL 800 MG DAILY Overdose Professional PO Olanzapine SS Effexor SS Date:06/17/02ISR Number: 3935557-8Report Type:Expedited (15-DaCompany Report #2002UW06165 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Foreign Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Hyperthyroidism Study PO Required Suicidal Ideation Health Ranitidine C Intervention to Syncope Professional Tricyclen C Prevent Permanent Vomiting Other Flonase C Impairment/Damage Weight Decreased Date:06/17/02ISR Number: 3935664-XReport Type:Expedited (15-DaCompany Report #A04200200129 Age:0 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Neonatal Health Stilnox - (Zolpidem) Hypotonia Neonatal Professional Tablet - 10 Mg PS TRANSPLACENTAL 5 MG, QD Maternal Drugs Affecting Seroquel "Zeneca" Foetus (Quetiapine Neonatal Respiratory Fumarate) - Tablet SS TRANSPLACENTAL 400 MG Depression Date:06/18/02ISR Number: 3935572-4Report Type:Expedited (15-DaCompany Report #02-04-0324 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Health Clozapine - Ivax Eosinophilia Professional Pharmaceuticals, Exercise Tolerance Inc. Tablets PS Ivax Decreased Pharmaceuticals, Sudden Death Inc. ORAL 24-450 MG QD ORAL Seroquel SS Haldol C Atrovent C Vanceril C 22-Feb-2006 08:31 AM Page: 460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/02ISR Number: 3935898-4Report Type:Expedited (15-DaCompany Report #2002SE03596 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Neutropenia Health PO Professional Leponex "Novartis" C Other Date:06/18/02ISR Number: 3935901-1Report Type:Expedited (15-DaCompany Report #2002AP01037 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS ORAL 25 MG DAILY Decreased Health PO Professional Seroquel SS ORAL 50 MG DAILY Other PO Seroquel SS ORAL 75 MG DAILY PO Seroquel SS ORAL 100 MG DAILY PO Seroquel SS ORAL 150 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Lithium Carbonate C Clonazepam C Levomepromazine Maleate C Date:06/18/02ISR Number: 3936838-4Report Type:Expedited (15-DaCompany Report #2002AP00901 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS ORAL 300 MG DAILY Required Drug Interaction Health PO Intervention to Fungal Infection Professional Seroquel SS ORAL 400 MG DAILY Prevent Permanent Hepatocellular Damage Other PO Impairment/Damage Rash Contomin C Rash Pustular Serenace C Levotomin C Vegetamin B C Selbex C Kamag G C Date:06/19/02ISR Number: 3936404-0Report Type:Expedited (15-DaCompany Report #2002PK00157 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Seroquel "Zeneca" PS BELOW 300 Initial or Prolonged Pancytopenia Health MG/DAY Pharyngitis Streptococcal Professional Seroquel "Zeneca" SS ORAL 300 MG DAILY Pyrexia Other PO Nexium SS ORAL 20 MG DAILY PO Trileptal SS BELOW 1500 MG Trileptal SS ORAL 1500 MG DAILY PO Nozinan SS BELOW 100 22-Feb-2006 08:31 AM Page: 461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MG/DAY Nozinan SS ORAL 100 MG DAILY PO Trittico SS ORAL 300 MG DAILY PO Voltaren "Novartis" SS Novartis ORAL 200 MG DAILY PO Effectin C Date:06/19/02ISR Number: 3936425-8Report Type:Expedited (15-DaCompany Report #2002UW06580 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acne Health Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Aggression Professional PO Required Anger Depakote SS 500 MG DAILY Intervention to Hepatic Fibrosis Paxil SS 30 MG DAILY Prevent Permanent Hepatitis Ambien C Impairment/Damage Schizophrenia Zyprexa C Date:06/19/02ISR Number: 3936462-3Report Type:Expedited (15-DaCompany Report #2002UW07853 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Seroquel PS ORAL 750 MG DAILY Health PO Professional Neurontin C Other Divalproic C Date:06/19/02ISR Number: 3936466-0Report Type:Expedited (15-DaCompany Report #2002AP01661 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Seroquel PS Health Professional Other Date:06/19/02ISR Number: 3936565-3Report Type:Expedited (15-DaCompany Report #HQ2721814JUN2002 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Health Inderal (Propranolol Other Decreased Professional Hydrochloride, Blood Pressure Decreased Other Unspec) PS ORAL 30 TABLETS Circulatory Collapse TAKEN AT ONCE 1 DAY Coma Procyclidine Intentional Overdose (Procyclidine) SS ORAL TOOK IN Pulse Absent EXCESS Seroquel (Quetiapine,) SS ORAL OVERDOSE 1 DAY 22-Feb-2006 08:31 AM Page: 462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/02ISR Number: 3937805-7Report Type:Expedited (15-DaCompany Report #2002UW08401 Age:2 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Health Seroquel PS ORAL 50 MG ONCE PO Coma Professional Date:06/21/02ISR Number: 3937817-3Report Type:Expedited (15-DaCompany Report #2002UW05882 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cognitive Disorder Health Seroquel PS ORAL 50 MG BID PO Intervention to Condition Aggravated Professional Seroquel SS ORAL 75 MG BID PO Prevent Permanent Confusional State Seroquel SS ORAL 75 MG HS PO Impairment/Damage Drug Interaction Seroquel SS ORAL 25 MG BID PO Dysphagia Coumadin SS Hallucination, Visual Flomax C International Normalised Lipitor C Ratio Increased Digoxin C Memory Impairment Pepcid C Pneumonia Lasix C Speech Disorder Prednisone C Serevent C Guaifenesin C Azmacort C Ativan C Date:06/21/02ISR Number: 3937878-1Report Type:Expedited (15-DaCompany Report #2002AP00632 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Seroquel PS ORAL SEE IMAGE Nasopharyngitis Health Wintermin C Sudden Death Professional Akineton C Other Benzalin C Pl Gran C Dasen C Rohypnol C Date:06/21/02ISR Number: 3938094-XReport Type:Expedited (15-DaCompany Report #2002SE03588 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Seroquel PS ORAL 25 MG DAILY, Initial or Prolonged Granulocytopenia Health PO Leukopenia Professional Seroquel SS ORAL 100 MG TID PO Thrombocytopenia Other Date:06/21/02ISR Number: 3938137-3Report Type:Expedited (15-DaCompany Report #2002UW08229 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Seroquel PS ORAL 200 MG QD PO Fatigue Professional Seroquel SS ORAL 100 MG HS PO Medication Error Seroquel SS ORAL 300 MG HS PO Zoloft C Buspar C 22-Feb-2006 08:31 AM Page: 463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/02ISR Number: 3939025-9Report Type:Expedited (15-DaCompany Report #2002SE03692 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Pain Foreign Seroquel PS ORAL 600 MG DAILY Intervention to Galactorrhoea Health PO Prevent Permanent Professional Solian SS ORAL 800 MG DAILY Impairment/Damage Other PO Risperdal SS ORAL 4 MG DAILY PO Temesta C Bactrim Forte C Zithromax C Date:06/24/02ISR Number: 3939027-2Report Type:Expedited (15-DaCompany Report #2002AP01782 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Hypoaesthesia Health PO Joint Stiffness Professional Seroquel SS ORAL 125 MG DAILY Other PO Seroquel SS ORAL 75 MG DAILY PO Date:06/24/02ISR Number: 3939244-1Report Type:Expedited (15-DaCompany Report #02P-151-0194509-00 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Sodium Initial or Prolonged Drug Interaction Health Valproate/Valproic Required Extensor Plantar Response Professional Acid (Sodium Intervention to Hyporeflexia Other Valproate/Valproic Prevent Permanent Lethargy Acid (Sodium PS ORAL 500 MG, 4 IN Impairment/Damage Sleep Apnoea Syndrome 1 D, PER ORAL Snoring ; 1000 MG, Tachycardia 1 IN 1 D, PER ORAL Quetiapine (Quetiapine) SS ORAL SEE IMAGE Lorazepam (Lorazepam) (Lorazepam) SS ORAL 0.25 MG, 1 IN 1 D, PER ORAL Tramadol Hydrochloride (Tramadol Hydrochloride) SS 12.5 MG, 1 IN 1 D Alprazolam (Alprazolam) SS 0.25 MG Haldol C Date:06/25/02ISR Number: 3939961-3Report Type:Expedited (15-DaCompany Report #2002AP01726 Age:64 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability PT Report Source Product Role Manufacturer Route Dose Duration Drug Withdrawal Syndrome Foreign Seroquel PS ORAL 400 MG DAILY Granulocytopenia Health PO Hepatic Function Abnormal Professional Symmetrel C Hypokalaemia Other Amoxan C Pancytopenia Silece C Adalat L C Date:06/25/02ISR Number: 3940072-1Report Type:Expedited (15-DaCompany Report #2002GB00910 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Increased Foreign Seroquel PS ORAL 150 MG BID PO Intervention to Drug Interaction Health Clozaril SS Prevent Permanent Palpitations Professional Oxybutynin SS 7.5 MG BID Impairment/Damage Other Amitriptyline SS ORAL 50 MG HS PO Frusemide C Perindopril C Carbamazepine C Paroxetine C Date:06/25/02ISR Number: 3940122-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000633 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Foreign Risperdal (Tablet) Depressed Level Of Health (Risperidone) PS ORAL MG, DAILY, Consciousness Professional ORAL Glucose Urine Present Quetiapine Fumarate Ketoacidosis (Quetiapine Polydipsia Fumarate) SS ORAL MG, DAILY, Weight Increased ORAL Nitrazepam (Nitrazepam) C Ethyl Loflazepate (Ethyl Loflazepate) C Date:06/25/02ISR Number: 3940386-5Report Type:Direct Company Report #CTU 170845 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Tourette'S Disorder Seroquil PS 100 MG TABLET Hospitalization - Initial or Prolonged Disability Other Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/02ISR Number: 3940529-3Report Type:Expedited (15-DaCompany Report #HQ2838717JUN2002 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Health Sonata (Zaleplon, Initial or Prolonged Anuria Professional Capsule) PS ORAL 10 MG 1X PER Rash 1 DAY, ORAL Celebrex (Celecoxib, ) SS Celexa (Citalopram Hydrobromide, Tablet) SS ORAL ORAL Depakote (Valproate Semisodium, ) SS UNKNOWN Seroquel (Quetiapine, ) SS UNKNOWN Meclizine (Meclozine) C Zantac (Ranitidine Hydrochloride) C Estrogen Nos (Estrogen Nos) C Depakote (Valproate Semisodium) C Lamictal (Lamotrigine) C Darvocet-N (Dextropropoxyphene/ Paracetamol) C Date:06/26/02ISR Number: 3940759-0Report Type:Expedited (15-DaCompany Report #2002GB01374 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Antinuclear Antibody Foreign Seroquel PS Intervention to Positive Study Prevent Permanent Arthralgia Health Impairment/Damage Professional Other Date:06/26/02ISR Number: 3940779-6Report Type:Expedited (15-DaCompany Report #2002GB01431 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Circulatory Collapse Foreign Seroquel PS ORAL 25 MG ONCE PO Intervention to Depressed Level Of Health Sulpiride C Prevent Permanent Consciousness Professional Impairment/Damage Hypotension Other Date:06/26/02ISR Number: 3940946-1Report Type:Direct Company Report #CTU 171007 Age:52 YR Gender:Female I/FU:I Outcome PT Life-Threatening Ageusia Anorexia Blood Glucose Decreased Blood Pressure Decreased Bone Pain Contusion 22-Feb-2006 08:31 AM Page: 466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disturbance In Attention Dizziness Dyspepsia Report Source Product Role Manufacturer Route Dose Duration Fear Seroquel PS 25MG 3 TABS Insomnia BEDTIME Mania Memory Impairment Muscle Spasms Nausea Panic Attack Vision Blurred Date:06/28/02ISR Number: 3942259-0Report Type:Expedited (15-DaCompany Report #EMADSS2002003793 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Extensor Plantar Response Foreign Tramal (Unspecified) Grunting Health (Tramadol Hyperreflexia Professional Hydrochloride) PS ORAL 12.5 MG, Malaise DAILY, ORAL Pain Seroquel (Seroquel) SS ORAL SEE IMAGE Respiratory Arrest Depakine(Valproate Snoring Sodium) SS ORAL 2000 MG, Somnolence DAILY, ORAL Tachycardia Xanax (Alprazolam) SS Temesta (Lorazepam) SS ORAL 2.5 MG, DAILY, ORAL Haldol(Haloperidol) C Date:07/01/02ISR Number: 3942394-7Report Type:Direct Company Report #CTU 171378 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Conjunctival Hyperaemia Quetiapine PS Hospitalization - Hypotension Diphenhydramine SS Initial or Prolonged Hypothermia Sertraline C Required Miosis Olanzapine C Intervention to Mucosal Dryness Acetaminophen C Prevent Permanent Overdose Thiamine C Impairment/Damage Respiratory Rate Folic Acid C Decreased Mvi C Somnolence Ibuprofen C Toxicologic Test Abnormal Date:07/01/02ISR Number: 3942897-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Haldol (Tablet) Initial or Prolonged Blood Glucose Increased Health (Haloperidol) PS ORAL MG, DAILY, Blood Pressure Increased Professional ORAL Condition Aggravated Risperdal (Tablet) Delusion (Risperidone) SS ORAL SEE IMAGE Hallucination Quetiapine Fumarate Respiratory Distress (Quetiapine Fumarate) SS ORAL MG, DAILY, ORAL Hydroxyzine Pamoate 22-Feb-2006 08:31 AM Page: 467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Hydroxyzine) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:07/01/02ISR Number: 3942900-2Report Type:Expedited (15-DaCompany Report #2002AP01772 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Seroquel PS ORAL 200 MG DAILY Blood Pressure Decreased Health PO Blood Triglycerides Professional Seroquel SS ORAL 300 MG DAILY Increased Other PO Coma Risperdal SS ORAL 2 MG DAILY PO Depressed Level Of Risperdal SS ORAL 3 MG DAILY PO Consciousness Risperdal SS ORAL 4 MG DAILY PO Diabetes Mellitus Meilax C Diabetic Ketoacidosis Benzalin C Drug Ineffective Insomnia Shock Weight Decreased Date:07/01/02ISR Number: 3943465-1Report Type:Expedited (15-DaCompany Report #2002SE03020 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Thromboplastin Time Health PO Prolonged Professional Haldol "Janssen" C International Normalised Other Marcoumar C Ratio Increased Plavix C Prothrombin Time Tenormin C Prolonged Date:07/01/02ISR Number: 3943466-3Report Type:Expedited (15-DaCompany Report #2002SE03842 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Insomnia Health PO Leukopenia Professional Seroquel SS ORAL 200 MG DAILY Neutropenia Other PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Temesta C Truxal C Kefexin C 22-Feb-2006 08:31 AM Page: 468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/02ISR Number: 3943824-7Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal (Tablet) Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL SEE IMAGE Phosphokinase Increased Professional Haldol (Tablet) Blood Glucose Increased (Haloperiodol) SS ORAL MG, DAILY, Blood Pressure Increased ORAL Condition Aggravated Quetiapine Fumarate Delusion (Quetiapine Glycosylated Haemoglobin Fumarate) SS ORAL MG, DAILY, Glycosylated Haemoglobin ORAL Increased Hydroxyzine Pamoate Hallucination (Hydroxyzine) C Hypoventilation Estazolam Insomnia (Estazolam) C Oxygen Saturation Zopiclone Decreased (Zopiclone) C Respiratory Distress Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:07/01/02ISR Number: 3943826-0Report Type:Expedited (15-DaCompany Report #APCDSS2002000633 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depressed Level Of Foreign Risperdal (Tablet) Consciousness Health (Risperidone) PS ORAL MG, DAILY, Diabetic Hyperglycaemic Professional ORAL Coma Quetiapine Fumarate Insomnia (Quetiapine Ketoacidosis Fumarate) SS ORAL MG, DAILY, Malaise ORAL Polydipsia Nitrazepam Weight Increased (Nitrazepam) C Ethyl Loflazepate (Ethyl Loflazepate) C Date:07/02/02ISR Number: 3943412-2Report Type:Expedited (15-DaCompany Report #2002SE03908 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Seroquel PS ORAL 400 MG DAILY Cyanosis Health PO Dyspnoea Professional Solian SS ORAL 400 MG DAILY Hyponatraemia Other PO Neuroleptic Malignant Tegretol SS ORAL 800 MG DAILY Syndrome PO Pyrexia Tegretol SS INTRAVENOUS 200 MG DAILY Tachycardia IV Leponex Novartis SS Novartis Lasix C Coversum C Aspirin Cardio C Aldactone C 22-Feb-2006 08:31 AM Page: 469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/02ISR Number: 3943563-2Report Type:Expedited (15-DaCompany Report #2002SE03878 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Thrombocytopenia Foreign Seroquel PS START: MID Intervention to Health SEPTEMBER Prevent Permanent Professional Seroquel SS ORAL 400 MG DAILY Impairment/Damage Other PO Seroquel SS ORAL 500 MG DAILY PO Depakine C Temesta C Zyprexa C Haldol "Janssen" C Valium C 'Risperdal C Zoloft C Dalmadorm "Hoffman" C Stilnox C Solian C Date:07/02/02ISR Number: 3943583-8Report Type:Expedited (15-DaCompany Report #PHBS2002CH07405 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Tegretol Hospitalization - Congestive Cardiomyopathy Health (Carbamazepine) Initial or Prolonged Convulsion Professional Unknown PS ORAL 200 TO 800 Disability Hepatic Cirrhosis Other MG/DAY, ORAL Hyponatraemia Leponex (Clozapine) Intracardiac Thrombus Unknown SS ORAL ORAL Neuroleptic Malignant Solian (Amisulpride) SS ORAL 400 MG/DAY, Syndrome ORAL Pneumonia Seroquel (Quetiapine Pulmonary Embolism Fumarate) SS ORAL 400 MG/DAY, Pulmonary Haemorrhage ORAL Pulmonary Infarction Lasix C Coversum (Perindopril) C Aspirin Cardio C Aldactone C Date:07/02/02ISR Number: 3943702-3Report Type:Expedited (15-DaCompany Report #2002UW08725 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Seroquel PS ORAL 12.5 MG HS PO Initial or Prolonged Professional Metoprolol C Tums C Insulin C Imdur C Date:07/02/02ISR Number: 3945501-5Report Type:Expedited (15-DaCompany Report #2002UW08447 Age: Gender: I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Body Temperature Health Seroquel PS Decreased Professional Date:07/02/02ISR Number: 3945503-9Report Type:Expedited (15-DaCompany Report #2002UW08401 Age:24 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Health Seroquel PS ORAL 50 MG ONCE PO Coma Professional Other Medications SS Date:07/03/02ISR Number: 3944431-2Report Type:Expedited (15-DaCompany Report #2002AP01772 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Seroquel PS ORAL 200 MG DAILY Blood Triglycerides Health PO Increased Professional Seroquel SS ORAL 300 MG DAILY Coma Other PO Diabetic Ketoacidosis Risperdal SS ORAL 2 MG DAILY PO Insomnia Risperdal SS ORAL 3 MG DAILY PO Shock Risperdal SS ORAL 4 MG DAILY PO Weight Decreased Meilax C Benzalin C Date:07/03/02ISR Number: 3944920-0Report Type:Expedited (15-DaCompany Report #2002UW08863 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Seroquel PS ORAL 25 MG ONCE PO Initial or Prolonged Headache Seroquel SS ORAL 25 MG BID PO Insomnia Seroquel SS ORAL 25 MG DAILY Myocardial Infarction PO Weight Increased Seroquel SS ORAL 50 MG DAILY PO Seroquel SS ORAL 50 MG DAILY PO Serzone C Glucophage C Lipitor C Zestril C Nitro-Spray C Imdur C Date:07/03/02ISR Number: 3944949-2Report Type:Expedited (15-DaCompany Report #2002UW01819 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Health Seroquel "Zeneca" PS "Zeneca" ORAL 800 MG DAILY Hepatic Steatosis Professional PO Ill-Defined Disorder Olanzapine SS Overdose Effexor SS Treatment Noncompliance Medication For Hypertension SS 22-Feb-2006 08:31 AM Page: 471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/02ISR Number: 3945702-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB01966 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Clozaril (Clozapine) PS Hypertension Health Seroquel (Quetiapine Palpitations Professional Fumarate) SS ORAL 300 MG/DAY, Other ORAL Oxybutynin (Oxybutynin) SS 15 MG/DAY Amitriptyline (Amitriptyline) SS ORAL 50 MG/DAY, ORAL Frusemide C Perindopril (Perindopril) C Carbamazepine C Paroxetine (Paroxetine) C Date:07/03/02ISR Number: 3945705-1Report Type:Expedited (15-DaCompany Report #D0038775A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Foreign Lithium Carbonate Initial or Prolonged Drug Effect Decreased Health Tablet (Non-Us Drug Interaction Professional Product) PS ORAL ORAL Speech Disorder Quetiapine Fumarate Tongue Disorder Tablet (Quetiapine Fumarate) SS ORAL ORAL Imipramine Hydrochloride C Lorazepam C Ranitidine Hydrochloride C Olanzapine C Date:07/09/02ISR Number: 3945724-5Report Type:Direct Company Report #CTU 171873 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Quetiapine 200 Mg & Disability Hypertriglyceridaemia 300 Mg Astrazeneca PS Astrazeneca ORAL 600-800 MG Required Weight Increased QHS ORAL Intervention to Haloperidol C Prevent Permanent Depakote C Impairment/Damage Thiothixene C Date:07/09/02ISR Number: 3946819-2Report Type:Expedited (15-DaCompany Report #PHEH2002US05617 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Clozaril (Clozapine) Drug Interaction Professional Tablet PS ORAL 200 MG, QID, Drug Level Increased Company ORAL Representative Seroquel (Quetiapine Fumarate) SS Paxil (Paroxetine Hydrochloride) SS 22-Feb-2006 08:31 AM Page: 472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin (Benzatropine Mesilate SS Date:07/09/02ISR Number: 3948070-9Report Type:Expedited (15-DaCompany Report #2002PK00637 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Seroquel PS ORAL 600 MG DAILY Decreased PO Carbamazepin C Neurocil C Zopiclon C Date:07/10/02ISR Number: 3947692-9Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Haldol (Tablet) Initial or Prolonged Blood Creatine Health (Haloperidol) PS ORAL MG, DAILY, Phosphokinase Increased Professional ORAL Blood Pressure Increased Risperidal (Tablet) Diabetes Mellitus (Risperidone) SS ORAL MG, DAILY, Hypoventilation ORAL Insomnia Quetiapine Fumarate Oxygen Saturation (Quetiapine Decreased Fumarate) SS ORAL MG, DAILY, Respiratory Distress ORAL Schizophrenia Hydroxyzine Pamoate (Hydroxyzine) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:07/10/02ISR Number: 3947694-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperidal (Tablet) Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL MG, DAILY, Phosphokinase Increased Professional ORAL Blood Pressure Increased Haldol (Tablet) Diabetes Mellitus (Haloperidol) SS ORAL MG, DAILY, Hypoventilation ORAL Insomnia Quetiapine Fumarate Oxygen Saturation (Quetiapine Decreased Fumarate) SS ORAL MG, DAILY, Respiratory Distress ORAL Schizophrenia Hydroxyzine Pamoate (Hydroxyzine) C Estazolam (Estazolam) C Zopiclone 22-Feb-2006 08:31 AM Page: 473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Zopiclone) C Biperiden Hydrochloride (Biperiden (Hydrochloride) C Date:07/10/02ISR Number: 3947739-XReport Type:Expedited (15-DaCompany Report #2002SE03879 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Circulatory Collapse Foreign Seroquel PS ORAL 400 MG DAILY Intervention to Drug Level Below Health PO Prevent Permanent Therapeutic Professional Lorazepam C Impairment/Damage Palpitations Other Shock Tachycardia Date:07/10/02ISR Number: 3947740-6Report Type:Expedited (15-DaCompany Report #2002AP02134 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Seroquel PS ORAL 75 MG DAILY Initial or Prolonged Phosphokinase Increased Health PO Circulatory Collapse Professional Seroquel SS ORAL 200 MG DAILY Pain Other PO Rhabdomyolysis Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 50 MG DAILY PO Linton C Horizon C Date:07/11/02ISR Number: 3948230-7Report Type:Expedited (15-DaCompany Report #2002AP01772 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Seroquel PS ORAL 200 MG DAILY Blood Triglycerides Health PO Increased Professional Seroquel SS ORAL 300 MG DAILY Depressed Level Of Other PO Consciousness Risperdal SS ORAL 2 MG DAILY PO Diabetic Hyperosmolar Risperdal SS ORAL 3 MG DAILY PO Coma Risperdal SS ORAL 4 MG DAILY PO Diabetic Ketoacidosis Meilax C Insomnia Benzalin C Shock Weight Decreased Weight Increased Date:07/11/02ISR Number: 3948234-4Report Type:Expedited (15-DaCompany Report #2002GB01056 Age:26 YR Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Foreign Seroquel PS ORAL 600 MG DAILY Torticollis Health PO Professional Seroquel SS ORAL 800 MG DAILY Other PO Seroquel SS ORAL 200 MG BID PO Prozac C Minocin C Date:07/11/02ISR Number: 3948528-2Report Type:Expedited (15-DaCompany Report #PHBS2002US07851 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Literature Carbamazepine Coordination Abnormal Health (Carbamazepine) PS Drug Interaction Professional Quetiapine Drug Level Increased (Quetiapine) SS Date:07/11/02ISR Number: 3948750-5Report Type:Expedited (15-DaCompany Report #2002UW08229 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Seroquel PS ORAL 200 MG QD PO Required Depression Professional Seroquel SS ORAL 100 MG HS PO Intervention to Diabetic Ketoacidosis Seroquel SS ORAL 300 MG HS PO Prevent Permanent Diabetic Nephropathy Zoloft C Impairment/Damage Epistaxis Buspar C Fatigue Tequin C Medication Error Mouth Haemorrhage Renal Failure Self Esteem Decreased Suicidal Ideation Date:07/11/02ISR Number: 3948933-4Report Type:Expedited (15-DaCompany Report #PHBS2002US07869 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Literature Carbamazepine Drug Level Increased Health (Carbamazepine) Professional Unknown PS Quetiapine (Quetiapine) SS Date:07/11/02ISR Number: 3948986-3Report Type:Expedited (15-DaCompany Report #APCDSS2002000633 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Triglycerides Foreign Risperdal (Tablet) Increased Health (Risperidone) PS ORAL MG, DAILY, Diabetic Hyperglycaemic Professional ORAL Coma Quetiapine Fumarate Insomnia (Quetiapine Weight Increased Fumarate) SS ORAL MG, DAILY, ORAL 22-Feb-2006 08:31 AM Page: 475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nitrazepam (Nitrazepam) C Ethyl Loflazepate (Ethyl Loflazepate) C Date:07/16/02ISR Number: 3949756-2Report Type:Expedited (15-DaCompany Report #2002GB00788 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Foreign Seroquel PS ORAL 150 MG BID PO Intervention to Drug Exposure During Health Prevent Permanent Pregnancy Professional Impairment/Damage Pregnancy Other Date:07/16/02ISR Number: 3949764-1Report Type:Expedited (15-DaCompany Report #2002AP01782 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Hypoaesthesia Health PO Muscle Rigidity Professional Seroquel SS ORAL 25 MG DAILY Paraesthesia Other PO Seroquel SS ORAL 50 MG DAILY PO Seroquel SS ORAL 75 MG DAILY PO Seroquel SS ORAL 125 MG DAILY PO Rohypnol SS Seroquel SS ORAL 75 MG DAILY PO Seroquel SS ORAL 100 MG DAILY PO Lendormin C Limas C Liyarisan Bm C Reslin C Pursennid C Norvasc C Renivace C Ubretid C Date:07/16/02ISR Number: 3949848-8Report Type:Expedited (15-DaCompany Report #2002AP02135 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel PS ORAL 700 MG DAILY Sudden Death Health PO Professional Zyprexa C Other Serenace C Hirnamin C Contomin C Benzalin C Pyrethia C Artane C Barnetil C Tegretol C 22-Feb-2006 08:31 AM Page: 476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/02ISR Number: 3949853-1Report Type:Expedited (15-DaCompany Report #2002AP01561 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Seroquel PS ORAL 600 MG DAILY Condition Aggravated Health PO Psychiatric Symptom Professional Linton SS ORAL 6 MG DAILY PO Other Contomin SS ORAL 150 MG DAILY PO Tasmolin SS ORAL 6 MG DAILY PO Depas C Risumic C Benzalin C Rohypnol C Levotomin C Hiberna C Date:07/16/02ISR Number: 3949855-5Report Type:Expedited (15-DaCompany Report #2002PK00637 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS ORAL 600 MG DAILY Decreased Health PO Professional Carbamazepin C Other Neurocil C Zopiclon C Date:07/16/02ISR Number: 3950339-9Report Type:Expedited (15-DaCompany Report #2002PK00643 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Foreign Seroquel PS ORAL 100 MG BID PO Leukopenia Health Mirtazapin C Neutropenia Professional Citalopram C Pyrexia Other Thrombocytopenia Date:07/16/02ISR Number: 3950345-4Report Type:Expedited (15-DaCompany Report #2002PK00637 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS ORAL 600 MG DAILY Decreased Health PO Professional Carbamazepin C Other Neurocil C Zopiclon C Date:07/17/02ISR Number: 3949409-0Report Type:Direct Company Report #CTU 172442 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Quetiapine 100mg Intervention to Non-Insulin-Dependent Astra Zenaca PS Astra Zeneca ORAL DAILY ORAL Prevent Permanent Risperidone C Impairment/Damage 22-Feb-2006 08:31 AM Page: 477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/17/02ISR Number: 3950752-XReport Type:Expedited (15-DaCompany Report #2002UW09406 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetic Ketoacidosis Health Seroquel PS ORAL 300 MG PO Intervention to Professional Prevent Permanent Impairment/Damage Date:07/17/02ISR Number: 3950756-7Report Type:Expedited (15-DaCompany Report #2002GB01622 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Deep Vein Thrombosis Foreign Quetiapine PS ORAL 200 MG DAILY Hospitalization - Pulmonary Embolism Health PO Initial or Prolonged Professional Fluphenazine C Other Date:07/17/02ISR Number: 3950913-XReport Type:Expedited (15-DaCompany Report #2002UW09474 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 75 MG; PO Decreased Professional Date:07/17/02ISR Number: 3950914-1Report Type:Expedited (15-DaCompany Report #2002UW09475 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 600 MG; PO; Decreased Professional 400 MG; PO Date:07/17/02ISR Number: 3950990-6Report Type:Expedited (15-DaCompany Report #2002AP01772 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Blood Bicarbonate Health PO Initial or Prolonged Decreased Professional Seroquel SS ORAL 300 MG DAILY Blood Triglycerides Other PO Increased Risperdal SS ORAL 2 MG DAILY PO Diabetic Hyperosmolar Risperdal SS ORAL 3 MG DAILY PO Coma Risperdal SS ORAL 4 MG DAILY PO Diabetic Ketoacidosis Meilax C Hyperkalaemia Benzalin C Insomnia Shock Weight Fluctuation Date:07/18/02ISR Number: 3951223-7Report Type:Expedited (15-DaCompany Report #2002UW09421 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 225 MG DAILY Decreased Professional PO Zyprexa C 22-Feb-2006 08:31 AM Page: 478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/02ISR Number: 3951338-3Report Type:Expedited (15-DaCompany Report #APCDSS2002000633 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Triglycerides Foreign Risperdal PS ORAL MG, DAILY, Increased Health ORAL Diabetic Hyperglycaemic Professional Quetiapine Fumarate Coma (Quetiapine Diabetic Ketoacidosis Fumarate) SS ORAL MG, DAILY, Insomnia ORAL Weight Decreased Ethyl Loflazepate Weight Increased (Ethyl Loflazepate) C Nitrazepam (Nitrazepam) C Date:07/19/02ISR Number: 3951202-XReport Type:Direct Company Report #USP 54942 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel 100mg (Quetiapine Fumarate 100mg) PS Astra Serzone 100mg (Nefazodone Hydrochloride 100mg) SS Bristol-Myers Date:07/19/02ISR Number: 3952448-7Report Type:Expedited (15-DaCompany Report #2002UW09532 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Seroquel PS Psychotropic Medications C Date:07/23/02ISR Number: 3953063-1Report Type:Expedited (15-DaCompany Report #2002UW09630 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 800 MG DAILY Decreased Professional PO Date:07/24/02ISR Number: 3953179-XReport Type:Expedited (15-DaCompany Report #2002UW09817 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Other Seroquel PS ORAL 200 MG HS PO Required Leukopenia Clozapine SS ORAL 25 MG QAM PO Intervention to Depakote - Slow Prevent Permanent Release SS ORAL 500 MG BID PO Impairment/Damage Senokot C Miralax C Lithium C Clozaril C 22-Feb-2006 08:31 AM Page: 479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/02ISR Number: 3953468-9Report Type:Expedited (15-DaCompany Report #2002AP02304 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Consciousness Health PO Required Hyperglycaemia Professional Seroquel SS ORAL 600 MG DAILY Intervention to Ketoacidosis Other PO Prevent Permanent Serenace C Impairment/Damage Akineton C Artane C Wintermin C Hirnamin C Vegetamin A C Date:07/24/02ISR Number: 3953470-7Report Type:Expedited (15-DaCompany Report #2002GB01374 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Antinuclear Antibody Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Positive Study PO Prevent Permanent Arthralgia Health Sodium Valproate C Impairment/Damage Professional Fluoxetine C Other Oestrogen C Date:07/24/02ISR Number: 3953481-1Report Type:Expedited (15-DaCompany Report #2002AP02291 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphopenia Foreign Seroquel PS ORAL 700 MG DAILY Initial or Prolonged Pyrexia Health PO Rash Professional Teril SS ORAL 600 MG DAILY White Blood Cell Count Other PO Decreased Clopixol (Decanoate) C Cogentin C Date:07/24/02ISR Number: 3953482-3Report Type:Expedited (15-DaCompany Report #2002SE04289 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cyanosis Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Dizziness Postural Health PO Prevent Permanent Fatigue Professional Impairment/Damage Incontinence Other Pallor Somnolence Speech Disorder Date:07/24/02ISR Number: 3953504-XReport Type:Expedited (15-DaCompany Report #2002AP01561 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Seroquel PS ORAL 600 MG DAILY Psychotic Disorder Health PO Sudden Death Professional Linton SS ORAL 6 MG DAILY PO Other Contomin SS ORAL 150 MG DAILY PO Tasmolin SS ORAL 6 MG DAILY PO 22-Feb-2006 08:31 AM Page: 480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depas C Risumic C Benzalin C Rohyonol C Levotomin C Hiberna C Date:07/25/02ISR Number: 3953999-1Report Type:Expedited (15-DaCompany Report #2002AP02297 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Exfoliative Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Hypersensitivity Health PO Hypotension Professional Epilim C Jaundice Other Liver Function Test Abnormal Date:07/25/02ISR Number: 3954903-2Report Type:Expedited (15-DaCompany Report #2002AP02329 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Seroquel PS ORAL 600 MG DAILY Intervention to Ketoacidosis Health PO Prevent Permanent Medication Error Professional Artane C Impairment/Damage Other Telesmin C Linton C Landsen C Rohypnol C Lodopin C Humulin C Novolin R C Date:07/26/02ISR Number: 3954712-4Report Type:Expedited (15-DaCompany Report #2002AP02298 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dry Mouth Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Dyskinesia Health PO Hypertonia Professional Seroquel SS Leukocytosis Other Aropax SS 80 MG DAILY Mydriasis Neuroleptic Malignant Syndrome Urinary Retention Date:07/26/02ISR Number: 3954713-6Report Type:Expedited (15-DaCompany Report #2002AP01898 Age:37 YR Gender:Female I/FU:I Outcome PT Life-Threatening Anxiety Coma Decreased Appetite Depressed Mood Hallucination, Auditory Intentional Overdose Persecutory Delusion 22-Feb-2006 08:31 AM Page: 481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicidal Ideation Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 200 MG DAILY Health PO Professional Seroquel SS ORAL 25 MG DAILY Other PO Abilit SS ORAL 100 MG DAILY PO Contomin C Akineton C Nelbon C Seniran C Date:07/29/02ISR Number: 3956456-1Report Type:Expedited (15-DaCompany Report #2002GB00910 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Increased Foreign Seroquel PS ORAL 150 MG BID PO Intervention to Drug Interaction Health Clozaril SS Prevent Permanent Palpitations Professional Oxybutynin SS 7.5 MG BID Impairment/Damage Other Amitriptyline SS ORAL 50 MG HS PO Frusemide C Perindopril C Carbamazepine C Paroxetine C Date:07/29/02ISR Number: 3956458-5Report Type:Expedited (15-DaCompany Report #2002GB01069 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Oedema Foreign Seroquel PS 25MG OR 50MG Hospitalization - Epilepsy Health NOCTE Initial or Prolonged Hostility Professional Hyponatraemia Other Inappropriate Antidiuretic Hormone Secretion Paranoia Date:07/30/02ISR Number: 3955116-0Report Type:Direct Company Report #CTU 173160 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cogwheel Rigidity Consumer Seroquel PS Astrazeneca Drooling Pharmaceuticals ORAL 25MG TWICE Musculoskeletal Stiffness DAILY ORAL Posture Abnormal Neurontin C Trazadone C Aricept C Plavix C 22-Feb-2006 08:31 AM Page: 482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/02ISR Number: 3956535-9Report Type:Expedited (15-DaCompany Report #2002UW08229 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Seroquel PS ORAL 200 MG QD PO Required Cholelithiasis Professional Seroquel SS ORAL 300 MG HS PO Intervention to Depression Serouel SS ORAL 100 MG HS PO Prevent Permanent Diabetic Complication Zoloft C Impairment/Damage Diabetic Ketoacidosis Buspar C Epistaxis Tequin C Fatigue Hepatic Steatosis Laboratory Test Abnormal Medication Error Mouth Haemorrhage Obesity Renal Failure Suicidal Ideation Date:07/30/02ISR Number: 3956537-2Report Type:Expedited (15-DaCompany Report #2002UW09798 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Loss Of Consciousness Professional PO Required Memory Impairment Paxil SS 20 MG DAILY Intervention to Haldol C Prevent Permanent Anti-Psychotic Impairment/Damage Medications C Date:07/31/02ISR Number: 3957043-1Report Type:Expedited (15-DaCompany Report #2002SE03596 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Neutropenia Health PO Professional Leponex "Novartis" C Other Date:07/31/02ISR Number: 3957044-3Report Type:Expedited (15-DaCompany Report #2002PK00693 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 400 MG DAILY Health PO Professional Glianimon C Other Rohypnol C Orfiril C Neurocil C Pirenzepin C Microgynon C Diazepam C Tavor C Fraxiparin C 22-Feb-2006 08:31 AM Page: 483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3956265-3Report Type:Direct Company Report #CTU 173332 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Glucose Increased Quetiapine 200 Mg Glycosylated Haemoglobin Zeneca PS Zeneca ORAL 400 MG BID Increased ORAL Risperidone 4 Mg Jansen SS Jansen ORAL 10 MG QHS ORAL Divalproex C Atenolol C Dyazide C Atorvastatin C Cardizem C Lisinopril C Date:08/01/02ISR Number: 3956266-5Report Type:Direct Company Report #CTU 173333 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Glucose Increased Olanzapine 20 Mg Glucose Urine Present Lilly PS Lilly OPHTHALMIC 20 MG QHS Glycosylated Haemoglobin ORAL Increased Quetiapine 1200 Mg Zeneca SS Zeneca ORAL 600 MG BID ORAL Atenolol C Dyazide C Date:08/01/02ISR Number: 3957598-7Report Type:Expedited (15-DaCompany Report #2002PK00718 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 900 MG DAILY Health PO Professional Tavor C Other Cipramil C Date:08/01/02ISR Number: 3958156-0Report Type:Expedited (15-DaCompany Report #2002AP01782 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Hypoaesthesia Health PO Muscle Rigidity Professional Seroquel SS ORAL 25 MG DAILY Paraesthesia Other PO Seroquel SS ORAL 50 MG DAILY PO Seroquel SS ORAL 75 MG DAILY PO Seroquel SS ORAL 125 MG DAILY PO Seroquel SS ORAL 75 MG DAILY PO Seroquel SS ORAL 100 MG DAILY PO Lendormin C Rohypnol C 22-Feb-2006 08:31 AM Page: 484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Limas C Miyarisan Bm C Reslin C Pursennid C Norvasc C Renivace C Ubretid C Date:08/01/02ISR Number: 3958161-4Report Type:Expedited (15-DaCompany Report #PHBS2002CA05923 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Carbamazepine PS 1400 MG/DAY Drug Level Decreased Literature Quetiapine Health (Quetiapine) SS 800 MG /DAY Professional Other Date:08/01/02ISR Number: 3958500-4Report Type:Expedited (15-DaCompany Report #2002AP02404 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Breast Abscess Foreign Seroquel PS Breast Necrosis Health Risperdal C Breast Pain Professional Other Date:08/01/02ISR Number: 3958501-6Report Type:Expedited (15-DaCompany Report #2002AP02399 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Seroquel PS ORAL 75 MG DAILY Drug Ineffective Study PO Tinea Capitis Health Seroquel SS ORAL 300 MG DAILY White Blood Cell Count Professional PO Decreased Other Itrizole SS ORAL 100 MG DAILY PO Risperdal C Tasmolin C Wypax C Date:08/01/02ISR Number: 3958502-8Report Type:Expedited (15-DaCompany Report #2002SE03588 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Hypersensitivity Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Drug Ineffective Health PO Granulocytopenia Professional Seroquel SS ORAL 100 MG TID PO Leukopenia Other Thrombocytopenia 22-Feb-2006 08:31 AM Page: 485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3958503-XReport Type:Expedited (15-DaCompany Report #2002SE04337 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Queseroquel PS ORAL 100 MG DAILY Health PO Professional Other Date:08/02/02ISR Number: 3961135-0Report Type:Periodic Company Report #NSADSS2002008366 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Unspecified)( Company Risperidone) PS ORAL ORAL Representative Seroquel (Seroquel) SS ORAL ORAL Date:08/05/02ISR Number: 3958446-1Report Type:Expedited (15-DaCompany Report #2002UW10361 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Seroquel PS Decreased Professional Ritalin C White Blood Cell Count Clonidine C Decreased Date:08/05/02ISR Number: 3958447-3Report Type:Expedited (15-DaCompany Report #2002UW08229 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Seroquel PS ORAL 200 MG QD PO Cholelithiasis Professional Seroquel SS ORAL 300 MG HS PO Diabetic Ketoacidosis Seroquel SS ORAL 100 MG HS PO Fatigue Zoloft C Hepatic Steatosis Buspar C Medication Error Tequin C Obesity Renal Failure Suicidal Ideation Toxicologic Test Abnormal Vomiting Date:08/06/02ISR Number: 3958532-6Report Type:Direct Company Report #CTU 173623 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Fluoxeine 40 Mg PS ORAL 40 MG Q DAY Depression PO Drug Ineffective Seroquel 25 Mg SS ORAL (25 MG)2 Impatience TABLETS EVERY 6H PRN ANXIETY 100 MGPO HS Klonapin 0.5 Mg SS ORAL 1 TABLET AIN AM, NOON N 2 TABLETS QHS Trazodone 100 Mg SS ORAL 1 TABLET PO 22-Feb-2006 08:31 AM Page: 486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report QHS Topamax 100 Mg SS ORAL 100 MG PO BID Depakote C Zyprexa C Effexor Xr C Phenargan C Xanax C Valium C Date:08/06/02ISR Number: 3959145-2Report Type:Expedited (15-DaCompany Report #2002002637 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Zeldox (Ziprasidone) PS ORAL 80 MG (BID), Hospitalization - Dysarthria Health ORAL Initial or Prolonged Dystonia Professional Seroquel (Quetiapine Opisthotonus Fumarate) SS ORAL 250 MG Respiratory Depression (DAILY), ORAL Tremor Date:08/06/02ISR Number: 3959235-4Report Type:Expedited (15-DaCompany Report #2002AP02135 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Seroquel PS ORAL 700 MG DAILY Sudden Death Health PO Professional Zyprexa C Other Serenace C Hirnamin C Contomin C Benzalin C Pyrethia C Artane C Barnetil C Tegretol C Date:08/06/02ISR Number: 3959236-6Report Type:Expedited (15-DaCompany Report #2002AP01726 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Withdrawal Syndrome Foreign Seroquel PS ORAL 400 MG DAILY Disability Granulocytopenia Health PO Required Haemoglobin Abnormal Professional Symmetrel C Intervention to Hepatic Function Abnormal Other Amoxan C Prevent Permanent Hypokalaemia Silece C Impairment/Damage Leukopenia Adalat L C Platelet Count Abnormal Magnesium Oxide C Alosenn C Date:08/06/02ISR Number: 3959253-6Report Type:Expedited (15-DaCompany Report #2002UW09406 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Professional Prevacid C Ibuprofen C Multivitamins C Metamucil C 22-Feb-2006 08:31 AM Page: 487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/02ISR Number: 3959559-0Report Type:Expedited (15-DaCompany Report #2002GB01708 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Foreign Seroquel PS DOSE Electrocardiogram Qt Health GRADUALLY Prolonged Professional INCREASED TO Other 50MG BID Dexamethasone C Madopar Cr C Madopar C Aspirin C Ismn C Metoprolol C Venlafaxine C Senna C Omeprazole C Date:08/07/02ISR Number: 3959804-1Report Type:Expedited (15-DaCompany Report #2002AP02412 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Disorder Foreign Seroquel PS ORAL 150 MG DAILY Initial or Prolonged Health PO Professional Seroquel SS ORAL 250 MG DAILY Other PO Seroquel SS ORAL 350 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 500 MG DAILY PO Contomin SS ORAL 25 MG DAILY PO Date:08/07/02ISR Number: 3960068-3Report Type:Expedited (15-DaCompany Report #2002UW09985 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Seroquel PS ORAL 200 MG DAILY Decreased Professional PO White Blood Cell Count Concerta C Decreased Tenex C Date:08/07/02ISR Number: 3960109-3Report Type:Expedited (15-DaCompany Report #2002UW10496 Age:94 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Seroquel PS ORAL 25 MG BID PO Professional Tamoxifen C Glyburide C Date:08/07/02ISR Number: 3960111-1Report Type:Expedited (15-DaCompany Report #2002UW10353 Age: Gender: I/FU:I Outcome PT Death Aspiration Coronary Artery Stenosis 22-Feb-2006 08:31 AM Page: 488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Other Seroquel PS ORAL 25 MG QID PO Seroquel SS ORAL 500 MG PO Date:08/07/02ISR Number: 3960503-0Report Type:Expedited (15-DaCompany Report #2002AP02329 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Schizophrenia Health PO Required Viral Infection Professional Artane C Intervention to Other Telesmin C Prevent Permanent Linton C Impairment/Damage Landsen C Rohypnol C Lodopin C Humulin R C Hirnamin C Novolin N C Date:08/07/02ISR Number: 3960508-XReport Type:Expedited (15-DaCompany Report #2002AP02304 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Seroquel PS ORAL 100 MG DAILY Hospitalization - Dysarthria Health PO Initial or Prolonged Hyperglycaemia Professional Seroquel SS ORAL 600 MG DAILY Required Hyperreflexia Other PO Intervention to Ketoacidosis Serenace C Prevent Permanent Pyrexia Akineton C Impairment/Damage Artane C Wintermin C Hirnamin C Vegetamin A C Date:08/07/02ISR Number: 3960510-8Report Type:Expedited (15-DaCompany Report #2002SE04421 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chest Pain Foreign Seroquel PS ORAL 50 MG DAILY Iron Deficiency Anaemia Health PO Weight Increased Professional Efexor Er C Other Date:08/07/02ISR Number: 3960538-8Report Type:Expedited (15-DaCompany Report #2002UW03320 Age:45 YR Gender:Female I/FU:I Outcome PT Required Abortion Induced Intervention to Complications Of Maternal Prevent Permanent Exposure To Therapeutic Impairment/Damage Drugs Intra-Uterine Death Maternal Drugs Affecting Foetus 22-Feb-2006 08:31 AM Page: 489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pregnancy Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS Zeneca ORAL 50 MG DAILY Professional PO Date:08/08/02ISR Number: 3959899-5Report Type:Direct Company Report #CTU 173808 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Haldol 10mg Iv Body Temperature 6-17-02(0400) PS INTRAVENOUS IV, 10MG X 1 Increased Seroquel 100am And Heart Rate Increased 200mg Hs SS ORAL PO, 100AM 2 Incontinence DAYS Lethargy Movement Disorder Date:08/08/02ISR Number: 3960586-8Report Type:Expedited (15-DaCompany Report #2002052511 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Literature Gabapentin Initial or Prolonged Blood Glucose Increased (Gabapentin) PS ORAL 54 GRAM Blood Pressure Decreased (ONCE), ORAL Coma Quetiapine SS Drug Level Above Bupropion C Therapeutic Clonazepam C Electrocardiogram Qt Clopidogrel C Corrected Interval Glibenclamide C Prolonged Losartan C Electrocardiogram St Metoprolol C Segment Abnormal Mydriasis Overdose Pco2 Decreased Pyrexia Vomiting White Blood Cell Count Increased Date:08/08/02ISR Number: 3960598-4Report Type:Expedited (15-DaCompany Report #2002UW10534 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel PS ORAL 400 MG QD PO Initial or Prolonged Drug Screen False Professional Positive Date:08/08/02ISR Number: 3961136-2Report Type:Expedited (15-DaCompany Report #2002AP02297 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Jaundice Health PO Liver Function Test Professional Epilim C Abnormal Other 22-Feb-2006 08:31 AM Page: 490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/02ISR Number: 3961787-5Report Type:Expedited (15-DaCompany Report #2002GB01741 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ketoacidosis Foreign Seroquel PS Hospitalization - Health Seroquel SS ORAL 800 MG DAILY Initial or Prolonged Professional PO Other Adalat C Neotigason C Trazodone C Atorvastatin C Date:08/09/02ISR Number: 3961789-9Report Type:Expedited (15-DaCompany Report #2002AP02399 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Disease Recurrence Foreign Seroquel PS ORAL 75 MG DAILY Tinea Capitis Study PO White Blood Cell Count Health Seroquel SS ORAL 300 MG DAILY Decreased Professional PO Other Itrizole SS ORAL 100 MG DAILY PO Risperdal C Tasmolin C Wypax C Date:08/12/02ISR Number: 3961432-9Report Type:Expedited (15-DaCompany Report #2002AP01726 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS ORAL 400 MG DAILY Disability Increased Health PO Required Aspartate Professional Symmetrel C Intervention to Aminotransferase Other Amoxan C Prevent Permanent Increased Silece C Impairment/Damage Depressed Level Of Adalat L C Consciousness Magnesium Oxide C Drug Withdrawal Syndrome Alosenn C Granulocytopenia Haemoglobin Decreased Hypokalaemia Leukopenia Muscle Rigidity Platelet Count Decreased Date:08/12/02ISR Number: 3961985-0Report Type:Expedited (15-DaCompany Report #2002AP02500 Age:61 YR Gender:Female I/FU:I Outcome PT Life-Threatening Aspiration Hospitalization - Coma Initial or Prolonged Drug Level Above Therapeutic Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram St Segment Abnormal Hypotension 22-Feb-2006 08:31 AM Page: 491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Pyrexia Respiratory Depression Report Source Product Role Manufacturer Route Dose Duration Vomiting Literature Quetiapine PS USUAL DAILY White Blood Cell Count Health DOSE 200 MG Increased Professional Gabapentin SS ORAL 54 G ONCE PO Bupropion C Klonopin C Clopidogrel C Glyburide C Losartan C Metoprolol C Date:08/12/02ISR Number: 3961986-2Report Type:Expedited (15-DaCompany Report #2002UW09532 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Seroquel PS ORAL 300 MG DAILY Cardio-Respiratory Arrest Professional PO Convulsion Seroquel SS Electromechanical Seroquel SS Dissociation Seroquel SS ORAL 100 MG PO Risperdal C Celexa C Date:08/12/02ISR Number: 3961987-4Report Type:Expedited (15-DaCompany Report #2002UW10496 Age:94 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Seroquel PS ORAL 25 MG BID PO Professional Glyburide C Nolvadex "Astra Zeneca" C Date:08/13/02ISR Number: 3961539-6Report Type:Direct Company Report #CTU 173993 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Oedema Seroquel 25mg Sig 1t Disability Cardiac Disorder 10 Tid Then 200mg Required Cerebrovascular Accident Bid -Prn -Ici Intervention to Pharmaceual PS Ici Pharmaceual 25MG SIG 1T Prevent Permanent 10 TID THEN Impairment/Damage 200MG BID -PRN 2 MON Date:08/13/02ISR Number: 3962828-1Report Type:Expedited (15-DaCompany Report #2002AP01772 Age:51 YR Gender:Male I/FU:F Outcome PT Death Anaemia Hospitalization - Blood Triglycerides Initial or Prolonged Increased Coma Condition Aggravated Dehydration Depressed Level Of 22-Feb-2006 08:31 AM Page: 492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Consciousness Diabetic Ketoacidosis Hyperkalaemia Hypokalaemia Report Source Product Role Manufacturer Route Dose Duration Hyponatraemia Foreign Seroquel PS ORAL 200 MG DAILY Insomnia Health PO Shock Professional Seroquel SS ORAL 300 MG DAILY Weight Decreased Other PO Risperdal SS ORAL 2 MG DAILY PO Risperdal SS ORAL 3 MG DAILY PO Risperdal SS ORAL 4 MG DAILY PO Meilax C Benzalin C Date:08/13/02ISR Number: 3963091-8Report Type:Expedited (15-DaCompany Report #2002AP02504 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Seroquel PS ORAL 50 MG DAILY Platelet Count Decreased Other PO White Blood Cell Count Seroquel SS ORAL 250 MG DAILY Decreased PO Risperdal C Date:08/14/02ISR Number: 3962202-8Report Type:Direct Company Report #CTU 174106 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Seroquel PS Initial or Prolonged Disorientation Celexa C Hallucination, Auditory Clonazepam C Mental Status Changes Xanax C Compazine C Oxycontin C Klonipin C Seroquel C Date:08/14/02ISR Number: 3962206-5Report Type:Direct Company Report #CTU 174108 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Seroquel PS Initial or Prolonged Dysarthria Neurontin C Oral Intake Reduced Seroquel C Vitamin E And C C Ambien C Glucophage C Actos C Gabitril C Gabitril C Date:08/14/02ISR Number: 3963281-4Report Type:Expedited (15-DaCompany Report #2002AP02482 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Death Fall Foreign Haemorrhage Intracranial Health Sudden Death Professional 22-Feb-2006 08:31 AM Page: 493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 175 MG DAILY PO Serenace C Date:08/14/02ISR Number: 3963294-2Report Type:Expedited (15-DaCompany Report #2002AP02135 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Seroquel PS ORAL 700 MG DAILY Delusion Health PO Hallucination Professional Zyprexa SS ORAL 10 MG DAILY Mydriasis Other PO Serenace SS ORAL 15 MG DAILY PO Hirnamin C Contomin C Benzalin C Pyrethia C Artane C Barnetil C Tegretol C Date:08/15/02ISR Number: 3962491-XReport Type:Direct Company Report #CTU 174190 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Systolic Haldol 10 Mg Iv Increased 6-17-02 (0040) PS INTRAVENOUS IV, 10 MG X 1 Body Temperature Seroquel 100 Am And Increased 200 Mg Hs SS ORAL PO, 100 AM , Heart Rate Increased 200 MG HS Incontinence Lethargy Date:08/15/02ISR Number: 3962560-4Report Type:Direct Company Report #CTU 174196 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Quetiapine PS Initial or Prolonged Phosphokinase Increased Haloperidal SS Olanzapine SS Date:08/15/02ISR Number: 3962941-9Report Type:Direct Company Report #CTU 174238 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Seroquel 50 Mg Required Extrapyramidal Disorder Astazenaca PS Astazeneca ORAL 50MG ONCE PER Intervention to ORAL Prevent Permanent Zoloft 50mg Pfizer SS Pfizer ORAL 50MG ONCE PER Impairment/Damage ORAL 22-Feb-2006 08:31 AM Page: 494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/02ISR Number: 3962999-7Report Type:Direct Company Report #CTU 174355 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Haloperidol PS INTRAVENOUS Initial or Prolonged Syndrome BOLUS 1MG Q4HPRN IV BOLUS Seroquel 25mg SS ORAL 25MG BID AND PRN ORAL Wellbutrin C Date:08/16/02ISR Number: 3964265-2Report Type:Expedited (15-DaCompany Report #02P-163-0197539-00 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Health Depakote Er Required Leukopenia Professional (Divalproex Sodium) Intervention to Other (Divalproex Sodium) PS ORAL 500 MG, 2 IN Prevent Permanent 1 D, PER ORAL Impairment/Damage Clozapine SS ORAL 25 MG, 1 IN 1 D, PER ORAL Quetiapine SS ORAL 200 MG, 1 IN 1 D, PER ORAL Senna Fruit C Macrogol C Date:08/19/02ISR Number: 3963520-XReport Type:Direct Company Report #CTU 174443 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Upper Quetiapine PS 1 DOSE Hospitalization - Blood Pressure Systolic Ranitidine SS Initial or Prolonged Increased ... SS Required Chest Pain Clozapine SS Intervention to Dizziness Valproic Acid SS Prevent Permanent Electrocardiogram St Docusate SS 1 DOSE Impairment/Damage Segment Depression Electrocardiogram T Wave Abnormal Fall Head Injury Hyperhidrosis Myocardial Ischaemia Overdose Sinus Tachycardia Vomiting Date:08/19/02ISR Number: 3964140-3Report Type:Direct Company Report #CTU 174520 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Ketoacidosis Seroquel 100mg Astra Hospitalization - Zeneca PS Astra Zeneca ORAL 400MG QAM Initial or Prolonged ORAL, 500MG Required HS ORAL Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/02ISR Number: 3964161-0Report Type:Direct Company Report #CTU 174533 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Back Pain Seroquel 25mg Astra Convulsion Zeneca PS Astra Zeneca 1/2 25MG 1HR Difficulty In Walking BEFORE Groin Pain BEDTIME Mobility Decreased Quetiapine Fumarate SS 1/4 25MG 1HR Pain In Extremity BEFORE BEDTIME Date:08/19/02ISR Number: 3964178-6Report Type:Direct Company Report #CTU 174514 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stomatitis Quetiapine 200mg Drug Study PS ORAL 200MG BID ORAL Date:08/20/02ISR Number: 3964560-7Report Type:Direct Company Report #CTU 174640 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Seroquel 25mg Astra Trismus Zeneca PS Astra Zeneca Reoia C Effexor C Neurontin C Ativan C Allegra C Zyprexa C Advair C Albuterol Mda C Singulair C Imtrex C Zyprexa C Dexamthasone C Tums C Motrin C Prevaril C Geodon C Navave C Cogentin C Benadryl C Date:08/20/02ISR Number: 3965314-8Report Type:Expedited (15-DaCompany Report #2002AP02482 Age:20 YR Gender:Female I/FU:F Outcome PT Death Cardiac Arrest Drug Ineffective Erythema Excoriation Faecal Incontinence Fall Gait Disturbance Haematoma Haemorrhage Intracranial 22-Feb-2006 08:31 AM Page: 496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Sounds Abnormal Insomnia Nausea Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Foreign Seroquel PS ORAL 175 MG DAILY Respiratory Arrest Health PO Vomiting Professional Serenace C Other Lodopin C Akineton C Tegretol C Levotomin C Halcion C Vegetamin C Doral C Date:08/20/02ISR Number: 3965803-6Report Type:Expedited (15-DaCompany Report #2002AP02542 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Seroquel PS ORAL 200 MG DAILY Hypothermia Health PO Professional Pursennid C Other Akineton C Depas C Efotinon C Landsen C Risumic C Tegretol C Evamyl C Date:08/20/02ISR Number: 3965804-8Report Type:Expedited (15-DaCompany Report #2002AP02134 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Seroquel PS ORAL 75 MG DAILY Rhabdomyolysis Health PO Professional Seroquel SS ORAL 200 MG DAILY Other PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 50 MG DAILY PO Linton C Horizon C Date:08/20/02ISR Number: 3965807-3Report Type:Expedited (15-DaCompany Report #2002AP02291 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel PS ORAL 700 MG DAILY Initial or Prolonged Pyrexia Health PO Rash Professional Teril SS ORAL 600 MG DAILY Other PO Clopixol (Decanoate) C Cogentin C 22-Feb-2006 08:31 AM Page: 497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/02ISR Number: 3965919-4Report Type:Expedited (15-DaCompany Report #2002AP01782 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Seroquel PS ORAL 25 MG DAILY; Initial or Prolonged Hypoaesthesia Health PO Muscle Rigidity Professional Seroquel SS ORAL 25 MG DAILY; Paraesthesia Other PO Seroquel SS ORAL 50 MG DAILY; PO Seroquel SS ORAL 75 MG DAILY; PO Seroquel SS ORAL 125 MG DAILY; PO Seroquel SS ORAL 75 MG DAILY; PO Seroquel SS ORAL 100 MG DAILY; PO Norvasc SS ORAL 5 MG DAILY; PO Renivace SS ORAL 5 MG DAILY; PO Lendormin C Rohypnol C Limas C Miyarisan Bm C Reslin C Pursennid C Ubretid C Date:08/20/02ISR Number: 3965966-2Report Type:Expedited (15-DaCompany Report #2002UW05916 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Seroquel PS ORAL 200 MG TID PO Hospitalization - Adrenal Disorder Professional Seroquel SS ORAL 400 MG DAILY Initial or Prolonged Atelectasis PO Required Blood Pressure Increased Celexa C Intervention to Brain Oedema Ditropan C Prevent Permanent Cardiac Disorder Ddavp C Impairment/Damage Cardiomegaly Albuterol C Cerebral Atrophy Coronary Ostial Stenosis Diabetes Mellitus Non-Insulin-Dependent Diabetic Hyperosmolar Coma Encephalopathy Fibrosis Hepatic Congestion Hepatomegaly Infection Leukocytosis Loss Of Consciousness Mental Status Changes Nausea Pancreatic Disorder Pharyngolaryngeal Pain Pulmonary Congestion Renal Failure Acute Vomiting 22-Feb-2006 08:31 AM Page: 498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/21/02ISR Number: 3964940-XReport Type:Direct Company Report #CTU 174688 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Olanzepine 10 PS ORAL 5 BID ORAL Initial or Prolonged Blood Pressure Abnormal Seroquel 50 SS ORAL 50 QD PRN Chills ORAL Cogwheel Rigidity Trazadone C Flushing Synthroid C Heart Rate Abnormal Effexor Xr C Hyperhidrosis Ativan C Joint Stiffness Cogentin C Mental Status Changes Colace C Palpitations Tylenol C Tachycardia Metronidazole C Tremor Erythromycin C Nizoral C Date:08/22/02ISR Number: 3967298-5Report Type:Expedited (15-DaCompany Report #2002AP02582 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Quetiapine PS 300 MG DAILY Initial or Prolonged Meige'S Syndrome Literature Haloperidol C Required Ophthalmoplegia Health Chlorpromazine C Intervention to Professional Trihexyphenidyl C Prevent Permanent Other Impairment/Damage Date:08/23/02ISR Number: 3965967-4Report Type:Direct Company Report #CTU 174917 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Seroquel 25mg PS ORAL 25MG QD ORAL Hospitalization - Grimacing Flonase C Initial or Prolonged Muscle Rigidity Apap C Required Tums C Intervention to Mom C Prevent Permanent Dulcolax C Impairment/Damage Pantanol C Enalapril C Sinemet C Paxil C Vit C C Vit E C Bactrim Ds C Date:08/23/02ISR Number: 3966242-4Report Type:Direct Company Report #CTU 174876 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Quetiapine PS ORAL SEE IMAGE Initial or Prolonged Blood Creatine Atenolol C Phosphokinase Increased Folic Acid C Chest Pain Thiamine C Confusional State Vasocon A C Neuroleptic Malignant Librium C Syndrome Lorazepam C Speech Disorder Lovastatin C 22-Feb-2006 08:31 AM Page: 499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mvi C Ziprasidone C Date:08/23/02ISR Number: 3966766-XReport Type:Expedited (15-DaCompany Report #2002AP02582 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Quetiapine PS 300 MG DAILY Initial or Prolonged Meige'S Syndrome Literature Haloperidol C Required Health Chlorpromazine C Intervention to Professional Trihexyphenidyl C Prevent Permanent Other Impairment/Damage Date:08/23/02ISR Number: 3967044-5Report Type:Expedited (15-DaCompany Report #2002GB01653 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cogwheel Rigidity Foreign Seroquel PS ORAL 50 MG DAILY Intervention to Joint Stiffness Health PO Prevent Permanent Somnolence Professional Sertraline C Impairment/Damage Other Sodium Valproate C Date:08/23/02ISR Number: 3967046-9Report Type:Expedited (15-DaCompany Report #2002GB01951 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS ORAL 750 MG DAILY Drug Level Above Health PO Therapeutic Professional Clopixol Sudden Death Other (Hydrochloride) C Haloperidol C Date:08/23/02ISR Number: 3967205-5Report Type:Expedited (15-DaCompany Report #2002AP02399 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS ORAL 75 MG DAILY Intervention to Drug Ineffective Study PO Prevent Permanent Tinea Capitis Health Seroquel SS ORAL 300 MG DAILY Impairment/Damage White Blood Cell Count Professional PO Decreased Other Itrizole SS ORAL 100 MG DAILY PO Risperdal C Tasmolin C Wypax C Date:08/23/02ISR Number: 3967505-9Report Type:Expedited (15-DaCompany Report #2002UW09532 Age:20 YR Gender:Male I/FU:F Outcome PT Death Arrhythmia Blood Glucose Abnormal Cardio-Respiratory Arrest Conduction Disorder Convulsion 22-Feb-2006 08:31 AM Page: 500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Death Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS ORAL 300 MG HS PO Professional Seroquel SS ORAL 200 MG HS PO Seroquel SS ORAL 100 MG HS PO Risperdal C Celexa C Date:08/26/02ISR Number: 3967954-9Report Type:Expedited (15-DaCompany Report #2002UW11235 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Urine Present Consumer Seroquel PS 12.5 - 25 MG Hospitalization - Catatonia DAILY 15 DAY Initial or Prolonged Heat Stroke Aceon C Required Incoherent Potassium C Intervention to Pyrexia Norvasc C Prevent Permanent Renal Atrophy Lipitor C Impairment/Damage Somnolence Toprol Xl C Daypro C Sinemet C Eldepryl C Parlodel C Exelon C Date:08/27/02ISR Number: 3968136-7Report Type:Expedited (15-DaCompany Report #2002GB01961 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Foreign Seroquel PS ORAL 100 MG BID PO Intervention to Complications Of Maternal Health Clomipramine C Prevent Permanent Exposure To Therapeutic Professional Impairment/Damage Drugs Other Nervous System Disorder Tremor Date:08/27/02ISR Number: 3968138-0Report Type:Expedited (15-DaCompany Report #2002AP02304 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Seroquel PS ORAL 100 MG DAILY Hospitalization - Depressed Level Of Health PO Initial or Prolonged Consciousness Professional Seroquel SS ORAL 600 MG DAILY Required Dysarthria Other PO Intervention to Hyperglycaemia Serenace C Prevent Permanent Ketoacidosis Akineton C Impairment/Damage Polydipsia Artane C Weight Increased Wintermin C Hirnamin C Vegetamin A C 22-Feb-2006 08:31 AM Page: 501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/02ISR Number: 3969184-3Report Type:Expedited (15-DaCompany Report #2002UW11316 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Seroquel PS ORAL 25 MG BID PO Drowning Professional Celexa C Ambien C Zyprexa C Trazodone C Date:08/28/02ISR Number: 3969659-7Report Type:Expedited (15-DaCompany Report #2002SE04733 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Seroquel PS Hospitalization - Coma Health Akineton SS 0.5 DF TID Initial or Prolonged Convulsion Professional Insulin C Hypoglycaemia Other Leukocytosis Loss Of Consciousness Pyrexia Date:08/30/02ISR Number: 3969489-6Report Type:Expedited (15-DaCompany Report #2002UW09570 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Health Seroquel PS 6-10 TABLETS Intervention to Electrocardiogram Qt Professional Depakote C Prevent Permanent Prolonged Zyprexa C Impairment/Damage Medication Error Wellbutrin C Date:08/30/02ISR Number: 3969491-4Report Type:Expedited (15-DaCompany Report #2002UW09601 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Headache Health Seroquel PS ORAL 400 MG BID PO Intervention to Medication Error Professional Haldol Decanoate C Prevent Permanent Sedation Prozac C Impairment/Damage Cogentin C Date:08/30/02ISR Number: 3969493-8Report Type:Expedited (15-DaCompany Report #2002UW11582 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Other Seroquel PS ORAL 100 MG QD PO Initial or Prolonged Clozapine SS 25 TO 50 MG DAILY Depakote C 500 MG BID Date:08/30/02ISR Number: 3969682-2Report Type:Direct Company Report #CTU 175362 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Quetiapine 100 Mg Non-Insulin-Dependent Astrazeneca PS Astrazeneca ORAL 100 MG QAM Hyperglycaemia ORAL 22-Feb-2006 08:31 AM Page: 502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/02ISR Number: 3969813-4Report Type:Direct Company Report #CTU 175410 Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Quetiapine PS Astra-Zeneca ORAL 600MG PO QHS Overdose (POSSIBLE OD Respiratory Depression OF 10,800MG) Buspirone C Haloperidol Decanoate C Sertraline C Felodipine C Date:08/30/02ISR Number: 3969824-9Report Type:Expedited (15-DaCompany Report #2002SE04337 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 100 MG DAILY Neutropenia Health ORAL Professional Other Date:08/30/02ISR Number: 3970262-3Report Type:Expedited (15-DaCompany Report #2002UW11312 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Retinal Tear Consumer Seroquel PS Intervention to Prevent Permanent Impairment/Damage Date:08/30/02ISR Number: 3970269-6Report Type:Expedited (15-DaCompany Report #2002AP02482 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS ORAL 175 MG DAILY Drug Ineffective Health PO Excoriation Professional Serenace C Faecal Incontinence Other Lodopin C Fall Akineton C Haematoma Tegretol C Haemorrhage Intracranial Levotomin C Head Injury Halcion C Injury Vegetamin A C Insomnia Doral C Nausea Psychomotor Hyperactivity Pulse Pressure Decreased Respiratory Arrest Restlessness Vomiting Date:08/30/02ISR Number: 3970471-3Report Type:Expedited (15-DaCompany Report #HQ2838717JUN2002 Age:40 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anticholinergic Syndrome Initial or Prolonged Anuria 22-Feb-2006 08:31 AM Page: 503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Urine Present Drug Level Below Therapeutic Report Source Product Role Manufacturer Route Dose Duration Oedema Health Sonata (Zaleplon, Pallor Professional Capsule) PS ORAL 10 MG 1X PER Rash 1 DAY, ORAL Celebrex (Celecoxib) SS UNKNOWN Celexa (Citalopram Hydrochloride, Tablet) SS ORAL 20 MG 1X PER 1 DAY, ORAL Depakote (Valproate Semisodium, ) SS UNKNOWN 1000 MG 1X PER 1 DAY, UNKNOWN Seroquel (Quetiapine, ) SS UNKNOWN 300 MG 1X PER 1 DAY, UNKNOWN Meclizine (Meclozine) C Zantac (Ranitidine Hydrochloride) C Estradiol (Estradiol) C Lamictal (Lamotrigine) C Xanax (Alprazolam) C Darvocet-N (Dextropropoxyphene/ Paracetamol) C Doxycycline (Doxycycline) C Neurontin (Gabapentin) C Allegra-D (Fexofenadine Hydrochloride/Pseudo ephedrine Hydrochloride) C Date:09/04/02ISR Number: 3971438-1Report Type:Expedited (15-DaCompany Report #2002AP02699 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Shock Foreign Seroquel PS Health Tolopelon C Professional Akineton C Other Eurodin C Benzalin C Date:09/04/02ISR Number: 3971538-6Report Type:Expedited (15-DaCompany Report #NSADSS2001039330 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Topamax (Topiramate) PS ORAL ORAL Drug Toxicity Professional Risperdal (2 Mg Myocardial Infarction Tablet) Risperidone) SS ORAL 2 MG, 2 IN DAILY, ORAL 22-Feb-2006 08:31 AM Page: 504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Citalopram SS Propoxyphene (Dextropropoxyphene) SS Quetiapine (Quetiapine) SS Triazolam (Triazolam) SS Diphenhydramine C Acetaminophen (Paracetamol) C Bupropion (Amfebutamone) C Ultram (50 Mg Tablet) (Tramadol Hydrochloride) C Nizoral (Ketoconazole) C Seroquel C Remeron (Mirtazapine) C Multivitamins C Relafen (Nabumetone) C Skelaxin (Metaxalone) C Guaibid (Guaifenesin) C Advair (Fluticasone) C Albuterol (Salbutamol) C Desonide C Depakote (Valproate Semisodium) C Prevacid (Lansoprazole) C Date:09/05/02ISR Number: 3972571-0Report Type:Expedited (15-DaCompany Report #HQ3961327AUG2002 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Inderal (Propranolol Hospitalization - Coma Professional Hydrochloride, Initial or Prolonged Heart Rate Increased Tablet) PS ORAL 30 TABLET 1X Hypotension PER 1 DAY, Hypothermia ORAL Overdose Seroquel Respiratory Rate (Quetiapine,) SS ORAL 60 TABLET 1X Decreased PER 1 DAY, ORAL Marijuana (Cannabis) C Nsaid'S (Nsaid') C Date:09/05/02ISR Number: 3972986-0Report Type:Expedited (15-DaCompany Report #2002SE04823 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Overdose Foreign Seroquel PS Loss Of Consciousness Health Citalopram SS Somnolence Professional Suicide Attempt 22-Feb-2006 08:31 AM Page: 505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/05/02ISR Number: 3972989-6Report Type:Expedited (15-DaCompany Report #2002AP02504 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Seroquel PS ORAL 50 MG DAILY Platelet Count Decreased Health PO White Blood Cell Count Professional Seroquel SS ORAL 250 MG DAILY Decreased PO Risperdal C Forit C Date:09/05/02ISR Number: 3973116-1Report Type:Expedited (15-DaCompany Report #A04200200129 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Stilnox (Zolpidem) Initial or Prolonged Drug Withdrawal Syndrome Professional Tablet, 10 Mg PS TRANSPLACENTAL 5 MG OD, Neonatal TRANSPLACENTA Dyspnoea L 3 MON Exostosis Seroquel "Zeneca" Hypotonia Neonatal (Quetiapine Intercostal Retraction Fumarate) - Tablet SS TRANSPLACENTAL 400 MG Maternal Drugs Affecting Foetus Neonatal Infection Neonatal Respiratory Acidosis Neonatal Respiratory Depression Petechiae Premature Baby Transient Tachypnoea Of The Newborn Date:09/06/02ISR Number: 3972082-2Report Type:Direct Company Report #USP 55107 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Seroquel (Quetiapine Feeling Abnormal Fumarate) PS Astra Zeneca Medication Error Serzone( Nefazodone Sedation Hydrochloride) SS Bristol-Myers Squibb Somnolence Date:09/06/02ISR Number: 3972387-5Report Type:Direct Company Report #USP 54962 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Serzone (Nefazodone Anger Hydrochloride) PS Bristol-Myers Squibb Irritability Seroquel (Quetiapine Medication Error Fumarate) SS Astra Zeneca Thinking Abnormal 22-Feb-2006 08:31 AM Page: 506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/02ISR Number: 3972443-1Report Type:Direct Company Report #USP 54965 Age:60 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Serzone PS Bristol-Myers Squibb Seroquel SS Astra Zeneca Date:09/06/02ISR Number: 3972476-5Report Type:Direct Company Report #USP 55152 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel (Quetiapine Fumarate) PS Astrazeneca TABLET, 100 MG .UNIT DOSE CONTAINER Serzone (Nefazodone Hydrochloride) SS Bristol-Myers Squib TABLET, 100 MG , UNIT DOSE CONTAINER Date:09/06/02ISR Number: 3972492-3Report Type:Direct Company Report #USP 55146 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel (Quetiapine Fumarate) PS Astra Zeneca Serzone (Nefazodone Hydrochloride) SS Bristol-Myers Squibb Date:09/06/02ISR Number: 3972521-7Report Type:Direct Company Report #USP 54909 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Seroquel PS Astra Zeneca Initial or Prolonged Serzone SS Bristol-Myers Squibb Date:09/06/02ISR Number: 3972522-9Report Type:Direct Company Report #USP 54908 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Serzone (Nefazodone Hydrochloride) PS Bristol-Myers Squibb Seroquel (Quetiapine Fumarate) SS Astra Zeneca Date:09/06/02ISR Number: 3972523-0Report Type:Direct Company Report #USP 54907 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Serzone PS Bristol-Myers Squibb Seroquel SS Astra Zeneca 22-Feb-2006 08:31 AM Page: 507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/02ISR Number: 3972838-6Report Type:Expedited (15-DaCompany Report #2002UW11716 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Thrombocytopenia Professional PO Seroquel SS ORAL 1100 MG DAILY PO Date:09/06/02ISR Number: 3972928-8Report Type:Expedited (15-DaCompany Report #2002SE04421 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Iron Deficiency Anaemia Foreign Seroquel PS ORAL 50 MG DAILY Health PO Professional Efexor Er C Other Date:09/06/02ISR Number: 3972939-2Report Type:Expedited (15-DaCompany Report #2002AP02708 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 400 MG DAILY Health PO Professional Seroquel SS ORAL 300 MG DAILY Other PO Date:09/06/02ISR Number: 3972940-9Report Type:Expedited (15-DaCompany Report #2002AP02697 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Foreign Seroquel PS ORAL 25 MG DAILY Hospitalization - Status Epilepticus Health PO Initial or Prolonged Professional Brovarin C Required Other Tetramide C Intervention to Prevent Permanent Impairment/Damage Date:09/06/02ISR Number: 3973432-3Report Type:Expedited (15-DaCompany Report #2002AP02542 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Hypotension Health PO Initial or Prolonged Hypothermia Professional Zyprexa SS ORAL 5 MG DAILY PO Other Pursennid C Akineton C Depas C Efotinon C Landsen C Risumic C Tegretol C Magnesium Oxide C Pantosin C Evamyl C Doral C 22-Feb-2006 08:31 AM Page: 508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/02ISR Number: 3973242-7Report Type:Direct Company Report #USP 55037 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Serzone (Nefazodone Hydrochloride) PS Bristol-Myers Squibb Seroquel (Quetiapine Fumarate) SS Astra Zeneca Date:09/09/02ISR Number: 3973415-3Report Type:Direct Company Report #USP 55114 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Serzone PS Bristol-Myers Squibb TABLET 200 MG Seroquel SS Astra Zeneca TABLET 200 MG Date:09/10/02ISR Number: 3973601-2Report Type:Expedited (15-DaCompany Report #2002UW11999 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Foreign Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Convulsion Health Acetaminophen C Pyrexia Professional Cipro C Other Clindamycin C Kcl-Zyma C Diazepam C Divaproex C Phenytoin C Famotidine C Haloperidol C Risperidone C Date:09/10/02ISR Number: 3974010-2Report Type:Expedited (15-DaCompany Report #2002UW11792 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Consumer Seroquel PS ORAL 200 MG PO Initial or Prolonged Dry Mouth Seroquel SS ORAL 300 MG PO Required Tardive Dyskinesia Seroquel SS ORAL 400 MG PO Intervention to Seroquel SS ORAL 600 MG PO Prevent Permanent Seroquel SS ORAL 400 MG PO Impairment/Damage Seroquel SS ORAL 60 MG PO Seroquel SS ORAL 400 MG PO Seroquel SS ORAL 200 MG PO Prolixin C Lithobid C Cogentin C Vitamin E C Vitamin B6 C Remeron C Klononpin C Lorazepam C Trazodone C 22-Feb-2006 08:31 AM Page: 509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/02ISR Number: 3974270-8Report Type:Expedited (15-DaCompany Report #2002AP02620 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspartate Foreign Seroquel PS ORAL 600 MG DAILY Hospitalization - Aminotransferase Health PO Initial or Prolonged Increased Professional Akineton SS ORAL 3 MG DAILY PO Required Blood Creatine Other Silece SS ORAL 2 MG DAILY PO Intervention to Phosphokinase Increased Levotomin SS ORAL 5 MG DAILY PO Prevent Permanent Coma Impairment/Damage Somnolence Suicide Attempt Date:09/11/02ISR Number: 3974297-6Report Type:Expedited (15-DaCompany Report #2002AP02709 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ileus Paralytic Foreign Seroquel PS ORAL 75 MG DAILY Intervention to Study PO Prevent Permanent Health Seroquel SS ORAL 200 MG DAILY Impairment/Damage Professional PO Other Seroquel SS ORAL 300 MG DAILY PO Lasix C Gaster C Date:09/11/02ISR Number: 3974475-6Report Type:Expedited (15-DaCompany Report #PHBS2002CA05923 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Foreign Tegretol Other Drug Level Decreased Literature (Carbamazepine) PS ORAL 1400 MG/DAY, Health ORAL Professional Quetiapine Other (Quetiapine) SS 800 MG/DAY Date:09/11/02ISR Number: 3974611-1Report Type:Expedited (15-DaCompany Report #2002UW12005 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Seroquel PS ORAL 25 MG PO Initial or Prolonged Flushing Professional Risperdal C Headache Protonix "Pharmacia" C Hyperhidrosis Paxil C Date:09/12/02ISR Number: 3975122-XReport Type:Expedited (15-DaCompany Report #2002AP02542 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Blood Pressure Decreased Health PO Initial or Prolonged Condition Aggravated Professional Zyprexa SS ORAL 5 MG DAILY PO Drug Interaction Other Pursennid C Gait Disturbance Akineton C Hypothermia Depas C Efotinon C Landsen C Risumic C 22-Feb-2006 08:31 AM Page: 510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tegretol C Magnesium Oxide C Pantosin C Evamyl C Doral C Date:09/12/02ISR Number: 3975164-4Report Type:Expedited (15-DaCompany Report #2002AP02482 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Seroquel PS ORAL 175 MG DAILY Required Erythema Health PO Intervention to Faecal Incontinence Professional Serenace C Prevent Permanent Fall Other Lodopin C Impairment/Damage Haemorrhage Intracranial Akineton C Head Injury Tegretol C Myocardial Infarction Levotomin C Nausea Halcion C Respiratory Arrest Vegetamin A C Restlessness Doral C Vomiting Date:09/12/02ISR Number: 3999203-XReport Type:Periodic Company Report #001-0719-M0200060 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myopathy Health Lopid (Gemfibrozil) PS 1200 MG Professional (BID), Simvastatin (Simvastatin) SS 20 MG (DAILY) Quetiapine SS 300 MG (BID) Date:09/13/02ISR Number: 3975777-XReport Type:Expedited (15-DaCompany Report #2002UW12085 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Seroquel PS Initial or Prolonged Health Professional Other Date:09/13/02ISR Number: 3975794-XReport Type:Expedited (15-DaCompany Report #2002AP02763 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS Health Professional Other Date:09/16/02ISR Number: 3976678-3Report Type:Expedited (15-DaCompany Report #2002SE04859 Age:34 YR Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Foreign Seroquel PS ORAL 300 MG DAILY Loss Of Consciousness Health PO Professional Seroquel SS ORAL 200 MG DAILY Other PO Date:09/17/02ISR Number: 3978424-6Report Type:Expedited (15-DaCompany Report #2002AP02699 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Seroquel PS ORAL 25 MG DAILY Body Temperature Health PO Decreased Professional Tolopelon C Coma Other Akineton C Cyanosis Pyrethia C Depressed Level Of Eurodin C Consciousness Benzalin C Heart Rate Increased Serenace C Pallor Dantrolene Sodium C Peripheral Coldness Respiratory Rate Increased Date:09/17/02ISR Number: 3979030-XReport Type:Expedited (15-DaCompany Report #2002SE04943 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 200 MG DAILY Health PO Professional Prozac C Other Trankimazin C Plenur C Risperidone C Date:09/17/02ISR Number: 3979036-0Report Type:Expedited (15-DaCompany Report #2002SE04898 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 200 MG BID PO Intentional Overdose Health Disipal SS Professional Haldol Decanoate C Other Date:09/17/02ISR Number: 3980089-4Report Type:Expedited (15-DaCompany Report #2002UW12169 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS ORAL 125 MG BID PO Intervention to Study Serax C Prevent Permanent Health Impairment/Damage Professional Other 22-Feb-2006 08:31 AM Page: 512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/02ISR Number: 3980090-0Report Type:Expedited (15-DaCompany Report #2002GB02088 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Quetiapine PS Therapeutic Other Clopixol Sudden Death (Hydrochloride) SS Date:09/18/02ISR Number: 3977660-2Report Type:Direct Company Report #CTU 176782 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Quetiapine PS 75MG QHS Initial or Prolonged Gabapentin C Venlafaxine C Methadone C Simvastatin C Terazosin C Divalproex C Ranitidine C Baclofen C Date:09/19/02ISR Number: 3977713-9Report Type:Expedited (15-DaCompany Report #B0279490A Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Paxil (Paroxetine Overdose Health Hydrochloride) PS Professional Quetiapine (Quetiapine) SS Hydroxyzine (Hydroxyzine) SS Date:09/19/02ISR Number: 3977790-5Report Type:Expedited (15-DaCompany Report #2002AP02697 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Failure Foreign Seroquel PS ORAL 25 MG DAILY Hospitalization - Cardiac Arrest Health PO Initial or Prolonged Convulsion Professional Brovarin C Required Drug Ineffective Other Tetramide C Intervention to Loss Of Consciousness Serenace C Prevent Permanent Oliguria Pansporin C Impairment/Damage Pneumonia Mucosolvan C Respiratory Arrest Bisolvon C Theodur/Jpn/ C Clarith C Date:09/19/02ISR Number: 3978197-7Report Type:Expedited (15-DaCompany Report #2002AP02843 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Function Abnormal Foreign Seroquel PS ORAL 200 MG DAILY; Respiratory Arrest Health PO Professional Tryptanol C Other Nfedipine C Digoxin C 22-Feb-2006 08:31 AM Page: 513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/02ISR Number: 3978323-XReport Type:Expedited (15-DaCompany Report #B0279371A Age:55 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lithium Salt Intentional Overdose Health (Lithium Salt) PS ORAL ORAL Professional Fluphenazine (Fluphenazine) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL Date:09/19/02ISR Number: 3978455-6Report Type:Expedited (15-DaCompany Report #A0379989A Age:16 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Sr Intentional Overdose Health Tablet-Controlled Professional Release (Bupropion Hydrochloride) PS ORAL ORAL Quetiapine (Quetiapine) SS Valproic Acid (Valproic Acid) SS Date:09/19/02ISR Number: 3978704-4Report Type:Expedited (15-DaCompany Report #2002UW12295 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Health Seroquel PS Initial or Prolonged Sedation Professional Serzone SS Thinking Abnormal Date:09/19/02ISR Number: 4008034-6Report Type:Periodic Company Report #S01-USA-02411-01 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Celexa (Citalopram Professional Hydrobromide) PS ORAL 40 MG QD PO Celexa (Citalopram Hydrobromide) SS ORAL 10 MG QD PO Seroquel SS 25 MG Ambien (Zolpidem Tartrate) C Lorazepam C Date:09/20/02ISR Number: 3978977-8Report Type:Expedited (15-DaCompany Report #2002UW12530 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Seroquel PS Health Professional 22-Feb-2006 08:31 AM Page: 514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/02ISR Number: 3979464-3Report Type:Expedited (15-DaCompany Report #2002GB02109 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 600 MG DAILY Drug Level Increased Health PO Intentional Overdose Professional Citalopram SS 20 MG Other Diazepam C Methadone C Morphine C Topiramate C Date:09/20/02ISR Number: 3979465-5Report Type:Expedited (15-DaCompany Report #2001PK00187 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Seroquel "Zeneca" PS Zeneca ORAL 600 MG DAILY Initial or Prolonged Grand Mal Convulsion Literature PO Hypersensitivity Health Influenza Like Illness Professional Laboratory Test Abnormal Other Leukopenia Pericarditis Thrombocytopenia Date:09/22/02ISR Number: 4013043-7Report Type:Periodic Company Report #A119959 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Thiothixene Initial or Prolonged Professional (Tiotixene) PS ORAL ORAL Required Zyprexa (Olanzapine) SS Intervention to Haldol (Haloperidol) SS Prevent Permanent Seroquel (Quetiapine Impairment/Damage Fumarate) SS Date:09/23/02ISR Number: 3979580-6Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal (Tablet) Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL MG, DAILY, Phosphokinase Increased Professional ORAL Blood Pressure Increased Haldol (Tablet) Diabetes Mellitus (Haloperidol) SS ORAL MG, DAILY, Hypoventilation ORAL Insomnia Quetiapine Fumarate Respiratory Distress (Quetiapine Schizophrenia Fumarate) SS ORAL MG, DAILY, ORAL Hydroxyzine Pamoate (Hydroxyzine) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden 22-Feb-2006 08:31 AM Page: 515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:09/24/02ISR Number: 3980830-0Report Type:Direct Company Report #CTU 177063 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuropathy Peripheral Seroquel 100mg 1/2 Tab Bid PS Date:09/24/02ISR Number: 3980925-1Report Type:Expedited (15-DaCompany Report #2002SE05060 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Health Professional Other Date:09/24/02ISR Number: 3980938-XReport Type:Expedited (15-DaCompany Report #2002AP02883 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Foreign Seroquel PS ORAL 75 MG DAILY Dyspnoea Health PO Polydipsia Professional Seroquel SS ORAL 200 MG DAILY Retching Other PO Vomiting Serenace C Impromen C Date:09/24/02ISR Number: 3980978-0Report Type:Expedited (15-DaCompany Report #2002UW12580 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Increased Other PO Blood Lactate Ascorbic Acid C Dehydrogenase Increased Betaxolol C Gamma-Glutamyltransferase Clotrimazole C Increased Estraderm C Jaundice Provera C Multivitamins C Zopiclone C Gentamicin C Gravol C Tylenol C Date:09/24/02ISR Number: 3981113-5Report Type:Expedited (15-DaCompany Report #2002AP02542 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Hypotension Health PO Initial or Prolonged Hypothermia Professional Zyprexa SS ORAL 5 MG DAILY PO Other Pursennid C Akineton C Depas C Efotinon C 22-Feb-2006 08:31 AM Page: 516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Landsen C Risumic C Tegretol C Magnesium Oxide C Pantosin C Evamyl C Doral C Date:09/24/02ISR Number: 3981247-5Report Type:Expedited (15-DaCompany Report #2002AP02898 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Foreign Seroquel PS Loss Of Consciousness Health Overdose Professional Psychotic Disorder Other Date:09/24/02ISR Number: 3981248-7Report Type:Expedited (15-DaCompany Report #2001SE06912 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Foreign Seroquel "Zeneca" PS ORAL 200 MG DAILY Hospitalization - Distress Syndrome Health PO Initial or Prolonged Depressed Level Of Professional Buspar C Consciousness Other Zoloft C Lung Infiltration Overdose Psychotic Disorder Restlessness Sedation Somnolence Suicide Attempt Date:09/24/02ISR Number: 3981894-0Report Type:Expedited (15-DaCompany Report #2002UW12510 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Renal Failure Health Seroquel PS ORAL 400 MG HS PO Intervention to Rhabdomyolysis Professional Trazodone C Prevent Permanent Remeron C Impairment/Damage Trileptal "Ciba-Geigy" C Topamax C Klonopin C Alcohol C Date:09/25/02ISR Number: 3982451-2Report Type:Expedited (15-DaCompany Report #2002UW12485 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Health Seroquel PS Professional 22-Feb-2006 08:31 AM Page: 517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/02ISR Number: 3981641-2Report Type:Expedited (15-DaCompany Report #2002AP02709 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS ORAL 75 MG DAILY Intervention to Ileus Paralytic Study PO Prevent Permanent Health Seroquel SS ORAL 200 MG DAILY Impairment/Damage Professional PO Other Seroquel SS ORAL 300 MG DAILY PO Lasix C Gaster C Date:09/27/02ISR Number: 3981642-4Report Type:Expedited (15-DaCompany Report #2002AP02699 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Seroquel PS ORAL 25 MG DAILY Body Temperature Health PO Decreased Professional Tolopelon C Coma Other Akineton C Cyanosis Pyrethia C Heart Rate Increased Eurodin C Hypersensitivity Benzalin C Pallor Serenace C Peripheral Coldness Dantrolene Sodium C Respiratory Rate Increased Date:09/27/02ISR Number: 3981651-5Report Type:Expedited (15-DaCompany Report #2002GB02176 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Seroquel PS NOT MORE THAN Initial or Prolonged Insulin-Dependent Health 400MG PER DAY Diabetic Coma Professional Lithium C Other Date:09/27/02ISR Number: 3982085-XReport Type:Direct Company Report #CTU 177459 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required International Normalised Warfarin 1.5mg PS ORAL 1.5 MG SN, Intervention to Ratio Increased TU, TH, ST Prevent Permanent ORAL Impairment/Damage Quetiapine 200mg SS ORAL 200 MG QHS ORAL Ropinrole C Sinemet C Folic Acid C Lasix C Mirtazapine C Kcl C Zinc C Enalapril C Digoxin C Carvedilol C Aldactone C Nitroglycerine C 22-Feb-2006 08:31 AM Page: 518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Golide C Pericolace C Quetiapine C Date:09/27/02ISR Number: 3984386-8Report Type:Expedited (15-DaCompany Report #2002UW12169 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS ORAL 125 MG BID PO Intervention to Study Serax C Prevent Permanent Health Impairment/Damage Professional Other Date:09/27/02ISR Number: 3984389-3Report Type:Expedited (15-DaCompany Report #2002AP02947 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Seroquel PS ORAL 150 MG DAILY Hospitalization - Consciousness Health PO Initial or Prolonged Hyperglycaemia Professional Tegretol C Mental Status Changes Other Gramalil C Neuroleptic Malignant Solon C Syndrome Tasmolin C Pyrexia Magnesium Oxide C Date:09/27/02ISR Number: 3984701-5Report Type:Expedited (15-DaCompany Report #2002PK00718 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS Health Seroquel SS ORAL 175 MG DAILY Professional PO Other Seroquel SS ORAL 225 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 900 MG DAILY PO Tavor C Cipramil C Date:09/27/02ISR Number: 3984703-9Report Type:Expedited (15-DaCompany Report #2002AP02709 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ileus Paralytic Foreign Seroquel PS ORAL 75 MG DAILY Intervention to Study PO Prevent Permanent Health Seroquel SS ORAL 200 MG DAILY Impairment/Damage Professional PO Other Seroquel SS ORAL 300 MG DAILY PO Lasix C Gaster C 22-Feb-2006 08:31 AM Page: 519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/02ISR Number: 3985194-4Report Type:Expedited (15-DaCompany Report #2002UW12949 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Seroquel PS ORAL 50 MG DAILY Hospitalization - Injury Asphyxiation Professional PO 1 DAY Initial or Prolonged Seroquel SS ORAL 100 MG DAILY PO 1 DAY Seroquel SS ORAL 200 MG DAILY PO 1 DAY Seroquel SS ORAL 300 MG DAILY PO 1 DAY Effexor C Wellbutrin C Topamax C Date:09/27/02ISR Number: 3985469-9Report Type:Expedited (15-DaCompany Report #2001AP05205 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Literature Quetiapine PS Cardiac Arrest Health Alprazolam C Completed Suicide Professional Overdose Date:10/01/02ISR Number: 3983558-6Report Type:Expedited (15-DaCompany Report #2002054894 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zoloft (Sertraline) PS Initial or Prolonged Balance Disorder Health Seroquel (Quetiapine Other Depression Suicidal Professional Fumarate) SS Drooling Buspar (Buspirone Drug Effect Decreased Hydrochloride) SS Drug Interaction Risperdal Dyskinesia (Risperidone) SS Hallucinations, Mixed Verapamil C Insomnia Famotidine C Tremor Date:10/01/02ISR Number: 3986090-9Report Type:Expedited (15-DaCompany Report #2002UW13044 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Consumer Seroquel PS ORAL 50 MG HS PO Hospitalization - Burning Sensation Seroquel SS ORAL 150 MG DAILY Initial or Prolonged Injury PO Joint Stiffness Lithium C Paranoia Zyprexa C Pruritus Refusal Of Treatment By Patient Road Traffic Accident Theft Thirst Tremor 22-Feb-2006 08:31 AM Page: 520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 3986093-4Report Type:Expedited (15-DaCompany Report #2001AP05204 Age:55 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Drug Toxicity Health Fluphenazine SS Professional Lithium SS Date:10/01/02ISR Number: 4008679-3Report Type:Periodic Company Report #2002UW07306 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS <100 MG PER Intervention to Professional DAY 4 MON Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4008683-5Report Type:Periodic Company Report #2002UW07601 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Health Seroquel PS ORAL 600 MG HS PO Intervention to Increased Professional Seroquel SS ORAL 400 MG HS PO Prevent Permanent Aspartate Zyprexa C Impairment/Damage Aminotransferase Klonopin C Increased Tardive Dyskinesia Date:10/01/02ISR Number: 4008685-9Report Type:Periodic Company Report #2002UW07629 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Health Seroquel PS TITRATED Intervention to Increased Professional Seroquel SS ORAL 800 MG DAILY Prevent Permanent Aspartate PO Impairment/Damage Aminotransferase Increased Date:10/01/02ISR Number: 4008687-2Report Type:Periodic Company Report #2002UW07716 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Deep Vein Thrombosis Health Seroquel PS ORAL 150 MG BID PO Intervention to Urinary Tract Infection Professional Seroquel SS 25 TO 50 MG Prevent Permanent PER DAY Impairment/Damage Topamax C Dilantin C Antihypertensive C Thyroid Medication C Antibiotics C Date:10/01/02ISR Number: 4008689-6Report Type:Periodic Company Report #2002UW07965 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Health Seroquel PS ORAL 50 MG PO Initial or Prolonged Professional Seroquel SS ORAL 25 MG PO 22-Feb-2006 08:31 AM Page: 521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS ORAL 25 MG PO Zocor C Aspirin C Corgard C Date:10/01/02ISR Number: 4008691-4Report Type:Periodic Company Report #2002UW07976 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pancreatitis Health Seroquel PS ORAL 200 MG HS PO Intervention to Professional Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4008692-6Report Type:Periodic Company Report #2002UW08154 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypotension Study Seroquel PS ORAL 2 DF DAILY PO Intervention to Tachycardia Health Seroquel SS ORAL 4 DF DAILY PO Prevent Permanent Professional Lorazepam C Impairment/Damage Acetaminophen C Diphenhydramine Hydrochloride C Sertraline C Risperdal C Seroquel C Date:10/01/02ISR Number: 4008693-8Report Type:Periodic Company Report #2002UW08484 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel PS ORAL 150 MG DAILY Intervention to Professional PO Prevent Permanent Vioxx C Impairment/Damage Date:10/01/02ISR Number: 4008694-XReport Type:Periodic Company Report #2002UW08543 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecaloma Health Seroquel PS ORAL 250 MG BID PO Initial or Prolonged Professional Lithobid C Date:10/01/02ISR Number: 4008695-1Report Type:Periodic Company Report #2002UW08681 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Health Seroquel PS ORAL 600 MG PO Intervention to Tongue Oedema Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4008706-3Report Type:Periodic Company Report #1998UW49037 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Literature Seroquel "Zeneca" PS Zeneca ORAL 200 MG PO Initial or Prolonged Chest Pain Health Required Electrocardiogram Qt Professional Intervention to Prolonged Prevent Permanent Hypokalaemia Impairment/Damage Hypotension Loss Of Consciousness Overdose Sinus Tachycardia Date:10/01/02ISR Number: 4008709-9Report Type:Periodic Company Report #1998UW47645 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Platelet Count Decreased Literature Seroquel PS ORAL 200 MG BID PO Intervention to White Blood Cell Count Health Seroquel SS ORAL 200 MG DAILY Prevent Permanent Decreased Professional PO Impairment/Damage Olanzapine SS 10 MG DAILY Risperdal C Date:10/01/02ISR Number: 4008711-7Report Type:Periodic Company Report #2001AP05211 Age:16 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Valproic Acid SS Professional Bupropion SS Date:10/01/02ISR Number: 4008715-4Report Type:Periodic Company Report #2001AP05208 Age:55 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Cyclic Professional Antidepressant SS Date:10/01/02ISR Number: 4008718-XReport Type:Periodic Company Report #2001AP05205 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Alprazolam C Professional Date:10/01/02ISR Number: 4008720-8Report Type:Periodic Company Report #2001AP05204 Age:55 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Fluphenazine SS Professional Barium SS 22-Feb-2006 08:31 AM Page: 523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4008721-XReport Type:Periodic Company Report #2001AP05198 Age:55 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Diphenhydramine SS Professional Mirazapine SS Date:10/01/02ISR Number: 4008722-1Report Type:Periodic Company Report #2001AP04973 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Literature Seroquel "Zeneca" PS Zeneca ORAL 125 MG DAILY Intervention to Health PO 13 WK Prevent Permanent Professional Lithium C Impairment/Damage Carbamazepine C Divalproex Sodium C Lamotrigine C Fluoxetine C Bupropion C Gabapentin C Topiramate C Olanzapine C Risperidone C Date:10/01/02ISR Number: 4008723-3Report Type:Periodic Company Report #2001AP04165 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Literature Quetiapine PS 25 MG BID Initial or Prolonged Syndrome Health Levothyroxine C Professional Haloperidol C Chlorpromazine C Lorazepam C Date:10/01/02ISR Number: 4008724-5Report Type:Periodic Company Report #2001AP05254 Age:30 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Amitriptylline PS Health Trazodone SS Professional Crustiapine SS Date:10/01/02ISR Number: 4008726-9Report Type:Periodic Company Report #2002UW04898 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel PS ORAL 50 MG PRN PO Initial or Prolonged Syndrome Professional Prevacid C Neurontin C Claritin C Oscal C Mellaril C Niaspan C Synthroid C Ditropan Xl C Lithium C 22-Feb-2006 08:31 AM Page: 524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4008727-0Report Type:Periodic Company Report #2002UW04998 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Health Seroquel PS ORAL 200 MG TID PO Initial or Prolonged Decreased Professional Seroquel SS ORAL 550 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Clonidine C Neurontin C Hemocyte Plus C Date:10/01/02ISR Number: 4008729-4Report Type:Periodic Company Report #2002UW05159 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Health Seroquel PS ORAL 100 MG DAILY Hospitalization - Chest Pain Professional PO Initial or Prolonged Dizziness Trazodone C Dyspnoea Insomnia Somnolence Date:10/01/02ISR Number: 4008730-0Report Type:Periodic Company Report #2002UW05351 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4008731-2Report Type:Periodic Company Report #2002UW05515 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 600 MG DAILY Intervention to Professional PO Prevent Permanent Seroquel SS ORAL 800 MG DAILY Impairment/Damage PO Zyprexa C Neurontin C Vitamin E C Mellaril C Ativan C Thorazine C Haldol C Prolixin C Risperdal C Clozaril C Depakote C Cogentin C 22-Feb-2006 08:31 AM Page: 525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4008733-6Report Type:Periodic Company Report #2002UW05607 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Failure Health Seroquel PS ORAL 450 MG DAILY Intervention to Congestive Professional PO Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4008735-XReport Type:Periodic Company Report #2002UW05589 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Other Seroquel PS Initial or Prolonged Extrapyramidal Disorder Erythropoietin SS SUBCUTANEOUS 1400 U WEEK Psychotic Disorder SQ Date:10/01/02ISR Number: 4008738-5Report Type:Periodic Company Report #2002UW05648 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dehydration Health Seroquel PS ORAL 200 MG TID PO Required Neuroleptic Malignant Professional Seroquel SS ORAL 25 MG DAILY Intervention to Syndrome PO Prevent Permanent Pneumonitis Sinemet C Impairment/Damage Date:10/01/02ISR Number: 4008741-5Report Type:Periodic Company Report #2002UW05726 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Eye Rolling Health Seroquel PS ORAL 800 MG DAILY Intervention to Psychotic Disorder Professional PO Prevent Permanent Tremor Seroquel SS ORAL 400 MG DAILY Impairment/Damage PO Wellbutrin C Ativan C Remeron C Date:10/01/02ISR Number: 4008743-9Report Type:Periodic Company Report #2002UW05783 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Health Seroquel PS ORAL 600 MG QD PO Intervention to Prolonged Professional Other Medications Prevent Permanent (Not Specified) SS Impairment/Damage Date:10/01/02ISR Number: 4008783-XReport Type:Periodic Company Report #2002UW00348 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel "Zeneca" PS Zeneca ORAL 50 MG HS PO Intervention to Professional Zyprexa SS 7.5 MG HS Prevent Permanent Zyprexa SS 10 MG HS Impairment/Damage Effexor SS 150 MG Effexor SS 75 MG 22-Feb-2006 08:31 AM Page: 526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin C Humalin C Glucovance C Vitamin E C Toprol C Norvasc C Ultram C Prevacid C Mellaril C Date:10/01/02ISR Number: 4008784-1Report Type:Periodic Company Report #2002UW00572 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Other Seroquel "Zeneca" PS Zeneca ORAL 25 MG BID PO Initial or Prolonged Feeling Drunk Luvox C Hallucination, Auditory Pain In Extremity Pruritus Genital Vomiting Date:10/01/02ISR Number: 4008785-3Report Type:Periodic Company Report #2002UW00827 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grand Mal Convulsion Study Seroquel "Zeneca" PS ORAL 600 MG DAILY Intervention to Health PO Prevent Permanent Professional Geodon C Impairment/Damage Haldol Decanoate C Trazodone C Benadryl C Ativan C Allegra-D C Purified Protein Derivative C Date:10/01/02ISR Number: 4008786-5Report Type:Periodic Company Report #2002UW00850 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Health Seroquel "Zeneca" PS Intervention to Extrapyramidal Disorder Professional Fentanyl C Prevent Permanent Pyrexia Effexor C Impairment/Damage Tardive Dyskinesia Date:10/01/02ISR Number: 4008787-7Report Type:Periodic Company Report #2002UW00925 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depression Literature Seroquel "Zeneca" PS ORAL 5 MG DAILY PO Intervention to Hallucination, Auditory Other Seroquel "Zeneca" SS ORAL 2 MG DAILY PO Prevent Permanent Somnolence Impairment/Damage 22-Feb-2006 08:31 AM Page: 527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4008788-9Report Type:Periodic Company Report #2002UW00953 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Orthostatic Hypotension Study Seroquel "Zeneca" PS ORAL 600 MG DAILY Intervention to Health PO Prevent Permanent Professional Risperidone C Impairment/Damage Ativan C Ambien C Date:10/01/02ISR Number: 4008789-0Report Type:Periodic Company Report #2002UW01323 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Health Seroquel PS Intervention to Professional Zyprexa C Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4008790-7Report Type:Periodic Company Report #2002UW01476 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Seroquel PS Initial or Prolonged Professional Date:10/01/02ISR Number: 4008791-9Report Type:Periodic Company Report #2002UW02097 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel PS 5-10 GRAMS Intervention to Overdose Professional Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4008792-0Report Type:Periodic Company Report #2002UW02223 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Seroquel PS ORAL 700 MG DAILY Liver Function Test Professional PO Abnormal Clozapine SS ORAL 525 MG QD PO Neutropenia Depakote SS ORAL 1750 MG QD PO Levothyroxine C Lithium C Interferon C Date:10/01/02ISR Number: 4008793-2Report Type:Periodic Company Report #2002UW05825 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Parkinson'S Disease Health Seroquel PS Intervention to Professional Ssri C Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4008794-4Report Type:Periodic Company Report #2002UW06101 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4008795-6Report Type:Periodic Company Report #2002UW06190 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Seroquel PS ORAL 500 GM DAILY Initial or Prolonged Hallucination PO Heart Rate Increased Seroquel SS ORAL 300 MG QD PO Sleep Terror Date:10/01/02ISR Number: 4008796-8Report Type:Periodic Company Report #2002UW06346 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Memory Impairment PO 5 DAY Paranoia Zoloft C Thinking Abnormal Depakote C Date:10/01/02ISR Number: 4008797-XReport Type:Periodic Company Report #2002UW06790 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel PS ORAL 200 MG TID PO Initial or Prolonged Syndrome Professional Date:10/01/02ISR Number: 4008798-1Report Type:Periodic Company Report #2002UW06808 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Health Seroquel PS ORAL 100 MG QID PO Required Professional Seroquel SS ORAL 25 MG QID PO Intervention to Adderall C Prevent Permanent Imipramine C Impairment/Damage Risperdal C Date:10/01/02ISR Number: 4008799-3Report Type:Periodic Company Report #2002UW06828 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Seroquel PS ORAL 400 MG HS PO Initial or Prolonged Weight Increased Professional Seroquel SS ORAL 100 MG HS PO Norvasc C Ativan C Paxil C Depakote C 22-Feb-2006 08:31 AM Page: 529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4008800-7Report Type:Periodic Company Report #2002UW07017 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Health Seroquel PS ORAL 600 MG PO Initial or Prolonged Professional Date:10/01/02ISR Number: 4008801-9Report Type:Periodic Company Report #2002UW07016 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Health Seroquel PS ORAL 400 MG PO Initial or Prolonged Professional Date:10/01/02ISR Number: 4008802-0Report Type:Periodic Company Report #2002UW06998 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Consumer Seroquel PS Initial or Prolonged Memory Impairment Paranoia Date:10/01/02ISR Number: 4008803-2Report Type:Periodic Company Report #2002UW02327 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 100 MG HS PO Intervention to Professional Seroquel SS ORAL 50 MG HS PO Prevent Permanent Fluvoxamine C Impairment/Damage Paxil C Zoloft C Navane C Date:10/01/02ISR Number: 4008804-4Report Type:Periodic Company Report #2002UW02400 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Other Seroquel PS Intervention to Syndrome Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4008805-6Report Type:Periodic Company Report #2002UW02601 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Consumer Seroquel "Zeneca" PS Zeneca ORAL 1 DF QD PO Intervention to Drug Ineffective Other Clonazepam SS ORAL 0.5 MG TID PO Prevent Permanent Hostility Neurontin C Impairment/Damage Mania Topamax C Suicidal Ideation 22-Feb-2006 08:31 AM Page: 530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4008806-8Report Type:Periodic Company Report #2002UW02645 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Visual Disturbance Health Seroquel "Zeneca" PS Zeneca ORAL 50 MG DAILY Intervention to Professional PO Prevent Permanent Accolate C Impairment/Damage Hydrocodone C Oxycotin C Flonase C Altace C Lorazepam C Albuterol C Corticosteroids C Prevacid C Serevent Diskus C Theophylline C Date:10/01/02ISR Number: 4008807-XReport Type:Periodic Company Report #2002UW02798 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Seroquel "Zeneca" PS Zeneca ORAL 500 MG DAILY Initial or Prolonged Dehydration PO Memory Impairment Depakote C Mental Status Changes Ritalin C Nasopharyngitis Somnolence White Blood Cell Count Increased Date:10/01/02ISR Number: 4008808-1Report Type:Periodic Company Report #2002UW03119 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Health Seroquel PS ORAL 600 MG DAILY Intervention to Cataract Professional PO Prevent Permanent Paxil C Impairment/Damage Neurontin C Date:10/01/02ISR Number: 4008809-3Report Type:Periodic Company Report #2002UW03623 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Professional PO Disability Depakote C Date:10/01/02ISR Number: 4008810-XReport Type:Periodic Company Report #2002UW04707 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Polydipsia Psychogenic Study Seroquel PS ORAL 800 MG DAILY Hospitalization - Health PO Initial or Prolonged Professional Ambien C Ativan C Zyprexa C Seroquel C 22-Feb-2006 08:31 AM Page: 531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4008811-1Report Type:Periodic Company Report #2002UW04738 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Study Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Health Professional Date:10/01/02ISR Number: 4008812-3Report Type:Periodic Company Report #2002UW04834 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Health Seroquel PS ORAL 100 MG HS PO Intervention to Tardive Dyskinesia Professional Seroquel SS ORAL 100 MG HS PO Prevent Permanent Weight Increased Seroquel SS ORAL 200 MG HS PO Impairment/Damage Risperdal C Wellbutrin C Date:10/01/02ISR Number: 4027247-0Report Type:Periodic Company Report #2001UW16648 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel "Zeneca" PS Zeneca ORAL 150 MG DAILY Intervention to Professional PO Prevent Permanent Effexor C Impairment/Damage Cogentin C Sinemet C Stelazine C Date:10/01/02ISR Number: 4027248-2Report Type:Periodic Company Report #2002AP00525 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Literature Quetiapine PS 200 MG DAILY Hospitalization - Syndrome Health Clozapine C Initial or Prolonged Pneumonia Professional Divalproex Sodium C Lamotrigene C Clonazepam C Loxapine C Droperidol C Date:10/01/02ISR Number: 4027249-4Report Type:Periodic Company Report #2002AP00441 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertriglyceridaemia Literature Quetiapine PS 200 MG DAILY Intervention to Health Lithium C Prevent Permanent Professional Impairment/Damage Date:10/01/02ISR Number: 4027250-0Report Type:Periodic Company Report #2002AP00433 Age:50 YR Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Hypertriglyceridaemia Literature Quetiapine PS 250 MG DAILY Health Valproic Acid C Professional Nelfinavir C Date:10/01/02ISR Number: 4027251-2Report Type:Periodic Company Report #2002AP00323 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Literature Quetiapine PS 25 MG DAILY 6 DAY Hospitalization - Suicide Attempt Health Quetiapine SS 100 MG DAILY Initial or Prolonged Professional Quetiapine SS 200 MG DAILY 4 MON Required Olanzapine SS 10 MG DAILY 3 YR Intervention to Olanzapine SS 20 MG DAILY Prevent Permanent Olanzapine SS 30 MG DAILY Impairment/Damage Valproate C Clonazepam C Haloperidol C Date:10/01/02ISR Number: 4027255-XReport Type:Periodic Company Report #2002AP01071 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fat Redistribution Literature Quetiapine Fumarate PS ORAL 800 MG DAILY Initial or Prolonged Hallucination, Auditory Health PO 10 MON Paranoia Professional Clozapine C Schizophrenia Date:10/01/02ISR Number: 4027256-1Report Type:Periodic Company Report #2002AP01607 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Abnormal Literature Quetiapine PS 600 MG DAILY Initial or Prolonged Diabetes Mellitus Health Divalproex C Non-Insulin-Dependent Professional Paroxetine C Hyperlipidaemia Metformin C Valproic Acid C Date:10/01/02ISR Number: 4027257-3Report Type:Periodic Company Report #2002AP02020 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Quetiapine PS ORAL 13 DF ONCE PO Initial or Prolonged Overdose Health Somnolence Professional Date:10/01/02ISR Number: 4027264-0Report Type:Periodic Company Report #2002UW00015 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Study Seroquel "Zeneca" PS Zeneca ORAL 600 MG QD PO Initial or Prolonged Health Disability Professional 22-Feb-2006 08:31 AM Page: 533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4027269-XReport Type:Periodic Company Report #2002UW00069 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Palpitations Consumer Seroquel "Zeneca" PS Zeneca ORAL 200 MG PO Intervention to Tardive Dyskinesia Lotrel C Prevent Permanent Hormone Therapy C Impairment/Damage Detrol C Zebeta C Date:10/01/02ISR Number: 4027271-8Report Type:Periodic Company Report #2001UW13695 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Consumer Seroquel "Zeneca" PS Intervention to Clonopin C Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4027273-1Report Type:Periodic Company Report #2001UW13650 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel "Zeneca" PS Intervention to Professional Celexa C Prevent Permanent Risperdal C Impairment/Damage Date:10/01/02ISR Number: 4027275-5Report Type:Periodic Company Report #2001UW13977 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Seroquel "Zeneca" PS ORAL 1000 MG DAILY Initial or Prolonged Professional PO 1 YR Lanoxin C Ativan C Date:10/01/02ISR Number: 4027276-7Report Type:Periodic Company Report #2001UW14502 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Seroquel "Zeneca" PS ORAL 500 MG DAILY Initial or Prolonged Professional PO Date:10/01/02ISR Number: 4027279-2Report Type:Periodic Company Report #2001UW14789 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel "Zeneca" PS ORAL 800 MG PO Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4027281-0Report Type:Periodic Company Report #2001UW14662 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel "Zeneca" PS ORAL 300 MG DAILY Intervention to Glaucoma Professional PO Prevent Permanent Photophobia Seroquel "Zeneca" SS 120 MG TO 200 Impairment/Damage MG DAILY Depakote C Date:10/01/02ISR Number: 4027287-1Report Type:Periodic Company Report #2001UW15005 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel "Zeneca" PS Intervention to Professional Zyprexa C Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4027289-5Report Type:Periodic Company Report #2001UW14820 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperreflexia Health Seroquel PS ORAL 300 MG DAILY Intervention to Tardive Dyskinesia Professional PO Prevent Permanent Risperidone C Impairment/Damage Wellbutrin C Date:10/01/02ISR Number: 4027291-3Report Type:Periodic Company Report #2001UW15230 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Health Seroquel "Zeneca" PS ORAL 700 MG DAILY Intervention to Syncope Professional PO Prevent Permanent Cogentin C Impairment/Damage Date:10/01/02ISR Number: 4027292-5Report Type:Periodic Company Report #2001UW15996 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Orthostatic Hypotension Health Seroquel PS ORAL 50 MG QID PO Initial or Prolonged Stupor Professional Ativan C Lipitor C Plavix C Timoptic C Aricept C Insulin C Prandin "Kuhn" C Zocor "Dieckmann" C Levofloxacin C Eye Drops C 22-Feb-2006 08:31 AM Page: 535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4027293-7Report Type:Periodic Company Report #2001AP05976 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Literature Quetiapine PS ORAL 675 MG ONCE Initial or Prolonged Priapism Health PO Required Professional Tegretol C Intervention to Prozac C Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4027295-0Report Type:Periodic Company Report #2001UW00724 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombosis Health Seroquel "Zeneca" PS 300 MG DAILY Initial or Prolonged Professional Seroquel "Zeneca" SS 25 MG BID Date:10/01/02ISR Number: 4027297-4Report Type:Periodic Company Report #2001UW01274 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Orthostatic Hypotension Study Seroquel PS Intervention to Health Atenolol SS ORAL 100 MG DAILY Prevent Permanent Professional PO Impairment/Damage Losartan Potassium SS ORAL 50 MG DAILY PO Lorazepam C Valproate C Septra C Acetaminophen C Date:10/01/02ISR Number: 4027298-6Report Type:Periodic Company Report #2001UW05267 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Seroquel "Zeneca" PS ORAL 1000 MG DAILY Initial or Prolonged Professional PO Seroquel "Zeneca" SS ORAL 200 MG BID PO Inderal C Axid C Celebrex C Ranitidine C Lorazepam C Risperdal C Date:10/01/02ISR Number: 4027300-1Report Type:Periodic Company Report #2001UW05357 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gastrointestinal Disorder Health Seroquel "Zeneca" PS ORAL 50 MG BID PO Intervention to Grand Mal Convulsion Professional Seroquel "Zeneca" SS ORAL 100 MG BID PO Prevent Permanent Seroquel "Zeneca" SS ORAL 100 MG DAILY Impairment/Damage PO Remeron C Morphine C Cotazym C Nabumetone C 22-Feb-2006 08:31 AM Page: 536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lansoprazole C Mirtazapine C Date:10/01/02ISR Number: 4027309-8Report Type:Periodic Company Report #2001UW05633 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Consumer Seroquel "Zeneca" PS ORAL 700 MG DAILY Initial or Prolonged Asthenia PO Confusional State Seroquel "Zeneca" SS ORAL 100 MG BID PO Depression Seroquel "Zeneca" SS ORAL 600 MG DAILY Fatigue PO Hypomania Seroquel "Zeneca" SS ORAL 500 MG QD PO Hypothyroidism Seroquel "Zeneca" SS ORAL 200 MG TID PO Malaise Seroquel "Zeneca" SS ORAL 800 MG DAILY Paranoia PO Persecutory Delusion Risperdal C Photophobia Depakote C Platelet Count Decreased Neurontin C Sedation Clonapin C Sleep Disorder Prevacid C Stress Tapazole C Weight Increased Lasix C Rhinocort Aqua C Zoloft C Celebrex C Wellbutrin C Date:10/01/02ISR Number: 4027311-6Report Type:Periodic Company Report #2001UW05683 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Health Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG BID PO Intervention to Psychotic Disorder Professional Seroquel "Zeneca" SS "Zeneca" 400 MG HS Prevent Permanent Seroquel "Zeneca" SS "Zeneca" ORAL 500 MG HS PO Impairment/Damage Clozaril SS 300 MG DAILY Zyprexa C Iron Supplement C Klonopin C Date:10/01/02ISR Number: 4027314-1Report Type:Periodic Company Report #2001UW06912 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel "Zeneca" PS ORAL 650 MG DAILY Intervention to Professional PO Prevent Permanent Lithium C Impairment/Damage Diazepam C Lorazepam C Donnatal C Famotidine C Naproxen C Maalox Plus C Docusate C Gaviscon Liquid "Boehringer Ingelheim" C Mom C 22-Feb-2006 08:31 AM Page: 537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4027317-7Report Type:Periodic Company Report #2001UW07551 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drooling Health Seroquel "Zeneca" PS ORAL 400 MG QAM PO Intervention to Neuroleptic Malignant Professional Seroquel "Zeneca" SS ORAL 1600 MG HS PO Prevent Permanent Syndrome Haldol SS ORAL 5 MG BID PO Impairment/Damage Lithium SS ORAL 600 MG QAM PO Lithium SS ORAL 300 MG HS PO Propranolol C Date:10/01/02ISR Number: 4027319-0Report Type:Periodic Company Report #2001UW08694 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel "Zeneca" PS ORAL 200 MG TID PO Intervention to Professional Paxil C Prevent Permanent Synthroid C Impairment/Damage Date:10/01/02ISR Number: 4027322-0Report Type:Periodic Company Report #2001UW08893 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Health Seroquel "Zeneca" PS Zeneca Intervention to Professional Atenolol C Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4027325-6Report Type:Periodic Company Report #2001UW09349 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatinine Health Seroquel "Zeneca" PS Zeneca ORAL 300 MG, DAILY Intervention to Increased Professional PO Prevent Permanent Cyclosporine C Impairment/Damage Zoloft C Prednisone C Risperidone C Cellcept C Date:10/01/02ISR Number: 4027327-XReport Type:Periodic Company Report #2001UW09358 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel "Zeneca" PS Zeneca Intervention to Professional Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4027328-1Report Type:Periodic Company Report #2001UW09518 Age:45 YR Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Health Seroquel "Zeneca" PS ORAL 25 MG HS PO Sleep Disorder Professional Urinary Retention Date:10/01/02ISR Number: 4027330-XReport Type:Periodic Company Report #2001UW09811 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Health Seroquel "Zeneca" PS 150-200 MG Intervention to Syndrome Professional Clozaril SS Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4027332-3Report Type:Periodic Company Report #2001UW10064 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel "Zeneca" PS Zeneca ORAL 100 MG QID PO Initial or Prolonged Syndrome Professional Fluoxetine C Date:10/01/02ISR Number: 4027334-7Report Type:Periodic Company Report #2001UW10072 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Exacerbated Health Seroquel "Zeneca" PS Zeneca ORAL 400 MG DAILY Intervention to Professional PO Prevent Permanent Seroquel "Zeneca" SS Zeneca ORAL 300 MG DAILY Impairment/Damage PO Seroquel "Zeneca" SS Zeneca ORAL 200 MG DAILY PO Mirapex "Boehringer Ingelheim" C Neurontin C Wellbutrin C Effexor C Date:10/01/02ISR Number: 4027335-9Report Type:Periodic Company Report #2001UW10262 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel "Zeneca" PS Zeneca ORAL 400 MG DAILY Intervention to Professional PO Prevent Permanent Seroquel "Zeneca" SS Zeneca ORAL 100 MG DAILY Impairment/Damage PO Depakote C Celexa C Lamictal C 22-Feb-2006 08:31 AM Page: 539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4027337-2Report Type:Periodic Company Report #2001UW10376 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Seroquel "Zeneca" PS Zeneca ORAL MG PO Date:10/01/02ISR Number: 4027338-4Report Type:Periodic Company Report #2001UW10342 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Seroquel "Zeneca" PS ORAL 25 MG BID PO Initial or Prolonged Professional Seroquel "Zeneca" SS ORAL 100 MG BID PO Zyprexa C Haldol Decanoate C Navane C Cogentin C Date:10/01/02ISR Number: 4027341-4Report Type:Periodic Company Report #2001UW10606 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Seroquel "Zeneca" PS Zeneca ORAL 4 G PO Initial or Prolonged Suicide Attempt Professional Date:10/01/02ISR Number: 4027342-6Report Type:Periodic Company Report #2001UW11137 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel "Zeneca" PS Zeneca ORAL 100 MG HS PO Intervention to Professional Seroquel "Zeneca" SS Zeneca ORAL 75 MG HS PO Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4027343-8Report Type:Periodic Company Report #2001UW11369 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Seroquel "Zeneca" PS Zeneca ORAL 50 MG BID PO Initial or Prolonged Condition Aggravated Seroquel "Zeneca" SS Zeneca ORAL 500 MG DAILY Deafness PO Gait Disturbance Many Medications C Hypertension Hypotension Pain Stupor Tooth Loss Date:10/01/02ISR Number: 4027347-5Report Type:Periodic Company Report #2001UW11434 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Seroquel "Zeneca" PS Zeneca ORAL 700 MG PO Initial or Prolonged Professional 22-Feb-2006 08:31 AM Page: 540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4027348-7Report Type:Periodic Company Report #2001UW11403 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Menstrual Disorder Health Seroquel "Zeneca" PS Zeneca Professional Date:10/01/02ISR Number: 4027351-7Report Type:Periodic Company Report #2001UW11613 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel "Zeneca" PS Zeneca ORAL 800 MG DAILY Initial or Prolonged Syndrome Professional PO Haldol SS ORAL 0.5 MG BID PO Date:10/01/02ISR Number: 4027361-XReport Type:Periodic Company Report #2001UW11634 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel "Zeneca" PS Zeneca ORAL 600 MG DAILY Intervention to Professional PO Prevent Permanent Geodon C Impairment/Damage Date:10/01/02ISR Number: 4027369-4Report Type:Periodic Company Report #2001UW11757 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel "Zeneca" PS Zeneca ORAL 100 MG HS PO Professional Seroquel "Zeneca" SS Zeneca ORAL 150 MG HS PO Topamax SS 100 MG BID Topamax SS 100 MG BID Date:10/01/02ISR Number: 4027371-2Report Type:Periodic Company Report #2001UW11845 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Subcapsular Health Seroquel "Zeneca" PS Zeneca ORAL 150 MG PO 6 MON Intervention to Professional Triamterene C Prevent Permanent Singulair C Impairment/Damage Paxil C Trazodone C Albuterol C Serevent C Pulmicort C Hydrochlorothiazide C Propoxyphene Hydrochloride C Date:10/01/02ISR Number: 4027372-4Report Type:Periodic Company Report #2001UW12178 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Health Seroquel "Zeneca" PS Zeneca ORAL 200 MG QD PO Hospitalization - Professional Initial or Prolonged 22-Feb-2006 08:31 AM Page: 541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4027383-9Report Type:Periodic Company Report #2001UW12297 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Health Seroquel "Zeneca" PS ORAL 400 MG DAILY Intervention to Professional PO Prevent Permanent Haldol C Impairment/Damage Hiv Medications C Date:10/01/02ISR Number: 4027385-2Report Type:Periodic Company Report #2001UW12494 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Seroquel "Zeneca" PS ORAL 300 MG PO 1 MON Initial or Prolonged Diarrhoea Professional Glucophage C Depakote C Trazodone C Date:10/01/02ISR Number: 4027388-8Report Type:Periodic Company Report #2001UW12559 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Consumer Seroquel "Zeneca" PS ORAL 25 MG DAILY Initial or Prolonged Mania PO Seroquel "Zeneca" SS ORAL 250 MG DAILY PO Depakote C Risperdal C Adderall C Date:10/01/02ISR Number: 4027390-6Report Type:Periodic Company Report #2001UW12621 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Consumer Seroquel "Zeneca" PS Zeneca Intervention to Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4027392-XReport Type:Periodic Company Report #2001UW12989 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Study Seroquel "Zeneca" PS ORAL 2 DF BID PO Initial or Prolonged Health Seroquel "Zeneca" SS ORAL 4 DF BID PO Professional Seroquel "Zeneca" SS ORAL 3 DF BID PO Seroquel "Zeneca" SS ORAL 2 DF BID PO Cogentin SS INTRAMUSCULAR 1 MG BID IM Cogentin SS 0.5 MG TID Thorazine SS INTRAMUSCULAR 50 MG QD IM Benadryl SS INTRAMUSCULAR 25 MG QD IM Keflex C Diflucan C 22-Feb-2006 08:31 AM Page: 542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4027393-1Report Type:Periodic Company Report #2001UW13169 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Seroquel "Zeneca" PS 100 MG Initial or Prolonged Tachycardia Professional Date:10/01/02ISR Number: 4027395-5Report Type:Periodic Company Report #2001UW13238 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel "Zeneca" PS ORAL 25 MG DAILY Initial or Prolonged Syndrome Professional PO Rhabdomyolysis Date:10/01/02ISR Number: 4027404-3Report Type:Periodic Company Report #2001UW13252 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Tongue Oedema Health Seroquel "Zeneca" PS ORAL 100 MG DAILY Hospitalization - Torticollis Professional PO Initial or Prolonged Risperdal SS 2 MG Zoloft C Buspar C Clonapin C Date:10/01/02ISR Number: 4027407-9Report Type:Periodic Company Report #2001UW13263 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Renal Failure Acute Health Seroquel "Zeneca" PS ORAL 300 MG PO Intervention to Professional Seroquel "Zeneca" SS ORAL 400 MG PO Prevent Permanent Zoloft C Impairment/Damage Lithium C Date:10/01/02ISR Number: 4027409-2Report Type:Periodic Company Report #2001UW13521 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epistaxis Health Seroquel "Zeneca" PS ORAL 50 MG HS PO Initial or Prolonged Professional Zyprexa C Paxil C Cogentin C Date:10/01/02ISR Number: 4027413-4Report Type:Periodic Company Report #2002UW10245 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Decreased Health Seroquel PS ORAL 100 MG DAILY Hospitalization - Professional PO Initial or Prolonged Atacand C Aggrenox C K-Dur C Lasix C Synthroid C Humulin C 22-Feb-2006 08:31 AM Page: 543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4027414-6Report Type:Periodic Company Report #2002UW09009 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Consumer Seroquel PS ORAL 550 MG PO Intervention to Seroquel SS ORAL 500 MG PO Prevent Permanent Klonopin C Impairment/Damage Topamax C Date:10/01/02ISR Number: 4027416-XReport Type:Periodic Company Report #2002UW09040 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel PS ORAL 25 MG HS PO Initial or Prolonged Syndrome Professional Seroquel SS ORAL 25 MG PRN PO Prozac C Benadryl C Date:10/01/02ISR Number: 4027417-1Report Type:Periodic Company Report #2002UW09197 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Intraocular Pressure Health Seroquel PS Intervention to Increased Professional Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4027418-3Report Type:Periodic Company Report #2002UW09329 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Seroquel PS TITRATED UP Initial or Prolonged Professional TO 300 MG PER DAY Risperdal C Date:10/01/02ISR Number: 4027449-3Report Type:Periodic Company Report #2002UW09383 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Health Seroquel PS Intervention to Tardive Dyskinesia Professional Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4027451-1Report Type:Periodic Company Report #2002UW09425 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Health Seroquel PS Intervention to Tardive Dyskinesia Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4027453-5Report Type:Periodic Company Report #2002UW09464 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 600 MG DAILY Intervention to Professional PO Prevent Permanent Celexa SS 10 MG Impairment/Damage Risperdal C Date:10/01/02ISR Number: 4027455-9Report Type:Periodic Company Report #2002UW09713 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS 500 - 600 MG Intervention to Professional Zyprexa C Prevent Permanent Glucovance C Impairment/Damage Atenolol C Clonazepam C Vitamin E C Date:10/01/02ISR Number: 4027456-0Report Type:Periodic Company Report #2002UW09620 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nightmare Health Seroquel PS Initial or Prolonged Therapeutic Response Professional Decreased Date:10/01/02ISR Number: 4027457-2Report Type:Periodic Company Report #2002UW09817 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Seroquel PS ORAL 200 MG HS PO Required Leukopenia Clozapine SS ORAL 25 MG QAM PO Intervention to Depakote - Slow Prevent Permanent Release SS ORAL 500 MG BID PO Impairment/Damage Senokot C Clozaril C Miralax C Lithium C Date:10/02/02ISR Number: 3984615-0Report Type:Expedited (15-DaCompany Report #2002AP02993 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Cardiomyopathy Health PO Required Professional Clomipramine Intervention to Other Hydrochloride C Prevent Permanent Zyprexa C Impairment/Damage 22-Feb-2006 08:31 AM Page: 545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/02ISR Number: 3986285-4Report Type:Expedited (15-DaCompany Report #2002UW12947 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Health Seroquel PS 100 MG AM AND Intervention to Dystonia Professional NOON 200 MG Prevent Permanent Grimacing HS Impairment/Damage Tongue Disorder Seroquel SS 50 MG AM & NON 400 MG HS Seroquel SS 50 MG AM & NOON 400 MG HS Seroquel SS 25 MG AM & NOON 400 MG HS Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Risperdal SS ORAL 1 MG HS PO Risperdal SS .25 MG AM & NOON 1 MG HS Risperdal SS 0.5 MG AM & NOON 1 MG HS Risperdal SS 1 MG TID Risperdal SS 1 MG AM & NOON 2 MG HS Date:10/02/02ISR Number: 3987326-0Report Type:Expedited (15-DaCompany Report #2002GB01961 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Foreign Seroquel PS ORAL 350 MG DAILY Intervention to Complications Of Maternal Health PO Prevent Permanent Exposure To Therapeutic Professional Seroquel SS ORAL 100 MG BID PO Impairment/Damage Drugs Other Clomipramine C Neurological Symptom Pregnancy Tremor Date:10/02/02ISR Number: 3987328-4Report Type:Expedited (15-DaCompany Report #2002AP02883 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Seroquel PS ORAL 75 MG DAILY Cardiac Arrest Health PO Dehydration Professional Seroquel SS ORAL 200 MG DAILY Diarrhoea Other PO Dyspnoea Serenace C Gastrointestinal Disorder Impromen C Hyperglycaemia Akineton C Hyperkalaemia Halcion C Ketoacidosis Rohypnol C Polydipsia Ubretid C Pyrexia Retching Vomiting 22-Feb-2006 08:31 AM Page: 546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/02ISR Number: 3987329-6Report Type:Expedited (15-DaCompany Report #2002AP02620 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspartate Foreign Seroquel PS ORAL 600 MG DAILY Hospitalization - Aminotransferase Health PO Initial or Prolonged Increased Professional Akineton SS ORAL 3 MG DAILY PO Required Blood Creatine Other Silece SS ORAL 2 MG DAILY PO Intervention to Phosphokinase Increased Levotomin SS ORAL 5 MG DAILY PO Prevent Permanent Coma Impairment/Damage Depressed Level Of Consciousness Hepatic Function Abnormal Overdose Somnolence Suicide Attempt Date:10/02/02ISR Number: 3987332-6Report Type:Expedited (15-DaCompany Report #2002AP02304 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Seroquel PS ORAL 100 MG DAILY Hospitalization - Blood Amylase Increased Health PO Initial or Prolonged Blood Creatinine Professional Seroquel SS ORAL 600 MG DAILY Required Increased Other PO Intervention to Blood Urea Increased Seroquel SS ORAL 300 MG DAILY Prevent Permanent Coma PO Impairment/Damage Dehydration Serenace C Heart Rate Increased Akineton C Hyperglycaemia Artane C Hyperreflexia Wintermin C Ketoacidosis Hirnamin C Pyrexia Vegetamin A C Speech Disorder Thirst Weight Increased White Blood Cell Count Increased Date:10/03/02ISR Number: 3987425-3Report Type:Expedited (15-DaCompany Report #2002GB01336 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Seroquel PS Initial or Prolonged Health Chlorpromazine C Professional Other Date:10/03/02ISR Number: 3987429-0Report Type:Expedited (15-DaCompany Report #2002GB01336 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Seroquel PS Initial or Prolonged Health Chlorpromazine C Professional Other 22-Feb-2006 08:31 AM Page: 547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/02ISR Number: 3988227-4Report Type:Expedited (15-DaCompany Report #2002UW12295 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Seroquel PS Sedation Professional Serzone SS Thinking Abnormal Date:10/04/02ISR Number: 3988362-0Report Type:Expedited (15-DaCompany Report #2002AP02947 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anger Foreign Seroquel PS ORAL 100 MG DAILY Cerebrovascular Disorder Health PO Condition Aggravated Professional Tegretol C Crying Other Gramalil C Depressed Level Of Solon C Consciousness Tasmolin C Hyperglycaemia Magnesium Oxide C Hypernatraemia Inappropriate Affect Incoherent Insomnia Mental Disorder Mood Altered Neuroleptic Malignant Syndrome Oliguria Peripheral Coldness Date:10/04/02ISR Number: 3988366-8Report Type:Expedited (15-DaCompany Report #2002AP02843 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Bicarbonate Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Increased Health PO Initial or Prolonged Blood Ph Decreased Professional Tryptanol C Required Circulatory Collapse Other Herlat C Intervention to Coma Digosin C Prevent Permanent Contusion Impairment/Damage Convulsion Delirium Hepatic Function Abnormal Pco2 Abnormal Respiratory Depression Date:10/04/02ISR Number: 3988368-1Report Type:Expedited (15-DaCompany Report #2002GB02265 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 750 MG DAILY Neutropenia Health PO Professional Other 22-Feb-2006 08:31 AM Page: 548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/02ISR Number: 3989247-6Report Type:Expedited (15-DaCompany Report #2002AP03042 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 250 MG DAILY Initial or Prolonged Increased Health PO Aspartate Professional Solanax C Aminotransferase Other Sepazon C Increased Sediel C Blood Alkaline Depas C Phosphatase Increased Isomytal C Blood Bilirubin Increased Magnesium Oxide C Blood Lactate Amoban C Dehydrogenase Increased Yodel C Gamma-Glutamyltransferase Paxil C Increased Tetramide C Hepatic Function Abnormal Jaundice Date:10/08/02ISR Number: 3986707-9Report Type:Expedited (15-DaCompany Report #2002UW13275 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Date:10/08/02ISR Number: 3986711-0Report Type:Expedited (15-DaCompany Report #2002UW13269 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Seroquel PS Tenormin SS Date:10/08/02ISR Number: 3987206-0Report Type:Expedited (15-DaCompany Report #02P-163-0201368-00 Age:16 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Valproic Acid Completed Suicide Health (Depakene) (Valproic Professional Acid) (Valproic Acid) PS Quetiapine SS Bupropion SS Date:10/08/02ISR Number: 3989589-4Report Type:Expedited (15-DaCompany Report #2002003819 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS ORAL 40 MG (TWICE Initial or Prolonged Electrocardiogram Qt Professional A DAY), ORAL Corrected Interval Trifluoperazine Prolonged Hydrochloride SS 5 MG (DAILY) Quetiapine Fumarate SS Citalopram Hydrobromide C 22-Feb-2006 08:31 AM Page: 549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/02ISR Number: 3989743-1Report Type:Direct Company Report #CTU 178236 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Quitiapine 25 Mg PS ORAL 25 MG BID & Initial or Prolonged Syndrome 50 MG ORAL Renal Failure Acute Haloperidol 5mg/Ml Inj SS Sertraline C Furosemide C Docusate C Enalapril C Pantoprazole C Ipratropium C Date:10/08/02ISR Number: 3989822-9Report Type:Expedited (15-DaCompany Report #2002056537 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Parkinsonism Health Geodon (Ziprasidone) PS 160 MG (BID), Other Tardive Dyskinesia Professional Seroquel (Quetiapine Company Fumarate) SS 100 MG (TID), Representative Valium (Diazepam) C Wellbutrin (Bupropion Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Vicodin Es (Vicodin) C Naprosyn (Naproxen) C Date:10/08/02ISR Number: 3990392-XReport Type:Expedited (15-DaCompany Report #2002AP03075 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Seroquel PS ORAL 125 MG DAILY Initial or Prolonged Diabetic Ketoacidosis Health PO Professional Seroquel SS ORAL 200 MG DAILY Other PO Akineton C Glucobay C Euglucon C Tsumura Byakkokaninjinto C Picoben C Lendormin C Rohypnol C Tegretol C Lipitor C Magnesium Oxide C Date:10/08/02ISR Number: 3990523-1Report Type:Expedited (15-DaCompany Report #2002090023 Age:59 YR Gender:Female I/FU:I Outcome PT Life-Threatening Dizziness Hypotension Hypothermia Memory Impairment 22-Feb-2006 08:31 AM Page: 550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Doral (Quazepam) Health Tablets PS ORAL 15 MG/D, PO Professional Quetiapine Fumarate SS ORAL 200 MG/D, PO Olanzapine SS ORAL 5 MG/D PO Etizolam SS ORAL 3 MG/D PO Clonazepam SS ORAL 1 MG/D PO Carbamazepine SS ORAL 150 MG/D PO Lormetazepam SS ORAL 1 MG/D PO Sennosides C Biperiden Hcl C Etilefrine Hcl C Amezinium Metilsulfate C Magnesium Oxide C Pantethine C Date:10/08/02ISR Number: 3990641-8Report Type:Expedited (15-DaCompany Report #2002SE05210 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Seroquel PS ORAL 12.5 MG DAILY Initial or Prolonged Loss Of Consciousness Health PO Professional Seroquel SS ORAL 25 MG DAILY Other PO Sinemet C Transipeg C Carbasalaatcalcium Poeder C Persantin C Axid C Date:10/09/02ISR Number: 3987380-6Report Type:Direct Company Report #USP 55303 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel PS Astra Zeneca Serzone SS Bristol-Myers Squibb Date:10/09/02ISR Number: 3991306-9Report Type:Expedited (15-DaCompany Report #2002AP03042 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 250 MG DAILY Initial or Prolonged Increased Health PO Aspartate Professional Solanax C Aminotransferase Other Sepazon C Increased Sediel C Blood Alkaline Isomytal C Phosphatase Increased Magnesium Oxide C Blood Bilirubin Increased Amoban C Blood Lactate Yodel C Dehydrogenase Increased Paxil C Gamma-Glutamyltransferase Tetramide C Increased 22-Feb-2006 08:31 AM Page: 551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/02ISR Number: 3991309-4Report Type:Expedited (15-DaCompany Report #2002UW13313 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Foreign Seroquel PS ORAL 400 MG DAILY Thromboplastin Time Health PO Prolonged Professional Seroquel SS ORAL 300 MG DAILY Leukopenia Other PO Lymphocyte Count Seroquel SS ORAL 300 MG DAILY Decreased PO Platelet Count Decreased Loxapine C Diltiazem C Premarin C Dyazide C Vitamin E C Date:10/09/02ISR Number: 3991311-2Report Type:Expedited (15-DaCompany Report #2002SE04943 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 200 MG DAILY Health PO Professional Prozac C Other Trankimazin C Plenur C Risperidone C Date:10/09/02ISR Number: 3991314-8Report Type:Expedited (15-DaCompany Report #2002UW12169 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS ORAL 125 MG BID PO Intervention to White Blood Cell Count Study Serax C Prevent Permanent Decreased Health Impairment/Damage Professional Other Date:10/09/02ISR Number: 3991770-5Report Type:Expedited (15-DaCompany Report #2002GB02176 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Seroquel PS NOT MORE THAN Hospitalization - Insulin-Dependent Health 400MG PER DAY Initial or Prolonged Diabetic Coma Professional Lithium C Hypernatraemia Other Date:10/09/02ISR Number: 3991954-6Report Type:Expedited (15-DaCompany Report #2002UW13496 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Seroquel PS ORAL 100 MG HS PO 4 WK Initial or Prolonged Professional 22-Feb-2006 08:31 AM Page: 552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/02ISR Number: 3991939-XReport Type:Expedited (15-DaCompany Report #2002GB01503 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Injury Asphyxiation Health Professional Other Date:10/10/02ISR Number: 3991943-1Report Type:Expedited (15-DaCompany Report #2002AP03145 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS ORAL 600 MG DAILY Decreased Health PO Professional Risperdal C Other Date:10/11/02ISR Number: 3991643-8Report Type:Direct Company Report #CTU 178559 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Quetiapine 25mg PS ORAL 50MG BID ORAL Initial or Prolonged Grimacing Quetiapine 25mg SS ORAL 25MG BID ORAL Muscle Rigidity Flonase C Apap C Tums C Mom C Dulcolax C Pantanol C Enalapril C Sinemet C Paxil C Vit C C Vit E C Bactrim Ds C Date:10/11/02ISR Number: 3992955-4Report Type:Expedited (15-DaCompany Report #2002AP02843 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Coma Health PO Initial or Prolonged Contusion Professional Tryptanol C Required Convulsion Other Herlat C Intervention to Delirium Digosin C Prevent Permanent Hepatic Function Abnormal Impairment/Damage Injury Nervous System Disorder Oxygen Saturation Decreased Respiratory Depression 22-Feb-2006 08:31 AM Page: 553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/02ISR Number: 3993040-8Report Type:Expedited (15-DaCompany Report #2002GB02273 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Seroquel PS ORAL 600 MG DAILY Neutropenia Health PO Psychotic Disorder Professional Seroquel SS ORAL 400 MG DAILY Other PO Clozapine C Date:10/11/02ISR Number: 3993042-1Report Type:Expedited (15-DaCompany Report #2002SE05214 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Foreign Seroquel PS ORAL 300 MG DAILY Hyperpyrexia Health PO Metabolic Acidosis Professional Renal Failure Acute Other Respiratory Failure Rhabdomyolysis Date:10/15/02ISR Number: 3992949-9Report Type:Expedited (15-DaCompany Report #S02-UKI-02207-01 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Cipramil (Citalopram Intentional Overdose Health Hydrobromide) PS Professional Seroquel Other (Quetiapine) SS ORAL 600 MG PO Diazepam C Methadone C Topiramate C Morphine C Date:10/16/02ISR Number: 3992652-5Report Type:Direct Company Report #CTU 178769 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Status Changes Quetiapine PS 600MG BID ; Initial or Prolonged Pneumonia Aspiration 600MG QAM, Respiratory Distress 900MG QD Somnolence Date:10/16/02ISR Number: 3992713-0Report Type:Direct Company Report #CTU 178876 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Movement Disorder Seroquel 25mg Astra Zeneca PS Astra Zeneca ORAL 50MG HS PO Nicoderm C Eskalith Cr C B-Complex +C C Tylenol C Maalox C Dulcolaxs C Pepcid C 22-Feb-2006 08:31 AM Page: 554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/02ISR Number: 3993621-1Report Type:Direct Company Report #CTU 178850 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cataract Seroquel PS Astra Zeneca 400MG BID 1 YR Initial or Prolonged Date:10/16/02ISR Number: 3993640-5Report Type:Expedited (15-DaCompany Report #2002AP02993 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Cardiomyopathy Health PO Initial or Prolonged Professional Clomipramine Required Other Hydrochloride C Intervention to Zyprexa C Prevent Permanent Impairment/Damage Date:10/16/02ISR Number: 3993654-5Report Type:Expedited (15-DaCompany Report #2002SE05071 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dementia Foreign Seroquel PS ORAL 25 MG BID PO Diabetes Mellitus Health Seroquel SS ORAL 100 MG DAILY Diabetic Coma Professional PO Leukocytosis Other Phenytoin Sodium SS ORAL 300 MG DAILY Loss Of Consciousness PO Pyrexia Rivastigmine Urinary Incontinence Hydrogen Tartrate C Urinary Tract Infection Acarbose C Sertraline C Glucobay C Zyprexa C Date:10/16/02ISR Number: 3994584-5Report Type:Expedited (15-DaCompany Report #2002UW13817 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Self-Injury Health Seroquel PS Hospitalization - Overdose Professional Zyprexa SS Initial or Prolonged Physical Assault Ventricular Tachycardia Date:10/16/02ISR Number: 3994592-4Report Type:Expedited (15-DaCompany Report #1998UW47645 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatitis C Literature Seroquel PS ORAL 200 MG BID PO Intervention to Leukopenia Health Seroquel SS ORAL 200 MG DAILY Prevent Permanent Neutropenia Professional PO Impairment/Damage Paranoia Olanzapine SS 10 MG DAILY Physical Assault Risperdal C Psychotic Disorder Thrombocytopenia 22-Feb-2006 08:31 AM Page: 555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/02ISR Number: 3995859-6Report Type:Expedited (15-DaCompany Report #2002AP02947 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anger Foreign Seroquel PS ORAL 100 MG DAILY Hospitalization - Cerebrovascular Disorder Health PO Initial or Prolonged Coma Professional Tegretol SS ORAL 1 G DAILY PO Required Condition Aggravated Other Tasmolin SS ORAL 0.3 G DAILY Intervention to Crying PO Prevent Permanent Dehydration Gramalil SS ORAL 0.6 G DAILY Impairment/Damage Disseminated PO Intravascular Coagulation Serenace SS Euphoric Mood Fludecasin SS 250 MG ONCE Glycosylated Haemoglobin IM Increased Solon C Haemodialysis Linton C Hyperglycaemia Magnesium Oxide C Hypernatraemia Cercine C Insomnia Ischaemia Malnutrition Neuroleptic Malignant Syndrome Renal Failure Acute Shock White Blood Cell Count Increased Date:10/16/02ISR Number: 3995924-3Report Type:Expedited (15-DaCompany Report #2002AP03075 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Seroquel PS ORAL 125 MG DAILY Initial or Prolonged Inadequate Control Other PO Seroquel SS ORAL 200 MG DAILY PO Akineton C Glucobay C Euglucon C Picoben C Lendormin C Rohypnol C Tegretol C Lipitor C Magnesium C Date:10/16/02ISR Number: 3995925-5Report Type:Expedited (15-DaCompany Report #2002GB00788 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Foreign Seroquel PS ORAL 150 MG BID PO Intervention to Complications Of Maternal Health Prevent Permanent Exposure To Therapeutic Professional Impairment/Damage Drugs Other Foetal Growth Retardation Haemorrhage Maternal Drugs Affecting Foetus 22-Feb-2006 08:31 AM Page: 556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/02ISR Number: 4012516-0Report Type:Periodic Company Report #001-0945-M0200505 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Neurontin Professional (Gabapentin) PS Quetiapine SS Paroxetine Hydrochloride C Date:10/17/02ISR Number: 3995660-3Report Type:Expedited (15-DaCompany Report #2002SE05260 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disseminated Foreign Seroquel PS Initial or Prolonged Intravascular Coagulation Health Professional Other Date:10/17/02ISR Number: 3995664-0Report Type:Expedited (15-DaCompany Report #2002AP03042 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS ORAL 150 MG DAILY Hospitalization - Increased Health PO Initial or Prolonged Aspartate Professional Seroquel SS ORAL 250 MG DAILY Aminotransferase Other PO Increased Solanax C Blood Alkaline Sepazon C Phosphatase Increased Sediel C Gamma-Glutamyltransferase Depas C Increased Isomytal C Jaundice Magnesium Oxide C Amoban C Yodel C Paxil C Tetramide C Date:10/17/02ISR Number: 3995665-2Report Type:Expedited (15-DaCompany Report #2002SE05214 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Foreign Seroquel PS ORAL 300 MG DAILY Hyperpyrexia Health PO Metabolic Acidosis Professional Renal Failure Acute Other Respiratory Failure Rhabdomyolysis Date:10/17/02ISR Number: 3997318-3Report Type:Expedited (15-DaCompany Report #2002UW13833 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Health Seroquel PS ORAL 200 MG PO Drug Interaction Professional Methadone SS 22-Feb-2006 08:31 AM Page: 557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/02ISR Number: 3997319-5Report Type:Expedited (15-DaCompany Report #2002UW13615 Age:65 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pulmonary Arterial Wedge Health Seroquel PS ORAL 50 MG DAILY Intervention to Pressure Increased Professional PO Prevent Permanent Pulmonary Oedema B Blockers C Impairment/Damage Ace Inhibitor C Aspirin C Bayer Statin Drug C Lasix C Potassium Supplement C Coumadin "Boots" C Prevacid C Digoxin C Date:10/21/02ISR Number: 3998466-4Report Type:Expedited (15-DaCompany Report #2002UW13909 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Tenormin SS Date:10/22/02ISR Number: 3998834-0Report Type:Expedited (15-DaCompany Report #2002GB00679 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Foreign Seroquel PS 750 MG DAILY Intervention to Complications Of Maternal Health Procyclidine C Prevent Permanent Exposure To Therapeutic Professional Chlorpromazine C Impairment/Damage Drugs Other Carbamazepine C Maternal Drugs Affecting Nitrazepam C Foetus Lamotrigine C Sertraline C Lansoprazole C Kolanticon C Picosulphate C Fish Oil C Date:10/22/02ISR Number: 3998837-6Report Type:Expedited (15-DaCompany Report #2002AP03237 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Platelet Count Decreased Health PO Prevent Permanent Professional Seroquel SS ORAL 500 MG DAILY Impairment/Damage Other PO Seroquel SS ORAL 600 MG DAILY PO Depakene C Horizon C Hypnotics C 22-Feb-2006 08:31 AM Page: 558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/02ISR Number: 3999345-9Report Type:Expedited (15-DaCompany Report #2002GB02408 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Seroquel PS Health Professional Other Date:10/23/02ISR Number: 3999351-4Report Type:Expedited (15-DaCompany Report #2002UW13313 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Foreign Seroquel PS ORAL 400 MG DAILY Thromboplastin Time Health PO Prolonged Professional Seroquel SS ORAL 300 MG DAILY Leukopenia Other PO Lymphocyte Count Seroquel SS ORAL 300 MG DAILY Decreased PO Platelet Count Decreased Loxapine C Diltiazem C Premarin C Dyazide C Vitamin E C Date:10/23/02ISR Number: 3999408-8Report Type:Expedited (15-DaCompany Report #A0383148A Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Intentional Overdose Health Unspecified Tablet Professional (Bupropion Hydrochloride) PS ORAL ORAL Quetiapine (Formulation Unknown) (Quetiapine) SS Date:10/23/02ISR Number: 3999612-9Report Type:Expedited (15-DaCompany Report #A0383147A Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Intentional Overdose Health Unspecified Tablet Professional (Bupropion Hydrochloride) PS ORAL ORAL Quetiapine (Formulation Unknown) (Quetiapine) SS Date:10/24/02ISR Number: 4000570-1Report Type:Expedited (15-DaCompany Report #2002SE05467 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Life-Threatening Intentional Overdose Foreign Suicide Attempt Health Professional 22-Feb-2006 08:31 AM Page: 559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 800 MG QD PO Date:10/24/02ISR Number: 4000789-XReport Type:Expedited (15-DaCompany Report #2002UW14097 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Literature Seroquel PS Health Serzone SS Professional Date:10/24/02ISR Number: 4001238-8Report Type:Expedited (15-DaCompany Report #2002AP03279 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Infarction Foreign Seroquel PS ORAL 200 MG DAILY Health PO Professional Seroquel SS ORAL 300 MG DAILY Other PO Forit C Tegretol C Fluphenazine Enantate C Date:10/24/02ISR Number: 4001240-6Report Type:Expedited (15-DaCompany Report #2002UW14087 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Date:10/29/02ISR Number: 4001307-2Report Type:Direct Company Report #CTU 179922 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Seroquel PS 100 QD AND Initial or Prolonged Hallucination, Visual 300QHS CHRONIC Sinemet SS 25/100 1.5 TABS QD 1 TAB BID CHRONIC Oxybutynin SS 2.5MG Q 12HR Lorazepam SS INTRAVENOUS 0.5-1MG IV Q 1-2 PRN 1 DAY Reminyl C Propranolol C Fosamax C Carbidopa C Dulcolax Supp C Oscal C Comtan C 22-Feb-2006 08:31 AM Page: 560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/02ISR Number: 4002991-XReport Type:Expedited (15-DaCompany Report #2002AP03376 Age:60 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Seroquel PS ORAL 200 MG DAILY Health PO Professional Hirnamin C Other Rohypnol C Risperdal C Date:10/29/02ISR Number: 4003106-4Report Type:Expedited (15-DaCompany Report #2002UW14255 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS ORAL 25 MG PO Professional Date:10/29/02ISR Number: 4003108-8Report Type:Expedited (15-DaCompany Report #2002UW14266 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Seroquel PS ORAL 600 MG DAILY Professional PO Date:10/29/02ISR Number: 4003110-6Report Type:Expedited (15-DaCompany Report #2002UW14448 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Date:10/29/02ISR Number: 4003112-XReport Type:Expedited (15-DaCompany Report #2002UW14320 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Health Seroquel PS ORAL 200 MG PO Initial or Prolonged Professional Date:10/29/02ISR Number: 4003133-7Report Type:Expedited (15-DaCompany Report #2002UW14288 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Seroquel PS ORAL 325 MG DAILY Blood Pressure Decreased Health PO Convulsion Professional Alesse SS ORAL 1 DF DAILY PO Drug Interaction Other Topamax SS ORAL 150 MG BID PO Drug Level Increased Clozaril SS ORAL 400 MG DAILY Dyspnoea PO Oedema Peripheral Effexor - Slow Pulmonary Embolism Release SS ORAL 187.5 MG Tachycardia DAILY PO Ativan C Flonase C Haldol "Janssen" C Vitamin B12 C 22-Feb-2006 08:31 AM Page: 561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/02ISR Number: 4003134-9Report Type:Expedited (15-DaCompany Report #2002PK01060 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythropenia Foreign Seroquel PS ORAL 300 MG DAILY Gamma-Glutamyltransferase Health PO Increased Professional Leukopenia Other Thrombocytopenia Date:10/29/02ISR Number: 4003136-2Report Type:Expedited (15-DaCompany Report #2002GB02176 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Seroquel PS NOT MORE THAN Hospitalization - Insulin-Dependent Health 400 MG PER Initial or Prolonged Diabetic Coma Professional DAY Hypernatraemia Other Lithium C Date:10/29/02ISR Number: 4003140-4Report Type:Expedited (15-DaCompany Report #2002SE05214 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Foreign Seroquel PS ORAL 300 MG DAILY Hyperpyrexia Health PO Metabolic Acidosis Professional Renal Failure Acute Other Respiratory Failure Rhabdomyolysis Date:10/30/02ISR Number: 4002203-7Report Type:Direct Company Report #CTU 180000 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Olanzapine PS Seroquel 25 Mg Tablet SS Date:10/31/02ISR Number: 4003678-XReport Type:Expedited (15-DaCompany Report #2002UW14397 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 50 MG DAILY Intervention to Prothrombin Time Health PO Prevent Permanent Prolonged Professional Warfarin SS 2.5 MG INT Impairment/Damage Other Avandia C Clonazepam C Digoxin C Duragesic C Lipitor C Metformin C Metoprolol C Neurontin C Niacin C Nortriptyline C Prevacid C Risperdal C Serzone C 22-Feb-2006 08:31 AM Page: 562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vioxx C Date:10/31/02ISR Number: 4003688-2Report Type:Expedited (15-DaCompany Report #2002UW14416 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS ORAL 75 MG BID PO Intervention to Agitation Health Cipro "Bayer" SS ORAL 500 MG BID PO 10 DAY Prevent Permanent Apnoea Professional Ergocalciferol C Impairment/Damage Depressed Level Of Other Levothyroxine C Consciousness Pantoloc "Byk Hemiparesis Madaus" C Muscle Twitching Prednisone C Prolopa C Date:10/31/02ISR Number: 4004050-9Report Type:Expedited (15-DaCompany Report #2002SE05185 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Foreign Seroquel PS ORAL 600 MG DAILY Intervention to Phosphokinase Increased Health PO Prevent Permanent Professional Lexotan C Impairment/Damage Other Date:10/31/02ISR Number: 4004396-4Report Type:Expedited (15-DaCompany Report #2002AP03444 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Quetiapine PS ORAL 200 MG DAILY Hospitalization - Akinesia Literature PO Initial or Prolonged Ammonia Increased Health Quetiapine SS ORAL 20000MG ONCE Required Coma Professional PO Intervention to Depression Other Valproate SS ORAL 200 MG TID PO Prevent Permanent Dysphoria Valproate SS ORAL 16000 MG ONCE Impairment/Damage Excitability PO Hostility Chloridemethyl-Diaze Intentional Overdose pam C Irritability Venlafaxine C Respiratory Rate Decreased Suicide Attempt Tachycardia Tremor Date:10/31/02ISR Number: 4004400-3Report Type:Expedited (15-DaCompany Report #2002UW14342 Age:79 YR Gender:Male I/FU:I Outcome PT Required Alanine Aminotransferase Intervention to Increased Prevent Permanent Aspartate Impairment/Damage Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Gamma-Glutamyltransferase 22-Feb-2006 08:31 AM Page: 563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS 1 WK Health Divalproex Sodium C Professional Methotrimeprazine C Other Metoprolol C Date:10/31/02ISR Number: 4004405-2Report Type:Expedited (15-DaCompany Report #2002GB02434 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blepharospasm Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Oral Discomfort Health PO Prevent Permanent Professional Seroquel SS ORAL 100 MG BID PO Impairment/Damage Other Date:10/31/02ISR Number: 4004407-6Report Type:Expedited (15-DaCompany Report #2002UW14400 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Purpura Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Thrombocytopenia Health PO 9 DAY Prevent Permanent Professional Zyprexa SS 2.5 MG DAILY 19 MON Impairment/Damage Other Asa C Centrum Forte C Cimetidine C Lorazepam C Vitamin B Complex C Vitamin E C Zopiclone C Date:10/31/02ISR Number: 4004412-XReport Type:Expedited (15-DaCompany Report #2002AP02883 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Seroquel PS OROPHARINGEAL 75 MG DAILY Required Cardiac Arrest Health PO Intervention to Diabetes Mellitus Professional Seroquel SS ORAL 200 MG DAILY Prevent Permanent Diabetic Ketoacidosis Other PO Impairment/Damage Diarrhoea Serenace C Dyspnoea Impromen C Hyperkalaemia Akineton C Ketoacidosis Halcion C Nasopharyngitis Rohypnol C Psychiatric Symptom Ubretid C Date:10/31/02ISR Number: 4004886-4Report Type:Expedited (15-DaCompany Report #2002AP03630 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Intentional Overdose Health Amoxapine SS Professional 22-Feb-2006 08:31 AM Page: 564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/02ISR Number: 4004887-6Report Type:Expedited (15-DaCompany Report #2002AP03616 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Literature Quetiapine PS Suicide Attempt Health Verapamil SS Professional Valproic Acid SS Date:10/31/02ISR Number: 4004888-8Report Type:Expedited (15-DaCompany Report #2002AP03609 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Quetiapine PS Completed Suicide Health Bupropion SS Intentional Overdose Professional Date:10/31/02ISR Number: 4004924-9Report Type:Expedited (15-DaCompany Report #2002AP03602 Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Quetiapine PS Completed Suicide Health Bupropion SS Intentional Overdose Professional Date:10/31/02ISR Number: 4004926-2Report Type:Expedited (15-DaCompany Report #2002AP03598 Age:56 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Intentional Overdose Health Amitriptyline SS Professional Date:10/31/02ISR Number: 4004928-6Report Type:Expedited (15-DaCompany Report #2002AP03585 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Intentional Overdose Health Professional Date:10/31/02ISR Number: 4004929-8Report Type:Expedited (15-DaCompany Report #2002AP03573 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Intentional Overdose Health Olanzapine SS Toxicologic Test Abnormal Professional Date:10/31/02ISR Number: 4004937-7Report Type:Expedited (15-DaCompany Report #2002AP03567 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Quetiapine PS Health Flurazepam SS Professional Benztropine SS 22-Feb-2006 08:31 AM Page: 565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/02ISR Number: 4004939-0Report Type:Expedited (15-DaCompany Report #2002AP03530 Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Intentional Overdose Health Tricyclic Professional Antidepressant SS Cocaine SS Date:10/31/02ISR Number: 4004940-7Report Type:Expedited (15-DaCompany Report #2002AP03589 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Intentional Overdose Health Professional Date:11/01/02ISR Number: 4005346-7Report Type:Expedited (15-DaCompany Report #2002UW12580 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Increased Health PO Blood Lactate Professional Ascorbic Acid C Dehydrogenase Increased Other Betaxolol C Gamma-Glutamyltransferase Clotrimazole C Increased Estraderm C Jaundice Provera C Multivitamins C Zopiclone C Gentamicin C Gravol C Tylenol C Date:11/01/02ISR Number: 4005519-3Report Type:Expedited (15-DaCompany Report #2002UW14393 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Foreign Seroquel PS ORAL 500 MG QD PO Intervention to Loss Of Consciousness Health Clozaril SS ORAL 150 MG QD PO Prevent Permanent Professional Nifedipine C Impairment/Damage Other Date:11/04/02ISR Number: 4003180-5Report Type:Direct Company Report #CTU 180232 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Medication Error Seroquel 200mg Astrazeneca PS Astrazeneca Serzone 200mg Bristol Myers Squibb SS Bristol Myers Squibb 22-Feb-2006 08:31 AM Page: 566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/02ISR Number: 4003689-4Report Type:Direct Company Report #CTU 180297 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antinuclear Antibody Seroquel PS ORAL 50 MG PO Q HS 3 WK Life-Threatening Positive Lithium C Hospitalization - Hepatic Failure Altace C Initial or Prolonged Metformin C Colace C Vitamins C Date:11/06/02ISR Number: 4007425-7Report Type:Expedited (15-DaCompany Report #HQ5017401NOV2002 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Inderal (Propranolol Completed Suicide Hydrochloride, Intentional Overdose Unspec) PS ORAL ORAL Quetiapine (Quetiapine,) SS Valproic Acid (Valproic Acid,) SS Date:11/06/02ISR Number: 4007696-7Report Type:Expedited (15-DaCompany Report #HQ5017301NOV2002 Age:32 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Inderal (Propranolol Intentional Overdose Hydrochloride, Unspec) PS ORAL ORAL Alprazolam (Alprazolam, ) SS Quetiapine (Quetiapine, ) SS Date:11/06/02ISR Number: 4007744-4Report Type:Expedited (15-DaCompany Report #2002UW14708 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Health Seroquel PS ORAL 100 MG PO Life-Threatening Professional Lithium C Hospitalization - Altace C Initial or Prolonged Metformin C Disability Date:11/06/02ISR Number: 4007746-8Report Type:Expedited (15-DaCompany Report #2002UW14646 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Seroquel PS ORAL 200 MG DAILY Professional PO 22-Feb-2006 08:31 AM Page: 567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/02ISR Number: 4007868-1Report Type:Expedited (15-DaCompany Report #2002UW14457 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Catatonia Foreign Seroquel PS ORAL 50 MG BID PO Intervention to Confusional State Health Clonazepam C Prevent Permanent Dehydration Professional Serzone C Impairment/Damage Mutism Other Vioxx C Neuroleptic Malignant Syndrome Neutropenia Date:11/06/02ISR Number: 4007914-5Report Type:Expedited (15-DaCompany Report #2002AP03576 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Literature Propranolol PS Suicide Attempt Health Quetiapine SS Professional Valproic Acid SS Date:11/06/02ISR Number: 4007932-7Report Type:Expedited (15-DaCompany Report #2002PK01101 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Seroquel PS ORAL 37.5 MG DAILY Health PO Professional Madopar C Other Requip C Biperiden Neurax C Pholedrin C Date:11/06/02ISR Number: 4007934-0Report Type:Expedited (15-DaCompany Report #2002UW14430 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 800 MG QD PO Intervention to Drug Level Decreased Health Tegretol SS 1400 MG DAILY Prevent Permanent Professional Impairment/Damage Other Date:11/06/02ISR Number: 4008257-6Report Type:Expedited (15-DaCompany Report #2002GB02463 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS ORAL 400 MG DAILY Decreased Health PO Professional Venlafaxine C Other Date:11/06/02ISR Number: 4008284-9Report Type:Expedited (15-DaCompany Report #2002UW14373 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Seroquel PS ORAL 50 MG TID PO Initial or Prolonged Health Prozac SS 40 MG DAILY Professional Effexor-Xr C Other Trazodone C 22-Feb-2006 08:31 AM Page: 568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tylenol No. 2 C Toradol C Flexeril C Ativan C Codeine C Date:11/06/02ISR Number: 4008549-0Report Type:Expedited (15-DaCompany Report #2002GB02468 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 250 MG DAILY Muscle Spasms Health PO Neutropenia Professional Depakote SS ORAL 3000 MG DAILY Other PO Date:11/06/02ISR Number: 4008552-0Report Type:Expedited (15-DaCompany Report #2002AP02699 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abulia Foreign Seroquel PS ORAL 25 MG DAILY Required Apnoea Health PO Intervention to Asthenia Professional Tolopelon C Prevent Permanent Blood Pressure Decreased Other Akineton C Impairment/Damage Body Temperature Pyrethia C Decreased Eurodin C Coma Benzalin C Cyanosis Serenace C Delusion Dantrolene Sodium C Depressed Level Of Consciousness Drug Hypersensitivity Heart Rate Increased Hyperglycaemia Hypersensitivity Neuroleptic Malignant Syndrome Pallor Pneumonia Respiratory Rate Increased Date:11/07/02ISR Number: 4008351-XReport Type:Expedited (15-DaCompany Report #2002GB02278 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Neonatal Initial or Prolonged Complications Of Maternal Exposure To Therapeutic Drugs Drug Withdrawal Syndrome Feeding Disorder Neonatal Foreign Body Aspiration Hypervigilance Hypotonia Neonatal Induced Labour Insomnia Maternal Drugs Affecting Foetus 22-Feb-2006 08:31 AM Page: 569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neonatal Aspiration Neonatal Disorder Premature Baby Report Source Product Role Manufacturer Route Dose Duration Premature Rupture Of Foreign Seroquel PS 400 MG BID Membranes Health TPL Professional Paroxetine SS 20 MG QD TPL Other Pethidine C Date:11/07/02ISR Number: 4009076-7Report Type:Expedited (15-DaCompany Report #2002AP03574 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Propranolol PS Intentional Overdose Health Quetiapine SS Professional Alprazolam SS Date:11/07/02ISR Number: 4009158-XReport Type:Expedited (15-DaCompany Report #2002UW14867 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Health Seroquel PS Initial or Prolonged Myocardial Infarction Professional Altace C Lopressor C Imdur C Plavix C Zocor "Dieckmann" C Date:11/07/02ISR Number: 4009253-5Report Type:Expedited (15-DaCompany Report #2002UW14645 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Seroquel PS Date:11/07/02ISR Number: 4009290-0Report Type:Expedited (15-DaCompany Report #2002SE05653 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Seroquel PS Health Methadone C Professional Benzodiazepine C Other Date:11/08/02ISR Number: 4009519-9Report Type:Expedited (15-DaCompany Report #2002SE05579 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Herpes Zoster Foreign Seroquel PS ORAL 600 MG QD PO Intervention to Leukopenia Health Seroquel SS ORAL 400 MG QD PO Prevent Permanent Rash Macular Professional Lexotanil C Impairment/Damage Other Akineton C Stelazine C Granulokine C Lithium C 22-Feb-2006 08:31 AM Page: 570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/02ISR Number: 4009529-1Report Type:Expedited (15-DaCompany Report #2002SE05604 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS ORAL 2002 MG QD PO Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:11/08/02ISR Number: 4009531-XReport Type:Expedited (15-DaCompany Report #2002AP02883 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel PS ORAL 300 MG DAILY Death Health PO Dehydration Professional Serenace C Diabetic Ketoacidosis Other Impromen C Dyspnoea Akineton C Hyperkalaemia Halcion C Nasopharyngitis Rohypnol C Psychiatric Symptom Ubretid C Date:11/08/02ISR Number: 4009742-3Report Type:Expedited (15-DaCompany Report #2002UW14793 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Unilateral Health Seroquel PS ORAL 200 MG DAILY Required Professional PO Intervention to Prozac C Prevent Permanent Impairment/Damage Date:11/08/02ISR Number: 4009746-0Report Type:Expedited (15-DaCompany Report #2002UW14815 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Insipidus Health Seroquel PS ORAL 300 MG PO Intervention to Professional Effexor-Xr SS 225 MG Prevent Permanent Eskalith SS 450 MG Impairment/Damage Date:11/08/02ISR Number: 4009749-6Report Type:Expedited (15-DaCompany Report #2002UW12530 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Cirrhosis Study Seroquel PS Health Professional Date:11/11/02ISR Number: 4008356-9Report Type:Direct Company Report #CTU 180654 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dyspnoea Seroquel 100mg Qd PS ORAL 100 MG PO QD 1 MON Neuroleptic Malignant Wellbutrin C Syndrome Catapres C 22-Feb-2006 08:31 AM Page: 571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/02ISR Number: 4008304-1Report Type:Direct Company Report #CTU 180737 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Seroquel PS Initial or Prolonged Cyanopsia Paxil C Disability Dyskinesia Speech Disorder Date:11/12/02ISR Number: 4008830-5Report Type:Expedited (15-DaCompany Report #2002UW11532 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Seroquel PS ORAL 50 MG DAILY Medication Error PO Psychiatric Symptom Seroquel SS ORAL 250 MG DAILY PO Serzone SS 200 MG Date:11/12/02ISR Number: 4008831-7Report Type:Expedited (15-DaCompany Report #2002UW11666 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Other Seroquel PS ORAL 100 MG ONCE Feeling Abnormal PO Medication Error Serzone SS 100 MG PO Sedation Date:11/12/02ISR Number: 4008832-9Report Type:Expedited (15-DaCompany Report #2002UW07428 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Seroquel PS ORAL 1400 MG HS PO Professional Serzone SS Glucovance C Effexor C Neurontin C Zestril C Lorazepam C Verapamil C Depakote C Tricor C Remeron C Pravachol C Prozac C Date:11/12/02ISR Number: 4008833-0Report Type:Expedited (15-DaCompany Report #2002UW12213 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Seroquel PS ORAL 100 MG PO Professional Serzone SS ORAL 100 MG PO 22-Feb-2006 08:31 AM Page: 572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/02ISR Number: 4008834-2Report Type:Expedited (15-DaCompany Report #2002UW12214 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Consumer Seroquel PS Serzone SS Date:11/12/02ISR Number: 4008835-4Report Type:Expedited (15-DaCompany Report #2002UW12259 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Seroquel PS ORAL 200 MG HS PO Professional Serzone SS ORAL 200 MG HS PO Date:11/12/02ISR Number: 4008836-6Report Type:Expedited (15-DaCompany Report #2002UW12263 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Seroquel PS ORAL 100 MG ONCE Anxiety PO Decreased Activity Serzone SS Dizziness Heart Rate Increased Medication Error Vertigo Date:11/12/02ISR Number: 4008837-8Report Type:Expedited (15-DaCompany Report #2002UW12269 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Auditory Health Seroquel PS ORAL 200 MG PO Medication Error Professional Serzone SS ORAL 200 MG PO Date:11/12/02ISR Number: 4008838-XReport Type:Expedited (15-DaCompany Report #2002UW12271 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Seroquel PS ORAL 200 MG BID PO Anger Professional Seroquel SS ORAL 200 MG BID Irritability ORAL Medication Error Serzone SS Thinking Abnormal Date:11/12/02ISR Number: 4008839-1Report Type:Expedited (15-DaCompany Report #2002UW12293 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Other Seroquel PS ORAL 200 MG PO Dizziness Serzone SS 200 MG Insomnia Medication Error 22-Feb-2006 08:31 AM Page: 573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/02ISR Number: 4008840-8Report Type:Expedited (15-DaCompany Report #2002UW12295 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Seroquel PS Mental Impairment Professional Serzone SS Sedation Date:11/12/02ISR Number: 4008841-XReport Type:Expedited (15-DaCompany Report #2002UW12302 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Seroquel PS ORAL 200 MG ONCE Professional PO Serzone SS ORAL 200 MG PO Date:11/13/02ISR Number: 4011014-8Report Type:Expedited (15-DaCompany Report #2002UW14901 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Encephalopathy Foreign Seroquel PS ORAL 12.5 MG HS PO Hospitalization - Hepatitis Acute Health Effexor SS ORAL 325 MG DAILY Initial or Prolonged Professional PO Required Other Lopressor C Intervention to Asa C Prevent Permanent Vitamin K C Impairment/Damage Multivitamin "Lappe" C Heparin C Date:11/13/02ISR Number: 4011066-5Report Type:Expedited (15-DaCompany Report #2002GB02562 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS ORAL 200 MG BID PO Decreased Health Professional Other Date:11/13/02ISR Number: 4011817-XReport Type:Expedited (15-DaCompany Report #2002AP03781 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Foreign Seroquel PS ORAL 2002 MG TID Initial or Prolonged Infarction Health PO Required Cardiomyopathy Professional Olanzapine SS Intervention to Delirium Other Cipramil C Prevent Permanent Depressed Level Of Haloperidol C Impairment/Damage Consciousness Temazepam C Electrocardiogram T Wave Abnormal Psychotic Disorder Ventricular Hypokinesia 22-Feb-2006 08:31 AM Page: 574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/02ISR Number: 4011827-2Report Type:Expedited (15-DaCompany Report #2002GB02579 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Quetiapine PS Health Professional Other Date:11/13/02ISR Number: 4011857-0Report Type:Expedited (15-DaCompany Report #2002GB02434 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blepharospasm Foreign Seroquel PS ORAL 25 MG QD PO Intervention to Extrapyramidal Disorder Health Seroquel SS ORAL 100 MG QD PO Prevent Permanent Professional Impairment/Damage Other Date:11/13/02ISR Number: 4011998-8Report Type:Expedited (15-DaCompany Report #2002UW14858 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Seroquel PS 6 MON Decreased Professional Topamax SS 6 MON White Blood Cell Count Motrin C Decreased Milk Of Magnesia C Multivitamin "Lappe" C Date:11/14/02ISR Number: 4009872-6Report Type:Direct Company Report #CTU 180921 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperthermia Malignant Seroquel PS Hospitalization - Mental Status Changes Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:11/14/02ISR Number: 4012406-3Report Type:Expedited (15-DaCompany Report #2001UW14977 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Seroquel PS ORAL 200 MG DAILY Condition Aggravated Professional PO Drug Level Above Seroquel SS ORAL 600 MG DAILY Therapeutic PO Electrocardiogram Qt Seroquel SS ORAL 800 MG DAILY Prolonged PO Syncope Seroquel SS ORAL 1000 MG DAILY PO Seroquel SS ORAL 1200 MG DAILY PO Alprazolam C Mirtazapine C 22-Feb-2006 08:31 AM Page: 575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/02ISR Number: 4012597-4Report Type:Expedited (15-DaCompany Report #2002PK00498 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Caesarean Section Foreign Seroquel PS TOPICAL 400 MG DAILY Intervention to Convulsion Neonatal Health TPL Prevent Permanent Hypotonia Neonatal Professional Seroquel SS TOPICAL 100 MG BID Impairment/Damage Maternal Drugs Affecting Other TPL Foetus Stilnox C Neonatal Respiratory Ferro-Folgamma C Failure Date:11/14/02ISR Number: 4012904-2Report Type:Expedited (15-DaCompany Report #2002UW15251 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Seroquel PS ORAL 100 MG HS PO Hospitalization - Hepatic Failure Professional Lithobid C Initial or Prolonged Altace C Glucophage "Abic" C Geodon C Date:11/14/02ISR Number: 4012919-4Report Type:Expedited (15-DaCompany Report #2002133067US Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Xanax (Alprazolam) Health Tablet PS Professional Propranolol (Propranolol) SS Quetiapine (Quetiapine) SS Date:11/14/02ISR Number: 4012928-5Report Type:Expedited (15-DaCompany Report #2002133331US Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Calan (Verapamil) Intentional Overdose Health Tablet PS ORAL ORAL Professional Quetiapine (Quetiapine) SS Vaproic Acid (Valproic Acid) SS - Date:11/15/02ISR Number: 4014318-8Report Type:Expedited (15-DaCompany Report #2002AP03444 Age:38 YR Gender:Male I/FU:I Outcome PT Life-Threatening Agitation Hospitalization - Akinesia Initial or Prolonged Ammonia Increased Required Coma Intervention to Depression Prevent Permanent Dysphoria Impairment/Damage Excitability Hostility Intentional Overdose Irritability 22-Feb-2006 08:31 AM Page: 576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Tachycardia Tremor Report Source Product Role Manufacturer Route Dose Duration Foreign Quetiapine PS ORAL 200 MG DAILY Literature PO Health Quetiapine SS ORAL 20000 MG ONCE Professional PO Other Valproate SS ORAL 200 MG TID PO Valproate SS ORAL 16000 MG ONCE PO Chloridemethyl-Diaze pam C Venlafaxine C Date:11/15/02ISR Number: 4014375-9Report Type:Expedited (15-DaCompany Report #2002AP03376 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Seroquel PS ORAL 50 MG DAILY Phosphokinase Increased Health PO Cardio-Respiratory Arrest Professional Seroquel SS ORAL 200 MG DAILY Dehydration Other PO Fall Flumezin C Hypokalaemia Eurodin C Malnutrition Hirnamin C Rohypnol C Halcion C Risperdal C Glucose W/Electrolytes C Aspara K C Pyrethia C Date:11/15/02ISR Number: 4014598-9Report Type:Expedited (15-DaCompany Report #2002GB02590 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Duodenal Ulcer Health PO Haematocrit Decreased Professional Amisulpride SS Haemoglobin Decreased Other Platelet Count Decreased White Blood Cell Count Decreased Date:11/18/02ISR Number: 4013413-7Report Type:Expedited (15-DaCompany Report #2002PK01060 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythropenia Foreign Seroquel PS ORAL 300 MG DAILY Gamma-Glutamyltransferase Health PO Increased Professional Leukopenia Other Thrombocytopenia 22-Feb-2006 08:31 AM Page: 577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/02ISR Number: 4013522-2Report Type:Expedited (15-DaCompany Report #2002UW15389 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Professional Date:11/18/02ISR Number: 4013523-4Report Type:Expedited (15-DaCompany Report #2002UW15201 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 450 MG DAILY Decreased Professional PO 3 YR Date:11/18/02ISR Number: 4013524-6Report Type:Expedited (15-DaCompany Report #2002UW15161 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 200 MG PO Decreased Professional Depakote C Celexa C Date:11/18/02ISR Number: 4013525-8Report Type:Expedited (15-DaCompany Report #2002UW14837 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Seroquel PS 300-400 MG Decreased Professional DAILY Zoloft C Date:11/18/02ISR Number: 4014887-8Report Type:Expedited (15-DaCompany Report #2002AP03781 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Foreign Seroquel PS ORAL 200 MG TID PO Initial or Prolonged Infarction Health Olanzapine SS Required Cardiomyopathy Professional Cipramil C Intervention to Delirium Other Haloperidol C Prevent Permanent Depressed Level Of Temazepam C Impairment/Damage Consciousness Electrocardiogram T Wave Abnormal Ventricular Hypokinesia Date:11/19/02ISR Number: 4012648-7Report Type:Direct Company Report #CTU 181288 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Seroquel PS SEE IMAGE Cataract Congenital Neurontin C Weight Increased Remeron C Wellbutrin C Vioxx C Estradiol C 22-Feb-2006 08:31 AM Page: 578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/02ISR Number: 4014998-7Report Type:Expedited (15-DaCompany Report #2002UW14448 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Date:11/19/02ISR Number: 4015000-3Report Type:Expedited (15-DaCompany Report #2002UW12005 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Encephalitis Professional PO Flushing Risperdal C Headache Postoperative Protonix Pharmacia C Hyperhidrosis Paxil C Buspar C Date:11/19/02ISR Number: 4015002-7Report Type:Expedited (15-DaCompany Report #2002UW14129 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Seroquel PS ORAL 200 MG BID Initial or Prolonged Drug Interaction Professional PO Hallucination Seroquel SS ORAL 500 MG DAILY PO Skelaxin SS 400 MG BID Baclofen C Date:11/19/02ISR Number: 4015004-0Report Type:Expedited (15-DaCompany Report #2002UW15153 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Seroquel PS ORAL 600 MG PO Nausea Professional Serzone SS 500 MG Platelet Count Decreased Vomiting White Blood Cell Count Decreased Date:11/19/02ISR Number: 4015121-5Report Type:Expedited (15-DaCompany Report #2000UW00285 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Health Seroquel PS Zeneca Drug Level Decreased Professional Injury Overdose Date:11/19/02ISR Number: 4015169-0Report Type:Expedited (15-DaCompany Report #2002AP02883 Age:30 YR Gender:Female I/FU:F Outcome Death Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Foreign Seroquel PS ORAL 75 MG DAILY Cardiac Arrest Health PO Diabetic Ketoacidosis Professional Seroquel SS ORAL 300 MG DAILY Diarrhoea Other PO Dyspnoea Seroquel SS ORAL 200 MG DAILY Hyperkalaemia PO Nasopharyngitis Serenace C Renal Failure Acute Impromen C Akineton C Halcion C Rohypnol C Ubretid C Date:11/19/02ISR Number: 4015172-0Report Type:Expedited (15-DaCompany Report #2002GB02603 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS ORAL 2000 MG ONCE Hospitalization - Depressed Level Of Health PO Initial or Prolonged Consciousness Professional Zopiclone SS ORAL 75 MG ONCE PO Hypokalaemia Other Alcohol SS Hypotension Overdose Date:11/19/02ISR Number: 4015175-6Report Type:Expedited (15-DaCompany Report #2002AP02883 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Seroquel PS ORAL 75 MG DAILY Required Cardiac Arrest Health PO Intervention to Diabetic Ketoacidosis Professional Seroquel SS ORAL 300 MG DAILY Prevent Permanent Diarrhoea Other PO Impairment/Damage Dyspnoea Seroquel SS ORAL 200 MG DAILY Hyperkalaemia PO Nasopharyngitis Serenace C Polydipsia Impromen C Psychiatric Symptom Akineton C Pyrexia Halcion C Renal Failure Acute Rohypnol C Retching Ubretid C Vomiting Date:11/19/02ISR Number: 4015199-9Report Type:Expedited (15-DaCompany Report #2002AP02993 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Cardiomyopathy Health PO Initial or Prolonged Professional Clomipramine Required Other Hydrochloride C Intervention to Zyprexa C Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/02ISR Number: 4015205-1Report Type:Expedited (15-DaCompany Report #2002AP03883 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Seroquel PS ORAL 375 MG DAILY Cardiac Arrest Health PO Depressed Level Of Professional Seroquel SS ORAL 300 MG DAILY Consciousness Other PO Harnal C Date:11/19/02ISR Number: 4015209-9Report Type:Expedited (15-DaCompany Report #2002GB02408 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Seroquel PS Overdose Health Dextropropoxyphene Toxicologic Test Abnormal Professional /Paracetamol SS OVERDOSE Other Date:11/20/02ISR Number: 4015206-3Report Type:Expedited (15-DaCompany Report #2002AP02883 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel PS ORAL 75 MG DAILY Required Diabetic Ketoacidosis Health PO Intervention to Hyperkalaemia Professional Seroquel SS ORAL 300 MG DAILY Prevent Permanent Nasopharyngitis Other PO Impairment/Damage Renal Failure Acute Seroquel SS ORAL 200 MG DAILY PO Serenace C Impromen C Akineton C Halcion C Rohypnol C Ubretid C Date:11/20/02ISR Number: 4016638-XReport Type:Expedited (15-DaCompany Report #2002AP02763 Age:38 YR Gender:Female I/FU:F Outcome PT Death Abdominal Pain Hospitalization - Activated Partial Initial or Prolonged Thromboplastin Time Prolonged Alanine Aminotransferase Increased Arrhythmia Supraventricular Aspartate Aminotransferase Increased Blood Amylase Increased Blood Bilirubin Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Blood Ph Decreased Blood Potassium Increased 22-Feb-2006 08:31 AM Page: 581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report C-Reactive Protein Increased Condition Aggravated Report Source Product Role Manufacturer Route Dose Duration Constipation Foreign Seroquel PS ORAL 600 MG DAILY Dyspnoea Exertional Health PO Electrocardiogram St Professional Prednisolone C Segment Elevation Other Pepcidin C Gamma-Glutamyltransferase Lipitor C Increased Haemoglobin Decreased International Normalised Ratio Decreased Metabolic Acidosis Platelet Count Decreased Pleural Effusion Pulmonary Congestion Renal Failure Acute Shock Systemic Lupus Erythematosus Date:11/21/02ISR Number: 4015896-5Report Type:Expedited (15-DaCompany Report #PHBS2002US07851 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Literature Carbamazepine Agitation Health (Carbamazepine) PS 700 MG, BID Coordination Abnormal Professional Quetiapine Drug Interaction (Quetiapine)`` SS 700 MG/DAY Drug Level Increased Date:11/21/02ISR Number: 4015902-8Report Type:Expedited (15-DaCompany Report #PHBS2002US07869 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Literature Carbamazepine Drug Interaction Health (Carbamazepine) PS 200 MG, TID Drug Level Increased Professional Quetiapine (Quetiapine) SS 700 MG/DAY Date:11/21/02ISR Number: 4016656-1Report Type:Expedited (15-DaCompany Report #2002SE05185 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Foreign Seroquel PS ORAL 400 BID PO Intervention to Phosphokinase Increased Health Lexotan C Prevent Permanent Professional Impairment/Damage Other Date:11/22/02ISR Number: 4016089-8Report Type:Expedited (15-DaCompany Report #2002SE05604 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS ORAL 200 MG QD PO Intervention to Health Seroquel SS ORAL 300 MG QD PO Prevent Permanent Professional Seroquel SS ORAL 400 MG QD PO Impairment/Damage Other Lipanthyl 22-Feb-2006 08:31 AM Page: 582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bristol-Myers Squibb C Temesta C Coversyl C Date:11/22/02ISR Number: 4016188-0Report Type:Expedited (15-DaCompany Report #2002UW13909 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Tenormin SS Date:11/25/02ISR Number: 4014430-3Report Type:Expedited (15-DaCompany Report #B0285228A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Paroxetine PS Glaxo Wellcome 20MG Per day Initial or Prolonged Pregnancy Seroquel SS 400MG Twice Other Drug Withdrawal Syndrome per day Neonatal Feeding Disorder Neonatal Feeling Jittery Hypertonia Neonatal Hypervigilance Maternal Drugs Affecting Foetus Date:11/25/02ISR Number: 4016361-1Report Type:Expedited (15-DaCompany Report #2002UW15810 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS ORAL 75 MG HS PO Professional Neurontin C Ambien C Celexa C Date:11/25/02ISR Number: 4017329-1Report Type:Expedited (15-DaCompany Report #2002SE05260 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS Hospitalization - Disseminated Health Haldol "Janssen" C Initial or Prolonged Intravascular Coagulation Professional Stilnoct C Other Trazolan C Date:11/26/02ISR Number: 4017636-2Report Type:Expedited (15-DaCompany Report #2002PK01220 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertension Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Insomnia Health PO 3 DAY Prevent Permanent Restless Legs Syndrome Professional Impairment/Damage Other 22-Feb-2006 08:31 AM Page: 583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/02ISR Number: 4017637-4Report Type:Expedited (15-DaCompany Report #2002AP04103 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Intentional Overdose Health PO Suicide Attempt Professional Seroquel SS ORAL 5800 MG ONCE Other PO Date:11/26/02ISR Number: 4017638-6Report Type:Expedited (15-DaCompany Report #2002AP04011 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS ORAL 300 MG DAILY Required Increased Health PO Intervention to Aspartate Professional Seroquel SS ORAL 400 MG DAILY Prevent Permanent Aminotransferase Other PO Impairment/Damage Increased Seroquel SS ORAL 600 MG DAILY Blood Creatine PO Phosphokinase Increased Contomin C Blood Glucose Increased Rohypnol C Blood Lactate Dehydrogenase Increased C-Reactive Protein Increased Cardiac Arrest Neuroleptic Malignant Syndrome Productive Cough Pyrexia Respiratory Failure Shock Tachycardia Wheezing White Blood Cell Count Increased Date:11/26/02ISR Number: 4018177-9Report Type:Expedited (15-DaCompany Report #2002UW15922 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS ORAL 200 MG DAILY Professional PO Neurontin C Date:11/27/02ISR Number: 4018856-3Report Type:Expedited (15-DaCompany Report #2002GB02590 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Duodenal Ulcer Health PO Haematocrit Decreased Professional Amisulpride SS ORAL 1000 MG DAILY Haemoglobin Decreased Other PO Platelet Count Decreased Zopiclone C Vitamin B12 Deficiency Procyclidine C White Blood Cell Count Paracetamol C Decreased 22-Feb-2006 08:31 AM Page: 584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/02ISR Number: 4018857-5Report Type:Expedited (15-DaCompany Report #2002AP02883 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Seroquel PS ORAL 75 MG DAILY Required Arrhythmia Health PO Intervention to Cardiac Arrest Professional Seroquel SS ORAL 300 MG DAILY Prevent Permanent Diabetic Ketoacidosis Other PO Impairment/Damage Diarrhoea Seroquel SS ORAL 200 MG DAILY Dyspnoea PO Electrolyte Imbalance Serenace C Hyperglycaemia Impromen C Nasopharyngitis Akineton C Polydipsia Halcion C Pyrexia Rohypnol C Renal Failure Acute Ubretid C Retching Vomiting Date:11/27/02ISR Number: 4018990-8Report Type:Expedited (15-DaCompany Report #2002AP03376 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Seroquel PS 50 MG DAILY Death Health PO Drug Effect Decreased Professional Seroquel SS 200 MG DAILY Other PO Risperdal SS 1 MG DAILY PO Risperdal SS 2 MG DAILY PO Flumezin C Eurodin C Hirnamin C Rohypnol C Halcion C Glucose W/Electrolytes C Aspara K C Pyrethia C Date:11/27/02ISR Number: 4019037-XReport Type:Expedited (15-DaCompany Report #2002067242 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Health Geodon (Ziprasidone) PS Hospitalization - Sepsis Professional Metformin SS Initial or Prolonged Ramipril SS Other Quetiapine Fumarate SS Lithium Carbonate SS Date:11/29/02ISR Number: 4018865-4Report Type:Expedited (15-DaCompany Report #SKEL000113 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Skelaxin Professional (Metaxalone) PS ORAL ORAL Seroquel (Quetiapine) SS ORAL ORAL Clonazepam (Clonazepam) SS ORAL ORAL 22-Feb-2006 08:31 AM Page: 585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ambien (Zolpidem) SS ORAL ORAL Ethanol (Ethanol) SS ORAL ORAL Topamax (Topiramate) SS ORAL ORAL Vioxx C Date:12/02/02ISR Number: 4018461-9Report Type:Direct Company Report #CTU 181953 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Back Pain Risperdal 1mg Difficulty In Walking Janssen PS Janssen ORAL 1MG ONCE A Dystonia DAY ORAL Pain In Extremity Seroquel 25mg Zeneca SS Zeneca ORAL 50MG 3X DAY ORAL Zoloft C Cogentin C Neurontin C Date:12/02/02ISR Number: 4020759-5Report Type:Expedited (15-DaCompany Report #325901 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disorientation Foreign Rivotril Excoriation Study (Clonazepam) PS Grand Mal Convulsion Health Aurorix Insomnia Professional (Moclobemide) SS ORAL 300 MG DAILY Schizoaffective Disorder ORAL Leponex (Clozapine) SS ORAL 800 MG DAILY ORAL Seroquel (Quetapine Fumarate) SS ORAL 50 MG DAILY ORAL Fluanxol (Flupentixol) SS ORAL 5 MG DAILY ORAL Orfiril (Valproate Sodium) C Date:12/02/02ISR Number: 4020796-0Report Type:Expedited (15-DaCompany Report #2002AP03883 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Foreign Seroquel PS ORAL 75 MG DAILY Anger Health PO Cardiac Arrest Professional Seroquel SS ORAL 100 MG DAILY Condition Aggravated Other PO Dissociative Fugue Seroquel SS ORAL 150 MG DAILY Hepatic Steatosis PO Po2 Decreased Seroquel SS ORAL 200 MG DAILY Psychomotor Hyperactivity PO Somnolence Seroquel SS ORAL 250 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 375 MG DAILY PO Harnal C Myslee C 22-Feb-2006 08:31 AM Page: 586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lac B C Magnesium Oxide C Pursennid C Flivas C Date:12/02/02ISR Number: 4020797-2Report Type:Expedited (15-DaCompany Report #2002PK01060 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythropenia Foreign Seroquel PS ORAL 300 MG DAILY Gamma-Glutamyltransferase Health PO Increased Professional Leukopenia Other Thrombocytopenia Date:12/03/02ISR Number: 4021294-0Report Type:Expedited (15-DaCompany Report #2002UW15932 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Seroquel PS Initial or Prolonged Professional Date:12/03/02ISR Number: 4021417-3Report Type:Expedited (15-DaCompany Report #02P-151-0205048-00 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Klacid (Biaxin) Initial or Prolonged Drug Interaction Health (Clarithromycin) Disability Dyspnoea Exacerbated Professional (Clarithromycin) PS ORAL 500 MG, 2 IN Required Fall 1 D, PER ORAL Intervention to Lung Infiltration Quetiapine SS ORAL 25 MG, 1 IN 1 Prevent Permanent Orthostatic Hypotension D, PER ORAL Impairment/Damage Pyrexia Cefepime Hydrochloride C Acetylsalicylic Acid C Clopidogrel Sulfate C Heparin-Fraction, Sodium Salt C Torasemide C Corvaton Reterd C Amlodipine Besilate C Sortis C Omeprazole C Date:12/03/02ISR Number: 4021503-8Report Type:Expedited (15-DaCompany Report #2002UW16011 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Potassium Increased Health Seroquel PS White Blood Cell Count Professional Remeron C Decreased Cogentin C Haldol"Janssen" C 22-Feb-2006 08:31 AM Page: 587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/02ISR Number: 4019373-7Report Type:Direct Company Report #CTU 182132 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Depakote PS Initial or Prolonged Seroquel SS Quetiapine C Lasix C Divalproex C Date:12/04/02ISR Number: 4021659-7Report Type:Expedited (15-DaCompany Report #2002GB02590 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Disorder Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Drug Ineffective Health PO Duodenal Ulcer Professional Amisulpride SS ORAL 1000 MG DAILY Haematocrit Decreased Other PO Haemoglobin Decreased Zopiclone C Platelet Count Decreased Procyclidine C Vitamin B12 Deficiency Paracetamol C White Blood Cell Count Decreased Date:12/04/02ISR Number: 4022362-XReport Type:Expedited (15-DaCompany Report #2002SE05185 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Foreign Seroquel PS ORAL 400 BID PO Intervention to Phosphokinase Increased Health Lexotan C Prevent Permanent Professional Impairment/Damage Other Date:12/04/02ISR Number: 4022363-1Report Type:Expedited (15-DaCompany Report #2002AP04105 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Seroquel PS ORAL 500 MG DAILY Initial or Prolonged Phosphokinase Increased Health PO Professional Seroquel SS ORAL 400 MG DAILY Other PO Ludiomil C Seniran C Eurodin C Rhythmy C Date:12/04/02ISR Number: 4022421-1Report Type:Expedited (15-DaCompany Report #2002UW16166 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional 22-Feb-2006 08:31 AM Page: 588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/02ISR Number: 4022493-4Report Type:Expedited (15-DaCompany Report #2002UW11792 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Cancer Stage Ii Health Seroquel PS ORAL 200 MG PO Intervention to Dry Mouth Professional Seroquel SS ORAL 300 MG PO Prevent Permanent Mania Seroquel SS ORAL 400 MG PO Impairment/Damage Seroquel SS ORAL 600 MG PO Seroquel SS ORAL 400 MG PO Seroquel SS ORAL 600 MG PO Seroquel SS ORAL 400 MG PO Seroquel SS ORAL 200 MG QD PO Prolixin C Lithobid C Ogentin C Vitamin E C Vitamin B6 C Remeron C Klonopin C Lorazepam C Trazodone C Date:12/06/02ISR Number: 4022519-8Report Type:Expedited (15-DaCompany Report #2002UW16050 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Dependence Consumer Seroquel PS ORAL 300 MG DAILY Faeces Discoloured PO Insomnia Lithium C Date:12/06/02ISR Number: 4022587-3Report Type:Expedited (15-DaCompany Report #B0284789A Age:55 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Diphenhydramine Health Hydrochloride Professional (Formulation Unknown) (Diphenhydramine PS ORAL ORAL Quetiapine (Formulation Unknown) (Quetiapine) SS ORAL ORAL Mirtazapine (Formulation Unknown) (Mirtazapine) SS ORAL ORAL Date:12/06/02ISR Number: 4022782-3Report Type:Expedited (15-DaCompany Report #2002UW02766 Age:25 YR Gender:Male I/FU:F Outcome PT Life-Threatening Acute Sinusitis Hospitalization - Asthenia Initial or Prolonged Body Temperature Increased Catheter Related Complication Circulatory Collapse 22-Feb-2006 08:31 AM Page: 589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coma Difficulty In Walking Leukocytosis Report Source Product Role Manufacturer Route Dose Duration Metabolic Encephalopathy Health Seroquel "Zeneca" PS ORAL 100 MG HS PO Muscle Twitching Professional Seroquel "Zeneca" SS ORAL 200 MG DAILY Neuroleptic Malignant PO Syndrome Depakote SS 40 TO 50 Overdose PILLS OF 500 Pneumothorax MG TABLETS Respiratory Failure Depakote SS 500 MG TID Suicide Attempt Effexor C Tachycardia Viamin B12 C Pepcid C Multivitamins C Date:12/06/02ISR Number: 4023348-1Report Type:Expedited (15-DaCompany Report #2002AP02883 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS ORAL 75 MG DAILY Required Cardiac Arrest Health PO Intervention to Diabetic Ketoacidosis Professional Seroquel SS ORAL 300 MG DAILY Prevent Permanent Diarrhoea Other PO Impairment/Damage Dyspnoea Seroquel SS ORAL 200 MG DAILY Electrolyte Imbalance PO Gastrointestinal Disorder Serenace C Hyperkalaemia Impromen C Nasopharyngitis Akineton C Psychiatric Symptom Halcion C Renal Failure Acute Rohypnol C Retching Ubretid C Vomiting Date:12/06/02ISR Number: 4023366-3Report Type:Expedited (15-DaCompany Report #2002SE05993 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Drug Interaction Health PO Prevent Permanent Fall Professional Clarithromycin SS ORAL 1000 MG DAILY Impairment/Damage Orthostatic Hypotension Other PO Maxipime C Aspirine C Palvix C Dalteparin C Torem C Corvaton Retard C Norvasc C Sortis C Antra C Date:12/06/02ISR Number: 4023369-9Report Type:Expedited (15-DaCompany Report #2002SE06067 Age:22 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Seroquel PS ORAL 600 MG QD PO Health Xanax C Professional Other Date:12/06/02ISR Number: 4023374-2Report Type:Expedited (15-DaCompany Report #2002SE05653 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Seroquel PS ORAL 25 MG QD PO Folate Deficiency Health Seroquel SS ORAL 100 MG QD PO Mean Cell Volume Professional Zoloft SS ORAL 50 MG QD PO Increased Other En SS ORAL 4 MG QD PO Sudden Death Methadon SS ORAL 70 MG QD PO Vitamin B12 Deficiency Flunox SS ORAL 30 MG QD PO Tavor C Entumin C Date:12/09/02ISR Number: 4023325-0Report Type:Expedited (15-DaCompany Report #2002UW14814 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Health Seroquel PS ORAL 200 MG BID PO Required Diabetes Insipidus Professional Lithium Carbonate C Intervention to Diabetes Mellitus Neurontin C Prevent Permanent Diabetic Ketoacidosis Klonopin C Impairment/Damage Dyspnoea Zyprexa C Pancreatitis Date:12/09/02ISR Number: 4023346-8Report Type:Expedited (15-DaCompany Report #2002UW16205 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Seroquel PS ORAL 900 MG QD PO Initial or Prolonged Blood Glucose Abnormal Professional Seroquel SS ORAL 600 MG QD PO Cardio-Respiratory Arrest Olanzapine C Fall Clozaril C Loss Of Consciousness Weight Decreased Date:12/09/02ISR Number: 4024287-2Report Type:Expedited (15-DaCompany Report #2002AP04136 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Chloride Increased Foreign Seroquel PS ORAL 75 MG DAILY Blood Potassium Increased Health PO Diabetic Hyperosmolar Professional Serenance C Coma Other Emilace C Artane C Spironolactone C Lasix C Levotomin C Rhythmy C 22-Feb-2006 08:31 AM Page: 591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/02ISR Number: 4024288-4Report Type:Expedited (15-DaCompany Report #2002GB02278 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Neonatal Foreign Seroquel PS TRANSPLACENTAL 400 MG BID Hospitalization - Drug Withdrawal Syndrome Health TPL Initial or Prolonged Neonatal Professional Paroxetine SS TRANSPLACENTAL 20 MG QD TPL Required Feeding Disorder Neonatal Other Pethidine C Intervention to Hypervigilance Prevent Permanent Hypotonia Neonatal Impairment/Damage Induced Labour Maternal Drugs Affecting Foetus Neonatal Aspiration Neonatal Disorder Date:12/09/02ISR Number: 4024300-2Report Type:Expedited (15-DaCompany Report #2002UW16288 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Agitation Consumer PO Anger Other Alti-Ciprofloxacin C Crying Zyprexa C Dizziness Dry Mouth Headache Muscle Twitching Psychomotor Hyperactivity Pyrexia Tension Date:12/10/02ISR Number: 4024912-6Report Type:Expedited (15-DaCompany Report #02P-062-0205405-00 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Ergenyl Solution 300 Initial or Prolonged Drug Interaction Health Mg/Ml (Depacon) Disability Sedation Professional (Valproate Sodium) Venous Thrombosis Limb Other (Valproate Sodium) PS INTRAVENOUS SEE IMAGE Ergenyl Tablets (Depakene Tablets) (Valproate Sodium) (Valproate Sodium) SS ORAL SEE IMAGE Quetiapine SS ORAL SEE IMAGE Levomepromazine Maleate SS ORAL SEE IMAGE Zuclopenthixol Acetate SS INTRAMUSCULAR 50 MG, 2 IN 2 D, INTRAMUSCULAR Zuclopenthixol Decanoate SS INTRAMUSCULAR 200 MG, 2 IN 2 D, INTRAMUSCULAR Zuclopenthixol Hydrochloride SS ORAL 40 MG, DAILY, PER ORAL Ergenyl Chrono Tablets (Depakene 22-Feb-2006 08:31 AM Page: 592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets) (Valproate Sodium) (Valproate Sodium) C Risperidone C Heparin-Fraction, Sodium Salt C Nadroparin Calcium C Date:12/10/02ISR Number: 4024914-XReport Type:Expedited (15-DaCompany Report #2002AP04238 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Literature Quetiapine PS ORAL 10800 MG ONCE Cardiomegaly Health PO Coma Professional Quetiapine SS ORAL 600 MG DAILY Pulmonary Congestion PO Respiratory Distress Risperidone C Ventricular Hypertrophy Felodipine C Sertraline C Buspirone C Haloperidol Decanoate C Date:12/10/02ISR Number: 4024918-7Report Type:Expedited (15-DaCompany Report #2002UW16145 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS Decreased Professional Date:12/10/02ISR Number: 4024920-5Report Type:Expedited (15-DaCompany Report #2001UW06550 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel "Zeneca" PS Zeneca 100 - 200 MG Drug Toxicity Professional PRN Intentional Overdose Seroquel "Zeneca" SS Zeneca 200-300 MG PER DAY Citalopram C Buspirone C Date:12/10/02ISR Number: 4025387-3Report Type:Expedited (15-DaCompany Report #2002GB02627 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Ketoacidosis Foreign Seroquel PS ORAL 200 MG BID; Hospitalization - Weight Increased Health PO Initial or Prolonged Professional Lactulose C Required Other Orphenadrine C Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/02ISR Number: 4024234-3Report Type:Expedited (15-DaCompany Report #2002SE06022 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Foreign Quetiapine PS 400 MG DAILY Intervention to Aplasia Pure Red Cell Health Prevent Permanent Professional Impairment/Damage Other Date:12/11/02ISR Number: 4024236-7Report Type:Expedited (15-DaCompany Report #2002AP04011 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Foreign Seroquel PS ORAL 300 MG DAILY Required Aspartate Health PO; Intervention to Aminotransferase Professional Seroquel SS ORAL 400 MG DAILY Prevent Permanent Increased Other PO Impairment/Damage Attention Seroquel SS ORAL 600 MG DAILY Deficit/Hyperactivity PO Disorder Contomin SS ORAL 75 MG DAILY Blood Creatine PO Phosphokinase Increased Contomin SS ORAL 100 MG DAILY Blood Lactate PO Dehydrogenase Increased Contomin SS ORAL 75 MG DAILY Cardio-Respiratory Arrest PO Dissociative Fugue Contomin SS ORAL 50 MG DAILY Hyperglycaemia PO Myocardial Ischaemia Contomin SS ORAL 75 MG DAILY Neuroleptic Malignant PO Syndrome Rohypnol C Pneumonia Nisori C Respiratory Failure Shock Sputum Culture Positive Staphylococcal Infection Stupor Tachycardia Date:12/11/02ISR Number: 4025299-5Report Type:Expedited (15-DaCompany Report #2001UW10039 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dry Mouth Consumer Seroquel "Zeneca" PS Zeneca ORAL 500 MG DAILY Dysgeusia PO Speech Disorder Seroquel "Zeneca" SS Zeneca ORAL 200 MG DAILY Tardive Dyskinesia PO Seroquel "Zeneca" SS Zeneca ORAL 600 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 400 MG DAILY PO Symmetrel C Paxil C Klonopin C Accupril C Lipitor C 22-Feb-2006 08:31 AM Page: 594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/02ISR Number: 4023543-1Report Type:Direct Company Report #CTU 182684 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Ziprasadone PS 100MG BID Intervention to Prolonged Quetiapine SS 300 AM 600HS Prevent Permanent Impairment/Damage Date:12/13/02ISR Number: 4027217-2Report Type:Expedited (15-DaCompany Report #02P-163-0205474-00 Age:30 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Valproic Acid Completed Suicide Health (Depakene) (Valproic Professional Acid) (Valproic Acid) PS ORAL PER ORAL Propranolol SS ORAL PER ORAL Quetiapine SS ORAL PER ORAL Date:12/16/02ISR Number: 4023973-8Report Type:Expedited (15-DaCompany Report #B0287184A Age:0 DY Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Consumer Paroxetine PS Glaxo Wellcome 20MG Per day Initial or Prolonged Neonatal Quetiapine SS 400MG Twice Other Maternal Drugs Affecting per day Foetus Pethidine C 1 DAY Date:12/16/02ISR Number: 4023987-8Report Type:Expedited (15-DaCompany Report #B0287184A Age:0 DY Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Paroxetine PS Glaxo Wellcome 20MG Per day Initial or Prolonged Neonatal Quetiapine SS 400MG Twice Other Maternal Drugs Affecting per day Foetus Pethidine C 1 DAY Date:12/16/02ISR Number: 4026564-8Report Type:Expedited (15-DaCompany Report #2002AP04136 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Foreign Seroquel PS ORAL 75 MG DAILY Increased Health PO Decreased Appetite Professional Lasix C Diabetic Hyperosmolar Other Spironolactone C Coma Serenace C Heart Rate Increased Emilace C Oxygen Saturation Levotomin C Decreased Artane C Pneumonia Rhythmy C Tremor Magnesium Oxide C 22-Feb-2006 08:31 AM Page: 595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/02ISR Number: 4026617-4Report Type:Expedited (15-DaCompany Report #2002GB02562 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lymphopenia Foreign Seroquel PS ORAL 200 MG BID PO Neutropenia Health Professional Other Date:12/16/02ISR Number: 4026620-4Report Type:Expedited (15-DaCompany Report #2002GB02810 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Withdrawal Foreign Seroquel PS ORAL 175 MG BID PO Intervention to Convulsions Health Seroquel SS ORAL 150 MG BID PO Prevent Permanent Sedation Professional Seroquel SS ORAL 275 MG DAILY Impairment/Damage Other PO Seroquel SS ORAL 150 MG HS PO Date:12/16/02ISR Number: 4026940-3Report Type:Expedited (15-DaCompany Report #02P-163-0205458-00 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Verapamil (Isoptin) Health (Verapamil) PS ORAL PER ORAL Professional Valproic Acid (Depakene) (Valproic Acid) (Valproic Acid) SS ORAL PER ORAL Quetiapine SS ORAL PER ORAL Date:12/16/02ISR Number: 4026990-7Report Type:Expedited (15-DaCompany Report #2000UW00285 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Health Seroquel "Zeneca" PS Zeneca Injury Professional Methadone C Pulmonary Congestion Amitriptyline C Pulmonary Oedema Nortriptyline C Road Traffic Accident Citalopram C Toxicologic Test Abnormal Date:12/17/02ISR Number: 4028525-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal (Tablet) Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL MG, DAILY, Phosphokinase Increased Professional ORAL Blood Pressure Increased Haldol (Tablet) Condition Aggravated (Haloperidol) SS ORAL MG, DAILY, Delusion ORAL Diabetes Mellitus Quetiapine Fumarate Hallucination (Quetiapine Hypoventilation Fumarate) SS ORAL MG, DAILY, Insomnia ORAL Respiratory Distress Hydroxyzine Pamoate Schizophrenia (Hydroxyzine) C 22-Feb-2006 08:31 AM Page: 596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:12/17/02ISR Number: 4028692-XReport Type:Expedited (15-DaCompany Report #2002SE05260 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS Hospitalization - Disseminated Health Haldol "Janssen" C Initial or Prolonged Intravascular Coagulation Professional Stilnoct C Drug Toxicity Other Trazolan C Date:12/17/02ISR Number: 4029067-XReport Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Haldol (Tablet) Initial or Prolonged Blood Creatine Health (Haloperidol) PS ORAL MG, DAILY, Phosphokinase Increased Professional ORAL Blood Pressure Increased Risperdal (Tablet) Condition Aggravated (Risperidone) SS ORAL MG, DAILY, Delusion ORAL Diabetes Mellitus Quetiapine Fumarate Hallucination (Quetiapine Insomnia Fumarate) SS ORAL MG, DAILY, Respiratory Distress ORAL Hydroxyzine Pamoate (Hydroxyzine) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:12/18/02ISR Number: 4025725-1Report Type:Direct Company Report #CTU 183007 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Movement Disorder Seroquel 300mg Tabs Astra Zeneca PS Astra Zeneca ORAL 600MG PO QHS Geodon 80mg Caps Pfizer SS Pfizer ORAL 80MG PO BID Altace C Valproic Acid C Prevacid C Klonopin C Glucophage C Motrin C Tylenol C 22-Feb-2006 08:31 AM Page: 597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Kaopectate C Maalox C Date:12/18/02ISR Number: 4025726-3Report Type:Direct Company Report #CTU 183008 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Seroquel 100mg, Decreased 200mg, & 300mg. Tabs Neutrophil Count Astra Zeneca PS Astra Zeneca SEE DESCRIBE Decreased EVENT White Blood Cell Count Benadryl C Decreased Maalox C Date:12/18/02ISR Number: 4029090-5Report Type:Expedited (15-DaCompany Report #2002UW15582 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysarthria Health Seroquel PS ORAL 250 MG DAILY Treatment Noncompliance Professional PO Weight Increased Depakote C Prozac C Date:12/18/02ISR Number: 4029091-7Report Type:Expedited (15-DaCompany Report #2002UW16893 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Health Seroquel PS ORAL 300 MG DAILY Professional PO Parnate SS Paxil C Date:12/18/02ISR Number: 4029094-2Report Type:Expedited (15-DaCompany Report #CATIE1-0329 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Derailment Study Quetiapine Capsule, Initial or Prolonged Dysarthria Health 100mg(Dibasic Mental Status Changes Professional Dicaclcium Phosphate Somnolence Dihydrate) PS Speech Disorder Protonix C Thought Blocking Ativan C Imitrex C Wellbutrin Sr C Buspar C Date:12/18/02ISR Number: 4029214-XReport Type:Expedited (15-DaCompany Report #2002GB02895 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS ORAL 150 MG BID PO Intervention to Neutropenia Health Seroquel SS ORAL 750 MG DAILY Prevent Permanent Schizophrenia, Paranoid Professional PO Impairment/Damage Type Other 22-Feb-2006 08:31 AM Page: 598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/02ISR Number: 4029245-XReport Type:Expedited (15-DaCompany Report #2002SE06175 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Seroquel PS ORAL 350 MG QD PO Anxiety Health Stedon C Dizziness Professional Dipiperon C Hypotension Other Aloperidin C Myocardial Infarction Zyprexa C Pyrexia Akineton C Tenormin C Date:12/20/02ISR Number: 4028635-9Report Type:Direct Company Report #CTU 183181 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Quetiapine PS ORAL 100MG PO HS Initial or Prolonged Heart Rate Irregular Quetiapine SS ORAL 200MG PO HS Muscle Twitching Citalopram C Palpitations Acetaminophen C Restlessness Date:12/20/02ISR Number: 4030656-7Report Type:Expedited (15-DaCompany Report #2002UW17079 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Red Blood Cell Count Foreign Seroquel PS Decreased Study Neurontin C Health Ativan C Professional Dicetel C Other Imovane C Prevacid C Clonazepam C Vitamin B12 C Synthroid C Date:12/20/02ISR Number: 4030657-9Report Type:Expedited (15-DaCompany Report #2002SE06232 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypereosinophilic Foreign Seroquel PS ORAL 200 MG BID PO Syndrome Health Alvityl C Professional Etumine C Other Floxyfral C Stilnoct C Trazolan C Date:12/20/02ISR Number: 4030874-8Report Type:Expedited (15-DaCompany Report #2002UW16992 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Myopathy Health Seroquel PS ORAL 300 MG TID PO Intervention to Professional Naproxyn C Prevent Permanent Dexedrine "Medeva" C Impairment/Damage Paxil C Klonopin C 22-Feb-2006 08:31 AM Page: 599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/02ISR Number: 4029135-2Report Type:Direct Company Report #CTU 183279 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Somnolence Quetiapine 50 Mg Bid Po PS Date:12/23/02ISR Number: 4032361-XReport Type:Expedited (15-DaCompany Report #B0287819A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Paracetamol Overdose (Acetaminophen) PS ORAL ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL ORAL Dextropropoxyphene (Dextropropoxyphene) SS Date:12/23/02ISR Number: 4032431-6Report Type:Expedited (15-DaCompany Report #2002UW17056 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Foreign Seroquel PS ORAL 50 MG BID PO Initial or Prolonged Abnormal Health Wellbutrin C Lymphocyte Count Professional Decreased Mononucleosis Syndrome Neutrophil Count Decreased White Blood Cell Count Decreased Date:12/23/02ISR Number: 4033025-9Report Type:Expedited (15-DaCompany Report #2002UW17079 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Red Blood Cell Count Foreign Seroquel PS Decreased Health Neurontin C Professional Ativan C Other Dicetel C Imovane C Prevacid C Clonazepam C Vitamin B12 C Synthroid C Date:12/23/02ISR Number: 4033027-2Report Type:Expedited (15-DaCompany Report #2002AP04380 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Seroquel PS Lethargy Health Methadone SS Malaise Professional Other 22-Feb-2006 08:31 AM Page: 600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/02ISR Number: 4033087-9Report Type:Expedited (15-DaCompany Report #2002UW16166 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Withdrawal Health Seroquel PS ORAL 200 MG, BID; Syndrome Professional PO Cardiac Disorder Haldol C Janssen Diabetes Mellitus Date:12/24/02ISR Number: 4033938-8Report Type:Expedited (15-DaCompany Report #2002UW16830 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blister Health Seroquel PS ORAL 100 MG HS PO Initial or Prolonged Professional Date:12/24/02ISR Number: 4033992-3Report Type:Expedited (15-DaCompany Report #2002SE06285 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Eczema Foreign Seroquel PS ORAL 25 MG BID PO Intervention to Erythema Health Tenox C Prevent Permanent Professional Impairment/Damage Other Date:12/24/02ISR Number: 4033993-5Report Type:Expedited (15-DaCompany Report #2002SE06235 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Transient Foreign Seroquel PS ORAL 500 MG QD PO Intervention to Eye Pain Health Paracetamol C Prevent Permanent Professional Impairment/Damage Other Date:12/24/02ISR Number: 4033994-7Report Type:Expedited (15-DaCompany Report #2002GB02911 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Foreign Seroquel PS ORAL 500 MG DAILY Intervention to Blood Thyroid Stimulating Health PO Prevent Permanent Hormone Increased Professional Depakote C Impairment/Damage Microcytic Anaemia Other Cipramil C Date:12/24/02ISR Number: 4033995-9Report Type:Expedited (15-DaCompany Report #2002GB02909 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Withdrawal Syndrome Foreign Quetiapine PS TOPICAL 400 MG DAILY Intervention to Neonatal Health TPL Prevent Permanent Maternal Drugs Affecting Professional Diazepam C Impairment/Damage Foetus Other Fluoxetine C Pregnancy 22-Feb-2006 08:31 AM Page: 601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/24/02ISR Number: 4033996-0Report Type:Expedited (15-DaCompany Report #2002GB02894 Age:0 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Maternal Drugs Affecting Foreign Seroquel PS TRANSPLACENTAL 200 MG BID Foetus Health TPL Talipes Professional Citalopram SS TRANSPLACENTAL 40 MG QD TPL Other Date:12/24/02ISR Number: 4033997-2Report Type:Expedited (15-DaCompany Report #2002GB01858 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Complications Of Maternal Foreign Seroquel PS 200 MG BID PO Intervention to Exposure To Therapeutic Health Cipramil SS 40 MG QD Prevent Permanent Drugs Professional Ventolin C Impairment/Damage Induced Labour Other Pregnancy Induced Hypertension Date:12/24/02ISR Number: 4033998-4Report Type:Expedited (15-DaCompany Report #2002AP03781 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Foreign Seroquel PS 200 MG TID PO Initial or Prolonged Infarction Health Olanzapine SS Required Cardiomyopathy Professional Cipramil C Intervention to Delirium Other Haloperidol C Prevent Permanent Psychotic Disorder Temazepam C Impairment/Damage Ventricular Hypokinesia Date:12/24/02ISR Number: 4034024-3Report Type:Expedited (15-DaCompany Report #2002AP04371 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Encephalopathy Foreign Seroquel PS Hepatitis Fulminant Health Professional Other Date:12/24/02ISR Number: 4034026-7Report Type:Expedited (15-DaCompany Report #2002AP04390 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Seroquel PS Initial or Prolonged Drug Interaction Health Methadone C Professional Other Date:12/24/02ISR Number: 4034027-9Report Type:Expedited (15-DaCompany Report #2002SE06175 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Seroquel PS ORAL 350 MG QD PO Health Stedon C Professional Dipiperon C Other Aloperidin C 22-Feb-2006 08:31 AM Page: 602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa C Akineton C Tenormin C Date:12/26/02ISR Number: 4030786-XReport Type:Direct Company Report #CTU 183384 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Thorazine 1400 Mg Qd PS SEE ABOVE Initial or Prolonged Carbamazepine 600 Mg Qd SS Benztropine 2mg Bid SS Seroquel 800 Mg Qd SS Metamucil C Depakote C Chronulac C Clonazepam C Mg Citrate C Date:12/26/02ISR Number: 4031753-2Report Type:Periodic Company Report #02-06-0510 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine- Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25 MG AM ORAL Seroquel Tablets SS ORAL 200MG AM ORAL Depakote Tablets SS ORAL ER 500MG BID ORAL; SEE IMAGE Date:12/26/02ISR Number: 4036404-9Report Type:Periodic Company Report #02-07-0637 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-50 MG QD ORAL Depakote SS 500MG BID Seroquel SS 100MG QD Date:12/27/02ISR Number: 4034462-9Report Type:Expedited (15-DaCompany Report #2002UW17056 Age:14 YR Gender:Male I/FU:F Outcome PT Hospitalization - Infectious Mononucleosis Initial or Prolonged Liver Function Test Abnormal Lymphocyte Count Decreased Neutrophil Count 22-Feb-2006 08:31 AM Page: 603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 50 MG BID PO Health Wellbutrin C Professional Other Date:12/27/02ISR Number: 4034463-0Report Type:Expedited (15-DaCompany Report #2002SE06067 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Menstruation Irregular Foreign Seroquel PS ORAL 600 MG QD PO Intervention to Thrombocytopenia Health Xanax C Prevent Permanent Professional Impairment/Damage Other Date:12/27/02ISR Number: 4034466-6Report Type:Expedited (15-DaCompany Report #2002SE06332 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel PS ORAL 100 MG QID PO Initial or Prolonged Neutropenia Health Serenase C Professional Temesta C Other Thyroxin C Burana C Date:12/27/02ISR Number: 4034747-6Report Type:Expedited (15-DaCompany Report #2002071920 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anger Foreign Zoloft (Sertraline) PS ORAL 20 MG Drug Abuser Health (DAILY), ORAL Parkinson'S Disease Professional Quetiapine SS ORAL ORAL Methadone SS ORAL 70 MG (DAILY), ORAL Chlorpromazine C Clotiapine C Delorazepam C Flurazepam C Date:12/27/02ISR Number: 4034993-1Report Type:Expedited (15-DaCompany Report #2002GB02891 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Quetiapine PS TOPICAL 400 MG BID Initial or Prolonged Exposure To Therapeutic Health TPL Required Drugs Professional Paroxetine SS TOPICAL 20 MG QD TPL Intervention to Drug Withdrawal Syndrome Other Pethidine C Prevent Permanent Neonatal Impairment/Damage Hypervigilance Hypotonia Neonatal Induced Labour Insomnia Maternal Drugs Affecting Foetus Neonatal Disorder 22-Feb-2006 08:31 AM Page: 604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/02ISR Number: 4035604-1Report Type:Expedited (15-DaCompany Report #PHBS2002ITI3692 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Faecal Incontinence Foreign Tegretol Hallucination Health (Carbamazepine) PS ORAL 600 MG/DAY, Restlessness Professional ORAL Tremor Other Seroquel (Quetiapine Urinary Incontinence Fumarate) SS ORAL 50 MG/DAY, ORAL Trittico (Trazodone Hydrochloride) SS ORAL 75 MG/DAY, ORAL Carbolithium C Lorans C Mirapexin (Pramipexole Dihydrochloride) C Neurontin (Gabapentin) C Zyprexa C Date:12/30/02ISR Number: 4036572-9Report Type:Expedited (15-DaCompany Report #2002UW17209 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS 1 WK Thrombocytopenia Professional Depakote C Librium "Hoffman" C Date:12/30/02ISR Number: 4036574-2Report Type:Expedited (15-DaCompany Report #2002AP04423 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Foreign Seroquel PS ORAL 50 MG DAILY Intervention to Convulsion Health PO Prevent Permanent Depressed Level Of Professional Epos C Impairment/Damage Consciousness Other Sediel C Hypochloraemia Juvela C Hyponatraemia Gasmotin C Oedema Magnesium Oxide C Weight Increased Date:12/30/02ISR Number: 4036575-4Report Type:Expedited (15-DaCompany Report #2002AP04103 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Seroquel PS ORAL 1400 MG DAILY Initial or Prolonged Sensory Disturbance Health PO Suicide Attempt Professional Seroquel SS ORAL 5800 MG ONCE Other PO Vegetamin A C Nelurolen C Brovarin C Phenobal C 22-Feb-2006 08:31 AM Page: 605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/02ISR Number: 4036595-XReport Type:Expedited (15-DaCompany Report #2002AP04105 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Seroquel PS ORAL 500 MG DAILY Initial or Prolonged Phosphokinase Increased Health PO Chills Professional Seroquel SS ORAL 400 MG DAILY Disseminated Other PO Intravascular Coagulation Ludiomil C Enterobacter Infection Seniran C Neuroleptic Malignant Eurodin C Syndrome Rhythmy C Sepsis Date:12/31/02ISR Number: 4036795-9Report Type:Expedited (15-DaCompany Report #EMADSS2002007917 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Haldol (Unspecified) Initial or Prolonged Drug Interaction Health (Haloperidol) PS 25 MG, DAILY Epilepsy Professional Nozinan (Levomepromazine) SS 25 MG, DAILY Seropram (Citalopram Hydrobromide) SS ORAL 30 MG, DAILY, ORAL Maxipime (Cefepime) SS INTRAVENOUS 1 G, IV Seroquel (Seroquel) SS ORAL 25 MG, DAILY, ORAL Akineton (Biperiden Hydrochloride) SS INTRAVENOUS 2 G, DAILY, IV Dafalgan (Paracetamol) C Nitroderm (Glyceryl Trinitrate) C Antra (Omeprazole) C Morfina (Morphine) C Atrovent (Ipratropium Bromide) C Ventolin (Salbutamol) C Dobutrex (Dobutamine Hydrochloride) C Heparin (Heparin) C Flagyl (Metronidazole) C Date:01/02/03ISR Number: 4038632-5Report Type:Expedited (15-DaCompany Report #2002AP04514 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Hyperosmolar Foreign Seroquel PS ORAL 75 MG DAILY Initial or Prolonged Coma Health PO Required Professional Predonine SS 2.5 MG DAILY Intervention to Other Predonine SS 20 MG DAILY Prevent Permanent Predonine SS 10 MG DAILY Impairment/Damage Predonine SS 7.5 MG DAILY Chlorpromazine C 22-Feb-2006 08:31 AM Page: 606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levomepromazine C Haloperidol C Risperidone C Date:01/03/03ISR Number: 4035421-2Report Type:Direct Company Report #USP 55373 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Zoloft PS Pfizer Uspg Seroquel (Quetiapine Fumarate) SS Astrazeneca Date:01/06/03ISR Number: 4036926-0Report Type:Direct Company Report #CTU 183917 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel PS Serzone SS Date:01/06/03ISR Number: 4037024-2Report Type:Direct Company Report #CTU 183950 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Quetiapine Fumarate PS Initial or Prolonged Mental Status Changes Northriptyline SS ORAL ORAL Required Amitriptyline C Intervention to Prevent Permanent Impairment/Damage Date:01/08/03ISR Number: 4040456-XReport Type:Expedited (15-DaCompany Report #2003PK00002 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Foreign Seroquel PS ORAL 300 MG DAILY Health PO Professional Other Date:01/08/03ISR Number: 4040487-XReport Type:Expedited (15-DaCompany Report #2002UW16584 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Health Seroquel PS ORAL 100 MG HS PO Intervention to Complications Of Maternal Professional Zoloft C Prevent Permanent Exposure To Therapeutic Clonopin C Impairment/Damage Drugs Maternal Drugs Affecting Foetus 22-Feb-2006 08:31 AM Page: 607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/03ISR Number: 4040769-1Report Type:Expedited (15-DaCompany Report #2002SE06407 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Granulocytopenia Foreign Seroquel PS ORAL SEE IMAGE Intervention to Health Idalprem C Prevent Permanent Professional Prozac C Impairment/Damage Other Date:01/10/03ISR Number: 4040888-XReport Type:Expedited (15-DaCompany Report #2002070102 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Ineffective Health Geodon (Ziprasidone) PS 160 MG (BID) Feeling Abnormal Professional Quetiapine Fumarate SS Hallucination, Auditory Company Paroxetine Nausea Representative Hydrochloride C Paranoia Haloperidol C Vomiting Date:01/10/03ISR Number: 4040944-6Report Type:Expedited (15-DaCompany Report #2003UW00170 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Eczema Consumer Seroquel PS ORAL 200 MG BID PO Intervention to Feeling Abnormal Prevent Permanent Medication Error Impairment/Damage Psoriasis Date:01/10/03ISR Number: 4041118-5Report Type:Expedited (15-DaCompany Report #2003UW00091 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Disorder Consumer Seroquel PS ORAL 300 MG HS PO 2 YR Initial or Prolonged Platelet Count Decreased Prednisone C Aspirin "Bayer" C Nexium C Date:01/10/03ISR Number: 4041161-6Report Type:Expedited (15-DaCompany Report #2001AP05804 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypokalaemia Foreign Seroquel PS ORAL 400 MG DAILY Hypomania Study PO Hypotension Health Seroquel SS ORAL 600 MG DAILY Inadequate Diet Professional PO Iron Deficiency Anaemia Other Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 150 MG DAILY PO Seroquel SS ORAL 75 MG DAILY PO Barnetil C Lodopin C 22-Feb-2006 08:31 AM Page: 608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tasmolin C Doral C Date:01/13/03ISR Number: 4040971-9Report Type:Direct Company Report #CTU 184244 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Doxepin PS Ribavirin 200mg Cap SS Diazepam 5mg Tab SS Morphine 30mg Tab, Sa SS Peginterferon Alpha-2b 120mcg/ SS Paroxetine Hcl 40mg Tab SS Quetiapine 25mg Tab SS Quetiapine 100mg Tab SS Date:01/14/03ISR Number: 4043505-8Report Type:Expedited (15-DaCompany Report #2002AP03279 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS ORAL 200 MG DAILY Increased Health PO Aspartate Professional Seroquel SS ORAL 400 MG DAILY Aminotransferase Other PO Increased Seroquel SS ORAL 300 MG DAILY Blood Creatine PO Phosphokinase Increased Seroquel SS ORAL 200 MG DAILY Blood Lactate PO Dehydrogenase Increased Seroquel SS ORAL 400 MG DAILY Deep Vein Thrombosis PO Dysphoria Tegretol C Electrocardiogram T Wave Hirnamin C Abnormal Neuleptil C Fall Methylcobal C Heart Rate Decreased Fludecasin C Logorrhoea Mental Status Changes Muscle Rigidity Pulmonary Infarction Sedation Ventricular Extrasystoles White Blood Cell Count Abnormal Date:01/15/03ISR Number: 4043018-3Report Type:Expedited (15-DaCompany Report #2003AP00108 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Foreign Seroquel PS ORAL 100 MG DAILY Depressed Level Of Health PO Consciousness Professional Other 22-Feb-2006 08:31 AM Page: 609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/03ISR Number: 4042967-XReport Type:Direct Company Report #CTU 184733 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Increased Clozaril PS 50MG Q HS Initial or Prolonged Hyperhidrosis Seraquil SS 50MG AT HS Pyrexia Tremor Date:01/17/03ISR Number: 4044637-0Report Type:Expedited (15-DaCompany Report #2003GB00028 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Foreign Quetiapine PS ORAL 25 MG DAILY; Sudden Death Health PO Professional Paracetamol C Other Amoxycillin C Glycerol C Omeprazole C Chlorpheniramine C Lactulose C Valium C Date:01/17/03ISR Number: 4044638-2Report Type:Expedited (15-DaCompany Report #2002SE06232 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Seroquel PS ORAL 200 MG, BID; White Blood Cell Count Health PO Increased Professional Alvityl C Other Etumine C Floxyfral C Stilnoct C Trazolan C Date:01/17/03ISR Number: 4044639-4Report Type:Expedited (15-DaCompany Report #2003UW00519 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Bilirubin Increased Foreign Seroquel PS Intervention to Leukocytosis Health Dexedrine "Medeva" C Prevent Permanent Platelet Count Decreased Professional Impairment/Damage Other Date:01/21/03ISR Number: 4043972-XReport Type:Direct Company Report #CTU 184840 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel 200 Mg PS ORAL T QHS ORAL Required Nausea Serzone 200 Mg SS ORAL T QHS ORAL Intervention to Vomiting Lipitor C Prevent Permanent Weight Decreased Depakote Er C Impairment/Damage Ranitidine C Wellbutrin Sr C Haldo C Effexor 37 C Asa C 22-Feb-2006 08:31 AM Page: 610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/03ISR Number: 4044184-6Report Type:Direct Company Report #CTU 184886 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Seroquel 300 Mg In Initial or Prolonged Syndrome Am, 100 Mg In Pm PS 4 MON Glucophage C Synthroid C Date:01/21/03ISR Number: 4044717-XReport Type:Expedited (15-DaCompany Report #2003UW00549 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Health Seroquel PS ORAL 600 MG PO Initial or Prolonged Professional Lithium SS Date:01/21/03ISR Number: 4045123-4Report Type:Expedited (15-DaCompany Report #2003UW00322 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Seroquel PS ORAL 600 MG PO Initial or Prolonged White Blood Cell Count Professional Risperdal C Decreased Date:01/21/03ISR Number: 4045125-8Report Type:Expedited (15-DaCompany Report #2003UW00550 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Health Seroquel PS ORAL 600 MG PO Initial or Prolonged Professional Trileptal SS Date:01/21/03ISR Number: 4045201-XReport Type:Expedited (15-DaCompany Report #2002GB02668 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Thyroid Stimulating Foreign Seroquel PS ORAL 700 MG DAILY Hormone Increased Health PO Microcytic Anaemia Professional Cipramil C Other Depakote C Date:01/21/03ISR Number: 4045560-8Report Type:Expedited (15-DaCompany Report #SKEL000113 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Skelaxin Drug Toxicity Professional (Metaxalone) PS ORAL ORAL Seroquel (Quetiapine) SS ORAL ORAL Topamax (Topiramate) SS ORAL Ethanol (Ethanol) C ORAL ORAL Clonazepam C Ambien C Vioxx C 22-Feb-2006 08:31 AM Page: 611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/03ISR Number: 4045630-4Report Type:Expedited (15-DaCompany Report #B0285904A Age:47 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Literature Aspirin (Formulation Intentional Overdose Health Unknown) (Aspirin) PS ORAL ORAL Professional Paracetamol (Formulation Unknown) (Acetaminophen) SS ORAL ORAL Quetiapine (Formulation Unknown) (Quetiapine) SS ORAL ORAL Date:01/21/03ISR Number: 4046132-1Report Type:Expedited (15-DaCompany Report #2002GB02562 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lymphopenia Foreign Seroquel PS ORAL 200 MG BID PO Neutropenia Health Professional Other Date:01/21/03ISR Number: 4046133-3Report Type:Expedited (15-DaCompany Report #2002AP04371 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ammonia Increased Foreign Seroquel PS ORAL 300 MG DAILY Life-Threatening Asphyxia Health PO Cardio-Respiratory Arrest Professional Depakene SS ORAL 400 MG DAILY Cold Sweat Other PO Coma Depakene SS ORAL 800 MG DAILY Condition Aggravated PO Decerebration Haemoglobin Decreased Haemorrhagic Stroke Hepatic Failure Hepatitis Fulminant Hypoglycaemia Mental Disorder Muscle Rigidity Mydriasis Platelet Count Decreased Date:01/21/03ISR Number: 4046135-7Report Type:Expedited (15-DaCompany Report #2003SE00101 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Seroquel PS ORAL 400 MG QD PO Complete Health Ventolin C Bradycardia Professional Remeron C Other Serlain C 22-Feb-2006 08:31 AM Page: 612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/03ISR Number: 4046136-9Report Type:Expedited (15-DaCompany Report #2003AP00121 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Lactate Foreign Seroquel PS ORAL 200 MG DAILY Dehydrogenase Increased Health PO Hepatic Function Abnormal Professional Akineton C Hypoglycaemia Other Amoban C Reye'S Syndrome Rohypnol C Sennoside C Risperdal C Brovarin C Date:01/23/03ISR Number: 4045677-8Report Type:Direct Company Report #CTU 185115 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Quetiapine 25mg PS ORAL 25MG BID ORAL Hypertonia Joint Stiffness Date:01/23/03ISR Number: 4046258-2Report Type:Expedited (15-DaCompany Report #2003SE00051 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS ORAL 800 MG QD PO Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:01/23/03ISR Number: 4046400-3Report Type:Expedited (15-DaCompany Report #2003GB00079 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Maternal Drugs Affecting Foreign Seroquel PS TOPICAL 100 MG BID Hospitalization - Foetus Health TPL Initial or Prolonged Pregnancy Professional Congenital Anomaly Transient Tachypnoea Of Other The Newborn Ventricular Septal Defect Date:01/23/03ISR Number: 4046402-7Report Type:Expedited (15-DaCompany Report #2003SE00051 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS ORAL 800 MG QD PO Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:01/23/03ISR Number: 4046712-3Report Type:Expedited (15-DaCompany Report #2003UW00738 Age:58 YR Gender:Male I/FU:I Outcome PT Hospitalization - Bradycardia Initial or Prolonged Cardio-Respiratory Arrest Dehydration 22-Feb-2006 08:31 AM Page: 613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS ORAL 400 MG BID PO Professional Atenolol SS 75 MG BID Risperdal SS 1 MG BID Benazepril SS 10 MG HS Hydrochlorothiazide SS 50 MG DAILY Date:01/23/03ISR Number: 4046713-5Report Type:Expedited (15-DaCompany Report #2003UW00667 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anorexia Health Seroquel PS ORAL 9000 MG OCNE Intervention to Fatigue Professional PO Prevent Permanent Hypersomnia Impairment/Damage Nausea Overdose Date:01/23/03ISR Number: 4046714-7Report Type:Expedited (15-DaCompany Report #2003UW00170 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depressed Level Of Consumer Seroquel PS ORAL 200 MG BID PO Intervention to Consciousness Prevent Permanent Eczema Impairment/Damage Feeling Abnormal Medication Error Psoriasis Date:01/23/03ISR Number: 4046715-9Report Type:Expedited (15-DaCompany Report #2003UW00738 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Seroquel PS ORAL 400 MG BID PO Initial or Prolonged Cardio-Respiratory Arrest Professional Atenolol SS 75 MG BID Dehydration Risperdal SS 1 MG BID Hypotension Benazepril SS 10 MG HS Hydrochlorothiazide SS 50 MG DAILY Date:01/23/03ISR Number: 4046716-0Report Type:Expedited (15-DaCompany Report #2003UW00667 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anorexia Health Seroquel PS ORAL 9000 MG ONCE Intervention to Fatigue Professional PO Prevent Permanent Hypersomnia Impairment/Damage Nausea Overdose Date:01/23/03ISR Number: 4046717-2Report Type:Expedited (15-DaCompany Report #2003UW00170 Age:4 YR Gender:Male I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Eczema Consumer Seroquel PS ORAL 200 MG BID PO Feeling Abnormal Medication Error Psoriasis Date:01/23/03ISR Number: 4047068-2Report Type:Expedited (15-DaCompany Report #2002067242 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autoimmune Hepatitis Health Geodon (Ziprasidone) PS ORAL ORAL Hospitalization - Cholelithiasis Professional Metformin SS ORAL 500 MG Initial or Prolonged General Physical Health (DAILY), ORAL Other Deterioration Ramipril SS Hepatic Failure Quetiapine Fumarate SS 100 MG Ischaemia (DAILY) Pancreatitis Lithium Carbonate SS Sepsis Vitamins C Docusate Sodium C Psyllium C Date:01/23/03ISR Number: 4047179-1Report Type:Expedited (15-DaCompany Report #A108646 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Geodon(Ziprasidone) PS ORAL ORAL Initial or Prolonged Mania Health Neurontin Medication Error Professional (Gabapentin) SS 3600 MG Schizophrenia (TID); UNKNOWN Quetiapine Fumarate SS ORAL 300 MG (DAILY); ORAL Ethanol SS ORAL (UNKNOWN), ORAL Valproate Semisodium C Clonazepam C Date:01/23/03ISR Number: 4047192-4Report Type:Expedited (15-DaCompany Report #L03-USA-00139-06 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Propranolol PS Intentional Overdose Health Valproic Acid SS Professional Quetiapine SS Additional Substances Nos SS Date:01/23/03ISR Number: 4047238-3Report Type:Expedited (15-DaCompany Report #L03-USA-00139-05 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Propranolol PS Intentional Overdose Health Alprazolam SS Professional Quetiapine SS Additional 22-Feb-2006 08:31 AM Page: 615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Substances Nos SS Date:01/23/03ISR Number: 4047530-2Report Type:Expedited (15-DaCompany Report #2003PK00051 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Foreign Seroquel PS Life-Threatening Health Hospitalization - Professional Initial or Prolonged Other Date:01/24/03ISR Number: 4047758-1Report Type:Expedited (15-DaCompany Report #2002GB02590 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Pernicious Anaemia Health PO Platelet Count Decreased Professional Amisulpride SS ORAL 1000 MG DAILY White Blood Cell Count Other PO Decreased Zopiclone C Procyclidine C Paracetamol C Date:01/24/03ISR Number: 4047841-0Report Type:Expedited (15-DaCompany Report #2002AP04423 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS ORAL 50 MG DAILY Intervention to Convulsion Health PO Prevent Permanent Depressed Level Of Professional Epos C Impairment/Damage Consciousness Other Sediel C Hyperglycaemia Juvela C Hypochloraemia Gasmotin C Hyponatraemia Magnesium Oxide C Date:01/27/03ISR Number: 4047356-XReport Type:Direct Company Report #CTU-185314 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dysphagia Seroquel 100mg Intervention to Astra/Zenica PS Astra/Zenica ORAL 150 MG DAILY Prevent Permanent ORAL Impairment/Damage Atorvastatin C Benztropine C Valproic Acid C Date:01/27/03ISR Number: 4048065-3Report Type:Expedited (15-DaCompany Report #2003UW00929 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Seroquel PS ORAL 150 MG DAILY Initial or Prolonged Ventricular Extrasystoles Professional PO Glucophage SS 22-Feb-2006 08:31 AM Page: 616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/03ISR Number: 4048735-7Report Type:Expedited (15-DaCompany Report #2003AP00243 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Seroquel PS 200 MG DAILY Death Health PO Nasopharyngitis Professional Seroquel SS 400 MG DAILY Other PO Benzalin C Minzain C Gasmotin C Pantethine C Magnesium Oxide C Alosenn C Ubtec C Mashinin C Date:01/27/03ISR Number: 4048736-9Report Type:Expedited (15-DaCompany Report #2003AP00257 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Seroquel PS 100 MG DAILY Initial or Prolonged Fracture Health PO Disability Hip Arthroplasty Professional Contomin SS 25 MG DAILY Required Other PO Intervention to Rohypnol C Prevent Permanent Artane C Impairment/Damage Doral C Date:01/28/03ISR Number: 4047972-5Report Type:Expedited (15-DaCompany Report #B0289906A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Seroxat PS Glaxo Wellcome ORAL 20MG Per day Initial or Prolonged Bacterial Infection Seroquel SS ORAL 300MG Per day Other Diabetic Ketoacidosis Methylenedioxymetham Haemodialysis phetamine SS ORAL 1 DAY Hypokalaemia Alcohol SS ORAL Pneumonia Aspiration Renal Failure Staphylococcal Infection Date:01/28/03ISR Number: 4048826-0Report Type:Expedited (15-DaCompany Report #M0063-2003 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Health Mirtzapine PS ORAL 15 MG ORAL Initial or Prolonged Professional Venlafaxine Hydrochloride SS ORAL 150 MG ORAL Seroquel SS ORAL 200 MG ORAL Ciprofloxacin C Date:01/28/03ISR Number: 4048992-7Report Type:Expedited (15-DaCompany Report #2003UW00898 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS ORAL 400 MG BID PO Professional 22-Feb-2006 08:31 AM Page: 617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/03ISR Number: 4049044-2Report Type:Expedited (15-DaCompany Report #2003AP00108 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Foreign Seroquel PS ORAL 100 MG DAILY Clonic Convulsion Health PO Coma Professional Diprivan SS 1% Excitability Other Rohypnol SS INTRAVENOUS 4 MG DAILY IV Staphylococcal Infection Rohypnol SS ORAL 2 MG DAILY PO Serenace C Biperiden C Tolopelon C Hibernia C Date:01/28/03ISR Number: 4049045-4Report Type:Expedited (15-DaCompany Report #2002GB01961 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Complications Of Maternal Foreign Seroquel PS ORAL 350 MG DAILY Intervention to Exposure To Therapeutic Health PO Prevent Permanent Drugs Professional Seroquel SS ORAL 100 MG BID PO Impairment/Damage Multiple Sclerosis Other Clomipramine C Pregnancy Date:01/28/03ISR Number: 4049095-8Report Type:Expedited (15-DaCompany Report #2003AP00245 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Seroquel PS ORAL 24 G PO Body Temperature Health Diazepam SS 2 G Decreased Professional Dexamphetamine SS Candidiasis Other Cardiotoxicity Collapse Of Lung Coma Diabetes Mellitus Inadequate Control Grand Mal Convulsion Haemodialysis Hypertension Intentional Overdose Lactic Acidosis Renal Failure Renal Tubular Necrosis Sepsis Sputum Culture Positive Stridor Wheezing Date:01/29/03ISR Number: 4048936-8Report Type:Direct Company Report #CTU 185538 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Seroquel PS ORAL PO Initial or Prolonged Anorexia Atenolol C Dizziness Albuterol C Gait Disturbance Depakote C Flovent C Serevent C 22-Feb-2006 08:31 AM Page: 618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atrovent C Allegra C Date:01/29/03ISR Number: 4050337-3Report Type:Expedited (15-DaCompany Report #2003002471 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Consumer Lipitor Initial or Prolonged (Atorvastatin) PS ORAL 10 MG (DAILY), ORAL Neurontin (Gabapentin) SS ORAL (TID), ORAL Quetiapine Fumarate SS (DAILY) Carbamazepine SS 900 MG (TID) Fluphenazine Hydrochloride SS Valproate Semisodium C Date:01/30/03ISR Number: 4049504-4Report Type:Direct Company Report #CTU 185669 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Back Pain Haldol Deck Shot And Hospitalization - Dysuria 20 Mg Pill PS 20 MGS Initial or Prolonged Pain Seroquel 100 And 200 Disability Mg Pills SS 100 MGS Required MORNING 200 Intervention to MGS NIGHTLY Prevent Permanent Impairment/Damage Date:01/30/03ISR Number: 4050496-2Report Type:Expedited (15-DaCompany Report #2003GB00149 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Seroquel PS ORAL 200 MG DAILY Sudden Death Health PO Professional Seroquel SS ORAL 100 MG DAILY Other PO Lithium C Paroxetine C Date:01/30/03ISR Number: 4050497-4Report Type:Expedited (15-DaCompany Report #2002AP04371 Age:52 YR Gender:Male I/FU:F Outcome PT Death Asphyxia Life-Threatening Cardio-Respiratory Arrest Cerebral Haemorrhage Cold Sweat Decerebration Depressed Level Of Consciousness Haemoglobin Decreased Hepatic Failure Hepatitis Fulminant Hypoglycaemia 22-Feb-2006 08:31 AM Page: 619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Muscle Rigidity Mydriasis Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Foreign Seroquel PS ORAL 300 MG DAILY Health PO Professional Depakene SS ORAL 400 MG DAILY Other PO Depakene SS ORAL 800 MG DAILY PO Date:01/30/03ISR Number: 4050498-6Report Type:Expedited (15-DaCompany Report #2003UW00962 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Seroquel PS ORAL 1500 MG PO Hospitalization - Loss Of Consciousness Professional Initial or Prolonged Overdose Date:01/30/03ISR Number: 4050499-8Report Type:Expedited (15-DaCompany Report #2003AP00301 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Seroquel PS ORAL 400 MG DAILY Required Creatine Phosphokinase Health PO Intervention to Decreased Professional Seroquel SS ORAL 200 MG DAILY Prevent Permanent Neuroleptic Malignant Other PO Impairment/Damage Syndrome Oedema Pneumonitis Date:02/03/03ISR Number: 4051430-1Report Type:Expedited (15-DaCompany Report #2003AP00121 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Seroquel PS ORAL 200 MG DAILY Life-Threatening Increased Health PO Aspartate Professional Risperdal SS ORAL 0.5 MG QID PO Aminotransferase Other Akineton C Increased Amoban C Blood Glucose Decreased Rohypnol C Blood Lactate Sennoside C Dehydrogenase Increased Brovarin C Blood Pressure Decreased Blood Urea Increased Brain Oedema Convulsion Depressed Level Of Consciousness Disseminated Intravascular Coagulation Dysphagia Hepatic Function Abnormal Pallor Po2 Decreased Reye'S Syndrome Somnolence 22-Feb-2006 08:31 AM Page: 620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/03ISR Number: 4051440-4Report Type:Expedited (15-DaCompany Report #2003UW01251 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Health Seroquel PS ORAL 300 MG DAILY Intervention to Delusion Professional PO Prevent Permanent Murder Serentil C Impairment/Damage Date:02/03/03ISR Number: 4051441-6Report Type:Expedited (15-DaCompany Report #2003UW00738 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Seroquel PS ORAL 400 MG BID PO Initial or Prolonged Dehydration Professional Seroquel SS ORAL 500 MG BID PO Dizziness Atenolol SS 75 MG BID Hypotension Risperdal SS 1 MG BID Psychotic Disorder Benazepril SS 10 MG HS Restlessness Hydrochlorothiazide SS 50 MG DAILY Syncope Date:02/04/03ISR Number: 4051671-3Report Type:Direct Company Report #CTU 185928 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Clomipramine PS 10MG Q HS 1 DAY Skin Odour Abnormal Seroquel SS 75MG QD Clonidine C Date:02/04/03ISR Number: 4052275-9Report Type:Expedited (15-DaCompany Report #2003UW01281 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Seroquel PS ORAL 200 MG PO Initial or Prolonged Lethargy Professional Serzone SS 200 MG Medication Error Muscular Weakness Date:02/04/03ISR Number: 4052300-5Report Type:Expedited (15-DaCompany Report #2003UW00274 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Swelling Health Seroquel PS ORAL 25 MG QD PO Intervention to Urticaria Professional Neurontin C Prevent Permanent Prozac C Impairment/Damage Klonopin C Desyrel C Orap C Zyprexa C Date:02/04/03ISR Number: 4052301-7Report Type:Expedited (15-DaCompany Report #2003UW01255 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Multi-Organ Failure Consumer Seroquel PS ORAL 900 MG TID PO Overdose Seroquel SS ORAL 200 MG TID PO 2 WK Schizophrenia Trazodone C 22-Feb-2006 08:31 AM Page: 621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Venlafaxine C Date:02/04/03ISR Number: 4052323-6Report Type:Expedited (15-DaCompany Report #2003SE00244 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Other Seroquel PS ORAL 100 MG BID PO Intervention to Angioneurotic Oedema Seroquel SS ORAL 200 MG BID PO Prevent Permanent Dizziness Fluvoxamin C Impairment/Damage Hypothermia Somnolence Date:02/04/03ISR Number: 4052324-8Report Type:Expedited (15-DaCompany Report #2003AP00312 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Ketoacidosis Health PO Prevent Permanent Professional Zyprexa SS ORAL 5 MG DAILY PO Impairment/Damage Other Zyprexa SS ORAL 10 MG DAILY PO Zyprexa SS ORAL 20 MG DAILY PO Zyprexa SS ORAL 15 MG DAILY PO Toledomin C Contomin C Date:02/04/03ISR Number: 4052341-8Report Type:Expedited (15-DaCompany Report #2003AP00123 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Seroquel PS ORAL 75 MG DAILY Initial or Prolonged Diabetes Mellitus Health PO Weight Decreased Professional Solanax C Other Depakene C Berotec C Meptin C Serevent C Flutide Diskus C Penfill R C Gasmotin C Paxil C Date:02/04/03ISR Number: 4052870-7Report Type:Expedited (15-DaCompany Report #2003002870 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Accident Initial or Prolonged Blood Pressure Decreased Other Bronchitis Fall Forearm Fracture Increased Appetite Joint Sprain Loss Of Consciousness Menorrhagia 22-Feb-2006 08:31 AM Page: 622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Aspiration Somnolence Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zoloft(Sertraline) PS ORAL 200 MG (DAILY), ORAL Risperidone SS ORAL 3 MG (DAILY), ORAL Quetiapine Fumarate SS ORAL ORAL Fexofenadine Hydrochloride C Desloratadine C Atenolol C Ibuprofen C Date:02/04/03ISR Number: 4053084-7Report Type:Expedited (15-DaCompany Report #2003002870 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Consumer Zoloft (Sertraline) PS ORAL 200 MG Initial or Prolonged Bronchitis (DAILY), ORAL Other Fall Risperidone SS ORAL 3 MG (DAILY), Increased Appetite ORAL Intentional Overdose Quetiapine Fumarate SS ORAL ORAL Joint Sprain Ibuprofen SS ORAL ORAL Loss Of Consciousness Diphenhydramine Menorrhagia Hydrochloride SS ORAL ORAL Pneumonia Aspiration Fexofenadine Somnolence Hydrochloride C Suicide Attempt Desloratadine C Upper Limb Fracture Atenolol C Weight Increased Date:02/07/03ISR Number: 4053725-4Report Type:Expedited (15-DaCompany Report #2002UW03339 Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG DAILY Initial or Prolonged Professional PO Seroquel "Zeneca" SS "Zeneca" ORAL 25 MG DAILY PO Date:02/07/03ISR Number: 4054097-1Report Type:Expedited (15-DaCompany Report #2003SE00379 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Foreign Seroquel PS Intervention to Tachycardia Health Prevent Permanent Professional Impairment/Damage Other Date:02/07/03ISR Number: 4054115-0Report Type:Expedited (15-DaCompany Report #2003AP00257 Age:71 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged Disability 22-Feb-2006 08:31 AM Page: 623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Fall Foreign Seroquel PS ORAL 100 MG DAILY Hip Fracture Health PO Professional Contomin SS ORAL 25 MG DAILY Other PO Rohypnol C Artane C Doral C Date:02/07/03ISR Number: 4054122-8Report Type:Expedited (15-DaCompany Report #2002SE06235 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Transient Foreign Seroquel PS ORAL 500 MG QD PO Intervention to Eye Irritation Health Paracetamol C Prevent Permanent Eye Pain Professional Impairment/Damage Other Date:02/07/03ISR Number: 4054125-3Report Type:Expedited (15-DaCompany Report #2003AP00348 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Kleptomania Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Study PO Health Seroquel SS ORAL 200 MG DAILY Professional PO Other Seroquel SS ORAL 300 MG DAILY PO Tegretol C Impromen C Tasmolin C Urso C Date:02/10/03ISR Number: 4055102-9Report Type:Expedited (15-DaCompany Report #2003003076 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Gabapentin(Gabapenti Intentional Overdose Health n) PS ORAL ORAL Professional Amoxapine SS ORAL ORAL Quetiapine SS ORAL ORAL Date:02/11/03ISR Number: 4055923-2Report Type:Expedited (15-DaCompany Report #2003UW01662 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Organ Failure Consumer Seroquel PS Hospitalization - Overdose Initial or Prolonged Pulmonary Embolism 22-Feb-2006 08:31 AM Page: 624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/03ISR Number: 4056703-4Report Type:Expedited (15-DaCompany Report #2003AP00301 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Seroquel PS ORAL SEE IMAGE Life-Threatening Cardio-Respiratory Arrest Health Neodopaston C Hospitalization - Cyanosis Professional Artane C Initial or Prolonged Neuroleptic Malignant Other Depas C Syndrome Eurodin C Pneumonia Lexotan C Productive Cough Date:02/12/03ISR Number: 4056748-4Report Type:Expedited (15-DaCompany Report #2003AP00301 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Seroquel PS ORAL 150 MG DAILY Life-Threatening Cardio-Respiratory Arrest Health PO Hospitalization - Cardiomegaly Professional Seroquel SS ORAL 200 MG DAILY Initial or Prolonged Condition Aggravated Other PO Cyanosis Seroquel SS ORAL 300 MG DAILY Insomnia PO Neuroleptic Malignant Seroquel SS ORAL 400 MG DAILY Syndrome PO Pneumonia Seroquel SS ORAL 200 MG DAILY PO Neodopaston C Artane C Depas C Eurodin C Lexotan C Date:02/12/03ISR Number: 4057014-3Report Type:Expedited (15-DaCompany Report #2002GB02895 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel PS ORAL 150 MG BID PO Initial or Prolonged Schizophrenia Health Seroquel SS ORAL 750 MG DAILY Required Urinary Tract Infection Professional PO Intervention to Other Haloperidol C Prevent Permanent Procyclidine C Impairment/Damage Lansoprazole C Cefalexin C Piportil C Date:02/12/03ISR Number: 4057015-5Report Type:Expedited (15-DaCompany Report #2003PK00051 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angiopathy Foreign Seroquel PS ORAL 300 MG DAILY Life-Threatening Brain Damage Health PO Hospitalization - Cardiac Failure Professional Fluphenazin C Initial or Prolonged Laboratory Test Abnormal Other Pulmonary Embolism Renal Failure Acute Tachycardia 22-Feb-2006 08:31 AM Page: 625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/03ISR Number: 4057647-4Report Type:Periodic Company Report #A0372146A Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Overdose Health Paxil Hospitalization - Professional Tablet-Controlled Initial or Prolonged Company Release (Paroxetine Representative Hydrochloride) PS ORAL 312.5 MG / SINGLE DOSE / ORAL Quetiapine Fumarate Tablet (Quetiapine Fumarate) SS ORAL SINGLE DOSE / ORAL Date:02/13/03ISR Number: 4056509-6Report Type:Direct Company Report #CTU 186613 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anorexia Adderall PS ORAL 10 MG ORAL Intervention to Asthenia Seroquel SS ORAL 100 MG ORAL Prevent Permanent Depression Impairment/Damage Dry Mouth Menstruation Irregular Neutropenia Red Blood Cell Count Decreased White Blood Cell Count Decreased Date:02/13/03ISR Number: 4057531-6Report Type:Expedited (15-DaCompany Report #2003AP00312 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Diabetic Ketoacidosis Health PO Prevent Permanent Nasopharyngitis Professional Zyprexa SS ORAL 5 MG DAILY PO Impairment/Damage Weight Increased Other Zyprexa SS ORAL 10 MG DAILY PO Zyprexa SS ORAL 20 MG DAILY PO Zyprexa SS ORAL 15 MG DAILY PO Toledomin C Contomin C Date:02/13/03ISR Number: 4058055-2Report Type:Expedited (15-DaCompany Report #2003UW01724 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fatigue Consumer Seroquel PS 500-600 MG 18 MON Intervention to Hepatomegaly Seroquel SS 100-200 MG Prevent Permanent Liver Function Test Impairment/Damage Abnormal Sleep Disorder Splenomegaly 22-Feb-2006 08:31 AM Page: 626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/03ISR Number: 4056063-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0396676A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Wellbutrin PS Glaxosmithkline ORAL Drug Interaction Provigil SS Ambien SS Seroquel SS Date:02/14/03ISR Number: 4060043-7Report Type:Expedited (15-DaCompany Report #GB9217523OCT2002 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Efexor Xl Completed Suicide Professional (Venlafaxine Convulsion Hydrochloride, Intentional Overdose Capsule, Extended Loss Of Consciousness Release, 0) PS 300 MG 1X PER 1 DAY 6 MON Quetiapine (Quetiapine, , 0) SS ORAL 700MG DIVIDED DOSES Naltrexone (Naltrexone) C Epilim Chrono (Valproate Sodium) C Cetirizine (Cetirizine) C Date:02/19/03ISR Number: 4057811-4Report Type:Direct Company Report #CTU 186816 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Seroquel 1200 To Initial or Prolonged Delirium 1500 Qd PS Required Hallucination, Visual Intervention to Insomnia Prevent Permanent Mental Status Changes Impairment/Damage Neuroleptic Malignant Syndrome Psychotic Disorder Date:02/19/03ISR Number: 4059673-8Report Type:Expedited (15-DaCompany Report #2003AP00108 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Foreign Seroquel PS ORAL 100 MG DAILY Clonic Convulsion Health PO Coma Professional Diprivan SS 1% 5-15MG/HR Excitability Other Rohypnol SS INTRAVENOUS 4 MG DAILY IV Pyrexia Rohypnol SS ORAL 2 MG DAILY PO Staphylococcal Infection Seranace C Biperiden C Tolopelon C Hiberna C 22-Feb-2006 08:31 AM Page: 627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/03ISR Number: 4059891-9Report Type:Expedited (15-DaCompany Report #2003AP00123 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Seroquel PS ORAL 75 MG DAILY Initial or Prolonged Diabetes Mellitus Health PO Professional Berotec C Other Meptin C Serevent C Flutide Diskus C Penfill R C Gasmotin C Solanax C Paxil C Depakene C Date:02/19/03ISR Number: 4059894-4Report Type:Expedited (15-DaCompany Report #2003GB00278 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS STARTED ON White Blood Cell Count Health 100/150 MG Decreased Professional Seroquel SS ORAL 500 MG DAILY Other PO Propanolol C Date:02/19/03ISR Number: 4060034-6Report Type:Expedited (15-DaCompany Report #2003AP00738 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Phosphokinase Increased Health PO Drug Ineffective Professional Seroquel SS ORAL 200 MG DAILY, Schizophrenia Other PO Serenace SS ORAL 4 MG DAILY PO Serenace SS ORAL 2 MG DAILY PO Clofekton SS 40 MG DAILY Tasmolin C Pantosin C Etilefrine Hydrochloride C Dihydergot C Date:02/19/03ISR Number: 4060225-4Report Type:Expedited (15-DaCompany Report #2003AP00301 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Seroquel PS ORAL 150 MG DAILY Life-Threatening Cardio-Respiratory Arrest Health PO Hospitalization - Cardiomegaly Professional Seroquel SS ORAL 200 MG DAILY Initial or Prolonged Cyanosis Other PO Difficulty In Walking Seroquel SS ORAL 300 MG DAILY Insomnia PO Neuroleptic Malignant Seroquel SS ORAL 400 MG DAILY Syndrome PO Pneumonia Seroquel SS ORAL 200 MG DAILY PO Neodopaston C Artane C 22-Feb-2006 08:31 AM Page: 628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depas C Eurodin C Lexotan C Date:02/19/03ISR Number: 4060448-4Report Type:Expedited (15-DaCompany Report #NSADSS2003005795 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Risperidone Initial or Prolonged Drug Level Increased Health (Unspecified)(Risper Hepatic Encephalopathy Professional idone) PS Ziprasidone SS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS Zoloft (Sertraline Hydrochloride) C Gabitril (Tiagabine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Artane (Trihexyphenidyl Hydrochloride) C Date:02/20/03ISR Number: 4058195-8Report Type:Direct Company Report #USP 55416 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel (Quetiapine Fumarate) PS Astra Zeneca Serzone(Nefazodone Hydrochloride) SS Bristol -Meyers Squibb Us Med Grp Date:02/20/03ISR Number: 4061196-7Report Type:Expedited (15-DaCompany Report #GB9217523OCT2002 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Efexor Xl Completed Suicide Professional (Venlafaxine Convulsion Hydrochloride, Intentional Overdose Capsule, Extended Loss Of Consciousness Release, 0) PS ORAL ORAL 6 MON Quetiapine (Quetiapine, , 0) SS ORAL 700 MG DIVIDED DOSES ORAL 6 MON Naltrexone (Naltrexone) C Epilim Chrono (Valproate Sodium) C Cetirizine (Cetirizine) C 22-Feb-2006 08:31 AM Page: 629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/03ISR Number: 4061929-XReport Type:Expedited (15-DaCompany Report #2002GB02876 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Foreign Seroquel PS 300 - 400 MG Intervention to Complications Of Maternal Health Prevent Permanent Exposure To Therapeutic Professional Impairment/Damage Drugs Other Drug Exposure During Pregnancy Pregnancy Date:02/20/03ISR Number: 4061931-8Report Type:Expedited (15-DaCompany Report #2003AP00312 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Diabetic Ketoacidosis Health PO Prevent Permanent Dry Mouth Professional Zyprexa SS ORAL 5 MG DAILY PO Impairment/Damage Nasopharyngitis Other Zyprexa SS ORAL 10 MG DAILY PO Zyprexa SS ORAL 20 MG DAILY PO Zyprexa SS ORAL 15 MG DAILY PO Toledomin C Contomin C Date:02/20/03ISR Number: 4061996-3Report Type:Expedited (15-DaCompany Report #2003UW01866 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Foreign Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Jaundice Health PO Professional Seroquel SS ORAL 400 MG DAILY Other PO 1 YR Date:02/20/03ISR Number: 4061998-7Report Type:Expedited (15-DaCompany Report #2003AP00804 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Quetiapine PS ORAL 32 DF PO Completed Suicide Literature Depression Health Intentional Overdose Professional Persecutory Delusion Other Restlessness Date:02/21/03ISR Number: 4059532-0Report Type:Direct Company Report #CTU 187147 Age:50 YR Gender:Female I/FU:I Outcome PT Other Chest Pain Coma Cough Delirium Drooling Headache 22-Feb-2006 08:31 AM Page: 630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Serotonin Syndrome Report Source Product Role Manufacturer Route Dose Duration Seroquel 25 Mg Po Qd PS Erythromycin 400 Mg Po Tid SS Prozac 60 Mg Qd SS Date:02/24/03ISR Number: 4059841-5Report Type:Direct Company Report #CTU 187166 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Serzone PS NOT DX Medication Error Seroquel SS 100MG Depakote C Effexor C Date:02/24/03ISR Number: 4064753-7Report Type:Expedited (15-DaCompany Report #2003002870 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Consumer Zoloft (Sertraline) PS ORAL 200 MG Initial or Prolonged Blood Pressure Decreased Health (DAILY), ORAL Other Bronchitis Professional Risperidone SS ORAL 3 MG (DAILY), Fall ORAL Forearm Fracture Quetiapine Fumarate SS ORAL ORAL Increased Appetite Ibuprofen SS ORAL ORAL Joint Sprain Diphenhydramine Loss Of Consciousness Hydrochloride SS ORAL ORAL Menorrhagia Fexofenadine Pneumonia Aspiration Hydrochloride C Somnolence Desloratadine C Suicide Attempt Atenolol C Weight Increased Date:02/25/03ISR Number: 4065254-2Report Type:Expedited (15-DaCompany Report #APCDSS2003000210 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Risperidone Diabetic Coma Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL ORAL Date:02/25/03ISR Number: 4065684-9Report Type:Expedited (15-DaCompany Report #2003UW02253 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Incoherent Health Seroquel PS Professional 22-Feb-2006 08:31 AM Page: 631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/03ISR Number: 4065685-0Report Type:Expedited (15-DaCompany Report #2003UW02211 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Rhabdomyolysis Seroquel PS Intervention to Prevent Permanent Impairment/Damage Date:02/25/03ISR Number: 4066028-9Report Type:Expedited (15-DaCompany Report #2003UW02184 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ventricular Tachycardia Health Seroquel PS ORAL 1500 MG DAILY Intervention to Professional PO Prevent Permanent Zyprexa C Impairment/Damage .. C Date:02/25/03ISR Number: 4066030-7Report Type:Expedited (15-DaCompany Report #2003UW01894 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiomyopathy Health Seroquel PS ORAL 600 MG PO Intervention to Professional Prevent Permanent Impairment/Damage Date:02/25/03ISR Number: 4066189-1Report Type:Expedited (15-DaCompany Report #2003UW00091 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Consumer Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Red Blood Cell PO 4 YR Abnormality Prednisone C Red Blood Cell Count Aspirin "Bayer" C Decreased Nexium C Zoloft C Date:02/25/03ISR Number: 4066217-3Report Type:Expedited (15-DaCompany Report #2003UW01722 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Pulmonary Disease Other PO Constipation Combivent C Faecaloma Salbutamol C Benztropine C Clonazepam C Date:02/25/03ISR Number: 4066548-7Report Type:Expedited (15-DaCompany Report #2003GB00149 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS ORAL 200 MG BID PO Dyskinesia Health Seroquel SS ORAL 100 MG DAILY Sudden Death Professional PO Other Lithium Carbonate C 22-Feb-2006 08:31 AM Page: 632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paroxetine C Date:02/26/03ISR Number: 4066661-4Report Type:Expedited (15-DaCompany Report #2003AP00923 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Seroquel PS Health Professional Other Date:02/27/03ISR Number: 4066709-7Report Type:Expedited (15-DaCompany Report #23100176 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Alanine Aminotransferase Foreign Novastan Increased Health (Argatroban) PS INTRAVENOUS 20 MG DAILY Aspartate Professional IV Aminotransferase Mucosta SS ORAL 300 MG DAILY Increased PO Blood Alkaline Pyrinazin SS ORAL 500 MG DAILY Phosphatase Increased PO Blood Lactate Seroquel SS ORAL 150 MG DAILY Dehydrogenase Increased PO Condition Aggravated Wintermin SS ORAL 25 MG DAILY Gamma-Glutamyltransferase PO Increased Liver Disorder Date:02/27/03ISR Number: 4067448-9Report Type:Expedited (15-DaCompany Report #2003002870 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Consumer Zoloft (Sertraline) PS ORAL 200 MG Initial or Prolonged Blood Pressure Decreased Health (DAILY), ORAL Other Blood Pressure Increased Professional Risperidone SS ORAL 3 MG (DAILY), Bronchitis ORAL Dry Mouth Quetiapine Fumarate SS ORAL ORAL Fall Ibuprofen SS ORAL ORAL Fear Diphenhydramine Forearm Fracture Hydrochloride SS ORAL ORAL Increased Appetite Geodon (Ziprasidone) SS ORAL ORAL Joint Sprain Fexofenadine Loss Of Consciousness Hydrochloride C Malaise Desloratadine C Menorrhagia Atenolol C Pneumonia Aspiration Somnolence Suicide Attempt Weight Increased Date:02/27/03ISR Number: 4068258-9Report Type:Expedited (15-DaCompany Report #APCDSS2003000210 Age:54 YR Gender:Male I/FU:F Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Diabetes Mellitus 22-Feb-2006 08:31 AM Page: 633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetic Coma Psychiatric Symptom Report Source Product Role Manufacturer Route Dose Duration Foreign Risperidone (Tablet) Health (Risperidone) PS ORAL SEE IMAGE, Professional ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Diazepam (Diazepam) C Haldol (Haloperidol) C Date:02/27/03ISR Number: 4068316-9Report Type:Expedited (15-DaCompany Report #2003GB00420 Age:0 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Seroquel PS 350 MG BID Initial or Prolonged Feeding Disorder Neonatal Health TPL Foetal Distress Syndrome Professional Fluvoxamine C Jaundice Neonatal Other Fluoxetine C Maternal Drugs Affecting Lorazepam C Foetus Nosocomial Infection Oedema Neonatal Prolonged Labour Respiratory Disorder Neonatal Date:02/27/03ISR Number: 4068317-0Report Type:Expedited (15-DaCompany Report #2002GB02336 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Complex Partial Seizures Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Drug Withdrawal Syndrome Health PO Prevent Permanent Epilepsy Professional Seroquel SS ORAL 50 MG BID PO Impairment/Damage Mental Impairment Other Date:02/27/03ISR Number: 4068318-2Report Type:Expedited (15-DaCompany Report #2002GB01105 Age:15 YR Gender:Female I/FU:I Outcome PT Hospitalization - Caesarean Section Initial or Prolonged Complications Of Maternal Required Exposure To Therapeutic Intervention to Drugs Prevent Permanent Feeding Disorder Neonatal Impairment/Damage Foetal Distress Syndrome Induced Labour Jaundice Neonatal Maternal Drugs Affecting Foetus Nosocomial Infection Oedema Oedema Neonatal 22-Feb-2006 08:31 AM Page: 634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pre-Eclampsia Pregnancy Premature Baby Report Source Product Role Manufacturer Route Dose Duration Prolonged Labour Foreign Seroquel PS ORAL 350 MG BID PO Health Seroquel SS ORAL 150 MG BID PO Professional Fluvoxamine C Other Fluoxetine C Lorazepam C Date:02/28/03ISR Number: 4062367-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12144952 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify PS Otsuka Pharmaceutical Company, Ltd. Seroquel SS Date:02/28/03ISR Number: 4067749-4Report Type:Expedited (15-DaCompany Report #2003UW02493 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Meningitis Viral Professional Rash Date:02/28/03ISR Number: 4067750-0Report Type:Expedited (15-DaCompany Report #2003UW02571 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS Professional Date:02/28/03ISR Number: 4067752-4Report Type:Expedited (15-DaCompany Report #2003UW02480 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Health Seroquel PS Intervention to Complications Of Maternal Professional Prevent Permanent Exposure To Therapeutic Impairment/Damage Drugs Maternal Drugs Affecting Foetus Date:02/28/03ISR Number: 4068008-6Report Type:Expedited (15-DaCompany Report #2003UW01722 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Pulmonary Disease Other PO Constipation Combivent C Faecaloma Salbutamol C Benztropine C Clonazepam C 22-Feb-2006 08:31 AM Page: 635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/03ISR Number: 4069426-2Report Type:Expedited (15-DaCompany Report #2003UW02601 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Seroquel PS Initial or Prolonged Professional Date:03/03/03ISR Number: 4069486-9Report Type:Expedited (15-DaCompany Report #2003PK00332 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Lymphocyte Count Health PO Prevent Permanent Increased Professional Seroquel SS ORAL 200 MG DAILY Impairment/Damage Neutrophil Count Other PO Decreased Orfiril C Thrombocytopenia Date:03/04/03ISR Number: 4069872-7Report Type:Expedited (15-DaCompany Report #2002UW13313 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Foreign Seroquel PS ORAL 300 MG DAILY Thromboplastin Time Health PO Prolonged Professional Seroquel SS ORAL 400 MG DAILY Leukopenia Other PO Lymphocyte Count Seroquel SS ORAL 300 MG DAILY Decreased PO Platelet Count Decreased Seroquel SS ORAL 600 MG HS PO Loxapine C Diltiazem C Premarin C Dyazide C Vitamin E C Date:03/04/03ISR Number: 4070329-8Report Type:Expedited (15-DaCompany Report #2003UW02574 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Health Seroquel PS 50 MG DAILY Intervention to Pancytopenia Professional PO Prevent Permanent Impairment/Damage Date:03/05/03ISR Number: 4068030-XReport Type:Direct Company Report #USP 55526 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel (Quetiapine Fumarate) PS Astra Zeneca Serzone (Nefazodone Hydrochloride) SS Bristol-Myers Squibb 22-Feb-2006 08:31 AM Page: 636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/03ISR Number: 4068032-3Report Type:Direct Company Report #USP 55527 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Seroquel (Quetiapine Medication Error Fumarate) PS Astra Zeneca Serzone (Nefazodone Hydrochloride) SS Bristol-Myers Squibb Date:03/05/03ISR Number: 4068094-3Report Type:Direct Company Report #USP 55535 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroauel (Quetiapine Fumarate) PS Astra Zeneca Serzone ( Nefazodone Hydrochloride) SS Bristol- Myers Squibb Us Pharm Date:03/05/03ISR Number: 4068173-0Report Type:Direct Company Report #USP 55478 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel (Quetiapine Fumarate) PS Astra Zeneca Serzone (Nefazodone Hydrochloride) SS Bristol-Myers Squibb Date:03/05/03ISR Number: 4070215-3Report Type:Periodic Company Report #2002072017 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Ziprasidone Initial or Prolonged Dizziness (Ziprasidone) PS ORAL 60 MG (BID), Other Hypothyroidism ORAL Schizophreniform Disorder Quetiapine SS ORAL UNK, ORAL Valproate Semisodium SS Vitamins Nos C Docusate Sodium C Date:03/05/03ISR Number: 4071447-0Report Type:Expedited (15-DaCompany Report #2003AP01034 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Constipation Foreign Seroquel PS ORAL 100 MG QD PO Intervention to Diabetes Mellitus Study Seroquel SS ORAL 50 MG TID PO Prevent Permanent Myofascitis Health Seroquel SS ORAL 100 MG TID PO Impairment/Damage Tinea Pedis Professional Basen C Toothache Other Lexotan C Risperdal C Tegretol C Lendmorin C Rohypnol C Serenace C Akineton C 22-Feb-2006 08:31 AM Page: 637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/03ISR Number: 4071449-4Report Type:Expedited (15-DaCompany Report #2003SE00890 Age:85 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS Health Professional Other Date:03/05/03ISR Number: 4071452-4Report Type:Expedited (15-DaCompany Report #2003AP00243 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Abnormal Foreign Seroquel PS ORAL 100 MG BID PO Cardio-Respiratory Arrest Health Seroquel SS ORAL 100 MG TID PO Pyrexia Professional Seroquel SS ORAL 100 MG QID PO Other Seroquel SS ORAL 100 MG BID PO Benzalin C Minzain C Gasmotin C Magnesium Oxide C Alosenn C Ubtec C Mashinin C Pantethine C Date:03/05/03ISR Number: 4071455-XReport Type:Expedited (15-DaCompany Report #2003SE00819 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Foreign Seroquel PS 400 MG QD Intervention to Complete Study Remergon SS Prevent Permanent Health Serlain C Impairment/Damage Professional Movicol C Other Urgenin C Eulexin C D-Cure C Folavit C Laxoberon C Date:03/06/03ISR Number: 4068585-5Report Type:Direct Company Report #CTU 188080 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dizziness Quetiapine Fumarate PS ORAL 25 MG P.O. Hospitalization - Overdose TID & 125 MG Initial or Prolonged Sedation HS Required Salmeterol C Intervention to Triamcinolone C Prevent Permanent Irbesartan C Impairment/Damage Albuterol C Diazepam C Metoclopramide C Rabeprazole C Simvastatin C Prazosin C Citalopram Hydrobromide C Diclofenac C 22-Feb-2006 08:31 AM Page: 638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zafirlukast C Sildenafil Citrate C Fexofenadine Hcl C Date:03/06/03ISR Number: 4068595-8Report Type:Direct Company Report #CTU 188086 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ecchymosis Quetiapine PS ORAL 125 MG, QHS, Pruritus ORAL Senna C Oxycodone Hcl C Propranolol Hcl C Rabeprazole C Ranitidine Hcl C Fosinopril C Diltiazem (Tiazac) C Lovastatin C Date:03/06/03ISR Number: 4071990-4Report Type:Expedited (15-DaCompany Report #2003GB00079 Age:0 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congenital Anomaly Foreign Seroquel PS TOPICAL 100 MG BID Initial or Prolonged Maternal Drugs Affecting Health TPL Congenital Anomaly Foetus Professional Cephradine C Transient Tachypnoea Of Other The Newborn Ventricular Septal Defect Acquired Date:03/06/03ISR Number: 4072117-5Report Type:Expedited (15-DaCompany Report #2003UW02718 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthma Consumer Seroquel PS ORAL 25 MG PO Intervention to Chest Pain Seroquel SS ORAL 100 MG PO Prevent Permanent Coma Haloperidol C Impairment/Damage Epilepsy Penicillin C Extrapyramidal Disorder Mysoline C Joint Range Of Motion Sulfa C Decreased Codeine C Parkinson'S Disease Effexor C Rash Prolixin C Thermal Burn Geodon C Visual Disturbance Risperdal C Dilantin C Darvon C Date:03/10/03ISR Number: 4073045-1Report Type:Expedited (15-DaCompany Report #2003UW02826 Age:35 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Pressure Decreased Initial or Prolonged Delirium Depressed Level Of Consciousness 22-Feb-2006 08:31 AM Page: 639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Heart Rate Increased Miosis Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS ORAL 1200 MG QD Professional PO Seroquel SS ORAL 1200 MG ONCE PO Seroquel SS ORAL 900 MG QD PO Paxil SS 20 MG QD Paxil SS 20 MG ONCE Date:03/11/03ISR Number: 4069553-XReport Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0398702A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Paxil Cr PS Glaxosmithkline ORAL Increased Professional Remeron SS UNKNOWN Blood Triglycerides Seroquel SS UNKNOWN Increased Low Density Lipoprotein Increased Date:03/11/03ISR Number: 4072933-XReport Type:Direct Company Report #CTU 188530 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Seroquel 25mg Po Qd PS Erythromycin 400mg Po Tid SS Prozac 60mg Qd SS Date:03/11/03ISR Number: 4074651-0Report Type:Expedited (15-DaCompany Report #2003UW02954 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eating Disorder Health Seroquel PS 300 - 400 MG Eosinophilia Professional Seroquel SS 800 - 1200 MG Thyroid Function Test Pancreatic Exocrine Abnormal Replacement Enzymes C Weight Increased Albuterol C Klonopin C Zoloft C Date:03/11/03ISR Number: 4074652-2Report Type:Expedited (15-DaCompany Report #2003UW02721 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Basophil Count Increased Health Seroquel PS Intervention to Lymphocyte Count Professional Prevent Permanent Increased Impairment/Damage Monocyte Count Increased Neutrophil Count Decreased 22-Feb-2006 08:31 AM Page: 640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/03ISR Number: 4074712-6Report Type:Expedited (15-DaCompany Report #2003AP00301 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Seroquel PS ORAL 150 MG DAILY Life-Threatening Cyanosis Health PO Hospitalization - Drug Effect Decreased Professional Seroquel SS ORAL 200 MG DAILY Initial or Prolonged Insomnia Other PO Neuroleptic Malignant Seroquel SS ORAL 300 MG DAILY Syndrome PO Pneumonia Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Neodopaston C Artane C Depas C Eurodin C Lexotan C Date:03/11/03ISR Number: 4074713-8Report Type:Expedited (15-DaCompany Report #2003SE00379 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Foreign Seroquel PS ORAL 500 MG QD PO Intervention to Bundle Branch Block Left Health Prevent Permanent Sinus Tachycardia Professional Impairment/Damage Other Date:03/11/03ISR Number: 4074714-XReport Type:Expedited (15-DaCompany Report #2002GB01951 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Seroquel PS ORAL 700 MG DAILY Therapeutic Health PO Sudden Death Professional Clopixol Other (Hydrochloride) C Haloperidol C Nitrazepam C Procyclidine C Al-Calcidol C Date:03/11/03ISR Number: 4074715-1Report Type:Expedited (15-DaCompany Report #2003AP01134 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Quetiapine PS ORAL 150 MG DAILY Intervention to Leukopenia Literature PO Prevent Permanent Neutropenia Health Quetiapine SS ORAL 600 MG DAILY Impairment/Damage Professional PO Other Chlorpromazine C Olanzapine C Risperidone C Haloperidol C 22-Feb-2006 08:31 AM Page: 641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/03ISR Number: 4074994-0Report Type:Expedited (15-DaCompany Report #APCDSS2003000210 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Risperidon (Tablet) Initial or Prolonged Diabetes Mellitus Health (Risperidone) PS ORAL 12 MG, DAILY, Diabetic Coma Professional ORAL Infection Quetiapine Fumarate Leukopenia (Quetiapine Psychiatric Symptom Fumarate) SS ORAL 500 MG, Schizophrenia DAILY, ORAL; 8 MG, DAILY, ORAL; 12 MG, DAILY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Diazepam (Diazepam) C Haldol (Unspecified) (Haloperidol) C Date:03/13/03ISR Number: 4073565-XReport Type:Direct Company Report #CTU 188667 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Seroquel 100mg Po Intervention to Pneumonia Tid PS ORAL 100MG PO TID Prevent Permanent Zyprexa 5mg Po Bid SS 5MG BID Impairment/Damage Zantac C Vancomycin C Flovent C Date:03/13/03ISR Number: 4075670-0Report Type:Expedited (15-DaCompany Report #2002GB02336 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Epilepsy Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Mental Impairment Health PO Prevent Permanent Therapeutic Response Professional Seroquel SS ORAL 50 MG BID PO Impairment/Damage Unexpected Other Date:03/14/03ISR Number: 4076523-4Report Type:Expedited (15-DaCompany Report #HQWYE950710MAR03 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Effexor Xr Back Pain (Venlafaxine Crying Hydrochloride, Drug Ineffective Capsule, Extended Drug Withdrawal Syndrome Release) PS ORAL SEE IMAGE Eye Movement Disorder Ativan (Lorazepam, Hypomania Tablet) SS ORAL 0.5 MG AS Migraine NEEDED, ORAL Mood Swings Prozac (Fluoxetine Myalgia Hydrochloride, ) SS ORAL 20 MG 1X PER Photosensitivity Reaction 1 DAY, ORAL 1 WK Somnolence Seroquel Weight Increased (Quetiapine, ) SS 3 MON 22-Feb-2006 08:31 AM Page: 642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Topamax (Topiramate) SS ORAL 25 MG 2X PER 1 DAY, ORAL Geodon (Ziprasidone) C Klonopin (Clonazepam) C Date:03/17/03ISR Number: 4077682-XReport Type:Expedited (15-DaCompany Report #2002SE05185 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Foreign Seroquel PS ORAL 400 BID PO Intervention to Phosphokinase Increased Health Lexotan C Prevent Permanent Professional Impairment/Damage Other Date:03/17/03ISR Number: 4077683-1Report Type:Expedited (15-DaCompany Report #2003AP01166 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Foreign Seroquel PS ORAL 75 MG DAILY Decreased Health PO Professional Seroquel SS ORAL 200 MG TID PO Other Diazepam C Hiberna C Levomepromazine C Pursennid C Date:03/17/03ISR Number: 4077763-0Report Type:Expedited (15-DaCompany Report #2003PK00417 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Seroquel PS ORAL 50 MG DAILY; Life-Threatening Brain Damage Other PO Hospitalization - Cardiac Arrest Seroquel SS ORAL 100 MG DAILY; Initial or Prolonged Delusion PO Drug Screen Positive Seroquel SS ORAL 150 MG, Drug Toxicity DAILY; PO Refusal Of Treatment By Seroquel SS ORAL 200 MG DAILY; Patient PO Suicidal Ideation Seroquel SS ORAL 250 MG DAILY; Tachycardia PO Seroquel SS ORAL 300 MG DAILY; PO Seroquel SS ORAL 400 MG DAILY; PO Seroquel SS ORAL 450 MG DAILY; PO Seroquel SS ORAL 500 MG DAILY; PO Seroquel SS ORAL 550 MG DAILY; PO Seroquel SS ORAL 800 MG DAILY; PO Glianimon SS ORAL 20 MG DAILY; PO Glianimon SS ORAL 32 MG DAILY; PO Glianimon SS ORAL 38 MG DAILY; 22-Feb-2006 08:31 AM Page: 643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Glianimon SS ORAL 40 MG DAILY; PO Glianimon SS ORAL 30 MG DAILY; PO Valiquid SS ORAL 20 MG DAILY; PO Valiquid SS ORAL 40 MG DAILY; PO Valiquid SS ORAL 30 MG DAILY; PO Neurocil SS ORAL 100 MG DAILY; PO Neurocil SS ORAL 200 MG DAILY; PO Neurocil SS ORAL 250 MG DAILY; PO Neurocil SS ORAL 300 MG DAILY; PO Neurocil SS ORAL 275 MG DAILY; PO Neurocil SS ORAL 250 MG DAILY; PO Neurocil SS ORAL 225 MG DAILY; PO Neurocil SS ORAL 200 MG DAILY; PO Akineton Retard SS ORAL 4 MG DAILY; PO Bifiteral SS ORAL 30 ML DAILY; PO Lefax SS ORAL 252 MG DAILY; PO Beloc Zok SS ORAL 47.5 MG DAILY; PO Paspertin SS ORAL 15 GTT DAILY; PO Paracetamol SS ORAL 1000 MG DAILY; PO Zuclopenthixol SS NOT STATED Date:03/19/03ISR Number: 4077526-6Report Type:Direct Company Report #USP 55602 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel PS Astra Zeneca Seroquel SS Astra Zeneca Date:03/19/03ISR Number: 4078517-1Report Type:Expedited (15-DaCompany Report #200300783S Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health (Myslee) Zolpidem Professional Tablet 10 Mg PS ORAL 10 MG 18 MON (Dogmatyl) Sulpiride Tablet 100 Mg SS 200 MG 88 MON (Limas) Lithium Carbonate Tablet 200 Mg SS ORAL 800MG 2 YR (Artane) 22-Feb-2006 08:31 AM Page: 644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trihexyphenidyl Hydrochloride Tablet 2mg SS ORAL 4MG 21 MON (Toledomin) Milnacipran Hydrochloride Tablet SS ORAL 100MG 7 MON (Tetramide) Mianserin Hydrochloride Tablet SS 20MG 88 MON (Contmin) Chlorpromazine Tablet 25mg SS 25MG 21 MON (Silece) Flunitrazepam Tablet 2mg SS 2MG 61 MON (Seroquel) Quetiapine Fumarate Tablet SS 150MG 11 MON Date:03/19/03ISR Number: 4078742-XReport Type:Expedited (15-DaCompany Report #2003UW03374 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Infarction Health Seroquel PS ORAL 25 MG PO Circulatory Collapse Professional Lotrel C Abilify C Date:03/19/03ISR Number: 4078743-1Report Type:Expedited (15-DaCompany Report #2003UW03245 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 900 MG DAILY Decreased Professional PO No Match C Date:03/19/03ISR Number: 4078744-3Report Type:Expedited (15-DaCompany Report #2002UW12949 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Seroquel PS ORAL 50 MG DAILY Hospitalization - Foreign Body Trauma Professional PO 1 DAY Initial or Prolonged Injury Asphyxiation Seroquel SS ORAL 100 MG DAILY PO 1 DAY Seroquel SS ORAL 200 MG DAILY PO 1 DAY Seroquel SS ORAL 300 MG DAILY PO 1 DAY Effexor C Wellbutrin C Topamax C Date:03/19/03ISR Number: 4079145-4Report Type:Expedited (15-DaCompany Report #2003GB00598 Age:30 YR Gender: I/FU:I Outcome PT Report Source Other Agranulocytosis Foreign Health Professional 22-Feb-2006 08:31 AM Page: 645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel PS Date:03/20/03ISR Number: 4078206-3Report Type:Direct Company Report #USP 55664 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel PS Astra Zeneca Serzone SS Bristol-Myers Squibb Date:03/20/03ISR Number: 4080132-0Report Type:Expedited (15-DaCompany Report #2003GB00556 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Convulsion Health PO Prevent Permanent Irritability Professional Seroquel SS ORAL 500 MG DAILY Impairment/Damage Other PO Seroquel SS ORAL 300 MG DAILY PO Carbamazepine C Date:03/20/03ISR Number: 4080146-0Report Type:Expedited (15-DaCompany Report #EMADSS2003002183 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperdone) PS ORAL SEE IMAGE Seroquel (Seroquel) SS ORAL SEE IMAGE Depakine (Valproate Sodium) SS ORAL SEE IMAGE Zoloft (Sertraline Hydrochloride) SS ORAL 50 MG, DAILY, ORAL Date:03/20/03ISR Number: 4080675-XReport Type:Expedited (15-DaCompany Report #2003010586 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Foreign Zoloft (Sertraline) PS ORAL 50 MG Grand Mal Convulsion Health (DAILY), ORAL Thoracic Vertebral Professional Quetiapine Fumarate SS ORAL 400 MG Fracture (DAILY), ORAL Melperone Hydrochloride SS ORAL 75 MG (DAILY), ORAL Lorazepam C 22-Feb-2006 08:31 AM Page: 646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/03ISR Number: 4078435-9Report Type:Direct Company Report #CTU 189264 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Menorrhagia Seroquel PS ORAL ORAL Intervention to Menstruation Irregular Adderal SS ORAL ORAL Prevent Permanent Pain Impairment/Damage Rash Tinnitus Date:03/21/03ISR Number: 4080869-3Report Type:Expedited (15-DaCompany Report #2003UW03376 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Seroquel PS ORAL 25 MG TID PO Neutrophil Count Professional Clonidine C Decreased Depakote C White Blood Cell Count Decreased Date:03/21/03ISR Number: 4082013-5Report Type:Expedited (15-DaCompany Report #2002AP04514 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Seroquel PS ORAL 75 MG DAILY Hospitalization - Diabetic Hyperosmolar Health PO Initial or Prolonged Coma Professional Prednisolone Acetate SS ORAL 20 MG DAILY Drug Interaction Other PO Hepatic Function Abnormal Risperidone SS ORAL 2 MG DAILY PO Risperidone SS ORAL 3 MG DAILY PO Chlorpromazine C Levomepromazine C Haloperidol C Artane C Brovarin C Isomytal C Date:03/24/03ISR Number: 4082272-9Report Type:Expedited (15-DaCompany Report #2003010500 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Foreign Zoloft (Sertraline) PS ORAL 50 MG, ORAL Initial or Prolonged Hepatic Steatosis Health Valproic Acid SS ORAL 1200 MG, ORAL Other Hepatitis Professional Quetiapine Fumarate SS ORAL 1000 MG, ORAL Clonazepam C Date:03/24/03ISR Number: 4082352-8Report Type:Expedited (15-DaCompany Report #03P-062-0213191-00 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Akineton (Biperiden) Hospitalization - Drug Level Increased Health (Biperiden) PS ORAL 4 MG, PER Initial or Prolonged Tachypnoea Professional ORAL Toxicologic Test Abnormal Quetiapine SS ORAL 50-800 MG DAILY, PER ORAL Benperidol SS ORAL 20-40 MG DAILY, PER 22-Feb-2006 08:31 AM Page: 647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Diazepam SS ORAL 20-40 MG DAILY, PER ORAL Levomepromazine Maleate SS ORAL SEE IMAGE Metoprolol Succinate SS ORAL 47.5 MG, PER ORAL Lactulose C Dimeticone, Activated C Metoclopramide Hydrochloride C Paracetamol C Date:03/24/03ISR Number: 4082809-XReport Type:Expedited (15-DaCompany Report #2001UW09079 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Literature Seroquel "Zeneca" PS Zeneca ORAL 100 MG TID PO 3 DAY Hospitalization - Pyrexia Health Serzone SS Initial or Prolonged Respiratory Arrest Professional Antipsychotics C Depakote C Cogentin C Atrovent C Dilaudid C Clozaril C Date:03/25/03ISR Number: 4080162-9Report Type:Direct Company Report #CTU 189402 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Citolapram PS ORAL 20MG PO Q DAY Initial or Prolonged Quietapine SS Date:03/25/03ISR Number: 4082237-7Report Type:Direct Company Report #CTU 189479 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Depression Seroquel PS 25MG Q HS [2 Somatic Delusion NIGHTS ONLY] Tinnitus Estrogen Replacement C Date:03/25/03ISR Number: 4083224-5Report Type:Expedited (15-DaCompany Report #2003GB00149 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Seroquel PS ORAL 200 MG BID PO Arrhythmia Health Seroquel SS ORAL 100 MG DAILY Sudden Death Professional PO Urinary Tract Infection Other Lithium Carbonate C White Blood Cell Count Paroxetine C Increased 22-Feb-2006 08:31 AM Page: 648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/03ISR Number: 4083229-4Report Type:Expedited (15-DaCompany Report #2002GB01069 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Oedema Foreign Seroquel PS 25MG OR 50MG Hospitalization - Convulsion Health NOCTE Initial or Prolonged Hyponatraemia Professional Inappropriate Other Antidiuretic Hormone Secretion Loss Of Consciousness Date:03/25/03ISR Number: 4083267-1Report Type:Expedited (15-DaCompany Report #2003AP01166 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Foreign Seroquel PS ORAL 25 MG TID PO Hypothermia Health Seroquel SS ORAL 50 MG TID PO Hypothyroidism Professional Seroquel SS ORAL 100 MG TID PO Shock Other Seroquel SS ORAL 200 MG TID PO Diazepam SS ORAL 5 MG TID PO Levomepromazine Maleate SS ORAL 25 MG DAILY PO Date:03/25/03ISR Number: 4083271-3Report Type:Expedited (15-DaCompany Report #2003AP01266 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Foreign Seroquel PS ORAL 600 MG DAILY Hospitalization - Confusional State Health PO Initial or Prolonged Consciousness Fluctuating Professional Olanzapine SS Required Myocardial Infarction Other Cipramil C Intervention to Psychotic Disorder Prevent Permanent Impairment/Damage Date:03/25/03ISR Number: 4083273-7Report Type:Expedited (15-DaCompany Report #2003AP01273 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Glycosylated Haemoglobin Health PO Prevent Permanent Increased Professional Impairment/Damage Weight Decreased Other Date:03/25/03ISR Number: 4083274-9Report Type:Expedited (15-DaCompany Report #2003AP01289 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS ORAL 25 MG DAILY Hospitalization - Disseminated Health PO Initial or Prolonged Intravascular Coagulation Professional Seroquel SS ORAL 50 MG DAILY Required Hyperglycaemic Other PO Intervention to Hyperosmolar Nonketotic Seroquel SS ORAL 75 MG DAILY Prevent Permanent Syndrome PO Impairment/Damage Seroquel SS ORAL 50 MG DAILY PO 22-Feb-2006 08:31 AM Page: 649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ubretid C Lopemin C Biofermin C Miyarisan C Polycarbophil C Date:03/26/03ISR Number: 4083968-5Report Type:Expedited (15-DaCompany Report #2003AP01290 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compulsions Foreign Seroquel PS ORAL 25 MG TID PO Initial or Prolonged Jealous Delusion Study Seroquel SS ORAL 50 MG TID PO Health Seroquel SS ORAL 100 MG TID PO Professional Seroquel SS ORAL 500 MG DAILY Other PO Seroquel SS ORAL 200 MG TID PO Seroquel SS ORAL 100 MG TID PO Luvox SS Contomin C Haloperidol C Tasmolin C Cinnarizine C Pantosin C Magnesium C Silece C Eurodin C Date:03/26/03ISR Number: 4083971-5Report Type:Expedited (15-DaCompany Report #2003SE01315 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Foreign Seroquel PS Health Professional Other Date:03/26/03ISR Number: 4083975-2Report Type:Expedited (15-DaCompany Report #2003AP01246 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Foreign Seroquel PS ORAL 50 MG TID, PO Sudden Death Health Limas SS ORAL 200 MG QID PO Professional Artane SS ORAL 2 MG BID PO Other Dogmatyl SS ORAL 100 MG BID PO Toledomin SS ORAL 50 MG PO Tetramide SS ORAL 20 MG QD PO Contomin SS ORAL 25 MG QD PO Silece SS ORAL 2 MG QD PO Zolpidem SS ORAL 10 MG QD PO Date:03/26/03ISR Number: 4083985-5Report Type:Expedited (15-DaCompany Report #2003GB00628 Age: Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Foreign Seroquel PS ORAL 200 MG BID PO Sensory Disturbance Health Seroquel SS ORAL 100 MG DAILY Tardive Dyskinesia Professional PO Other Therapy Unspecified C Date:03/27/03ISR Number: 4083300-7Report Type:Direct Company Report #USP 55677 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel PS Astra Zeneca Serzone SS B/M Us Med Date:03/27/03ISR Number: 4086824-1Report Type:Expedited (15-DaCompany Report #2003SE01298 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Foreign Seroquel PS 400 MG QD Deterioration Study Serlain C Health Movicol C Professional Urgenin C Other Eulexin C D-Cure C Folavit C Laxoberon C Date:03/27/03ISR Number: 4086885-XReport Type:Expedited (15-DaCompany Report #03P-167-0213681-00 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Depakote (Divalproex Drug Interaction Health Sodium) (Divalproex Oedema Peripheral Professional Sodium) PS 500 MG, 1 IN Pitting Oedema Company 1 D Pulmonary Congestion Representative Quetiapine SS ORAL 300 MG, ORAL Pulmonary Oedema Diclofenac Sodium C Somnolence Lisinopril C Senna C Date:03/27/03ISR Number: 4086988-XReport Type:Expedited (15-DaCompany Report #2003AP01248 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Foreign Seroquel PS Life-Threatening Inadequate Control Health Silece SS Haematemesis Professional Pyrethia SS Sudden Death Other Benzalin SS Depas SS Hirnamin SS Brovarin SS Isomytal SS Pursennid SS Lendormin SS Euglucon C Lipitor C 22-Feb-2006 08:31 AM Page: 651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Actos C Glucobay C Amlodin C Date:03/27/03ISR Number: 4086989-1Report Type:Expedited (15-DaCompany Report #2003AP01249 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Seroquel PS ORAL 100 MG DAILY Increased Health PO Aspartate Professional Seroquel SS ORAL 150 MG DAILY Aminotransferase Other PO Increased Akineton SS ORAL 1 MG TID PO Blood Triglycerides Akineton SS Increased Parlodel SS ORAL 25 MG DAILY Cardiac Tamponade PO Electrocardiogram Risperdal C Abnormal Pzc C Myocardial Infarction Neoperidol C Sudden Death Date:03/28/03ISR Number: 4083702-9Report Type:Direct Company Report #CTU 189726 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Metoclopropamide 5mg PS ORAL 5MG AC ORAL Seroquel SS ORAL 25MG HS ORAL Date:03/28/03ISR Number: 4086776-4Report Type:Expedited (15-DaCompany Report #2002GB02278 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Neonatal Foreign Seroquel PS TOPICAL 400 MG BID Hospitalization - Drug Withdrawal Syndrome Health TPL Initial or Prolonged Neonatal Professional Paroxetine SS TRANSPLACENTAL 20 MG QD TPL Required Feeding Disorder Neonatal Other Pethidine C Intervention to Hypervigilance Prevent Permanent Hypotonia Neonatal Impairment/Damage Insomnia Maternal Drugs Affecting Foetus Neonatal Aspiration Neonatal Disorder Date:03/28/03ISR Number: 4087087-3Report Type:Expedited (15-DaCompany Report #2003UW02980 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Seroquel PS ORAL 125 MG QD PO Gait Disturbance Insulin C Glipizide C Olanzapine C 22-Feb-2006 08:31 AM Page: 652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/03ISR Number: 4087871-6Report Type:Expedited (15-DaCompany Report #2003SE01315 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Foreign Seroquel PS Health Professional Other Date:03/28/03ISR Number: 4087873-XReport Type:Expedited (15-DaCompany Report #2003SE00890 Age:88 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS ORAL 25 MG QD PO Health Seroquel SS ORAL 32.5 MG QD PO Professional Corvatard C Other Lasix C No Match C Date:03/28/03ISR Number: 4087874-1Report Type:Expedited (15-DaCompany Report #2003SE00101 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Seroquel PS ORAL 400 MG QD PO Complete Health Ventolin C Bradycardia Professional Remergon C Metastases To Bone Other Serlain C Prostate Cancer Metastatic Date:04/01/03ISR Number: 4084528-2Report Type:Direct Company Report #CTU 189884 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Quetiapine Fumarate Intervention to Keratoconjunctivitis (Seroquel) PS ORAL 400 MG PO BID Prevent Permanent Sicca Artigrual Tears C Impairment/Damage Clonazepam C Risperidone C Megestrol C Cojugated Estrogens C Date:04/01/03ISR Number: 4084861-4Report Type:Direct Company Report #CTU 189965 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Seroquel PS 100MG BID Initial or Prolonged Pruritus Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/03ISR Number: 4084914-0Report Type:Direct Company Report #CTU 189925 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ageusia Prolixin PS 3 PILLS Hospitalization - Anorexia INJECTION 5 Initial or Prolonged Aphonia MG 2 WK Disability Asthenia Seraquel (2001 & Other Asthma 2002) SS 250 MG, 100 Required Attention MG 25 MG, Intervention to Deficit/Hyperactivity PILL FORM Prevent Permanent Disorder Keppra C Impairment/Damage Blood Creatinine Felbamate C Increased Zonegram C Candidiasis Ativan C Cerebrovascular Accident Allegra C Chest Pain Synthroid C Condition Aggravated Prevacid C Drug Toxicity Advair Discus C Epilepsy Flonase C Eye Disorder Foltax C Fall Amantadine C Fungal Infection Benadryl C Gastrooesophageal Reflux Cogentin C Disease Lodeen Xl C Gingival Disorder Multi-Vitamins C Headache Calcium W/ Vitamin D C Hypersensitivity Hypothyroidism Malaise Nausea Neuroleptic Malignant Syndrome Oedema Parkinson'S Disease Pharyngolaryngeal Pain Rash Rhinitis Scleroderma Syncope Thinking Abnormal Tooth Disorder Visual Disturbance Weight Increased Date:04/01/03ISR Number: 4087292-6Report Type:Expedited (15-DaCompany Report #2003GB00556 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Foreign Seroquel PS ORAL 300 MG DAILY Required Convulsion Health PO Intervention to Coordination Abnormal Professional Seroquel SS ORAL 500 MG DAILY Prevent Permanent Cyanosis Other PO Impairment/Damage Irritability Seroquel SS ORAL 300 MG DAILY Loss Of Consciousness PO Somnolence Carbamazepine SS ORAL 200 MG QAM PO Diazepam C 22-Feb-2006 08:31 AM Page: 654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/03ISR Number: 4101315-7Report Type:Periodic Company Report #2002-04-2830 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Theo-Dur Initial or Prolonged Professional (Theophylline) Other Tablets PS ORAL >20 TABS* ORAL; 200MG BID ORAL Seroquel (Quetiapine Fumurate) Tablets SS ORAL ORAL Serevent C Ambien (Zolpidem Tartrate) C Date:04/02/03ISR Number: 4088344-7Report Type:Expedited (15-DaCompany Report #USA-2002-0001677 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alopecia Consumer Oxycontin Tablets 10 Hospitalization - Anxiety Health Mg(Oxycodone Initial or Prolonged Arterial Occlusive Professional Hydrochloride)Cr Disease Other Tablet PS 10 MG Arthralgia Oxycontin Tablets 20 Asthma Mg(Oxycodone Back Pain Hydrochloride)Cr Carpal Tunnel Syndrome Tablet SS 20 MG 1008 DAY Coma Hydrocodone Depression Bitartrate(Similar Disturbance In Attention To Ind Drug Ineffective 59,175)(Hydrocodone Emphysema Bitartrate)Unknown SS 1008 DAY Exfoliative Rash Alprazolam Fatigue (Alprazolam) SS 1008 DAY Feeling Abnormal Ephedrine(Epedrine) SS 1008 DAY Flushing Pseudoephedrine ( Hilar Lymphadenopathy Pseudoephedrine) SS 1008 DAY Influenza Effexor(Venlafaxine Insomnia Hydrochloride) SS 75 MG, DAILY 1008 DAY Irritability Codeine(Codeine) SS 1008 DAY Libido Decreased Neutrontin(Gabapenti Memory Impairment n) SS 100 MG, TID 1008 DAY Nausea Metoclopramide Nervousness (Metoclopramide ) SS 1008 DAY Night Sweats Quetiapine(Quetiapin Overdose e) SS 1008 DAY Pain Claritin Pain In Extremity (Loratadine) C Pneumonia Vitamin C (Ascorbic Pulmonary Oedema Acid) C Rash Generalised Celebrex(Celecoxib) C Rash Pruritic Prilosec(Omeprazole) C Skin Nodule Daypro(0xaproxin) C Somnolence Trandate(Labetalol Upper Respiratory Tract Hydrochloride) C Infection Axid(Nizatidine) C Urinary Incontinence Paxil(Paroxetine Weight Increased Hydrochloride) C Medrol (Methylprednisoone) C Macro 22-Feb-2006 08:31 AM Page: 655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Antioxidant(Ascorbic Acid, Cystine, Tocopherol, Calcium Ascorbate, C Zocor (Smvasatin) C Risperdal (Risperidone) C Fioricet(Butalbital) C Flonase (Fluticasone Propionate) C Phenobarbital (Phenobarbital) C Donnatal (Atropine Sulfate,Hyoscine Hydrobromide, Hyoscyamine Sulfate, Phenobarbital) C Bellergal-S (Belladonna Alkaloids, Erogotamine Tartrate, C Weight Loss Supplment C Ibuprofen C Ambien (Zolpidem Tartrate) C Baclofen (Baclfoen) C (Labetalol Hydrochloride) C Celexa (Cialopram Hydrobromide) C Cortisone (Cortisone) C Atarax (Hydroxyzine Hydrochloride) C Proventil Tablet (Salbutamol Sulfate) C Amitrptyline (Amitriptyline) C Cyclobenzaprine (Cyclobenzaprine) C Date:04/03/03ISR Number: 4089148-1Report Type:Expedited (15-DaCompany Report #2003AP01435 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Seroquel PS ORAL 500 MG QAM PO Initial or Prolonged Leukopenia Health Seroquel SS ORAL 900 MG HS PO Neutropenia Professional Sodium Valproate SS ORAL 400 MG QAM PO Other Sodium Valproate SS ORAL 800 MG HS PO Date:04/03/03ISR Number: 4089515-6Report Type:Expedited (15-DaCompany Report #2003UW04049 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Seroquel PS Initial or Prolonged Professional 22-Feb-2006 08:31 AM Page: 656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/03/03ISR Number: 4091529-7Report Type:Expedited (15-DaCompany Report #2003003276 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Foreign Zeldox (Capsules) Initial or Prolonged Aggression Health (Ziprasidone) PS ORAL 160 MG (BID), Other Blood Creatine Professional ORAL Phosphokinase Increased Company Zoloft (Sertraline) SS ORAL ORAL Coma Representative Quetiapine Fumarate Disseminated (Quetiapine Intravascular Coagulation Fumarate) SS ORAL ORAL Infection Penicillin Nos Intestinal Gangrene (Penicillin Nos) C Neuroleptic Malignant Clopenthixol Syndrome Hydrochloride Psychomotor Hyperactivity (Clopenthixol Pulmonary Embolism Hydrochloride) C Respiratory Failure Terbutaline Sulfate Sedation (Terbutaline Suicidal Ideation Sulfate) C Chlorprothixene Hydrochloride (Chlorprothixene Hydrochloride) C Clonazepam (Clonazepam) C Citalopram Hydrobromide (Citalopram Hydrobromide) C Salmeterol Xinafoate (Salmeterol Xinafoate) C Date:04/04/03ISR Number: 4088091-1Report Type:Direct Company Report #CTU 190280 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Quatiapina Fumarata PS ORAL 25MG PO QHS Palpitations Azithromycin C Guaifenisen C Ativan C Remeron C Date:04/04/03ISR Number: 4090055-9Report Type:Expedited (15-DaCompany Report #200300783S Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign ...Yslee Zolpidem Health Tablet 10mg PS ORAL 10MG, PO 18 MON Professional Dogmatyl Sulpiride Tablet 100mg SS 4 MG 94 MON ...Imas Lithium Carbonate Tablet 200mg SS 80MG, 2 YR Artane Trihexyphonidyl Hydrochloride Tablet 2mg SS 4MG 21 MON Toledomin 22-Feb-2006 08:31 AM Page: 657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Milnacipran Hydrochloride Tablet SS 100MG 7 MON Tetramide Mianserin Hydrochloride Tablet SS 20MG 88 MON Contmin Chlorpromazine Tablet 25mg SS 25MG 21 MON Silece Flunitrazepam Tablet 2mg SS 2MG 61 MON Seroquel Quetiapine Fumarate Tablet SS 150MG 11 MON Date:04/08/03ISR Number: 4091709-0Report Type:Expedited (15-DaCompany Report #2003UW04139 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ventricular Tachycardia Health Seroquel PS 1 WK Initial or Prolonged Professional Fluoxetine C Date:04/08/03ISR Number: 4091837-XReport Type:Expedited (15-DaCompany Report #2003GB00726 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Seroquel PS Health Professional Other Date:04/08/03ISR Number: 4092174-XReport Type:Expedited (15-DaCompany Report #USA-2002-0001677 Age:41 YR Gender:Female I/FU:F Outcome PT Death Alopecia Hospitalization - Amnesia Initial or Prolonged Angiopathy Anxiety Arterial Bruit Arterial Occlusive Disease Arthritis Back Pain Carpal Tunnel Syndrome Chest Pain Coma Depression Disturbance In Attention Drug Ineffective Emphysema Exfoliative Rash Fatigue Flushing Influenza Insomnia Irritability Libido Decreased Lymphadenopathy Nausea Nervousness 22-Feb-2006 08:31 AM Page: 658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Night Sweats Overdose Pneumonia Report Source Product Role Manufacturer Route Dose Duration Pulmonary Oedema Consumer Oxycontin Tablets 10 Pulse Absent Health Mg(Oxycodone Rash Generalised Professional Hydrochloride) Cr Rash Pruritic Other Tablet PS 10 MG Somnolence Oxycontin Tablets Upper Respiratory Tract 20mg(Oxycodone Infection Hydrochloride) Cr Urinary Incontinence Tablet SS 20 MG 1008 DAY Weight Increased Hydrocodone Bitartrate (Similar To Ind 59, 175)(Hydrocodone Bitartrate) Unknown SS 1008 DAY Alprazolam(Alprazola m) SS 1008 DAY Ephedrine(Ephedrine) SS 1008 DAY Pseudoephedrine(Pseu doephedrine) SS 1008 DAY Effexor(Venlafaxine Hydrochloride) SS 75 MG, DAILY 1008 DAY Codeine(Codeine) SS 1008 DAY Neurontin(Gabapentin ) SS 100 MG, TID 1008 DAY Metoclopramide(Metoc lopramide) SS 1008 DAY Quetiapine(Quetiapin e) SS 1008 DAY Claritin (Loratadine) C Vitamin C(Ascorbic Acid) C Celebrex(Celecoxib) C Prilosec(Omeprazole) C Daypro(Oxaprozin) C Trandate(Labetalol Hydrochloride) C Axid (Nizatidine) C Paxil (Paroxetine Hydrochloride) C Medrol (Methylprednisolone) C Macro Antioxidant (Ascorbic Acid, Cystine, Tocopherol, Calcium Ascorbate, Beta Carotene, C Zocor (Simvastatin) C Risperdal (Risperidone) C Fioricet (Butalbital) C Phenobarbital (Phenobarbital) C Donnatal (Atropine Sulfate, Hyoscine Hydrobromide, Hyoscyamine Sulfate, Phenobarbital) C 22-Feb-2006 08:31 AM Page: 659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bellergal-S (Belldadonna Alkaloids, Erogotamine Tartrate, C Weight Loss Supplement (Does Not Code) C Ibuprofen C Ambien (Zolpidem Tartrate) C Baclofen(Baclofen) C Trandate (Labetalol Hydrochloride) C Celexa (Citalopram Hydrobromide) C Cortisone (Cortisone) C Atarax (Hydroxyzine Hydrochloride) C Proventil Tablet (Salbutamol Sulfate) C Amitriptyline (Amitriptyline) C Cyclobenzaprine (Cyclobenzaprine) C Augmentin (Amoxicillin Trihydrate, Clavulanate Potassium) C Ergobel (Nicergoline) C Date:04/09/03ISR Number: 4090571-XReport Type:Direct Company Report #CTU 190569 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Seroquel, 10mg, Intervention to Zeneca PS Zeneca 150MG X 1 DAY Prevent Permanent (BY MOUTH) 3 YR Impairment/Damage Date:04/10/03ISR Number: 4088688-9Report Type:Direct Company Report #USP 55785 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Seroquel PS Astra Zeneca Quinidine Sulfate SS Date:04/10/03ISR Number: 4093663-4Report Type:Expedited (15-DaCompany Report #2003AP01134 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Required Agranulocytosis Foreign Intervention to Literature Prevent Permanent Health Impairment/Damage Professional 22-Feb-2006 08:31 AM Page: 660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Quetiapine PS ORAL 150 MG DAILY PO Quetiapine SS ORAL 600 MG DAILY PO Chlorpromazine C Olanzapine C Risperidone C Haloperidol C Date:04/10/03ISR Number: 4093669-5Report Type:Expedited (15-DaCompany Report #2003AP01273 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Insulin Resistance Health PO Prevent Permanent Professional Impairment/Damage Other Date:04/11/03ISR Number: 4094053-0Report Type:Expedited (15-DaCompany Report #2003014036 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Literature Ziprasidone Initial or Prolonged Corrected Interval Health (Ziprasidone) PS ORAL 1760 MG, ORAL Other Prolonged Professional Quetiapine Somnolence (Quetiapine) SS ORAL 1000 MG, ORAL Suicide Attempt Date:04/11/03ISR Number: 4094340-6Report Type:Expedited (15-DaCompany Report #2003AP01530 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Maternal Drugs Affecting Foreign Seroquel PS TRANSPLACENTAL 25 MG TPL Intervention to Foetus Health Paxil SS Prevent Permanent Tremor Neonatal Professional Impairment/Damage Other Date:04/11/03ISR Number: 4094341-8Report Type:Expedited (15-DaCompany Report #2003SE01633 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS ORAL 300 MG DAILY Health PO Professional Seroquel SS ORAL 50 MG BID PO Other Seroquel SS ORAL 100 MG QD PO Remeron C Date:04/11/03ISR Number: 4094342-XReport Type:Expedited (15-DaCompany Report #2003AP01539 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Ileus Paralytic Foreign Initial or Prolonged Health 22-Feb-2006 08:31 AM Page: 661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 50 MG TID PO Seroquel SS ORAL 100 MG TID PO Seroquel SS ORAL 200 MG BID PO Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 300 MG BID PO Seroquel SS ORAL 700 MG DAILY PO Seroquel SS ORAL 300 MG BID PO Seroquel SS ORAL 200 MG TID PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 100 MG TID PO Seroquel SS ORAL 100 MG BID PO Date:04/11/03ISR Number: 4094343-1Report Type:Expedited (15-DaCompany Report #2003AP01290 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compulsions Foreign Seroquel PS ORAL 25 MG TID PO Initial or Prolonged Jealous Delusion Study Seroquel SS ORAL 50 MG TID PO Health Seroquel SS ORAL 100 MG TID PO Professional Seroquel SS ORAL 500 MG DAILY Other PO Seroquel SS ORAL 200 MG TID PO Seroquel SS ORAL 100 MG TID PO Luvox SS Contomin C Haloperidol C Tasmolin C Cinnarizine C Pantosin C Magnesium Oxide C Silece C Eurodin C Date:04/11/03ISR Number: 4094347-9Report Type:Expedited (15-DaCompany Report #2003AP00243 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Seroquel PS ORAL 100 MG BID PO Nasopharyngitis Health Seroquel SS ORAL 100 MG TID PO Pyrexia Professional Seroquel SS ORAL 100 MG QID PO Respiratory Failure Other Seroquel SS ORAL 100 MG BID PO Sinus Tachycardia Influenza Virus Sudden Death Vaccine SS Benzalin C Minzain C Gasmotin C Pantethine C Magnesium Oxide C Alosenn C Ubtec C Mashinin C 22-Feb-2006 08:31 AM Page: 662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/03ISR Number: 4094348-0Report Type:Expedited (15-DaCompany Report #2003AP01166 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Foreign Seroquel PS ORAL 25 MG TID PO Required Hypothyroidism Health Seroquel SS ORAL 50 MG TID PO Intervention to Shock Professional Seroquel SS ORAL 100 MG TID PO Prevent Permanent Other Seroquel SS ORAL 200 MG TID PO Impairment/Damage Diazepam SS ORAL 5 MG TID PO Levomepromazine Maleate SS ORAL 25 MG TID PO Date:04/11/03ISR Number: 4094349-2Report Type:Expedited (15-DaCompany Report #2002AP03279 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS ORAL 200 MG DAILY Aspartate Health PO Aminotransferase Professional Seroquel SS ORAL 400 MG DAILY Blood Creatine Other PO Phosphokinase Seroquel SS ORAL 300 MG DAILY Blood Lactate PO Dehydrogenase Seroquel SS ORAL 200 MG DAILY Deep Vein Thrombosis PO Dysphoria Seroquel SS ORAL 400 MG DAILY Electrocardiogram T Wave PO Inversion Tegretol C Fall Hirnamin C Heart Rate Decreased Neuleptil C Logorrhoea Methylcobal C Mental Status Changes Fludecasin C Muscle Rigidity Pulmonary Infarction Sedation Ventricular Extrasystoles White Blood Cell Count Date:04/14/03ISR Number: 4094895-1Report Type:Expedited (15-DaCompany Report #2002AP04514 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Hyperosmolar Foreign Seroquel PS ORAL 75 MG DAILY Hospitalization - Coma Health PO Initial or Prolonged Drug Interaction Professional Prednisolone Acetate SS ORAL 20 MG DAILY Other PO Risperidone SS ORAL 2 MG DAILY PO Risperidone SS ORAL 3 MG DAILY PO Chlorpromazine C Levomepromazine C Haloperidol C Brovarin C Isomytal C Artane C 22-Feb-2006 08:31 AM Page: 663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/03ISR Number: 4094897-5Report Type:Expedited (15-DaCompany Report #2002SE06175 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Seroquel PS ORAL 350 MG QD PO Dizziness Health Stedon C Hypotension Professional Dipiperon C Myocardial Infarction Other Zyprexa C Psychomotor Hyperactivity Akineton C Pyrexia Tenormin C Date:04/15/03ISR Number: 4095405-5Report Type:Expedited (15-DaCompany Report #2003UW02826 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Health Seroquel PS ORAL 1200 MG HS PO Intervention to Blood Potassium Decreased Professional Seroquel SS ORAL 1200 MG ONCE Prevent Permanent Blood Pressure Decreased PO Impairment/Damage Coma Seroquel SS ORAL 900 MG HS PO Delirium Seroquel SS ORAL 1200 MG HS PO Drug Interaction Paxil SS ORAL 20 MG DAILY Hypokalaemia PO Miosis Paxil SS ORAL 20 MG DAILY Sinus Tachycardia PO Treatment Noncompliance Haldol C Date:04/15/03ISR Number: 4095597-8Report Type:Expedited (15-DaCompany Report #2003AP01246 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Foreign Seroquel PS ORAL 50 MG TID PO Sudden Death Health Limas SS ORAL 200 MG QID PO Professional Artane SS ORAL 2 MG BID PO Other Dogmatyl SS ORAL 100 MG BID PO Toledomin SS ORAL 50 MG PO Tetramide SS ORAL 20 MG QD PO Contomin SS ORAL 25 MG QD PO Silece SS ORAL 2 MG QD PO Zolpidem SS ORAL 10 MG QD PO Date:04/15/03ISR Number: 4095602-9Report Type:Expedited (15-DaCompany Report #2003GB00726 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Seroquel PS Health Anusol C Professional Lactulose C Other Date:04/15/03ISR Number: 4097671-9Report Type:Expedited (15-DaCompany Report #2003AP01524 Age:85 YR Gender:Male I/FU:I Outcome PT Death Cardiac Arrest Required Cardiac Failure Acute Intervention to Dehydration Prevent Permanent Electrolyte Imbalance Impairment/Damage Heart Rate Decreased 22-Feb-2006 08:31 AM Page: 664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Oliguria Polyuria Report Source Product Role Manufacturer Route Dose Duration Vomiting Foreign Seroquel PS ORAL 50 MG QD PO Health Seroquel SS ORAL 25 MG QD PO Professional Toledomin SS ORAL 25 MG QD PO Other Toledomin SS ORAL 50 MG QD PO Toledomin SS ORAL 50 MG QD PO Risperdal C Pyrethia C Date:04/15/03ISR Number: 4097672-0Report Type:Expedited (15-DaCompany Report #2003AP01531 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Supraventricular Foreign Seroquel PS 600 MG DAILY Intervention to Tachycardia Health Prevent Permanent Professional Impairment/Damage Other Date:04/15/03ISR Number: 4097674-4Report Type:Expedited (15-DaCompany Report #2003AP01540 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Seroquel PS ORAL 25 MG TID PO Initial or Prolonged Study Seroquel SS ORAL 50 MG TID PO Required Health Seroquel SS ORAL 250 MG DAILY Intervention to Professional PO Prevent Permanent Other Seroquel SS ORAL 450 MG DAILY Impairment/Damage PO Seroquel SS ORAL 650 MG DAILY PO Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 100 MG BID PO No Match C Tasmolin C Date:04/15/03ISR Number: 4097677-XReport Type:Expedited (15-DaCompany Report #2003GB00755 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Foreign Quetiapine PS ORAL 300 MG DAILY Initial or Prolonged Cholelithiasis Health PO Drug Interaction Professional Depakote SS 250 MG DAILY Fatigue Other Depakote SS 500 MG DAILY Oedema Peripheral Depakote SS 1000 MG DAILY Pulmonary Oedema Diclofenac C Somnolence Lisinopril C Senna C Date:04/15/03ISR Number: 4115362-2Report Type:Periodic Company Report #2003UW00738 Age:59 YR Gender:Male I/FU:I Outcome PT Hospitalization - Dehydration Initial or Prolonged Hypotension 22-Feb-2006 08:31 AM Page: 665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Syncope Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS ORAL 400 MG BID PO Professional Seroquel SS ORAL 500 MG BID PO Atenolol SS 75 MG BID Risperdal SS 1 MG BID Benazepril SS 10 MG HS Hydrochlorothiazide SS 50 MG DAILY Date:04/16/03ISR Number: 4096097-1Report Type:Direct Company Report #CTU 190997 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Seroquel PS Dry Mouth Dyspnoea Malaise Medication Error Paraesthesia Somnolence Tremor Date:04/16/03ISR Number: 4096114-9Report Type:Direct Company Report #CTU 191108 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Seroquel PS 600MG QHS Initial or Prolonged Corrected Interval Prolonged Date:04/16/03ISR Number: 4097257-6Report Type:Expedited (15-DaCompany Report #2003GB00778 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Neuroleptic Malignant Consumer PO Required Syndrome Other Haloperidol C Intervention to Overdose Chlorpromazine C Prevent Permanent Sedation Risperidone C Impairment/Damage Somnolence Valium C Date:04/16/03ISR Number: 4097258-8Report Type:Expedited (15-DaCompany Report #2003AP01435 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Drug Interaction Health PO Leukopenia Professional Sodium Valproate SS ORAL 1 G DAILY PO Neutropenia Other Sodium Valproate SS 2 WK Suicidal Ideation 22-Feb-2006 08:31 AM Page: 666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/03ISR Number: 4097303-XReport Type:Expedited (15-DaCompany Report #2003AP01518 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Laboratory Test Literature Quetiapine PS 200 MG TID Intervention to Interference Health Nortriptyline C Prevent Permanent Professional Levothyroxine C Impairment/Damage Lithium C Date:04/16/03ISR Number: 4097311-9Report Type:Expedited (15-DaCompany Report #2003AP01249 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Seroquel PS ORAL 100 MG DAILY Increased Health PO Aspartate Professional Seroquel SS ORAL 150 MG DAILY Aminotransferase Other PO Increased Akineton SS ORAL 1 MG TID PO Blood Triglycerides Akineton SS Increased Parlodel SS ORAL 25 MG DAILY Cardiac Tamponade PO Electrocardiogram St-T Risperdal C Change Pzc C Myocardial Infarction Neoperidol C Sudden Death White Blood Cell Count Increased Date:04/16/03ISR Number: 4097987-6Report Type:Expedited (15-DaCompany Report #USA-2002-0001677 Age:41 YR Gender:Female I/FU:F Outcome PT Death Alopecia Hospitalization - Angiopathy Initial or Prolonged Anxiety Apnoea Arterial Occlusive Disease Arthropathy Asthma Atherosclerosis Back Pain Cardiac Arrest Carpal Tunnel Syndrome Chest Pain Coma Depression Disturbance In Attention Drug Ineffective Exfoliative Rash Fatigue Finger Deformity Flushing Hilar Lymphadenopathy Hypoaesthesia Influenza Like Illness Insomnia Libido Decreased Liver Disorder Memory Impairment 22-Feb-2006 08:31 AM Page: 667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myofascial Pain Syndrome Nausea Nervousness Report Source Product Role Manufacturer Route Dose Duration Night Sweats Consumer 0xycontin Tablet 10 Osteoarthritis Health Mg(Oxycodoen Overdose Professional Hydrochloride) Cr Paraesthesia Other Tablet PS 10 MG , Peripheral Vascular 0xycontin Tablet 20 Disorder Mg(Oxycodoen Pneumonia Hydrochloride) Cr Pulmonary Interstitial Tablet SS 20 MG 1008 DAY Emphysema Syndrome Hydrocodone Pulmonary Oedema Bitartrate Similar Pulse Abnormal To Ind Rash Pruritic 59,175)(Hydrocodone Shock Betartrate)Unknown SS 1008 DAY Somnolence Alprazolam Upper Respiratory Tract (Alprazolam) SS 1008 DAY Infection Ephedrine (Epedrine) SS 1008 DAY Urinary Incontinence Pseudoephedrine Weight Increased (Pseudoephedrine) SS 1008 DAY Effexor (Venlafaxine Hydrochloride) SS 75 MG, DAILY 1008 DAY Codeine (Codeine) SS 1008 DAY Neurontin (Gabapetin) SS 100 MG, TID 1008 DAY Metoclopramide (Metoclopramide) SS 1008 DAY Quetiapine (Quetiapine) SS 1008 DAY Claritin (Loratadine) C Vitamin C (Ascorbic Acid) C Celebrex (Celecoxib) C Prilosec (Omeprazole) C Daypro (Oxaprozin) C Trandate (Labetalol Hydrochloride) C Axid (Nizatidine) C Paxil (Paroxetine Hydrochloriede) C Medrol (Methylprednisolone) C Marco Antioxidant (Ascorgic Acid, Cystine, Tocopherol, Calcium Ascorgate, Betacarotene,Mangane C Zocor (Simvastatin) C Risperdal (Risperidone) C Fioricet (Butalbital) C Flonase (Fluticasone Propionate) C Phenobarbital (Phenobarbital) C Donnatal (Atropine Sulfate, Hyoscine 22-Feb-2006 08:31 AM Page: 668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrobromide, Hyoscyamine Sulfate, Phenobarbital) C Bellergal-S (Belladonna Alkaloids, Ergotamine Tartrate, Phenobarbital) C Weight Loss Supplement (Does Not Code) C Ibuprofen C Ambien(Zolpidem Tartrate) C Balcofen (Balcofen) C Trandate (Labetalol Hydrochloride) C Celexa (Citalopram Hydrobromide) C Cortisone (Cortisone) C Atarax (Hydroxyzine Hydrochloriede) C Proventil Tablet (Salbutamol Sulfate) C Amitriptyline (Amitriptyline) C Cyclobenzaprine (Cyclobenzaprine) C Aaugmentin (Amoxicillin Trihydrate, Clavulanate Potassium) C Ergobel (Nicergoline) C Date:04/18/03ISR Number: 4098549-7Report Type:Expedited (15-DaCompany Report #2003UW01594 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatic Steatosis Health Seroquel PS ORAL 200 MG DAILY Intervention to Obesity Professional PO Prevent Permanent Impairment/Damage Date:04/18/03ISR Number: 4098987-2Report Type:Expedited (15-DaCompany Report #2003SE01633 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS ORAL 300 MG DAILY Somnolence Health PO White Blood Cell Count Professional Seroquel SS ORAL 50 MG BID PO Decreased Other Seroquel SS ORAL 100 MG QD PO Remeron C 22-Feb-2006 08:31 AM Page: 669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/03ISR Number: 4098989-6Report Type:Expedited (15-DaCompany Report #2003AP01539 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Seroquel PS ORAL 50 MG TID PO Initial or Prolonged Health Seroquel SS ORAL 100 MG TID PO Professional Seroquel SS ORAL 200 MG BID PO Other Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 300 MG BID PO Seroquel SS ORAL 700 MG DAILY PO Seroquel SS ORAL 300 MG BID PO Seroquel SS ORAL 200 MG TID PO Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 100 MG TID PO Seroquel SS ORAL 100 MG BID PO Date:04/21/03ISR Number: 4096777-8Report Type:Direct Company Report #CTU 191322 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Spasms Seroquel 100mg Initial or Prolonged Myalgia Astrazeneca PS Astrazeneca ORAL 100MG AM 200 Required Neuroleptic Malignant ORAL Intervention to Syndrome Risperdal 1mg Prevent Permanent Janssen SS Janssen ORAL 1MG AM/2MG Impairment/Damage ORAL Metformin C Trazodone C Acetaminphen C Keflex C Seroquel C Symmetrel C Parlodel C Risperdal C Lithium Carbonate C Wellbutrin C Date:04/21/03ISR Number: 4099569-9Report Type:Expedited (15-DaCompany Report #2002GB02131 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Foreign Seroquel PS ORAL 25 MG PID PO Intervention to Anxiety Health Hydroxychloroquine C Prevent Permanent Asthenia Professional Amisulpride C Impairment/Damage Constipation Other Prempak-C C Diarrhoea Dysuria Lethargy Memory Impairment Somnolence 22-Feb-2006 08:31 AM Page: 670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/03ISR Number: 4099573-0Report Type:Expedited (15-DaCompany Report #2003SE00379 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Foreign Seroquel PS ORAL 500 MG QD PO Intervention to Bundle Branch Block Health Prevent Permanent Conversion Disorder Professional Impairment/Damage Fear Other Heart Rate Abnormal Hyperventilation Myocardial Infarction Panic Attack Paraesthesia Personality Disorder Tachycardia Date:04/22/03ISR Number: 4096496-8Report Type:Direct Company Report #CTU 191378 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Ability 10mg Initial or Prolonged Bms-Otsuka PS Bms-Otsuka 10MG ONCE DAILY Seroquel 200mg Asta Zeneca SS Astra Zeneca 800MG PER DAY Valproic Acid C Haloperidol C Date:04/22/03ISR Number: 4100211-9Report Type:Expedited (15-DaCompany Report #2003AP01524 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Seroquel PS ORAL 50 MG QD PO Required Cardiac Arrest Health Seroquel SS ORAL 25 MG QD PO Intervention to Cardiac Failure Acute Professional Toledomin SS ORAL 25 MG QD PO Prevent Permanent Dehydration Other Toledomin SS ORAL 50 MG QD PO Impairment/Damage Delirium Toledomin SS ORAL 25 MG QD PO Depressed Level Of Risperdal C Consciousness Pyrethia C Electrolyte Imbalance Polyuria Vomiting Date:04/22/03ISR Number: 4100849-9Report Type:Expedited (15-DaCompany Report #2003UW04863 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Date:04/22/03ISR Number: 4100851-7Report Type:Expedited (15-DaCompany Report #2003UW04998 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Health Seroquel PS ORAL 600 MG DAILY Hospitalization - Coma Professional PO Initial or Prolonged Refusal Of Treatment By Haldol C Patient Cogentin C 22-Feb-2006 08:31 AM Page: 671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin C Lithium C Date:04/23/03ISR Number: 4101056-6Report Type:Expedited (15-DaCompany Report #2003GB00717 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Disease Recurrence Foreign Seroquel PS ORAL 600 MG PO Required Drug Hypersensitivity Health Cipramil C Intervention to Dysphagia Professional Risperidone C Prevent Permanent Pharyngeal Oedema Other Impairment/Damage Tongue Oedema Date:04/23/03ISR Number: 4101991-9Report Type:Expedited (15-DaCompany Report #2003AP01642 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Quetiapine PS 600 MG DAILY Intervention to Neutrophil Count Literature Chlorpromazine C Prevent Permanent Decreased Health Olanzapine C Impairment/Damage Professional Risperidone C Other Haloperidol C Date:04/23/03ISR Number: 4102156-7Report Type:Expedited (15-DaCompany Report #2003UW04837 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Malaise Professional Pyrexia Date:04/23/03ISR Number: 4102157-9Report Type:Expedited (15-DaCompany Report #2003UW04929 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Seroquel PS ORAL 600 MG PO Initial or Prolonged Loss Of Consciousness Professional Oxazepam C Paxil C Lamictal C Keppra C Date:04/23/03ISR Number: 4102158-0Report Type:Expedited (15-DaCompany Report #2003UW04993 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Health Seroquel PS Initial or Prolonged Overdose Professional Date:04/23/03ISR Number: 4102159-2Report Type:Expedited (15-DaCompany Report #2003UW04950 Age:11 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Septic Shock Health Seroquel PS Initial or Prolonged Toxicologic Test Abnormal Professional 22-Feb-2006 08:31 AM Page: 672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/03ISR Number: 4102201-9Report Type:Expedited (15-DaCompany Report #HQ4282718SEP2002 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Effexor Xr Exposure To Therapeutic Professional (Venlafaxine Drugs Hydrochloride, Drug Withdrawal Syndrome Capsule, Extended Induced Labour Release) PS ORAL 225 MG 1X PER Oligohydramnios 1 DAY, ORAL Pregnancy Celexa (Citalopram Pregnancy Induced Hydrobromide, Hypertension Tablet) SS Seroquel (Quetiapine,) SS Topamax (Topiramate,) SS Date:04/24/03ISR Number: 4102491-2Report Type:Expedited (15-DaCompany Report #2003UW02721 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Seroquel PS ORAL 100 MG BID PO Full Blood Count Abnormal Professional Depakote C Topamax C Date:04/24/03ISR Number: 4102801-6Report Type:Expedited (15-DaCompany Report #2003AP01676 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Asphyxiation Foreign Seroquel PS ORAL 50 MG DAILY Health PO Professional Seroquel SS ORAL 150 MG BID PO Other Risperidone C Potassium Slow Release C Panteston C Moclobemide C Date:04/25/03ISR Number: 4097820-2Report Type:Direct Company Report #USP 51438 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel PS Zeneca Pharmaceuticals TABLET 100 MG Serzone SS Bristol-Myers Squibb TABLET 100 MG Date:04/25/03ISR Number: 4102949-6Report Type:Expedited (15-DaCompany Report #2003AP01538 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyponatraemia Foreign Seroquel PS ORAL 300 MG DAILY Nervous System Disorder Study PO Polydipsia Health Seroquel SS ORAL 600 MG DAILY Water Intoxication Professional PO Other Hirnamin C Tasmolin C Dalmate C 22-Feb-2006 08:31 AM Page: 673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rohipnol C Pursennid C Chinese Herbal Medicine C Benapy C Norvasc C Date:04/25/03ISR Number: 4103003-XReport Type:Expedited (15-DaCompany Report #2003AP01598 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Disease Recurrence Foreign Seroquel PS ORAL 25 MG TID PO Ileus Paralytic Study Seroquel SS ORAL 50 MG TID PO Psychomotor Hyperactivity Health Seroquel SS ORAL 100 MG TID PO Restlessness Professional Levotomin SS ORAL 85 MG DAILY Other PO Levotomin SS ORAL 200 MG DAILY PO Tasmolin C Depakene C Vegetamin C Benzalin C Lendormin C Forsenid C Laxoberon C Date:04/25/03ISR Number: 4103149-6Report Type:Expedited (15-DaCompany Report #HQWYE711216APR03 Age:0 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Maternal Drugs Affecting Health Effexor Xr Initial or Prolonged Foetus Professional (Venlafaxine Premature Baby Hydrochloride, Respiratory Disorder Capsule, Extended Neonatal Release) PS TRANSPLACENTAL 225 MG 1X PER 1 DAY Celexa (Citalopram Hydrobromide, Tablet) SS TRANSPLACENTAL Seroquel (Quetiapine, ) SS TRANSPLACENTAL Topamax (Topiramate, ) SS TRANSPLACENTAL Date:04/25/03ISR Number: 4103171-XReport Type:Expedited (15-DaCompany Report #2003016563 Age:55 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Lithane (Lithium) PS ORAL ORAL Health Quetiapine Professional (Quetiapine) SS ORAL ORAL Fluphenazine (Fluphenazine) SS ORAL ORAL 22-Feb-2006 08:31 AM Page: 674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/03ISR Number: 4103208-8Report Type:Expedited (15-DaCompany Report #2003016400 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Hydroxyzine Other Completed Suicide Health Hydrochloride Professional (Tablet) (Hydroxyzine Hydrochloride) PS ORAL ORAL Paroxetine (Paroxetine) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL Date:04/25/03ISR Number: 4117239-5Report Type:Periodic Company Report #NSADSS2002038339 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Health Ultram (50 Mg Initial or Prolonged Professional Tablet) (Tramadol Hydrochloride) PS 50 MG Q 4 HOURS Gabitril(Tiagabine Hydrochloride) SS 4 MG BID TO TID Seroquel (Seroquel) SS Paxil(Paroxetine Hydrochloride) SS Klonopin(Clonazepam) C Levoxyl(Levothyroxin e Sodium) C Clonidine(Clonidine) C Prilosec(Omeprazole) C Premarin (Estrogens Conjugated) C Trazodone(Trazodone) C Date:04/28/03ISR Number: 4101327-3Report Type:Direct Company Report #CTU 191777 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Adhesions Clozapine PS Condition Aggravated Thorazine SS Intestinal Obstruction Seroquel SS Vistaril SS Date:04/29/03ISR Number: 4103029-6Report Type:Direct Company Report #CTU 191812 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Cholesterol Seroquel 300mg., Intervention to Increased 200mg, 25 Mg Prevent Permanent Blood Glucose Increased Astra-Zeneca PS Astra-Zeneca ORAL 550 MG DAY Impairment/Damage Blood Triglycerides ORAL Increased 22-Feb-2006 08:31 AM Page: 675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/03ISR Number: 4104681-1Report Type:Expedited (15-DaCompany Report #2003AP01273 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Glycosylated Haemoglobin Health PO Prevent Permanent Increased Professional Impairment/Damage Other Date:04/30/03ISR Number: 4104766-XReport Type:Expedited (15-DaCompany Report #2003PK00531 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Phosphokinase Increased Study PO Required Blood Creatine Health Fevarin C Intervention to Phosphokinase Mb Professional Metoprolol C Prevent Permanent Increased Other Impairment/Damage Chest Discomfort Chest Pain Dry Mouth Loss Of Libido Somnolence Tachycardia Date:04/30/03ISR Number: 4104854-8Report Type:Expedited (15-DaCompany Report #2002UW13313 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Foreign Seroquel PS ORAL 300 MG DAILY Thromboplastin Time Health PO Prolonged Professional Seroquel SS ORAL 400 MG DAILY Leukopenia Other PO Lymphocyte Count Seroquel SS ORAL 300 MG DAILY Decreased PO Platelet Count Decreased Seroquel SS ORAL 600 MG HS PO Seroquel SS ORAL 500 MG DAILY PO Loxapine C Diltiazem C Premarin C Dyazide C Vitamin E C Date:04/30/03ISR Number: 4104867-6Report Type:Expedited (15-DaCompany Report #2003GB00904 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Health Professional Other 22-Feb-2006 08:31 AM Page: 676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/03ISR Number: 4105767-8Report Type:Expedited (15-DaCompany Report #2003UW05252 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothyroidism Health Seroquel PS 400 MG DAILY Leukopenia Professional Naltrexone C Synthroid C Date:05/01/03ISR Number: 4106381-0Report Type:Expedited (15-DaCompany Report #2003AP01726 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel PS Death Health Bosmin C Electrocardiogram Professional Abnormal Other Obstructive Airways Disorder Sedation Date:05/01/03ISR Number: 4106391-3Report Type:Expedited (15-DaCompany Report #2003SE02162 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Foreign Seroquel PS ORAL 250 MG DAILY Intervention to Confusional State Health PO Prevent Permanent Dementia Professional Efexor C Impairment/Damage Hypertension Other Tradolan C Date:05/01/03ISR Number: 4106761-3Report Type:Expedited (15-DaCompany Report #2003UW05344 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Chills Health Seroquel PS ORAL 50 MG DAILY Intervention to Malaise Professional PO Prevent Permanent Pyrexia Remeron C Impairment/Damage Red Blood Cell Topamax C Abnormality Splenomegaly Weight Decreased White Blood Cell Count Decreased Date:05/05/03ISR Number: 4106345-7Report Type:Direct Company Report #CTU 192264 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Quetiapine PS ORAL 300MG QHS PO Initial or Prolonged Heart Rate Increased Other Musculoskeletal Stiffness Respiratory Rate Increased 22-Feb-2006 08:31 AM Page: 677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/03ISR Number: 4106631-0Report Type:Direct Company Report #CTU 192331 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Seroquel 200mg Medication Error Astrazeneca PS Astrazeneca ORAL 1 TABLE 2 Paralysis TIMES ORAL Serzone 200 Mg Bristol Myers SS Bristol Myers ORAL 1 TABLE 2 TIMES ORAL Date:05/06/03ISR Number: 4108616-7Report Type:Expedited (15-DaCompany Report #2003AP01767 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspepsia Foreign Seroquel PS ORAL 1000 MG DAILY Intervention to Gastric Ulcer Health PO 18 MON Prevent Permanent Gastritis Professional Tramadol SS 50-100MG TDS Impairment/Damage Iron Deficiency Anaemia Other Oesophagitis Date:05/06/03ISR Number: 4108717-3Report Type:Expedited (15-DaCompany Report #2003UW05544 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Consumer Seroquel PS Hospitalization - Initial or Prolonged Date:05/06/03ISR Number: 4108725-2Report Type:Expedited (15-DaCompany Report #HQWYE711216APR03 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Health Effexor Xr Initial or Prolonged Neonatal Professional (Venlafaxine Maternal Drugs Affecting Hydrochloride, Foetus Extended Release) PS TRANSPLACENTAL 225 MG 1 X Neonatal Apnoeic Attack PER 1 DAY, Premature Baby TRANSPLANCENT Respiratory Disorder AL Neonatal Celexa (Citalopram Temperature Regulation Hydrobromide, Disorder Tablet) SS TRANSPLACENTAL TRANSPLACENTA L Seroquel (Quetiapine) SS TRANSPLACENTAL TRANSPLACENTA L Topamax (Topiramate) SS TRANSPLACENTAL TRANSPLACENTA L Antibiotic C Date:05/06/03ISR Number: 4108803-8Report Type:Expedited (15-DaCompany Report #2003UW02480 Age:17 YR Gender:Female I/FU:F Outcome Congenital Anomaly Required Intervention to 22-Feb-2006 08:31 AM Page: 678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Complications Of Maternal Health Seroquel PS ORAL 300 MG BID PO Exposure To Therapeutic Professional Wellbutrin - Slow Drugs Release C Intra-Uterine Death Maternal Drugs Affecting Foetus Pregnancy Uterine Dilation And Curettage Date:05/06/03ISR Number: 4108804-XReport Type:Expedited (15-DaCompany Report #2003UW05648 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Seroquel PS ORAL 50 MG DAILY Aggression Professional PO Agitation Seroquel SS ORAL 200 MG TID PO Drooling Seroquel SS ORAL 400 MG DAILY Drug Level Increased PO Somnolence Seroquel SS ORAL 100 MG DAILY Sudden Death PO Klonopin C Cogentin C Depakote C Risperdal C Date:05/07/03ISR Number: 4107491-4Report Type:Direct Company Report #CTU 192449 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Seroquel 25mg PS 25MG HS PRN Initial or Prolonged Condition Aggravated Toprol Xl C Confusional State Zithromax C Delusion Prinivil C Hallucination, Visual Sinemet C Lethargy Unasyn C Sedation Guaifenesin C Aspirin C Lasix C Date:05/07/03ISR Number: 4109577-7Report Type:Expedited (15-DaCompany Report #2003UW05590 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Seroquel PS ORAL 12 G ONCE PO Initial or Prolonged Distress Syndrome Professional Seroquel SS ORAL 600 MG PO Infection Geodon SS 3.36 G ONCE Intentional Overdose Geodon SS Lethargy Paralysis Pneumonia Aspiration Pulmonary Oedema Sedation Ventricular Tachycardia 22-Feb-2006 08:31 AM Page: 679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/03ISR Number: 4109579-0Report Type:Expedited (15-DaCompany Report #2003UW05698 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Cardiac Death Health Seroquel PS OVER ONE YEAR Professional Date:05/07/03ISR Number: 4109749-1Report Type:Expedited (15-DaCompany Report #2003018220 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Geodon (Ziprasidone) PS ORAL 3.36 GRAM, Initial or Prolonged Phosphokinase Increased Professional ORAL Other Hypoxia Quetiapine Fumarate Intentional Overdose (Quetiapine Ventricular Tachycardia Fumarate) SS 12 GRAM Date:05/08/03ISR Number: 4108234-0Report Type:Direct Company Report #CTU 192534 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Seroquel Astra Initial or Prolonged Blood Glucose Increased Zeneca PS Astra Zeneca ORAL 650MG DAILY Required Fatigue ORAL Intervention to Nausea Geodon Pfizer SS Pfizer Prevent Permanent Polydipsia Zoloft C Impairment/Damage Polyuria Depakote C Vomiting Date:05/08/03ISR Number: 4109763-6Report Type:Expedited (15-DaCompany Report #2003AP01539 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Foreign Seroquel PS ORAL 50 MG TID PO Initial or Prolonged Health Seroquel SS ORAL 100 MG TID PO Professional Seroquel SS ORAL 200 MG BID PO Other Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 300 MG BID PO Seroquel SS ORAL 700 MG DAILY PO Seroquel SS ORAL 300 MG BID PO Seroquel SS ORAL 200 MG TID PO Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 100 MG TID PO Seroquel SS ORAL 100 MG BID PO Tolopelon SS 8 MG DAILY Miradol SS 600 MG DAILY Aleviatin SS 60 MG DAILY Tremin SS 3 MG DAILY Stomilase C Pantosin C Magnesium Oxide C Dioctyl Sodium Sulfosuccinate C Cystatin C 22-Feb-2006 08:31 AM Page: 680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/03ISR Number: 4109774-0Report Type:Expedited (15-DaCompany Report #2003AP01530 Age:0 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Maternal Drugs Affecting Foreign Seroquel PS TRANSPLACENTAL 25 MG TPL Intervention to Foetus Health Paxil SS Prevent Permanent Respiratory Disorder Professional Impairment/Damage Neonatal Other Tremor Neonatal Date:05/08/03ISR Number: 4110115-3Report Type:Expedited (15-DaCompany Report #2003UW05734 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Retinal Haemorrhage Health Seroquel PS ORAL 25 MG DAILY Intervention to Professional PO Prevent Permanent Eskalith SS 300 MG Impairment/Damage Xanax SS 0.25 MG PRN Wellbutrin SS 150 MG BID Date:05/08/03ISR Number: 4110123-2Report Type:Expedited (15-DaCompany Report #2003UW00898 Age: Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Seroquel PS ORAL 400 MG BID PO Pulmonary Disease Professional Depakote C Renal Failure Chronic Celexa C Zantac C Date:05/09/03ISR Number: 4110268-7Report Type:Expedited (15-DaCompany Report #2003AP01774 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Faecal Incontinence Study PO Thinking Abnormal Health Seroquel SS ORAL 25 MG BID PO Urinary Incontinence Professional Seroquel SS ORAL 75 MG PO Other Seroquel SS 50 MG BID Seroquel SS ORAL 150 MG PO Seroquel SS 100 MG BID Seroquel SS ORAL 100 MG TID PO Seroquel SS 125 MG TID Seroquel SS ORAL 475 MG PO Seroquel SS ORAL 125 MG QID PO Seroquel SS ORAL 200 MG TID PO Seroquel SS ORAL 700 MG PO Seroquel SS ORAL 750 MG PO Seroquel SS Timiperone SS Akineton C Levotomin C Benzalin C Rohypnol C 22-Feb-2006 08:31 AM Page: 681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/03ISR Number: 4110554-0Report Type:Expedited (15-DaCompany Report #2003UW05594 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetic Ketoacidosis Health Seroquel PS ORAL 1000 MG DAILY Intervention to Professional PO Prevent Permanent Impairment/Damage Date:05/09/03ISR Number: 4110825-8Report Type:Direct Company Report #USP 55843 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Seroquel PS Astrazeneca TABLET, Dysphagia DELAYED Dyspnoea RELEASE Medication Error ENTERIC Paralysis COATED Serzone SS Bristol Myers DELAYED RELEASE (ENTERIC COATED) Date:05/09/03ISR Number: 4119852-8Report Type:Periodic Company Report #02P-163-0199017-00 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Depakote Tablets Initial or Prolonged Professional (Depakote) Other (Divalproex Sodium) (Divalproex Sodium) PS 500 MG, 2 IN 1 D Clozapine SS ORAL MG, 1 IN 1 D, ORAL Quetiapine SS 100 MG, 1 IN 1 D Date:05/12/03ISR Number: 4110930-6Report Type:Expedited (15-DaCompany Report #2003AP01530 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Maternal Drugs Affecting Foreign Seroquel PS 25 MG TPL Intervention to Foetus Health Paxil SS Prevent Permanent Tremor Neonatal Professional Impairment/Damage Other Date:05/13/03ISR Number: 4111547-XReport Type:Expedited (15-DaCompany Report #2003AP01803 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Seroquel PS ORAL 700 MG DAILY Sudden Death Health PO Professional Clozapine SS 200 MG DAILY Other 22-Feb-2006 08:31 AM Page: 682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/03ISR Number: 4111607-3Report Type:Expedited (15-DaCompany Report #2003UW05699 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gait Disturbance Health Seroquel PS ORAL 1100 MG HS PO Initial or Prolonged Hyperhidrosis Professional Sinemet C Mental Status Changes Date:05/14/03ISR Number: 4112318-0Report Type:Expedited (15-DaCompany Report #2003AP01290 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compulsions Foreign Seroquel PS ORAL 25 MG TID; PO Initial or Prolonged Jealous Delusion Study Seroquel SS ORAL 50 MG TID; PO Health Seroquel SS ORAL 100 MG TID; Professional PO Other Seroquel SS ORAL 500 MG DAILY; PO Seroquel SS ORAL 200 MG TID; PO Seroquel SS ORAL 100 MG TID; PO Luvox SS ORAL 75 MG UNK; PO Luvox SS ORAL 150 MG UNK; PO Contomin C Haloperidol C Tasmolin C Cinnarizine C Pantosin C Magnesium Oxide C Silece C Eurodin C Date:05/14/03ISR Number: 4112515-4Report Type:Expedited (15-DaCompany Report #2003UW05544 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Consumer Seroquel PS Hospitalization - Other Paxil SS Initial or Prolonged Date:05/14/03ISR Number: 4112569-5Report Type:Expedited (15-DaCompany Report #HQWYE052405MAY03 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Temesta (Lorazepam, Initial or Prolonged Leukopenia Professional Tablet) PS ORAL SEE IMAGE 69 DAY Other Neutropenia Other Clopixol (Zuclopenthixol Decanoate) SS ORAL SEE IMAGE 16 DAY Haldol (Haloperidol) SS ORAL SEE IMAGE 5 DAY Seroquel (Quetiapine) SS ORAL SEE IMAGE 1 DAY Risperdal (Risperdone) C Konakion (Phytomenadione) C Zyprexa (Olanzapine) C 22-Feb-2006 08:31 AM Page: 683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/03ISR Number: 4113643-XReport Type:Direct Company Report #CTU 192979 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Clonazepam PS #39 Consciousness Quetiapine SS #24 Drug Screen Positive Lethargy Overdose Date:05/15/03ISR Number: 4112926-7Report Type:Expedited (15-DaCompany Report #PHEH2002US08318 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alcohol Use Health Trileptal(Oxcarbazep Hospitalization - Condition Aggravated Professional ine)Tablet PS ORAL 300 MG, BID, Initial or Prolonged Drug Abuser ORAL Hypersomnia Seroquel (Quetiapine Insomnia Fumarate) SS 400 MG, QHS Loss Of Consciousness Klonopin C Medication Error Topamax (Topiramate) C Renal Failure Remeron Rhabdomyolysis (Mirtazapine) C Trazodone (Trazodone) C Date:05/15/03ISR Number: 4113197-8Report Type:Expedited (15-DaCompany Report #2003GB01174 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 750 MG DAILY Health PO Professional Date:05/19/03ISR Number: 4114636-9Report Type:Direct Company Report #CTU 193330 Age:3 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Seroquel 200 PS INTRACARDIAC ONCE PERDAY Initial or Prolonged Anxiety INTRACARDIAC Other Decreased Interest Required Depression Intervention to Fatigue Prevent Permanent Paranoia Impairment/Damage Date:05/19/03ISR Number: 4114702-8Report Type:Direct Company Report #CTU 193340 Age:1 DY Gender:Male I/FU:I Outcome PT Other Apgar Score Low Catatonia Dyskinesia Neonatal Eye Movement Disorder High-Pitched Crying Maternal Drugs Affecting Foetus Neonatal Complications Of 22-Feb-2006 08:31 AM Page: 684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Substance Abuse Neonatal Disorder Premature Baby Psychomotor Hyperactivity Report Source Product Role Manufacturer Route Dose Duration Celexa PS Seroquil SS Cocaine C Date:05/19/03ISR Number: 4114987-8Report Type:Expedited (15-DaCompany Report #2003UW06070 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Vith Nerve Paralysis Consumer Seroquel PS ORAL 25 MG BID PO Intervention to Risperdal C Prevent Permanent Impairment/Damage Date:05/19/03ISR Number: 4115158-1Report Type:Expedited (15-DaCompany Report #2003GB01037 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Quetiapine Fumarate PS ORAL 25 MG BID PO Health Professional Other Date:05/19/03ISR Number: 4115187-8Report Type:Expedited (15-DaCompany Report #2003GB00631 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Foreign Seroquel PS Intervention to Memory Impairment Health Metformin C Prevent Permanent Mental Impairment Professional Lisinopril C Impairment/Damage Neglect Of Personal Other Lacidipine C Appearance Date:05/20/03ISR Number: 4114257-8Report Type:Expedited (15-DaCompany Report #2003AP01034 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS ORAL 100 MG QD PO Intervention to Constipation Study Seroquel SS ORAL 50 MG TID PO Prevent Permanent Diabetes Mellitus Health Seroquel SS ORAL 100 MG TID PO Impairment/Damage Drug Ineffective Professional Ms Poultice C Gastrointestinal Other Impromen C Hypomotility Serenace C Hypertension Akineton C Myofascitis Basen C Tinea Pedis Lexotan C Toothache Risperdal C Tegretol C Lendormin C Rohypnol C 22-Feb-2006 08:31 AM Page: 685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/03ISR Number: 4114258-XReport Type:Expedited (15-DaCompany Report #2003UW06180 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Health PO Prevent Permanent Professional Piportil C Impairment/Damage Other Levothyroxine C Benztropine C Ranitidine C Date:05/20/03ISR Number: 4115441-XReport Type:Expedited (15-DaCompany Report #2003UW06128 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel PS Intervention to Dysphagia Professional Serzone SS Prevent Permanent Dyspnoea Impairment/Damage Medication Error Paralysis Date:05/21/03ISR Number: 4114915-5Report Type:Direct Company Report #USP 50657 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Serzone PS Bristol-Myers Squibb Serzone SS Bristol-Myers Squibb Seroquel SS Zeneca Pharmaceuticals Seroquel SS Zeneca Pharmaceuticals Date:05/21/03ISR Number: 4115513-XReport Type:Expedited (15-DaCompany Report #2003UW06219 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Health Seroquel PS ORAL 300 MG PO Hospitalization - Atrioventricular Block Professional Initial or Prolonged Convulsion Hypotension Mental Status Changes Overdose Date:05/21/03ISR Number: 4115720-6Report Type:Expedited (15-DaCompany Report #2003UW02184 Age:47 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Health Seroquel PS ORAL 1500 MG DAILY Intervention to Professional PO Prevent Permanent Zyprexa C Impairment/Damage Unspecified C 22-Feb-2006 08:31 AM Page: 686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/03ISR Number: 4116117-5Report Type:Expedited (15-DaCompany Report #2003AP01846 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Seroquel PS ORAL 40 MG DAILY Hospitalization - Diabetes Mellitus Health PO Initial or Prolonged Pulmonary Oedema Professional Depakene C Vegetamin C Eurodin C Tinelac C Magnesium Oxide C Date:05/21/03ISR Number: 4116122-9Report Type:Expedited (15-DaCompany Report #2003SE02378 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Health PO Prevent Permanent Professional Impairment/Damage Date:05/21/03ISR Number: 4116201-6Report Type:Expedited (15-DaCompany Report #2003SE02331 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Foreign Seroquel PS ORAL 400 MG BID PO Initial or Prolonged Health Depakine C Professional Venlafaxine C Other Date:05/21/03ISR Number: 4116295-8Report Type:Expedited (15-DaCompany Report #2003GB00628 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Arthralgia Foreign Seroquel PS ORAL 200 MG BID PO Required Condition Aggravated Health Seroquel SS ORAL 100 MG DAILY Intervention to Feeling Abnormal Professional PO Prevent Permanent Myalgia Other Gliclazide C Impairment/Damage Tardive Dyskinesia Oxybutynin C Aspirin C Lansoprazole C Thyroxine C Date:05/21/03ISR Number: 4116298-3Report Type:Expedited (15-DaCompany Report #2003AP01598 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ileus Foreign Seroquel PS ORAL 25 MG TID PO Intervention to Study Seroquel SS ORAL 50 MG TID PO Prevent Permanent Health Seroquel SS ORAL 100 MG TID PO Impairment/Damage Professional Levotomin SS ORAL 85 MG DAILY Other PO Levotomin SS ORAL 200 MG DAILY PO Perospirone Hcl Hydrate C Tasmolin C Depakene C 22-Feb-2006 08:31 AM Page: 687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vegetamin C Benzalin C Lendormin C Forsenid C Laxoberon C Date:05/21/03ISR Number: 4117209-7Report Type:Direct Company Report #CTU 193597 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Seroquel, Initial or Prolonged Neuroleptic Malignant Astra-Zeneca PS Astra-Zeneca Syndrome Renal Failure Acute Rhabdomyolysis Date:05/22/03ISR Number: 4116412-XReport Type:Direct Company Report #USP 51166 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Serzone PS Bristol Myers Squibb Seroquel SS Zeneca Date:05/22/03ISR Number: 4116668-3Report Type:Expedited (15-DaCompany Report #2003SE02305 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Health PO Prevent Permanent Professional Haloperidol C Impairment/Damage Other Temesta C Date:05/22/03ISR Number: 4116669-5Report Type:Expedited (15-DaCompany Report #2003AP01834 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS ORAL 25 MG DAILY Health PO Professional Other Date:05/22/03ISR Number: 4117206-1Report Type:Direct Company Report #USP 51065 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Serzone PS Bristol-Myers Squibb TABLET Seroquel SS Zeneca TABLET Date:05/23/03ISR Number: 4116923-7Report Type:Expedited (15-DaCompany Report #2003UW06482 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional K Supplements C Vicodin C 22-Feb-2006 08:31 AM Page: 688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/03ISR Number: 4118603-0Report Type:Direct Company Report #USP 55843 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Quetiapine Fumarate PS Astra Zeneca Dysphagia Nefazodone SS Bristol Myers Dyspnoea Medication Error Movement Disorder Paralysis Date:05/23/03ISR Number: 4118614-5Report Type:Direct Company Report #USP 55855 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Serzone PS Bristol-Myers Squibb TABLET Medication Error Seroquel SS Astra Zeneca Pharmaceutical Product Complaint Somnolence Date:05/23/03ISR Number: 4118683-2Report Type:Direct Company Report #USP 55860 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Seroquel PS Astra Zeneca Date:05/27/03ISR Number: 4117844-6Report Type:Expedited (15-DaCompany Report #USA-2002-0001677 Age:41 YR Gender:Female I/FU:F Outcome PT Death Alopecia Hospitalization - Amnesia Initial or Prolonged Angiopathy Anxiety Arterial Occlusive Disease Arthralgia Asthma Atherosclerosis Back Pain Carpal Tunnel Syndrome Chest Pain Coma Condition Aggravated Depression Disturbance In Attention Drug Ineffective Emphysema Fatigue Femoral Bruit Finger Deformity Flushing Hilar Lymphadenopathy Hypoaesthesia Influenza Influenza Like Illness Insomnia Irritability 22-Feb-2006 08:31 AM Page: 689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Libido Decreased Memory Impairment Myalgia Report Source Product Role Manufacturer Route Dose Duration Nausea Consumer Oxycontin Tablets 10 Nervousness Health Mg(Oxycodone Night Sweats Professional Hydrochloride) Cr Overdose Other Tablet PS 10 MG, Pain Oxycontin Tablets 20 Pain In Extremity Mg(Oxycodone Paraesthesia Hydrochloride) Cr Peripheral Occlusive Tablet SS 20 MG, 1008 DAY Disease Hydrocodone Pneumonia Bitartrate (Similar Pulmonary Oedema To Ind 59,175) Pulse Absent (Hydrocodone Rash Pruritic Bitartrate) Unknown SS 1008 DAY Shock Alprazolam Somnolence (Alprazolam) SS 1008 DAY Toxicologic Test Abnormal Ephedrine Upper Respiratory Tract (Ephedrine) SS 1008 DAY Infection Pseudoephedrine Urinary Incontinence (Pseudoephedrine) SS 1008 DAY Weight Increased Effexor(Venlafaxine Hydrochloride) SS 75 MG, DAILY 1008 DAY Codeine (Codeine) SS 1008 DAY Neurontin(Gabapentin ) SS 100 MG, TID, 1008 DAY Metoclopramide(Metoc lopramide) SS 1008 DAY Quetiapine(Quetiapin e) SS 1008 DAY Claritin (Loratadine) C Vitamin C (Ascorbic Acid) C Celebrex (Celecoxib) C Prilosec (Omeprazole) C Daypro (Oxaprozin) C Trandate (Labetaolol Hydrochloride) C Axid (Nizatidine) C Paxil (Paroxetine Hydrochloride) C Medrol (Methylprednisolone) C Macro Antioxidant (Ascorbic Acid, Cystine, Tocopherol, Calcium Ascorbate, Betacarotene, C Zocor (Simvastatin) C Risperdal (Risperidone) C Fioricet (Butalbital) C Flonase (Fluticasone Propionate) C Phenobarbital (Phenobarbital) C Donnatal (Atropine 22-Feb-2006 08:31 AM Page: 690 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sulfate, Hyoscine Hydrobromide, Hyoscyamine Sulfate, Phenobarbital) C Bellergal-S (Belladonna Alkaloids, Ergotamine Tartrate, Phenobarbital) C Weight Loss Supplement (Does Not Code) C Ibuprofen C Ambien (Zolpidem Tartrate) C Baclofen (Baclofen) C Trandate (Labetatol Hydrochloride) C Celexa (Citalopram Hydrbromide) C Cortisone (Cortisone) C Atarax (Hydroxyzine Hydrochloride) C Proventil Tablet (Salbutamol Sulfate) C Amitriptyline (Amitriptyline) C Cyclobenzaprine (Cyclobenzaprine) C Augmentin (Amoxicillin Trihydrate, Clavulanate Potassium) C Ergobel (Nicergoline) C Date:05/27/03ISR Number: 4117927-0Report Type:Expedited (15-DaCompany Report #DEWYE137120MAY03 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Tavor (Lorazepam, Initial or Prolonged Phosphokinase Increased Health Tablet, 0) PS ORAL ORAL 1 DAY Overdose Professional Aurorix Somnolence (Moclobemide, ,0) SS ORAL ORAL 1 DAY Euphylong (Theophylline, ,0) SS ORAL ORAL 1 DAY Ibuprofen (Ibuprofen, ,0) SS ORAL ORAL 1 DAY Katadolon (Flupirtine Maleate, ,0) SS ORAL ORAL 1 DAY Oxycodone (Oxycodone, ,0) SS ORAL ORAL 1 DAY Seroquel (Quetiapine Fumarate, ,0) SS ORAL ORAL 1 DAY Taxilan (Perazine, ,0) SS ORAL ORAL 1 DAY 22-Feb-2006 08:31 AM Page: 691 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/03ISR Number: 4118298-6Report Type:Expedited (15-DaCompany Report #2003SE02399 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Health PO Prevent Permanent Professional Fluctine SS ORAL 20 MG DAILY Impairment/Damage Other PO Temesta SS ORAL 0.5 MG DAILY PO Supradyn SS 1 DF DAILY Date:05/27/03ISR Number: 4118302-5Report Type:Expedited (15-DaCompany Report #2002GB00282 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Seroquel "Zeneca" PS COMMENCED Hospitalization - Phosphokinase Increased Health WITH STARTER Initial or Prolonged Diabetes Mellitus Professional PACK Required Insulin-Dependent Other Risperidone C Intervention to Diabetic Ketoacidosis Cocaine C Prevent Permanent Drug Dependence Impairment/Damage Pulse Absent Restlessness Sleep Disorder Snoring Sudden Death Date:05/28/03ISR Number: 4117831-8Report Type:Direct Company Report #CTU 194107 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Halperidol(Haldol) PS INTRAMUSCULAR 5.0MG X1 IM Initial or Prolonged Phosphokinase Increased Quetiapine Muscle Rigidity (Seroquel) SS ORAL 50MG TID PO Neuroleptic Malignant Syndrome Pyrexia Date:05/28/03ISR Number: 4118426-2Report Type:Expedited (15-DaCompany Report #2003UW06490 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Professional Celebrex C Ibuprofen C Colace C Premarin C Medroxyprogesterone C Abacavir C Viracept C Epivir C Meclizine C Unspecified Hiv Clinical Trial Medications C 22-Feb-2006 08:31 AM Page: 692 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4119043-0Report Type:Expedited (15-DaCompany Report #2003GB01259 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Foreign Seroquel PS ORAL 350 MG DAILY Intervention to Condition Aggravated Health PO Prevent Permanent Mania Professional Seroquel SS ORAL 600 MG DAILY Impairment/Damage Restlessness Other PO Date:05/28/03ISR Number: 4119044-2Report Type:Expedited (15-DaCompany Report #2002UW13313 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Foreign Seroquel PS ORAL 300 MG DAILY Thromboplastin Time Health PO Prolonged Professional Seroquel SS ORAL 400 MG DAILY Leukopenia Other PO Platelet Count Decreased Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 600 MG HS PO Seroquel SS ORAL 500 MG DAILY PO Date:05/28/03ISR Number: 4119665-7Report Type:Expedited (15-DaCompany Report #2003UW06180 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Health PO Prevent Permanent Professional Piportil C Impairment/Damage Other Levothyroxine C Benztropine C Ranitidine C Date:05/29/03ISR Number: 4120044-7Report Type:Expedited (15-DaCompany Report #2003SE02288 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Disorder Foreign Seroquel PS ORAL 600 MG DAILY Neutropenia Health PO Professional Absenor C Other Date:05/29/03ISR Number: 4120416-0Report Type:Expedited (15-DaCompany Report #2003SE02450 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel PS ORAL 400 MG DAILY Intervention to Health PO Prevent Permanent Professional Impairment/Damage 22-Feb-2006 08:31 AM Page: 693 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4120419-6Report Type:Expedited (15-DaCompany Report #2003AP01834 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS ORAL 25 MG DAILY Health PO Professional Date:05/30/03ISR Number: 4120110-6Report Type:Expedited (15-DaCompany Report #B0300000A Age:17 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Paxil (Formulation Health Unknown) (Paroxetine Professional Hydrochloride) PS ORAL ORAL Quetiapine (Formulation Unknown) (Quetiapine) SS ORAL ORAL Date:05/30/03ISR Number: 4120626-2Report Type:Expedited (15-DaCompany Report #2003UW06820 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Sudden Death Professional Effexor C Date:05/30/03ISR Number: 4120632-8Report Type:Expedited (15-DaCompany Report #USA-2002-0001677 Age:41 YR Gender:Female I/FU:F Outcome PT Death Alopecia Hospitalization - Amnesia Initial or Prolonged Anxiety Apnoea Arthralgia Arthritis Atherosclerosis Back Pain Cardiac Arrest Cardiac Disorder Chest Pain Coma Condition Aggravated Depression Disturbance In Attention Drug Ineffective Emphysema Exfoliative Rash Fatigue Finger Deformity Flushing Hilar Lymphadenopathy Hyperventilation Hypoaesthesia Increased Tendency To Bruise Influenza Initial Insomnia 22-Feb-2006 08:31 AM Page: 694 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Irritability Libido Decreased Report Source Product Role Manufacturer Route Dose Duration Memory Impairment Consumer Oxycontin Tablets 10 Muscular Weakness Health Mg (Oxycodone Nausea Professional Hydrochloride) Cr Nervousness Other Tablet PS 10 MG Night Sweats Oxycontin Tablets 20 Overdose Mg (Oxycodone Pain Hydrochloride) Cr Pain In Extremity Tablet SS 20 MG 1008 DAY Paraesthesia Hydrocodone Peripheral Occlusive Bitartrate (Similar Disease To Ind 59,175) Pneumonia (Hydrocodone Portal Triaditis Bitartrate) SS 1008 DAY Pruritus Alprazolam Pulmonary Oedema (Alprazolam) SS 1008 DAY Rash Pruritic Ephedrine Shock (Ephedrine) SS 1008 DAY Somnolence Pseudoephedrine Upper Respiratory Tract (Pseudoephedrine) SS 1008 DAY Infection Effexor (Venlafaxine Urinary Incontinence Hydrochloride) SS 75 MG, DAILY 1008 DAY Weight Increased Codeine (Codeine) SS 1008 DAY Neurontin (Gabapentin) SS 100 MG, TID 1008 DAY Metoclopramide (Metoclopramide) SS 1008 DAY Quetiapine (Quetiapine) SS 1008 DAY Claritin (Loratadine) C Vitamin C (Ascorbic Acid) C Celebrex (Celecoxib) C Prilosec (Omeprazole) C Daypro (Oxaprozin) C Trandate (Labetalol Hydrochloride) C Axid (Nizatidine) C Paxil (Paroxetine Hydrochloride) C Medrol (Methylprednisolone) C Macro Antioxidant (Ascorbic Acid, Cystine, Tocopherol, Calcium Ascorbate, Betacarotene, C Zocor (Simvastatin) C Risperdal (Risperidone) C Fioricet (Butalbital) C Flonase (Fluticasone Propionate) C Phenobarbital (Phenobarbital) C Donnatal (Atropine 22-Feb-2006 08:31 AM Page: 695 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sulfate, Hyoscine Hydrobromide, Hyoscyamine Sulfate, Phenobarbital) C Bellergal-S (Belladonna Alkaloids, Ergotamine Tartrate, Phenobarbital) C Weight Loss Supplement (Does Not Code) C Ibuprofen C Ambien (Zolpidem Tartrate) C Baclofen (Baclofen) C Trandate (Labetalol Hydrochloride) C Celexa (Citalopram Hydrobromide) C Cortisone (Cortisone) C Atarax (Hydroxyzine Hydrochloride) C Proventil Tablet (Salbutamol Sulfate) C Amitriptyline (Amitriptyline) C Cyclobenzaprine (Cyclobenzaprine) C Augmentin (Amoxicillin Trihydrate, Clavulanate Potassium) C Ergobel (Nicergoline) C Date:05/30/03ISR Number: 4120873-XReport Type:Expedited (15-DaCompany Report #2003GB01281 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Seroquel PS Health Professional Other Date:05/30/03ISR Number: 4120874-1Report Type:Expedited (15-DaCompany Report #2003SE02268 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Seroquel PS ORAL 75 MG DAILY Lethargy Health PO Malaise Professional Mean Cell Volume Other 22-Feb-2006 08:31 AM Page: 696 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/03ISR Number: 4121206-5Report Type:Expedited (15-DaCompany Report #2003UW06180 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Health PO Prevent Permanent Professional Piportil C Impairment/Damage Other Levothyroxine C Benztropine C Ranitidine C Date:06/02/03ISR Number: 4121816-5Report Type:Direct Company Report #CTU 194511 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Olanzapine 7.5mg Qhs PS 7.5MG QHS Hospitalization - Blood Creatine Quetiapine 25mg One SS Initial or Prolonged Phosphokinase Increased Synthroid C Catatonia Neuroleptic Malignant Syndrome Pyrexia Tachycardia Date:06/02/03ISR Number: 4122196-1Report Type:Expedited (15-DaCompany Report #2003UW06687 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Seroquel PS ORAL 500 MG DAILY Death Professional PO Geodon C Date:06/02/03ISR Number: 4122347-9Report Type:Expedited (15-DaCompany Report #2003AP02031 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS 100-800 Intervention to Vision Blurred Health MG/DAY Prevent Permanent Visual Disturbance Professional Prothiaden SS LOW DOSE Impairment/Damage Other Phenergan "Aventis Pharma" SS Amisulpride C Date:06/02/03ISR Number: 4122348-0Report Type:Expedited (15-DaCompany Report #2003UW06705 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Foreign Seroquel PS ORAL 700 MG DAILY Hospitalization - Health PO Initial or Prolonged Professional Other 22-Feb-2006 08:31 AM Page: 697 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/03ISR Number: 4122349-2Report Type:Expedited (15-DaCompany Report #2003AP01846 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Acute Foreign Seroquel PS ORAL 200 MG BID PO Hospitalization - Convulsion Health Depakene C Initial or Prolonged Diabetes Mellitus Professional Vegetamin C Electrocardiogram Q Wave Other Eurodin C Abnormal Tinelac C Pneumonia Magnesium Oxide C Pulmonary Oedema Weight Increased Date:06/02/03ISR Number: 4122350-9Report Type:Expedited (15-DaCompany Report #2003SE02305 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Health PO Prevent Permanent Professional Haloperidol C Impairment/Damage Other Temesta C Date:06/02/03ISR Number: 4122545-4Report Type:Expedited (15-DaCompany Report #2003AP01803 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Seroquel PS ORAL 700 MG DAILY Sudden Death Health PO 6 MON Professional Clozaril SS 200 MG DAILY Other Date:06/02/03ISR Number: 4122548-XReport Type:Expedited (15-DaCompany Report #2003AP02031 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS DOSE: 100-800 Intervention to Vision Blurred Health MG/DAY Prevent Permanent Visual Disturbance Professional Prothiaden SS LOW DOSE Impairment/Damage Other Phenergan "Aventis Pharma" SS Aventis Pharma Amisulpride C Date:06/02/03ISR Number: 4122550-8Report Type:Expedited (15-DaCompany Report #2003UW06705 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Foreign Seroquel PS ORAL 700 MG DAILY Hospitalization - Health PO Initial or Prolonged Professional Other Date:06/02/03ISR Number: 4122551-XReport Type:Expedited (15-DaCompany Report #2003AP01846 Age:60 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:31 AM Page: 698 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Failure Acute Foreign Seroquel PS ORAL 200 MG BID PO Chest Pain Health Depakene C Communication Disorder Professional Vegetamin C Convulsion Other Eurodin C Cyanosis Tinelac C Diabetes Mellitus Magnesium Oxide C Electrocardiogram Q Wave Abnormal Oxygen Saturation Decreased Pneumonia Pulmonary Oedema Weight Decreased Date:06/02/03ISR Number: 4122554-5Report Type:Expedited (15-DaCompany Report #2003SE02305 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Health PO Prevent Permanent Professional Haloperidol C Impairment/Damage Other Temesta C Date:06/02/03ISR Number: 4122566-1Report Type:Expedited (15-DaCompany Report #2003AP01803 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Seroquel PS ORAL 700 MG DAILY Sudden Death Health PO 6 MON Professional Clozaril SS 200 MG DAILY Other Date:06/03/03ISR Number: 4122985-3Report Type:Expedited (15-DaCompany Report #2003UW05648 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Seroquel PS ORAL 200 MG HS PO Agitation Professional Seroquel SS ORAL 450 MG DAILY Anxiety PO Death Seroquel SS ORAL 500 MG DAILY Hallucination PO Sudden Death Seroquel SS ORAL 550 MG DAILY PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 700 MG DAILY PO Depakote C Risperdal C Klonopin C Cogentin C 22-Feb-2006 08:31 AM Page: 699 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/03ISR Number: 4123104-XReport Type:Expedited (15-DaCompany Report #2003UW06863 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Health Seroquel PS Intervention to Musculoskeletal Stiffness Professional Prevent Permanent Impairment/Damage Date:06/03/03ISR Number: 4123466-3Report Type:Expedited (15-DaCompany Report #2002AP01726 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS ORAL 400 MG DAILY Disability Aspartate Health PO Required Aminotransferase Professional Symmetrel C Intervention to Coma Other Amoxan C Prevent Permanent Condition Aggravated Silece C Impairment/Damage Depressed Level Of Adalat L C Consciousness Magnesium Oxide C Drug Withdrawal Syndrome Alosenn C Hepatic Function Abnormal Hyperhidrosis Hypokalaemia Muscle Rigidity Nausea Pancytopenia Pyrexia Vomiting Date:06/03/03ISR Number: 4123572-3Report Type:Expedited (15-DaCompany Report #2003GB01346 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Foreign Seroquel PS Weight Increased Health Olanzapine C Professional Other Date:06/03/03ISR Number: 4124212-XReport Type:Expedited (15-DaCompany Report #2003GB00717 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dysphagia Foreign Seroquel PS ORAL 750 MG DAILY Hypersensitivity Health PO Oropharyngeal Swelling Professional Cipramil C Sensory Disturbance Other Risperidone C Swollen Tongue Sodium Valproate C Zopiclone C Lorazepam C Date:06/03/03ISR Number: 4124461-0Report Type:Expedited (15-DaCompany Report #2003GB01280 Age:45 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 700 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Rash Vesicular Foreign Seroquel PS ORAL 25 MG TID PO Health Zopiclone C Professional Other Date:06/04/03ISR Number: 4122380-7Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0410574A Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Eskalith PS Glaxosmithkline 2 DAY Initial or Prolonged Mania Seroquel SS 206 DAY Other Mydriasis Prolixin SS Swelling Face Date:06/04/03ISR Number: 4124148-4Report Type:Expedited (15-DaCompany Report #2003GB01276 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Blindness Foreign Quetiapine PS 400 MG DAILY Required Cardiac Murmur Health TPL Intervention to Coloboma Professional Magnesium Sulphate C Prevent Permanent Eye Disorder Other Impairment/Damage Maternal Drugs Affecting Foetus Premature Baby Date:06/04/03ISR Number: 4124801-2Report Type:Expedited (15-DaCompany Report #2003UW06629 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Health Seroquel PS ORAL 400 MG HS PO Initial or Prolonged Incoherent Professional Ativan C Leukopenia Cogentin C Celexa C Neurontin C Date:06/05/03ISR Number: 4123737-0Report Type:Direct Company Report #CTU 195050 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Risperdal 1 Mg Medication Error Janssen PS Janssen ORAL 1MG BEDTIME Mental Impairment ORAL Pharmaceutical Product Seroquel 25 Mg Complaint Astrazeneca SS Astrazeneca ORAL 25MG BEDTIME ORAL Date:06/05/03ISR Number: 4123748-5Report 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 Seroquel Zeneca PS Zeneca ORAL 175MG BID PO Serzone 22-Feb-2006 08:31 AM Page: 701 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bristol-Myers Squibb SS Bristol-Myers Squibb ORAL 175MG BID PO Date:06/05/03ISR Number: 4123932-0Report Type:Direct Company Report #CTU 195099 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Quetiapine 25mg PS ORAL 25MG PO BID Date:06/05/03ISR Number: 4125343-0Report Type:Expedited (15-DaCompany Report #2003GB01168 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Foreign Seroquel PS ORAL 400 MG BID PO Intervention to Confusional State Health Seroquel SS ORAL 25 MG DAILY Prevent Permanent Drug Withdrawal Syndrome Professional PO Impairment/Damage Fear Other Metformin C Malaise Ferrous Sulphate C Social Avoidant Behaviour Folic Acid C Speech Disorder Aspirin C Weight Decreased Finasteride C Sinemet C Sodium Valproate C Alfusozin C Date:06/06/03ISR Number: 4125727-0Report Type:Expedited (15-DaCompany Report #2003UW06905 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemodynamic Instability Health Seroquel PS Initial or Prolonged Professional Pseudoephedrine C Date:06/09/03ISR Number: 4126368-1Report Type:Expedited (15-DaCompany Report #2003AP01846 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Acute Foreign Seroquel PS 200 MG BID PO Hospitalization - Chest Pain Health Depakene C Initial or Prolonged Communication Disorder Professional Vegetamin C Convulsion Other Eurodin C Cyanosis Tinelac C Dyspnoea Magnesium Oxide C Electrocardiogram Q Wave Abnormal Hyperglycaemia Loss Of Consciousness Oxygen Saturation Decreased Pneumonia Polydipsia Post Gastric Surgery Syndrome Pulmonary Oedema Somnolence Weight Fluctuation 22-Feb-2006 08:31 AM Page: 702 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/03ISR Number: 4126369-3Report Type:Expedited (15-DaCompany Report #2003GB01364 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bradycardia Foreign Quetiapine PS 25 MG BID PO Intervention to Circulatory Collapse Health Olanzapine SS 20 MG QD PO Prevent Permanent Hypotonia Professional Lansoprazole C Impairment/Damage Other Lorazepam C Finasteride C Date:06/09/03ISR Number: 4126370-XReport Type:Expedited (15-DaCompany Report #2003AP01846 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Acute Foreign Seroquel PS 200 MG BID PO Hospitalization - Chest Pain Health Depakene C Initial or Prolonged Communication Disorder Professional Vegetamin C Convulsion Other Eurodin C Cyanosis Tinelac C Dyspnoea Magnesium Oxide C Hyperglycaemia Loss Of Consciousness Oxygen Saturation Decreased Pneumonia Polydipsia Post Gastric Surgery Syndrome Pulmonary Oedema Somnolence Weight Fluctuation Date:06/09/03ISR Number: 4126515-1Report Type:Expedited (15-DaCompany Report #2003GB01364 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bradycardia Foreign Quetiapine PS ORAL 25 MG BID PO Intervention to Circulatory Collapse Health Olanzapine SS ORAL 20 MG QD PO Prevent Permanent Hypotonia Professional Lansoprazole C Impairment/Damage Other Lorazepam C Finasteride C Date:06/10/03ISR Number: 4126615-6Report Type:Expedited (15-DaCompany Report #2003AP02113 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Increased Health PO Aspartate Professional Myslee C Aminotransferase Other Cerocral C Increased Aricept C Blood Bilirubin Increased Gamma-Glutamyltransferase Increased Jaundice Liver Disorder 22-Feb-2006 08:31 AM Page: 703 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/03ISR Number: 4127181-1Report Type:Direct Company Report #CTU 195552 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Seroquel PS ORAL ORAL Syndrome Sertraline SS ORAL ORAL Date:06/11/03ISR Number: 4128108-9Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20030600012 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Foreign Risperdal Health (Risperidone) Professional Tablets PS ORAL 3 MG, ORAL Seroquel (Quetiapine Fumarate) Tablets SS ORAL 100 MG, ORAL Date:06/11/03ISR Number: 4128500-2Report Type:Expedited (15-DaCompany Report #2003SE02600 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Facial Palsy Foreign Seroquel PS Intervention to Health Risperdal SS Prevent Permanent Professional Impairment/Damage Other Date:06/11/03ISR Number: 4164683-6Report Type:Periodic Company Report #2002-07-0777 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Theo-Dur Initial or Prolonged Confusional State Professional (Theophylline) Convulsion Other Extended Release Tablet PS ORAL 200 MG BID ORAL Seroquel (Quetiapine Fumurate) Tablets SS ORAL UNKNOWN ORAL Risperdal SS UNKNOWN Ambien (Zolpidem Tartrate) SS ORAL 10 MG QD ORAL Serevent Inhalation Aerosol 1 Puff Bid Inhalation C Date:06/12/03ISR Number: 4129147-4Report Type:Expedited (15-DaCompany Report #2003UW07329 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Date:06/13/03ISR Number: 4129576-9Report Type:Expedited (15-DaCompany Report #2003GB01453 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Other Platelet Count Decreased Foreign Health 22-Feb-2006 08:31 AM Page: 704 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 100 MG DAILY PO Date:06/13/03ISR Number: 4129665-9Report Type:Expedited (15-DaCompany Report #2003GB01446 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Foreign Seroquel PS ORAL 300 MG BID PO Initial or Prolonged Dizziness Health Drug Withdrawal Syndrome Professional Loss Of Consciousness Other Treatment Noncompliance Date:06/13/03ISR Number: 4129866-XReport Type:Expedited (15-DaCompany Report #2003UW06820 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Effexor C Risperdal C Lexapro C Trileptal C Date:06/13/03ISR Number: 4129868-3Report Type:Expedited (15-DaCompany Report #2003UW06687 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Seroquel PS ORAL 500 MG DAILY Overdose Professional PO Geodon C Date:06/16/03ISR Number: 4130791-9Report Type:Expedited (15-DaCompany Report #2003UW07313 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS ORAL 100 MG PO Professional Date:06/17/03ISR Number: 4130560-XReport Type:Direct Company Report #CTU 196019 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphemia Seroquel 200mg - Initial or Prolonged Astra-Zeneca PS Astra-Zeneca ORAL 400MG PO HS Date:06/17/03ISR Number: 4131402-9Report Type:Expedited (15-DaCompany Report #2003UW06128 Age:57 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged Other 22-Feb-2006 08:31 AM Page: 705 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Convulsion Health Seroquel PS Dysphagia Professional Serzone SS Dyspnoea Medication Error Paralysis Date:06/17/03ISR Number: 4131601-6Report Type:Expedited (15-DaCompany Report #2003024145 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Medication Error Health Geodon (Ziprasidone) PS Hospitalization - Pyrexia Professional Clozapine Initial or Prolonged Rhabdomyolysis (Clozapine) SS ORAL 400 MG (BID), Other ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS Risperidone (Risperidone) SS Sertraline Hydrochloride (Sertraline Hydrochloride) C Oxcarbazepine (Oxcarbazepine) C Bisacodyl (Bisacodyl) C Trazodone Hydrochloride (Trazodone Hydrochloride) C Hydroxyzine Embonate (Hydroxyzine Embonate) C Fluphenazine Decanoate (Fluphenazine Decanoate) C Date:06/17/03ISR Number: 4131693-4Report Type:Expedited (15-DaCompany Report #HQWYE570111JUN03 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Maternal Drugs Affecting Health Effexor Xr Initial or Prolonged Foetus Professional (Venlfaxine Neonatal Disorder Hydrochloride, Pulmonary Oedema Neonatal Capsule, Extended Release) PS TRANSPLACENTAL 300 MG 1X PER 1 DAY, TRANSPLACENTA L; 450 MG 1X PER 1 DAY, Seroquel (Quetiapine, ) SS TRANSPLACENTAL 300 MG 1X PER 1 DAY, TRANSPLACENTA 22-Feb-2006 08:31 AM Page: 706 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report L; DISCONTINUED Date:06/17/03ISR Number: 4131799-XReport Type:Expedited (15-DaCompany Report #2002SE06232 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Seroquel PS ORAL 200 MG BID PO White Blood Cell Count Health Alvityl C Increased Professional Etumine C Other Floxyfral C Stilnoct C Trazolan C Date:06/17/03ISR Number: 4132031-3Report Type:Expedited (15-DaCompany Report #03P-163-0221213-00 Age:67 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Verapamil (Isoptin) Medication Error Health (Verapamil) Professional (Verapamil) PS ORAL PER ORAL Quetiapine SS ORAL PER ORAL Date:06/18/03ISR Number: 4132241-5Report Type:Expedited (15-DaCompany Report #2003UW06687 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Seroquel PS 300 MG DAILY Overdose Professional PO Seroquel SS 500 MG DAILY PO Heroin SS Geodon C Date:06/19/03ISR Number: 4132847-3Report Type:Expedited (15-DaCompany Report #2003UW06705 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Ineffective Foreign Seroquel PS ORAL 700 MG DAILY Hospitalization - Leukopenia Health PO Initial or Prolonged Professional Medroxyprogesterone C Required Other Estradiol C Intervention to Amoxicillin C Prevent Permanent Haldol C Impairment/Damage Ativan C Trazodone C Benztropine C Date:06/19/03ISR Number: 4132852-7Report Type:Expedited (15-DaCompany Report #2003GB01468 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 150 MG BID PO Syncope Health Seroquel SS ORAL 100 MG BID PO Professional Other 22-Feb-2006 08:31 AM Page: 707 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/03ISR Number: 4133113-2Report Type:Expedited (15-DaCompany Report #2003UW02480 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Health Seroquel PS ORAL 300 MG BID PO Intervention to Complications Of Maternal Professional Wellbutrin - Slow Prevent Permanent Exposure To Therapeutic Release C Impairment/Damage Drugs Maternal Drugs Affecting Foetus Pregnancy Date:06/19/03ISR Number: 4133254-XReport Type:Expedited (15-DaCompany Report #2003AP02172 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Deep Vein Thrombosis Foreign Seroquel PS Intervention to Pulmonary Embolism Health Prevent Permanent Professional Impairment/Damage Other Date:06/19/03ISR Number: 4133259-9Report Type:Expedited (15-DaCompany Report #2003AP01774 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Seroquel PS ORAL 25 MG DAILY; Initial or Prolonged Increased Study PO Blood Creatine Health Seroquel SS ORAL 25 MG BID; Phosphokinase Increased Professional ORAL Condition Aggravated Other Seroquel SS ORAL 75 MG DAILY; Faecal Incontinence PO Thinking Abnormal Seroquel SS ORAL 50 MG BID; PO Urinary Incontinence Seroquel SS ORAL 150 MG DAILY; PO Seroquel SS ORAL 100 MG BID; PO Seroquel SS ORAL 100 MG TID; PO Seroquel SS ORAL 125 MG TID; PO Seroquel SS ORAL 475 MG DAILY; PO Seroquel SS ORAL 125 MG QID; PO Seroquel SS ORAL 200 MG TID; PO Seroquel SS ORAL 700 MG DAILY; PO Seroquel SS ORAL 750 MG DAILY; PO Seroquel SS ORAL 700 MG DAILY; PO Seroquel SS ORAL 150 MG QID; PO Seroquel SS ORAL 500 MG DAILY; PO Seroquel SS ORAL 100 MG QID; PO Seroquel SS ORAL 300 MG DAILY; PO 22-Feb-2006 08:31 AM Page: 708 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS ORAL 100 MG BID; PO Seroquel SS NI Tolopelon SS ORAL 21 MG DAILY; PO Tolopelon SS UNKNOWN 18 DAILY; UNK Tolopelon SS ORAL 15 MG DAILY; PO Tolopelon SS ORAL 12 MG DAILY; PO Tolopelon SS ORAL 9 MG DAILY; PO Tolopelon SS ORAL 6 MG DAILY; PO Tolopelon SS ORAL 3 MG DAILY; PO Tolopelon SS ORAL 1 MG DAILY; PO Akineton C Levotomin C Benzalin C Rohypnol C Risperdal C Date:06/19/03ISR Number: 4133462-8Report Type:Expedited (15-DaCompany Report #2003UW07589 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS Decreased Professional Date:06/23/03ISR Number: 4134250-9Report Type:Direct Company Report #CTU 196345 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Seroquel 100 Mg Astra/Zeneca PS Astra/Zeneca ORAL 100 MG 3 X /DAY ORAL Date:06/23/03ISR Number: 4134282-0Report Type:Expedited (15-DaCompany Report #2003UW07382 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoeic Attack Other Seroquel PS 100 MG BID Initial or Prolonged Coma Lithium C Medication Error Ambien C Lithobid C Date:06/23/03ISR Number: 4134333-3Report Type:Direct Company Report #CTU 196369 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Parnate-Tranylcyprom Syndrome ine Glaxosmithkline PS Glaxosmithkline Seroquel-Quetiapine- Astrazeneca SS Astrazeneca 22-Feb-2006 08:31 AM Page: 709 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/03ISR Number: 4134674-XReport Type:Expedited (15-DaCompany Report #2003GB01459 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 50 MG QD PO Health Propanolol C Professional Lormetazepam C Other Venlafaxine C Date:06/23/03ISR Number: 4134800-2Report Type:Expedited (15-DaCompany Report #2003GB01174 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Foreign Seroquel PS ORAL 400 MG BID PO Interference Health Neutropenia Professional Therapeutic Response Other Decreased Date:06/24/03ISR Number: 4135864-2Report Type:Expedited (15-DaCompany Report #2003UW04998 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Seroquel PS ORAL 500 MG DAILY Life-Threatening Coma Professional PO Hospitalization - Laboratory Test Abnormal Haldol C Initial or Prolonged Respiratory Arrest Cogentin C Klonopin C Lithium C Date:06/25/03ISR Number: 4136529-3Report Type:Expedited (15-DaCompany Report #2003AP02281 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Foreign Seroquel PS ORAL 50 MG BID PO Intervention to Increased Study Seroquel SS ORAL 50 MG TID PO Prevent Permanent Condition Aggravated Health Seroquel SS Impairment/Damage Nasopharyngitis Professional Tamsolin C Psychiatric Symptom Other Lendormin C Stress Silece C Risperdal C Wypax C Impromen C Contomin C Trihexyphenidyl Hydrochloride C Date:06/25/03ISR Number: 4136530-XReport Type:Expedited (15-DaCompany Report #2003SE02853 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tongue Oedema Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Urticaria Health PO Prevent Permanent Professional Zyprexa C Impairment/Damage Other Femoden C 22-Feb-2006 08:31 AM Page: 710 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/03ISR Number: 4137016-9Report Type:Expedited (15-DaCompany Report #2003AP01539 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Flatulence Foreign Seroquel PS ORAL SEE IMAGE Initial or Prolonged Ileus Health Tolopelon SS ORAL 8 MG DAILY Professional Aleviatin SS 60 MG DAILY Tremin SS 3 MG DAILY Miradol SS 600 MG DAILY Stomilase C Pantosin C Magnesium Oxide C Cystanin C Date:06/26/03ISR Number: 4137020-0Report Type:Expedited (15-DaCompany Report #2003AP02246 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Foreign Seroquel PS ORAL 100 MG DAILY Hospitalization - Aseptic Necrosis Bone Health PO Initial or Prolonged Blood Glucose Decreased Professional Limas C Blood Glucose Increased Other Prednisolone C Depressed Level Of Rivotril C Consciousness Depakene C Dizziness Postural Eukodin C Drug Withdrawal Syndrome Bufferin C Hyperinsulinaemia Gaster C Hypoglycaemia Lipitor C Hypothyroidism Basen C Mania Humalog C Weight Decreased Aldactone C Lasix C Date:06/26/03ISR Number: 4137090-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030601235 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Risperidone Blood Lactate Health (Risperidone) Dehydrogenase Professional Tablets PS ORAL 8 MG, 1 IN 1 Hepatocellular Damage DAY, ORAL Pyrexia Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL 300 MG, 1 IN 1 DAY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Vegetamin A (Vegetamin A) C Sennoside (All Other Therapeutic Products) C Flunitrazepam (Plunitrazepam) C Haloperidol (Haloperidol) C Chlorpromazine Hydrochloride 22-Feb-2006 08:31 AM Page: 711 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Chlorpromazine Hyderochloride) C Date:06/26/03ISR Number: 4137411-8Report Type:Expedited (15-DaCompany Report #2003UW07657 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Consumer Seroquel PS Syndrome Other Parnate SS Date:06/26/03ISR Number: 4137515-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601813 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Study Risperidone Initial or Prolonged Aspartate Health (Risperidone) Aminotransferase Professional Unspecified PS Blood Alkaline Perphenazine Phosphatase (Perphenazine) SS Blood Bicarbonate Olanzapine Blood Calcium (Olanzapine) SS Blood Chloride Quetiapine Blood Creatine (Quetiapine) SS Phosphokinase Ziprasidone Blood Creatine (Ziprasidone) SS Phosphokinase Mb Clonazepam () Blood Creatinine Clonazepam C Blood Glucose Mirtazapine () Blood Magnesium Mirtazapine C Blood Ph Increased Catopril () Blood Potassium Captopril C Blood Sodium Glipizide () Dyspnoea Glipizide C Electrocardiogram T Wave Abnormal Glucose Urine Present Haemoglobin Mental Disorder Oxygen Saturation Decreased Pco2 Po2 Protein Total Pulmonary Congestion Pulmonary Vascular Disorder Red Blood Cells Urine Positive Sinus Tachycardia Thirst Urine Ketone Body Present White Blood Cells Urine Positive 22-Feb-2006 08:31 AM Page: 712 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/03ISR Number: 4138111-0Report Type:Expedited (15-DaCompany Report #2003UW07882 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Complications Of Maternal Health PO Prevent Permanent Exposure To Therapeutic Professional Lithium C Impairment/Damage Drugs Other Effexor C Drug Exposure During Pregnancy Pregnancy Date:06/27/03ISR Number: 4138688-5Report Type:Expedited (15-DaCompany Report #03P-062-0222060-00 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Akineton (Biperiden) Initial or Prolonged Intentional Overdose Health (Biperiden) PS ORAL 2 MG, 6 Required Somnolence Professional TABLETS AT Intervention to Suicide Attempt ONCE, PER Prevent Permanent ORAL Impairment/Damage Quetiapine SS ORAL 1875 MG, AT ONCE, PER ORAL Diazepam SS ORAL 90 MG, AT ONCE, PER ORAL Date:06/27/03ISR Number: 4138747-7Report Type:Expedited (15-DaCompany Report #2003UW06687 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Seroquel PS ORAL 300 MG DAILY Circulatory Collapse Professional PO Overdose Seroquel SS ORAL 500 MG DAILY PO Geodon C Date:06/27/03ISR Number: 4138995-6Report Type:Expedited (15-DaCompany Report #2003AP01846 Age:60 YR Gender:Male I/FU:F Outcome PT Life-Threatening Cardiac Failure Acute Hospitalization - Chest Pain Initial or Prolonged Chest X-Ray Abnormal Communication Disorder Convulsion Cyanosis Dyspnoea Electrocardiogram Q Wave Abnormal Electroencephalogram Abnormal Gaze Palsy Hyperglycaemia Hyponatraemia Loss Of Consciousness Pneumonia Po2 Decreased 22-Feb-2006 08:31 AM Page: 713 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Post Gastric Surgery Syndrome Pulmonary Oedema Report Source Product Role Manufacturer Route Dose Duration Shock Foreign Seroquel PS ORAL 200 MG BID PO Somnolence Health Depakene C Sputum Abnormal Professional Vegetamin C Sputum Discoloured Other Eurodin C Water Intoxication Tinelac C Weight Fluctuation Magnesium Oxide C Date:06/27/03ISR Number: 4138996-8Report Type:Expedited (15-DaCompany Report #2003GB01346 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Foreign Seroquel PS Sudden Death Health Seroquel SS ORAL 200 MG DAILY Weight Increased Professional PO Other Olanzapine C Date:06/30/03ISR Number: 4138273-5Report 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 Seroquel Zeneca PS Zeneca ORAL 175MG BID PO Serzone Bristol-Myers Squibb SS Bristol-Myers Squibb ORAL 175MG BID PO Date:06/30/03ISR Number: 4139293-7Report Type:Expedited (15-DaCompany Report #2003GB00726 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Seroquel PS Drug Level Above Health Citalopram SS Therapeutic Professional Anusol C Hepatic Congestion Other Lactulose C Overdose Pulmonary Alveolar Haemorrhage Pulmonary Congestion Pulmonary Oedema Renal Disorder Date:06/30/03ISR Number: 4139467-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anorexia Initial or Prolonged Blood Creatine Phosphokinase Increased Blood Pressure Increased Condition Aggravated Delusion Diabetes Mellitus Hallucination Hypoventilation 22-Feb-2006 08:31 AM Page: 714 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Respiratory Distress Schizophrenia Report Source Product Role Manufacturer Route Dose Duration Foreign Haldol (Haloperidol Health Decanoate) Professional Unspecified PS ORAL 10.5 MG, 1 IN 1 DAY, ORAL Risperdal (Risperidone) Tablets SS ORAL SEE IMAGE Quetiapine Fumarate (Quetiapine Fumarate) Tablets SS ORAL 600 MG, 1 IN 1 DAY, ORAL Hydroxyzine Pamoate (Hydroxyzine Embonate) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:06/30/03ISR Number: 4139475-4Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Haldol (Haloperidol Initial or Prolonged Blood Creatine Health Decanoate) PS ORAL 10.5 MG, 1 IN Phosphokinase Increased Professional 1 DAY, ORAL Blood Pressure Increased Risperidal Condition Aggravated (Risperidone) Delusion Tablets SS ORAL SEE IMAGE, Diabetes Mellitus ORAL Hallucination Quetiapine Fumarate Hypoventilation (Quetiapine Insomnia Fumarate) Tablets SS ORAL 600 MG, 1 IN Oxygen Saturation 1 DAY, ORAL Decreased Hydroxyzine Pamoate Respiratory Distress (Hydroxyzine Schizophrenia Embonate) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:06/30/03ISR Number: 4139500-0Report Type:Expedited (15-DaCompany Report #2003UW07563 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Professional 22-Feb-2006 08:31 AM Page: 715 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/03ISR Number: 4139504-8Report Type:Expedited (15-DaCompany Report #2003UW07792 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Health Seroquel PS Intervention to Abnormal Professional Zoloft C Prevent Permanent Electrocardiogram Qrs Neurontin C Impairment/Damage Complex Prolonged Date:06/30/03ISR Number: 4139528-0Report Type:Expedited (15-DaCompany Report #2003UW07749 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Overdose Professional Seroquel SS ORAL 10000 MG ONCE PO Date:07/01/03ISR Number: 4138562-4Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0411363A Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bilirubin Conjugated Other Parnate PS Glaxosmithkline ORAL 10MG Three Increased times per day Blood Creatine Seroquel SS Phosphokinase Increased Cardiac Arrest Cardiomegaly Cough Feeling Abnormal Heart Rate Increased Hyperhidrosis Hyperventilation Hypoglycaemia Leukocytosis Neuroleptic Malignant Syndrome Pyrexia Tachycardia Tremor Ventricular Hypertrophy Date:07/01/03ISR Number: 4139863-6Report Type:Direct Company Report #CTU 197068 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Status Epilepticus Seroquel PS 25MG BID Initial or Prolonged Tegretol (Carbatrol) C Date:07/01/03ISR Number: 4140024-5Report Type:Direct Company Report #CTU 197022 Age:56 YR Gender:Male I/FU:I Outcome PT Death Blood Pressure Increased Hospitalization - Cardiac Arrest Initial or Prolonged Chills Decreased Activity Dyspnoea Haematemesis 22-Feb-2006 08:31 AM Page: 716 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucinations, Mixed Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Pneumonia Aspiration Risperidone PS RISPERIDONE Tachypnoea 0.5 BID Quetiapine SS QUETIAPINE 25 MG QHS Lexapro C Quinine Sulfate C Date:07/01/03ISR Number: 4140519-4Report Type:Expedited (15-DaCompany Report #2003UW05648 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Seroquel PS ORAL 200 MG HS PO Aggression Professional Seroquel SS ORAL 450 MG DAILY Agitation PO Anxiety Seroquel SS ORAL 500 MG DAILY Coma PO Drooling Seroquel SS ORAL 550 MG DAILY Drug Screen Positive PO Drug Toxicity Seroquel SS ORAL 600 MG DAILY Pulmonary Congestion PO Pulmonary Oedema Seroquel SS ORAL 700 MG DAILY Somnolence PO Depakote C Risperdal C Klonopin C Congentin C Date:07/01/03ISR Number: 4140580-7Report Type:Expedited (15-DaCompany Report #2003UW07801 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Renal Failure Acute Health Seroquel PS Intervention to Rhabdomyolysis Professional Prevent Permanent Impairment/Damage Date:07/01/03ISR Number: 4140684-9Report Type:Expedited (15-DaCompany Report #2002GB01951 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS ORAL 700 MG DAILY Sudden Death Health PO Professional Clopixol Other (Hydrochloride) C Haloperidol C Nitrazepam C Procyclidine C Al-Calcidol C 22-Feb-2006 08:31 AM Page: 717 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/03ISR Number: 4140955-6Report Type:Expedited (15-DaCompany Report #2003AP00257 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 50 MG BID PO Initial or Prolonged Fall Study Contomin SS ORAL 25 MG, DAILY, Disability Fracture Health PO Required Hip Arthroplasty Professional Rohypnol C Intervention to Orthostatic Hypotension Other Artane C Prevent Permanent Tinea Pedis Doral C Impairment/Damage Griseofulvin C Date:07/01/03ISR Number: 4140956-8Report Type:Expedited (15-DaCompany Report #2003GB01240 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Foreign Seroquel PS ORAL 400 MG DAILY Intervention to Complications Of Maternal Health PO Prevent Permanent Exposure To Therapeutic Professional Impairment/Damage Drugs Other Drug Exposure During Pregnancy Pregnancy Date:07/01/03ISR Number: 4140957-XReport Type:Expedited (15-DaCompany Report #2003GB00992 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Seroquel PS ORAL 50 MG ONCE PO Hypotension Health Fluoxetine C Road Traffic Accident Professional Risperidone C Other Date:07/01/03ISR Number: 4141012-5Report Type:Expedited (15-DaCompany Report #2003AP02246 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperinsulinaemia Foreign Seroquel PS ORAL 100 MG DAILY Hospitalization - Hypoglycaemia Health PO Initial or Prolonged Hypothyroidism Professional Limas C Other Prednisolone C Rivotril C Depakene C Eurodin C Bufferin C Gaster C Lipitor C Basen C Humalog C Aldactone C Lasix C Date:07/02/03ISR Number: 4141585-2Report Type:Expedited (15-DaCompany Report #2003SE02712 Age:12 YR Gender:Male I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 718 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Foreign Seroquel PS 62.5 MG DAILY Breast Pain Health PO Professional Other Date:07/02/03ISR Number: 4141588-8Report Type:Expedited (15-DaCompany Report #2003GB01547 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dysphagia Foreign Seroquel PS Intervention to Dyspnoea Health Prevent Permanent Hypersensitivity Professional Impairment/Damage Localised Oedema Other Throat Tightness Date:07/03/03ISR Number: 4141985-0Report Type:Expedited (15-DaCompany Report #2003UW08028 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Health Seroquel PS ORAL 400 MG QD PO Initial or Prolonged Sedation Professional Depakote C Thrombocytopenia Date:07/03/03ISR Number: 4142129-1Report Type:Expedited (15-DaCompany Report #2003GB01637 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS ORAL 450 MG DAILY Intervention to Pneumonia Health PO Prevent Permanent Postoperative Infection Professional Impairment/Damage Other Date:07/03/03ISR Number: 4142914-6Report Type:Expedited (15-DaCompany Report #2003UW08137 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel PS Initial or Prolonged Hypotension Professional Overdose Date:07/03/03ISR Number: 4143065-7Report Type:Expedited (15-DaCompany Report #2003UW08175 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Health Seroquel PS Professional 22-Feb-2006 08:31 AM Page: 719 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/03ISR Number: 4143068-2Report Type:Expedited (15-DaCompany Report #2003UW08324 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Seroquel PS Sudden Death Professional Date:07/07/03ISR Number: 4144218-4Report Type:Expedited (15-DaCompany Report #2003UW06629 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Health Seroquel PS ORAL 400 MG HS PO Initial or Prolonged Incoherent Professional Ativan C Leukopenia Cogentin C Neutropenia Celexa C Date:07/07/03ISR Number: 4144220-2Report Type:Expedited (15-DaCompany Report #2003UW02574 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Marrow Hyperplasia Health Seroquel PS ORAL 50 MG DAIY PO Initial or Prolonged Pancytopenia Professional Lithium Carbonate C Required Thioridazine C Intervention to Alendrnate C Prevent Permanent Primidone C Impairment/Damage Terazosin C Date:07/07/03ISR Number: 4144223-8Report Type:Expedited (15-DaCompany Report #2003UW08176 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Syndrome Professional PO Date:07/07/03ISR Number: 4144409-2Report Type:Expedited (15-DaCompany Report #2003GB01653 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Musculoskeletal Stiffness Foreign Seroquel PS ORAL 300 MG BID PO Intervention to Overdose Health Seroquel SS ORAL 45 DF ONCE PO Prevent Permanent Sedation Professional Fluoxetine C Impairment/Damage Other Date:07/08/03ISR Number: 4143271-1Report Type:Direct Company Report #CTU 197450 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Seroquel PS ORAL 25 MG BID Syndrome ORAL Zyprexa SS ORAL 2.5 MG BID ORAL 22-Feb-2006 08:31 AM Page: 720 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4144800-4Report Type:Expedited (15-DaCompany Report #2003PK01112 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Cerebellar Atrophy Health PO Cerebral Atrophy Professional Seroquel SS ORAL 100 MG DAILY Drug Interaction Other PO Gamma-Glutamyltransferase Seroquel SS ORAL 150 MG DAILY Increased PO Hemiparesis Seroquel SS ORAL 200 MG DAILY Pleurothotonus PO Supraventricular Seroquel SS ORAL 300 MG DAILY Extrasystoles PO Ventricular Extrasystoles Seroquel SS ORAL 400 MG DAILY PO Seroguel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 650 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Haldol SS ORAL 10 MG DAILY PO Haldol SS ORAL 5 MG DAILY PO Haldol SS ORAL 30 MG DAILY PO Haldol SS ORAL 32.5 MG DAILY PO Haldol SS ORAL 22.5 MG DAILY PO Haldol SS ORAL 20 MG DAILY PO Haldol SS ORAL 15 MG DAILY PO Haldol SS ORAL 17.5 MG DAILY PO Haldol SS ORAL 15 MG DAILY PO Haldol SS ORAL 20 MG DAILY PO Haldol SS ORAL 22.5 MG DAILY PO Haldol SS ORAL 5 MG DAILY PO Valiquid C Akineton Retard C Bifiteral C Date:07/08/03ISR Number: 4144906-XReport Type:Expedited (15-DaCompany Report #2003SE03021 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyponatraemia Foreign Seroquel PS ORAL 300 MG BID PO Leukopenia Health Neurotol - Slow Professional Release C Other Fevarin C Aurorix C 22-Feb-2006 08:31 AM Page: 721 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4144907-1Report Type:Expedited (15-DaCompany Report #2003GB01471 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Seroquel PS 150 MG QID Initial or Prolonged Feeding Disorder Health TPL Feeling Jittery Professional Lorazepam SS 2 MG TID TPL Hypertonia Other Maternal Drugs Affecting Foetus Nasal Flaring Pyrexia Respiratory Distress Date:07/08/03ISR Number: 4144908-3Report Type:Expedited (15-DaCompany Report #2003PK01107 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Drug Level Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Above Therapeutic Health PO Blood Amylase Increased Professional Seroquel SS ORAL 100 MG DAILY Leukopenia Other PO Lipase Increased Seroquel SS ORAL 200 MG DAILY Neutropenia PO Thrombocytopenia Orfiril SS ORAL 300 MG DAILY PO Orfiril SS ORAL 500 MG DAILY PO Orfiril SS ORAL 1000 MG DAILY PO Orfiril SS ORAL 1200 MG DAILY PO Orfiril SS ORAL 1000 MG DAILY PO Euthyrox C Date:07/08/03ISR Number: 4145507-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601813 Age:36 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acute Respiratory Initial or Prolonged Distress Syndrome Alanine Aminotransferase Aspartate Aminotransferase Blood Alkaline Phosphatase Blood Bicarbonate Blood Calcium Blood Chloride Blood Creatine Blood Creatine Phosphokinase Blood Creatine Phosphokinase Mb Blood Glucose Blood Magnesium Blood Urine Chest X-Ray Abnormal Dyspnoea 22-Feb-2006 08:31 AM Page: 722 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram T Wave Abnormal Glucose Urine Present Report Source Product Role Manufacturer Route Dose Duration Haematocrit Decreased Study Risperidone Haemoglobin Health (Risperidone) Hypokalaemia Professional Unspecified PS Hyponatraemia Perphenazine Mental Disorder (Perphenazine) SS Pco2 Decreased Olanzapine Po2 Decreased (Olanzapine) SS Polydipsia Psychogenic Quetiapine Protein Total (Quetiapine) SS Pulmonary Congestion Ziprasidone Respiratory Failure (Ziprasidone) SS Sinus Tachycardia Clonazepam C Thirst Mirtazapine C Troponin Catopril C White Blood Cells Urine Glipizide C Positive Date:07/09/03ISR Number: 4144448-1Report Type:Direct Company Report #CTU 197517 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sensory Disturbance Seroquel PS 1.25 M/L Initial or Prolonged Tinnitus DAILY Disability Required Intervention to Prevent Permanent Impairment/Damage Date:07/09/03ISR Number: 4145966-2Report Type:Expedited (15-DaCompany Report #USA-2002-0001677 Age:41 YR Gender:Female I/FU:F Outcome PT Death Alopecia Hospitalization - Anxiety Initial or Prolonged Arterial Occlusive Disease Asthenia Back Pain Cardiac Arrest Cardiac Enzymes Increased Cardiac Murmur Chest Pain Coma Contusion Depression Diabetes Mellitus Disturbance In Attention Drug Ineffective Dyspnoea Flushing Hyperhidrosis Hyperventilation Hypoxia Influenza Insomnia 22-Feb-2006 08:31 AM Page: 723 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Libido Decreased Memory Impairment Report Source Product Role Manufacturer Route Dose Duration Muscular Weakness Consumer Oxycontin Tablets 10 Nausea Health Mg(Oxycodone Nervousness Professional Hydrochloride) Cr Night Sweats Other Tablet PS 10 MG Overdose Oxycontin Tablets Pain 20mg(Oxycodone Peripheral Occlusive Hydrochloride) Cr Disease Tablet SS 20 MG 1008 DAY Pneumonia Hydrocodone Pruritus Bitartrate (Similat Pulse Absent To Ind 59,159) Rash Pruritic (Hydrocodone Somnolence Bitartrate) Unknown SS 1008 DAY Suicide Attempt Alprazolam(Alprazola Upper Respiratory Tract m) SS 1008 DAY Infection Ephedrine(Ephedrine) SS 1008 DAY Urinary Incontinence Metoclopramide(Metoc Weight Increased lopramide) SS 1008 DAY Quetiapine(Quetiapin e) SS 1008 DAY Pseudoephedrine(Pseu doephedrine) SS 1008 DAY Effexor (Venlafaxine Hydrochloride) SS 75 MG, DAILY, 1008 DAY Codeine(Codeine) SS 1008 DAY Neurontin(Gabapentin ) C 100 MG, TID 1008 DAY Claritin (Loratadine) C Vitamin C (Ascorbic Acid) C Celebrex (Celecoxib) C Prilosec (Omeprazole) C Daypro (Oxaprozin) C Trandate (Labetalol Hydrochloride) C Axid (Nizatidine) C Paxil (Paroxetine Hydrochloride) C Medrol (Methylprednisolone) C Macro Antioxidant (Ascorbic Acid, Cystine, Tocopherol, Calcium Ascorbate, Betacarotene, C Zocor (Simvastatin) C Risperdal (Risperidone) C Fioricet (Butalbital) C Flonase (Fluticasone Propionate) C Phenobarbital (Phenobarbital) C Donnatal (Atropine Sulfate, Hyoscine 22-Feb-2006 08:31 AM Page: 724 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrobromide, Hyoscyamine Sulfate, Phenobarbital) C Bellergal-S (Belladonna Alkaloids, Ergotamine Tartrate, Phenobarbital) C Weight Loss Supplement (Does Not Code) C Ibuprofen C Ambien (Zolpidem Tartrate) C Baclofen (Baclofen) C Trandate (Labetalol Hydrochloride) C Celexa (Citalopram Hydrobromide) C Cortisone (Cortisone) C Atarax (Hydroxyzine Hydrochloride) C Proventil Tablet(Salbutamol Sulfate) C Amitriptyline (Amitriptyline) C Cyclobenzaprine (Cyclobenzaprine) C Augmentin (Amoxicillin Trihydrate, Clavulanate Potassium) C Ergobel (Nicergoline) C Glucotrol Xl (Glipizide) C Humuline Nph (Insulin Human Injection, Isophane) C Capoten C Albuterol (Salbutamol) C Azmacort (Triamcinolone Acetonide) C Aciphex (Rabeprazole Sodium) C Seroquel (Quetiapine) C Date:07/10/03ISR Number: 4144486-9Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041363A Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradyarrhythmia Health Quilonum PS Glaxosmithkline ORAL Hypothermia Professional Taxilan SS ORAL Loss Of Consciousness Godamed SS Glaxosmithkline ORAL Clozapine SS ORAL 22-Feb-2006 08:31 AM Page: 725 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Akineton SS ORAL Pirenzepin SS ORAL Dominal Forte SS ORAL Lorazepam SS ORAL Chlorprothixen SS ORAL Rivotril SS ORAL Orfiril SS ORAL Zyprexa SS ORAL Topamax SS ORAL Seroquel SS ORAL Date:07/10/03ISR Number: 4146822-6Report Type:Expedited (15-DaCompany Report #2003AP02354 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Complications Of Maternal Foreign Quetiapine PS Intervention to Exposure To Therapeutic Literature Prevent Permanent Drugs Health Impairment/Damage Intra-Uterine Death Professional Maternal Drugs Affecting Other Foetus Stillbirth Date:07/10/03ISR Number: 4146857-3Report Type:Expedited (15-DaCompany Report #2003GB01715 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Quetiapine PS ORAL 25 MG HS PO Health Efexor C Professional Thyroxine C Other Date:07/11/03ISR Number: 4146068-1Report Type:Direct Company Report #CTU 197809 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Quetiapine Initial or Prolonged (Seroquil) PS ORAL 100 MG AM AND Required 600 MG HS PO Intervention to Depakote Er SS ORAL 500 MG BID PO Prevent Permanent Adderall C Impairment/Damage Date:07/11/03ISR Number: 4147803-9Report Type:Expedited (15-DaCompany Report #2003AP02246 Age:41 YR Gender:Male I/FU:F Outcome PT Life-Threatening Anorexia Hospitalization - Balance Disorder Initial or Prolonged Depressed Level Of Consciousness Diabetes Mellitus Inadequate Control Dizziness Postural Drug Withdrawal Syndrome Hyperinsulinaemia Hypoglycaemia 22-Feb-2006 08:31 AM Page: 726 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypothyroidism Mania Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 100 MG DAILY Health PO Professional Limas C Other Prednisolone C Rivotril C Depakene C Eurodin C Bufferin C Gaster C Lipitor C Basen C Humalog C Aldactone C Lasix C Date:07/14/03ISR Number: 4148306-8Report Type:Expedited (15-DaCompany Report #2003AP02354 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Complications Of Maternal Foreign Quetiapine PS TRANSPLACENTAL Intervention to Exposure To Therapeutic Literature Prevent Permanent Drugs Health Impairment/Damage Drug Exposure During Professional Pregnancy Other Pregnancy Stillbirth Date:07/14/03ISR Number: 4148419-0Report Type:Expedited (15-DaCompany Report #2003SE02715 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Foreign Seroquel PS ORAL 200 MG PO Intervention to Health Etomine C Prevent Permanent Professional Impairment/Damage Other Date:07/14/03ISR Number: 4148540-7Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Haloperidol Initial or Prolonged Blood Creatine Health (Haloperidol) Phosphokinase Increased Professional Tablets PS ORAL SEE IMAGE Blood Pressure Increased Risperdal Condition Aggravated (Risperidone) Delusion Tablets SS ORAL SEE IMAGE Diabetes Mellitus Quetiapine Fumarate Hallucination (Quetiapine Hypoventilation Fumarate) Tablets SS ORAL 600 MG, 1 IN Hypoxia 1 DAY, ORAL Insomnia Hydroxyzine Pamoate Respiratory Distress (Hydroyzine Schizophrenia Embonate) C Estazolam (Estazolam) C 22-Feb-2006 08:31 AM Page: 727 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Sennoside (All Other Therapeutic Products) C Date:07/14/03ISR Number: 4148735-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Haloperidol Initial or Prolonged Blood Creatine Health (Haloperidol) Phosphokinase Increased Professional Tablets PS ORAL SEE IMAGE Blood Glucose Increased Risperdal Blood Pressure Increased (Risperidone) Condition Aggravated Tablets SS ORAL SEE IMAGE Delusion Quetiapine Fumarate Diabetes Mellitus (Quetiapine Glycosylated Haemoglobin Fumarate) Tablets SS ORAL 600 MG, 1 IN Increased 1 DAY, ORAL Hallucination Hydroxyzine Pamoate Hypoventilation (Hydroxyzine Hypoxia Embonate) C Insomnia Estazolam Po2 Increased (Estazolam) C Respiratory Distress Zopiclone Schizophrenia (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Sennoside (All Other Therapeutic Products) C Date:07/15/03ISR Number: 4147221-3Report Type:Direct Company Report #CTU 197905 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Condition Aggravated Seroquel 300mg PS ORAL 300MG ONCE A Required Congenital Hearing DAY ORAL Intervention to Disorder Klonopin C Prevent Permanent Disturbance In Attention Zoloft C Impairment/Damage Photophobia Vitamin E C Social Avoidant Behaviour Depakote C Temperature Intolerance Astelin C Weight Loss Poor Acetaminophen C Date:07/15/03ISR Number: 4149070-9Report Type:Expedited (15-DaCompany Report #2003UW08137 Age: Gender:Female I/FU:F Outcome PT Hospitalization - Coma Initial or Prolonged Haematocrit Decreased 22-Feb-2006 08:31 AM Page: 728 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemoglobin Decreased Hypotension Overdose Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS ORAL 200 MG PO Professional Date:07/15/03ISR Number: 4149075-8Report Type:Expedited (15-DaCompany Report #2003UW01894 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pericardial Effusion Health Seroquel PS ORAL 200 MG BID; Intervention to Professional PO Prevent Permanent Impairment/Damage Date:07/15/03ISR Number: 4150039-9Report Type:Expedited (15-DaCompany Report #2003GB01716 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel PS Intervention to Health Clozapine C Prevent Permanent Professional Impairment/Damage Other Date:07/15/03ISR Number: 4150040-5Report Type:Expedited (15-DaCompany Report #2003GB01680 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Foreign Quetiapine PS Intervention to Complications Of Maternal Health Rabeprazole C Prevent Permanent Exposure To Therapeutic Professional Mefenamic Acid C Impairment/Damage Drugs Other Drug Exposure During Pregnancy Pregnancy Date:07/16/03ISR Number: 4150044-2Report Type:Expedited (15-DaCompany Report #2003AP02457 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abulia Foreign Seroquel PS ORAL 25 MG TID PO Initial or Prolonged Anorexia Study Seroquel SS ORAL 100 MG TID PO Required Somnolence Health Seroquel SS ORAL 50 MG TID PO Intervention to Stupor Professional Seroquel SS ORAL 25 MG TID PO Prevent Permanent Other Tasmolin C Impairment/Damage Proheparum C Ubretid C Gaster C Harnal C Lendormin C Gasmotin C 22-Feb-2006 08:31 AM Page: 729 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/03ISR Number: 4150263-5Report Type:Expedited (15-DaCompany Report #200301854S Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Zolpidem PS ORAL 10MG, PO 14 DAY Initial or Prolonged Jaundice Health Seroquel Quetiapine Liver Disorder Professional Fumarate SS ORAL 25MG, PO 14 DAY Malaise Other Cerocral Ifenprodil Nausea Tartrate SS ORAL 60MG, PO 14 DAY Date:07/16/03ISR Number: 4150467-1Report Type:Expedited (15-DaCompany Report #2003AP02454 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Foreign Seroquel PS ORAL 50 MG BID PO Intervention to Drug Ineffective Study Seroquel SS ORAL 200 MG BID PO Prevent Permanent Insomnia Health Pantosin C Impairment/Damage Logorrhoea Professional Tasmolin C Mania Other Adalat C Suicidal Ideation Depas C Date:07/17/03ISR Number: 4151094-2Report Type:Expedited (15-DaCompany Report #2003UW08749 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Professional Prevacid SS Date:07/17/03ISR Number: 4151215-1Report Type:Expedited (15-DaCompany Report #03P-062-0223625-00 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradyarrhythmia Foreign Akineton(Biperiden) Initial or Prolonged Hypothermia Health (Biperiden) PS ORAL PER ORAL Loss Of Consciousness Professional Perazine SS ORAL PER ORAL Poisoning Godamed SS ORAL PER ORAL Clozapine SS ORAL PER ORAL Pirenzepine SS ORAL PER ORAL Prothipendyl Hydrochloride SS ORAL PER ORAL Lorazepam SS ORAL PER ORAL Chlorprothixene SS ORAL PER ORAL Clonazepam SS ORAL PER ORAL Orfiril SS ORAL PER ORAL Olanzapine SS ORAL PER ORAL Topiramate SS ORAL PER ORAL Quetiapine SS ORAL PER ORAL Lithium Carbonate SS ORAL PER ORAL Date:07/18/03ISR Number: 4150712-2Report Type:Direct Company Report #CTU 198196 Age:67 YR Gender:Male I/FU:I Outcome Death Life-Threatening Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:31 AM Page: 730 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 Abnormal Behaviour Ziprasidone 20mg/Ml Dehydration Pfizer PS Pfizer INTRAMUSCULAR 5 MG PRN Dementia INTRAMUSCULAR Electrolyte Imbalance Quetiapine 100 Mg Insomnia Tab Astra Zeneca SS Astra Zeneca ORAL 100 MG TID Neuroleptic Malignant ORAL Syndrome Lorazepam C Renal Failure Acute Acetaminophen C Rhabdomyolysis Haloperidol C White Blood Cell Count Metoprolol C Increased Donepezil C Date:07/18/03ISR Number: 4152353-XReport Type:Expedited (15-DaCompany Report #2003UW08873 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS Overdose Professional Klonopin SS Depakote SS Date:07/21/03ISR Number: 4152905-7Report Type:Expedited (15-DaCompany Report #2003AP02486 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Seroquel PS ORAL 350 MG DAILY Initial or Prolonged Health PO Professional Toledomin SS ORAL 25 MG BID PO Other Pacyl C Lendormin C Silece C Tetramide C Ancaron C Pletaal C Pursennid C Magnesium Oxide C Biofermin C Blopress C Gascon C Gaster C Date:07/21/03ISR Number: 4152907-0Report Type:Expedited (15-DaCompany Report #2003UW08719 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Health Seroquel PS Initial or Prolonged Ejection Fraction Professional Decreased Date:07/22/03ISR Number: 4155248-0Report Type:Expedited (15-DaCompany Report #2003UW08964 Age: Gender: I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 731 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Coma Health Seroquel PS ORAL 1200 MG PO Overdose Professional Date:07/22/03ISR Number: 4155252-2Report Type:Expedited (15-DaCompany Report #2003UW08966 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS Decreased Professional Depakote SS Date:07/23/03ISR Number: 4155527-7Report Type:Expedited (15-DaCompany Report #2003PK01229 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 500 MG DAILY Other PO Date:07/23/03ISR Number: 4155528-9Report Type:Expedited (15-DaCompany Report #2003GB01468 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS STARTED AT Syncope Health 150MG TWICE Professional DAILY, Other INCREASED TO 200MG TWICE Date:07/23/03ISR Number: 4155530-7Report Type:Expedited (15-DaCompany Report #2003AP02503 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS ORAL 300 MG PO Decreased Health Professional Other Date:07/23/03ISR Number: 4155544-7Report Type:Expedited (15-DaCompany Report #2003AP00923 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Foreign Seroquel PS ORAL 700 MG DAILY Drug Level Health PO Overdose Professional Citalopram SS ORAL 40 MG DAILY Other PO Date:07/24/03ISR Number: 4155918-4Report Type:Expedited (15-DaCompany Report #2003UW09178 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Seroquel PS Professional Celexa SS 22-Feb-2006 08:31 AM Page: 732 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/03ISR Number: 4156452-8Report Type:Expedited (15-DaCompany Report #HQWYE969914JUL03 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Health Ativan (Lorazepam) PS 6 MG 1X PER 1 Initial or Prolonged Drug Exposure During Professional DAY Pregnancy Other Seroquel Drug Withdrawal Syndrome (Quetiapine) SS 600 MG 1X PER Feeding Disorder Neonatal 1 DAY Feeling Jittery Hypertonia Intercostal Retraction Nasal Flaring Pyrexia Date:07/25/03ISR Number: 4154049-7Report Type:Expedited (15-DaCompany Report #CH-ROCHE-342681 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Torem Oral PS Roche ORAL Hospitalization - Chest Pain Seroquel SS ORAL 69 DAY Initial or Prolonged Cough Aldactone SS Roche ORAL TAKEN FOR Disorientation MONTHS. Dyspnoea Marcoumar C ORAL DOSE General Physical Health DEPENDENT ON Deterioration INR. TAKEN Pyrexia FOR MONTHS. Rales Beloc-Zok C ORAL TAKEN FOR Sputum Discoloured MONTHS. Wheezing White Blood Cell Count Decreased Date:07/25/03ISR Number: 4157626-2Report Type:Expedited (15-DaCompany Report #2003UW07944 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Seroquel PS ORAL 275 MG DAILY Initial or Prolonged Coordination Abnormal PO Crying Seroquel SS Decreased Activity Seroquel SS ORAL 12.5 MG Q5-7 Feeling Abnormal DAYS PO Heart Rate Increased Klonopin C Movement Disorder Lortab C Muscle Rigidity Nervous System Disorder Nuchal Rigidity Palpitations Panic Attack Paraesthesia Suicidal Ideation Date:07/25/03ISR Number: 4157757-7Report Type:Expedited (15-DaCompany Report #2003SE02715 Age:14 YR Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 733 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Agitation Foreign Seroquel PS ORAL 200 MG PO Dystonia Health Etomine SS ORAL 20 MG DAILY Professional PO Other Date:07/25/03ISR Number: 4157926-6Report Type:Expedited (15-DaCompany Report #2003UW09196 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 75 MG BID PO Initial or Prolonged Psychotic Disorder Study Health Professional Other Date:07/28/03ISR Number: 4155463-6Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12332615 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Maxipime For Inj PS Bristol-Myers Squibb Drug Interaction Company INTRAVENOUS Fall Plavix Tabs C Regulatory Health Orthostatic Hypotension Authority South Africa ORAL Aspirin C ORAL Fragmin C SUBCUTANEOUS Dosage form = kilo international units Torem C ORAL Sortis C ORAL Antramups C ORAL Norvasc C ORAL Corvaton Retard C ORAL Klacid I ORAL Seroquel I ORAL Date:07/28/03ISR Number: 4158004-2Report Type:Expedited (15-DaCompany Report #2003UW08898 Age:40 YR Gender:Male I/FU:I Outcome PT Required Abnormal Dreams Intervention to Back Pain Prevent Permanent Contusion Impairment/Damage Delirium Drug Ineffective Fall Head Injury Headache Hypoaesthesia Limb Injury Neck Pain Nightmare Pain Polytraumatism 22-Feb-2006 08:31 AM Page: 734 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Sleep Talking Tremor Report Source Product Role Manufacturer Route Dose Duration Consumer Seroquel PS ORAL 300 MG DAILY PO Seroquel SS Atarax C Paxil C Depakote C Date:07/28/03ISR Number: 4158254-5Report Type:Expedited (15-DaCompany Report #2003SE03403 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ventricular Extrasystoles Foreign Seroquel PS ORAL 700 MG DAILY Intervention to Health PO Prevent Permanent Professional Anaesthetics C Impairment/Damage Other Date:07/28/03ISR Number: 4158416-7Report Type:Expedited (15-DaCompany Report #2003169197CH Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Aldactone(Spironolac Hospitalization - Agranulocytosis Health tone) Tablet PS ORAL 50 MG, DAILY, Initial or Prolonged Angina Pectoris Professional ORAL C-Reactive Protein Other Seroquel(Quetiapine) SS ORAL ORAL Increased Torem(Torasemide) SS ORAL 10 MG DAILY, Cough ORAL Depression Marcoumar Disorientation (Phenprocoumon) C Dizziness Beloc Zok Dyspnoea (Metoprolol Lung Infection Succinate) C Neutropenia Pyrexia Restlessness Rhonchi Sputum Discoloured Vascular Dementia Wheezing Date:07/29/03ISR Number: 4157512-8Report Type:Direct Company Report #CTU 198893 Age:34 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Mental Retardation Seroquel PS Severity Unspecified Lithium SS Road Traffic Accident Date:07/29/03ISR Number: 4159248-6Report Type:Expedited (15-DaCompany Report #2003GB02021 Age: Gender:Female I/FU:I Outcome PT Report Source Other Electrocardiogram Foreign Abnormal Health Leukopenia Professional 22-Feb-2006 08:31 AM Page: 735 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel PS Seroxat C Ciba-Geigy Date:07/29/03ISR Number: 4159249-8Report Type:Expedited (15-DaCompany Report #2003GB01547 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hypersensitivity Foreign Seroquel PS ORAL 50 MG ONCE PO Required Health Sertraline C Intervention to Professional Depakote C Prevent Permanent Other Chlorpromazine C Impairment/Damage Date:07/29/03ISR Number: 4159627-7Report Type:Expedited (15-DaCompany Report #2003UW09220 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Seroquel PS Sedation Professional Methadone SS Date:07/29/03ISR Number: 4159658-7Report Type:Expedited (15-DaCompany Report #03P-062-0223625-00 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradyarrhythmia Foreign Akineton (Biperiden) Initial or Prolonged Hypothermia Health (Biperiden) PS ORAL PER ORAL Loss Of Consciousness Professional Perazine SS ORAL PER ORAL Poisoning Godamed SS ORAL PER ORAL Clozapine SS ORAL PER ORAL Pirenzepine SS ORAL PER ORAL Prothipendyl Hydrochloride SS ORAL PER ORAL Lorazepam SS ORAL PER ORAL Chlorprothixene SS ORAL PER ORAL Clonazepam SS ORAL PER ORAL Orfiril SS ORAL PER ORAL Olanzapine SS ORAL PER ORAL Topiramate SS ORAL PER ORAL Quetiapine SS ORAL PER ORAL Lithium Carbonate SS ORAL PER ORAL Date:07/30/03ISR Number: 4157813-3Report Type:Direct Company Report #CTU 198935 Age:16 YR Gender:Female I/FU:I Outcome PT Life-Threatening Condition Aggravated Hospitalization - Convulsion Initial or Prolonged Depression Disability Hallucination Required Headache Intervention to Heart Rate Increased Prevent Permanent Homicidal Ideation Impairment/Damage Panic Attack Suicidal Ideation 22-Feb-2006 08:31 AM Page: 736 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Prozac 20 Mg PS ORAL 20MG QD ORAL Seraquel 200mg SS ORAL 900MG 300AM/600PM ORAL Date:07/30/03ISR Number: 4158956-0Report Type:Expedited (15-DaCompany Report #PHBS2002CA12262 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Abdominal Pain Upper Pharma ORAL 400 mg/day 141 DAY Other Anxiety Paxil SS UNKNOWN 40 mg/day Appendicectomy Seroquel SS Appendicitis Chills Cyanosis Decreased Appetite Drug Interaction Drug Level Increased Drug Toxicity Emotional Distress Gastroenteritis Helicobacter Helicobacter Gastritis Hepatic Steatosis Hepatotoxicity Liver Function Test Abnormal Nausea Peritonitis Psychotic Disorder Pyrexia Vomiting Date:07/30/03ISR Number: 4160401-6Report Type:Expedited (15-DaCompany Report #2003SE03392 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - C-Reactive Protein Health PO Initial or Prolonged Increased Professional Aldactone SS ORAL 50 MG DAILY Chest Pain Other PO Cough Torem SS ORAL 10 MG DAILY Disorientation PO Dizziness Beloc C Dyspnoea Marcoumar C Lung Infection Rhonchi Tachypnoea 22-Feb-2006 08:31 AM Page: 737 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/03ISR Number: 4160403-XReport Type:Expedited (15-DaCompany Report #2003GB01964 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS Intervention to Tremor Health Clozapine C Prevent Permanent Professional Impairment/Damage Other Date:07/30/03ISR Number: 4161220-7Report Type:Expedited (15-DaCompany Report #2003UW07657 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bilirubin Conjugated Consumer Seroquel PS Increased Other Parnate SS ORAL 10 MG TID PO Cardiac Arrest Cardiomegaly Coronary Ostial Stenosis Cough Hepatic Steatosis Hepatosplenomegaly Hyperhidrosis Hyperventilation Hypoglycaemia Leukocytosis Neuroleptic Malignant Syndrome Pulmonary Congestion Pulmonary Oedema Renal Tubular Disorder Respiratory Rate Increased Tachycardia Tremor Ventricular Hypertrophy Date:07/31/03ISR Number: 4161901-5Report Type:Expedited (15-DaCompany Report #2003UW09270 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Sodium Decreased Consumer Seroquel PS ORAL 600 MG PO Dysuria Haematocrit Decreased Haemoglobin Decreased Red Blood Cell Count Decreased Date:07/31/03ISR Number: 4161902-7Report Type:Expedited (15-DaCompany Report #2003UW09285 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Platelet Count Decreased Health Seroquel PS ORAL 50 GM QD PO Intervention to White Blood Cell Count Professional Lithium C Prevent Permanent Decreased Zyprexa C Impairment/Damage Celexa C 22-Feb-2006 08:31 AM Page: 738 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4162079-4Report Type:Expedited (15-DaCompany Report #2003GB01979 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Multiple Drug Overdose Health Multiple Drugs SS Professional Other Date:07/31/03ISR Number: 4162100-3Report Type:Expedited (15-DaCompany Report #2003UW09393 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erythema Foreign Seroquel PS ORAL 800 UG DAILY Initial or Prolonged Pain In Extremity Health PO Sensory Disturbance Professional Paxil C Skin Disorder Other Rivotril C Skin Exfoliation Celebrex C Monocor C Date:08/01/03ISR Number: 4162116-7Report Type:Expedited (15-DaCompany Report #2003PK01306 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Seroquel PS Initial or Prolonged Blood Cholinesterase Health Seroquel SS ORAL 600 MG DAILY Increased Professional PO Other Seroquel SS ORAL 300 MG DAILY PO Date:08/01/03ISR Number: 4162864-9Report Type:Expedited (15-DaCompany Report #2003016781 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Geodon (Ziprasidone) PS Initial or Prolonged Phosphokinase Professional Haloperidol Other Blood Pressure Diastolic Company (Haloperidol) SS Decreased Representative Paroxetine Blood Pressure Systolic Hydrochloride Increased (Paroxetine Body Temperature Hydrochloride) SS Increased Quetiapine Fumarate Electrocardiogram Qt (Quetiapine Prolonged Fumarate) SS Heart Rate Increased Trihexyphenidyl Multiple Drug Overdose Hydrochloride Oxygen Saturation (Trihexyphenidyl Decreased Hydrochloride) SS Suicide Attempt White Blood Cell Count Date:08/01/03ISR Number: 4163427-1Report Type:Expedited (15-DaCompany Report #2003UW09012 Age:80 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 739 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Consumer Seroquel PS ORAL 25 MG HS PO Condition Aggravated Constipation Dementia Difficulty In Walking Dysuria Pain In Extremity Date:08/01/03ISR Number: 4163429-5Report Type:Expedited (15-DaCompany Report #2003UW09285 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Seroquel PS ORAL 50 MG QD PO White Blood Cell Count Professional Lithium C Decreased Zyprexa C Celexa C Date:08/04/03ISR Number: 4160770-7Report Type:Direct Company Report #CTU 199144 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Seroquel 50-100 PS Aggression Trileptal 300-600 SS Anger Straterra 25 SS Hypersomnia Date:08/04/03ISR Number: 4161014-2Report Type:Direct Company Report #CTU 199132 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Strattera 40 PS Bipolar Ii Disorder Prozac 20 SS Drug Ineffective Seroquel 50 SS Irritability Mood Altered Date:08/04/03ISR Number: 4161021-XReport Type:Direct Company Report #CTU 199136 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Trileptal PS 600-600 Drug Effect Decreased Lamictal SS 100-100 Seroquel SS 200 Strattera SS 60 Date:08/04/03ISR Number: 4161084-1Report Type:Direct Company Report #USP 55990 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Decreased Activity Seroquel PS Astra Zeneca Hypokinesia Serzone SS Medication Error 22-Feb-2006 08:31 AM Page: 740 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/03ISR Number: 4163888-8Report Type:Expedited (15-DaCompany Report #2003UW09289 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Seroquel PS ORAL 400 MG DAILY White Blood Cell Count Professional PO Decreased Seroquel SS ORAL 150 MG DAILY PO Depakote SS Date:08/04/03ISR Number: 4164306-6Report Type:Expedited (15-DaCompany Report #2003UW09532 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Psychotic Disorder Study PO Health Stelazine C Professional Dalmane C Other Trazodone C Remeron C Date:08/05/03ISR Number: 4164728-3Report Type:Expedited (15-DaCompany Report #2003UW05344 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Chills Health Seroquel PS ORAL 50 MG DAILY Intervention to Macrocytosis Professional PO Prevent Permanent Malaise Remeron C Impairment/Damage Pyrexia Topamax C Red Blood Cell Count Increased Splenomegaly Weight Decreased White Blood Cell Count Decreased Date:08/05/03ISR Number: 4165481-XReport Type:Expedited (15-DaCompany Report #S03-NZL-03214-01 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholelithiasis Foreign Cipramil (Citalopram Completed Suicide Health Hydrobromide) PS ORAL 40 MG QD PO Liver Function Test Professional Cipramil (Citalopram Abnormal Other Hydrobromide) SS Overdose Quetiapine SS Quetiapine SS ORAL 700 MG QD PO Date:08/05/03ISR Number: 4165522-XReport Type:Expedited (15-DaCompany Report #2003AP02454 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS ORAL 50 MG BID PO Intervention to Anxiety Study Seroquel SS ORAL 200 MG BID PO Prevent Permanent Drug Ineffective Health Pantosin C Impairment/Damage Insomnia Professional Tasmolin C Logorrhoea Other Adalat C Mania Depas C Suicidal Ideation 22-Feb-2006 08:31 AM Page: 741 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/03ISR Number: 4165613-3Report Type:Expedited (15-DaCompany Report #200301854S Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Myslee Initial or Prolonged Jaundice Health Zolpidem PS ORAL 10 MG, PO 14 DAY Liver Disorder Professional Seroquel Quetiapine Malaise Other Fumarate Tablet 25mg SS ORAL 25 MG, PO 14 DAY Nausea Cerocral Ifenprodil Tartrate Tablet 20mg SS ORAL 60 MG, PO 14 DAY Date:08/06/03ISR Number: 4162569-4Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041363A Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradyarrhythmia Quilonum Retard PS Glaxosmithkline ORAL Initial or Prolonged Hypothermia Taxilan SS ORAL Loss Of Consciousness Godamed SS Glaxosmithkline ORAL Clozapine SS ORAL Akineton SS ORAL Pirenzepin SS ORAL Dominal Forte SS ORAL Lorazepam SS ORAL Chlorprothixen SS ORAL Rivotril SS ORAL Orfiril SS ORAL Zyprexa SS ORAL Topamax SS ORAL Seroquel SS ORAL Date:08/06/03ISR Number: 4163196-5Report Type:Direct Company Report #CTU 199430 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel PS Serzone SS Date:08/06/03ISR Number: 4165423-7Report Type:Expedited (15-DaCompany Report #2003PK01344 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Intentional Overdose Health Solian SS Professional Benperidol SS Other Date:08/06/03ISR Number: 4165424-9Report Type:Expedited (15-DaCompany Report #2003UW06705 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Ineffective Foreign Seroquel PS ORAL 700 MG DAILY Hospitalization - Iron Deficiency Anaemia Health PO Initial or Prolonged Leukopenia Professional Medroxyprogesterone C Required Malnutrition Other Estradiol C Intervention to Amoxicillin C Prevent Permanent Haldol C Impairment/Damage Ativan C Trazodone C 22-Feb-2006 08:31 AM Page: 742 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benztropine C Date:08/06/03ISR Number: 4166474-9Report Type:Expedited (15-DaCompany Report #2003UW09458 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dystonia Health Seroquel PS Professional Cogentin C Date:08/06/03ISR Number: 4166478-6Report Type:Expedited (15-DaCompany Report #2003UW09606 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Consumer Seroquel PS 25-150 MG Intervention to Arthralgia Prevent Permanent Blood Osmolarity Impairment/Damage Decreased Diabetes Mellitus Gait Disturbance Gastritis Gastroduodenitis Hyperlipidaemia Hypertension Hyponatraemia Proteinuria Urinary Retention Weight Decreased Date:08/06/03ISR Number: 4166481-6Report Type:Expedited (15-DaCompany Report #2003UW09578 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Seroquel PS ORAL 2400 MG DAILY Initial or Prolonged Anxiety Professional PO Delusion Seroquel SS ORAL 900 MG DAILY Medication Error PO Overdose Benadryl C Self-Medication Urinary Hesitation Urinary Retention Date:08/07/03ISR Number: 4166904-2Report Type:Expedited (15-DaCompany Report #2003AP02457 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abulia Foreign Seroquel PS ORAL 25 MG TID PO Initial or Prolonged Anorexia Study Seroquel SS ORAL 100 MG TID PO Required Somnolence Health Seroquel SS ORAL 50 MG TID PO Intervention to Stupor Professional Seroquel SS ORAL 25 MG TID PO Prevent Permanent Other Tasmolin C Impairment/Damage Proheparum C Ubretid C 22-Feb-2006 08:31 AM Page: 743 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/03ISR Number: 4166943-1Report Type:Expedited (15-DaCompany Report #2003GB02072 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Seroquel PS Initial or Prolonged Health Risperdal SS Professional Other Date:08/07/03ISR Number: 4166947-9Report Type:Expedited (15-DaCompany Report #2003GB02048 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 300 MG BID PO Neutrophil Count Health Amlodipine C Decreased Professional Date:08/07/03ISR Number: 4167305-3Report Type:Expedited (15-DaCompany Report #2003UW09738 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS 700/800 MG Professional Date:08/07/03ISR Number: 4167306-5Report Type:Expedited (15-DaCompany Report #2003UW09644 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Disorder Health Seroquel PS Initial or Prolonged Swollen Tongue Professional Date:08/08/03ISR Number: 4166239-8Report Type:Direct Company Report #CTU 199634 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Quetiapine 300mg Initial or Prolonged Aggression Tabs PS ORAL 1200MG PO QHS Arthralgia Depakote 500mg Sa Drug Screen Positive Tabs SS 2000 MG QHS Hostility Tylenol SS 1-2 TABS Q4 Hypotension PRN Loss Of Consciousness Bzd SS Suicidal Ideation Colchicine C Treatment Noncompliance Lasix C Lisinopril C Daypro C Ranitidine C Simvastatin C Kcl C Venlafaxine C Date:08/09/03ISR Number: 4167213-8Report Type:Expedited (15-DaCompany Report #2003SE03510 Age:40 YR Gender:Female I/FU:I Outcome Disability Required 22-Feb-2006 08:31 AM Page: 744 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 Hepatic Function Abnormal Foreign Seroquel PS ORAL 400 MG DAILY Hepatitis Health PO Professional Flurazepam C Other Date:08/09/03ISR Number: 4167215-1Report Type:Expedited (15-DaCompany Report #2003UW09724 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 150 MG DAILY Health PO Professional Clonazepam C Other Parnate C Date:08/09/03ISR Number: 4167217-5Report Type:Expedited (15-DaCompany Report #2003AP02113 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Increased Health PO Anorexia Professional Myslee SS ORAL 10 MG DAILY Aspartate Other PO Aminotransferase Cerocral SS ORAL 20 MG TID PO Increased Blood Bilirubin Increased Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Jaundice Liver Disorder Malaise Pruritus Vomiting Date:08/11/03ISR Number: 4167476-9Report Type:Expedited (15-DaCompany Report #ENT 2003-0089 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Health Comtan (Entacapone) PS ORAL ORAL Hospitalization - Phosphokinase Professional Sinemet SS Initial or Prolonged Dysphagia Seroquel SS Neuroleptic Malignant Cipro "Bayer" C Syndrome Citrofurantoin C Treatment Noncompliance Florinef C Amatine C Heparin C Tylenol C Mvi 3 C Flagyl C Timentin C 22-Feb-2006 08:31 AM Page: 745 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/03ISR Number: 4167551-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030801273 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Foreign Haldol (Haloperidol) Initial or Prolonged Drug Interaction Health Unspecified PS ORAL SEE IMAGE Fall Professional Seroquel (Quetiapine Gait Disturbance Fumarate) SS ORAL SEE IMAGE Pleurothotonus Valiquid (Diazepam) C Akineton Ret (Biperiden Hydrochloride) C Bifiteral (Probucol) C Date:08/11/03ISR Number: 4168088-3Report Type:Expedited (15-DaCompany Report #2003AP02486 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Seroquel PS ORAL 150 MG DAILY Initial or Prolonged Ileus Paralytic Health PO Required Liver Disorder Professional Seroquel SS ORAL 225 MG DAILY Intervention to Pyrexia Other PO Prevent Permanent Vomiting Seroquel SS ORAL 350 MG DAILY Impairment/Damage PO Toledomin SS ORAL 15 MG BID PO Pacyl C Lendormin C Silece C Tetramide C Ancaron C Pletaal C Pursennid C Magnesium Oxide C Biofermin C Blopress C Gascon C Gaster C Date:08/12/03ISR Number: 4166990-XReport Type:Direct Company Report #CTU 199907 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Seroquel (D) 50 Mg Syndrome Po Qhs PS ORAL 2 WK Date:08/12/03ISR Number: 4168511-4Report Type:Expedited (15-DaCompany Report #2003GB01964 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS ORAL 250 MG BID PO Intervention to Tremor Health Clozapine C Prevent Permanent Professional Sodium Valproate C Impairment/Damage Other Multivitamins C Lansoprazole C 22-Feb-2006 08:31 AM Page: 746 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/03ISR Number: 4168513-8Report Type:Expedited (15-DaCompany Report #2003GB02170 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Foreign Seroquel PS ORAL 25 MG BID PO Intervention to Supraventricular Health Seroquel SS ORAL 100 MG BID PO Prevent Permanent Atrioventricular Block Professional Impairment/Damage First Degree Other Date:08/13/03ISR Number: 4167471-XReport Type:Direct Company Report #CTU 199960 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Seroquel 200mg PS ORAL ONE Q HS PO Chorea Tic Tremor Date:08/13/03ISR Number: 4169918-1Report Type:Expedited (15-DaCompany Report #03P-167-0227665-00 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Epilim Chrono Initial or Prolonged Musculoskeletal Stiffness Health (Sodium Valproate) Pain In Extremity Professional (Sodium Valproate) (Sodium Valproate) PS ORAL 500 MG, 1 IN 1 D, ORAL Quetiapine SS 500 MG, 1 IN 1 D Date:08/14/03ISR Number: 4169402-5Report Type:Expedited (15-DaCompany Report #2003UW09946 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Seroquel PS 300 MG HS, Initial or Prolonged Professional 100 MG QAM Date:08/14/03ISR Number: 4170713-8Report Type:Expedited (15-DaCompany Report #DEWYE240904AUG03 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Tavor (Lorazepam, Initial or Prolonged Erythema Health Tablet, 0) PS ORAL 100 TABLETS Eye Movement Disorder Professional (OVERDOSE Hypotension AMOUNT 50 MG) Intentional Overdose ORAL 1 DAY Miosis Decentan Respiratory Failure (Perphenazine, , 0) SS ORAL 150 TABLETS Tachycardia (OVERDOSE AMAOUNT 1200 MG) ORAL 1 DAY Seroquel (Quetiapine Fumarate, , 0) SS 80 TABLETS (OVERDOSE AMOUNT 8000 MG) ORAL 1 DAY Seroquel (Quetiapine Fumarate, , 0) SS ORAL 30 TABLETS 22-Feb-2006 08:31 AM Page: 747 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (OVERDOSE AMONT 6000MG) / ORAL 1 DAY Date:08/15/03ISR Number: 4169091-XReport Type:Direct Company Report #CTU 200031 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Activities Of Daily Seroquel 300 Mg PS ORAL 300 MG ONCE A Required Living Impaired DAY ORAL Intervention to Condition Aggravated Klonopin C Prevent Permanent Disturbance In Attention Zoloft C Impairment/Damage Hyperacusis Vitamin E C Impaired Work Ability Depakote C Photophobia Astelin C Temperature Intolerance Acetaminophen C Weight Loss Poor Date:08/15/03ISR Number: 4169874-6Report Type:Direct Company Report #CTU 200090 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Seroquel 100mg Po Initial or Prolonged Non-Insulin-Dependent Qhs PS Other Depo Provera C Topomex C Depokote C Prozac C Date:08/15/03ISR Number: 4169905-3Report Type:Direct Company Report #CTU 200099 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Chlorpromazine 200 Initial or Prolonged Orthostatic Hypotension Mg PS ORAL 200 MG HS PO Seroquel 300 Mg SS ORAL 300 MGBID PO Asa C Carbamazepine C Docusate C Fluoxetine C Lisinopril C Metoprolol C Simvastatin C Fish Oil C Folic Acid C Date:08/15/03ISR Number: 4170027-6Report Type:Direct Company Report #CTU 200083 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Seroquel PS ORAL 100 MG PO QHS 6 DAY Headache Risperidal C Mental Impairment Prednisone C Zoloft C Combivent & Advair C Benztropine C Neurontin C Zocor C 22-Feb-2006 08:31 AM Page: 748 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glucovance C Date:08/15/03ISR Number: 4170337-2Report Type:Expedited (15-DaCompany Report #2003-BP-05720RO Age:32 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Propranolol Hcl Oral Overdose Solution, 40mg/5ml (Propranolol Hydrochloride) PS ORAL PO Quetiapine (Antipsychotics) SS ORAL PO Alprazolam (Alprazolam) SS ORAL PO Date:08/15/03ISR Number: 4170339-6Report Type:Expedited (15-DaCompany Report #2003-BP-05721RO Age:30 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Propranolol Hcl Oral Overdose Solution, 40mg/5ml (Propranolol Hydrochloride) PS ORAL PO Quetiapine (Antipsychotics) SS ORAL PO Valproic Acid (Valproic Acid) SS ORAL PO Date:08/15/03ISR Number: 4172263-1Report Type:Expedited (15-DaCompany Report #2003PK01344 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Seroquel PS Health Solian SS Professional Benperidol SS Other Date:08/18/03ISR Number: 4172957-8Report Type:Expedited (15-DaCompany Report #2003AP02454 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS ORAL 50 MG BID PO Intervention to Anxiety Study Seroquel SS ORAL 200 MG BID PO Prevent Permanent Insomnia Health Pantosin C Impairment/Damage Logorrhoea Professional Tasmolin C Suicidal Ideation Other Adalat C Date:08/19/03ISR Number: 4171436-1Report Type:Direct Company Report #CTU 200216 Age:14 YR Gender:Male I/FU:I Outcome PT Blood Creatine Phosphokinase Increased Discomfort Dystonia Idiosyncratic Drug 22-Feb-2006 08:31 AM Page: 749 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Reaction Neuroleptic Malignant Syndrome White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Seroquel PS Date:08/19/03ISR Number: 4172658-6Report Type:Expedited (15-DaCompany Report #2003UW10122 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Seroquel PS Professional Date:08/19/03ISR Number: 4173844-1Report Type:Expedited (15-DaCompany Report #2003033325 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Sertraline Initial or Prolonged Galactorrhoea Health (Sertraline) PS ORAL 200 MG Professional (DAILY), ORAL Quetiapine (Quetiapine) SS ORAL 400 MG (DAILY), ORAL Vitamins Nos (Vitamins Nos) C Date:08/19/03ISR Number: 4174347-0Report Type:Expedited (15-DaCompany Report #2003UW10126 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Foreign Seroquel PS Initial or Prolonged Overdose Health Professional Other Date:08/20/03ISR Number: 4174737-6Report Type:Expedited (15-DaCompany Report #2003SE03636 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 100 DF ONCE Overdose Other PO Paracet SS Date:08/20/03ISR Number: 4175304-0Report Type:Expedited (15-DaCompany Report #2003AP02673 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Seroquel PS ORAL 12.5 MG BID Renal Failure Health PO Professional Astrix C Other Minidiab C Adalat Oros C Ostelin C Caltrate C Coloxyl C Senna C 22-Feb-2006 08:31 AM Page: 750 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/03ISR Number: 4175305-2Report Type:Expedited (15-DaCompany Report #2003AP02741 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Overdose Health PO Professional Pyrethia SS Other Rohypnol SS Norvasc SS Date:08/21/03ISR Number: 4171773-0Report Type:Direct Company Report #CTU 200417 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glycosylated Haemoglobin Quietiapine 25 Mg PS ORAL 12.5 MG EVERY Increased DAY ORAL Apap C Asa C Atenolol C Felodipine C Hctz C Levothyroxine C Lisinopril C Rabeprazole C Simvastatin C Rabeprazole C Simvastatin C Sorbitol C Date:08/21/03ISR Number: 4176984-6Report Type:Expedited (15-DaCompany Report #2003AP02778 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ventricular Extrasystoles Foreign Seroquel PS 75 MG DAILY Initial or Prolonged Health Seroquel SS 100 MG DAILY Professional Seroquel SS 50 MG DAILY Other Date:08/25/03ISR Number: 4172831-7Report Type:Expedited (15-DaCompany Report #PHEH2003US07262 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Zelnorm PS Novartis Sector: Initial or Prolonged Hypotension Pharma 6 mg, UNK Other Trileptal SS Seroquel SS Effexor-Xr SS Neurontin SS Hyzaar SS Date:08/25/03ISR Number: 4177250-5Report Type:Expedited (15-DaCompany Report #DSA-23143-2003 Age:0 DY Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Neonatal Initial or Prolonged Caesarean Section Complications Of Maternal Exposure To Therapeutic 22-Feb-2006 08:31 AM Page: 751 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drugs Drug Withdrawal Syndrome Feeding Disorder Neonatal Hypertonia Neonatal Report Source Product Role Manufacturer Route Dose Duration Intercostal Retraction Foreign Ativan PS 6 MG QD Maternal Drugs Affecting Health Seroquel SS 600 MG QD Foetus Professional Nasal Flaring Other Pyrexia Date:08/25/03ISR Number: 4177979-9Report Type:Expedited (15-DaCompany Report #2003UW10305 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Consumer Seroquel PS 300 MG QD PO Intervention to Chills Concerta C Prevent Permanent Crying Prozac C Impairment/Damage Dizziness Neurontin C Gait Disturbance Haematemesis Headache Insomnia Screaming Vomiting Projectile Date:08/25/03ISR Number: 4177980-5Report Type:Expedited (15-DaCompany Report #2001UW12082 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Health Seroquel "Zeneca" PS ORAL 50 MG DAILY Intervention to Condition Aggravated Professional PO Prevent Permanent Constipation Serzone SS Impairment/Damage Gastrointestinal Motility Disorder Insomnia Pruritus Tongue Disorder Date:08/25/03ISR Number: 4177981-7Report Type:Expedited (15-DaCompany Report #2003UW10122 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Health Seroquel PS Professional Date:08/26/03ISR Number: 4173474-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12363263 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Sinemet Cr Tabs PS Bristol-Myers Squibb Hospitalization - Syndrome Company ORAL "at bedtime" Initial or Prolonged Renal Failure Carbidopa + Levodopa Tabs SS Bristol-Myers Squibb Company ORAL narrative stated "20, once a day" and daily dose block on 22-Feb-2006 08:31 AM Page: 752 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quetiapine Fumarate SS Date:08/26/03ISR Number: 4174481-5Report Type:Direct Company Report #CTU 200669 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Seroquel PS ORAL 25 MG QD ORAL Initial or Prolonged Hypertension Lamictal C Atenolol C Lipetor C Metformin C Date:08/27/03ISR Number: 4174051-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0411363A Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Parnate PS Glaxosmithkline ORAL 10MG Three Bilirubin Conjugated times per day Increased Seroquel SS Blood Calcium Increased Clozapine C Blood Chloride Decreased Effexor C Blood Creatine Phosphokinase Increased Blood Phosphorus Increased Blood Potassium Increased Blood Sodium Decreased Blood Test Abnormal Cardiac Arrest Cardiomegaly Confusional State Cough Cyanosis Dyspnoea Fatigue Feeling Abnormal Heart Rate Increased Hyperhidrosis Hyperthermia Malignant Hyperventilation Hypoglycaemia Hypotension Leukocytosis Neuroleptic Malignant Syndrome Oliguria Pulmonary Hypertension Pulse Absent Pyrexia Restlessness Tachycardia Treatment Noncompliance Tremor Ventricular Hypertrophy 22-Feb-2006 08:31 AM Page: 753 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/03ISR Number: 4175340-4Report Type:Direct Company Report #CTU 200766 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Seroquel 600mg/Day Hospitalization - Anger Astra Zeneca PS Astra Zeneca ORAL 250 MORNING Initial or Prolonged Homicidal Ideation ORAL 350 Suicidal Ideation NIGHT ORAL Weight Decreased Date:08/27/03ISR Number: 4180638-XReport Type:Expedited (15-DaCompany Report #2003UW10563 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Seroquel PS ORAL 800 MG DAILY Hepatic Cirrhosis Professional PO Pulmonary Congestion Methadone C Pulmonary Oedema Zoloft C Date:08/27/03ISR Number: 4181188-7Report Type:Expedited (15-DaCompany Report #M0929-03 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Mirtazapine PS ORAL 60 MG ORAL Drug Interaction Seroquel SS ORAL 300 MG ORAL Hypotension Atropine Sulfate SS PARENTERAL 0.5 MG Supraventricular PARENTERAL 1 DAY Tachycardia Oxazepam C Date:08/28/03ISR Number: 4175080-1Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12246666 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Diabetes Mellitus Pharmaceutical Other Company, Ltd. ORAL 4 DAY Seroquel SS Valproic Acid C Haldol C Date:08/28/03ISR Number: 4175192-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12291316 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Abilify Tabs PS Otsuka Drug Interaction Pharmaceutical Hallucination Company, Ltd. Seroquel I Date:08/29/03ISR Number: 4175730-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12363263 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Sinemet Cr Tabs PS Bristol-Myers Squibb Hospitalization - Syndrome Company ORAL "at bedtime" Initial or Prolonged Renal Failure Carbidopa + Levodopa Tabs SS Bristol-Myers Squibb 22-Feb-2006 08:31 AM Page: 754 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company ORAL narrative stated "20, once a day" and daily dose block on Quetiapine Fumarate SS Date:08/29/03ISR Number: 4181119-XReport Type:Expedited (15-DaCompany Report #2003UW10739 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Professional Date:08/29/03ISR Number: 4182149-4Report Type:Expedited (15-DaCompany Report #2003UW10690 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Seroquel PS 200 MG AM AND Professional 400 HS Mellaril C Date:08/29/03ISR Number: 4182151-2Report Type:Expedited (15-DaCompany Report #2003UW10122 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Seroquel PS ORAL 1500 MG QD PO Hospitalization - Convulsion Professional Initial or Prolonged Intentional Overdose Loss Of Consciousness Vomiting Date:08/29/03ISR Number: 4182153-6Report Type:Expedited (15-DaCompany Report #2003UW10642 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Consumer Seroquel PS BEING WEANED Initial or Prolonged Oropharyngeal Swelling OFF Pyrexia Geodon C Tremor Date:08/29/03ISR Number: 4182465-6Report Type:Expedited (15-DaCompany Report #2003UW10631 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Consumer Seroquel PS ORAL 600 MG QD PO Initial or Prolonged Arrhythmia Blood Thyroid Stimulating Hormone Electrocardiogram T Wave Inversion 22-Feb-2006 08:31 AM Page: 755 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/03ISR Number: 4182500-5Report Type:Expedited (15-DaCompany Report #2003UW10394 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Laryngeal Oedema Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:08/29/03ISR Number: 4182659-XReport Type:Expedited (15-DaCompany Report #2003AP02805 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dystonia Foreign Seroquel PS ORAL 550 MG PO Malaise Consumer Seroquel SS ORAL 650 MG PO Suicidal Ideation Other Clozapine SS ORAL 25 MG PO Clozapine SS ORAL 100 MG PO Cipramil C Epilim C Diabex C Flixotide "Allen & Hanburys" C Oxis C Ventolin C Date:09/02/03ISR Number: 4183662-6Report Type:Expedited (15-DaCompany Report #USA-2002-0001677 Age:41 YR Gender:Female I/FU:F Outcome PT Death Alopecia Hospitalization - Angiopathy Initial or Prolonged Anxiety Asthenia Back Pain Cardiac Enzymes Increased Chest Pain Coma Depressed Mood Diabetes Mellitus Disturbance In Attention Drug Ineffective Dyspnoea Emphysema Exfoliative Rash Fatigue Finger Deformity Flushing Hilar Lymphadenopathy Hyperglycaemia Hyperhidrosis Hyperventilation Hypoxia Influenza Insomnia Irritability Libido Decreased Lobar Pneumonia Lung Disorder Nausea Nervousness 22-Feb-2006 08:31 AM Page: 756 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Night Sweats Overdose Pain Report Source Product Role Manufacturer Route Dose Duration Peripheral Occlusive Consumer Oxycontin Tablets 10 Disease Health Mg(Oxycodone Pleurisy Professional Hydrochloride) Cr Portal Triaditis Other Tablet PS 10 MG Pruritus Oxycontin Tablets 20 Pulmonary Congestion Mg (Oxycodone Pulmonary Oedema Hydrochloride) Cr Pulse Absent Tablet SS 20 MG 1008 DAY Rash Pruritic Hydrocodone Somnolence Bitartrate(Similar Troponin Increased To Ind Upper Respiratory Tract 59,175)(Hydrocodone Infection Bitartrate) SS 1008 DAY Urinary Incontinence Alprazolam(Alprazola Weight Increased m) SS 1008 DAY Ephedrine(Ephedrine) SS 1008 DAY Pseudoephedrine(Pseu doephedrine) SS 1008 DAY Effexor (Venlafaxine Hydrochloride) SS 75 MG, DAILY 1008 DAY Codeine (Codeine) SS 1008 DAY Neurontin (Gabapentin) SS 100 MG, TID 1008 DAY Metoclopramide (Metoclopramide) SS 1008 DAY Quetiapine (Quetiapine) SS 1008 DAY Claritin (Loratadine) C Vitamin C (Ascorbic Acid) C Celebrex (Celecoxib) C Prilosec (Omeprazole) C Daypro (Oxaprozin) C Trandate (Labetalol Hydrochloride) C Axid (Nizatidine) C Paxil (Paroxetine Hydrochloride) C Medrol (Methylprednisolone) C Macro Antioxidant (Ascorbic Acid, Cystine, Tocopherol, Calcium Ascorbate, Betacarotene, C Zocor (Simvastatin) C Risperidal (Risperidone) C Fioricet (Butalbital) C Flonase (Fluticasone Propionate) C Phenobarbital (Phenobarbital) C Donnatal (Atropine Sulfate, Hyoscine 22-Feb-2006 08:31 AM Page: 757 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrobromide, Hyoscyamine Sulfate, Phenobarbital) C Bellergal-S (Belladonna Alkaloids, Ergotamine Tartrate, Phenobarbital) C Weight Loss Supplement (Does Not Code) C Ibuprofen C Ambien (Zolpidem Tartrate) C Baclofen (Baclofen) C Trandate (Labetalol Hydrochloride) C Celexa (Citalopram Hydrobromide) C Cortisone (Cortisone) C Atarax (Hydroxyzine Hydrochloride) C Proventil Tablet (Salbutamol Sulfate) C Amitriptyline (Amitriptyline) C Cyclobenzaprine (Cyclobenzaprine) C Augmentin (Amoxicillin Trihydrate, Clavulanate Potassium) C Ergobel (Nicergoline) C Glucotrol Xl (Glipizide) Tablet C Humuline Nph (Insulin Human Injection, Isophane) Injectable C Capoten Tablet C Albuterol (Salbutamol) Inhaler C Azmacort (Triamcinolone Acetonide) Inhaler C Aciphex (Rabeprazole Sodium) Tablet C Seroquel (Quetiapine) Tablet C Date:09/02/03ISR Number: 4183729-2Report Type:Expedited (15-DaCompany Report #2003033325 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Sertraline Initial or Prolonged Galactorrhoea Health (Sertraline) PS ORAL 200 MG Professional (DAILY), ORAL Quetiapine 22-Feb-2006 08:31 AM Page: 758 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Quetiapine) SS ORAL 400 MG (DAILY), ORAL Vitamins Nos (Vitamins Nos) C Date:09/03/03ISR Number: 4179565-3Report Type:Direct Company Report #CTU 201168 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Quetiapine 25mg Intervention to Aggression Astra-Zeneca PS Astra-Zeneca ORAL 25MG QHS ORAL Prevent Permanent Arthralgia Impairment/Damage Confusional State Disorientation Dizziness Feeling Drunk Headache Hypersomnia Memory Impairment Micturition Frequency Decreased Muscle Rigidity Myalgia Night Sweats Pyrexia Syncope Urinary Hesitation Urinary Incontinence Date:09/03/03ISR Number: 4184391-5Report Type:Expedited (15-DaCompany Report #2003UW10394 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Laryngeal Oedema Foreign Seroquel PS ORAL 800 MG PO Intervention to Health Lamotrigine C Prevent Permanent Professional Neurontin C Impairment/Damage Other Date:09/03/03ISR Number: 4184504-5Report Type:Expedited (15-DaCompany Report #2003AP02246 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Foreign Seroquel PS ORAL 100 MG DAILY Hospitalization - Blood Glucose Increased Health PO Initial or Prolonged Catheter Related Professional Limas C Infection Other Prednisolone C Depressed Level Of Rivotril C Consciousness Depakene C Diarrhoea Eurodin C Dizziness Postural Bufferin C Hyperinsulinaemia Gaster C Hypoglycaemia Lipitor C Hypothyroidism Basen C Mania Humalog C Pyrexia Aldactone C Staphylococcal Infection Lasix C Weight Decreased 22-Feb-2006 08:31 AM Page: 759 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/03ISR Number: 4184526-4Report Type:Expedited (15-DaCompany Report #2003UW10805 Age:13 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS Decreased Professional Depakote C Ritalin C Date:09/03/03ISR Number: 4184890-6Report Type:Expedited (15-DaCompany Report #2003UW10892 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Legal Problem Foreign Seroquel PS ORAL 16 G ONCE PO Overdose Health Lithium C Professional Epival C Other Imovane C Date:09/04/03ISR Number: 4178687-0Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12363263 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Sinemet Cr Tabs PS Bristol-Myers Squibb Hospitalization - Syndrome Company ORAL "at bedtime" Initial or Prolonged Renal Failure Carbidopa + Levodopa Tabs SS Bristol-Myers Squibb Company ORAL narrative stated "20, once a day" and daily dose block on Quetiapine Fumarate SS Date:09/04/03ISR Number: 4180710-4Report Type:Direct Company Report #CTU 201243 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Seroquel Zeneca PS Zeneca ORAL SEE IMAGE Increased Celexa C Body Temperature Increased Cardiac Arrest Gastrointestinal Disorder Haemodialysis Hepatic Steatosis Oedema Pancreatitis Acute Peritoneal Disorder Shock Urine Output Decreased Date:09/04/03ISR Number: 4183977-1Report Type:Expedited (15-DaCompany Report #2003SE03783 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Psoriasis Foreign Seroquel PS Intervention to Health Orfiril C Prevent Permanent Professional Tegretol C Impairment/Damage Other Haloperidol C 22-Feb-2006 08:31 AM Page: 760 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/05/03ISR Number: 4180095-3Report Type:Expedited (15-DaCompany Report #PHBS2003TR09254 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Carbamazepine PS Novartis Sector: Condition Aggravated Pharma UNKNOWN 200 mg/d Convulsion Carbamazepine SS Novartis Sector: Grand Mal Convulsion Pharma UNKNOWN 400 mg/d Quetiapine SS UNKNOWN 25 mg/d Quetiapine SS UNKNOWN 100 mg/d Quetiapine SS UNKNOWN 500 mg/d Quetiapine SS UNKNOWN 150 mg/d Quetiapine SS UNKNOWN 200 mg/d Rivastigmine C UNKNOWN 3 mg/d 40320MIN Risperidone C UNKNOWN 0.5 mg/d Rivastigmine C UNKNOWN 6 mg/d Date:09/05/03ISR Number: 4185186-9Report Type:Expedited (15-DaCompany Report #2003UW10973 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Choking Health Seroquel PS ORAL 400 MG BID PO Intervention to Professional Prevent Permanent Impairment/Damage Date:09/05/03ISR Number: 4185672-1Report Type:Expedited (15-DaCompany Report #2003AP02791 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Chest Pain Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Sinoatrial Block Health PO Prevent Permanent Professional Zyprexa C Impairment/Damage Other Date:09/05/03ISR Number: 4185798-2Report Type:Expedited (15-DaCompany Report #2003UW10892 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Foreign Seroquel PS ORAL 16 G ONCE PO Imprisonment Health Lithium C Overdose Professional Epival C Other Imovane C Date:09/08/03ISR Number: 4185925-7Report Type:Expedited (15-DaCompany Report #TCI2003A03214 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancytopenia Health Leuplin For Pyrexia Professional Injection Kit3.75 (Leuprolide Acetate) (Injection) PS SUBCUTANEOUS 3.75 MG (3.75 MG, 1 IN 28 D) SUBCUTANEOUS 5 TIMES Casodex (Bicalutamide) 22-Feb-2006 08:31 AM Page: 761 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Tablets) SS ORAL PER ORAL Seroquel (Quetiapine Fumarate) (Tablets) SS ORAL PER ORAL Voltaren (Diclofenac Sodium) (Suppository) SS RECTAL PER RECTAL Lepetan (Buprenorphine Hydrochloride) (Suppository) SS RECTAL PER RECTAL Harnal (Tamsulosin Hydrochloride) (Capsules) SS ORAL PER ORAL Loxonin (Loxoprofen Sodium) (Preparation For Oral Use (Nos) ) C ORAL PER ORAL Date:09/09/03ISR Number: 4181233-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU01282 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Clozaril PS Novartis Sector: Pharma 25mg - 550 mg Citalopram SS Quetiapine SS Paracetamol SS Date:09/09/03ISR Number: 4181273-XReport Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0411363A Age:47 YR Gender:Male I/FU:F Outcome PT Death Abdominal Pain Agitation Anger Arrhythmia Asthenia Bilirubin Conjugated Increased Blood Calcium Increased Blood Chloride Decreased Blood Creatine Phosphokinase Increased Blood Phosphorus Increased Blood Potassium Increased Blood Pressure Increased Blood Sodium Decreased Blood Test Abnormal Cardiac Arrest Cardiomegaly Chest Pain Confusional State Cough Cyanosis Decreased Appetite Disturbance In Attention Drug Ineffective Dyspnoea Electrocardiogram Qrs Complex Abnormal 22-Feb-2006 08:31 AM Page: 762 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram Qrs Complex Prolonged Fatigue Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Parnate PS Glaxosmithkline ORAL 10MG Three Flat Affect times per day Headache Seroquel SS 300MG Twice Hyperhidrosis per day Hyperthermia Malignant Clozapine C Hyperventilation Effexor C Hypoglycaemia Hypotension Irritability Leukocytosis Memory Impairment Mental Status Changes Muscle Contractions Involuntary Muscle Twitching Neck Pain Neuroleptic Malignant Syndrome Oliguria Overdose Oxygen Saturation Decreased Pain Pulmonary Hypertension Pulse Absent Pyrexia Respiratory Rate Increased Restlessness Tachycardia Tremor Ventricular Hypertrophy Date:09/09/03ISR Number: 4187458-0Report Type:Expedited (15-DaCompany Report #AU_030806643 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Foreign Zyprexa-Oral Hospitalization - Myocarditis Health (Olanzapine) Initial or Prolonged Professional (Olanzapine) PS 20 MG/DAY Company Seroquel (Quetiapine Representative Fumarate) SS Other Date:09/09/03ISR Number: 4188268-0Report Type:Expedited (15-DaCompany Report #2003UW10999 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Ulcer Health Seroquel PS 800 MG DAILY Initial or Prolonged Haemorrhage Professional Seroquel SS 1200 MG DAILY Prothrombin Time Coumadin C Prolonged Pentasa C Zyprexa C Loxapine C Trazodone C Clonazepam C 22-Feb-2006 08:31 AM Page: 763 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mercaptopurine C Bentyl C Amitriptyline C Date:09/09/03ISR Number: 4188270-9Report Type:Expedited (15-DaCompany Report #2003UW10975 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Choking Health Seroquel PS ORAL 300 MG BID PO Intervention to Professional Prevent Permanent Impairment/Damage Date:09/09/03ISR Number: 4188271-0Report Type:Expedited (15-DaCompany Report #2003UW10976 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Health Seroquel PS ORAL 700 MG DAILY Initial or Prolonged Choking Professional PO Date:09/10/03ISR Number: 4188799-3Report Type:Expedited (15-DaCompany Report #2003GB00992 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Foreign Seroquel PS ORAL 50 MG ONCE PO Hypotension Health Fluoxetine SS 20 MG QD Professional Risperidone C Other High Dose Neuroleptics C Date:09/10/03ISR Number: 4188800-7Report Type:Expedited (15-DaCompany Report #2003AP02486 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Seroquel PS ORAL 150 MG DAILY Initial or Prolonged Liver Disorder Health PO Required Professional Seroquel SS ORAL 225 MG DAILY Intervention to Other PO Prevent Permanent Seroquel SS ORAL 350 MG DAILY Impairment/Damage PO Toledomin SS ORAL 15 MG BID PO Pacyl C Lendormin C Silece C Tetramide C Ancaron C Pletaal C Pursennid C Magnesium Oxide C Biofermin C Blopress C Gascon C Gaster C 22-Feb-2006 08:31 AM Page: 764 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/03ISR Number: 4188801-9Report Type:Expedited (15-DaCompany Report #2003AP02246 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Foreign Seroquel PS ORAL 100 MG DAILY Hospitalization - Blood Glucose Increased Health PO Initial or Prolonged Catheter Site Erythema Professional Limas C Required Catheter Site Infection Other Prednisolone C Intervention to Depressed Level Of Rivotril C Prevent Permanent Consciousness Depakene C Impairment/Damage Diabetes Mellitus Eurodin C Diarrhoea Bufferin C Dizziness Postural Gaster C Glucose Tolerance Lipitor C Impaired Basen C Hyperinsulinaemia Humalog C Hypothyroidism Aldactone C Mania Lasix C Pancreatic Islets Hyperplasia Pyrexia Weight Decreased Date:09/11/03ISR Number: 4185886-0Report Type:Direct Company Report #CTU 201656 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS ORAL 100 MG PO Date:09/11/03ISR Number: 4189350-4Report Type:Expedited (15-DaCompany Report #2003SE03510 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hepatitis Foreign Seroquel PS ORAL 400 MG DAILY Required Health PO Intervention to Professional Flurazepam C Prevent Permanent Other Impairment/Damage Date:09/11/03ISR Number: 4189351-6Report Type:Expedited (15-DaCompany Report #2003SE03869 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS ORAL 400 MG BID PO Depression Health Seroquel SS ORAL 20000 MG ONCE Intentional Overdose Professional PO Multiple Sclerosis Other Seroquel SS ORAL 100 MG BID PO Relapse Lorazepam SS ORAL 7.5 MG TID PO Suicide Attempt Date:09/11/03ISR Number: 4189519-9Report Type:Expedited (15-DaCompany Report #2003UW11210 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coma Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 765 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/03ISR Number: 4189520-5Report Type:Expedited (15-DaCompany Report #2003UW11209 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coma Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:09/12/03ISR Number: 4190305-4Report Type:Expedited (15-DaCompany Report #2003AP03058 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 25 MG BID PO Health Professional Other Date:09/15/03ISR Number: 4190769-6Report Type:Expedited (15-DaCompany Report #2003AP02510 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 25 MG TID PO Initial or Prolonged Convulsion Health Seroquel SS ORAL 25 MG QID PO Required Dyskinesia Professional Seroquel SS ORAL 125 MG DAILY Intervention to Electroencephalogram Other PO Prevent Permanent Abnormal Toledomin C Impairment/Damage Face Injury Silece C Loss Of Consciousness Benzalin C Pyrexia Tachycardia Date:09/15/03ISR Number: 4190817-3Report Type:Expedited (15-DaCompany Report #2003AP03058 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 25 MG BID PO Health Professional Other Date:09/16/03ISR Number: 4191122-1Report Type:Expedited (15-DaCompany Report #2003AP02454 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS ORAL 50 MG BID PO Intervention to Anxiety Study Seroquel SS ORAL 200 MG BID PO Prevent Permanent Drug Ineffective Health Pantosin C Impairment/Damage Insomnia Professional Tasmolin C Logorrhoea Other Adalat C Mania Depas C Suicidal Ideation 22-Feb-2006 08:31 AM Page: 766 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/03ISR Number: 4191403-1Report Type:Expedited (15-DaCompany Report #2003PK00792 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Foreign Seroquel PS ORAL 400 MG DAILY Exposure To Therapeutic Health PO Drugs Professional Seroquel SS ORAL 300 MG DAILY Varicella Other PO Weight Increased Zyprexa C Date:09/17/03ISR Number: 4191405-5Report Type:Expedited (15-DaCompany Report #2003AP00245 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atelectasis Foreign Seroquel PS ORAL 24 G PO Blood Glucose Fluctuation Health Diazepam SS 2 G Candidiasis Professional Cardiotoxicity Other Collapse Of Lung Coma Consciousness Fluctuating Fungus Sputum Test Positive Grand Mal Convulsion Haemodialysis Hypertension Hypothermia Hypoventilation Intentional Overdose Lactic Acidosis Renal Failure Renal Tubular Necrosis Sepsis Shock Stridor Wheezing Date:09/17/03ISR Number: 4193380-6Report Type:Expedited (15-DaCompany Report #2003AP00095 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS ORAL 150 MG DAILY Intervention to Delusion Health PO Prevent Permanent Diabetes Mellitus Professional Seroquel SS ORAL 300 MG DAILY Impairment/Damage Hallucination Other PO Hepatic Function Abnormal Seroquel SS ORAL 400 MG DAILY Hepatic Steatosis PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 150 MG DAILY PO Chlorpromazine Hydrochloride SS Risperidone SS ORAL 2 MG DAILY PO Risperidone SS ORAL 6 MG DAILY PO Haloperidol C Biperiden Hydrochloride C 22-Feb-2006 08:31 AM Page: 767 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levomepromazine Maleate C Nitrazepam C Promethasone C Olanzapine C Mexazolam C Date:09/18/03ISR Number: 4193756-7Report Type:Direct Company Report #CTU 202049 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypotonia Seroquel Intervention to Syncope (Quetiapine) PS ORAL 300 MG PO BID Prevent Permanent Impairment/Damage Date:09/22/03ISR Number: 4193576-3Report Type:Expedited (15-DaCompany Report #2003UW00170 Age:4 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eczema Health Seroquel PS ORAL 200 MG BID PO Required Feeling Abnormal Professional Intervention to Flat Affect Prevent Permanent Medication Error Impairment/Damage Psoriasis Date:09/22/03ISR Number: 4193878-0Report Type:Expedited (15-DaCompany Report #2003UW11441 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Health Seroquel PS Intervention to Maternal Drugs Affecting Professional Prevent Permanent Foetus Impairment/Damage Neonatal Disorder Neonatal Tachycardia Respiratory Rate Increased Date:09/22/03ISR Number: 4195034-9Report Type:Direct Company Report #CTU 202157 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Obstructive Seroquel 25 Mg Pulmonary Disease Astra Zeneca PS Astra Zeneca ORAL 25 MG HS Hypotension ORAL Respiratory Failure Dopamine Drip C Date:09/22/03ISR Number: 4195088-XReport Type:Expedited (15-DaCompany Report #2003AP03135 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 100 MG DAILY Multiple Drug Overdose Health PO Shock Professional Seroquel SS ORAL 700 MG ONCE Other PO Toledomin SS 22-Feb-2006 08:31 AM Page: 768 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paxil SS Epirenat SS Pursennid SS Date:09/22/03ISR Number: 4195091-XReport Type:Expedited (15-DaCompany Report #2003UW11535 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Vitamin B12 Deficiency Foreign Seroquel PS Initial or Prolonged Health Professional Other Date:09/22/03ISR Number: 4195303-2Report Type:Expedited (15-DaCompany Report #2003AP03124 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Activated Partial Foreign Quetiapine PS ORAL 12000 MG PO Disability Thromboplastin Time Literature Diazepam SS ORAL 70 MG PO Arm Amputation Health Brain Oedema Professional Clonus Other Decubitus Ulcer Depressed Level Of Consciousness Electrocardiogram Qt Corrected Interval Prolonged Heart Rate Increased Hyperreflexia Liver Function Test Abnormal Metabolic Acidosis Miosis Myoglobin Urine Present Neutrophilia Overdose Pseudomonas Infection Respiratory Rate Increased Respiratory Tract Infection Sinus Tachycardia Staphylococcal Infection Stupor Tachycardia Date:09/22/03ISR Number: 4195306-8Report Type:Expedited (15-DaCompany Report #2003PK01557 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Cleft Lip Foreign Seroquel PS TRANSPLACENTAL 400 MG DAILY Hyperbilirubinaemia Health TPL Neonatal Professional Seroquel SS TRANSPLACENTAL 300 MG DAILY Hypoglycaemia Neonatal Other TPL Maternal Drugs Affecting Zyprexa C Foetus Neonatal Disorder 22-Feb-2006 08:31 AM Page: 769 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/03ISR Number: 4195309-3Report Type:Expedited (15-DaCompany Report #2003AP02778 Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Pallor Health PO Prevent Permanent Ventricular Extrasystoles Professional Seroquel SS ORAL 25 MG BID PO Impairment/Damage Other Seroquel SS ORAL 25 MG BID PO Seroquel SS ORAL 25 MG TID PO Seroquel SS ORAL 25 MG QID PO Seroquel SS ORAL 25 MG BID PO Seroquel SS ORAL 25 MG TID PO Rhythmy C Laxoberon C Proctosedyl "Hoechst" C Hoechst Herbal Preparation C Date:09/22/03ISR Number: 4195990-9Report Type:Expedited (15-DaCompany Report #S03-UKI-03885-01 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Foreign Cipramil (Citalopram Drug Interaction Health Hydrobromide) PS ORAL 60 MG QD PO Vaginal Discharge Professional Seroquel (Quetiapine Other Fumarate) SS ORAL 25 MG BID PO Depakote (Valproate Semisodium) SS ORAL 1500 MG QD PO Date:09/22/03ISR Number: 4196054-0Report Type:Expedited (15-DaCompany Report #2003UW11451 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS Consumer Other Date:09/22/03ISR Number: 4196055-2Report Type:Expedited (15-DaCompany Report #2003GB02482 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diarrhoea Foreign Seroquel PS 25MG-150MG Intervention to Drug Interaction Health TWICE DAILY Prevent Permanent Professional Cipramil SS ORAL 60 MG DAILY Impairment/Damage Other PO Depakote SS ORAL 1500 MG DAILY PO Date:09/22/03ISR Number: 4196057-6Report Type:Expedited (15-DaCompany Report #2003AP03199 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Chorea Foreign Seroquel PS ORAL 150 MG DAILY Intervention to Convulsion Health PO Prevent Permanent Dysphasia Professional Avanza SS ORAL 60 MG DAILY Impairment/Damage Orthostatic Hypotension Other PO Syncope Effexor Xr SS ORAL 75 MG DAILY PO 22-Feb-2006 08:31 AM Page: 770 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/03ISR Number: 4196236-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030802503 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Osmolarity Foreign Risperidone Initial or Prolonged Bone Marrow Depression Health (Risperidone) Other Feeling Abnormal Professional Unspecified PS ORAL 4 MG 1 IN 1 Microcytic Anaemia DAY ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) Unknown SS ORAL 8 MG 1 IN 1 DAY ORAL Sulpiride (Sulpiride) SS ORAL 150 MG 1 IN 1 DAY ORAL Quetiapine Fumarate (Quetiapine Fumarate) Tablets SS ORAL 100 MG 1 IN 1 DAY ORAL Flunitrazepam (Flunitrazepam) SS ORAL 2 MG 1 IN 1 DAY ORAL Quazepam (Quazepam) SS ORAL 30 MG 1 IN 1 DAY ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL 25 MG 1 IN 1 DAY ORAL Date:09/24/03ISR Number: 4195444-XReport Type:Direct Company Report #CTU 202396 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Quetiapine 100 Mg PS ORAL 100 MG TID Initial or Prolonged Fall ORAL Hypoaesthesia Hypokinesia Muscle Spasms Date:09/24/03ISR Number: 4197708-2Report Type:Expedited (15-DaCompany Report #2003AP03118 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bradycardia Foreign Tenormin PS ORAL 100 MG DAILY Intervention to Circulatory Collapse Health PO Prevent Permanent Dehydration Professional Seroquel SS ORAL 400 MG DAILY Impairment/Damage Dizziness Other PO Faeces Discoloured Tegretol SS ORAL 200 MG DAILY Hyperkalaemia PO Hypotension Lithium C Renal Impairment Largactil C Modecate "Sanofi Winthrop" C Tazac C Lipitor C 22-Feb-2006 08:31 AM Page: 771 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/03ISR Number: 4198361-4Report Type:Expedited (15-DaCompany Report #2003UW11902 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Screen False Health Seroquel PS ORAL 25 MG BID PO Positive Professional Overdose Date:09/24/03ISR Number: 4198911-8Report Type:Expedited (15-DaCompany Report #03P-167-0233590-00 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diarrhoea Foreign Depakote (Divalproex Intervention to Drug Interaction Health Sodium) (Divalproex Prevent Permanent Professional Sodium) PS ORAL PER ORAL Impairment/Damage Quetiapine (Quetiapine) SS ORAL 2 IN 1 D, PER ORAL Citalopram Hydrobromide SS ORAL PER ORAL Date:09/24/03ISR Number: 4199227-6Report Type:Expedited (15-DaCompany Report #2003SE03510 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hepatic Function Abnormal Foreign Seroquel PS ORAL 400 MG DAILY Required Health PO Intervention to Professional Flurazepam C Prevent Permanent Other Impairment/Damage Date:09/24/03ISR Number: 4199233-1Report Type:Expedited (15-DaCompany Report #2003SE03869 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS ORAL 400 MG BID PO Intentional Overdose Health Seroquel SS ORAL 20000 MG ONCE Suicide Attempt Professional PO Other Seroquel SS ORAL 100 MG BID PO Lorazepam SS ORAL 7.5 MG TID PO Date:09/24/03ISR Number: 4199235-5Report Type:Expedited (15-DaCompany Report #2003UW11775 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Rapid Eye Movements Sleep Foreign Seroquel PS ORAL 12.5 MG DAILY Abnormal Health PO Professional Topamax C Other Lamictal C Synthroid C Ativan C Zantac C Florinef C 22-Feb-2006 08:31 AM Page: 772 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/03ISR Number: 4199254-9Report Type:Expedited (15-DaCompany Report #2003AP03237 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Seroquel PS NI Initial or Prolonged Electrocardiogram T Wave Health Clozapril SS ORAL 300 MG DAILY; Inversion Professional PO Heart Rate Increased Other Myocarditis Pericardial Effusion Pleuritic Pain Pyrexia Ventricular Dysfunction Vomiting Date:09/24/03ISR Number: 4199808-XReport Type:Expedited (15-DaCompany Report #2003SE04084 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Complication Foreign Seroquel PS Pulmonary Embolism Health Seroquel SS ORAL 1000 MG DAILY Sudden Death Professional PO Other Risperdal SS INTRAMUSCULAR 50 MG BIWK IM Cardace C Primaspan C Atarax C Temesta C Obsidan C Insulin C Date:09/24/03ISR Number: 4199809-1Report Type:Expedited (15-DaCompany Report #2003AP03202 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatitis Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Leukopenia Other PO Prevent Permanent Lymphopenia Impairment/Damage Neutropenia Thrombocytopenia Date:09/24/03ISR Number: 4199810-8Report Type:Expedited (15-DaCompany Report #2003AP03182 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Seroquel PS Initial or Prolonged Neutropenia Health Chlorpromazine White Blood Cell Count Professional Hydrochloride SS ORAL 100 MG DAILY Other PO Droperidol SS INTRAMUSCULAR 10 MG ONCE IM Date:09/25/03ISR Number: 4196770-0Report Type:Direct Company Report #CTU 202504 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arthralgia Quetiapine 100 Mg Intervention to Asthenia Astra Zeneca PS Astra Zeneca ORAL 100 MG PO AND Prevent Permanent Balance Disorder 200 MG PM Impairment/Damage Dizziness 22-Feb-2006 08:31 AM Page: 773 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/03ISR Number: 4196773-6Report Type:Direct Company Report #CTU 202506 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Seroquel 100 Mg Intervention to Dyspnoea Paroxysmal Astra Zeneca PS Astra Zeneca ORAL 100 MG AM PO Prevent Permanent Nocturnal - 300 MG PM Impairment/Damage Date:09/25/03ISR Number: 4196868-7Report Type:Direct Company Report #CTU 202478 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Seroquel PS ORAL 10 TABS, PO X Hospitalization - Body Temperature 1 Initial or Prolonged Chest Pain Electrocardiogram Qt Corrected Interval Prolonged Heart Rate Hyperhidrosis Hypotension Oxygen Saturation Respiratory Rate Suicide Attempt Date:09/25/03ISR Number: 4199552-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904715 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Areflexia Literature Topamax (Topiramate) PS ORAL ORAL Hospitalization - Cardiac Arrest Health Verapamil Initial or Prolonged Completed Suicide Professional (Verapamil) SS ORAL ORAL Drug Toxicity Distributor Acetaminophen Haemodynamic Instability (Paracetamol) SS ORAL ORAL Hypotension Propranolol Mental Status Changes (Propranolol) SS ORAL ORAL Miosis Hydroxychloroquine Overdose (Hydroxychloroquine) SS ORAL ORAL Prothrombin Time Naproxen (Naproxen) SS ORAL ORAL Prolonged Hydrocodone (Hydrocodone) SS ORAL ORAL Warfarin (Warfarin) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL Butalbital (Butalbital) SS ORAL ORAL Caffeine (Caffeine) SS ORAL ORAL Date:09/25/03ISR Number: 4200582-9Report Type:Expedited (15-DaCompany Report #2003GB01471 Age: Gender:Female I/FU:F Outcome PT Hospitalization - Agitation Neonatal Initial or Prolonged Cyanosis Neonatal Required Developmental Delay Intervention to Drug Withdrawal Syndrome Prevent Permanent Neonatal Impairment/Damage Feeding Disorder Neonatal 22-Feb-2006 08:31 AM Page: 774 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fever Neonatal Hypertonia Neonatal Maternal Drugs Affecting Report Source Product Role Manufacturer Route Dose Duration Foetus Foreign Seroquel PS TRANSPLACENTAL 150 MG QID Nasal Flaring Health TPL Neonatal Disorder Professional Lorazepam SS TRANSPLACENTAL 2 MG TID TPL Neonatal Respiratory Other Distress Syndrome Oxygen Saturation Decreased Respiratory Disorder Neonatal Respiratory Rate Increased Weight Decreased Weight Gain Poor Date:09/25/03ISR Number: 4200659-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030904254 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Foreign Risperidone Initial or Prolonged Insomnia Health (Risperidone) Oedema Professional Unspecified PS ORAL 2 MG IN 1 DAY Sluggishness ORAL Stevens-Johnson Syndrome Quetiapine (Quetiapine) Unknown SS ORAL 2 MG IN 1 DAY ORAL Date:09/25/03ISR Number: 4200713-0Report Type:Expedited (15-DaCompany Report #2003UW10563 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Seroquel PS ORAL 400 MG DAILY Hepatic Cirrhosis Professional PO Medication Error Methadone C Pulmonary Congestion Zoloft C Pulmonary Oedema Date:09/25/03ISR Number: 4200922-0Report Type:Expedited (15-DaCompany Report #2003GB02388 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Seroquel PS PT ON Health SEROQUEL FOR Professional 2-3 WEEKS Other Digoxin C Warfarin C Atenolol C Date:09/26/03ISR Number: 4197110-3Report Type:Direct Company Report #CTU 202721 Age:27 YR Gender:Male I/FU:I Outcome Life-Threatening Required Intervention to 22-Feb-2006 08:31 AM Page: 775 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Arrhythmia Seroquel 50 Mg Po Hs Atrial Fibrillation Astra Zeneca PS Astra Zeneca ORAL 50 MG PO HS Atrial Tachycardia Lexapro C Atrioventricular Block Ambien C Nodal Rhythm Sinus Arrest Sinus Tachycardia Syncope Date:09/26/03ISR Number: 4199350-6Report Type:Expedited (15-DaCompany Report #2003AP03253 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ecchymosis Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Fall Health PO Femur Fracture Professional Risperdal SS 0.5 MG DAILY Hallucination, Visual Other Hyperpyrexia Date:09/26/03ISR Number: 4199399-3Report Type:Expedited (15-DaCompany Report #2003UW11911 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Other Seroquel PS ORAL 100 MG PO Required Medication Error Seroquel SS Intervention to Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4200278-3Report Type:Expedited (15-DaCompany Report #2003GB02580 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Seroquel PS ORAL 550 MG DAILY Convulsion Health PO Loss Of Consciousness Professional Seroquel SS OVERDOSE Overdose Other Effexor SS Date:09/26/03ISR Number: 4209500-0Report Type:Periodic Company Report #2002UW11582 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Other Seroquel PS ORAL 100 MG QD PO Initial or Prolonged Clozapine SS 25 TO 50 MG DAILY Depakote SS 500 MG BID Date:09/26/03ISR Number: 4209511-5Report Type:Periodic Company Report #2002UW11650 Age:32 YR Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 776 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Seroquel PS ORAL 300 MG DAILY Professional PO Divalproex C Venlafaxine C Lorazepam C Date:09/26/03ISR Number: 4209517-6Report Type:Periodic Company Report #2002UW11701 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Unspecified Prevent Permanent Antipsychotic Drug C Impairment/Damage Date:09/26/03ISR Number: 4209519-XReport Type:Periodic Company Report #2002UW11716 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Thrombocytopenia Professional PO Seroquel SS ORAL 1100 MG DAILY PO Date:09/26/03ISR Number: 4209521-8Report Type:Periodic Company Report #2002UW11723 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Health Seroquel PS ORAL 200 MG PO Intervention to Tardive Dyskinesia Professional Seroquel SS ORAL 25 MG PO Prevent Permanent Eskalith C Impairment/Damage Zyprexa C Navane C Date:09/26/03ISR Number: 4209522-XReport Type:Periodic Company Report #2002UW11872 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 200 MG PO Intervention to Professional Seroquel SS ORAL 400 MG PO Prevent Permanent Seroquel SS ORAL 600 MG DAILY Impairment/Damage PO Serzone SS 100 MG HS Celexa SS 60 MG QAM Skelaxin SS Topamax C Risperdal C Depakote C 22-Feb-2006 08:31 AM Page: 777 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4209526-7Report Type:Periodic Company Report #2002UW12134 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4209527-9Report Type:Periodic Company Report #2002UW12184 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Syndrome Professional PO Seroquel SS Risperdal C Zyprexa C Tegretol C Date:09/26/03ISR Number: 4209533-4Report Type:Periodic Company Report #2002UW12356 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 800 MG DAILY Intervention to Professional PO Prevent Permanent Prempro C Impairment/Damage Vitamin E C Propranolol C Wellbutrin C Celexa C Buspar C Synthroid C Claritin C Mobic C Asa C Botox C Glucosamine C Risperdal C Effexor-Xr C Feldene C Cogentin C Lorazepam C Achiphex C Date:09/26/03ISR Number: 4209536-XReport Type:Periodic Company Report #2002UW12659 Age:11 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Health Seroquel PS Intervention to Professional Risperdal SS Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 778 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4209606-6Report Type:Periodic Company Report #2003UW08686 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Health Seroquel PS Intervention to Syndrome Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4209608-XReport Type:Periodic Company Report #2003UW09017 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Consumer Seroquel PS Intervention to Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4209609-1Report Type:Periodic Company Report #2003UW09107 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Professional PO Date:09/26/03ISR Number: 4209611-XReport Type:Periodic Company Report #2003UW09257 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Neuroleptic Malignant Professional Clozapine SS ORAL 100 MG BID PO Required Syndrome Intervention to Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4209612-1Report Type:Periodic Company Report #2003UW09284 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 100 MG QID PO Intervention to Professional Luvox C Prevent Permanent Anafarnil C Impairment/Damage Lorazepam C Trazodone C Date:09/26/03ISR Number: 4209614-5Report Type:Periodic Company Report #2003UW09332 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 779 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4209617-0Report Type:Periodic Company Report #2003UW09378 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel PS 150 MG DAILY Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4209618-2Report Type:Periodic Company Report #2003UW09478 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Professional PO Date:09/26/03ISR Number: 4209620-0Report Type:Periodic Company Report #2003UW09443 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS RAPIDLY Intervention to Professional TITRATED OVER Prevent Permanent 2-3 DAYS Impairment/Damage Date:09/26/03ISR Number: 4209622-4Report Type:Periodic Company Report #2003UW08453 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Health Seroquel PS 50 TABS Initial or Prolonged Overdose Professional INGESTED Sedation Trazodone SS 20 PILLS Suicide Attempt INGESTED Date:09/26/03ISR Number: 4209731-XReport Type:Periodic Company Report #2002UW14401 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depression Health Seroquel PS ORAL 300 MG BID PO Intervention to Psychotic Disorder Professional Remeron C Prevent Permanent Tardive Dyskinesia Impairment/Damage Date:09/26/03ISR Number: 4209736-9Report Type:Periodic Company Report #2002UW14402 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Seroquel PS ORAL 900 MG DAILY Initial or Prolonged Professional PO Date:09/26/03ISR Number: 4209739-4Report Type:Periodic Company Report #2002UW14698 Age:62 YR Gender:Male I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 780 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cataract Health Seroquel PS ORAL 300 MG DAILY Professional PO Klonopin C Prilosec C Paxil C Haldol "Janssen" C Depakote C Isosorbide C Synthroid C Mellaril C Lithium C Prozac C Date:09/26/03ISR Number: 4209743-6Report Type:Periodic Company Report #2002UW14829 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Health Seroquel PS ORAL 300 MG BIDPO Intervention to Syndrome Professional Seroquel SS ORAL 200 MG BID PO Prevent Permanent Haldol "Mcneil" SS "Mcneil" 5 MG PRN Impairment/Damage Depakote C Neurontin C Date:09/26/03ISR Number: 4209747-3Report Type:Periodic Company Report #2002UW15084 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Seroquel PS ORAL 2200 MG PO Initial or Prolonged Professional Date:09/26/03ISR Number: 4209750-3Report Type:Periodic Company Report #2002UW15128 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel PS ORAL 10 MG DAILY Intervention to Professional PO Prevent Permanent Paxil C Impairment/Damage Date:09/26/03ISR Number: 4209754-0Report Type:Periodic Company Report #2002UW15292 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Health Seroquel PS Intervention to Tardive Dyskinesia Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 781 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4209757-6Report Type:Periodic Company Report #2002UW15293 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grand Mal Convulsion Health Seroquel PS ORAL 25 MG DAILY Intervention to Professional PO Prevent Permanent Prozac C Impairment/Damage Date:09/26/03ISR Number: 4209759-XReport Type:Periodic Company Report #2002UW15325 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Professional PO 6 MON Seroquel SS ORAL 200 MG DAILY PO Clonopin C Wellbutrin C Date:09/26/03ISR Number: 4209762-XReport Type:Periodic Company Report #2002UW15334 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Health Seroquel PS Initial or Prolonged Professional Date:09/26/03ISR Number: 4210225-6Report Type:Periodic Company Report #2002AP04499 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Sedation Literature Quetiapine Fumarate PS 25 MG DAILY Intervention to Health Prevent Permanent Professional Impairment/Damage Date:09/26/03ISR Number: 4210246-3Report Type:Periodic Company Report #2002UW16491 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Seroquel PS ORAL 150 MG DAILY Initial or Prolonged Fatigue Professional PO Required Risperdal C Intervention to Cogentin C Prevent Permanent Serzone C Impairment/Damage Date:09/26/03ISR Number: 4210258-XReport Type:Periodic Company Report #2002AP04306 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Literature Quetiapine PS Health Oxycontin SS ORAL 120 MG DAILY Professional PO Diphenhydramine SS Promethazine SS Risperidone SS 22-Feb-2006 08:31 AM Page: 782 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Venlafaxine C Propoxyphene C Zaleplon C Carisoprodol C Hydrocodone C Propranolol C Clonazepam C Chlorpromazine C Gabapentin C Date:09/26/03ISR Number: 4210261-XReport Type:Periodic Company Report #2002AP04001 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Literature Quetiapine PS Intervention to Health Divalproex Sodium SS Prevent Permanent Professional Impairment/Damage Date:09/26/03ISR Number: 4210263-3Report Type:Periodic Company Report #2001UW14580 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Seroquel "Zeneca" PS Zeneca ORAL 50 MG TID PO Initial or Prolonged Professional Seroquel "Zeneca" SS Zeneca ORAL 25 MG TID PO Risperdal C Date:09/26/03ISR Number: 4210265-7Report Type:Periodic Company Report #1998UW47645 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Literature Seroquel PS ORAL 200 MG BID PO Intervention to Neutropenia Health Seroquel SS ORAL 200 MG DAILY Prevent Permanent Thrombocytopenia Professional PO Impairment/Damage Olanzapine SS 10 MG DAILY Risperdal C Date:09/26/03ISR Number: 4210267-0Report Type:Periodic Company Report #2002UW16567 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Status Changes Health Clozapine Vs Blinded Initial or Prolonged Professional Code Not Broken PS Seroquel SS ORAL 100 MG PO Protonix C Ativan C Imitrex "Cerenex" C Wellbutrin C Buspar C Date:09/26/03ISR Number: 4210268-2Report Type:Periodic Company Report #2003AP01288 Age:29 YR Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 783 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Sedation Literature Quetiapine PS ORAL 25 MG DAILY Health PO Professional Olanzapine C Sertraline C Valproic Acid C Venlafaxine C Date:09/26/03ISR Number: 4210271-2Report Type:Periodic Company Report #2003AP01283 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Sedation Literature Quetiapine PS Intervention to Health Carbamazepine C Prevent Permanent Professional Clonazepam C Impairment/Damage Date:09/26/03ISR Number: 4210277-3Report Type:Periodic Company Report #2003AP01203 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Literature Quetiapine PS ORAL 1250 MG ONCE Hospitalization - Hypotension Health PO Initial or Prolonged Intentional Overdose Professional Lethargy Tachycardia Date:09/26/03ISR Number: 4210279-7Report Type:Periodic Company Report #2002UW17482 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Seroquel PS ORAL 200 MG PO Initial or Prolonged Professional Date:09/26/03ISR Number: 4210280-3Report Type:Periodic Company Report #2002UW17283 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 700 MG PO Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210282-7Report Type:Periodic Company Report #2002UW17233 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Rigidity Consumer Seroquel PS ORAL 12.5 MG BID Initial or Prolonged PO Sinemet C Ativan C 22-Feb-2006 08:31 AM Page: 784 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210284-0Report Type:Periodic Company Report #2002UW16964 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Corrected Interval Professional PO Prolonged Wellbutrin C Date:09/26/03ISR Number: 4210287-6Report Type:Periodic Company Report #2002UW16665 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Health Seroquel PS ORAL 400 MG PO Intervention to Corrected Interval Professional Lamictal "Burroughs Prevent Permanent Prolonged Wellcome" C Impairment/Damage Clonapin C Date:09/26/03ISR Number: 4210288-8Report Type:Periodic Company Report #2002UW16583 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Seroquel PS Initial or Prolonged Professional Risperdal C Required Intervention to Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210309-2Report Type:Periodic Company Report #2003UW07033 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 25 MG TID PO Intervention to Professional Risperdal SS 1 MG TID Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210310-9Report Type:Periodic Company Report #2003UW07158 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 25 MG DAILY Intervention to Professional PO Prevent Permanent Seroquel SS ORAL 500 MG DAILY Impairment/Damage PO Seroquel SS ORAL 800 MG DAILY PO Date:09/26/03ISR Number: 4210311-0Report Type:Periodic Company Report #2003UW07518 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Consumer Seroquel PS Intervention to Convulsion Seroquel SS ORAL 300 MG HS PO Prevent Permanent Zyprexa SS Impairment/Damage Unspecified Medications C 22-Feb-2006 08:31 AM Page: 785 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210312-2Report Type:Periodic Company Report #2003UW07791 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Health Seroquel PS 600-800 MG Intervention to Syndrome Professional Haldol C Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210313-4Report Type:Periodic Company Report #2003UW07858 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Health Seroquel PS 100 MG Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210314-6Report Type:Periodic Company Report #2003UW07948 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Catatonia Health Seroquel PS ORAL 300 MG BID PO Intervention to Musculoskeletal Stiffness Professional Seroquel SS ORAL 300 MG HS PO Prevent Permanent Neuroleptic Malignant Impairment/Damage Syndrome Date:09/26/03ISR Number: 4210315-8Report Type:Periodic Company Report #2003UW07960 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 300 MG PO Intervention to Professional Seroquel SS ORAL 600 MG PO Prevent Permanent Seroquel SS ORAL 500 MG PO Impairment/Damage Depakote C Klonopin C Date:09/26/03ISR Number: 4210316-XReport Type:Periodic Company Report #2003UW08073 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210317-1Report Type:Periodic Company Report #2003UW08058 Age:27 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Professional PO 22-Feb-2006 08:31 AM Page: 786 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210319-5Report Type:Periodic Company Report #2003UW08123 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Seroquel PS Initial or Prolonged Professional Date:09/26/03ISR Number: 4210320-1Report Type:Periodic Company Report #2002UW13474 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 1200 MG DAILY Intervention to Professional PO Prevent Permanent Risperidal C Impairment/Damage Zyprexa C Geodon C Date:09/26/03ISR Number: 4210322-5Report Type:Periodic Company Report #2002UW013593 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cataract Health Seroquel PS Initial or Prolonged Professional Prolixin C Date:09/26/03ISR Number: 4210324-9Report Type:Periodic Company Report #2002UW13604 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Consumer Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Thinking Abnormal Risperdal SS Risperdal C Depakote C Ativan C Protonix "Pharmacia" C Date:09/26/03ISR Number: 4210325-0Report Type:Periodic Company Report #2002UW13607 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Subcapsular Health Seroquel PS ORAL 100 MG HS PO Intervention to Professional Seroquel SS ORAL 50 MG HS PO Prevent Permanent Ambien C Impairment/Damage Klonopin C Serzone C Effexor C Duragesic C Albuterol C Paxil C Zoloft C Date:09/26/03ISR Number: 4210326-2Report Type:Periodic Company Report #2002UW13773 Age:49 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 787 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Seroquel PS ORAL 600 MG DAILY Professional PO Seroquel SS ORAL 200 MG HS PO Cogentin C Zoloft C Date:09/26/03ISR Number: 4210327-4Report Type:Periodic Company Report #2002UW13836 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 25 MG DAILY Intervention to Professional PO Prevent Permanent Benzonatate SS 100 MG Impairment/Damage Risperdal C Date:09/26/03ISR Number: 4210328-6Report Type:Periodic Company Report #2002UW13797 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210329-8Report Type:Periodic Company Report #2002UW13876 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Decreased Appetite Consumer Seroquel PS ORAL 800 MG DAILY Intervention to Dry Mouth PO Prevent Permanent Energy Increased Seroquel SS ORAL 300 MG DAILY Impairment/Damage Gingivitis PO Insomnia Seroquel SS ORAL 200 MG TID PO Mania Clozaril SS 400 MG Pharyngolaryngeal Pain Nexium C Tardive Dyskinesia Ambien C Weight Decreased Trileptal "Ciba-Geigy" C Clozaril C Date:09/26/03ISR Number: 4210330-4Report Type:Periodic Company Report #2002UW14319 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Seroquel PS Initial or Prolonged Professional Date:09/26/03ISR Number: 4210331-6Report Type:Periodic Company Report #2002UW15360 Age:33 YR Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 788 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Seroquel PS ORAL 50 MG PO Anger Professional Seroquel SS ORAL 600 MG DAILY Delusional Disorder, PO Unspecified Type Clozaril SS 350 MG Tardive Dyskinesia Clozaril SS 25 MG Tremor Clozaril SS 100 MG Date:09/26/03ISR Number: 4210332-8Report Type:Periodic Company Report #2003UW05090 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 350 MG DAILY Intervention to Professional PO Prevent Permanent Tegretol C Impairment/Damage Neurontin C Tenex C Clozaril C Date:09/26/03ISR Number: 4210333-XReport Type:Periodic Company Report #2003UW05213 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210334-1Report Type:Periodic Company Report #2003UW05255 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Health Seroquel PS ORAL 600 MG DAILY Intervention to Corrected Interval Professional PO Prevent Permanent Prolonged Trileptal C Impairment/Damage Lithium C Clonidine C Rhinelander C Date:09/26/03ISR Number: 4210335-3Report Type:Periodic Company Report #2003UW05396 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Professional PO Abilify C Haloperidol C Valproic Acid C 22-Feb-2006 08:31 AM Page: 789 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210336-5Report Type:Periodic Company Report #2003UW05415 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS OROPHARINGEAL 12.5 MG BID Intervention to Professional PO Prevent Permanent Seroquel SS ORAL 25 MG BID PO Impairment/Damage Lithium C Depakote C Parnate C Klonopin C Synthroid C Nadolol C Cytomel C Sulpiride C Date:09/26/03ISR Number: 4210337-7Report Type:Periodic Company Report #2003UW05885 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 300 MG DAILY Intervention to Professional PO Prevent Permanent Wellbutrin C Impairment/Damage Xanax C Celebrex C Diovan C Prilosec C Premarin C Atenolol C Prempro C Nasonex C Claritin C Lithium C Tegretol C Paxil C Klonopin C Prozac C Date:09/26/03ISR Number: 4210338-9Report Type:Periodic Company Report #2003UW05895 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 125 MG PO Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210340-7Report Type:Periodic Company Report #2003UW06003 Age:81 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Orthostatic Hypotension Consumer Seroquel PS ORAL 12.5 MG BID Initial or Prolonged PO Seroquel SS ORAL 50 MG QD PO Detrol C Xalatan C 22-Feb-2006 08:31 AM Page: 790 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210342-0Report Type:Periodic Company Report #2003UW06087 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Seroquel PS ORAL 200 MG TID PO 1 YR Initial or Prolonged Professional Vitamin E C Trazodone C Date:09/26/03ISR Number: 4210344-4Report Type:Periodic Company Report #2003UW06089 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grand Mal Convulsion Health Seroquel PS ORAL 800 MG DAILY Intervention to Professional PO Prevent Permanent Zoloft C Impairment/Damage Xanax C Date:09/26/03ISR Number: 4210371-7Report Type:Periodic Company Report #2003UW02863 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akinesia Health Seroquel PS ORAL 25 MG HS PO Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210372-9Report Type:Periodic Company Report #2003UW02911 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Seroquel PS ORAL 300 MG HS PO Initial or Prolonged Professional Chloral Hydrate C Date:09/26/03ISR Number: 4210373-0Report Type:Periodic Company Report #2003UW02938 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Glaucoma Health Seroquel PS ORAL 12.5 MG PO 6 MON Intervention to Professional Wellbutrin - Slow Prevent Permanent Release C Impairment/Damage Remeron C Date:09/26/03ISR Number: 4210374-2Report Type:Periodic Company Report #2003UW03229 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Seroquel PS Initial or Prolonged Tardive Dyskinesia Professional Multiple Disability Antipsychotics C Required Olanzapine C Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 791 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210375-4Report Type:Periodic Company Report #2003UW02939 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 25 MG DAILY Intervention to Professional PO Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210376-6Report Type:Periodic Company Report #2003UW02945 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Seroquel PS Initial or Prolonged Rash Professional Date:09/26/03ISR Number: 4210377-8Report Type:Periodic Company Report #2003UW03007 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Professional PO Seroquel SS ORAL 25 MG DAILY PO Effexor C Neurontin C Ambien C Date:09/26/03ISR Number: 4210378-XReport Type:Periodic Company Report #2003UW03011 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210379-1Report Type:Periodic Company Report #2003UW03012 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Seroquel PS ORAL 50 MG QD PO Initial or Prolonged Professional Paxil SS ORAL 25 MG QD PO Required Effexor C Intervention to Abilify C Prevent Permanent Risperidone C Impairment/Damage Date:09/26/03ISR Number: 4210380-8Report Type:Periodic Company Report #2003UW03128 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS 200 MG HS PO 15 MON Intervention to Professional Geodon C Prevent Permanent Paxil C Impairment/Damage Lithobid C Risperdal C 22-Feb-2006 08:31 AM Page: 792 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210381-XReport Type:Periodic Company Report #2003UW04343 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Prolonged Professional PO Methadone C Date:09/26/03ISR Number: 4210382-1Report Type:Periodic Company Report #2003UW04380 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Retention Health Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Professional PO Date:09/26/03ISR Number: 4210383-3Report Type:Periodic Company Report #2003UW04615 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Angle Closure Glaucoma Consumer Seroquel PS ORAL 100 MG DAILY Intervention to Blood Cholesterol PO Prevent Permanent Increased Seroquel SS ORAL 200 MG DAILY Impairment/Damage Blood Triglycerides PO Increased Celexa C Body Temperature Risperdal C Increased Lexapro C Eye Pain Desyrel C Ocular Hyperaemia Trileptal C Vision Blurred Weight Increased Date:09/26/03ISR Number: 4210384-5Report Type:Periodic Company Report #2003UW04581 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Health Seroquel PS ORAL 1000 MG PO Hospitalization - Professional Seroquel SS ORAL 1000 MG PO Initial or Prolonged Geodon C Risperdal C Clonidine C Depakote C Zyprexa C Prolixin C Klonopin C Date:09/26/03ISR Number: 4210385-7Report Type:Periodic Company Report #2003UW05072 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 600 MG DAILY Intervention to Professional PO Prevent Permanent Paxil C Impairment/Damage Buspar C Trilafon C Amantadine C 22-Feb-2006 08:31 AM Page: 793 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210386-9Report Type:Periodic Company Report #2003UW06318 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Muscle Twitching Professional PO Seroquel SS ORAL 50 MG BID PO Risperdal C Dexedrine C Clonidine C Date:09/26/03ISR Number: 4210387-0Report Type:Periodic Company Report #2003UW06350 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS 12.5 MG BID Intervention to Professional Thyroid Medication C Prevent Permanent Phenobarb C Impairment/Damage Furosemide C Neurontin C Sinemet C Valproic Acid C Acetaminophen C Bisacodyl C Certagen C Docusate C Levothroid C Milk Of Magnesia C Pseudoephedrine Hcl C Combivent C Ultravate C Ear Drops C Vitamin A C Vitamin D C Fleet Enema C Date:09/26/03ISR Number: 4210388-2Report Type:Periodic Company Report #2003UW06464 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Status Changes Consumer Seroquel PS ORAL 500 MG DAILY Initial or Prolonged Tachycardia PO Abilify C Luvox C Geodon C Clozaril C Date:09/26/03ISR Number: 4210389-4Report Type:Periodic Company Report #2003UW08177 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Health Seroquel PS ORAL 25 MG DAILY Intervention to Professional PO Prevent Permanent Effexor C Impairment/Damage Trileptal C 22-Feb-2006 08:31 AM Page: 794 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210390-0Report Type:Periodic Company Report #2003UW08179 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Health Seroquel PS ORAL 600 MG PO Intervention to Tardive Dyskinesia Professional Stelazine C Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210391-2Report Type:Periodic Company Report #2003UW03383 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Seroquel PS ORAL 800 MG PO Initial or Prolonged Extrapyramidal Disorder Professional Risperdal SS 8 MG Date:09/26/03ISR Number: 4210392-4Report Type:Periodic Company Report #2003UW03399 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dysarthria Health Seroquel PS ORAL 900 MG DAILY Intervention to Overdose Professional PO Prevent Permanent Tardive Dyskinesia Lithium C Impairment/Damage Tinnitus Tegretol C Klonopin C Valium C Haldol C Date:09/26/03ISR Number: 4210393-6Report Type:Periodic Company Report #2003UW03488 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 200 MG BID PO Intervention to Professional Paxil Cr C Prevent Permanent Ambien C Impairment/Damage Date:09/26/03ISR Number: 4210395-XReport Type:Periodic Company Report #2003UW03865 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Health Seroquel PS ORAL 300 MG PO Initial or Prolonged Professional Seroquel SS ORAL 200 MG PO Date:09/26/03ISR Number: 4210396-1Report Type:Periodic Company Report #2003UW03985 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Decreased Health Seroquel PS ORAL 100 MG PO Intervention to Somnolence Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 795 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210397-3Report Type:Periodic Company Report #2003UW04049 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Seroquel PS ORAL 75 MG PO Initial or Prolonged Professional Clozaril C Premarin C Prinivil C Ativan C Dilantin C Zantac C Date:09/26/03ISR Number: 4210399-7Report Type:Periodic Company Report #2003UW04094 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Seroquel PS 100 MG AM/50 Initial or Prolonged Professional MG PM/300 MG Required HS Intervention to Seroquel SS Prevent Permanent Miralax C Impairment/Damage Date:09/26/03ISR Number: 4210400-0Report Type:Periodic Company Report #2003UW04109 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 300 MG BID PO Intervention to Professional Buspar C Prevent Permanent Wellbutrin C Impairment/Damage Sonata C Date:09/26/03ISR Number: 4210421-8Report Type:Periodic Company Report #2003UW04177 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Consumer Seroquel PS ORAL 25 MG PO 80 DAY Intervention to Drug Ineffective Sinemet C Prevent Permanent Suicide Attempt Mirapex C Impairment/Damage Date:09/26/03ISR Number: 4210422-XReport Type:Periodic Company Report #2003UW04443 Age:10 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Movement Disorder Health Seroquel PS ORAL 175 MG PO Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210425-5Report Type:Periodic Company Report #2003UW01675 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cataract Health Seroquel PS ORAL 300 MG BID PO Initial or Prolonged Professional Seroquel SS ORAL 300 MG DAILY PO 22-Feb-2006 08:31 AM Page: 796 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS ORAL 800 MG DAILY PO Neurontin C Trazodone C Date:09/26/03ISR Number: 4210427-9Report Type:Periodic Company Report #2003UW02728 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Seroquel PS ORAL 900 MG DAILY Initial or Prolonged Professional PO Seroquel SS ORAL 200 MG TID PO Date:09/26/03ISR Number: 4210429-2Report Type:Periodic Company Report #2003UW02040 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 700 MG PO Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210430-9Report Type:Periodic Company Report #2003UW02047 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Seroquel PS Initial or Prolonged Professional Paxil C Remeron C Date:09/26/03ISR Number: 4210433-4Report Type:Periodic Company Report #2003UW02223 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Status Changes Health Seroquel PS ORAL 1200 -1500 MG Initial or Prolonged Neuroleptic Malignant Professional PO DAILY Required Syndrome Haldol C Intervention to Psychotic Disorder Ativan C Prevent Permanent Renal Failure Klonopin C Impairment/Damage Remeron C Symmetrel C Date:09/26/03ISR Number: 4210434-6Report Type:Periodic Company Report #2003UW02377 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 100 MG BID PO 1 MON Intervention to Professional Vistaril C Prevent Permanent Depakote C Impairment/Damage Congentin C Geodon C 22-Feb-2006 08:31 AM Page: 797 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210439-5Report Type:Periodic Company Report #2003UW02508 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Health Seroquel PS ORAL 25 MG PO Initial or Prolonged Professional Seroquel SS ORAL 150 MG PO Serzone SS 600 MG Unspecified C Date:09/26/03ISR Number: 4210441-3Report Type:Periodic Company Report #2003UW02661 Age:38 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 Date:09/26/03ISR Number: 4210442-5Report Type:Periodic Company Report #2003UW01918 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Health Seroquel PS ORAL 300 MG PO Intervention to Professional Seroquel SS ORAL 150 MG PO Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210443-7Report Type:Periodic Company Report #2003UW01895 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 100 MG PO Intervention to Professional Seroquel SS ORAL 300 MG PO Prevent Permanent Lithium C Impairment/Damage Celexa C Zyprexa C Date:09/26/03ISR Number: 4210448-6Report Type:Periodic Company Report #2003UW00477 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210449-8Report Type:Periodic Company Report #2003UW00484 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 798 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210451-6Report Type:Periodic Company Report #2003UW00676 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Thrombocytopenia Health Seroquel PS Intervention to Professional Clozaril C Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210452-8Report Type:Periodic Company Report #2003UW00736 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Seroquel PS ORAL 800 MG HS PO Initial or Prolonged Professional Remeron C Date:09/26/03ISR Number: 4210454-1Report Type:Periodic Company Report #2003UW00738 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Seroquel PS ORAL 400 MG BID PO Initial or Prolonged Hypotension Professional Seroquel SS ORAL 500 MG BID PO Psychotic Disorder Atenolol SS 75 MG BID Syncope Risperdal SS 1 MG BID Hydrochlorothiazide C Benazepril C Metoprolol C Date:09/26/03ISR Number: 4210455-3Report Type:Periodic Company Report #2003UW00850 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 10 MG DAILY Intervention to Professional PO Prevent Permanent Seroquel SS ORAL 25 MG DAILY Impairment/Damage PO Risperdal C Lithium C Depakote C Synthroid C Haldol C Date:09/26/03ISR Number: 4210457-7Report Type:Periodic Company Report #2003UW00891 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Health Seroquel PS ORAL 275 MG DAILY Intervention to Tardive Dyskinesia Professional PO Prevent Permanent Paxil C Impairment/Damage Effexor-Xr C Neurontin C 22-Feb-2006 08:31 AM Page: 799 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210459-0Report Type:Periodic Company Report #2003UW00923 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 800 MG TID PO 2 YR Intervention to Professional Depakoth C Prevent Permanent Lithium C Impairment/Damage Risperidone C Date:09/26/03ISR Number: 4210460-7Report Type:Periodic Company Report #2003UW01127 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Health Seroquel PS ORAL 100 MG DAILY Intervention to Professional PO Prevent Permanent Cogentin C Impairment/Damage Remeron C Celexa C Date:09/26/03ISR Number: 4210461-9Report Type:Periodic Company Report #2003UW01135 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Seroquel PS ORAL 100 MG HS PO Initial or Prolonged Professional Paxil SS Concerta C Clonidine C Date:09/26/03ISR Number: 4210463-2Report Type:Periodic Company Report #2003AP02406 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Literature Quetiapine PS ORAL 1000 MG DAILY Hospitalization - Corrected Interval Health PO Initial or Prolonged Prolonged Professional Ziprasidone SS ORAL 1760 MG DAILY Intentional Overdose PO Suicide Attempt Date:09/26/03ISR Number: 4210464-4Report Type:Periodic Company Report #2003UW00277 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Seroquel PS ORAL 900 MG DAILY Initial or Prolonged Choreoathetosis Professional PO Dyskinesia Methadone C Date:09/26/03ISR Number: 4210465-6Report Type:Periodic Company Report #2003UW00322 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Seroquel PS ORAL 600 MG PO Initial or Prolonged White Blood Cell Count Professional Risperdal C Decreased 22-Feb-2006 08:31 AM Page: 800 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210466-8Report Type:Periodic Company Report #2003UW00329 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Professional PO Depakote C Date:09/26/03ISR Number: 4210467-XReport Type:Periodic Company Report #2003UW00347 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Seroquel PS ORAL 400 MG QD PO Initial or Prolonged Seroquel SS ORAL 800 MG QD PO Neurontin C Depakote C Date:09/26/03ISR Number: 4210468-1Report Type:Periodic Company Report #2003UW01197 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bradycardia Health Seroquel PS ORAL 50 MG HS PO Intervention to Electrocardiogram Qt Professional Premarin C Prevent Permanent Prolonged Alprazolam C Impairment/Damage Fatigue Levothyroxine C Date:09/26/03ISR Number: 4210469-3Report Type:Periodic Company Report #2003UW01304 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 100 MG BID PO Intervention to Professional Pamelor C Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210470-XReport Type:Periodic Company Report #2003UW01355 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Health Seroquel PS ORAL 250 MG PO Intervention to Tardive Dyskinesia Professional Seroquel SS ORAL 800 MG PO Prevent Permanent Seroquel SS ORAL 400 MG PO Impairment/Damage Risperdal C Date:09/26/03ISR Number: 4210471-1Report Type:Periodic Company Report #2003UW01396 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Other Seroquel PS ORAL 400 MG DAILY Intervention to PO Prevent Permanent Ziac C Impairment/Damage Celexa C Ambien C Serzone C Ventolin C Risperdal C 22-Feb-2006 08:31 AM Page: 801 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210472-3Report Type:Periodic Company Report #2003UW01451 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Professional PO Lithium C Tegretol C Cogentin C Celexa C Klonopin C Sonata C Date:09/26/03ISR Number: 4210892-7Report Type:Periodic Company Report #2002UW10700 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210893-9Report Type:Periodic Company Report #2002UW10893 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Olanzapine SS Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210895-2Report Type:Periodic Company Report #2002UW10887 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Seroquel PS 100 MG HS PO Initial or Prolonged Seroquel SS 200 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Humalog C Lipitor C Lamictal C Klonopin C Asa C Metoprolol C Lantus C Enlapril C Date:09/26/03ISR Number: 4210898-8Report Type:Periodic Company Report #2002UW10875 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Health Seroquel PS ORAL 700 MG DAILY Intervention to Professional PO Prevent Permanent Seroquel SS ORAL 300 MG BID PO Impairment/Damage Seroquel SS 250 MG BID PO Depakote SS ORAL 575 MG DAILY 22-Feb-2006 08:31 AM Page: 802 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Depakote SS ORAL 325 MG BID PO Depakote SS ORAL 575 MG DAILY PO Depakote SS 250 MG BID PO Date:09/26/03ISR Number: 4210908-8Report Type:Periodic Company Report #2002UW10839 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Seroquel PS Initial or Prolonged Professional Olanzapine C Date:09/26/03ISR Number: 4210910-6Report Type:Periodic Company Report #2002UW10774 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Amenorrhoea Health Seroquel PS ORAL 25 MG DAILY Intervention to Blood Prolactin Increased Professional PO Prevent Permanent Galactorrhoea Seroquel SS ORAL 100-200 MG Impairment/Damage Somnolence DAILY OVER THE WEEKEND Unspecified Psychotropics C Date:09/26/03ISR Number: 4210916-7Report Type:Periodic Company Report #2002UW11029 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Seroquel PS 800 MG QD PO Initial or Prolonged Vomiting Professional Lithium C Zyprexa C Date:09/26/03ISR Number: 4210920-9Report Type:Periodic Company Report #2002US11283 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 200 MG BID PO Intervention to Professional Lamictal C Prevent Permanent Ativan C Impairment/Damage Date:09/26/03ISR Number: 4210921-0Report Type:Periodic Company Report #2002UW12728 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Choreoathetosis Other Seroquel PS Intervention to Unspecified Prevent Permanent Antipsychotic C Impairment/Damage 22-Feb-2006 08:31 AM Page: 803 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210922-2Report Type:Periodic Company Report #2002UW13345 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Other Seroquel PS 24000 MG ONCE Initial or Prolonged Syndrome PO Overdose Sedation Date:09/26/03ISR Number: 4210923-4Report Type:Periodic Company Report #2002UW10243 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Consumer Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Urinary Tract Infection Seroquel SS ORAL 50 MG QAM PO Aricept C Plavix C Desyrel C Bactrim C Date:09/26/03ISR Number: 4210924-6Report Type:Periodic Company Report #2002UW10367 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Subcapsular Health Seroquel PS 600-800 MG Intervention to Professional Zyprexa C Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210925-8Report Type:Periodic Company Report #2002UW10475 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Effexor C Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210926-XReport Type:Periodic Company Report #2002UW10494 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS 300-600MG Intervention to Professional Prolixin C Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210927-1Report Type:Periodic Company Report #2002UW16443 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Intentional Overdose Health Seroquel PS ORAL 100 MG BID PO Intervention to Somnolence Professional Depakote C Prevent Permanent Suicide Attempt Lopressor C Impairment/Damage 22-Feb-2006 08:31 AM Page: 804 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210928-3Report Type:Periodic Company Report #2002UW09713 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 500 MG HS PO Intervention to Professional Zyprexa C Prevent Permanent Glucovance C Impairment/Damage Atenolol C Clonazepam C Vitamin E C Risperdal C Trilafon C Navane C Date:09/26/03ISR Number: 4210929-5Report Type:Periodic Company Report #2002UW08543 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Seroquel PS ORAL 250 MG BID PO Initial or Prolonged Faecal Incontinence Professional Seroquel SS ORAL 600 MG DAILY Faecaloma PO Lithobid C Date:09/26/03ISR Number: 4210930-1Report Type:Periodic Company Report #2002UW08484 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Seroquel PS ORAL 150 MG DAILY Intervention to Professional PO Prevent Permanent Vioxx C Impairment/Damage Date:09/26/03ISR Number: 4210931-3Report Type:Periodic Company Report #2002UW07867 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Professional Seroquel SS ORAL 25 MG HS PO Disability Risperdal C Celexa C Gabitril C Levsin C Procardia Xl C Multivitamins C Oscal C Zantac C Date:09/26/03ISR Number: 4212204-1Report Type:Periodic Company Report #2002UW16191 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 805 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/03ISR Number: 4196800-6Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0308485A Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Paxil PS Glaxosmithkline ORAL 185 DAY Aspartate Professional Milnacipran Aminotransferase Hydrochloride SS ORAL 185 DAY Blood Amylase Sennoside SS Glaxosmithkline ORAL 36MG per day 660 DAY Blood Pressure Decreased Sodium Valproate SS ORAL 400MG per day 179 DAY Coma Quetiapine Fumarate SS ORAL 201 DAY Completed Suicide Haloxazolam SS ORAL 10MG per day 185 DAY Drug Toxicity Chinese Medicine SS ORAL 6G per day 185 DAY Intentional Overdose Laceration Pneumonia Aspiration Pyrexia Self-Injurious Ideation Vomiting Date:09/29/03ISR Number: 4201700-9Report Type:Expedited (15-DaCompany Report #2003AP03281 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Subcutaneous Foreign Seroquel PS ORAL 25 MG TID PO Haemorrhagic Diathesis Health Wintermin SS ORAL 62.5 MG DAILY Idiopathic Professional PO Thrombocytopenic Purpura Other Wintermin SS ORAL 25 MG DAILY PO Risperdal SS ORAL 1 MG TID PO Serenace SS 0.75 MG TID Seven Ep C Date:09/29/03ISR Number: 4201702-2Report Type:Expedited (15-DaCompany Report #2003SE04133 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Foreign Seroquel PS ORAL 500 MG DAILY Health PO Professional Risperdal C Other Date:09/29/03ISR Number: 4201704-6Report Type:Expedited (15-DaCompany Report #2003AP02741 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Depressed Level Of Health PO Required Consciousness Professional Seroquel SS ORAL 25 MG BID PO Intervention to Heart Rate Increased Other Seroquel SS ORAL 100 MG DAILY Prevent Permanent Overdose PO Impairment/Damage Platelet Count Decreased Pyrethia SS ORAL 25 MG DAILY Pneumonia Aspiration PO Suicide Attempt Rohypnol SS ORAL 1 MG BID PO Norvasc C 22-Feb-2006 08:31 AM Page: 806 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/03ISR Number: 4202467-0Report Type:Expedited (15-DaCompany Report #200304848 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Literature Unspecified Required Blood Pressure Decreased Other Cyclobenzaprine Intervention to Completed Suicide Product Unk PS Prevent Permanent Convulsion Quetiapine SS Impairment/Damage Drug Screen Positive Clonazepam SS Electrocardiogram Qrs Cocaine SS Complex Prolonged Opiate SS Heart Rate Decreased Loss Of Consciousness Overdose Date:09/29/03ISR Number: 4202731-5Report Type:Expedited (15-DaCompany Report #200304738 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Areflexia Literature Unspecified Other Bradycardia Other Ibuprofen Product PS Required Cardiac Arrest Quetiapine SS Intervention to Completed Suicide Fluoxetine C Prevent Permanent Convulsion Impairment/Damage Glasgow Coma Scale Abnormal Hyperhidrosis Hypotension Intentional Overdose Loss Of Consciousness Somnolence Tachycardia Vomiting Date:09/29/03ISR Number: 4202851-5Report Type:Expedited (15-DaCompany Report #200304644 Age:48 YR Gender:Female I/FU:I Outcome PT Death Acute Respiratory Hospitalization - Distress Syndrome Initial or Prolonged Alanine Aminotransferase Required Increased Intervention to Analgesic Drug Level Prevent Permanent Increased Impairment/Damage Aspartate Aminotransferase Increased Blood Creatinine Increased Blood Pressure Decreased Blood Urea Decreased Bowel Sounds Abnormal Cardiac Arrest Coma Completed Suicide Electrocardiogram Qrs Complex Shortened Electrocardiogram T Wave Abnormal Haemorrhage 22-Feb-2006 08:31 AM Page: 807 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Intentional Overdose International Normalised Report Source Product Role Manufacturer Route Dose Duration Ratio Increased Literature Unspecified Metabolic Acidosis Other Acetaminophen Multiple Drug Overdose Product PS ORAL PO Prothrombin Time Cocaine SS Prolonged Caffeine SS ORAL PO Urine Output Decreased Citalopram SS ORAL PO Quetiapine SS ORAL PO Clonidine SS ORAL PO Olanzapine SS ORAL PO Nicotine SS Pantoprazole SS ORAL PO Clonazepam SS ORAL PO Aspirin SS Levothyroxine SS ORAL PO Date:09/30/03ISR Number: 4203105-3Report Type:Expedited (15-DaCompany Report #2003UW12067 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Seroquel PS 300 MG T ID Thrombocytopenia Professional AND 900 MG QHS Topamax C Depakote C Date:09/30/03ISR Number: 4203435-5Report Type:Expedited (15-DaCompany Report #2003GB02170 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required No Adverse Drug Effect Foreign Seroquel PS ORAL 25 MG BID PO Intervention to Health Seroquel SS ORAL 100 MG BID PO Prevent Permanent Professional Impairment/Damage Other Date:09/30/03ISR Number: 4203437-9Report Type:Expedited (15-DaCompany Report #2003SE03510 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hepatic Steatosis Foreign Seroquel PS ORAL 400 MG DAILY Required Hepatitis Health PO Intervention to Professional Flurazepam C Prevent Permanent Other Impairment/Damage Date:10/01/03ISR Number: 4203623-8Report Type:Expedited (15-DaCompany Report #2003039929 Age:64 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Doxepin (Caps) Other Completed Suicide Health (Doxepin) PS ORAL ORAL Professional Baclofen (Baclofen) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL All Other 22-Feb-2006 08:31 AM Page: 808 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Products SS ORAL ORAL Date:10/01/03ISR Number: 4203629-9Report Type:Expedited (15-DaCompany Report #2003039901 Age:33 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Doxepin (Caps) Health (Doxepin) PS ORAL ORAL Professional Quetiapine (Quetiapine) SS ORAL ORAL Chlordiazepoxide (Chlordiazepoxide) SS ORAL ORAL Date:10/01/03ISR Number: 4204254-6Report Type:Expedited (15-DaCompany Report #2003UW11775 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Rapid Eye Movements Sleep Foreign Seroquel PS ORAL 12.5 MG DAILY Abnormal Health PO Professional Topamax C Other Lamictal C Synthroid C Ativan C Zantac C Florinef C Date:10/01/03ISR Number: 4204790-2Report Type:Expedited (15-DaCompany Report #2003UW12036 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Arrest Health Seroquel PS ORAL 900 MG HS PO Professional Cough Syrup C Antipsychotic Medication C Date:10/02/03ISR Number: 4200094-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12363263 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Sinemet Cr Tabs PS Bristol-Myers Squibb Hospitalization - Syndrome Company ORAL "at bedtime" Initial or Prolonged Renal Failure Carbidopa + Levodopa Tabs SS Bristol-Myers Squibb Company ORAL narrative:"20 , once a day" & daily dose block on cioms:"20 Quetiapine Fumarate SS Date:10/02/03ISR Number: 4201591-6Report Type:Direct Company Report #CTU 203067 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Seroquel PS ORAL 50MG PO BID 6 MON Lip Disorder Remeron C Tremor Advil C 22-Feb-2006 08:31 AM Page: 809 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Soma C Premarin C Lipitor C Date:10/02/03ISR Number: 4202097-0Report Type:Direct Company Report #CTU 203007 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anhedonia Seroquel Other Depression (Quietiapine Emotional Disorder Fumarate) PS ORAL 500 MG/DAY Fatigue ORAL Mental Impairment Muscle Rigidity Muscle Spasms Muscular Weakness Pain Paralysis Parkinsonism Respiratory Depression Somnolence Date:10/03/03ISR Number: 4204743-4Report Type:Expedited (15-DaCompany Report #2003UW12236 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Seroquel PS Professional Date:10/03/03ISR Number: 4205683-7Report Type:Expedited (15-DaCompany Report #2003UW10631 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Thyroid Stimulating Health Seroquel PS ORAL 100 MG BID - Initial or Prolonged Hormone Abnormal Professional 600 MG DAILY Chest Pain PO Electrocardiogram T Wave Ambien C Inversion Lithium C Sinus Arrhythmia Clonaqpam C Date:10/03/03ISR Number: 4205974-XReport Type:Expedited (15-DaCompany Report #2003SE04229 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Platelet Disorder Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Thrombocytopenia Health PO Prevent Permanent Professional Haloperidol C Impairment/Damage Other Date:10/03/03ISR Number: 4206328-2Report Type:Expedited (15-DaCompany Report #2003AP03124 Age:29 YR Gender:Male I/FU:I Outcome PT Life-Threatening Arm Amputation Disability Brain Oedema Clonus 22-Feb-2006 08:31 AM Page: 810 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decubitus Ulcer Depressed Level Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Foreign Quetiapine PS ORAL 12000 MG PO Prolonged Literature Diazepam SS ORAL 70 MG PO Hyperreflexia Health International Normalised Professional Ratio Decreased Other Leukocytosis Liver Function Test Abnormal Metabolic Acidosis Miosis Myoglobin Urine Present Neutrophil Count Increased Overdose Pseudomonas Infection Pupillary Reflex Impaired Respiratory Rate Increased Respiratory Tract Infection Sinus Tachycardia Staphylococcal Infection Stupor Tachycardia Date:10/06/03ISR Number: 4205151-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030802503 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Foreign Risperidone Initial or Prolonged Feeling Abnormal Health (Risperidone) Other Myelodysplastic Syndrome Professional Unspecified PS ORAL 4 MG, 1 IN 1 DAY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) SS ORAL 8 MG, 1 IN 1, DAY, ORAL Sulpiride (Sulpiride) Unknown SS ORAL 150 MG, 1 IN 1 DAY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) Tablets SS ORAL 100 MG, 1 IN 1 DAY, ORAL Flunitrazepam (Flunitrazepam) Unknown SS ORAL 2 MG, 1 IN 1 DAY, ORAL Quazepam (Quazepam) Unknown SS ORAL 30 MG, 1 IN 1 DAY, ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) Unknown SS ORAL 25 MG, 1 IN 1 22-Feb-2006 08:31 AM Page: 811 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY, ORAL Date:10/06/03ISR Number: 4205714-4Report Type:Expedited (15-DaCompany Report #2003039954 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ziprasidone (Caps) Multiple Drug Overdose Health (Ziprasidone) PS Professional Quetiapine (Quetiapine) SS Date:10/07/03ISR Number: 4206791-7Report Type:Expedited (15-DaCompany Report #2003UW12290 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Seroquel PS ORAL 1200 MG ONCE Initial or Prolonged Drug Screen Positive Professional PO Medication Error Niaspan SS 2000 MG HS Nausea Respiratory Distress Date:10/07/03ISR Number: 4206829-7Report Type:Expedited (15-DaCompany Report #2003178456US Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Alprazolam Overdose Health (Alprazolam) PS Professional Propoxyphene (Dextropropoxyphene) SS ORAL ORAL Quetiapine (Quetiapine) SS Date:10/07/03ISR Number: 4206881-9Report Type:Expedited (15-DaCompany Report #2003039703 Age:36 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Exposure Literature Gliplizide Gits Other Health (Glipizide) PS ORAL ORAL Professional Metformin (Metformin SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL All Other Therapeutic Products SS ORAL ORAL Date:10/07/03ISR Number: 4207287-9Report Type:Expedited (15-DaCompany Report #2003UW10999 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Seroquel PS ORAL 900 MG DAILY Initial or Prolonged Gastrointestinal Professional PO Haemorrhage Seroquel SS ORAL 1200 MG DAILY Gastrointestinal Ulcer PO International Normalised Coumadin C Ratio Increased Pentasa C Lower Gastrointestinal Zyprexa C Haemorrhage Loxapine C Prothrombin Time Trazodone C 22-Feb-2006 08:31 AM Page: 812 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin C Purinethol C Bentyl C Amitriptyline C Date:10/07/03ISR Number: 4207371-XReport Type:Expedited (15-DaCompany Report #2003UW12579 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Seroquel PS ORAL 400 MG QD PO Initial or Prolonged Disease Recurrence Study Cyclosporine C Schizophrenia Health Prednisone C Professional Zyprexa C Other Date:10/07/03ISR Number: 4207373-3Report Type:Expedited (15-DaCompany Report #2003UW12284 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Foreign Seroquel PS ORAL 300 MG HS PO Initial or Prolonged Health Glyburide C Professional Other Date:10/08/03ISR Number: 4207965-1Report Type:Expedited (15-DaCompany Report #2003AP03427 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS 300 MG DAILY Intervention to Health PO Prevent Permanent Professional Clozaril C Impairment/Damage Other Solian C Date:10/08/03ISR Number: 4207967-5Report Type:Expedited (15-DaCompany Report #2003GB01471 Age:0 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Seroquel PS 150 MG QID Initial or Prolonged Craniosynostosis Health TPL Required Cyanosis Neonatal Professional Lorazepam SS 2 MG TID TPL Intervention to Developmental Delay Prevent Permanent Drug Withdrawal Syndrome Impairment/Damage Neonatal Feeding Disorder Neonatal Feeling Jittery Heart Rate Increased Hypertonia Neonatal Maternal Drugs Affecting Foetus Neonatal Disorder Neonatal Respiratory Distress Syndrome Poor Weight Gain Neonatal Pyrexia Respiratory Rate Increased Tremor 22-Feb-2006 08:31 AM Page: 813 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4208735-0Report Type:Direct Company Report #CTU 203514 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Sodium Decreased Clozapine 400 Mg Hospitalization - Convulsion Bid-Ivax PS Ivax 400 MG BID Initial or Prolonged Haematemesis Atorvastatin 20 Mg Required Haemodialysis Od Parke Davis SS Parke Davis 20 MG OD Intervention to Neuroleptic Malignant Quetiapine 400 Mg Prevent Permanent Syndrome Bid Astrazeneca SS Astrazeneca 400 MG BID Impairment/Damage Polydipsia Metoprolol C Renal Failure Acute Enalapril C Rhabdomyolysis Monetasone Furoate Nasal Spray C Date:10/09/03ISR Number: 4208928-2Report Type:Direct Company Report #CTU 203553 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Lithium PS Large Intestinal Quetiapine SS Obstruction Gabapentin SS Shock Clonazepam SS Vomiting Date:10/09/03ISR Number: 4209192-0Report Type:Expedited (15-DaCompany Report #KII-2003-0002499 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Health Oxycodone Initial or Prolonged Alanine Aminotransferase Professional Hydrochloride Other Aspartate (Similar To Nda Aminotransferase 20-553) (Oxycodone Blood Alkaline Hydrochloride) PS ORAL ORAL Phosphatase Coumadin(Warfarin Blood Potassium Sodium) SS ORAL ORAL Blood Pressure Systolic Wellbutrin(Amfebutam Increased one Hydrochloride) SS ORAL ORAL Depressed Level Of Seroquel(Quetiapine) SS ORAL ORAL Consciousness Acetaminophen(Parace Epistaxis tamol) SS Haematocrit Haemoglobin Heart Rate Increased Intentional Overdose Multiple Drug Overdose Pharyngeal Haemorrhage Prothrombin Time Respiratory Rate Decreased Suicide Attempt White Blood Cell Count Date:10/10/03ISR Number: 4208834-3Report Type:Expedited (15-DaCompany Report #2003UW12657 Age: Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 814 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration T-Lymphocyte Count Other Seroquel PS ORAL 25 MG DAILY Decreased PO Seroquel SS ORAL 25 MG DAILY PO Paxil Cr C Ativan C Date:10/10/03ISR Number: 4208967-1Report Type:Expedited (15-DaCompany Report #2003UW12678 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hair Growth Abnormal Foreign Seroquel PS Health Oral Contraceptives C Professional Other Date:10/10/03ISR Number: 4209244-5Report Type:Expedited (15-DaCompany Report #2003AP03135 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspartate Foreign Seroquel PS ORAL 100 MG DAILY Aminotransferase Health PO Increased Professional Seroquel SS ORAL 100 MG BID PO Blood Amylase Increased Other Seroquel SS ORAL 50 MG BID PO Blood Pressure Decreased Seroquel SS ORAL 700 MG ONCE Coma PO Completed Suicide Toledomin SS ORAL 50 MG BID PO Depression Toledomin SS ORAL 75 MG BID PO Drug Toxicity Paxil SS ORAL 20 MG DAILY Intentional Overdose PO Pneumonia Aspiration Paxil SS ORAL 40 MG DAILY Po2 Decreased PO Pyrexia Epirenat SS Sexual Assault Victim Pursennid SS Shock Herbal Preparation C Vomiting Amoxapine C Clomipramine Hydrochloride C Trimipramine Maleate C Levomepromazine Maleate C Date:10/13/03ISR Number: 4210015-4Report Type:Direct Company Report #CTU 203690 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Quetiapine / Cardiac Arrest Astrazeneca Pharmaceuticals PS Astrazeneca Pharmaceuticals 1400 MG DAY (3 DIVIDED DOSES) Enalapril C Hydrochlorothiazide C 22-Feb-2006 08:31 AM Page: 815 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/03ISR Number: 4210935-0Report Type:Expedited (15-DaCompany Report #HQWYE115110OCT03 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Advil (Ibuprofen, Intentional Overdose Unspec) PS ORAL ORAL Fluoxetine Hydrochloride (Fluoxetine Hydrochloride, ) SS ORAL ORAL Quetiapine (Quetiapine, ) SS ORAL ORAL Date:10/14/03ISR Number: 4209976-9Report Type:Expedited (15-DaCompany Report #2003UW08324 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Health Seroquel PS Drug Level Increased Professional Overdose Sudden Death Date:10/15/03ISR Number: 4210236-0Report Type:Expedited (15-DaCompany Report #GBWYE327302OCT03 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Efexor (Venlafaxine Initial or Prolonged Convulsion Professional Hydrochloride, Loss Of Consciousness Other Tablet, 0) PS OVERDOSE 1 DAY Overdose Seroquel (Quetiapine) SS ORAL OVERDOSE, UNK QUANTITY 1 DAY Date:10/15/03ISR Number: 4210242-6Report Type:Expedited (15-DaCompany Report #GBWYE327302OCT03 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Efexor (Venlafaxine Initial or Prolonged Convulsion Professional Hydrochloride, Fall Other Tablet, 0) PS OVERDOSE 1 DAY Loss Of Consciousness Seroquel Overdose (Quetiapine, , 0) SS ORAL OVERDOSE ORAL Date:10/15/03ISR Number: 4210275-XReport Type:Expedited (15-DaCompany Report #2003SE04519 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Supraventricular Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Tachycardia Health PO Professional Seroquel SS ORAL 100 MG DAILY Other PO 22-Feb-2006 08:31 AM Page: 816 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/03ISR Number: 4210394-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030802503 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypochromic Anaemia Foreign Risperidone Initial or Prolonged Myelodysplastic Syndrome Health (Risperidone) Other Professional Tablets PS ORAL 4 MG, IN 1 DAY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) Unknown SS ORAL 8 MG, 1 IN 1 DAY, ORAL Sulpiride (Sulpiride) Unknown SS ORAL 150 MG, 1 IN 1 DAY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) Tablets SS ORAL 100 MG, 1 IN 1 DAY, ORAL Flunitrazepam (Flunitrazepam) Unknown SS ORAL 2 MG, 1 IN 1 DAY, ORAL Quazepam (Quazepam) Unknown SS ORAL 30 MG, 1 IN 1 DAY, ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) Unknown SS ORAL 25 MG, 1 IN 1 DAY, ORAL Date:10/15/03ISR Number: 4210498-XReport Type:Expedited (15-DaCompany Report #2003GB02048 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 300 MG BID PO Neutrophil Count Health Seroquel SS ORAL 200 MG BID PO Decreased Professional Amlodipine C Other Date:10/15/03ISR Number: 4210943-XReport Type:Expedited (15-DaCompany Report #2003UW10976 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Choking Health Seroquel PS ORAL 700 MG DAILY Hospitalization - Hypoxia Professional PO Initial or Prolonged Pneumonia Cardizem C Colace C Neurontin C 22-Feb-2006 08:31 AM Page: 817 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/03ISR Number: 4211030-7Report Type:Expedited (15-DaCompany Report #2003UW13081 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alcohol Use Health Seroquel PS Hospitalization - Overdose Professional Initial or Prolonged Respiratory Failure Date:10/15/03ISR Number: 4211206-9Report Type:Expedited (15-DaCompany Report #2003UW10975 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Choking Health Seroquel PS Respiratory Arrest Professional Seroquel SS ORAL 300 MG BID PO Cogentin C Klonopin C Celexa C Plavix C Atrovent C Lithium Carbonate C Vitamin E C Risperidone C Date:10/15/03ISR Number: 4211268-9Report Type:Expedited (15-DaCompany Report #2003UW12489 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dysphagia Other Seroquel PS ORAL 25 MG DAILY Intervention to Impaired Work Ability PO Prevent Permanent Medication Error Serzone SS Impairment/Damage Mobility Decreased Date:10/15/03ISR Number: 4211369-5Report Type:Expedited (15-DaCompany Report #2003UW13084 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS ORAL 100 MG BID PO Hospitalization - Gastrointestinal Professional Klonopin C Initial or Prolonged Haemorrhage Ultracet C Required Hypoglycaemia Prevacid C Intervention to Doxepin C Prevent Permanent Synthroid C Impairment/Damage Miacalcin C Calcium C Date:10/15/03ISR Number: 4211749-8Report Type:Expedited (15-DaCompany Report #2003018220 Age:20 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Convulsion Drug Interaction Potentiation Electrocardiogram Qrs Complex Shortened Hypoxia Intentional Overdose 22-Feb-2006 08:31 AM Page: 818 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Aspiration Ventricular Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 3.36 GRAM, Professional ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS 12 GRAM Lithium (Lithium) SS Date:10/15/03ISR Number: 4213830-6Report Type:Expedited (15-DaCompany Report #2003UW12826 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 800 MG DAILY Health PO Professional Fluvoxamine C Other Epival C Date:10/16/03ISR Number: 4211419-6Report Type:Expedited (15-DaCompany Report #2003AP00923 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 700 MG DAILY Drug Screen Positive Health PO Fall Professional Cipramil SS ORAL 30 MG DAILY Injury Other PO Multiple Drug Overdose Erythromycin C Date:10/17/03ISR Number: 4214231-7Report Type:Expedited (15-DaCompany Report #2003AP03622 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Overdose Literature Health Professional Date:10/17/03ISR Number: 4214234-2Report Type:Expedited (15-DaCompany Report #2003SE03783 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Delirium Foreign Seroquel PS ORAL 400 MG DAILY Intervention to Dermatitis Bullous Health PO Prevent Permanent Dermatitis Exfoliative Professional Orfiril C Impairment/Damage Drug Eruption Other Tegretol C Eyelid Oedema Spirix C Generalised Oedema Furix C Xyloproct C Vallergan C Imodium C Hemineurin C 22-Feb-2006 08:31 AM Page: 819 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/03ISR Number: 4214664-9Report Type:Expedited (15-DaCompany Report #2003UW12989 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Health Seroquel PS Hypothyroidism Professional Seroquel SS ORAL 600 MG DAILY Leukopenia PO Pyrexia Klonopin C Lamictal C Lithium C Ambien C Date:10/20/03ISR Number: 4212382-4Report Type:Direct Company Report #CTU 204145 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Dizziness Seroquel 25 Mg Required Malaise Tablets Astra Zeneca PS Astra Zeneca ORAL SEE IMAGE Intervention to Prevent Permanent Impairment/Damage Date:10/20/03ISR Number: 4214757-6Report Type:Expedited (15-DaCompany Report #2003UW13275 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS Hospitalization - Cardiac Enzymes Increased Professional Haldol C Initial or Prolonged Depression Cogentin C Psychotic Disorder Lexapro C Cozaar C Date:10/20/03ISR Number: 4215387-2Report Type:Expedited (15-DaCompany Report #2003GB02744 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Seroquel PS Neuroleptic Malignant Health Syndrome Professional Pulmonary Embolism Other Date:10/21/03ISR Number: 4215308-2Report Type:Expedited (15-DaCompany Report #FLUV00303002962 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Function Abnormal Foreign Luvox 25 Hospitalization - Pyrexia Health (Fluvoxamine Initial or Prolonged Professional Maleate) PS ORAL 50 MG DAILY Other PO, 300 MG DAILY PO Seroquel (Seroquel) SS ORAL 700 MG DAILY PO Risperdal (Risperidone) C Zyprexa (Olanzapine) C 22-Feb-2006 08:31 AM Page: 820 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/03ISR Number: 4215515-9Report Type:Direct Company Report #CTU 204244 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Geodon PS 20 MG QAM 80 Initial or Prolonged Dysphagia MG QHS Dyspnoea Seroquel SS QHS Muscle Twitching Prevacid C Tongue Disorder Albuterol C Date:10/21/03ISR Number: 4216247-3Report Type:Expedited (15-DaCompany Report #2003UW12931 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS ORAL 800 MG DAILY Professional PO Clozapine SS ORAL 400 MG DAILY PO Risperdal SS 4 MG BID Depakote SS 1500 MG DAILY Date:10/22/03ISR Number: 4215403-8Report Type:Direct Company Report #CTU 204287 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Libido Increased Quetiapine PS Intervention to Prevent Permanent Impairment/Damage Date:10/22/03ISR Number: 4216798-1Report Type:Expedited (15-DaCompany Report #2003AP03182 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel PS Initial or Prolonged Health Chlorpromazine Professional Hydrochloride SS ORAL 100 MG DAILY Other PO Droperidol SS INTRAMUSCULAR 10 MG ONCE IM Date:10/22/03ISR Number: 4216801-9Report Type:Expedited (15-DaCompany Report #2003SE04513 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Coma Foreign Seroquel PS ORAL 200 MG BID PO Health Glucophage C Professional Diamicron C Other Date:10/22/03ISR Number: 4216804-4Report Type:Expedited (15-DaCompany Report #2003AP03693 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Foreign Seroquel PS ORAL 400 MG DAILY Health PO Professional Nexium C Other Trifeme 28 C 22-Feb-2006 08:31 AM Page: 821 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/03ISR Number: 4219831-6Report Type:Expedited (15-DaCompany Report #2003019160 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Nardil (Phenelzine Initial or Prolonged Anorgasmia Sulfate) PS 37 MG (DAILY) Drug Interaction Quetiapine Fumarate Dry Mouth (Quetiapine Headache Fumarate) SS 50 MG (DAILY) Hypersomnia Olanzapine Insomnia (Olanzapine) SS Mental Disorder Lithium Carbonate Nausea (Lithium Carbonate) SS 900 MG (BID) Rapid Eye Movements Sleep Lamotrigine Abnormal (Lamotrigine) SS 50 MG Salivary Gland Disorder Novothyral Skin Disorder (Levothyroxine Weight Increased Sodium, Liothyronine Sodium) C Date:10/24/03ISR Number: 4220004-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003649 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS 4 MG, 2 IN 1 DAY, UNKNOWN Clozapine (Clozapine) SS 400 MG, 1 IN 1 DAY Depakote (Valproate Semisodium) SS 1500 MG, 1 IN 1 DAY Seroquel (Quetiapine Fumarate) SS 800 MG, 1 IN 1 DAY Date:10/24/03ISR Number: 4220112-5Report Type:Expedited (15-DaCompany Report #KII-2002-0004115 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatinine Initial or Prolonged Increased Other Blood Pressure Decreased Body Temperature Increased Depressed Level Of Consciousness Disorientation Intentional Overdose Intentional Self-Injury Liver Function Test Abnormal Loss Of Consciousness Mouth Haemorrhage Multiple Drug Overdose Neuroleptic Malignant Syndrome Pain 22-Feb-2006 08:31 AM Page: 822 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rales Respiratory Depression Salivary Hypersecretion Report Source Product Role Manufacturer Route Dose Duration Sinus Tachycardia Health Oxycontin Tablets Somnolence Professional (Oxycodone Suicidal Ideation Hydrochloride) Cr White Blood Cell Count Tablets PS Increased Seroquel (Quetiapine) SS Acetaminophen (Paracetamol) SS Acetylsalicylic Acid (Acetylsalicylic Acid) SS Lithium (Lithium) SS Depakote (Valproate Semisodium) SS Date:10/24/03ISR Number: 4220155-1Report Type:Expedited (15-DaCompany Report #2003AP03088 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Increased Health PO Aspartate Professional Keiten C Aminotransferase Other Asverin C Increased Mucodyne C Blood Alkaline Phosphatase Increased Blood Lactate Dehydrogenase Increased Gamma-Glutamyltransferase Increased Liver Disorder Date:10/24/03ISR Number: 4220395-1Report Type:Expedited (15-DaCompany Report #2003UW13641 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Seroquel PS Initial or Prolonged Phosphokinase Increased Professional Geodon C Rhabdomyolysis Neurontin C Amitriptyline C Synthroid C Gabitril C Date:10/24/03ISR Number: 4220396-3Report Type:Expedited (15-DaCompany Report #2003UW13371 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Health Seroquel PS Intervention to Encephalopathy Professional Lithium SS Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 823 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/03ISR Number: 4219723-2Report Type:Direct Company Report #CTU 204640 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperglycaemia Zyprexa 5mg PS Intervention to Polydipsia Seroquel SS Prevent Permanent Weight Decreased Impairment/Damage Date:10/27/03ISR Number: 4221039-5Report Type:Expedited (15-DaCompany Report #2003GB02769 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocarditis Foreign Seroquel PS Initial or Prolonged Health Professional Other Date:10/27/03ISR Number: 4221040-1Report Type:Expedited (15-DaCompany Report #2003SE04708 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancytopenia Foreign Seroquel PS ORAL 300 MG DAILY Health PO Professional Depamide SS ORAL 600 MG DAILY Other PO Femoston "Solvay" SS 1 TAB Diazepam C Date:10/27/03ISR Number: 4221167-4Report Type:Expedited (15-DaCompany Report #2003UW13423 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dementia Consumer Seroquel PS ORAL 600 MG DAILY Intervention to Dyspnoea Exertional PO Prevent Permanent Oedema Peripheral Depakote C Impairment/Damage Weight Increased Ativan C Synthroid C Propanolol C Date:10/28/03ISR Number: 4222711-3Report Type:Expedited (15-DaCompany Report #DSA_23484_2003 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Tavor PS ORAL 50 MG ONCE PO Initial or Prolonged Erythema Health Decentan SS ORAL 1200 MG ONCE Eye Movement Disorder Professional PO Hypotension Other Seroquel SS ORAL 8000 MG ONCE Intentional Overdose PO Miosis Seroquel SS ORAL 6000 MG ONCE Respiratory Failure PO Tachycardia 22-Feb-2006 08:31 AM Page: 824 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/03ISR Number: 4222874-XReport Type:Expedited (15-DaCompany Report #2003AP03281 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Fluctuation Foreign Seroquel PS ORAL 25 MG TID PO Blood Glucose Increased Health Wintermin SS ORAL 62.5 MG DAILY Cardio-Respiratory Arrest Professional PO Cerebral Haemorrhage Other Wintermin SS ORAL 25 MG DAILY Clostridium Colitis PO Generalised Oedema Serenace SS 0.75 MG TID Haemorrhage Subcutaneous UNK Haemorrhagic Diathesis Serenace SS Hepatic Function Abnormal Risperdal SS ORAL 1 MG TID PO Hernia Seven Ep C Herpes Zoster Hypoglycaemia Hypoproteinaemia Hypothyroidism Immunosuppression Oral Candidiasis Pneumonia Pupils Unequal Thrombocytopenic Purpura Urinary Tract Infection Date:10/28/03ISR Number: 4222875-1Report Type:Expedited (15-DaCompany Report #2003UW13680 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Seroquel PS ORAL 50 MG PO Initial or Prolonged Excitability Health Seroquel SS ORAL 25 MG PO Haematuria Professional Lithium C Hepatitis Toxic Other Pain Date:10/29/03ISR Number: 4223314-7Report Type:Expedited (15-DaCompany Report #2003UW13779 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Seroquel PS ORAL 200 MG BID PO Hospitalization - Death Professional Lisinopril C Initial or Prolonged Lithium C Date:10/29/03ISR Number: 4223607-3Report Type:Expedited (15-DaCompany Report #KII-2003-0003747 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Oxycontin Tablets Initial or Prolonged Intentional Overdose Professional (Oxycodone Other Loss Of Consciousness Other Hydrochloride) Cr Multiple Drug Overdose Tablet PS ORAL SEE TEXT, Respiratory Depression ORAL Sinus Tachycardia Mepergan (Pethidine Hydrochloride, Promethazine Hydrochloride) SS ORAL SEE TEXT, ORAL Skelaxin (Metaxalone) SS 22-Feb-2006 08:31 AM Page: 825 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel(Quetiapine) SS Clonazepam(Clonazepa m) SS Ibuprofen(Ibuprofen ) SS Amfetamine(Amfetamin e) SS Apap(Paracetamol) SS Asa(Acetylsalicylic Acid) SS Date:10/30/03ISR Number: 4223209-9Report Type:Direct Company Report #CTU 204950 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Quetiapine PS 125 MG QD 1 MON Abnormal Date:10/30/03ISR Number: 4224000-XReport Type:Expedited (15-DaCompany Report #S03-GER-04403-01 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Toxicity Foreign Cipramil (Citalopram Nephritis Interstitial Health Hydrobromide) PS ORAL 40 MG QD PO Renal Tubular Disorder Professional Risperdal Other (Risperidone) SS Eunerpan (Melperone Hydrochloride) SS Seroquel (Quetiapine Fumarate) SS Date:10/30/03ISR Number: 4224209-5Report Type:Expedited (15-DaCompany Report #OXYT000086 Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Roxicodone Completed Suicide Health (Oxycodone Hcl) PS Multiple Drug Overdose Professional Clonazepam (Clonazepam) SS Quetiapine (Quetiapine) SS Date:10/30/03ISR Number: 4224343-XReport Type:Expedited (15-DaCompany Report #2003AP03768 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS ORAL 700 MG DAILY Increased Health PO Aspartate Professional Luvox SS ORAL 50 MG DAILY Aminotransferase Other PO Increased Luvox SS ORAL 300 MG DAILY Blood Lactate PO Dehydrogenase Increased Risperdal C Eosinophil Count Olanzapine C Increased Hepatic Function Abnormal Pyrexia 22-Feb-2006 08:31 AM Page: 826 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/03ISR Number: 4224344-1Report Type:Expedited (15-DaCompany Report #2003PK01801 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Interstitial Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Health PO Professional Other Date:10/31/03ISR Number: 4223848-5Report Type:Expedited (15-DaCompany Report #2003UW13874 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Health Seroquel PS ORAL 500 MG BID PO Intervention to Decreased Professional Seroquel SS TAPERED OFF Prevent Permanent AT 100 MG Impairment/Damage DECREASE PER WEEK Atenolol C Depakote C Date:10/31/03ISR Number: 4224878-XReport Type:Expedited (15-DaCompany Report #KII-2003-0004112 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acid Base Balance Health Oxycontin Cr PS Life-Threatening Abnormal Professional Methadone Hospitalization - Blood Glucose Abnormal Other (Methadone) SS Initial or Prolonged Blood Lactic Acid Trazodone(Trazodone) SS Other Increased Gabapentin(Gabapenti Blood Pressure Decreased n) SS 400 MG Blood Pressure Increased Quetiapine(Quetiapin Body Temperature e) SS 200 MG Increased Citalopram(Citalopra Bradycardia m) SS 20 MG Cardiac Arrest Clonazepam Coma (Clonazepam) SS 1 MG Depression Zanaflex(Tizanidine Electrocardiogram Qt Hydrochloride) SS ORAL 4 MG, ORAL Corrected Interval Bupropion(Amfebutamo Prolonged ne) SS 150 MG Electroencephalogram Cyclobenazprine(Cycl Abnormal obenzaprine) SS 10 MG Heart Rate Increased Amitriptyline(Amitri Miosis ptyline) SS 50 MG Multiple Drug Overdose Estalopram() SS Muscle Twitching Mydriasis Posturing Pupil Fixed Respiratory Rate Decreased Respiratory Rate Increased 22-Feb-2006 08:31 AM Page: 827 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4226096-8Report Type:Expedited (15-DaCompany Report #2003UW13821 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sleep Apnoea Syndrome Health Seroquel PS ORAL 1200 MG QD PO Professional Date:11/03/03ISR Number: 4226098-1Report Type:Expedited (15-DaCompany Report #2003UW13607 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Consumer Seroquel PS ORAL 600 MG ONCE Intervention to Balance Disorder PO Prevent Permanent Ill-Defined Disorder Serzone SS Impairment/Damage Medication Error Paxil C Memory Impairment Muscle Spasms Muscle Twitching Paranoia Date:11/03/03ISR Number: 4226124-XReport Type:Expedited (15-DaCompany Report #2003UW13923 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Withdrawal Syndrome Health Seroquel PS Intervention to Feeling Jittery Professional Prevent Permanent Hypertonia Neonatal Impairment/Damage Maternal Drugs Affecting Foetus Neonatal Disorder Date:11/03/03ISR Number: 4226629-1Report Type:Expedited (15-DaCompany Report #2003GB02744 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Seroquel PS ORAL 300 MG BID PO Hospitalization - Neuroleptic Malignant Health Carbamazepine C Initial or Prolonged Syndrome Professional Losec C Pneumonia Aspiration Other Akineton C Pulmonary Embolism Date:11/03/03ISR Number: 4226854-XReport Type:Expedited (15-DaCompany Report #2003UW13857 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Seroquel PS Initial or Prolonged Drug Effect Decreased Health Calcium C Epistaxis Professional Tylenol C Platelet Count Decreased Other Isopto C Olanzapine C Date:11/03/03ISR Number: 4226882-4Report Type:Expedited (15-DaCompany Report #2003-DE-05125GD Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Methadone Multiple Drug Overdose (Methadone) PS ORAL PO 22-Feb-2006 08:31 AM Page: 828 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quetiapine SS ORAL PO Date:11/03/03ISR Number: 4226883-6Report Type:Expedited (15-DaCompany Report #2003SE04806 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fat Tissue Increased Foreign Seroquel PS ORAL 400 MG DAILY Intervention to Health PO Prevent Permanent Professional Seroquel SS ORAL 25 MG DAILY Impairment/Damage Other PO Seroxat C Date:11/03/03ISR Number: 4226927-1Report Type:Expedited (15-DaCompany Report #2003-DE-05242GD Age:44 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Literature Mirtazapine PS ORAL PO Completed Suicide Quietiapine SS ORAL PO Multiple Drug Overdose Ethanol (Ethanol) C ORAL PO Date:11/04/03ISR Number: 4227134-9Report Type:Expedited (15-DaCompany Report #2003UW12826 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 800 MG DAILY Health PO Professional Fluvoxamine C Other Epival C Date:11/04/03ISR Number: 4227136-2Report Type:Expedited (15-DaCompany Report #2003GB02828 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Seroquel PS ORAL 50 MG BID PO Initial or Prolonged Heart Rate Irregular Consumer Visual Disturbance Other Date:11/05/03ISR Number: 4228598-7Report Type:Expedited (15-DaCompany Report #2003UW14010 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Health Seroquel PS ORAL 50 MG DAILY Intervention to Dystonia Professional PO Prevent Permanent Eye Rolling Seroquel SS ORAL 100 MG DAILY Impairment/Damage Joint Stiffness PO Musculoskeletal Stiffness Seroquel SS ORAL 200 MG PO Swollen Tongue Xanax C Paxil C Date:11/05/03ISR Number: 4228772-XReport Type:Expedited (15-DaCompany Report #2003AP03831 Age:76 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 829 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Aggression Foreign Seroquel PS ORAL 400 MG DAILY Condition Aggravated Health PO Depression Professional Tegretol SS Drug Interaction Other Domin SS Drug Level Decreased Epirenat C Dyskinesia Rivotril C Dystonia Excitability Psychomotor Hyperactivity Tremor Date:11/05/03ISR Number: 4228871-2Report Type:Expedited (15-DaCompany Report #2003UW14301 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Seroquel PS Initial or Prolonged Platelet Count Increased Health Tegretol C White Blood Cell Count Professional Decreased Date:11/05/03ISR Number: 4228873-6Report Type:Expedited (15-DaCompany Report #2003GB02580 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Seroquel PS ORAL 550 MG DAILY Convulsion Health PO; Loss Of Consciousness Professional Efexor SS 150 MG BID Multiple Drug Overdose UNK; Pneumonia Seroquel SS OVERDOSE OF 5 WEEKS WORTH OF MEDICATION Efexor SS OVERDOSE OF 5 WEEKS OF MEDICATION Date:11/05/03ISR Number: 4228951-1Report Type:Expedited (15-DaCompany Report #2003UW14168 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Apnoea Foreign Nexium PS ORAL 100 MG QD PO Intervention to Pallor Health Seroquel SS ORAL 700 MG QD PO 2 DAY Prevent Permanent Somnolence Professional Haldol SS 5 MG 2 DAY Impairment/Damage Tremor Other Ancef C Atarax C Ativan C Demerol C Lasix C Merrem C Oxygen C Pantoloc C Sandostatin C Sodium Chloride C Tylenol C 22-Feb-2006 08:31 AM Page: 830 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/03ISR Number: 4227894-7Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0371291A Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cataract Wellbutrin PS Glaxosmithkline ORAL 300MG Twice Initial or Prolonged Confusional State per day 2 YR Other Crying Lamictal SS Glaxosmithkline ORAL Dissociation Wellbutrin SS Glaxosmithkline ORAL Drooling Pain Medication SS ORAL Drug Ineffective Wellbutrin SS Glaxosmithkline ORAL 600MG per day Dysgeusia Ultracet SS Dyskinesia Seroquel SS ORAL Emotional Disorder Nicotine Gum SS Glaxosmithkline ORAL Excoriation Zyprexa SS ORAL Feeling Jittery Klonopin C ORAL Gastric Disorder Lorazepam C Grand Mal Convulsion Ortho Tri-Cyclen C ORAL Head Injury Nicotine Patch C Glaxosmithkline TRANSDERMAL Insomnia Effexor C Mania Lescol C Musculoskeletal Stiffness Nail Disorder Nausea Pain Prescribed Overdose Psoriasis Road Traffic Accident Scratch Thinking Abnormal Tooth Loss Vaginal Infection Vomiting Vulvovaginal Mycotic Infection Weight Decreased Weight Increased Date:11/06/03ISR Number: 4228242-9Report Type:Direct Company Report #CTU 205407 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Seroquel 25 Mg PS ORAL PO DAILY Initial or Prolonged Urinary Tract Infection Lisinopril C Required Trazodone C Intervention to Prenatal Vitamin C Prevent Permanent Vioxx C Impairment/Damage Tylenol C Fibercon C Colace C Date:11/07/03ISR Number: 4231399-7Report Type:Expedited (15-DaCompany Report #2003UW14141 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Foreign Seroquel PS ORAL 25 MG BID PO Intervention to Extrapyramidal Disorder Health Reminyl SS 8 MG BID Prevent Permanent Professional Ativan C Impairment/Damage Other Carbolith C Entrophen C Neurontin C 22-Feb-2006 08:31 AM Page: 831 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Noctec C Remeron C Rivatril C Senokot C Date:11/07/03ISR Number: 4231404-8Report Type:Expedited (15-DaCompany Report #2003UW14169 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 200 MG QD PO 15 DAY Intervention to Neutropenia Health Ativan C Prevent Permanent Platelet Production Professional Polyvinyl Alcohol Impairment/Damage Decreased Other Ophthalmic C Haloperidol C Sulfacetamide Sodium C Date:11/07/03ISR Number: 4231559-5Report Type:Expedited (15-DaCompany Report #2003UW12236 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Seroquel PS ORAL 250-300 MG Initial or Prolonged Agitation Professional DAILY PO Required Thrombocytopenia Topamax C Intervention to Trazodone C Prevent Permanent Paxil C Impairment/Damage Date:11/07/03ISR Number: 4231580-7Report Type:Expedited (15-DaCompany Report #2003UW14293 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Menorrhagia Foreign Seroquel PS ORAL 50 MG DAILY Intervention to Health PO Prevent Permanent Professional Synthroid C Impairment/Damage Other Date:11/07/03ISR Number: 4231581-9Report Type:Expedited (15-DaCompany Report #2003UW14175 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperglycaemia Foreign Seroquel PS 125 MG DAILY Intervention to Leukopenia Health Clozaril SS Prevent Permanent Pancreatitis Professional Epival SS 500 MG BID Impairment/Damage Pulmonary Embolism Other Fluanxol SS Bayer 6 MG, DAILY Clonazepam C Paxil C Rivotril C Tenormin C Date:11/07/03ISR Number: 4231635-7Report Type:Direct Company Report #CTU 205541 Age: Gender:Male I/FU:I Outcome PT Death Abasia Abdominal Pain Abnormal Behaviour 22-Feb-2006 08:31 AM Page: 832 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Confusional State Hyperglycaemia Hyperglycaemic Report Source Product Role Manufacturer Route Dose Duration Hyperosmolar Nonketotic Zyprexa 61/2 Yrs. Syndrome Consistantly From Nausea 12/3/01-10/15/03. Pancreatitis Dose Mostly Polydipsia 7.5mg/Day PS Vomiting Seroquel 1/12/00->10/15/2003 Dose Mostly 400 Mg Sqd SS Paxil 9/98->10/15//03 Dose 60 Mg Qd Last 10 Days SS Trazodone 50 Mg One @Hs Since 8/12/03 SS Date:11/07/03ISR Number: 4231654-0Report Type:Expedited (15-DaCompany Report #2003UW14165 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Foreign Seroquel PS Intervention to Chills Health Clozaril SS ORAL 400 MG QD PO Prevent Permanent Cyanosis Professional Paxil SS ORAL 40 MG QD PO Impairment/Damage Decreased Appetite Other Clopixol (Decanoate) C Drug Level Increased Lorazepam C Gastritis Gastroenteritis Hepatic Steatosis Hepatotoxicity Increased Appetite Liver Function Test Abnormal Psychotic Disorder Pyrexia Vomiting Date:11/07/03ISR Number: 4231657-6Report Type:Expedited (15-DaCompany Report #2003UW14113 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperhidrosis Foreign Seroquel PS ORAL 100 MG PO Intervention to Loss Of Consciousness Health Ativan SS ORAL 1 MG PO Prevent Permanent Muscle Twitching Professional Paxil SS ORAL 20 MG PO Impairment/Damage Pyrexia Other Trazodone SS Serotonin Syndrome Diazepam C Somnolence Sorbitol Lactated Tachycardia Ringer'S Solution C Date:11/07/03ISR Number: 4231666-7Report Type:Expedited (15-DaCompany Report #2003AP03851 Age:22 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:31 AM Page: 833 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Foreign Seroquel PS ORAL 400 MG DAILY Amenorrhoea Health PO Biliary Dilatation Professional Stilnox C Cholelithiasis Other Chromaturia Jaundice Nausea Vomiting Weight Weight Increased Date:11/07/03ISR Number: 4231854-XReport Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0420960A Age: YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chapped Lips Wellbutrin PS Glaxosmithkline ORAL Cheilitis Seroquel SS Erythema Celexa SS Lip Dry Zoloft SS Overdose Date:11/07/03ISR Number: 4232168-4Report Type:Expedited (15-DaCompany Report #2003UW13930 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sleep Apnoea Syndrome Health Seroquel PS ORAL 1200 MG PO Professional Date:11/07/03ISR Number: 4232170-2Report Type:Expedited (15-DaCompany Report #2003UW14074 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Professional Luvox SS 200 MG DAILY Date:11/07/03ISR Number: 4232187-8Report Type:Expedited (15-DaCompany Report #2003UW14207 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bruxism Consumer Seroquel PS ORAL 250 MG DAILY Intervention to Disease Recurrence PO Prevent Permanent Dry Mouth Detrol C Impairment/Damage Epistaxis Lip Ulceration Mental Disorder Movement Disorder Parkinsonian Rest Tremor Somnolence Speech Disorder Tongue Disorder Urinary Incontinence 22-Feb-2006 08:31 AM Page: 834 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/03ISR Number: 4232189-1Report Type:Expedited (15-DaCompany Report #2003UW14076 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Seroquel PS Initial or Prolonged Professional Date:11/09/03ISR Number: 4232883-2Report Type:Direct Company Report #CTU 205701 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Zyprexa 15mg Lilly PS Lilly ORAL 2 TABLETS BID Disability Diabetic Neuropathy ORAL Required General Physical Health Seroquel 100mg Intervention to Deterioration Astrazeneca SS Astrazeneca ORAL 1 TABLET ONCE Prevent Permanent Hypertension DAILY ORAL Impairment/Damage Ketoacidosis Effexor C Proteinuria Synthroid C Buspar C Albuterol C Date:11/10/03ISR Number: 4233485-4Report Type:Expedited (15-DaCompany Report #2003PK01801 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Interstitial Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Normochromic Normocytic Health PO Required Anaemia Professional Risperidon SS ORAL 4 MG DAILY PO Intervention to Renal Tubular Disorder Other Melperon SS ORAL 25 MG DAILY Prevent Permanent PO Impairment/Damage Citalopram SS ORAL 40 MG DAILY PO Date:11/10/03ISR Number: 4233486-6Report Type:Expedited (15-DaCompany Report #2003UW14171 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dysphemia Foreign Seroquel PS ORAL 125 MG QD PO Intervention to Dyspnoea Health Effexor SS 93.75 MG Prevent Permanent Feeling Abnormal Professional Ativan C Impairment/Damage Hypertension Other Benztropine C Swollen Tongue Tachycardia Date:11/10/03ISR Number: 4233694-4Report Type:Expedited (15-DaCompany Report #2003UW14430 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Seroquel PS ORAL 500 MG QD PO Initial or Prolonged Depressed Level Of Seroquel SS 25 MG, PRN Consciousness Neurontin C Fall Lamictal C Hypotonia Zoloft C Intentional Overdose Wellbutrin C Respiratory Arrest Suicidal Ideation 22-Feb-2006 08:31 AM Page: 835 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/03ISR Number: 4234677-0Report Type:Expedited (15-DaCompany Report #2003UW09786 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Erythema Health Seroquel PS ORAL 75 MG DAILY Intervention to Face Oedema Professional PO Prevent Permanent Oedema Peripheral Klonopin C Impairment/Damage Luvox C Date:11/12/03ISR Number: 4234680-0Report Type:Expedited (15-DaCompany Report #2003UW14378 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Seroquel PS ORAL 500 MG DAILY Initial or Prolonged Professional PO Geodon C Date:11/12/03ISR Number: 4234757-XReport Type:Expedited (15-DaCompany Report #2003UW14576 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS ORAL 800 MG QD PO Rash Professional Depakote C Thyroxine Decreased Date:11/12/03ISR Number: 4234969-5Report Type:Expedited (15-DaCompany Report #2003UW14166 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS Intervention to Agitation Health Divalproex Sodium SS 500 MG Prevent Permanent Depressed Level Of Professional Impairment/Damage Consciousness Other Hallucination Muscle Twitching Tachycardia Date:11/12/03ISR Number: 4235058-6Report Type:Expedited (15-DaCompany Report #2003UW14708 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Foreign Seroquel PS Intervention to Overdose Health Prevent Permanent Professional Impairment/Damage Other Date:11/12/03ISR Number: 4235063-XReport Type:Expedited (15-DaCompany Report #2003UW14301 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Seroquel PS Initial or Prolonged Platelet Count Increased Health Tegretol C White Blood Cell Count Professional Decreased Other 22-Feb-2006 08:31 AM Page: 836 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/03ISR Number: 4235068-9Report Type:Expedited (15-DaCompany Report #2003SE03403 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ventricular Extrasystoles Foreign Seroquel PS ORAL 700 MG DAILY Initial or Prolonged Health PO Professional Anaesthetics SS Other Propranolol C Oxazepam C Date:11/12/03ISR Number: 4235069-0Report Type:Expedited (15-DaCompany Report #2002AP02898 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 14 G PO Dyspnoea Health Seroquel SS ORAL 500 MG DAILY Loss Of Consciousness Professional PO Overdose Other Psychotic Disorder Date:11/12/03ISR Number: 4235099-9Report Type:Expedited (15-DaCompany Report #2003GB01945 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Seroquel PS ORAL 150 MG BID PO Orthostatic Hypotension Health Metformin C Sinus Tachycardia Professional Gliclazide C Syncope Vasovagal Other Ibuprofen C Date:11/13/03ISR Number: 4235642-XReport Type:Expedited (15-DaCompany Report #2003AP03831 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Drug Interaction Health PO Required Drug Level Increased Professional Tegretol SS ORAL 400 MG DAILY Intervention to Mania Other PO Prevent Permanent Parkinsonism Tegretol SS ORAL 600 MG DAILY Impairment/Damage Psychomotor Hyperactivity PO Tremor Domin SS Epirenat C Rivotril C Hiberna C Lipitor C Date:11/13/03ISR Number: 4235681-9Report Type:Expedited (15-DaCompany Report #2003SE04876 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sinus Bradycardia Foreign Seroquel Code Not Initial or Prolonged Study Broken PS ORAL 40 MG BID PO Health Felodipine SS ORAL 5 MG DAILY PO Professional Amiodaron SS ORAL 200 MG DAILY Other PO Furosemide SS ORAL 40 MG DAILY PO Levodopa C Aspirina C 22-Feb-2006 08:31 AM Page: 837 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/03ISR Number: 4235850-8Report Type:Expedited (15-DaCompany Report #2003UW14671 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Seroquel PS ORAL 25 MG ONCE PO Initial or Prolonged Professional Date:11/14/03ISR Number: 4235294-9Report Type:Direct Company Report #CTU 206068 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Malaise Seroquel (Quetiapine Pharmaceutical Product Fumarate- PS 25 MG , TAB, Complaint TWICE DAILY Vomiting Date:11/14/03ISR Number: 4235306-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0411363A Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anger Parnate PS Glaxosmithkline ORAL 10MG Three Asthenia times per day Bilirubin Conjugated Seroquel SS 300MG Twice Increased per day Blood Calcium Increased Clozapine C Blood Chloride Decreased Effexor C Blood Creatine Zyprexa C 10MG At night Phosphokinase Increased Risperdal C Blood Phosphorus Increased Blood Potassium Increased Blood Sodium Decreased Cardiac Arrest Chest Pain Confusional State Cough Disturbance In Attention Drug Ineffective Dyspnoea Fatigue Feeling Abnormal Flat Affect Headache Heart Rate Increased Hyperthermia Malignant Hyperventilation Irritability Leukocytosis Memory Impairment Micturition Frequency Decreased Neck Pain Neuroleptic Malignant Syndrome Pulse Absent Pyrexia Restlessness Tremor Ventricular Hypertrophy 22-Feb-2006 08:31 AM Page: 838 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/03ISR Number: 4235464-XReport Type:Direct Company Report #CTU 206083 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Muscle Rigidity Seroquel 100 Mg Neuroleptic Malignant Astra-Zeneca PS Astra-Zeneca ORAL 100 MG ORAL Syndrome Date:11/14/03ISR Number: 4235535-8Report Type:Direct Company Report #CTU 206077 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Pruritic Seroquel 100mg Bid PS 100 MG BID Date:11/14/03ISR Number: 4236208-8Report Type:Expedited (15-DaCompany Report #2003116212 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dissociation Consumer Neurontin Initial or Prolonged Feeling Abnormal (Gabapentin) PS ORAL 300 MG (TID), Other Overdose ORAL Respiratory Arrest Quetiapine Fumarate Suicide Attempt (Quetiapine Fumarate) SS Clonidine (Clonidine) SS Sertraline Hydrochloride (Sertraline Hydrochloride) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Risperidone (Risperidone) C Ibuprofen (Ibuprofen) C All Other Therapeutic Products C Date:11/14/03ISR Number: 4236214-3Report Type:Expedited (15-DaCompany Report #2003178929US Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Xanax (Alprazolam) Multiple Drug Overdose Professional Tablet PS ORAL ORAL Prozac (Fluoxetine Hydrochloride) SS ORAL ORAL Seroquel (Quetiapine) SS All Other Therapeutic Products SS 22-Feb-2006 08:31 AM Page: 839 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/03ISR Number: 4236618-9Report Type:Expedited (15-DaCompany Report #2003GB02985 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cogwheel Rigidity Foreign Quetiapine PS ORAL 300 MG PO Dyskinesia Health Risperidone SS ORAL 10 MG PO Dystonia Professional Efexor Xl C Movement Disorder Other Restlessness Date:11/17/03ISR Number: 4237051-6Report Type:Expedited (15-DaCompany Report #S03-GER-04403-01 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Toxicity Foreign Cipramil (Citalopram Nephritis Interstitial Health Hydrobromide) PS ORAL 40 MG QD PO Normochromic Normocytic Professional Risperdal Anaemia Other (Risperidone) SS ORAL 4 MG QD PO Red Blood Cell Eunerpan (Melperone Sedimentation Rate Hydrochloride) SS ORAL 25 MG QD PO Increased Seroquel (Quetiapine Renal Tubular Disorder Fumarate) SS ORAL 750 MG QD PO Schizophrenia Sleep Disorder Date:11/17/03ISR Number: 4237173-XReport Type:Expedited (15-DaCompany Report #2003AP03641 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Epilepsy Health Seroquel SS ORAL 125 MG DAILY Required Fall Professional PO Intervention to Loss Of Consciousness Other Seroquel SS ORAL 100 MG BID PO Prevent Permanent Musculoskeletal Stiffness Seroquel SS ORAL 100 MG TID PO Impairment/Damage Pyrexia Seroquel SS ORAL 100 MG BID PO Somnolence Seroquel SS ORAL 125 MG DAILY PO Seroquel SS ORAL 100 MG DAILY PO Seroquel SS ORAL 75 MG DAILY PO Myslee C Fursennid C Date:11/18/03ISR Number: 4237130-3Report Type:Expedited (15-DaCompany Report #FLUV00303002962 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Level Increased Foreign Luvox 25 Eosinophilia Health (Fluvoxamine Erythema Professional Maleate) PS 50 MG DAILY ; Hepatocellular Damage Other 300 MG DAILY Pyrexia Seroquel (Seroquel) SS 50 MG DALY; Viral Infection SEE IMAGE Risperdal (Risperidone) C 22-Feb-2006 08:31 AM Page: 840 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/03ISR Number: 4237465-4Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0379987A Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Consumer Bupropion PS Glaxosmithkline ORAL Hospitalization - Cardiovascular Disorder Venlafaxine SS UNKNOWN Initial or Prolonged Completed Suicide Methylphenidate SS UNKNOWN Convulsion Quetiapine SS Depressed Level Of Clonazepam SS Consciousness Trazodone SS Hypotension Gabapentin SS Hypothermia Lansoprazole SS Intentional Overdose Respiratory Depression Date:11/19/03ISR Number: 4238602-8Report Type:Expedited (15-DaCompany Report #2003AP03972 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pyrexia Foreign Seroquel PS ORAL 100 MG DAILY Thrombocytopenia Health PO Professional Cravit C Other Telesmin C Risperdal C Vegetamin C Date:11/19/03ISR Number: 4238604-1Report Type:Expedited (15-DaCompany Report #2003SE04984 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Level Increased Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Priapism Health PO Prevent Permanent Professional Nortrilen C Impairment/Damage Other Haloperidol C Levomepromazine C Date:11/19/03ISR Number: 4238726-5Report Type:Expedited (15-DaCompany Report #2003GB01945 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autonomic Neuropathy Foreign Seroquel PS ORAL 150 MG BID PO Choking Health Metformin C Orthostatic Hypotension Professional Gliclazide C Sinus Tachycardia Other Ibuprofen C Syncope Vasovagal Date:11/19/03ISR Number: 4238842-8Report Type:Expedited (15-DaCompany Report #2003UW14836 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS Decreased Professional Geodon C 22-Feb-2006 08:31 AM Page: 841 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/03ISR Number: 4239057-XReport Type:Expedited (15-DaCompany Report #2003-03830 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Clonazepam (Watson Health Laboratories)(Clonaz Professional epam) Tablet PS Cyclobenzaprine Hydrochloride (Watson Laboratories) (Cyclobenzaprine SS Quetiapine (Unknown Manufacturer) (Quetiapine) SS Date:11/19/03ISR Number: 4239407-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031102715 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Study Risperidone Weight Increased Health (Risperidone) Professional Unspecified PS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS Ziprasidone (Ziprasidone) SS Perphenazine (Perphenazine) SS Date:11/19/03ISR Number: 4239432-3Report Type:Expedited (15-DaCompany Report #2003UW14871 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fungal Infection Health Seroquel PS ORAL 200 MG HS PO Initial or Prolonged Professional Ranitidine C Remeron C Dilaudid C Amoxicillin C Flonase C Steroids C Amitriptyline C Serzone C Zoloft C Lexapro C Date:11/19/03ISR Number: 4239433-5Report Type:Expedited (15-DaCompany Report #2003UW14976 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS Decreased Professional Geodon SS 22-Feb-2006 08:31 AM Page: 842 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/03ISR Number: 4239548-1Report Type:Expedited (15-DaCompany Report #2003-03807 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Metformin Health Hydrochloride Professional (Watson Laboratories) (Metformin PS Watson Laboratories Quetiapine (Quetiapine) SS Olazapine(Olanzapine ) SS Date:11/20/03ISR Number: 4238033-0Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0379989A Age:16 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Bupropion PS Glaxosmithkline ORAL Cardio-Respiratory Arrest Quetiapine SS UNKNOWN Coma Valproic Acid SS UNKNOWN Completed Suicide Convulsion Depressed Level Of Consciousness Hypotension Intentional Overdose Multiple Drug Overdose Mydriasis Pupil Fixed Date:11/20/03ISR Number: 4238046-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0383147A Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Bupropion PS Glaxosmithkline ORAL Cardio-Respiratory Arrest Quetiapine SS UNKNOWN Completed Suicide Levofloxacin SS Intentional Overdose Date:11/20/03ISR Number: 4238047-0Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0383148A Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Bupropion PS Glaxosmithkline ORAL Completed Suicide Quetiapine SS UNKNOWN Intentional Overdose Date:11/20/03ISR Number: 4239356-1Report Type:Expedited (15-DaCompany Report #2003-03838 Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Clonazepam (Watson Health Laboratories)(Clonaz Professional epam) Tablet PS Waston Laboratories Oxycodone Hydrochloride/Apap (Waston) (Oxycodone 22-Feb-2006 08:31 AM Page: 843 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride, Acetaminophen) SS Waston Quetiapine(Quetiapin e) SS Date:11/21/03ISR Number: 4239112-4Report Type:Expedited (15-DaCompany Report #AU-ROCHE-351957 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atelectasis Diazepam PS Roche ORAL PATIENT WAS Initial or Prolonged Cardiac Failure REPORTED TO Coma HAVE TAKEN Grand Mal Convulsion 400 TABLETS. 1 DAY Hypothermia Seroquel SS ORAL PATIENT Hypoventilation REPORTED TO Intentional Overdose HAVE TAKEN 80 Lactic Acidosis TABLETS. 1 DAY Renal Failure Dexamphetamine C Sepsis Shock Date:11/21/03ISR Number: 4239390-1Report Type:Direct Company Report #CTU 206565 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Quetiapine 50mg PS ORAL 50 MG BID Initial or Prolonged Head Injury ORAL Limb Injury Lorazepam C Treatment Noncompliance Lithium C Enalapril C Aspirin C Combivent C Date:11/21/03ISR Number: 4240494-8Report Type:Expedited (15-DaCompany Report #2003186096JP Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Halcion(Triazolam) Initial or Prolonged Consciousness Health Tablet PS ORAL 0.5 MG, QD, Drug Ineffective Professional ORAL Neuroleptic Malignant Other Seroquel Syndrome (Quetiapine) SS Pyrexia Ravona (Pentobarbital Calcium) C Date:11/21/03ISR Number: 4240509-7Report Type:Expedited (15-DaCompany Report #GBWYE403413NOV03 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Health Efexor (Venlafaxien Hospitalization - Convulsion Professional Hydrochloride, Initial or Prolonged Intentional Overdose Other Unspec, 0) PS ORAL 300 MG 1X PER Loss Of Consciousness 1 DAY ORAL Pneumonia Seroquel (Quetiapine, , 0) SS ORAL 550 MG 1X PER 1 DAY ORAL 22-Feb-2006 08:31 AM Page: 844 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/03ISR Number: 4240510-3Report Type:Expedited (15-DaCompany Report #GBWYE403413NOV03 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Health Efexor (Venlafaxine Hospitalization - Convulsion Professional Hydrochloride, Initial or Prolonged Intentional Overdose Other Unspec, O) PS ORAL OVERDOSE, Loss Of Consciousness AMOUNT Pneumonia UNKNONW ORAL Seroquel (Quetiapine, , 0) SS ORAL 550 MG 1X PER 1 DAY ORAL Date:11/24/03ISR Number: 4240473-0Report Type:Direct Company Report #CTU 206663 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Seroquel 100 Mg. Initial or Prolonged Anxiety Astra Zeneca PS Astra Zeneca BUCCAL 100 MG. AM & Disability Chest Pain 225MG BUCCAL Other Condition Aggravated Zoloft 75 Mg. Pfizer SS Pfizer BUCCAL 75MG AM ONLY Dizziness BUCCAL Drug Ineffective Fear Hallucination Hallucination, Auditory Hypoaesthesia Weight Increased Date:11/24/03ISR Number: 4241165-4Report Type:Expedited (15-DaCompany Report #2003UW15044 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Medication Error Consumer Seroquel PS Unevaluable Event Seroquel SS Date:11/24/03ISR Number: 4241167-8Report Type:Expedited (15-DaCompany Report #2003UW13872 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Health Seroquel PS ORAL 50 MG HS PO Initial or Prolonged Increased Professional Seroquel SS ORAL 600 MG QD PO Required Diabetes Mellitus Seroquel SS ORAL 500 MG QD PO Intervention to Non-Insulin-Dependent Seroquel SS ORAL 400 MG QD PO Prevent Permanent Liver Function Test Seroquel SS ORAL 600 MG QD PO Impairment/Damage Abnormal Seroquel SS ORAL 700 MG QD PO Renal Failure Seroquel SS ORAL 800 MG QD PO Nexium C Depakote C Lithium C Date:11/24/03ISR Number: 4241617-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12416723 Age:2 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:31 AM Page: 845 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lexapro SS ORAL Seroquel SS ORAL Date:11/24/03ISR Number: 4241719-5Report Type:Expedited (15-DaCompany Report #2003-04037 Age:34 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Trihexyphenidyl Health Hydrochloride Professional (Watson Laboratories)(Trihex yphenidyl PS Watson Laboratories Valproic Acid (Valproic Acid) SS Quetiapine (Quetiapine) SS Date:11/24/03ISR Number: 4241784-5Report Type:Expedited (15-DaCompany Report #2003UW14764 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other International Normalised Foreign Seroquel PS ORAL 50 MG BID PO Ratio Decreased Health Coumadin Boots C Professional Triazid Ct Other Azneimittel C Docusate Sodium C Timoptic C Xalatan C Remeron C Date:11/24/03ISR Number: 4241863-2Report Type:Expedited (15-DaCompany Report #2003-04000 Age:64 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Baclofen (Watson Health Laboratories)(Baclof Professional en) Tablet PS Watson Laboratories Doxepin (Watson Laboratories) (Doxepin Hydrochloride) Capsule SS Quetiapine (Quetiapine) SS Date:11/25/03ISR Number: 4242115-7Report Type:Expedited (15-DaCompany Report #2003-03906 Age:44 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Mirtazapine (Watson Laboratories)(Mirtaz apine) Tablet PS Watson Laboratories Quetiapine (Quetiapine) SS Ethanol (Ethanol) SS 22-Feb-2006 08:31 AM Page: 846 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/03ISR Number: 4242197-2Report Type:Expedited (15-DaCompany Report #2003-03904 Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Glipizide (Watson Health Laboratories) Professional (Glipizide) Tablet PS UNKNOWN UNK, UNK, UNK Metformin Hydrochloride (Watson Laboratories) (Metformin SS UNKNOWN UNK, UNK, UNK Quetiapine (Quetiapine) SS UNKNOWN UNK, UNK, UNK Date:11/25/03ISR Number: 4242454-XReport Type:Expedited (15-DaCompany Report #03P-163-0241006-00 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Valproic Acid Health (Depakene) PS ORAL ORAL Professional Quetiapine SS ORAL ORAL Risperidone SS ORAL ORAL Date:11/25/03ISR Number: 4242505-2Report Type:Expedited (15-DaCompany Report #03P-163-0240954-00 Age:48 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Valproic Acid Health (Depakene) (Valproic Professional Acid) (Valproic Acid) PS ORAL ORAL Quetiapine SS ORAL ORAL Date:11/25/03ISR Number: 4242506-4Report Type:Expedited (15-DaCompany Report #03P-163-0241002-00 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Valproic Acid Health (Depakene) (Valproic Professional Acid) (Valproic Acid) PS Quetiapine SS Phencyclidine SS Date:11/25/03ISR Number: 4242586-6Report Type:Expedited (15-DaCompany Report #03P-163-0240933-00 Age:34 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Valproic Acid Completed Suicide Health (Depakene) (Valproic Professional Acid) (Valproic Acid) PS ORAL ORAL Trihexyphenidyl SS ORAL ORAL Quetiapine SS ORAL ORAL 22-Feb-2006 08:31 AM Page: 847 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/03ISR Number: 4242613-6Report Type:Expedited (15-DaCompany Report #2003-03912 Age:33 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Chlordiazepoxide Health Hydrochloride Professional (Watson Laboratories) (Chlordiazepoxide PS Watson Laboratories Doxepin (Watson Laboratories) (Doxepin Hydrochloride) Capsule SS Watson Laboratories Quetiapine (Quetiapine) SS Date:11/25/03ISR Number: 4242635-5Report Type:Expedited (15-DaCompany Report #2003118418 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytopenia Foreign Zoloft (Sertraline) PS ORAL 100 MG, ORAL Initial or Prolonged Health Quetiapine Fumarate Professional (Quetiapine Fumarate) SS ORAL 400 MG, ORAL Levothyroxine Sodium (Levothyroxine Sodium) C Date:11/26/03ISR Number: 4243785-XReport Type:Expedited (15-DaCompany Report #2003UW14166 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS Intervention to Agitation Health Divalproex Sodium SS 500 MG Prevent Permanent Depressed Level Of Professional Impairment/Damage Consciousness Other Hallucination Muscle Twitching Tachycardia Date:11/26/03ISR Number: 4243816-7Report Type:Expedited (15-DaCompany Report #2003GB03102 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Seroquel PS ORAL 1200 MG DAILY Required Tachycardia Health PO Intervention to Professional Seroquel SS OVERDOSE Prevent Permanent Other Amisulpride C Impairment/Damage Date:11/26/03ISR Number: 4244180-XReport Type:Expedited (15-DaCompany Report #2003GB00151 Age:34 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 848 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Caesarean Section Foreign Seroquel PS ORAL 600 MG DAILY Complications Of Maternal Health PO Exposure To Therapeutic Professional Chlorpromazine SS ORAL 200 MG DAILY Drugs Other PO Drug Abuser Folic Acid SS ORAL 400 UG DAILY Intentional Self-Injury PO Pregnancy Cannabis SS Psychotic Disorder Amphetamine SS Vaginal Haemorrhage Date:11/26/03ISR Number: 4244190-2Report Type:Expedited (15-DaCompany Report #2003AP04020 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pancytopenia Literature Quetiapine PS 25 MG BID Intervention to Health Carbidopa C Prevent Permanent Professional Levodopa C Impairment/Damage Sertraline C Hydrochlorothiazide C Terazosin C Tolterodine C Rabeprazole C Date:11/26/03ISR Number: 4244191-4Report Type:Expedited (15-DaCompany Report #2003GB03136 Age:0 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Caesarean Section Foreign Seroquel PS TRANSPLACENTAL 600 MG DAILY Required Fluid Retention Health TPL Intervention to Maternal Drugs Affecting Professional Chlorpromazine SS TRANSPLACENTAL 200 MG DAILY Prevent Permanent Foetus Other TPL Impairment/Damage Renal Impairment Neonatal Folic Acid SS TRANSPLACENTAL 400 UG DAILY Umbilical Cord Around TPL Neck Cannabis SS Amphetamine SS Date:11/26/03ISR Number: 4244194-XReport Type:Expedited (15-DaCompany Report #2003PK01959 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytopenia Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Leukopenia Health PO Professional Zoloft C Other Thyronajod C Date:11/26/03ISR Number: 4244195-1Report Type:Expedited (15-DaCompany Report #2003UW13641 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Health Seroquel PS 800 MG PO Initial or Prolonged Professional Geodon C Neurontin C Amitriptyline C Synthroid C 22-Feb-2006 08:31 AM Page: 849 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gabitril C Date:11/26/03ISR Number: 4244197-5Report Type:Expedited (15-DaCompany Report #2003SE05276 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Nasal Congestion Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Palpitations Health PO Prevent Permanent Swollen Tongue Professional Efexor C Impairment/Damage Throat Tightness Other Date:11/26/03ISR Number: 4244281-6Report Type:Expedited (15-DaCompany Report #2003PK01801 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacterial Infection Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Drug Toxicity Other PO Required Nephritis Interstitial Risperidon SS ORAL 4 MG DAILY PO Intervention to Nephropathy Melperon SS ORAL 25 MG DAILY Prevent Permanent Normochromic Normocytic PO Impairment/Damage Anaemia Citalopram SS ORAL 40 MG DAILY Red Blood Cell PO Sedimentation Rate Increased Renal Tubular Disorder Date:11/26/03ISR Number: 4244285-3Report Type:Expedited (15-DaCompany Report #2003AP03088 Age:91 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Increased Health PO Aspartate Professional No Match SS Aminotransferase Other Keiten C Increased Asverin C Blood Alkaline Mucodyne C Phosphatase Increased Blood Lactate Dehydrogenase Increased Delirium Liver Disorder Restlessness Date:11/26/03ISR Number: 4244304-4Report Type:Expedited (15-DaCompany Report #2003186096JP Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Halcion (Triazolam) Initial or Prolonged Cough Health Tablet PS ORAL 0.5 MG, QD, Insomnia Professional ORAL Neuroleptic Malignant Other Seroquel Syndrome (Quetiapine) SS ORAL 100 MG/DAY, ORAL Ravona (Pentobarbital Calcium) C 22-Feb-2006 08:31 AM Page: 850 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4243196-7Report Type:Direct Company Report #CTU 206999 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Seroquel 25 Mg PS ORAL 25 MG PO QHS Initial or Prolonged Hyperhidrosis Mevacor C Hypotension Cardizem C Medication Error Prinivil C Nausea Amiodarone C Pallor Levoxyl C Vomiting Aricept C Quetiapine C Feso4 C Vit E C Asa C Date:11/28/03ISR Number: 4243216-XReport Type:Direct Company Report #USP 56177 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Serzone PS Bristol-Meyers Squibb TABLET Seroquel SS Astrazeneca TABLET Date:11/28/03ISR Number: 4245381-7Report Type:Expedited (15-DaCompany Report #A-US2003-03701 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Study Tracleer(Bosentan) Initial or Prolonged Increased Health Tablet PS ORAL SEE IMAGE, Other Arthritis Infective Professional ORAL Aspartate Distributor Seroquel(Quetiapine) SS 25MG, BID Aminotransferase Maxzide Increased (Triamterene, Bipolar Disorder Hydrochlorothiazide) C Blood Alkaline Effexor (Venlafaxine Phosphatase Increased Hydrochloride) C Blood Bilirubin Increased Gamma-Glutamyltransferase Increased Haematemesis Haematocrit Decreased Haemoglobin Decreased Nausea Oesophagitis Date:12/01/03ISR Number: 4243788-5Report Type:Direct Company Report #CTU 207067 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Quetiapine 300 Mg PS BUCCAL 300 MG TWICE Intervention to Eye Disorder A DA BUCCAL Prevent Permanent Eye Pain Bupropion C Impairment/Damage Night Blindness Venlafaxine C Visual Acuity Reduced Divalproex C Multivitamin C Selenium C Folic Acid C Vitamin C C 22-Feb-2006 08:31 AM Page: 851 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/03ISR Number: 4245560-9Report Type:Expedited (15-DaCompany Report #2003UW15358 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diarrhoea Health Seroquel PS Intervention to Pleural Effusion Professional Prevent Permanent Impairment/Damage Date:12/02/03ISR Number: 4245561-0Report Type:Expedited (15-DaCompany Report #2003UW15411 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Seroquel PS ORAL 500 MG QD PO Hypotension Professional Date:12/02/03ISR Number: 4245562-2Report Type:Expedited (15-DaCompany Report #2003UW15501 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Seroquel PS Required Professional Intervention to Prevent Permanent Impairment/Damage Date:12/02/03ISR Number: 4245563-4Report Type:Expedited (15-DaCompany Report #2003UW15262 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperammonaemia Health Seroquel PS Initial or Prolonged Professional Fluoxetine SS Date:12/02/03ISR Number: 4245608-1Report Type:Expedited (15-DaCompany Report #2003UW15358 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diarrhoea Health Seroquel PS Intervention to Pleural Effusion Professional Prevent Permanent Impairment/Damage Date:12/02/03ISR Number: 4245609-3Report Type:Expedited (15-DaCompany Report #2003UW12162 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Brain Neoplasm Health Seroquel PS ORAL 1200 MG QD PO Intervention to Hyperprolactinaemia Professional Topamax C Prevent Permanent Lactation Disorder Impairment/Damage Weight Increased 22-Feb-2006 08:31 AM Page: 852 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/03ISR Number: 4246002-XReport Type:Expedited (15-DaCompany Report #AT-JNJFOC-20031104219 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Haloperidol Initial or Prolonged Increased Health (Haloperidol) Aspartate Professional Injection PS INTRAVENOUS SEE IMAGE Aminotransferase Depakine (Valproate Increased Sodium, Injection) SS INTRAVENOUS SEE IMAGE Blood Creatine Seroquel (Quetiapine Phosphokinase Increased Fumarate) SS ORAL SEE IMAGE Drug Interaction Rivotril Gamma-Glutamyltransferase (Clonazepam) Increased Injection C Akineton (Biperiden Hydrochloride) C Entumin (Clotiapine) Tablets C Claforan (Cefotaxime Sodium) Injection C Fragmin (Heparin-Fraction, Sodium Salt) Injection C Magnesium Sulfate (Magnesium Sulfate) C Date:12/02/03ISR Number: 4246009-2Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20031104222 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adenoma Benign Foreign Haldol (Haloperidol) Anaemia Health Unspecified PS 10 MG, IN 1 Arteriosclerosis Professional DAY Brain Oedema Corenitec Cardiac Arrest (Vaseretic) SS LONG TERM Coronary Artery Disease Seroquel (Quetiapine Dehydration Fumarate) SS 50 MG; 75 MG; Depression 100 MG Drug Interaction Isoptin (Verapamil Dyspnoea Hydrochloride) C Emphysema Calcium Carbonate Fall (Calcium Carbonate) C Fibrosis Fosamax (Alendronate Lipomatosis Sodium) C Marasmus Trittico (Trazodone Myocardial Fibrosis Hydrochloride) C Perirenal Haematoma Kcl Retard Psychomotor Hyperactivity (Potassium Chloride) C Pulmonary Embolism Pantoloc Pulmonary Infarction (Pantoprazole) C Venous Thrombosis Gewacalm (Diazepam) C Nacl (Sodium Chloride) C Akineton (Biperiden Hydrochloride) C 22-Feb-2006 08:31 AM Page: 853 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/03ISR Number: 4246087-0Report Type:Expedited (15-DaCompany Report #2003UW14168 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Apnoea Foreign Seroquel PS ORAL 700 MG QD PO 2 DAY Intervention to Pallor Health Haldol SS 5 MG 2 DAY Prevent Permanent Somnolence Professional Nozinan SS ORAL 100 MG QD PO Impairment/Damage Tremor Other Ancef C Atarax C Ativan C Lasix C Merrem C Oxygen C Pantoloc C Santoloc C Sandostatin C Sodium Chloride C Tylenol C Date:12/02/03ISR Number: 4246093-6Report Type:Expedited (15-DaCompany Report #2003PK01976 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel "Zeneca" PS Zeneca ORAL 50 MG DAILY Life-Threatening Emphysema Health PO Fall Professional Seroquel "Zeneca" SS Zeneca ORAL 75 MG DAILY Pulmonary Congestion Other PO Pulmonary Embolism Seroquel "Zeneca" SS Zeneca ORAL 100 MG DAILY Pulmonary Infarction PO Haldol SS ORAL 10 MG DAILY PO Co-Renitec SS Isoptin C Calciumcarbonat C Fosamax C Trittico C Kcl-Retard C Pantoloc C Gewacalm C Nacl C Akineton C Date:12/02/03ISR Number: 4246100-0Report Type:Expedited (15-DaCompany Report #2003UW15175 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel PS ORAL 100 BID PO Initial or Prolonged Neuroleptic Malignant Health Seroquel SS ORAL 100 BID PO Syndrome Professional Lamotrigine SS ORAL 150 DAILY PO Rash Other Venlax C Dormonid C Date:12/02/03ISR Number: 4246103-6Report Type:Expedited (15-DaCompany Report #2003UW14191 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Hospitalization - Oral Intake Reduced Foreign Initial or Prolonged Psychosocial Support Health Professional 22-Feb-2006 08:31 AM Page: 854 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 200 MG DAILY PO Seroquel SS Date:12/02/03ISR Number: 4246163-2Report Type:Expedited (15-DaCompany Report #2003UW03968 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gingival Erosion Consumer Seroquel PS ORAL 25 MG DAILY Intervention to Keratoconjunctivitis PO Prevent Permanent Sicca Seroquel SS ORAL 75 MG HS PO Impairment/Damage Muscle Rigidity Paxil C Pain In Extremity Xanax C Retinal Detachment Prozac C Retinal Tear Risperdal C Weight Increased Stelazine C Date:12/02/03ISR Number: 4246176-0Report Type:Expedited (15-DaCompany Report #2003UW13857 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Cholelithiasis Health Seroquel SS 25 MG BID AND Disease Recurrence Professional 50 QHS Epistaxis Other Calcium C Platelet Count Decreased Tylenol C Isopto Tears C Tear Gel C Olanzapine C Date:12/02/03ISR Number: 4246255-8Report Type:Expedited (15-DaCompany Report #2003119634 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Health Neurontin Hospitalization - Feeling Abnormal Professional (Gabapentin) PS ORAL ORAL Initial or Prolonged Heart Injury Metaxalone Other Insomnia (Metaxalone) SS Restlessness Cyclobenzaprine Suicide Attempt Hydrochloride (Cyclobenzaprine Hydrochloride ) SS Mirtazapine (Mirtazapine) SS Quetiapine Fumarate (Quetiapine Fumarate) SS Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS Estrogens Conjugated (Estrogens Conjugated) C Levothyroxine Sodium 22-Feb-2006 08:31 AM Page: 855 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Levothyroxine Sodium) C Oxycocet (Paracetamol, Oxycodone Hydrochloride) C Axotal (Old Form) (Caffeine, Butalbital, Paracetamol) C Tizanidine Hydrochloride (Tizanidine Hydrochloride) C Parafon Forte (Chlorzoxazone, Paracetamol) C Morphine (Morphine) C Date:12/02/03ISR Number: 4246296-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031102063 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abulia Foreign Risperdal Initial or Prolonged Anxiety Health (Risperidone) Asthenia Professional Unspecified PS ORAL 8 MG, 1 IN 1 Autism Other DAY, ORAL Catatonia Nemonapride Delusion (Nemonapride) SS ORAL 40 MG, IN 1 Dialysis DAY, ORAL Hallucination, Auditory Zotepine (Zotepine) SS ORAL 200 MG, IN 1 Hyperkalaemia DAY, ORAL Increased Appetite Quetiapine Fumarate Intentional Self-Injury (Quetiapine Palpitations Fumarate) SS ORAL 400 MG, IN 1 Renal Failure Acute DAY, ORAL Rhabdomyolysis Trihexphenidyl Weight Increased Hydrochloride (Trihexyphenidyl Hydrochloride) C Etilefrine Hydrochloride (Etilefrine Hydrochloride) C Carbamazepine (Carbamazepine) C Cloxazolam (Cloxazolam) C Sennoside (All Other Therapeutic Products) C Lorazepam (Lorazepam) C Date:12/03/03ISR Number: 4246175-9Report Type:Expedited (15-DaCompany Report #2003SE04513 Age:48 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:31 AM Page: 856 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Diabetic Coma Foreign Seroquel PS ORAL 200 MG BID PO Urine Ketone Body Present Health Glucophage C Professional Diamicron C Other Date:12/03/03ISR Number: 4246921-4Report Type:Expedited (15-DaCompany Report #DEWYE424626NOV03 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Study Trevilor Initial or Prolonged Incontinence (Venlafaxine Other Hydrochloride, Tablet, 0) PS ORAL 75 MG 1X PER 1 DAY, ORAL 8 DAY Seroquel (Quetiapine, , 0) SS ORAL 200 MG 1X PER 1 DAY, ORAL Insidon (Opipramoil Hydrochloride) C Date:12/03/03ISR Number: 4246966-4Report Type:Expedited (15-DaCompany Report #2003PK02002 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Carotid Artery Stenosis Foreign Seroquel "Zeneca" PS Zeneca ORAL 150 MG DAILY Cerebral Atrophy Health PO Confusional State Professional Praxiten SS ORAL 75 MG DAILY Depressed Level Of Other PO Consciousness Thyrex SS ORAL 1 MG DAILY PO Disorientation Secondary Hyperthyroidism Somnolence Date:12/03/03ISR Number: 4247074-9Report Type:Direct Company Report #CTU 207409 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Tenderness Seroquel 200 Mg PS ORAL 200 MG ORAL Seroquel 50 Mg SS ORAL 50 MG ORAL Date:12/03/03ISR Number: 4247076-2Report Type:Direct Company Report #CTU 207414 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blepharospasm Seroquel 200 Mg PS ORAL 200 MG HS Intervention to ORAL Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 857 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/03ISR Number: 4247298-0Report Type:Expedited (15-DaCompany Report #DEWYE424626NOV03 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Study Trevilor Initial or Prolonged Incontinence (Venlafaxine Other Hydrochloride, Tablet, 0) PS ORAL 75 MG 1X PER 1 DAY ORAL 8 DAY Seroquel (Quetiapine, , 0) SS ORAL 200 MG 1X PER 1 DAY ORAL Insidon (Opipramol Hydrochloride) C Date:12/04/03ISR Number: 4247574-1Report Type:Expedited (15-DaCompany Report #2003SE05377 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 300 MG BID PO Health Haloperidol SS ORAL 24 MG TID PO Professional Levomepromazin C Other Diazepam C Date:12/04/03ISR Number: 4247581-9Report Type:Expedited (15-DaCompany Report #2003GB02332 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Health Professional Other Date:12/04/03ISR Number: 4247587-XReport Type:Expedited (15-DaCompany Report #2003GB03170 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Disease Recurrence Foreign Seroquel PS ORAL 600 MG DAILY Intervention to Health PO Prevent Permanent Professional Impairment/Damage Other Date:12/04/03ISR Number: 4247589-3Report Type:Expedited (15-DaCompany Report #2003AP03768 Age:13 YR Gender:Female I/FU:F Outcome PT Life-Threatening Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Eosinophil Count Increased Erythema Feeling Hot Flushing Hepatic Function Abnormal Hepatocellular Damage 22-Feb-2006 08:31 AM Page: 858 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatomegaly Pyrexia Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 50 MG DAILY Health PO Professional Seroquel SS ORAL 300 MG DAILY Other PO Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 700 MG DAILY PO Risperdal C Luvox C Date:12/04/03ISR Number: 4248181-7Report Type:Expedited (15-DaCompany Report #2003PK01978 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Subileus Foreign Seroquel PS Zeneca ORAL 800 MG DAILY Initial or Prolonged Health PO Required Professional Seroquel "Zeneca" SS ORAL 900 MG DAILY Intervention to Other PO Prevent Permanent Seroquel "Zeneca" SS ORAL 1000 MG DAILY Impairment/Damage PO Seroquel "Zeneca" SS ORAL 500 MG DAILY PO Seroquel "Zeneca" SS ORAL 1000 MG DAILY PO Seroquel "Zeneca" SS ORAL 500 MG DAILY PO Tavor C Date:12/04/03ISR Number: 4248311-7Report Type:Expedited (15-DaCompany Report #2003SE05403 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Malaise Health PO Pharyngeal Oedema Professional Other Date:12/05/03ISR Number: 4247366-3Report Type:Expedited (15-DaCompany Report #2003116212 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dissociation Consumer Neurontin Initial or Prolonged Irritability Health (Gabapentin) PS ORAL 300 MG (TID), Other Mental Disorder Professional ORAL Overdose Quetiapine Fumarate Respiratory Arrest (Quetiapine Fumarate) SS Clonidine (Clonidine) SS Sertraline Hydrochloride (Sertraline Hydrochloride) C Bupropion 22-Feb-2006 08:31 AM Page: 859 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride (Bupropion Hydrochloride) C Risperidone (Risperidone) C Ibuprofen (Ibuprofen) C All Other Therapeutic C Date:12/05/03ISR Number: 4247686-2Report Type:Expedited (15-DaCompany Report #2003PK02022 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Health PO Professional Jantrosom N SS ORAL 10 MG DAILY Other PO Jatrosom N SS ORAL 20 MG DAILY PO Jatrosom N SS ORAL 30 MG DAILY PO Jatrosom N SS ORAL 40 MG DAILY PO Jatrosom N SS ORAL 50 MG DIALY PO Jatrosom N SS ORAL 50 MG DAILY PO Jatrosom N SS ORAL 40 MG DAILY PO Jatrosom N SS ORAL 30 MG DAILY PO Jatrosom N SS ORAL 20 MG DAILY PO Amitriptyline SS ORAL 25 MG DAILY PO Allopurinol C Cedur C Climopax C Effortil C Movicol C Date:12/05/03ISR Number: 4247687-4Report Type:Expedited (15-DaCompany Report #2003GB02956 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Haemoptysis Foreign Seroquel PS ORAL 25 MG HS PO Health Seroquel SS ORAL 25 MG HS PO Professional Lisinopril C Other Nicorandil C Digoxin C Warfarin C Atenolol C Mononitrate C 22-Feb-2006 08:31 AM Page: 860 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/03ISR Number: 4247688-6Report Type:Expedited (15-DaCompany Report #2003GB03165 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Quetiapine PS ORAL 200 MG BID PO Circulatory Collapse Health Haloperidol C Gastric Haemorrhage Professional Hyperventilation Other Thirst Date:12/05/03ISR Number: 4247907-6Report Type:Expedited (15-DaCompany Report #2003PK02042 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS ORAL 25 MG DAILY Intervention to White Blood Cell Count Health PO Prevent Permanent Decreased Professional Seroquel SS ORAL 50 MG DAILY Impairment/Damage Other PO Seroquel SS ORAL 75 MG DAILY PO Zyprexa C Date:12/05/03ISR Number: 4248314-2Report Type:Expedited (15-DaCompany Report #2003SE05375 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Intestinal Infarction Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:12/08/03ISR Number: 4248434-2Report Type:Direct Company Report #CTU 207607 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Seroquel PS ORAL 50 MG Initial or Prolonged Educational Problem EACH NIGHT Disability Heart Rate Increased Tardive Dyskinesia Date:12/08/03ISR Number: 4248551-7Report Type:Expedited (15-DaCompany Report #2003UW15595 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 300 MG PO Decreased Professional Date:12/08/03ISR Number: 4248683-3Report Type:Expedited (15-DaCompany Report #2003UW11294 Age:39 YR Gender:Male I/FU:I Outcome PT Other Agitation Anxiety Blood Pressure Decreased Dizziness Dry Mouth Fall 22-Feb-2006 08:31 AM Page: 861 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Decreased Insomnia Medication Error Report Source Product Role Manufacturer Route Dose Duration Night Sweats Consumer Seroquel PS Oral Intake Reduced Serzone SS 200 MG DAILY Respiratory Rate Neurontin C Decreased Somnolence Vertigo Date:12/08/03ISR Number: 4248684-5Report Type:Expedited (15-DaCompany Report #2003UW10212 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Consumer Seroquel PS ORAL 25 MG PO Date:12/08/03ISR Number: 4248685-7Report Type:Expedited (15-DaCompany Report #2003UW09155 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Consumer Seroquel PS ORAL 25 MG PO Effexor C Date:12/08/03ISR Number: 4248686-9Report Type:Expedited (15-DaCompany Report #2003UW09122 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Seroquel PS ORAL 200 MG HS PO Anorexia Professional Serzone SS Asthenia Lethargy Medication Error Weight Decreased Date:12/08/03ISR Number: 4248693-6Report Type:Expedited (15-DaCompany Report #2003UW07789 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Seroquel PS ORAL 200 MG PO Dizziness Professional Serzone SS ORAL 200 MG BID PO Medication Error Date:12/08/03ISR Number: 4248696-1Report Type:Expedited (15-DaCompany Report #2003UW07382 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Other Seroquel PS 100 MG BID Initial or Prolonged Coma Lithium C Depressed Level Of Ambien C Consciousness Lithobid C Medication Error 22-Feb-2006 08:31 AM Page: 862 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/03ISR Number: 4248698-5Report Type:Expedited (15-DaCompany Report #2002UW15026 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activities Of Daily Other Seroquel PS ORAL 200 MG ONCE Living Impaired PO Fear Serzone SS Feeling Abnormal Feeling Jittery Gastrointestinal Disorder Medication Error Date:12/08/03ISR Number: 4248701-2Report Type:Expedited (15-DaCompany Report #2003UW00330 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Seroquel PS ORAL 200 MG PO Medication Error Professional Serzone SS Somnolence Date:12/08/03ISR Number: 4248759-0Report Type:Expedited (15-DaCompany Report #2002UW15308 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Seroquel PS ORAL 100 MG DAILY Anxiety Health PO Dizziness Professional Serzone SS Medication Error Other Restlessness Date:12/08/03ISR Number: 4248814-5Report Type:Expedited (15-DaCompany Report #2003SE05377 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 300 MG BID PO Intentional Self-Injury Health Haloperidol SS ORAL 24 MG TID PO Professional Levomepromazin C Other Diazepam C Date:12/08/03ISR Number: 4248820-0Report Type:Expedited (15-DaCompany Report #2003PK02020 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eyelid Oedema Foreign Nexium PS 20 MG DAILY Initial or Prolonged Hyponatraemia Health Seroquel SS ORAL 1000 MG DAILY Urinary Retention Professional PO Other Seroquel SS ORAL 800 MG DAILY PO Zoloft SS ORAL 150 MG DAILY PO YR Nozinan SS ORAL 100 MG DAILY PO Tegretol SS ORAL 200 MG DAILY PO Tegretol SS ORAL 1200 MG DAILY PO Trileptal SS ORAL 600 MG DAILY PO 22-Feb-2006 08:31 AM Page: 863 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trileptal SS ORAL 1200 MG DAILY PO Trileptal SS ORAL 1800 MG DAILY PO Dalmadorm C Temesta C Prazine C Date:12/08/03ISR Number: 4249103-5Report Type:Expedited (15-DaCompany Report #2003UW00270 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Other Seroquel PS Serzone SS Date:12/08/03ISR Number: 4249104-7Report Type:Expedited (15-DaCompany Report #2003UW02701 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Consumer Seroquel PS ORAL 200 MG PO Seroquel SS Date:12/08/03ISR Number: 4249105-9Report Type:Expedited (15-DaCompany Report #2003UW02070 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysstasia Consumer Seroquel PS ORAL 400 MG ONCE Feeling Abnormal PO Hallucination Serzone SS ORAL 400 MG HS PO Medication Error Wllbutrin C Photopsia Provigil C Date:12/08/03ISR Number: 4249106-0Report Type:Expedited (15-DaCompany Report #2003UW01745 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Consumer Seroquel PS Serzone SS Date:12/08/03ISR Number: 4249107-2Report Type:Expedited (15-DaCompany Report #2003UW01446 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Consumer Seroquel PS ORAL 100 MG PO Dizziness Serzone SS 100 MG Feeling Abnormal Medication Error Date:12/08/03ISR Number: 4249108-4Report Type:Expedited (15-DaCompany Report #2003UW04952 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Consumer Seroquel PS ORAL 100 MG PO Medication Error Serzone SS 100 MG DAILY 22-Feb-2006 08:31 AM Page: 864 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/03ISR Number: 4249109-6Report Type:Expedited (15-DaCompany Report #2003UW05753 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Seroquel PS ORAL 200 MG ONCE Heart Rate Increased PO Medication Error Serzone SS 200 MG BID Sudafed C Date:12/08/03ISR Number: 4249153-9Report Type:Expedited (15-DaCompany Report #2003GB02739 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Increased Health Priadel - Slow Pyrexia Professional Release C Other Lansoprazole C Date:12/09/03ISR Number: 4248986-2Report Type:Direct Company Report #CTU 207737 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Geodon (Ziprasidone Coma Mesylate) 20 Mg/Ml Cyanosis Pfizer PS Pfizer INTRAMUSCULAR 10 MG I.M. X Torsade De Pointes 1 DOSE Haldol SS INTRAMUSCULAR 2 MG IM Seroquel SS ORAL 25 MG PO BID Date:12/09/03ISR Number: 4250125-9Report Type:Expedited (15-DaCompany Report #HQWYE333001DEC03 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chorea Health Efexor Xr Initial or Prolonged Convulsion Professional (Venlafaxine Dysphasia Other Hydrochloride, Orthostatic Hypotension Capsule, Extended Syncope Release) PS ORAL 75 MG 1X PER 1 DAY Mirtazapine (Mirtazapine, ) SS ORAL 60 MG Seroquel (Quetiapine, ) SS ORAL 150 MG 1X PER 1 DAY Date:12/10/03ISR Number: 4250429-XReport Type:Expedited (15-DaCompany Report #2003UW15950 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Seroquel PS Hospitalization - Depression Professional Klonopin SS Initial or Prolonged Multiple Drug Overdose Lamictal SS ORAL 50 MG PO Suicide Attempt Lamictal SS ORAL 25 MG PO Tachycardia Tegretol SS 22-Feb-2006 08:31 AM Page: 865 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/03ISR Number: 4250504-XReport Type:Expedited (15-DaCompany Report #2003UW16014 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Seroquel PS Zyprexa SS Date:12/10/03ISR Number: 4250506-3Report Type:Expedited (15-DaCompany Report #2003UW15827 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaphylactoid Reaction Health Seroquel PS Intervention to Dysphagia Professional Prevent Permanent Dyspnoea Impairment/Damage Throat Tightness Date:12/10/03ISR Number: 4250507-5Report Type:Expedited (15-DaCompany Report #2003UW15939 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Raynaud'S Phenomenon Health Seroquel PS ORAL 25 MG QAM PO Required Professional Seroquel SS ORAL 100 MG HS PO Intervention to Lithium C Prevent Permanent Impairment/Damage Date:12/10/03ISR Number: 4250518-XReport Type:Expedited (15-DaCompany Report #2003SE05371 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diplopia Foreign Seroquel PS ORAL 850 MG DAILY Intervention to Eye Pain Health PO Prevent Permanent Heterophoria Professional Clozapine C Impairment/Damage Other Fluoxetine C Nozinan C Date:12/10/03ISR Number: 4250562-2Report Type:Expedited (15-DaCompany Report #2003GB03175 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Quetiapine PS Intervention to Health Clozaril SS ORAL 200 MG DAILY Prevent Permanent Professional PO Impairment/Damage Other Valproate Sodium C Droperidol C Lorazepam C Citalopram C Olanzapine C Lithium C Date:12/10/03ISR Number: 4250564-6Report Type:Expedited (15-DaCompany Report #2003UW15750 Age: Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 866 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Foreign Seroquel PS ORAL 900 MG DAILY Neutropenia Health PO Treatment Noncompliance Professional Fluphenazine SS 120 MG Q2WK Other Date:12/10/03ISR Number: 4250566-XReport Type:Expedited (15-DaCompany Report #2003PK02056 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Potentiation Health PO Neutropenia Professional Seroquel SS ORAL 150 MG DAILY White Blood Cell Count Other PO Decreased Haldol SS ORAL 6 MG DAILY PO Orfiril SS ORAL 1800 MG DAILY PO Orfiril SS ORAL 2400 MG DAILY PO L-Thyroxin "Henning Berlin" C Neurium C Xanef C Insulin C Date:12/10/03ISR Number: 4250739-6Report Type:Expedited (15-DaCompany Report #2003UW11294 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Seroquel PS Required Anorexia Professional Serzone SS 200 MG DAILY Intervention to Anxiety Neurontin C Prevent Permanent Blood Pressure Decreased Impairment/Damage Dizziness Dry Mouth Fall Fatigue Feeling Abnormal Heart Rate Decreased Insomnia Loss Of Consciousness Medication Error Memory Impairment Night Sweats Respiratory Rate Decreased Somnolence Date:12/10/03ISR Number: 4250740-2Report Type:Expedited (15-DaCompany Report #2003UW15867 Age:31 YR Gender:Male I/FU:I Outcome PT Other Asthenia Fatigue Viral Infection White Blood Cell Count 22-Feb-2006 08:31 AM Page: 867 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS ORAL 800 MG PO Professional Seroquel SS ORAL 400 MG PO Depakote C Neubatone C Date:12/10/03ISR Number: 4250747-5Report Type:Expedited (15-DaCompany Report #2003GB03166 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Increased Foreign Quetiapine PS ORAL 25 MG QD PO Initial or Prolonged Loss Of Consciousness Health Zoladex C Professional Bisacodyl C Other Trazodone C Sinemet-Cr C Frusemide C Quinine Bisulphate C Durogesic C Thyroxine C Date:12/10/03ISR Number: 4250786-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030904254 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Eruption Foreign Risperidone Initial or Prolonged Insomnia Health (Risperidone) Oedema Professional Unspecified PS ORAL 2 MG, IN 1 Sluggishness DAY, ORAL Swelling Face Quetiapine (Quetiapine) Unknown SS Date:12/11/03ISR Number: 4251134-6Report Type:Expedited (15-DaCompany Report #2003UW15865 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Other Seroquel PS Darvon C Date:12/11/03ISR Number: 4251135-8Report Type:Expedited (15-DaCompany Report #2003UW13607 Age:58 YR Gender:Female I/FU:F Outcome PT Other Anxiety Required Asthenia Intervention to Balance Disorder Prevent Permanent Confusional State Impairment/Damage Crying Diarrhoea Gait Disturbance General Physical Condition Abnormal Headache Impaired Work Ability Medication Error Memory Impairment 22-Feb-2006 08:31 AM Page: 868 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Spasticity Muscle Twitching Paranoia Report Source Product Role Manufacturer Route Dose Duration Restlessness Health Seroquel PS ORAL 600 MG ONCE Somnolence Professional PO Tremor Serzone SS ORAL 600 MG DAILY PO Paxil C Date:12/11/03ISR Number: 4251136-XReport Type:Expedited (15-DaCompany Report #2002UW15251 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Seroquel PS ORAL 100 MG HS PO Hospitalization - Hepatic Failure Professional Lithobid C Initial or Prolonged Liver Function Test Altace C Abnormal Glucophage "Abic" C Geodon C Date:12/11/03ISR Number: 4251387-4Report Type:Expedited (15-DaCompany Report #2003GB02830 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Feeling Hot Foreign Seroquel PS ORAL 150 MG BID PO Intervention to Pharyngolaryngeal Pain Health Prevent Permanent Rash Professional Impairment/Damage Swelling Face Other Date:12/12/03ISR Number: 4251737-9Report Type:Expedited (15-DaCompany Report #2003186096JP Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chlamydial Infection Foreign Halcion Initial or Prolonged Condition Aggravated Health (Triazolam)Tablet PS ORAL 0.5 MG, QD, Cough Professional ORAL Depressed Level Of Other Seroquel Consciousness (Quetiapine) SS ORAL 100 MG/DAY, Drug Ineffective ORAL Hyperpyrexia Ravona Insomnia (Pentobarbital Nasopharyngitis Calcium) C Neuroleptic Malignant Syndrome Platelet Count Decreased Throat Tightness Tremor White Blood Cell Count Decreased Date:12/12/03ISR Number: 4251858-0Report Type:Expedited (15-DaCompany Report #2003SE05566 Age:2 DY Gender:Female I/FU:I Outcome PT Death Caesarean Section Cardiac Arrest Neonatal Compartment Syndrome Maternal Drugs Affecting 22-Feb-2006 08:31 AM Page: 869 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Foetus Necrotising Enterocolitis Neonatal Neonatal Disorder Report Source Product Role Manufacturer Route Dose Duration Neonatal Intestinal Foreign Seroquel PS 600 MG DAILY Dilatation Health TPL Premature Rupture Of Professional Membranes Other Date:12/15/03ISR Number: 4252096-8Report Type:Direct Company Report #CTU 208022 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cellulitis Seroquel 100 Mg Leukopenia Astra Zeneca PS Seneca ORAL 200 MG HS Neutropenia ORAL Cipro C Clindamycin C Trazodone C Ancef C Date:12/15/03ISR Number: 4252235-9Report Type:Expedited (15-DaCompany Report #FLUV00303002962 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eosinophilia Foreign Luvox 25 Erythema Health (Fluvoxamine Feeling Hot Professional Maleate) PS INTRAVENOUS SEE IMAGE Hepatic Function Abnormal Other Seroquel (Seroquel) SS INTRAVENOUS SEE IMAGE Hepatocellular Damage Risperdal Liver Function Test (Risperidone) C Abnormal Pyrexia Viral Infection Date:12/15/03ISR Number: 4252446-2Report Type:Expedited (15-DaCompany Report #2003GB01346 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Seroquel PS Hospitalization - Arrhythmia Health Seroquel SS ORAL 200 MG DAILY Initial or Prolonged Circulatory Collapse Professional PO Diabetic Ketoacidosis Other Olanzapine C Malaise Tinea Cruris Vomiting Weight Increased Date:12/15/03ISR Number: 4252507-8Report Type:Expedited (15-DaCompany Report #2003AP03641 Age:73 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Convulsion Required Epilepsy Intervention to Fall Prevent Permanent Loss Of Consciousness Impairment/Damage Pyrexia 22-Feb-2006 08:31 AM Page: 870 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 25 MG BID PO Health Seroquel SS ORAL 125 MG DAILY Professional PO Other Seroquel SS ORAL 100 MG BID PO Seroquel SS ORAL 100 MG TID PO Seroquel SS ORAL 100 MG BID PO Seroquel SS ORAL 125 MG DAILY PO Seroquel SS ORAL 100 MG DAILY PO Seroquel SS ORAL 75 MG DAILY PO Seroquel SS ORAL 225 MG DAILY PO Myslee C Pursennid C Date:12/15/03ISR Number: 4252577-7Report Type:Expedited (15-DaCompany Report #2003SE04513 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Foreign Seroquel PS ORAL 200 MG BID PO Hospitalization - Diabetic Coma Health Glucophage C Initial or Prolonged Urine Ketone Body Present Professional Diamicron C Other Date:12/15/03ISR Number: 4253388-9Report Type:Expedited (15-DaCompany Report #2003AP04361 Age:23 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Venlafaxine SS Professional Date:12/15/03ISR Number: 4253445-7Report Type:Expedited (15-DaCompany Report #2003AP04358 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Oxcarbazepine SS Professional Olanzapine SS Date:12/15/03ISR Number: 4253449-4Report Type:Expedited (15-DaCompany Report #2003AP04357 Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Exposure Literature Quetiapine PS Health Glipizide (Long Professional Acting) SS Metformin SS 22-Feb-2006 08:31 AM Page: 871 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/03ISR Number: 4253453-6Report Type:Expedited (15-DaCompany Report #2003AP04356 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Ethanol SS Professional Citalopram SS Date:12/15/03ISR Number: 4253461-5Report Type:Expedited (15-DaCompany Report #2003AP04355 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Cyclobenzapine SS Professional Clonazepam SS Date:12/15/03ISR Number: 4253579-7Report Type:Expedited (15-DaCompany Report #2003SE04683 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Hyperpyrexia Health PO Professional Remeron SS Other Xanax C Tavor C Date:12/15/03ISR Number: 4254906-7Report Type:Expedited (15-DaCompany Report #2003AP04354 Age:82 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Overdose Health ... SS Professional Date:12/16/03ISR Number: 4253630-4Report Type:Expedited (15-DaCompany Report #2003UW16178 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Health Seroquel PS Intervention to Drug Interaction Professional Diazepam SS 5 MG SID Prevent Permanent Liver Function Test Diazepam SS 2.5 MG SID Impairment/Damage Abnormal Unspecified Muscle Moaning Relaxant SS Date:12/16/03ISR Number: 4253631-6Report Type:Expedited (15-DaCompany Report #2003UW15044 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Consumer Seroquel PS ORAL 200 MG BID PO Hospitalization - Circulatory Collapse Serzone SS ORAL 200 MG BID PO Initial or Prolonged Dehydration Xanax C Other Fall Required Medication Error Intervention to Overdose Prevent Permanent Psychotic Disorder Impairment/Damage Transient Ischaemic Attack 22-Feb-2006 08:31 AM Page: 872 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/03ISR Number: 4253632-8Report Type:Expedited (15-DaCompany Report #2003AP04352 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Professional Date:12/16/03ISR Number: 4253633-XReport Type:Expedited (15-DaCompany Report #2003AP04353 Age:41 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Quetiapine PS Health Professional Date:12/16/03ISR Number: 4253634-1Report Type:Expedited (15-DaCompany Report #2003UW12514 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Disorder Health Seroquel PS Initial or Prolonged Surgery Professional Ritalin C No Match C Date:12/16/03ISR Number: 4253877-7Report Type:Expedited (15-DaCompany Report #2003GB01421 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Labour Foreign Seroquel PS ORAL 150 MG BID PO Intervention to Alpha 1 Foetoprotein Health Prevent Permanent Increased Professional Impairment/Damage Caesarean Section Other Cephalo-Pelvic Disproportion Complications Of Maternal Exposure To Therapeutic Drugs Maternal Distress During Labour Date:12/16/03ISR Number: 4253880-7Report Type:Expedited (15-DaCompany Report #2003SE05514 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Speech Disorder Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Health PO Prevent Permanent Professional Orap Forte C Impairment/Damage Other Effexor C Xanax C Date:12/16/03ISR Number: 4253894-7Report Type:Expedited (15-DaCompany Report #2003SE05578 Age:42 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 873 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Blood Osmolarity Foreign Seroquel PS ORAL 200 MG DAILY Decreased Health PO Hypochloraemia Professional Depakine Chrono C Hyponatraemia Other Tranxene C Staurodorm C Zantac C Antabuse C Bisoprolol C Cardioaspirin C Date:12/16/03ISR Number: 4254079-0Report Type:Expedited (15-DaCompany Report #20031200120 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Foreign Tavor (Lorazepam) PS 3 WK Initial or Prolonged Health Trevilor Retard Professional (Venlafaxine Other Hydrochloride) SS ORAL 75 MG BID PO 3 WK Planum (Temazepam) SS 3 WK Seroquel (Quetiapine) SS 3 WK Date:12/17/03ISR Number: 4254288-0Report Type:Expedited (15-DaCompany Report #2003SE05624 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Steatosis Foreign Seroquel PS Multiple Drug Overdose Health Nitrazepam SS Professional Oxazepam SS Other Date:12/17/03ISR Number: 4254499-4Report Type:Expedited (15-DaCompany Report #2003121910 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ankle Fracture Consumer Zoloft (Sertraline) PS ORAL (DAILY), Depression ORAL/3 TO 4 Drug Ineffective YEARS AGO Fatigue Quetiapine Fumarate Feeling Abnormal (Quetiapine Gastrointestinal Injury Fumarate) SS ORAL ORAL Haematoma Clonazepam Lung Injury (Clonazepam) C Memory Impairment Panic Attack Road Traffic Accident Somnolence Splenic Injury 22-Feb-2006 08:31 AM Page: 874 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/03ISR Number: 4254588-4Report Type:Expedited (15-DaCompany Report #2003AP04359 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Phencyclidine SS Professional Valproic Acid SS Date:12/17/03ISR Number: 4268450-4Report Type:Periodic Company Report #USA-2003-0008860 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Oxycontin Tablets Other Overdose Professional (Oxycodone Company Hydrochloride) PS 40 MG, Q12H, Representative Alcohol (Ethanol) SS ORAL ORAL Other Neurontin (Gabapentin) SS Elavil (Amitriptyline Hydrochloride) SS Paxil (Paroxetine Hydrochloride) SS Vicodin (Paracetamol, Hydrocodone Bitartrate) SS Clonazepam (Clonazepam) SS Ultram (Tramadol Hydrochloride) SS Norco (Hydrocodone Bitartrate, Paracetamol) SS Trazodone (Trazodone) SS Hydroxyzine Hydrochloride (Hydroxyzine Hydrochloride) SS Quetiapine (Quetiapine) SS Metoprolol (Metoprolol) SS Date:12/17/03ISR Number: 4268936-2Report Type:Periodic Company Report #USA-2003-0007158 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Health Oxycodone Professional Hydrochloride Other (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS Ethanol (Ethanol) SS Carisoprodol (Carisoprodol) SS Clonazepam (Clonazepam) SS Quetiapine 22-Feb-2006 08:31 AM Page: 875 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Quetiapine) SS Fluoxetine C Topamax C Date:12/17/03ISR Number: 4269306-3Report Type:Periodic Company Report #USA-2003-0008545 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Multiple Drug Overdose Professional Hydrochloride Other (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS MG Fenytoin (Phenytoin) SS Chlorpromazine (Chlorpromazine) SS Citalopram (Citalopram) SS Hydroxyzine (Hydroxyzine) SS Mirtazapine (Mirtazapine) SS Quetiapine (Quetiapine) SS Date:12/18/03ISR Number: 4255525-9Report Type:Expedited (15-DaCompany Report #2003AP04386 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Seroquel PS Initial or Prolonged Health Professional Other Date:12/18/03ISR Number: 4255651-4Report Type:Expedited (15-DaCompany Report #2003AP03890 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required General Nutrition Foreign Seroquel PS ORAL 100 MG QID PO Intervention to Disorder Health Vencoll C Prevent Permanent Stool Analysis Abnormal Professional Herbal Preparation C Impairment/Damage White Blood Cell Count Other Alosenin C Decreased Gascon C Magnesium Oxide C Levotomin C Doral C Date:12/18/03ISR Number: 4255730-1Report Type:Expedited (15-DaCompany Report #2003AP03831 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Drug Level Increased Health PO Required Mania Professional Tegretol SS ORAL 400 MG DAILY Intervention to Neurotoxicity Other PO Prevent Permanent Parkinsonism Tegretol SS ORAL 600 MG DAILY Impairment/Damage Psychomotor Hyperactivity PO Domin SS 22-Feb-2006 08:31 AM Page: 876 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Epirenat C Rivotril C Hiberna C Lipitor C Date:12/18/03ISR Number: 4255924-5Report Type:Expedited (15-DaCompany Report #2003UW16288 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Seroquel PS Initial or Prolonged Myocardial Infarction Professional Required Intervention to Prevent Permanent Impairment/Damage Date:12/18/03ISR Number: 4256484-5Report Type:Expedited (15-DaCompany Report #DSA_23670_2003 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Foreign Tavor PS 3 MG Q DAY Initial or Prolonged Health Orfiril SS ORAL 900 MG Q DAY Professional PO Other Trevilor Retard SS ORAL 300 MG Q DAY PO Seroquel SS Tavor C Planum C Jodid C Date:12/19/03ISR Number: 4256446-8Report Type:Expedited (15-DaCompany Report #2003123944 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Sudafed 12 Hour Initial or Prolonged Hypomania Professional (Pseudoephedrine) PS ORAL PRN, ORAL Malaise Diphenhydramine Mania (Diphenhydramine) SS ORAL 50 MG Q6H, Meniere'S Disease ORAL Mental Status Changes Fluoxetine Therapy Non-Responder Hydrochloride (Fluoxetine Hydrochloride) SS ORAL ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL ORAL Topiramate (Topiramate) SS ORAL ORAL Ziprasidone Hydrochloride (Ziprasidone Hydrochloride) C Valproate Semisodium (Valproate Semisodium) C Trazodone (Trazodone) C 22-Feb-2006 08:31 AM Page: 877 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/03ISR Number: 4257392-6Report Type:Expedited (15-DaCompany Report #2003AP04434 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Seroquel PS ORAL 50 MG DAILY Hospitalization - Consciousness Health PO Initial or Prolonged Hyperglycaemia Professional Gramalil C Required Other Intervention to Prevent Permanent Impairment/Damage Date:12/22/03ISR Number: 4257393-8Report Type:Expedited (15-DaCompany Report #2003SE05371 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diplopia Foreign Seroquel PS ORAL 850 MG DAILY Intervention to Eye Pain Health PO Prevent Permanent Heterophoria Professional Clozapine C Impairment/Damage Other Fluoxetine C Nozinan C Date:12/22/03ISR Number: 4257463-4Report Type:Expedited (15-DaCompany Report #2003AP03890 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required General Nutrition Foreign Seroquel PS ORAL 100 MG QID PO Intervention to Disorder Health Vencoll C Prevent Permanent Medication Residue Professional Herbal Preparation C Impairment/Damage White Blood Cell Count Other Alosenin C Decreased Gascon C Magnesium Oxide C Levotomin C Doral C Date:12/22/03ISR Number: 4257466-XReport Type:Expedited (15-DaCompany Report #2002GB00947 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Complications Of Maternal Foreign Seroquel PS ORAL 200 MG BID PO Intervention to Exposure To Therapeutic Health Seroquel SS ORAL 300 MG DAILY Prevent Permanent Drugs Professional PO Impairment/Damage Gestational Diabetes Other Seroquel SS 350-400MG/DAY Pregnancy SECOND TRIMESTER Seroquel SS 400-450MG/DAY THIRD TRIMESTER Olanzapine SS 10 MG DAILY 10 MON Date:12/22/03ISR Number: 4257516-0Report Type:Expedited (15-DaCompany Report #2003AP04360 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Risperidone SS Professional Valproic Acid SS 22-Feb-2006 08:31 AM Page: 878 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/03ISR Number: 4258513-1Report Type:Expedited (15-DaCompany Report #SUS1-2003-00510 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Adderall Xr Brain Oedema Professional (Amphetamine Completed Suicide Aspartate, Multiple Drug Overdose Amphetamine Sulfate, Prescribed Overdose Dextroamphetamine PS Pulmonary Congestion Seroquel (Quetiapine Fumarate) SS Lamotrigine (Lamotrigine) SS Effexor (Venlafaxine Hydrochloride) SS Carbamazepine (Carbamazepine) SS Sertraline (Sertraline) SS Date:12/23/03ISR Number: 4258543-XReport Type:Direct Company Report #CTU 208698 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Seroquel PS Affect Lability Amnesia Anger Anxiety Blood Pressure Decreased Chest Pain Confusional State Constipation Depression Disturbance In Attention Dizziness Postural Dry Mouth Dyspepsia Fatigue Fear Feeling Abnormal Hallucination, Auditory Heart Rate Increased Hypoaesthesia Hypoaesthesia Oral Impaired Driving Ability Injury Malaise Mental Impairment Muscle Spasms Musculoskeletal Stiffness Panic Attack Paraesthesia Paraesthesia Oral Psychotic Disorder Sinusitis Suicidal Ideation Tremor Weight Increased 22-Feb-2006 08:31 AM Page: 879 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/03ISR Number: 4261150-6Report Type:Expedited (15-DaCompany Report #2003UW16554 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS Health Epival C Professional Anaprox C Other Date:12/29/03ISR Number: 4261156-7Report Type:Expedited (15-DaCompany Report #2003AP04522 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pancytopenia Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:12/29/03ISR Number: 4261159-2Report Type:Expedited (15-DaCompany Report #2003SE05724 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Caesarean Section Foreign Seroquel PS TOPICAL 250 MG DAILY Hospitalization - Chills Health TPL Initial or Prolonged Drug Exposure During Professional Seroquel SS TOPICAL 25 MG DAILY Pregnancy Other TPL Neonatal Disorder Date:12/29/03ISR Number: 4261161-0Report Type:Expedited (15-DaCompany Report #2003SE05377 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 300 MG BID PO Health Haloperidol SS ORAL 24 MG TID PO Professional Levomepromazin C Other Diazepam C Date:12/29/03ISR Number: 4261163-4Report Type:Expedited (15-DaCompany Report #2003AP04510 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Foreign Seroquel PS ORAL 25 MG TID PO Intervention to Glycosylated Haemoglobin Study Risperdal C Prevent Permanent Increased Health Akineton C Impairment/Damage Professional Lullan C Other Lodopin C Amaryl C Rohypnol C Date:12/29/03ISR Number: 4261172-5Report Type:Expedited (15-DaCompany Report #2003GB01421 Age:35 YR Gender:Female I/FU:F Outcome PT Required Alpha 1 Foetoprotein Intervention to Increased Prevent Permanent Caesarean Section Impairment/Damage Complications Of Maternal 22-Feb-2006 08:31 AM Page: 880 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Exposure To Therapeutic Drugs Maternal Distress During Labour Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Foreign Seroquel PS ORAL 150 MG BID PO Myalgia Health Uterine Hypotonus Professional Other Date:12/29/03ISR Number: 4261243-3Report Type:Expedited (15-DaCompany Report #2003AP04504 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Congenital Anomaly Foreign Quetiapine Fumarate PS TRANSPLACENTAL 100 MG DAILY Maternal Drugs Affecting Health TPL Foetus Professional Haloperidol C Wolff-Parkinson-White Other Risperidone C Syndrome Clocapramine C Date:12/29/03ISR Number: 4261245-7Report Type:Expedited (15-DaCompany Report #2003PK02143 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Seroquel "Zeneca" PS ORAL 300 MG DAILY Initial or Prolonged Blood Sodium Decreased Study PO Circulatory Collapse Health Seroquel Zeneca SS ORAL 300 MG DAILY Eye Disorder Professional PO Hypokalaemia Other Diuretic SS Euphylong C Karvezide C L-Thyroxin C Melperon Ct-Arzneimittel C Noveril C Mirtazepin C Temazepam C Date:12/29/03ISR Number: 4261489-4Report Type:Expedited (15-DaCompany Report #2003120450 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Health Neurontin Initial or Prolonged Catatonia Professional (Gabapentin) PS ORAL 900 MG (TID), Other Electroencephalogram ORAL Abnormal Quetiapine Fumarate Hallucinations, Mixed (Quetiapine Fumarate) SS ORAL ORAL Zoloft (Sertraline) C Nortriptyline (Nortriptyline) C Carbamazepine (Carbamazepine) C Morphine Sulfate (Morphine Sulfate) C Oestranorm (Estradiol, Norethisterone) C Levothyroxine Sodium (Levothyroxine 22-Feb-2006 08:31 AM Page: 881 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Clonazepam (Clonazepam) C Date:12/29/03ISR Number: 4261670-4Report Type:Direct Company Report #CTU 208905 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Quietapine PS ORAL P.O. 350 Intervention to Neutropenia MG/DAY Prevent Permanent Effexor Xr C Impairment/Damage Date:12/29/03ISR Number: 4261718-7Report Type:Expedited (15-DaCompany Report #2003UW16557 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Seroquel PS ORAL 800 MG QD PO 5 MON Multiple Drug Overdose Professional Seroquel SS ORAL 1000 MG QD PO Methadone SS ORAL 10 MG TID PO Neurontin C Effexor-Xr C Klonopin C Date:12/29/03ISR Number: 4261719-9Report Type:Expedited (15-DaCompany Report #2003UW16754 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sedation Health Seroquel PS GREATER THAN Somnolence Professional 300 MG Seroquel SS LESS THAN 300 MG DAILY Date:12/29/03ISR Number: 4261720-5Report Type:Expedited (15-DaCompany Report #2003UW16631 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Consumer Seroquel PS Initial or Prolonged Levox C Date:12/29/03ISR Number: 4261721-7Report Type:Expedited (15-DaCompany Report #2003UW13423 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Consumer Seroquel PS ORAL 600 MG DAILY Intervention to Dementia PO Prevent Permanent Dyspnoea Depakote C Impairment/Damage Headache Ativan C Hyperventilation Synthroid C Oedema Peripheral Propanolol C Weight Increased 22-Feb-2006 08:31 AM Page: 882 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/03ISR Number: 4261722-9Report Type:Expedited (15-DaCompany Report #2003UW16946 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Professional Date:12/29/03ISR Number: 4261723-0Report Type:Expedited (15-DaCompany Report #2003UW16728 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Health Seroquel PS ORAL 300 MG DAILY Intervention to Nuchal Rigidity Professional PO Prevent Permanent Pyrexia Impairment/Damage Streptococcal Infection Swollen Tongue Date:12/30/03ISR Number: 4266748-7Report Type:Periodic Company Report #HQ5919627DEC2002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Consumer Effexor Xr Depressed Mood (Venlafaxine Drug Withdrawal Syndrome Hydrochloride, Hypersomnia Extended Release) PS ORAL 800 MG 1X PER 1 DAY, ORAL Risperdal (Risperidone, ) SS 1 MG 1X PER 1 DAY Seroquel (Quetiapine,) SS 50 MG 1X PER 1 DAY Trazodone (Trazodone, ) SS AS NEEDED Vitamins (Vitamins, ) SS Date:12/31/03ISR Number: 4261148-8Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12462453 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Ischaemia Health Maxipime For Inj PS Bristol-Myers Squibb Initial or Prolonged Cerebrovascular Accident Professional Company INTRAVENOUS Disability Confusional State Madopar SS ORAL 150 mg/37.5 Cough mg daily Hallucination, Visual Seroquel SS ORAL Hemiparesis Buprenorphine SS TRANSDERMAL patch Infection Asa C ORAL duration Insomnia "months" Lung Disorder Acetaminophen C ORAL "weeks" Mastoiditis Vitamin B C ORAL "months" Mitral Valve Incompetence Thiamine C ORAL "Months" Oxygen Saturation Alendronate C ORAL "Months" Decreased Calcium + Vitamin D C ORAL 1000 mg/ 800 Persecutory Delusion UI daily for Stasis Syndrome "months" 22-Feb-2006 08:31 AM Page: 883 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/03ISR Number: 4262400-2Report Type:Expedited (15-DaCompany Report #2002GB02668 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Thyroid Stimulating Foreign Seroquel PS ORAL 700 MG DAILY Hormone Increased Health PO Microcytic Anaemia Professional Cipramil C Other Depakote C Date:12/31/03ISR Number: 4262603-7Report Type:Expedited (15-DaCompany Report #2003UW14680 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS ORAL 500 MG DAILY Intervention to Headache Professional PO Prevent Permanent Visual Acuity Reduced Prozac C Impairment/Damage Synthroid C Xanax C Carbamezepine C Nexium C Phenergan C Tagamet C Femhrt C Date:12/31/03ISR Number: 4262604-9Report Type:Expedited (15-DaCompany Report #2003UW15950 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Seroquel PS ORAL 50 MG DAILY Hospitalization - Depression Professional PO Initial or Prolonged Multiple Drug Overdose Klonopin SS Suicide Attempt Lamictal SS ORAL 50 MG PO Tachycardia Lamictal SS ORAL 25 MG PO Tegretol SS Date:12/31/03ISR Number: 4262606-2Report Type:Expedited (15-DaCompany Report #2003UW17047 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Seroquel PS ORAL 100 MG PO Initial or Prolonged Diarrhoea Seroquel SS ORAL 125 MG PO Gastrointestinal Tract Insulin C Mucosal Discolouration Synthroid C Vomiting Asa C Tamoxifen C Kaochlor C Ferrous Sulfate C Calcium With Vitamin D C Folic Acid C Soy Isoflavine C Black Cohosh C Actinal C 22-Feb-2006 08:31 AM Page: 884 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/03ISR Number: 4262813-9Report Type:Expedited (15-DaCompany Report #S03-GER-04403-01 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Cipramil (Citalopram Initial or Prolonged Cognitive Disorder Health Hydrobromide) PS ORAL 40 MG QD PO Other Hallucination Professional Eunerpan (Melperone Nephritis Interstitial Other Hydrochloride) SS ORAL 25 MG QD PO Normochromic Normocytic Seroquel (Quetiapine Anaemia Fumarate) SS ORAL 750 MG QD PO Red Blood Cell Risperdal Sedimentation Rate (Risperidone) C ORAL 4 MG QD PO Increased Sleep Disorder Date:12/31/03ISR Number: 4262899-1Report Type:Expedited (15-DaCompany Report #2003GB03391 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Foreign Seroquel PS ORAL 200 MG BID PO Intervention to Health Amisulpride C Prevent Permanent Professional Impairment/Damage Other Date:12/31/03ISR Number: 4262908-XReport Type:Expedited (15-DaCompany Report #2003AP04524 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Quetiapine PS 50 MG BID Intervention to Electrocardiogram Qt Literature Quetiapine SS 100 MG BID Prevent Permanent Corrected Interval Health Quetiapine SS 50 MG BID Impairment/Damage Prolonged Professional Quetiapine SS 700 MG DAILY Tachycardia Other Amisulpride SS 50 MG DAILY Ventricular Extrasystoles Amisulpride SS 50 MG BID Amisulpride SS 150 MG DAILY Epilim C Temazepam C E-Vitamin C Lipex C Coloxyl C Clozapine C Date:12/31/03ISR Number: 4263468-XReport Type:Expedited (15-DaCompany Report #2003AP04434 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Foreign Seroquel PS ORAL 50 MG DAILY Hospitalization - Asthenia Health PO Initial or Prolonged Depressed Level Of Professional Gramalil C Required Consciousness Other Intervention to Fatigue Prevent Permanent Hyperglycaemia Impairment/Damage Somnolence 22-Feb-2006 08:31 AM Page: 885 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/03ISR Number: 4263475-7Report Type:Expedited (15-DaCompany Report #2003AP03851 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Bile Duct Stone Health PO Required Biliary Dilatation Professional Stilnox C Intervention to Jaundice Other Prevent Permanent Weight Increased Impairment/Damage Date:12/31/03ISR Number: 4263478-2Report Type:Expedited (15-DaCompany Report #2003SE04984 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Level Above Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Therapeutic Health PO Prevent Permanent Priapism Professional Nortrilen C Impairment/Damage Other Haloperidol C Levomepromazine C Date:01/02/04ISR Number: 4263608-2Report Type:Expedited (15-DaCompany Report #20031200120 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Foreign Trevilor Retard Initial or Prolonged Health (Venlafaxine Professional Hydrochloride) PS ORAL 300 MG DAILY Other PO 3 WK Orfiril (Valproate Sodium) SS ORAL 900 MG DAILY PO 3 WK Seroquel (Quetiapine) SS 300 MG DAILY 3 WK Tavor (Lorazepam) C Planum (Temazepam) C Jodid (Potassium Iodine) C Date:01/02/04ISR Number: 4263722-1Report Type:Expedited (15-DaCompany Report #2003GB03297 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Angioneurotic Oedema Foreign Seroquel PS ORAL 750 MG DAILY Intervention to Rash Erythematous Health PO Prevent Permanent Professional Impairment/Damage Other Date:01/02/04ISR Number: 4263724-5Report Type:Expedited (15-DaCompany Report #2003GB03357 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Health Professional Other 22-Feb-2006 08:31 AM Page: 886 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/04ISR Number: 4263725-7Report Type:Expedited (15-DaCompany Report #2003AP04386 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Diabetes Mellitus Health PO Non-Insulin-Dependent Professional Dogmatil C Diabetic Ketoacidosis Other Akineton C Glycosylated Haemoglobin Wypax C Increased Flumezin C Weight Decreased Proheparum C Contomin C Silece C Pyrethia C Zyloric "Glaxo Wellcome" C Date:01/02/04ISR Number: 4264777-0Report Type:Expedited (15-DaCompany Report #2003118418 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antisocial Behaviour Foreign Zoloft (Sertraline) PS ORAL 100 MG, ORAL Initial or Prolonged Borderline Personality Health Quetiapine Fumarate Disorder Professional (Quetiapine Granulocytopenia Fumarate) SS ORAL 400 MG, ORAL Hypothyroidism Levothyroxine Sodium Mental Impairment (Levothyroxine Overdose Sodium) C Restlessness Lorazepam Scar (Lorazepam) C Self Injurious Behaviour Pipamperone (Pipamperone) C .... C Opipramol (Opipramol) C Date:01/04/04ISR Number: 4263239-4Report Type:Direct Company Report #CTU 209255 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Seroquel PS 300 MG DAILY Initial or Prolonged Syndrome Date:01/04/04ISR Number: 4263451-4Report Type:Direct Company Report #CTU 209236 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bite Seroquel 25 Mg Intervention to Convulsion Astrazeneca PS Astrazeneca ORAL 25 MG Q HS Prevent Permanent Homicidal Ideation ORAL Impairment/Damage Sedation Diuretic C Ca And Mg Supplement C 22-Feb-2006 08:31 AM Page: 887 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/04ISR Number: 4265163-XReport Type:Direct Company Report #CTU 209414 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Quetiapine PS Initial or Prolonged Date:01/06/04ISR Number: 4266342-8Report Type:Expedited (15-DaCompany Report #03P-087-0245767-00 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ileus Foreign Akineton Intervention to Health (Biperiden) PS ORAL 6 MG, 1IN 1 Prevent Permanent Professional D, ORAL Impairment/Damage Other Zotepine SS ORAL 150 MG, 1 IN 1 D, ORAL Quetiapine SS ORAL 25 MG, 3 IN 1D, ORAL Haloperidol SS ORAL 26 MG, 1 IN 1 D, ORAL Trihexyphenidyl Hydrochloride SS ORAL 6 MG, 1 IN 1 D, ORAL Vegetamin SS ORAL ORAL Carbamazepine C Bromazepam C Flunitrazepam C Alosenn C Mosapride Citrate C Neostigmine Metilsulfate C Date:01/07/04ISR Number: 4267031-6Report Type:Expedited (15-DaCompany Report #2003UW08176 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Health Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Arthritis Bacterial Professional PO 5 WK Autonomic Nervous System Depakote C Imbalance Tylenol C Beta Haemolytic Motrin C Streptococcal Infection Blood Culture Positive Cardiomegaly Empyema Neuroleptic Malignant Syndrome Osteomyelitis Pericardial Effusion Red Blood Cell Sedimentation Rate Increased White Blood Cell Count Increased 22-Feb-2006 08:31 AM Page: 888 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/04ISR Number: 4268570-4Report Type:Expedited (15-DaCompany Report #2003SE05514 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Speech Disorder Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Health PO Prevent Permanent Professional Orap Forte C Impairment/Damage Other Effexor C Xanax C Date:01/08/04ISR Number: 4268576-5Report Type:Expedited (15-DaCompany Report #2003SE05852 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS ORAL 25 MG DAILY Health PO Professional Rytmonorm SS Other Amaryl C Tebokan C Monodur C Hyzaar C Diltiazem C Digoxine C Date:01/09/04ISR Number: 4268832-0Report Type:Expedited (15-DaCompany Report #2003GB03421 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ventricular Tachycardia Foreign Seroquel PS Initial or Prolonged Health Professional Other Date:01/09/04ISR Number: 4268833-2Report Type:Expedited (15-DaCompany Report #2003AP04593 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypothermia Foreign Seroquel PS Intervention to Health Loramet C Prevent Permanent Professional Farom C Impairment/Damage Other Date:01/12/04ISR Number: 4269415-9Report Type:Direct Company Report #CTU 209794 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Donepezil PS 20 QD Initial or Prolonged Blood Creatine Quetiapine SS 200 MG TID Phosphokinase Increased Fluoxetine SS 60 MG QHS Delirium Tylenol C Leukocytosis Ampicillin C Neuroleptic Malignant Rocephin C Syndrome Aspirin C Pyrexia T#3 C 22-Feb-2006 08:31 AM Page: 889 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/04ISR Number: 4270184-7Report Type:Expedited (15-DaCompany Report #HQWYE897223DEC03 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Balance Disorder Health Effexor Xr Blood Cholesterol Professional (Venlafaxine Increased Hydrochloride, Blood Triglycerides Capsule, PS ORAL ORAL Increased Colace (Docusate Depression Sodium, ) SS 1 WK Drug Interaction Effexor Xr Drug Withdrawal Syndrome (Venlafaxine Eating Disorder Hydrochloride, Fall Capsule, Extended Hypoaesthesia Release) SS ORAL ORAL Nausea Effexor Xr Oedema Peripheral (Venlafaxine Paraesthesia Hydrochloride, Rash Pruritic Capsule, Extended Scar Release) SS ORAL 225 MG 1X PER Stomatitis 1 DAY, ORAL Swollen Tongue Seroquel Vertigo (Quetiapine) SS Weight Increased Glucosamine (Glucosamine, ) SS Lithium (Lithium, ) SS Premarin (Conjugated Estrogens) C Xanax (Alprazolam) C Synthroid (Levothyroxine Sodium) C Protonix (Pantoprazole) C Hyoscine Hydrobromide (Hyoscine Hydrobromide) C Phenobarbital (Phenobarbital) C Atropine Sulfate (Atropine Sulfate) C Hyoscyamine Sulfate (Hyoscyamine Sulfate) C Pepcid (Famotidine) C Zyrtec (Cetirizine Hydrochloride) C Calcium With Vitamin D (Calcium Phosphate/Calcium Sodium Lactate/Ergocalcifer C Lexapro (Escitalopram) C Prozac (Fluoxetine Hydrochloride) C 22-Feb-2006 08:31 AM Page: 890 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/04ISR Number: 4270906-5Report Type:Expedited (15-DaCompany Report #2004AP00024 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ileus Foreign Seroquel PS ORAL 25 MG TID PO Intervention to Study Lodopin SS ORAL 150 MG DAILY Prevent Permanent Health PO Impairment/Damage Professional Serenace SS ORAL 26 MG DAILY Other PO Akineton SS ORAL 6 MG DAILY PO Artane SS ORAL 6 MG DAILY PO Vegetamin SS Tegretol C Lexotan C Rohypnol C Alosenn C Gasmotin C Vagostigmin #1 C Date:01/13/04ISR Number: 4270909-0Report Type:Expedited (15-DaCompany Report #2004SE00022 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Seroquel PS ORAL 300 MG QD PO Initial or Prolonged Henoch-Schonlein Purpura Health Remeron SS ORAL 45 MG QD PO Professional Efexor - Slow Other Release SS ORAL 225 MG QD PO Cisordinol C Disipal C Stilnoct C Date:01/13/04ISR Number: 4270912-0Report Type:Expedited (15-DaCompany Report #2003GB02769 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocarditis Foreign Seroquel PS Initial or Prolonged Health Professional Other Date:01/13/04ISR Number: 4271525-7Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20031104219 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Haloperidol Initial or Prolonged Increased Health (Haloperidol) Aspartate Professional Injection PS INTRAVENOUS SEE IMAGE Aminotransferase Depakine (Valproate Increased Sodium) Injection SS INTRAVENOUS SEE IMAGE Blood Alkaline Seroquel (Quetiapine Phosphatase Increased Fumarate) SS ORAL SEE IMAGE Blood Creatine Fragmin Phosphokinase Increased (Heparin-Fraction Blood Lactate Sodium Salt) Dehydrogenase Increased Injection SS INTRAVENOUS SEE IMAGE Drug Interaction Claforan (Cefotaxime Potentiation Sodium) Injection SS INTRAVENOUS 6000 MG, Gamma-Glutamyltransferase INTRAVENOUS Increased Rivotril 22-Feb-2006 08:31 AM Page: 891 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) C Akineton (Biperiden Hydrochloride) C Entumin (Clotiapine)Tablets C Magnesium Sulphate (Magnesium Sulfate) C Date:01/13/04ISR Number: 4271535-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040100037 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ileus Foreign Risperdal Health (Risperidone) PS SEE IMAGE Professional Seroquel (Quetiapine Fumarate) SS SEE IMAGE Tavor (Lorazepam) C Date:01/14/04ISR Number: 4272629-5Report Type:Direct Company Report #CTU 210123 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Seroquel/Quetiapine Pruritus Generalised Fumarate PS ORAL PO Ecasa C Lovastatin C Furosemide C Kcl C Metoprolol C Date:01/14/04ISR Number: 4272847-6Report Type:Expedited (15-DaCompany Report #2003UW12066 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Oculogyration Health Seroquel PS ORAL 600 MG DAILY Intervention to Professional PO Prevent Permanent Depakote C Impairment/Damage Zyprexa C Date:01/14/04ISR Number: 4272848-8Report Type:Expedited (15-DaCompany Report #2003UW16660 Age: Gender:Female I/FU:I Outcome PT Required Abdominal Distension Intervention to Amnesia Prevent Permanent Anger Impairment/Damage Anxiety Chest Pain Confusional State Constipation Depression Disturbance In Attention Dizziness Postural Dry Mouth Dyspepsia Fatigue Fear Hallucination 22-Feb-2006 08:31 AM Page: 892 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Auditory Heart Rate Increased Hypoaesthesia Report Source Product Role Manufacturer Route Dose Duration Hypotension Consumer Seroquel PS Impaired Driving Ability Seroquel SS ORAL 400 MG DAILY Indifference PO Muscle Spasms Seroquel SS ORAL 225 MG DAILY Musculoskeletal Stiffness PO Nervous System Disorder Seroquel SS ORAL 300 MG DAILY Panic Attack PO Paraesthesia Ambien C Psychotic Disorder Serzone C Suicidal Ideation Zyprexa C Treatment Noncompliance Effexor-Xr C Tremor Klonopin C Weight Increased Abilify C Weight Loss Poor Zoloft C Date:01/14/04ISR Number: 4272915-9Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20031104222 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adrenal Disorder Foreign Haldol (Haloperidol) Anaemia Health Unspecified PS 10 MG, IN 1 Arteriosclerosis Professional DAY Atrophy Corenitec Brain Oedema (Vaseretic) SS LONG TERM Cardiac Arrest Seroquel (Quetiapine Cardiomegaly Fumarate) SS SEE IMAGE Contusion Isoptin (Verapamil Coronary Artery Disease Hydrochloride) C Dehydration Calcium Carbonate Depression (Calcium Carbonate) C Dyspnoea Fosamax (Alendronate Emphysema Sodium) C Fall Trittico (Trazodone Fibrosis Hydrochloride) C Gastric Adenoma Kcl Retard Hydrocephalus (Potassium Chloride) C Hypokalaemia Pantoloc Hyponatraemia (Pantoprazole) C Lipomatosis Gewacalm (Diazepam) C Myocardial Fibrosis Nacl (Sodium Nervous System Disorder Chloride) C Oedema Akineton (Biperiden Pancreatic Disorder Hydrochloride) C Perirenal Haematoma Psychomotor Hyperactivity Pulmonary Congestion Pulmonary Embolism Pulmonary Infarction Renal Artery Atherosclerosis Splenic Neoplasm Malignancy Unspecified Venous Thrombosis 22-Feb-2006 08:31 AM Page: 893 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/04ISR Number: 4273782-XReport Type:Expedited (15-DaCompany Report #2003AP04386 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Diabetes Mellitus Health PO Non-Insulin-Dependent Professional Dogmatil C Diabetic Ketoacidosis Other Akineton C Wypax C Flumezin C Proheparum C Contomin C Silece C Pyrethia C Zyloric "Glaxo Wellcome" C Glaxo Wellcome Date:01/15/04ISR Number: 4274625-0Report Type:Expedited (15-DaCompany Report #2003SE05624 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Steatosis Foreign Seroquel PS Intentional Overdose Health Nitrazepam SS Professional Oxazepam SS Other Date:01/16/04ISR Number: 4275150-3Report Type:Expedited (15-DaCompany Report #2004SE00001 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Foreign Seroquel PS ORAL 400 MG BID PO Initial or Prolonged Intentional Overdose Health Seroquel SS ORAL 5.2 G ONCE PO Required Leukocytosis Professional Intervention to Sinus Tachycardia Other Prevent Permanent Somnolence Impairment/Damage Suicide Attempt Date:01/16/04ISR Number: 4275153-9Report Type:Expedited (15-DaCompany Report #2003GB03102 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Seroquel PS ORAL 1200 MG DAILY Required Tachycardia Health PO Intervention to Professional Seroquel SS OVERDOSE Prevent Permanent Other Amisulpride C Impairment/Damage Date:01/16/04ISR Number: 4275178-3Report Type:Expedited (15-DaCompany Report #2004GB00022 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Seroquel PS ORAL 150 MG BID PO Initial or Prolonged Agitation Professional Zispin C Required Suicidal Ideation Other Olanzapine C Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 894 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/04ISR Number: 4275355-1Report Type:Expedited (15-DaCompany Report #2004UW00377 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Seroquel PS Initial or Prolonged Decreased Professional Date:01/16/04ISR Number: 4275359-9Report Type:Expedited (15-DaCompany Report #2004UW00495 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Difficulty In Walking Health Seroquel PS ORAL 350 MG DAILY Intervention to Dysstasia Professional PO Prevent Permanent Muscular Weakness Impairment/Damage Date:01/20/04ISR Number: 4276556-9Report Type:Expedited (15-DaCompany Report #2004001063 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Literature Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Electrocardiogram Health Haloperidol Abnormal Professional (Haloperidol) SS Hyperprolactinaemia Risperidone Psychotic Disorder (Risperidone) SS Tardive Dyskinesia Olanzapine Weight Increased (Olanzapine) SS Quetiapine (Quetiapine) SS Valproate (Valproic Acid) C Date:01/20/04ISR Number: 4276899-9Report Type:Expedited (15-DaCompany Report #2002AP03781 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Foreign Seroquel PS ORAL 200 MG TID PO Initial or Prolonged Infarction Health Olanzapine SS Required Acute Psychosis Professional Cipramil C Intervention to Cardiomyopathy Other Haloperidol C Prevent Permanent Depressed Level Of Temazepam C Impairment/Damage Consciousness Date:01/20/04ISR Number: 4276909-9Report Type:Expedited (15-DaCompany Report #2004UW00602 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bone Marrow Depression Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 895 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/20/04ISR Number: 4276912-9Report Type:Expedited (15-DaCompany Report #2003UW15611 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Mydriasis Health Seroquel PS ORAL 50 MG HS PO Intervention to Sinus Tachycardia Professional Effexor-Xr C Prevent Permanent Rogaine C Impairment/Damage Ambien C Date:01/20/04ISR Number: 4276914-2Report Type:Expedited (15-DaCompany Report #2004UW00561 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Health Seroquel PS ORAL 800 MG PO Initial or Prolonged Muscle Rigidity Professional Klonopin C Pyrexia Date:01/20/04ISR Number: 4277321-9Report Type:Expedited (15-DaCompany Report #2003AP04524 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Phosphorus Foreign Quetiapine PS 50 MG BID Intervention to Increased Literature Quetiapine SS 100 MG BID Prevent Permanent Drug Interaction Health Quetiapine SS 50 MG BID Impairment/Damage Electrocardiogram Qt Professional Quetiapine SS 700 MG DAILY Corrected Interval Other Amisulpride SS 50 MG DAILY Prolonged Amisulpride SS 50 MG BID Sinus Tachycardia Amisulpride SS 150 MG DAILY Tardive Dyskinesia Epilim C Tremor Temazepam C Ventricular Extrasystoles E-Vitamin C Lipex C Coloxyl C Clozapine C Date:01/21/04ISR Number: 4277745-XReport Type:Expedited (15-DaCompany Report #2004GB00063 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Quetiapine PS ORAL 25 MG PO Initial or Prolonged Dehydration Health Betahistine C Hypoventilation Professional Fluoxetine C Somnolence Other Temazepam C Movicol C Date:01/22/04ISR Number: 4278586-XReport Type:Expedited (15-DaCompany Report #2004-DE-00070GD Age: Gender:Female I/FU:I Outcome PT Death Acute Respiratory Distress Syndrome Coma Confusional State Drug Interaction Drug Toxicity Encephalopathy Epilepsy Grand Mal Convulsion 22-Feb-2006 08:31 AM Page: 896 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hand Fracture Hepatic Failure Hepatic Steatosis Report Source Product Role Manufacturer Route Dose Duration Hepatotoxicity Literature Nevirapine(Nevirapin Liver Function Test e) PS 400 MG Abnormal Nefazodone Multi-Organ Failure (Nefazodone) SS Osteopenia Ritonavir Psychotic Disorder (Ritonavir) SS 600 MG Sudden Death Saquinavir Tibia Fracture (Saquinavir) SS 1200 MG Lamotrigine (Lamotrigine) SS DOSE ESACLATION UP TO 1800 MG/DAY Phenytoin (Phenytoin) SS RT Ris[Peridone (Risperidone) SS 2 MG Quetiapine (Quetiapine) SS Sertraline (Sertraline) C Lorazepam (Lorazepam) C Gabapentin (Gabapentin) C Date:01/22/04ISR Number: 4279683-5Report Type:Expedited (15-DaCompany Report #2004194353AT Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Fragmin (Dalteparin Increased Health Sodium)Solution, Aspartate Professional Sterile PS SUBCUTANEOUS SEE IMAGE Aminotransferase Other Depakine (Valproate Increased Sodium) SS INTRAVENOUS SEE IMAGE Blood Alkaline Haldol (Haloperidol) SS INTRAVENOUS 5 MG, DAILY, Phosphatase Increased IV Gamma-Glutamyltransferase Seroquel Increased (Quetiapine) SS ORAL 600 MG, Hepatic Enzyme Increased DAILY, ORAL Pantoprazole Sodium (Pantoprazole Sodium) SS INTRAVENOUS 40 MG, DAILY, IV Rivotril C Akineton Retard C Entumin (Clotiapine) C Magnesium C Date:01/26/04ISR Number: 4279845-7Report Type:Expedited (15-DaCompany Report #S03-NZL-03214-01 Age:40 YR Gender:Female I/FU:F Outcome PT Death Completed Suicide Fall Marital Problem 22-Feb-2006 08:31 AM Page: 897 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Report Source Product Role Manufacturer Route Dose Duration Foreign Cipramil (Citalopram Health Hydrobromide) PS ORAL 40 MG QD PO Professional Cipramil (Citalopram Other Hydrobromide) SS Quetiapine SS Quetiapine SS ORAL 700 MG QD PO Erythromycin C Date:01/26/04ISR Number: 4280144-8Report Type:Expedited (15-DaCompany Report #2004UW00815 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circadian Rhythm Sleep Foreign Seroquel PS Initial or Prolonged Disorder Study Seroquel C Disturbance In Attention Health Risperdal C Drug Intolerance Professional Family Stress Other Nervousness Paranoia Date:01/26/04ISR Number: 4280253-3Report Type:Expedited (15-DaCompany Report #2004SE00150 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Foreign Seroquel PS ORAL 25 MG DAILY Choking Sensation Health PO Constipation Professional Seroquel SS ORAL 100 MG DAILY Muscle Rigidity Other PO Tafil C Arintapin C Zeldox C Date:01/26/04ISR Number: 4280263-6Report Type:Expedited (15-DaCompany Report #A209807 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Incontinence Consumer Zoloft (Sertraline) PS Initial or Prolonged Insomnia Geodon (Ziprasidone) SS 120 MG (TID) Nightmare Quetiapine Thyroid Disorder (Quetiapine) SS Weight Increased Acetylsalicylic Acid (Acetylsalicylic Acid) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Paroxetine Hydrochloride (Paroxetine Hydrochloride) C Citalopram (Citalopram) C 22-Feb-2006 08:31 AM Page: 898 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/04ISR Number: 4280497-0Report Type:Expedited (15-DaCompany Report #2004SE00196 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Seroquel PS ORAL 50 MG HS PO Initial or Prolonged Facial Palsy Health Tegretol SS 400 MG BID Headache Professional Topamax C Ophthalmoplegia Other Cipramil C Temporal Lobe Epilepsy Mirena C Date:01/27/04ISR Number: 4280634-8Report Type:Expedited (15-DaCompany Report #2003UW16459 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Serotonin Syndrome Health Seroquel PS ORAL 250 MG DAILY Intervention to Professional PO Prevent Permanent Seroquel SS ORAL 600 MG DAILY Impairment/Damage PO Lexapro C Wellbutrin - Slow Release C Neurontin C Date:01/27/04ISR Number: 4280635-XReport Type:Expedited (15-DaCompany Report #2004UW01060 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Seroquel PS ORAL 25 MG PO Initial or Prolonged Loss Of Consciousness Wellbutrin C Pyrexia Trazodone C Date:01/27/04ISR Number: 4280637-3Report Type:Expedited (15-DaCompany Report #2003UW14671 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Health Seroquel PS ORAL 25 MG HS PO Intervention to Professional Prevent Permanent Impairment/Damage Date:01/29/04ISR Number: 4283031-4Report Type:Expedited (15-DaCompany Report #2004003087 Age:18 YR Gender:Female I/FU:I Outcome PT Death Anoxic Encephalopathy Brain Death Brain Herniation Brain Oedema Coma Corneal Opacity Grand Mal Convulsion Hepatic Encephalopathy Hepatic Failure Hepatic Necrosis Liver Function Test Abnormal Liver Transplant Liver Transplant 22-Feb-2006 08:31 AM Page: 899 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rejection Lymphadenopathy Mental Status Changes Post Procedural Report Source Product Role Manufacturer Route Dose Duration Complication Health Geodon (Ziprasidone) PS ORAL 20 MG Pulmonary Alveolar Professional (DAILY), ORAL Haemorrhage Other Lorazepam Pulmonary Congestion (Lorazepam) SS Rash Ciprofloxacin Renal Tubular Necrosis (Ciprofloxacin) SS Respiratory Failure Clavulin Upper Respiratory Tract (Claculanate Infection Potassium, Varices Oesophageal Amoxicillin Trihydrate) SS Oxcarbazepine (Oxcarbazepine) SS Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL 100 MG (DAILY), ORAL Date:01/29/04ISR Number: 4283058-2Report Type:Expedited (15-DaCompany Report #2004UW01061 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Seroquel PS ORAL 100 MG DAILY Syndrome Professional PO Celexa C Date:01/29/04ISR Number: 4283059-4Report Type:Expedited (15-DaCompany Report #2004UW00877 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choking Consumer Seroquel PS ORAL 300 MG PO 1 YR Initial or Prolonged Thinking Abnormal Valium C Date:01/29/04ISR Number: 4283060-0Report Type:Expedited (15-DaCompany Report #2004UW00940 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Health Seroquel PS 30000 MG Initial or Prolonged Medication Error Professional Required Overdose Intervention to Prevent Permanent Impairment/Damage Date:01/29/04ISR Number: 4283156-3Report Type:Expedited (15-DaCompany Report #2003GB03391 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Wolff-Parkinson-White Foreign Seroquel PS ORAL 200 MG BID PO Intervention to Syndrome Health Amisulpride C Prevent Permanent Professional Impairment/Damage Other 22-Feb-2006 08:31 AM Page: 900 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/04ISR Number: 4283157-5Report Type:Expedited (15-DaCompany Report #2004GB00089 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Foreign Seroquel PS ORAL 700 MG DAILY Pulmonary Embolism Health PO Professional Pain Killers C Other Anti Diabetics C Date:01/29/04ISR Number: 4283209-XReport Type:Expedited (15-DaCompany Report #2003PK02143 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Seroquel "Zeneca" PS Zeneca ORAL 300 MG DAILY Initial or Prolonged Atrial Fibrillation Study PO Blood Sodium Decreased Health Seroquel "Zeneca" SS Zeneca ORAL 300 MG DAILY Circulatory Collapse Professional PO Hypokalaemia Other Diuretic SS Visual Disturbance Euphylong C Karvezide C L-Thyroxin C Melperon "Ct-Arzneimittel" C Noveril C Mirtazepin C Temazepam C Date:01/29/04ISR Number: 4283313-6Report Type:Expedited (15-DaCompany Report #2004UW00815 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Seroquel PS Initial or Prolonged Drug Intolerance Study Seroquel C Insomnia Health Risperdal C Nervousness Professional Paranoia Other Somnolence Stress Date:01/29/04ISR Number: 4283398-7Report Type:Expedited (15-DaCompany Report #2004GB00107 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Foreign Seroquel PS ORAL 750 MG DAILY Intervention to Electrocardiogram Pr Health PO Prevent Permanent Prolongation Professional Atenolol C Impairment/Damage Electrocardiogram Qt Other Corrected Interval Prolonged Date:01/29/04ISR Number: 4283399-9Report Type:Expedited (15-DaCompany Report #2003AP03890 Age:56 YR Gender:Male I/FU:F Outcome PT Required General Nutrition Intervention to Disorder Prevent Permanent Monocyte Percentage Impairment/Damage Increased 22-Feb-2006 08:31 AM Page: 901 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stool Analysis Abnormal White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 100 MG QID PO Health Vencoll C Professional Herbal Preparation C Other Alosenin C Gascon C Magnesium Oxide C Levotomin C Doral C Date:01/29/04ISR Number: 4283401-4Report Type:Expedited (15-DaCompany Report #2003SE05724 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Abnormal Foreign Seroquel PS TRANSPLACENTAL 250 MG DAILY Hospitalization - Caesarean Section Health TPL Initial or Prolonged Drug Exposure During Professional Seroquel SS TRANSPLACENTAL 25 MG DAILY Pregnancy Other TPL Movement Disorder Neonatal Disorder Date:01/30/04ISR Number: 4284109-1Report Type:Expedited (15-DaCompany Report #2004UW01459 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Seroquel PS ORAL 800 MG DAILY Syndrome Professional PO Date:01/30/04ISR Number: 4284512-XReport Type:Expedited (15-DaCompany Report #2004UW00815 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Foreign Seroquel PS ORAL 100 MG ONCE Initial or Prolonged Drug Intolerance Study PO Insomnia Health Seroquel SS ORAL 100 MG BID PO Nervousness Professional Seroquel SS ORAL 300 MG DAILY Paranoia Other PO Somnolence Seroquel SS ORAL 400 MG DAILY Stress PO Seroquel SS ORAL 400 MG DAILY PO Risperdal C Seroquel C Date:01/30/04ISR Number: 4284526-XReport Type:Expedited (15-DaCompany Report #DSA_23863_2004 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Temesta PS ORAL 2.5 MG Q DAY Initial or Prolonged Increased Health PO Aspartate Professional Temesta SS ORAL 2 MG QD PO Aminotransferase Other Seroquel SS ORAL 800 MG Q DAY Increased PO Hepatic Enzyme Increased Seroquel SS ORAL 50 MG Q DAY PO 22-Feb-2006 08:31 AM Page: 902 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS ORAL 100 MG Q DAY PO Seroquel SS ORAL 200 MG Q DAY PO Seroquel SS ORAL 300 MG Q DAY PO Seroquel SS ORAL 400 MG Q DAY PO Seroquel SS ORAL 600 MG Q DAY PO Seroquel SS ORAL 600 MG Q DAY PO Seroquel SS ORAL 200 MG Q DAY PO Seroquel SS ORAL 100 MG Q DAY PO Truxal SS ORAL VAR Q DAY PO Date:01/30/04ISR Number: 4284651-3Report Type:Expedited (15-DaCompany Report #2003AP04522 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pancytopenia Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Health PO Prevent Permanent Professional Impairment/Damage Other Date:01/30/04ISR Number: 4284654-9Report Type:Expedited (15-DaCompany Report #2003AP01034 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS ORAL 100 MG QD PO Intervention to Constipation Study Seroquel SS ORAL 50 MG TID PO Prevent Permanent Diabetes Mellitus Health Seroquel SS ORAL 100 MG TID PO Impairment/Damage Drug Ineffective Professional Ms Poultice C Hypertension Other Impromen C Myofascitis Serenace C Neglect Of Personal Akineton C Appearance Basen C Stress Lexotan C Tension Risperdal C Tinea Pedis Tegretol C Toothache Lendormin C Rohypnol C Date:01/30/04ISR Number: 4284684-7Report Type:Expedited (15-DaCompany Report #IN-JNJFOC-20040103396 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Duodenal Ulcer Foreign Risperidone - Initial or Prolonged Microcytic Anaemia Study Blinded Other Health (Risperidone) Professional Tablets PS ORAL 2 DOSE (S), 2 IN 1 DAY, ORAL Quetiapine (Quetiapine) Capsules SS ORAL 2 DOSE (S), 2 22-Feb-2006 08:31 AM Page: 903 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report IN 1 DAY, ORAL Placebo (Placebo) Capsules SS ORAL 2 DOSE (S), 2 IN 1 DAY, ORAL Date:02/02/04ISR Number: 4284827-5Report Type:Expedited (15-DaCompany Report #2004SE00022 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Seroquel PS ORAL 300 MG QD PO Initial or Prolonged Henoch-Schonlein Purpura Health Seroquel SS ORAL 700 MG QD PO Skin Haemorrhage Professional Remeron SS ORAL 45 MG QD PO Other Efexor-Slow Release SS ORAL 225 MG QD PO Cisordinol C Disipal C Stilnoct C Date:02/03/04ISR Number: 4285418-2Report Type:Direct Company Report #CTU 211433 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Seroquel 400 Mg Hs PS 400 MG HS Initial or Prolonged Fluoxetine 80 Mg Daily SS Date:02/03/04ISR Number: 4285704-6Report Type:Expedited (15-DaCompany Report #2004SE00365 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 550 MG DAILY Health PO Professional Diazepam C Other Promazin C Flufenazin C Date:02/03/04ISR Number: 4285848-9Report Type:Expedited (15-DaCompany Report #2004PK00172 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS 50-125 MG Intervention to Health Depakine SS 1200-2000 Prevent Permanent Professional MG/D Impairment/Damage Other Quilonorm Retard C Diamicron C Aspirin Cardio C Actos "Lilly" C Xatral C Date:02/04/04ISR Number: 4286440-2Report Type:Expedited (15-DaCompany Report #2003UW13874 Age:23 YR Gender:Male I/FU:F Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 904 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Health Seroquel PS ORAL 500 MG BID PO Decreased Professional Seroquel SS TAPERED OFF White Blood Cell Count AT 100 MG Decreased DECREASE PER WEEK Depakote C Atenolol C Date:02/04/04ISR Number: 4286636-XReport Type:Expedited (15-DaCompany Report #2004PK00169 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Foreign Seroquel PS 400-475 MG/D Initial or Prolonged Cough Health Tegretol SS 200-800 MG/D Double Stranded Dna Professional Seropram SS ORAL 60 MG DAILY Antibody Other PO Lupus-Like Syndrome Eltroxin SS 0.1 MG DAILY Mobility Decreased Tolvon SS 90 MG DAILY Myalgia Cyclo-Premella SS 0.625 MG Oedema Peripheral DAILY Date:02/04/04ISR Number: 4286902-8Report Type:Expedited (15-DaCompany Report #2004PK00142 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram T Wave Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Amplitude Decreased Health PO Ventricular Extrasystoles Professional Ergenyl C Other L-Thyroxin C Lasix C Date:02/04/04ISR Number: 4286992-2Report Type:Expedited (15-DaCompany Report #2004UW00633 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Seroquel PS Dyspepsia Health Fosamax C Extrasystoles Professional Levothyroxine C Somnolence Other Sinemet C Weight Decreased Diuretic C Polysporin Drops C Calcium Carbonate C Calcium C Haloperidol C Lactulose Syrup C Colace C Glycerin Suppositories C Acetaminophen C 22-Feb-2006 08:31 AM Page: 905 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/04ISR Number: 4286993-4Report Type:Expedited (15-DaCompany Report #2004GB00212 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Seroquel PS Decreased Health Professional Other Date:02/05/04ISR Number: 4286160-4Report Type:Expedited (15-DaCompany Report #PHEH2003US11644 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Zelnorm PS Novartis Sector: Mania Pharma ORAL 6 mg, BID 53280MIN Serotonin Syndrome Lamictal "Glaxosmithkline" SS ORAL 300 mg, BID Seroquel SS ORAL 150 mg, QD Xanax C UNK, PRN Date:02/05/04ISR Number: 4286491-8Report Type:Direct Company Report #CTU 211624 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Valproic Acid PS 1 GM Q HS Initial or Prolonged Lethargy Quetiapine SS 75 MG Q HS Liver Function Test Atenolol C Abnormal Clonazepam C Memory Impairment Sertraline C Mental Status Changes Zolpidem C Date:02/05/04ISR Number: 4287300-3Report Type:Expedited (15-DaCompany Report #2004UW01486 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Health Seroquel PS Initial or Prolonged Professional Risperdal C Date:02/05/04ISR Number: 4287301-5Report Type:Expedited (15-DaCompany Report #2004UW01601 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Seroquel PS ORAL 300 MG HS PO Initial or Prolonged Professional Effexor C Haldol Decanoate C Date:02/05/04ISR Number: 4287499-9Report Type:Expedited (15-DaCompany Report #2004UW01772 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS ORAL 800 MG PO Multiple Drug Overdose Professional Celexa C Restoril C 22-Feb-2006 08:31 AM Page: 906 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/04ISR Number: 4287501-4Report Type:Expedited (15-DaCompany Report #2004UW01671 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Health Seroquel PS ORAL 600 MG DAILY Professional PO Date:02/05/04ISR Number: 4288562-9Report Type:Expedited (15-DaCompany Report #2004UW00495 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abasia Health Seroquel PS ORAL 350 MG DAILY Required Dysstasia Professional PO Intervention to Muscular Weakness Prevent Permanent Impairment/Damage Date:02/05/04ISR Number: 4288653-2Report Type:Expedited (15-DaCompany Report #2004UW01670 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hypoaesthesia Foreign Seroquel PS ORAL 100 MG DAILY Oedema Peripheral Health PO Professional Loxapac C Date:02/05/04ISR Number: 4288735-5Report Type:Expedited (15-DaCompany Report #2004PK00166 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL MG DAILY PO Intervention to Health Seroquel SS ORAL 500 MG DAILY Prevent Permanent Professional PO Impairment/Damage Other Date:02/05/04ISR Number: 4288739-2Report Type:Expedited (15-DaCompany Report #2004GB00243 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Foreign Seroquel PS Initial or Prolonged Health Professional Other Date:02/05/04ISR Number: 4288741-0Report Type:Expedited (15-DaCompany Report #2004GB00022 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS ORAL 150 MG BID PO Initial or Prolonged Agitation Health Zispin C Required Suicidal Ideation Professional Olanzapine C Intervention to Other Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 907 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/04ISR Number: 4288925-1Report Type:Expedited (15-DaCompany Report #2004UW00815 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asocial Behaviour Foreign Seroquel PS ORAL 100 MG ONCE Initial or Prolonged Circadian Rhythm Sleep Study PO Disorder Health Seroquel SS ORAL 100 MG BID PO Disturbance In Attention Professional Seroquel SS ORAL 300 MG DAILY Drug Intolerance Other PO Nervousness Seroquel SS ORAL 400 MG DAILY Paranoia PO Seroquel SS ORAL 400 MG DAILY PO Seroquel C Risperdal C Date:02/05/04ISR Number: 4289500-5Report Type:Expedited (15-DaCompany Report #2003GB03170 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Disease Recurrence Foreign Seroquel PS ORAL 600 MG DAILY Intervention to Health PO Prevent Permanent Professional Impairment/Damage Other Date:02/06/04ISR Number: 4289350-XReport Type:Expedited (15-DaCompany Report #2003SE04708 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bone Marrow Depression Foreign Seroquel PS ORAL 600 MG DAILY Pancytopenia Health PO Professional Depamide SS ORAL 900 MG DAILY Other PO Femoston "Solvay" SS 1 TAB Chlordesmethyldiazep am C Date:02/06/04ISR Number: 4289358-4Report Type:Expedited (15-DaCompany Report #2003UW17047 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Compartment Health Seroquel PS ORAL 125 MG BID PO Initial or Prolonged Syndrome Professional Seroquel SS ORAL 100 MG BID PO Insulin C Synthroid C Asa C Tamoxifen C Kaochlor C Ferrous Sulfate C Calcium With Vitamin D C Folic Acid C Soy Isoflavine C Black Cohosh C Actinal C Zelnorm C Procrit C Clonazepam C 22-Feb-2006 08:31 AM Page: 908 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/04ISR Number: 4290383-8Report Type:Direct Company Report #CTU 211754 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Seroquel 100 Mg PS ORAL 100 MG QHS Initial or Prolonged ORAL Date:02/10/04ISR Number: 4292759-1Report Type:Expedited (15-DaCompany Report #2004PK00206 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 400 MG DAILY Health PO Professional Zyprexa C Other Dipiperon C Tafil C Date:02/10/04ISR Number: 4292763-3Report Type:Expedited (15-DaCompany Report #2003SE05724 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Neonatal Foreign Seroquel PS 250 MG DAILY Hospitalization - Caesarean Section Health TPL Initial or Prolonged Chills Professional Seroquel SS 25 MG DAILY Complications Of Maternal Other TPL Exposure To Therapeutic Aldomet C Drugs Drug Withdrawal Syndrome Neonatal Dyspnoea Hyperbilirubinaemia Neonatal Maternal Drugs Affecting Foetus Neonatal Disorder Tremor Neonatal Date:02/10/04ISR Number: 4292766-9Report Type:Expedited (15-DaCompany Report #2003AP01034 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS ORAL 100 MG QD PO Intervention to Constipation Study Seroquel SS ORAL 50 MG TID PO Prevent Permanent Diabetes Mellitus Health Seroquel SS ORAL 100 MG TID PO Impairment/Damage Drug Ineffective Professional Ms Poultice C Hypertension Other Impromen C Myofascitis Serenace C Tinea Pedis Akineton C Toothache Basen C Lexotan C Risperdal C Tegretol C Lendormin C Rohypnol C 22-Feb-2006 08:31 AM Page: 909 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/04ISR Number: 4293039-0Report Type:Expedited (15-DaCompany Report #2004UW01286 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchospasm Foreign Seroquel PS ORAL 300 MG PO Initial or Prolonged Dizziness Health Claritin-D SS ORAL 120 MG PO Other Dyspnoea Professional Fall Company Headache Representative Medication Error Other Muscular Weakness Nausea Pharmaceutical Product Complaint Syncope Vomiting Date:02/10/04ISR Number: 4293966-4Report Type:Expedited (15-DaCompany Report #2004UW01911 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Arrest Health Seroquel PS ORAL 300 MG PO Intervention to Palpitations Professional Prevent Permanent Impairment/Damage Date:02/11/04ISR Number: 4294093-2Report Type:Expedited (15-DaCompany Report #2004UW02052 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Renal Failure Health Seroquel PS NI Intervention to Professional Prevent Permanent Impairment/Damage Date:02/11/04ISR Number: 4294104-4Report Type:Expedited (15-DaCompany Report #2003UW16288 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Health Seroquel PS ORAL 25 MG DAILY; Hospitalization - Myocardial Infarction Professional PO Initial or Prolonged Diltiazem C Required Lipitor C Intervention to Losartan C Prevent Permanent Impairment/Damage Date:02/11/04ISR Number: 4294719-3Report Type:Expedited (15-DaCompany Report #IN-JNJFOC-20040103396 Age:26 YR Gender:Male I/FU:F Outcome PT Hospitalization - Duodenal Ulcer Initial or Prolonged Eosinophil Count Other Increased Iron Deficiency Anaemia Jaundice Marrow Hyperplasia Microcytic Anaemia 22-Feb-2006 08:31 AM Page: 910 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain In Extremity Palpitations Report Source Product Role Manufacturer Route Dose Duration Foreign Risperidone PS ORAL 2 DOSE(S), 2 Study IN 1 DAY, Health ORAL Professional Quetiapine (Quetiapine) Capsules SS ORAL 2 DOSE(S), 2 IN 1 DAY, ORAL Placebo (Placebo) Capsules SS ORAL 2 DOSE(S), 2 IN 1 DAY, ORAL Fefol C Date:02/12/04ISR Number: 4292980-2Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0419919A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Paxil PS Glaxosmithkline ORAL 3 MON Aggression Seroquel SS Date:02/12/04ISR Number: 4296008-XReport Type:Expedited (15-DaCompany Report #2004PK00259 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Foreign Seroquel PS Intervention to Increased Health Fluanxol C Prevent Permanent Aspartate Professional Olanzapin C Impairment/Damage Aminotransferase Other Melperon C Increased Ziprasidon C Gamma-Glutamyltransferase Chlorprothixen C Increased Hallucination Leukopenia Paranoia Date:02/12/04ISR Number: 4296009-1Report Type:Expedited (15-DaCompany Report #2004AP00584 Age:53 YR Gender:Female I/FU:I Outcome PT Death Arrhythmia Biliary Neoplasm Cognitive Disorder Cystitis Diet Refusal Electrocardiogram Qt Prolonged Fall Gastric Ulcer Haemorrhage Gastritis Gastritis Erosive Gastrointestinal Erosion Goitre Melanosis Mydriasis 22-Feb-2006 08:31 AM Page: 911 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Parovarian Cyst Psychiatric Symptom Pulse Absent Report Source Product Role Manufacturer Route Dose Duration Pyrexia Foreign Seroquel PS ORAL 100 MG QD PO Respiratory Arrest Health Seroquel SS ORAL 100 MG BID PO Shock Professional Seroquel SS ORAL 100 MG TID PO Stupor Other Seroquel SS ORAL 400 MG DAILY Sudden Death PO Tongue Black Hairy Seroquel SS ORAL 100 MG BID PO Tonsillitis Impromen SS ORAL 1 MG TID PO Vomiting Impromen SS ORAL 3 MG TID PO Impromen SS ORAL 3 MG DAILY PO Abilit SS Halcion C Mucosta C Gaster C Pursennid C Date:02/12/04ISR Number: 4296044-3Report Type:Expedited (15-DaCompany Report #2004UW01946 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Consumer Seroquel PS ORAL 100 MG PO Blood Pressure Increased Seroquel SS ORAL 200 MG PO Chest Discomfort Seroquel SS ORAL 400 MG PO Disorientation Seroquel SS ORAL 100 MG BID PO Dizziness Seroquel SS ORAL 25 MG PO Dry Mouth Trileptal SS Dysphagia Depakote C Fear Of Disease Feeling Abnormal Refusal Of Treatment By Patient Respiratory Rate Decreased Stomach Discomfort Thinking Abnormal Tongue Discolouration Date:02/13/04ISR Number: 4297030-XReport Type:Expedited (15-DaCompany Report #2004UW01824 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Disorder Foreign Seroquel PS Intervention to Migraine Health Prevent Permanent Professional Impairment/Damage Date:02/13/04ISR Number: 4297031-1Report Type:Expedited (15-DaCompany Report #2004UW00815 Age:32 YR Gender:Male I/FU:F Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Disturbance In Attention Insomnia Nervousness Paranoia Somnolence 22-Feb-2006 08:31 AM Page: 912 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stress Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 100 MG ONCE Study PO Health Seroquel SS ORAL 100 MG BID PO Professional Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel C Risperdal C Date:02/13/04ISR Number: 4297391-1Report Type:Expedited (15-DaCompany Report #2004UW02120 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatotoxicity Health Seroquel PS Initial or Prolonged Jaundice Professional Tylenol SS Date:02/13/04ISR Number: 4297834-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040103698 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Thrombocytopenia Health (Risperidone) Professional Unspecified PS ORAL 2 MG, ORAL; 6 MG, IN 1 DAY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL ORAL; 300 MG, IN 1 DAY, ORAL; 100 MG, IN 1 DAY, ORAL; 75 MG, Date:02/16/04ISR Number: 4295652-3Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0419919A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Paxil PS Glaxosmithkline ORAL 3 MON Aggression Seroquel SS Date:02/16/04ISR Number: 4295723-1Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0430704A Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Exposure During Lamictal PS Glaxosmithkline ORAL 100MG Per day Pregnancy Seroquel SS ORAL 100MG Per day Effexor SS ORAL 150MG Per day 690 DAY 22-Feb-2006 08:31 AM Page: 913 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/04ISR Number: 4295775-9Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0432436A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Event Lamictal PS Glaxosmithkline ORAL 25MG Twice Initial or Prolonged Overdose per day Rash Seroquel SS Date:02/16/04ISR Number: 4295926-6Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0422341A Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Lamictal PS Glaxosmithkline ORAL 25MG Unknown 3 WK Hospitalization - Depression Seroquel SS Initial or Prolonged Multiple Drug Overdose Klonopin SS Other Suicide Attempt Carbamazepine SS Tachycardia Date:02/17/04ISR Number: 4296111-4Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0422341A Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Lamictal PS Glaxosmithkline ORAL 25MG Unknown 3 WK Hospitalization - Depression Seroquel SS Initial or Prolonged Multiple Drug Overdose Klonopin SS Other Suicide Attempt Carbamazepine SS Tachycardia Date:02/17/04ISR Number: 4297362-5Report Type:Direct Company Report #USP 56310 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Serzone PS Bristol Myers, Squib TABLET Seroquel SS Astra-Zeneca TABLET Date:02/17/04ISR Number: 4299034-XReport Type:Expedited (15-DaCompany Report #2004UW02215 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Health Professional Other Date:02/17/04ISR Number: 4299113-7Report Type:Expedited (15-DaCompany Report #2004UW02181 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Seroquel PS Syndrome Professional Sinemet SS 22-Feb-2006 08:31 AM Page: 914 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/04ISR Number: 4299115-0Report Type:Expedited (15-DaCompany Report #2004UW02477 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Health Seroquel PS Atherosclerosis Professional Neurontin SS Therapeutic Agent Lexapro SS Toxicity Clonazepam SS Date:02/17/04ISR Number: 4299360-4Report Type:Expedited (15-DaCompany Report #2004UW02209 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Health Professional Other Date:02/17/04ISR Number: 4299411-7Report Type:Expedited (15-DaCompany Report #2004GB00328 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:02/17/04ISR Number: 4299498-1Report Type:Expedited (15-DaCompany Report #2004UW02368 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Health Seroquel PS ORAL 200 MG BID PO Intervention to Decreased Professional Prevent Permanent Impairment/Damage Date:02/17/04ISR Number: 4299501-9Report Type:Expedited (15-DaCompany Report #2004UW01599 Age:55 YR Gender:Male I/FU:I Outcome PT Life-Threatening Agitation Required Blood Creatine Intervention to Phosphokinase Increased Prevent Permanent Blood Pressure Decreased Impairment/Damage Confusional State Dehydration Dyspnoea Hypotension Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Renal Failure Restlessness Sepsis Temperature Regulation Disorder White Blood Cell Count 22-Feb-2006 08:31 AM Page: 915 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS ORAL 100 MG DAILY Professional PO Seroquel SS ORAL 50 MG DAILY PO Seroquel SS ORAL 25 MG DAILY PO Haldol "Janssen" SS Janssen Benzodiazepine SS Mellaril C Trilafon C Triavil C Xanax C Date:02/17/04ISR Number: 4299871-1Report Type:Expedited (15-DaCompany Report #2004IC000024 Age:30 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Dalmane PS Health Benztropine Mesylate SS Professional Quetiapine SS Date:02/18/04ISR Number: 4300080-8Report Type:Expedited (15-DaCompany Report #2004AP00746 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Seroquel PS ORAL 600 MG DAILY Decreased Health PO Professional Other Date:02/18/04ISR Number: 4300241-8Report Type:Expedited (15-DaCompany Report #2003AP04593 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypothermia Foreign Seroquel PS Intervention to Health Loramet C Prevent Permanent Professional Farom C Impairment/Damage Other Date:02/18/04ISR Number: 4300350-3Report Type:Expedited (15-DaCompany Report #2003121910 Age:35 YR Gender:Female I/FU:F Outcome PT Other Ankle Fracture Depression Drug Ineffective Fatigue Gastrointestinal Injury Haematoma Lung Injury Malaise Memory Impairment Panic Attack Road Traffic Accident 22-Feb-2006 08:31 AM Page: 916 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Splenic Injury Report Source Product Role Manufacturer Route Dose Duration Consumer Zoloft (Sertraline) PS ORAL (DAILY) ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL ORAL Clonazepam (Clonazepam) C Date:02/18/04ISR Number: 4300471-5Report Type:Expedited (15-DaCompany Report #2004UW02433 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Seroquel PS Date:02/19/04ISR Number: 4301029-4Report Type:Expedited (15-DaCompany Report #2004PK00330 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatitis Foreign Seroquel PS UP TO 400 MG Intervention to Health Quilonorm C Prevent Permanent Professional Saroten Retard C Impairment/Damage Other Temesta C Date:02/19/04ISR Number: 4301052-XReport Type:Expedited (15-DaCompany Report #2004UW02506 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:02/19/04ISR Number: 4301053-1Report Type:Expedited (15-DaCompany Report #2004UW02496 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Health Seroquel PS ORAL 500M MG DAILY Intervention to Drug Level Increased Professional PO Prevent Permanent Seroquel SS ORAL 700 MG DAILY Impairment/Damage PO Tegretol - Slow Release SS 800 MG DAILY Lithium Citrate C Chlorpromazine C Levothyroxine C Multivitamin C Pyridoxine C Vitamin E C 22-Feb-2006 08:31 AM Page: 917 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/04ISR Number: 4301465-6Report Type:Expedited (15-DaCompany Report #2003UW17038 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abnormal Behaviour Health Seroquel PS Required Coordination Abnormal Professional Seroquel SS ORAL 100 MG DAILY Intervention to Drug Interaction PO Prevent Permanent Drug Toxicity Seroquel SS ORAL 150 MG DAILY Impairment/Damage PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 250 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 100 MG DAILY PO Tegretal Xr SS 2200 MG DAILY Tegretal Xr SS 2000 MG DAILY Tegretal Xr SS 1800 MG DAILY Tegretal Xr SS 1600 MG DAILY Tegretal Xr SS 1000 MG DAILY Tegretal SS Tegretal SS 600 MG DAILY Tegretal SS 800 MG DAILY Tegretal SS 1000 MG DAILY Tegretal SS 1200 MG DAILY Tegretal SS 1800 MG DAILY Tegretal SS 2000 MG DAILY Tegretal SS 1800 MG DAILY Tegretal SS 2000 MG DAILY Tegretal SS 1800 MG DAILY Tegretal SS 1600 MKG DAILY Tegretal SS 1400 MG DAILY Trileptal "Ciba-Geigy" SS Ciba-Geigy 900 MG DAILY Trileptal "Ciba-Geigy" SS "Ciba-Geigy" 1200 MG DAILY Trileptal "Ciba-Geigy" SS "Ciba-Geigy" 1500 MG DAILY Trileptal "Ciba-Geigy" SS "Ciba-Geigy" 900 MG DAILY Synthroid C Levothyroxine C Surfak C Milk Of Magnesia C Risperidone C 22-Feb-2006 08:31 AM Page: 918 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aricept C Olanzapine C Lithium C Date:02/19/04ISR Number: 4301596-0Report Type:Expedited (15-DaCompany Report #2004UW02498 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Health Seroquel PS ORAL 25 MG DAILY Drug Level Increased Professional PO Lethargy Seroquel SS ORAL 50 MG DAILY PO Seroquel SS ORAL 75 MG DAILY PO Seroquel SS ORAL 100 MG DAILY PO Seroquel SS ORAL 150 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 250 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 150 MG DAILY PO Seroquel SS ORAL 100 MG DAILY PO Seroquel SS ORAL 50 MG DAILY PO Tegretol SS Tegretol SS 1200 MG DAILY Tegretol SS 1400 MG DAILY Tegretol SS 1600 MG DAILY Tegretol SS 1800 MG DAILY Tegretol SS 2000 MG DAILY Tegretol SS 2000 MG DAILY Risperidone C Haldol C Librium C Bentyl C Bethanechol C Lithium C Nadolol C Colace C Psyllium C Synthroid C 22-Feb-2006 08:31 AM Page: 919 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/04ISR Number: 4301969-6Report Type:Expedited (15-DaCompany Report #2003UW16728 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Health Seroquel PS ORAL 300 MG HS PO Intervention to Dystonia Professional Prevent Permanent Musculoskeletal Stiffness Impairment/Damage Nuchal Rigidity Pharyngolaryngeal Pain Pyrexia Salivary Hypersecretion Streptococcal Infection Swollen Tongue Date:02/20/04ISR Number: 4301970-2Report Type:Expedited (15-DaCompany Report #2004GB00263 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Azoospermia Foreign Seroquel PS ORAL 150 MG QD PO Intervention to Health Citalopram SS ORAL 50 MG QD PO Prevent Permanent Professional Impairment/Damage Other Date:02/20/04ISR Number: 4301971-4Report Type:Expedited (15-DaCompany Report #2004UW02694 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Health Professional Company Representative Other Date:02/20/04ISR Number: 4302058-7Report Type:Expedited (15-DaCompany Report #03P-087-0245767-00 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ileus Foreign Akineton (Biperiden) Intervention to Health (Biperiden) PS ORAL 6 MG, 1 IN 1 Prevent Permanent Professional D, ORAL Impairment/Damage Other Zotepine SS ORAL 150 MG, 1 IN 1 D, ORAL Quetiapine SS ORAL 25 MG, 3 IN 1 D, ORAL Haloperidol SS ORAL 26 MG, 1 IN 1 D, ORAL Trihexyphenidyl Hydrochloride SS ORAL 6 MG, 1 IN 1 D, ORAL Vegetamin SS ORAL ORAL Carbamazepine C Bromazepam C Flunitrazepam C Alosenn C Mosapride Citrate C 22-Feb-2006 08:31 AM Page: 920 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/04ISR Number: 4302062-9Report Type:Expedited (15-DaCompany Report #IN-JNJFOC-20040103396 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Risperidone PS ORAL 2 DOSE(S), 2 Initial or Prolonged Phosphatase Increased Study IN 1 DAY, Other Blood Chloride Increased ORAL Bone Marrow Depression Quetiapine Diarrhoea (Quetiapine) SS ORAL 2 DOSE(S), 2 Duodenal Ulcer IN 1 DAY, Eosinophilia ORAL Haematochezia Placebo (Placebo) SS ORAL 2 DOSE(S), 2 Helicobacter Infection IN 1 DAY, Hyperbilirubinaemia ORAL Infection Parasitic Fefol Fefol C Iron Deficiency Anaemia Jaundice Leukopenia Microcytic Anaemia Pain Pain In Extremity Palpitations Transfusion Reaction Date:02/22/04ISR Number: 4303472-6Report Type:Expedited (15-DaCompany Report #2004UW02495 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Health Seroquel PS TRITATED UP Intervention to Drug Toxicity Professional FROM 25 TO Prevent Permanent Personality Change 400 MG/DAY Impairment/Damage Seroquel SS ORAL 900 MG DAILY PO Tegretol - Slow Releases SS Lansoprazole C Acetaminophen C Simethicone C Zyrtec C Senokot-S C Lactulose C Nulytely C Ibuprofen C Date:02/23/04ISR Number: 4303329-0Report Type:Expedited (15-DaCompany Report #IN-JNJFOC-20040103396 Age:26 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Lactate Initial or Prolonged Dehydrogenase Decreased Other Duodenal Ulcer Dyspnoea Exertional Eosinophilia Helicobacter Infection Hookworm Infection Hyperbilirubinaemia Hypochromic Anaemia Iron Deficiency Anaemia Jaundice Leukopenia 22-Feb-2006 08:31 AM Page: 921 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Marrow Hyperplasia Mean Cell Volume Decreased Report Source Product Role Manufacturer Route Dose Duration Nematodiasis Foreign Risperidone- Blinded Pallor Study (Risperidone) Palpitations Health Tablets PS ORAL 2 DOSE (S), 2 Platelet Count Abnormal Professional IN 1 DAY, Transfusion Reaction ORAL Quetiapine (Quetiapine) Capsules SS ORAL 2 DOSE (S), 2 IN 1 DAY, ORAL Placebo (Placebo) Capsules SS ORAL 2 DOSE (S), 2 IN 1 DAY, ORAL Fefol (Capsules) Fefol C Date:02/23/04ISR Number: 4303577-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202825 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Study Risperidone Initial or Prolonged Health (Risperidone) Professional Unspecified PS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL Ziprasidone (Ziprasidone) SS ORAL ORAL Perphenazine (Perphenazine) SS ORAL ORAL Lorazepam (Lorazepam) C Date:02/23/04ISR Number: 4304300-5Report Type:Expedited (15-DaCompany Report #DEWYE589818FEB04 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperlipidaemia Foreign Trevilor Retard Multi-Organ Failure Health (Venlafaxine Professional Hydrochloride, Capsule, Extended Release, 0) PS ORAL (HIGH DOSES) ORAL Seroquel (Quetiapine, ,0) SS ORAL (HIGH DOSES) ORAL Date:02/24/04ISR Number: 4303492-1Report Type:Direct Company Report #CTU 212990 Age: Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:31 AM Page: 922 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Intentional Overdose Zoloft 100 Mg Roerig Medication Error Pfizer PS Roerig Pfizer ORAL 300 MG DAILY ORAL Seroquel 100 Mg Astrazeneca SS Astrazeneca ORAL 100 MG HS ORAL Date:02/24/04ISR Number: 4304271-1Report Type:Expedited (15-DaCompany Report #2004UW02625 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ageusia Consumer Seroquel PS ORAL 150 MG PO Initial or Prolonged Anosmia Serzone SS Other Confusional State Toprol Xl C Loss Of Consciousness Plavix C Medication Error Acetylsalicylic Acid C Photosensitivity Reaction Protonix C Zocor C Lisinopril C Norvasc C Date:02/24/04ISR Number: 4304717-9Report Type:Expedited (15-DaCompany Report #2004GB00394 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Foreign Seroquel PS ORAL 150 MG PO Initial or Prolonged Consumer Other Date:02/26/04ISR Number: 4307380-6Report Type:Expedited (15-DaCompany Report #2003UW16254 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Health Seroquel PS ORAL 375 MG DAILY Intervention to Thinking Abnormal Professional PO Prevent Permanent Vision Blurred Seroquel SS ORAL 500 MG PO Impairment/Damage Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 300 MG HS PO Seroquel SS ORAL 200 MG PO Seroquel SS ORAL 300 MG PO Depakote C Abilify C Date:02/27/04ISR Number: 4308778-2Report Type:Expedited (15-DaCompany Report #2004GB00328 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel PS ORAL 300 MG BID PO Initial or Prolonged Neutropenia Health Venlfaxine Xl C Required Professional Intervention to Other Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 923 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/04ISR Number: 4308824-6Report Type:Expedited (15-DaCompany Report #2003UW16254 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Health Seroquel PS ORAL 600 MG DAILY Intervention to Thinking Abnormal Professional PO Prevent Permanent Vision Blurred Seroquel SS ORAL 375 MG DAILY Impairment/Damage PO Seroquel SS ORAL 500 MG PO Seroquel SS ORAL 300 MG HS PO Seroquel SS ORAL 200 MG PO Seroquel SS ORAL 300 MG PO Depakote C Abilify C Date:02/27/04ISR Number: 4308826-XReport Type:Expedited (15-DaCompany Report #2004UW00116 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Consumer Seroquel PS ORAL 300 MG HS PO Inflammation No Match SS Injury Corneal Risperdal SS Insomnia Zyprexa C Peripheral Coldness Nexium C Retinal Injury Geodon C Vitreous Floaters Lamisil C Vomiting Thiamine C Date:02/27/04ISR Number: 4308999-9Report Type:Expedited (15-DaCompany Report #2004SE00729 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Seroquel PS ORAL 300 MG DAILY Syndrome Health PO Serotonin Syndrome Professional Zoloft SS 50 MG DAILY Other Temazepanum C Ranitidinum C Date:02/27/04ISR Number: 4309122-7Report Type:Expedited (15-DaCompany Report #2004SE00729 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Seroquel PS ORAL 300 MG DAILY Syndrome Health PO Serotonin Syndrome Professional Temazepanum C Other Ranitidinum C Date:03/01/04ISR Number: 4308801-5Report Type:Direct Company Report #CTU 213424 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Seroquel Initial or Prolonged Anxiety (Quetiapine) 28:16 PS 1000 MG PO QD Required Aura Klonopin C Intervention to Confusional State Lexapro C Prevent Permanent Mania Synthroid C Impairment/Damage Syncope Ambien C Requip C 22-Feb-2006 08:31 AM Page: 924 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hctz C Zelnorm C Miralat C Depakote C Zetia C Date:03/01/04ISR Number: 4308849-0Report Type:Direct Company Report #CTU 213442 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Haldol 28:16 PS ORAL 5 MG PO BID Initial or Prolonged Coordination Abnormal [CHRONIC] Required Drug Toxicity Seroquel Intervention to Fall (Quetiapine)28:16 SS 200 MG @ NOON Prevent Permanent Metabolic Disorder , 600 MG QHS Impairment/Damage CHRONIC Haldol Dcanoate C Protonix C Multivitamin C Flunisolide C Norvasc C Date:03/01/04ISR Number: 4309406-2Report Type:Expedited (15-DaCompany Report #2004GB00475 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 150 MG BID PO Initial or Prolonged Dizziness Health Nausea Professional Schizophrenia Other Date:03/01/04ISR Number: 4309523-7Report Type:Expedited (15-DaCompany Report #2004PK00363 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS Intervention to Health Lithium C Prevent Permanent Professional Cipramil C Impairment/Damage Other Date:03/01/04ISR Number: 4310245-7Report Type:Direct Company Report #CTU 213502 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cataract Seroquel 300 Mgs Initial or Prolonged Drug Withdrawal Syndrome Astrazeneca PS Astrazeneca ORAL 300 MG Other NIGHTLY ORAL Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 925 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/04ISR Number: 4309539-0Report Type:Expedited (15-DaCompany Report #2004UW03165 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Seroquel PS ORAL 400 MG BID PO Klonopin C Lexapro C Thorazine C Trazodone C Ambien C Propoxyphene Napsylate C Date:03/02/04ISR Number: 4310803-XReport Type:Expedited (15-DaCompany Report #2004PK00356 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Fall Foreign Seroquel PS ORAL 200 MG DAILY Syncope Health PO Professional Other Date:03/02/04ISR Number: 4310811-9Report Type:Expedited (15-DaCompany Report #2003GB00198 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Foreign Seroquel PS ORAL 225 MG HS PO Intervention to Complications Of Maternal Health Combivent SS NASAL 2 PUFF QID IH Prevent Permanent Exposure To Therapeutic Professional Impairment/Damage Drugs Other Drug Exposure During Pregnancy Date:03/02/04ISR Number: 4310814-4Report Type:Expedited (15-DaCompany Report #2004UW03376 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel PS Intervention to Leukopenia Study Prevent Permanent Neutropenia Health Impairment/Damage Professional Other Date:03/02/04ISR Number: 4311160-5Report Type:Expedited (15-DaCompany Report #2004UW03255 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pancytopenia Health Seroquel PS ORAL 100 MG PO Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 926 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4311603-7Report Type:Direct Company Report #CTU 213696 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Celexa 40 Mg PS ORAL 40 MG QD ORAL Initial or Prolonged Seroquel 200 Mg SS ORAL 200MG/400 MG QAM/QPM ORAL Date:03/03/04ISR Number: 4311970-4Report Type:Expedited (15-DaCompany Report #2003GB00198 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Foreign Seroquel PS ORAL 225 MG HS PO Intervention to Complications Of Maternal Health Combivent SS RESPIRATORY Prevent Permanent Exposure To Therapeutic Professional (INHALATION) 2 PUFF QID IH Impairment/Damage Drugs Other Drug Exposure During Pregnancy Date:03/03/04ISR Number: 4311971-6Report Type:Expedited (15-DaCompany Report #2004UW03376 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel PS Intervention to Leukopenia Study Prevent Permanent Neutropenia Health Impairment/Damage Professional Other Date:03/03/04ISR Number: 4312513-1Report Type:Expedited (15-DaCompany Report #2004UW02924 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Self-Injury Health Seroquel PS ORAL 100 MG PO Required Medication Error Professional Serzone SS ORAL 100 MG PO Intervention to Prevent Permanent Impairment/Damage Date:03/03/04ISR Number: 4312515-5Report Type:Expedited (15-DaCompany Report #2004UW03255 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pancytopenia Health Seroquel PS ORAL 100 MG PO Intervention to Professional Prevent Permanent Impairment/Damage Date:03/04/04ISR Number: 4313273-0Report Type:Expedited (15-DaCompany Report #2003SE05578 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Osmolarity Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Decreased Health PO Prevent Permanent Hypochloraemia Professional Seroquel SS ORAL 200 MG DAILY Impairment/Damage Hyponatraemia Other PO Depakine Chrono C 22-Feb-2006 08:31 AM Page: 927 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tranxene C Staurodorm C Zantac C Antabuse C Bisoprolol C Cardioaspirin C Date:03/04/04ISR Number: 4313303-6Report Type:Expedited (15-DaCompany Report #2004SE00917 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatic Failure Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:03/04/04ISR Number: 4313402-9Report Type:Expedited (15-DaCompany Report #2004UW00940 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Seroquel PS ORAL 30000 MG PO Initial or Prolonged Respiratory Failure Professional Lisinopril C Required Suicide Attempt Effexor C Intervention to Trazodone C Prevent Permanent Synthroid C Impairment/Damage Clarinex C Detrol C Ketorolac C Nexium C Hctz C Date:03/04/04ISR Number: 4313800-3Report Type:Periodic Company Report #2003121405 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 160 MG Corrected Interval Professional (DAILY), ORAL Prolonged Haloperidol (Haloperidol) SS ORAL 5 MG, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL 1100 MG, ORAL Hydroxine Embonate (Hydroxyzine Embonate) C Gemfibrozil (Gemfibrozil) C Lorazepam (Lorazepam) C Levothyroxine Sodium (Levothyroxine Sodium) C Ferrous Sulfate (Ferrous Sulfate) C Gabapentin (Gabapentin) C Nordette (Ethinylestradiol, 22-Feb-2006 08:31 AM Page: 928 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levonorgestrel) C Date:03/04/04ISR Number: 4313809-XReport Type:Periodic Company Report #2003122959 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon (Ziprasidone) PS Initial or Prolonged Asthenia Professional Lithium (Lithium) Confusional State (Lithium) SS Coordination Abnormal Diphenhydramine Drug Ineffective (Diphenhydramine) SS Gait Disturbance Pseudoephedrine Hypomania (Pseudoephedrine) SS Malaise Fluoxetine Mania Hydrochloride Masked Facies (Fluoxetine Memory Impairment Hydrochloride) SS Meniere'S Disease Quetiapine Fumarate Muscle Twitching (Quetiapine Myalgia Fumarate) SS Pain Of Skin Topiramate Sleep Disorder (Topiramate) C Valproate Semisodium (Valproate Semisodium) C Trazodone (Trazodone) C Hyoscyamine (Hyoscyamine) C Antidepressants C Date:03/05/04ISR Number: 4313284-5Report Type:Direct Company Report #CTU 213942 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Seroquel PS Self-Medication Date:03/05/04ISR Number: 4313406-6Report Type:Direct Company Report #CTU 213973 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Seroquel Initial or Prolonged Neutropenia (Quetiaprole) PS ORAL 25 MG Q AM , Thrombocytopenia 50 MG QHS 1 YR Date:03/05/04ISR Number: 4313777-0Report Type:Expedited (15-DaCompany Report #2004UW01772 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS ORAL 600 MG HS PO Multiple Drug Overdose Professional Celexa C Restoril C 22-Feb-2006 08:31 AM Page: 929 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/04ISR Number: 4313778-2Report Type:Expedited (15-DaCompany Report #2004UW03417 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Seroquel PS 7 TABS ONCE Professional Ativan SS ORAL 17.5 MG ONCE PO Date:03/05/04ISR Number: 4313940-9Report Type:Expedited (15-DaCompany Report #2004UW03401 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Foreign Seroquel PS NI Intervention to Hypotension Health Prevent Permanent Loss Of Consciousness Professional Impairment/Damage Neuroleptic Malignant Other Syndrome Date:03/05/04ISR Number: 4313941-0Report Type:Expedited (15-DaCompany Report #2004UW03398 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Foreign Seroquel PS Health Professional Other Date:03/08/04ISR Number: 4314057-XReport Type:Direct Company Report #CTU 214028 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alcohol Use Risperidone 2 Mg Tab PS ORAL 1 MG HS ORAL Intervention to Drug Abuser Quetiapine 100mg Tab SS ORAL 50 MG HS ORAL Prevent Permanent Overdose Augmentin C Impairment/Damage Priapism Vicodin C Treatment Noncompliance Citalopram C Sertraline C Date:03/08/04ISR Number: 4314268-3Report Type:Expedited (15-DaCompany Report #2004UW03554 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Health Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Living Impaired Professional PO Blood Creatine Seroquel SS ORAL 300 MG PO Phosphokinase Increased Seroquel SS Confusional State Lithobid SS ORAL 1200 MG PO Drug Interaction Inderal SS ORAL 40 MG PO Muscle Rigidity Docusate SS ORAL 100 MG PO Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Pyrexia 22-Feb-2006 08:31 AM Page: 930 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/04ISR Number: 4314277-4Report Type:Expedited (15-DaCompany Report #2004UW03555 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Seroquel PS Thrombocytopenia Professional Date:03/08/04ISR Number: 4314278-6Report Type:Expedited (15-DaCompany Report #2004UW03849 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Dependence Health Seroquel PS Intervention to Overdose Professional Prevent Permanent Impairment/Damage Date:03/08/04ISR Number: 4314280-4Report Type:Expedited (15-DaCompany Report #2004UW01911 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Health Seroquel PS ORAL 300 MG HS PO Initial or Prolonged Palpitations Professional Klonopin C Required Intervention to Prevent Permanent Impairment/Damage Date:03/08/04ISR Number: 4314281-6Report Type:Expedited (15-DaCompany Report #2004UW02047 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Palpitations Professional PO Seroquel SS ORAL 25 MG - 100 MG Lithium Carbonate C Date:03/08/04ISR Number: 4314364-0Report Type:Expedited (15-DaCompany Report #2004UW00940 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacteraemia Health Seroquel PS ORAL 30000 MG PO Initial or Prolonged Overdose Professional Lisinopril C Required Respiratory Failure Effexor C Intervention to Suicide Attempt Trazodone C Prevent Permanent Synthroid C Impairment/Damage Clarinex C Detrol C Ketorolac C Nexium C Hctz C 22-Feb-2006 08:31 AM Page: 931 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/04ISR Number: 4314776-5Report Type:Expedited (15-DaCompany Report #2004SE01142 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Status Epilepticus Foreign Seroquel PS ORAL 400 MG DAILY Health PO Professional Modecate C Other Date:03/08/04ISR Number: 4314781-9Report Type:Expedited (15-DaCompany Report #2004UW03627 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Dependence Foreign Seroquel PS Intervention to Maternal Drugs Affecting Health Prevent Permanent Foetus Professional Impairment/Damage Neonatal Disorder Other Tremor Neonatal Date:03/08/04ISR Number: 4314788-1Report Type:Expedited (15-DaCompany Report #2004GB00525 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dermatitis Exfoliative Foreign Quetiapine PS Intervention to Dyspnoea Health Quetiapine SS ORAL 200 MG QD PO Prevent Permanent Flushing Professional Impairment/Damage Rash Other Date:03/10/04ISR Number: 4314900-4Report Type:Direct Company Report #CTU 214219 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Quetiapine 100 Mg Intervention to Non-Insulin-Dependent Astrazeneca Prevent Permanent Pharmaceuticals PS Astrazeneca Impairment/Damage Pharmaceuticals ORAL 700 MG QD ORAL Alprazolam-Xanax- C Citalopram-Celexa- C Date:03/10/04ISR Number: 4315846-8Report Type:Expedited (15-DaCompany Report #2004UW03963 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Date:03/10/04ISR Number: 4315858-4Report Type:Expedited (15-DaCompany Report #2004UW03962 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS ORAL 800 MG PO Professional Divalproex SS 200 MG 22-Feb-2006 08:31 AM Page: 932 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/10/04ISR Number: 4315860-2Report Type:Expedited (15-DaCompany Report #2004UW03645 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Toxicity Health Seroquel PS Intervention to Overdose Professional Prevent Permanent Impairment/Damage Date:03/10/04ISR Number: 4315886-9Report Type:Expedited (15-DaCompany Report #2004GB00524 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Emotional Disorder Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Jaundice Health PO Prevent Permanent Professional Co-Careldopa C Impairment/Damage Other Co-Danthramer C Date:03/10/04ISR Number: 4315941-3Report Type:Expedited (15-DaCompany Report #2004UW03955 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS 75 MG- 75 MG Health - 150 MG Professional Risperidone C Other Divalproex C Date:03/11/04ISR Number: 4315579-8Report Type:Direct Company Report #CTU 214260 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Disorder Seroquel 100 Mg PS ONE TAB AT Sleep Walking NIGHT Date:03/11/04ISR Number: 4315693-7Report Type:Direct Company Report #USP 56379 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Serzone PS Bristol-Myere TABLET Required Seroquel SS Intervention to Prevent Permanent Impairment/Damage Date:03/11/04ISR Number: 4316151-6Report Type:Direct Company Report #CTU 214270 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypotension Seroquel 300 Mg PS ORAL 325 MG QHS Intervention to ORAL Prevent Permanent Sildenafil Citrate C Impairment/Damage Rpazosin C Acetaminophen C Olanzapine C Etodolac C 22-Feb-2006 08:31 AM Page: 933 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/04ISR Number: 4316414-4Report Type:Expedited (15-DaCompany Report #PHHO2004CH03337 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Tegretol PS Novartis Sector: Initial or Prolonged Positive Pharma 200-800 mg/d 33120MIN Arthralgia Tegretol SS Novartis Sector: C-Reactive Protein Pharma 200-800 mg/d Increased Tegretol SS Novartis Sector: Cough Pharma NO TREATMENT 14400MIN Dna Antibody Positive Seroquel SS 400-475 mg/d Dysthymic Disorder Seropram C Hyponatraemia Eltroxin C Localised Oedema Cyclo-Premella C 75 DAY Myalgia Polyarthritis Pyrexia Systemic Lupus Erythematosus Date:03/12/04ISR Number: 4317135-4Report Type:Expedited (15-DaCompany Report #2004UW04322 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depressed Level Of Foreign Seroquel PS Intervention to Consciousness Health Prevent Permanent Loss Of Consciousness Professional Impairment/Damage Sinus Tachycardia Other Suicide Attempt Date:03/12/04ISR Number: 4317146-9Report Type:Expedited (15-DaCompany Report #2003AP04510 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Foreign Seroquel PS ORAL 25 MG TID PO Intervention to Glycosylated Haemoglobin Study Risperdal C Prevent Permanent Increased Health Akineton C Impairment/Damage Hyperphagia Professional Lullan C Polydipsia Other Lodopin C Amaryl C Rohypnol C Date:03/12/04ISR Number: 4317172-XReport Type:Expedited (15-DaCompany Report #2004UW04091 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Seroquel PS Intentional Misuse Professional Cocaine SS Date:03/12/04ISR Number: 4317485-1Report Type:Expedited (15-DaCompany Report #2004UW04222 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Seroquel PS Intervention to Professional Clozapine SS Prevent Permanent Motrin C Impairment/Damage Vistaril C 22-Feb-2006 08:31 AM Page: 934 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/04ISR Number: 4317489-9Report Type:Expedited (15-DaCompany Report #2004UW04321 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pancreatitis Necrotising Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:03/15/04ISR Number: 4318107-6Report Type:Expedited (15-DaCompany Report #2004UW04214 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS Professional Depakote C Date:03/15/04ISR Number: 4318407-XReport Type:Expedited (15-DaCompany Report #2004UW03376 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel PS Intervention to Leukopenia Study Clozaril SS Prevent Permanent Neutropenia Health Topamax SS Impairment/Damage Professional Lamotrigine C Other Epival C Date:03/15/04ISR Number: 4318715-2Report Type:Expedited (15-DaCompany Report #2004UW03398 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Granulocytopenia Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Literature PO Prevent Permanent Health Clozaril SS Impairment/Damage Professional Other Date:03/16/04ISR Number: 4319142-4Report Type:Expedited (15-DaCompany Report #2004PK00169 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Seroquel PS 400 MG DAILY Initial or Prolonged Positive Health PO C-Reactive Protein Professional Seroquel SS 450 MG DAILY Increased Other PO Complement Factor C4 Seroquel SS 475 MG DAILY Decreased PO Cough Tegretol SS 800 MG DAILY Drug Interaction PO Homans' Sign Tegretol SS 200 MG DAILY Hyponatraemia PO Myalgia Tegretol SS 400 MG DAILY Oedema Peripheral PO Systemic Lupus Tegretol SS 600 MG DAILY Erythematosus PO Seropram SS 60 MG DAILY PO Eltroxin SS 0.1 MG DAILY Tolvon SS 90 MG DAILY 22-Feb-2006 08:31 AM Page: 935 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cyclo-Premella SS 0.625 MG DAILY Date:03/16/04ISR Number: 4319331-9Report Type:Expedited (15-DaCompany Report #2004UW04321 Age:32 YR Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pancreatitis Necrotising Foreign Seroquel PS ORAL 400 MG DAILY Intervention to Health PO 6 MON Prevent Permanent Professional Epival SS Impairment/Damage Other Cisapride C Haldol C Paxil C Losec C Clozaril C Date:03/16/04ISR Number: 4319334-4Report Type:Expedited (15-DaCompany Report #2004UW04316 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Foreign Seroquel PS ORAL 50 MG TID PO Intervention to Hypoaesthesia Health Ativan C Prevent Permanent Speech Disorder Professional Epival C Impairment/Damage Tongue Paralysis Other Date:03/16/04ISR Number: 4319335-6Report Type:Expedited (15-DaCompany Report #2004GB00561 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS OVER THE 750 Intervention to Health MG BNF GUIDE Prevent Permanent Professional Impairment/Damage Other Date:03/16/04ISR Number: 4319910-9Report Type:Expedited (15-DaCompany Report #2004UW04402 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Seroquel PS ORAL 50 MG BID PO Initial or Prolonged Pelvic Fracture Professional Upper Limb Fracture Date:03/16/04ISR Number: 4319911-0Report Type:Expedited (15-DaCompany Report #2004UW01599 Age:44 YR Gender:Male I/FU:F Outcome PT Life-Threatening Agitation Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Required Confusional State Intervention to Dehydration Prevent Permanent Drug Withdrawal Syndrome Impairment/Damage Dyspnoea Hypotension Muscle Rigidity Neuroleptic Malignant 22-Feb-2006 08:31 AM Page: 936 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Renal Failure Restlessness Sepsis Report Source Product Role Manufacturer Route Dose Duration Temperature Regulation Health Seroquel PS ORAL 25 MG DAILY Disorder Professional PO Seroquel SS ORAL 50 MG DAILY PO Seroquel SS ORAL 100 MG DAILY PO Haldol "Janssen" SS INTRAMUSCULAR 1 MG ONCE IM Benzodiazepine SS Mellaril C Trilafon C Triavil C Xanax C Date:03/17/04ISR Number: 4318127-1Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0411363A Age:47 YR Gender:Male I/FU:F Outcome PT Death Abdominal Pain Anger Anuria Arrhythmia Asthenia Bilirubin Conjugated Increased Blood Calcium Increased Blood Chloride Decreased Blood Creatine Phosphokinase Increased Blood Phosphorus Increased Blood Potassium Increased Blood Sodium Decreased Blood Test Abnormal Cardiac Arrest Cardiomegaly Chest Pain Confusional State Cough Cyanosis Decreased Appetite Disturbance In Attention Drug Ineffective Dyspnoea Electrocardiogram Qrs Complex Prolonged Fatigue Feeling Abnormal Flat Affect Headache Heart Rate Increased Hyperhidrosis Hyperthermia Malignant Hyperventilation Hypoglycaemia Hypotension Irritability Leukocytosis 22-Feb-2006 08:31 AM Page: 937 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Memory Impairment Micturition Frequency Decreased Report Source Product Role Manufacturer Route Dose Duration Neck Pain Other Parnate PS Glaxosmithkline ORAL 10MG Three Neuroleptic Malignant times per day Syndrome Seroquel SS 300MG Twice Pulmonary Hypertension per day Pulse Absent Clozapine C Pyrexia Effexor C Restlessness Zyprexa C 10MG At night Tachycardia Risperdal C Tremor Ventricular Hypertrophy Date:03/17/04ISR Number: 4320297-6Report Type:Expedited (15-DaCompany Report #2004UW04395 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Lens Disorder Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:03/17/04ISR Number: 4320451-3Report Type:Expedited (15-DaCompany Report #2004UW04726 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Embolism Health Seroquel PS 2 MON Required Professional Intervention to Prevent Permanent Impairment/Damage Date:03/17/04ISR Number: 4320452-5Report Type:Expedited (15-DaCompany Report #2004UW04522 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Seroquel PS Neutropenia Professional Depakote C Weight Increased Date:03/17/04ISR Number: 4320539-7Report Type:Expedited (15-DaCompany Report #2004UW04364 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Health Seroquel PS ORAL 150 MG DAILY Intervention to Electrocardiogram Qt Professional PO Prevent Permanent Corrected Interval Fluoxetine SS Impairment/Damage Prolonged Olanzapine C Date:03/17/04ISR Number: 4320543-9Report Type:Expedited (15-DaCompany Report #2004UW04412 Age:13 YR Gender:Female I/FU:I Outcome Other Required 22-Feb-2006 08:31 AM Page: 938 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 Disturbance In Attention Consumer Seroquel PS Educational Problem Serzone SS ORAL 200 MG PO Medication Error Mood Swings Somnolence Date:03/18/04ISR Number: 4319075-3Report Type:Direct Company Report #CTU 214707 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Disorientation Quetiapine 25 Mg Intervention to Dizziness Astrazeneca PS Astrazeneca ORAL 25 MG QHS Prevent Permanent Headache ORAL Impairment/Damage Micturition Urgency Divalproen C Neuroleptic Malignant Hctz C Syndrome Lisinopril C Night Sweats Urine Output Decreased Date:03/19/04ISR Number: 4320500-2Report Type:Direct Company Report #CTU 214790 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Seroquel 25mg PS ORAL 25MG TID ORAL Initial or Prolonged Confusional State Lipitor C Disorientation Plavix C Asa C Hytrin C Date:03/19/04ISR Number: 4322211-6Report Type:Expedited (15-DaCompany Report #2004UW04894 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Mania Health Professional Other Date:03/19/04ISR Number: 4322213-XReport Type:Expedited (15-DaCompany Report #2004UW04893 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Mania Health Professional Other Date:03/22/04ISR Number: 4320628-7Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12462453 Age:70 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 939 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability PT Report Source Product Role Manufacturer Route Dose Duration Agitation Maxipime For Inj PS Bristol-Myers Squibb Confusional State Company INTRAVENOUS Cough Madopar SS ORAL 150 mg/37.5 Hallucination, Visual mg daily Heart Rate Increased Seroquel SS ORAL Insomnia Buprenorphine SS TRANSDERMAL patch Ischaemic Stroke Asa C ORAL duration Mitral Valve Incompetence "months" Oxygen Saturation Acetaminophen C ORAL "weeks" Decreased Vitamin B C ORAL "months" Persecutory Delusion Thiamine C ORAL "Months" Productive Cough Alendronate C ORAL "Months" Calcium + Vitamin D C ORAL 1000 mg/ 800 UI daily for "months" Date:03/22/04ISR Number: 4324763-9Report Type:Expedited (15-DaCompany Report #2004AP01504 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Seroquel PS ORAL 500 MG PO Health Linton C Professional Tasmolin C Other Levotomin C Propitan C Flunitrazepam C Benzalin C Sennoside A C Date:03/23/04ISR Number: 4323622-5Report Type:Expedited (15-DaCompany Report #2004PK00363 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 400 MG DAILY Intervention to Health PO Prevent Permanent Professional Sepram C Impairment/Damage Other Hypnorex C Date:03/23/04ISR Number: 4323710-3Report Type:Expedited (15-DaCompany Report #2004UW04395 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Lens Disorder Health PO Prevent Permanent Professional Seroquel SS ORAL 200 MG BID PO Impairment/Damage Other Fluoxetine C Haloperidol C Date:03/23/04ISR Number: 4323741-3Report Type:Expedited (15-DaCompany Report #2004GB00663 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Other Neutropenia Foreign Health 22-Feb-2006 08:31 AM Page: 940 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 300 MG BID PO Date:03/23/04ISR Number: 4323742-5Report Type:Expedited (15-DaCompany Report #2004UW04888 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Mania Health Professional Other Date:03/23/04ISR Number: 4323744-9Report Type:Expedited (15-DaCompany Report #2004SE01513 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Toxic Foreign Seroquel PS Initial or Prolonged Jaundice Cholestatic Health Professional Other Date:03/23/04ISR Number: 4324593-8Report Type:Expedited (15-DaCompany Report #2004-UK-00223UK Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Combivent PS RESPIRATORY Complications Of Maternal Health (INHALATION) 8 PUFFS DAILY Exposure To Therapeutic Professional (NR, 8 PUFFS Drugs Other DAILY) IH Maternal Drugs Affecting Seroquel (Nr) SS ORAL 225 MG (NR) Foetus PO Pregnancy Date:03/23/04ISR Number: 4325772-6Report Type:Expedited (15-DaCompany Report #2004UW02844 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Status Epilepticus Health Seroquel PS 25 TO 75 MG Initial or Prolonged Professional PER DAY Neurontin C Lexapro C Pamelor C Ultram C Date:03/25/04ISR Number: 4327527-5Report Type:Expedited (15-DaCompany Report #2004PK00142 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram T Wave Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Amplitude Decreased Health PO Ventricular Extrasystoles Professional Ergenyl C Other L-Thyroxin C Lasix C 22-Feb-2006 08:31 AM Page: 941 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/04ISR Number: 4327531-7Report Type:Expedited (15-DaCompany Report #2004UW05120 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Oculogyration Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:03/25/04ISR Number: 4327532-9Report Type:Expedited (15-DaCompany Report #2004GB00668 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diplegia Foreign Seroquel PS Intervention to Pain In Extremity Health Fluoxetine C Prevent Permanent Professional Olanzapine C Impairment/Damage Other Sertraline C Date:03/25/04ISR Number: 4327796-1Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040304325 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Ulcer Health Tramadol (Tramadol Initial or Prolonged Oesophagitis Professional Hydrochloride) Unspecified PS 150 MG Seroquel (Quetiapine Fumarate) SS ORAL 1 G, ORAL Date:03/25/04ISR Number: 4327828-0Report Type:Expedited (15-DaCompany Report #2004UW05171 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bone Marrow Depression Health Seroquel PS Intervention to Granulocytosis Professional Prevent Permanent Impairment/Damage Date:03/25/04ISR Number: 4327850-4Report Type:Expedited (15-DaCompany Report #2004AP01559 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperbilirubinaemia Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Impulsive Behaviour Health PO Overdose Professional Seroquel SS ORAL 50 MG DAILY Pyrexia Other PO Somnolence Seroquel SS ORAL 75 MG DAILY White Blood Cell Count PO Increased Seroquel SS ORAL 100 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 300 MG BID PO Seroquel SS ORAL 6000 MG ONCE PO Seroquel SS 22-Feb-2006 08:31 AM Page: 942 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/04ISR Number: 4327936-4Report Type:Expedited (15-DaCompany Report #2004AP01560 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Lactate Foreign Seroquel PS ORAL 4800 MG DAILY Initial or Prolonged Dehydrogenase Increased Health PO Required Depressed Level Of Professional Rohypnol C Intervention to Consciousness Other Depromel C Prevent Permanent Myoglobinuria Contomin C Impairment/Damage Overdose Gasmotin C Suicide Attempt Date:03/25/04ISR Number: 4327953-4Report Type:Expedited (15-DaCompany Report #2004UW05290 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Health Seroquel PS ORAL 200 MG DAILY Required Corrected Interval Professional PO Intervention to Prolonged Risperdal C Prevent Permanent Sudden Death Prolixin C Impairment/Damage Wellbutrin C Zoloft C Date:03/26/04ISR Number: 4325047-5Report Type:Direct Company Report #CTU 215364 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Quetiapine 25mg PS ORAL 25MG TID ORAL Initial or Prolonged Paranoia Hydroxyzine C Self-Injurious Ideation Imipramine C Digoxin C Lisinopril C Furosemide C Date:03/26/04ISR Number: 4326543-7Report Type:Direct Company Report #CTU 215399 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Seroquel PS 100 MG QAM/ Agitation 200 MG QPM White Blood Cell Count (AT TIME OF Decreased HOME CONSULT) Congentin C Aricept C Nizoral Cream C Date:03/29/04ISR Number: 4330031-1Report Type:Expedited (15-DaCompany Report #2004SE01561 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Seroquel PS ORAL 100 MG QD PO Hypotension Health Loss Of Consciousness Professional Other 22-Feb-2006 08:31 AM Page: 943 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/04ISR Number: 4330177-8Report Type:Expedited (15-DaCompany Report #2003AP03972 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Seroquel PS ORAL 100 MG DAILY Phosphokinase Increased Health PO Fracture Professional Cravit C Pyrexia Other Telesmin C Thrombocytopenia Risperdal C Date:03/29/04ISR Number: 4330178-XReport Type:Expedited (15-DaCompany Report #2004PK00517 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Foreign Seroquel PS ORAL 4000 MG ONCE Intervention to Increased Health PO Prevent Permanent Fatigue Professional Tegretal - Slow Impairment/Damage Gamma-Glutamyltransferase Other Release SS ORAL 600 MG ONCE Increased PO Overdose Suicide Attempt Date:03/29/04ISR Number: 4330179-1Report Type:Expedited (15-DaCompany Report #2001AP03486 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Seroquel Zeneca PS Zeneca ORAL 400 MG ONCE Initial or Prolonged Paralysis Health PO Psychotic Disorder Professional Seroquel Zeneca SS Zeneca ORAL 200 MG BID PO Tachycardia Other Premarin C Depixol C Date:03/29/04ISR Number: 4330247-4Report Type:Expedited (15-DaCompany Report #2004GB00618 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Supraventricular Foreign Seroquel PS Initial or Prolonged Tachycardia Health Professional Other Date:03/29/04ISR Number: 4331463-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304515 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Study Risperidone Initial or Prolonged Gallbladder Disorder Health (Risperidone) Headache Professional Unspecified PS 1 TABLET; 1 Hepatitis B TABLETS; 2 Hepatomegaly TABLET Vomiting Olanzapine (Olanzapine) SS 1 TABLET; 1 TABLET; 2 TABLETS Quetiapine (Quetiapine) SS 1 TABLET; 1 TABLET; 2 TABLETS 22-Feb-2006 08:31 AM Page: 944 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ziprasidone (Ziprasidone) Tablets SS 1 TABLET; 1 TABLET; 2 TABLET Perphenazine (Perphenazine) SS ONE TABLET; 1 TABLETS; 2 TABLETS Date:03/29/04ISR Number: 4331540-1Report Type:Expedited (15-DaCompany Report #2004UW05173 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Acute Myocardial Health Seroquel PS Intervention to Infarction Professional Prevent Permanent Electrocardiogram Qt Impairment/Damage Corrected Interval Prolonged Date:03/29/04ISR Number: 4331542-5Report Type:Expedited (15-DaCompany Report #2004UW05296 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Supraventricular Health Seroquel PS ORAL 1000 MG DAILY Intervention to Tachycardia Professional PO 3 DAY Prevent Permanent Depakote SS 1000 MG DAILY Impairment/Damage Effexor-Xr C Date:03/29/04ISR Number: 4331566-8Report Type:Expedited (15-DaCompany Report #2004UW05297 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Platelet Count Decreased Health Seroquel PS ORAL 150 MG DAILY Intervention to Professional PO Prevent Permanent Paxil C Impairment/Damage Lipitor C Baclofen C Bumex C Synthroid C Vicodin C Klonopin C Magnesium C Potassium C Colace C Multivitamins C Date:03/29/04ISR Number: 4331604-2Report Type:Expedited (15-DaCompany Report #2004UW05433 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatic Enzyme Increased Health Seroquel PS ORAL 100 MG HS PO 10 DAY Intervention to Jaundice Professional Thiamine C Prevent Permanent Lethargy Multivitamins C Impairment/Damage 22-Feb-2006 08:31 AM Page: 945 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/04ISR Number: 4331606-6Report Type:Expedited (15-DaCompany Report #2004UW02506 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Seroquel PS Intervention to Professional Remeron C Prevent Permanent Impairment/Damage Date:03/30/04ISR Number: 4332759-6Report Type:Expedited (15-DaCompany Report #2004AP00440 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Seroquel PS ORAL 12.5 MG DAILY Life-Threatening Bronchitis Health PO Hospitalization - Depressed Level Of Professional Seroquel SS ORAL 25 MG BID PO Initial or Prolonged Consciousness Other Seroquel SS ORAL 25 MG QID PO Dysuria Serenace C General Physical Health Deterioration Haemoglobin Decreased Hypotension Incontinence Myoglobinuria Neuroleptic Malignant Syndrome Oral Intake Reduced Renal Failure Respiratory Tract Infection Date:03/30/04ISR Number: 4333087-5Report Type:Expedited (15-DaCompany Report #USA-2003-0011987 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Health Morphine Sulfate Coma Professional (Similar To Nda Drug Toxicity Other 19-516) (Morphine Epistaxis Sulfate) Unknown PS Rectal Haemorrhage Phenytoin (Phenytoin) SS Amitriptyline (Amitriptyline) SS Sertraline (Sertraline) SS Quetiapine (Quietiapine) SS Lorazepam (Lorazepam) SS Date:03/31/04ISR Number: 4329105-0Report Type:Direct Company Report #CTU 215628 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Serzone PS ORAL 100 MG ORALLY Initial or Prolonged Confusional State BID 2 YR Depression Seroquel SS 7 DAY Medication Error Visual Disturbance 22-Feb-2006 08:31 AM Page: 946 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/04ISR Number: 4330855-0Report Type:Expedited (15-DaCompany Report #HQWYE015322MAR04 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Effexor Xr Initial or Prolonged Anger (Venlafaxine Condition Aggravated Hydrochloride, Hostility Capsule, Extended Suicidal Ideation Release) PS ORAL SEE IMAGE Seroquel (Quetiapine,) SS DAILY DOSING, Remeron (Mirtazapine) C Date:03/31/04ISR Number: 4331042-2Report Type:Expedited (15-DaCompany Report #2004UW05824 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Seroquel PS ORAL 800 MG DAILY Neuroleptic Malignant Professional PO Syndrome Seroquel SS ORAL 400 MG DAILY PO Date:03/31/04ISR Number: 4331047-1Report Type:Expedited (15-DaCompany Report #2004UW05602 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Angioneurotic Oedema Consumer Seroquel PS ORAL 400 MG DAILY Intervention to Anorexia PO Prevent Permanent Convulsion Seroquel SS 300 MG HS PO Impairment/Damage Diabetes Mellitus Avandia C Gastrooesophageal Reflux Glyburide C Disease Wellbutrin C Retinal Detachment Buspar C Salivary Hypersecretion Klonopin C Cogentin C Vitamins C Vitamin C C Date:03/31/04ISR Number: 4331048-3Report Type:Expedited (15-DaCompany Report #2004UW05478 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Skin Exfoliation Health Seroquel PS ORAL 800 MG DAILY Professional PO Date:03/31/04ISR Number: 4331081-1Report Type:Expedited (15-DaCompany Report #2004UW04726 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Embolism Health Seroquel PS 2 MON Required Professional Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 947 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/04ISR Number: 4331205-6Report Type:Expedited (15-DaCompany Report #2004AP01859 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Foreign Seroquel PS ORAL 400 MG DAILY Prolonged Health PO Hyperglycaemia Professional Risperdal C Other Magnesium Oxide C Solon C Date:04/01/04ISR Number: 4330372-8Report Type:Direct Company Report #CTU 215757 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Seroquel 200 Mg PS ORAL 400 MG BID Initial or Prolonged Blood Creatine ORAL Phosphokinase Increased Blood Glucose Increased Hyperglycaemia Oral Intake Reduced Renal Failure Acute Urinary Incontinence Date:04/01/04ISR Number: 4332143-5Report Type:Direct Company Report #CTU 215662 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Seroquel PS ORAL 75 MG HS ORAL Abnormal Macrobid SS ORAL 100 MG BID ORAL Date:04/01/04ISR Number: 4332345-8Report Type:Expedited (15-DaCompany Report #2004SE01733 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angioneurotic Oedema Foreign Seroquel PS ORAL 300 MG DAILY Urticaria Health PO Professional Alin SS ORAL 50 MG DAILY Other PO Risperdal C Largactil C Date:04/01/04ISR Number: 4332346-XReport Type:Expedited (15-DaCompany Report #2004GB00707 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:04/01/04ISR Number: 4332347-1Report Type:Expedited (15-DaCompany Report #2004SE01513 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Hospitalization - Hepatitis Toxic Foreign Initial or Prolonged Health 22-Feb-2006 08:31 AM Page: 948 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 50 MG DAILY PO Diltizem C Surgam C Madopar C Date:04/01/04ISR Number: 4332497-XReport Type:Expedited (15-DaCompany Report #2003AP03972 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Seroquel PS ORAL 100 MG DAILY Phosphokinase Increased Health PO Fracture Professional Cravit C Pyrexia Other Telesmin C Thrombocytopenia Risperdal C Gramalil C Date:04/01/04ISR Number: 4333217-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202825 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Valve Incompetence Study Risperidone Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL ORAL Phosphokinase Mb Professional Olanzapine Increased (Olanzapine) SS ORAL ORAL Cerebral Atrophy Quetiapine Electrocardiogram Q Waves (Quetiapine) SS ORAL ORAL Fall Ziprasidone Hypertension (Ziprasidone) SS ORAL ORAL Mobility Decreased Perphenazine ( Myoglobin Blood Increased Perphenazine) SS ORAL ORAL Proteinuria Lorazepam Qrs Axis Abnormal (Lorazepam) C Ventricular Extrasystoles Date:04/01/04ISR Number: 4333234-5Report Type:Expedited (15-DaCompany Report #2004UW05863 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Loss Of Consciousness Health Seroquel PS Intervention to Medication Error Professional Prevent Permanent Overdose Impairment/Damage Date:04/01/04ISR Number: 4333240-0Report Type:Expedited (15-DaCompany Report #2004UW05900 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Seroquel PS ORAL 500 MG DAILY Required Medication Error PO Intervention to Panic Attack Serzone SS ORAL 500 MG DAILY Prevent Permanent Suicidal Ideation PO 7 YR Impairment/Damage Neurontin C Skelaxin C 22-Feb-2006 08:31 AM Page: 949 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lasix C Flomax C Zocor C Lortab C Methadone C Risperdal C Xanax C Omeprazole C Date:04/01/04ISR Number: 4333255-2Report Type:Expedited (15-DaCompany Report #2004UW06043 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Seroquel PS Initial or Prolonged Skin Laceration Professional Seroquel SS ORAL 12.5 PO Zoloft C Date:04/01/04ISR Number: 4333257-6Report Type:Expedited (15-DaCompany Report #2004UW05903 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel PS ORAL 25 MG PO 1 WK Initial or Prolonged Neuroleptic Malignant Professional Prozac C Syndrome Date:04/02/04ISR Number: 4333620-3Report Type:Expedited (15-DaCompany Report #2004UW06060 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Malaise Health Seroquel PS Intervention to Multiple Drug Overdose Professional Paxil SS Prevent Permanent Tylenol With Codeine SS Impairment/Damage Date:04/02/04ISR Number: 4333621-5Report Type:Expedited (15-DaCompany Report #2004UW05737 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Seroquel PS 200 MG Initial or Prolonged Fall Professional TID-QID Mental Disorder Clozapine SS 200-300 NG Aripiprazole C Lorqzepam C Lexapro C Date:04/02/04ISR Number: 4333622-7Report Type:Expedited (15-DaCompany Report #2004UW05750 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Communication Disorder Consumer Seroquel PS ORAL 400 MG QD PO Intervention to Drug Ineffective Seroquel SS ORAL 100 MG QD PO Prevent Permanent Dyskinesia Impairment/Damage Euphoric Mood Mutism Myocardial Infarction Somnolence 22-Feb-2006 08:31 AM Page: 950 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/04ISR Number: 4333923-2Report Type:Expedited (15-DaCompany Report #HQWYE143426MAR04 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Effexor Xr Condition Aggravated (Venlafaxine Disturbance In Attention Hydrochloride, Feeling Abnormal Capsule, PS ORAL SEE IMAGE Hallucination, Auditory Seroquel Hypersomnia (Quetiapine) SS SEE IMAGE Panic Attack Zoloft (Sertraline Hydrochloride) C Zyprexa (Olanzapine) C Xanax (Alprazolam) C Date:04/05/04ISR Number: 4333243-6Report Type:Expedited (15-DaCompany Report #2004UW05928 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS Decreased Professional Depakote SS Clozaril C Date:04/05/04ISR Number: 4333924-4Report Type:Direct Company Report #CTU 215885 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Quetiapine 200 Mg Initial or Prolonged Orthostatic Decreased Tablets Astra-Zeneca PS Astra-Zeneca ORAL 200MG PO Q AM Cerebrovascular Accident 400 MG PO QHS Convulsion Diarrhoea Erosive Oesophagitis Fatigue Gastritis Gastrointestinal Haemorrhage Muscle Tightness Oesophagitis Oral Intake Reduced Pulse Abnormal Pyrexia Sedation Tooth Disorder Treatment Noncompliance Vomiting White Blood Cell Count Increased Date:04/05/04ISR Number: 4334890-8Report Type:Expedited (15-DaCompany Report #2004SE00917 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatic Failure Foreign Seroquel PS ORAL 300 MG TID PO Intervention to Health Diamicron C Prevent Permanent Professional Impairment/Damage Other 22-Feb-2006 08:31 AM Page: 951 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/04ISR Number: 4335389-5Report Type:Expedited (15-DaCompany Report #2004UW06139 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Other Seroquel PS Intervention to Cardiac Failure Clozaril SS Prevent Permanent Congestive Impairment/Damage Cardiomyopathy Leukocytosis Oedema Peripheral Phlebitis Date:04/06/04ISR Number: 4335395-0Report Type:Expedited (15-DaCompany Report #2004UW06116 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Conjunctivitis Other Seroquel PS Intervention to Granulocytopenia Depakote SS Prevent Permanent Neuroleptic Malignant Lithium SS Impairment/Damage Syndrome Loxitane SS Polyuria Risperdal SS Date:04/06/04ISR Number: 4335651-6Report Type:Expedited (15-DaCompany Report #2004UW05965 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Seroquel PS ORAL 100 MG QAM PO Initial or Prolonged Agitation Professional Seroquel SS ORAL 200 MG HS PO Haematocrit Decreased Cogentin C Haemoglobin Decreased Aricept C White Blood Cell Count Nizoral C Decreased Date:04/06/04ISR Number: 4335657-7Report Type:Expedited (15-DaCompany Report #2004AC00054 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Literature Quetiapine PS ORAL 300 MG DAILY Initial or Prolonged Psychotic Disorder Health PO Professional Risperidone C Date:04/08/04ISR Number: 4335375-5Report Type:Direct Company Report #CTU 216239 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypoglycaemia Venlafaxine PS Hospitalization - Hypotension Quetiapine SS Initial or Prolonged Lethargy Clonazepam C Overdose Respiratory Rate Increased Stress Tachycardia 22-Feb-2006 08:31 AM Page: 952 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/04ISR Number: 4336685-8Report Type:Expedited (15-DaCompany Report #2004UW06529 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Seroquel PS Initial or Prolonged Overdose Professional Sedation Date:04/08/04ISR Number: 4336686-XReport Type:Expedited (15-DaCompany Report #2004UW05171 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Toxic Health Seroquel PS Intervention to Granulation Present Professional Abilify C Prevent Permanent Impairment/Damage Date:04/08/04ISR Number: 4336756-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040306395 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Tylenol With Codeine Multiple Drug Overdose Professional (Acetaminophen/Codei ne) Unspecified PS Paxil (Paroxetine Hydrochloride) SS Seroquel (Quetiapine Fumarate) SS Date:04/08/04ISR Number: 4336939-5Report Type:Expedited (15-DaCompany Report #2004UW06455 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Seroquel PS Initial or Prolonged Blood Pressure Increased Professional Date:04/08/04ISR Number: 4336941-3Report Type:Expedited (15-DaCompany Report #2004UW06035 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abasia Consumer Seroquel PS Intervention to Dysstasia Wellbutrin SS Prevent Permanent Fall Motrin C Impairment/Damage Rhabdomyolysis Heparin C Ultram C Prednisone C Cellcept C Sleeping Pill C Date:04/08/04ISR Number: 4337543-5Report Type:Expedited (15-DaCompany Report #2004UW06405 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Seroquel PS Intervention to Rectal Haemorrhage Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 953 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/04ISR Number: 4335454-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12493342 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Abilify PS Otsuka Exposure To Therapeutic Pharmaceutical Drugs Company, Ltd. ORAL Intra-Uterine Death Seroquel SS 12.5 to 25 Maternal Drugs Affecting mg/day as Foetus needed Pregnancy Klonopin SS Lexapro SS Wellbutrin SS Date:04/09/04ISR Number: 4338324-9Report Type:Expedited (15-DaCompany Report #2004PK00582 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brief Psychotic Disorder, Foreign Seroquel PS ORAL 600 MG DAILY Initial or Prolonged With Postpartum Onset Health PO Required Condition Aggravated Professional Bromocriptin C Intervention to Other Prevent Permanent Impairment/Damage Date:04/09/04ISR Number: 4338346-8Report Type:Expedited (15-DaCompany Report #2004UW06668 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Other Date:04/09/04ISR Number: 4338348-1Report Type:Expedited (15-DaCompany Report #2004AP01560 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Foreign Seroquel PS ORAL 100 MG DAILY Hospitalization - Atelectasis Health PO Initial or Prolonged Depressed Level Of Professional Seroquel SS ORAL 100 MG BID PO Consciousness Other Seroquel SS ORAL 100 MG TID PO Feeling Abnormal Seroquel SS ORAL 200 MG BID PO Headache Seroquel SS ORAL 500 MG PO Irritability Seroquel SS ORAL 200 MG BID PO Loss Of Consciousness Seroquel SS ORAL 4800 MG PO Malaise Depromel SS ORAL 75 MG DAILY Overdose PO Renal Failure Acute Depromel SS ORAL 900 MG PO Rhabdomyolysis Contomin SS ORAL 25 MG DAILY Social Avoidant Behaviour PO Somnolence Contomin SS ORAL 300 MG PO Suicidal Ideation Contomin SS ORAL 25 MG PO Suicide Attempt Rohypnol C Gasmotin C 22-Feb-2006 08:31 AM Page: 954 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/04ISR Number: 4338352-3Report Type:Expedited (15-DaCompany Report #2004PK00605 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Foreign Seroquel PS UP TO 500 MG Hospitalization - Immeasurable Literature Trimipramin-Neuraxph Initial or Prolonged Blood Pressure Systolic Health arm SS UP TO 2000 MG Decreased Professional Valproat Neuraxpharm C Bradypnoea Other Coma Conduction Disorder Drug Effect Decreased Drug Interaction Drug Toxicity Electrocardiogram Qrs Complex Prolonged Hypotonia Metabolic Acidosis Shock Sinus Tachycardia Suicide Attempt Date:04/09/04ISR Number: 4338374-2Report Type:Expedited (15-DaCompany Report #2004AP01559 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperbilirubinaemia Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Overdose Health PO Pyrexia Professional Seroquel SS ORAL 50 MG DAILY Somnolence Other PO White Blood Cell Count Seroquel SS ORAL 75 MG DAILY Increased PO Seroquel SS ORAL 100 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 300 MG BID PO Seroquel SS ORAL 6000 MG ONCE PO Seroquel SS ORAL 300 MG ONCE PO Seroquel SS ORAL 600 MG DAILY PO Silece C Date:04/09/04ISR Number: 4338376-6Report Type:Expedited (15-DaCompany Report #2004AP01695 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Seroquel PS ORAL 100 MG BID PO Hypotension Health Akineton C Hypothermia Professional Impromen C Ketoacidosis Other Betazol C Otorrhoea Pyrexia Shock Swelling Face Vomiting 22-Feb-2006 08:31 AM Page: 955 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/04ISR Number: 4338377-8Report Type:Expedited (15-DaCompany Report #2003SE05306 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Foreign Seroquel PS ORAL 300 MG DAILY Hospitalization - Bradycardia Health PO Initial or Prolonged Electrocardiogram Qt Professional Cipramil C Prolonged Other Grand Mal Convulsion Hypokalaemia Overdose Psychotic Disorder Suicide Attempt Torsade De Pointes Ventricular Extrasystoles Date:04/09/04ISR Number: 4338386-9Report Type:Expedited (15-DaCompany Report #2004UW04395 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Foreign Seroquel PS ORAL 900 MG DAILY Intervention to Health PO 30 MON Prevent Permanent Professional Fluoxetine C Impairment/Damage Other Haldol C Glyburide C Date:04/09/04ISR Number: 4338388-2Report Type:Expedited (15-DaCompany Report #2004SE01815 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Foreign Seroquel PS Initial or Prolonged Health Professional Other Date:04/09/04ISR Number: 4338664-3Report Type:Expedited (15-DaCompany Report #2004UW00162 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Study Seroquel PS Required Cardiac Arrest Health Toprol Xl C Intervention to Overdose Professional Prevent Permanent Impairment/Damage Date:04/09/04ISR Number: 4338665-5Report Type:Expedited (15-DaCompany Report #2004UW06521 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diaphragmatic Paralysis Consumer Seroquel PS ORAL 100 MG QID PO Intervention to Seroquel SS ORAL 200 MG HS PO Prevent Permanent Zoloft C Impairment/Damage Lipitor C Hydrochlorothiazide C Prozac C Prilosec C Celebrex C Levaquin C 22-Feb-2006 08:31 AM Page: 956 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albuterol C Date:04/09/04ISR Number: 4342125-5Report Type:Periodic Company Report #03P-163-0231324-00 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Depakote (Divalproex Initial or Prolonged Increased Professional Sodium) (Divalproex Aspartate Company Sodium) PS 2 GM Aminotransferase Representative Trileptal Increased (Oxcarbazepine) SS 300 MG, AT Blood Alkaline BEDTIME Phosphatase Increased Seroquel Blood Sodium Decreased (Quetiapine) SS 600 MG, AT Condition Aggravated BEDTIME Night Sweats Haldol (Haloperidol) SS 10 MG, 1 IN 1 Oedema D Overdose Vomiting Weight Increased Date:04/09/04ISR Number: 4342137-1Report Type:Periodic Company Report #03P-163-0237507-00 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Depakote (Divalproex Professional Sodium) (Divalproex Other Sodium) PS 1500 MG Clozapine SS ORAL 400 MG, PER ORAL Risperidone SS 4 MG, 2 IN 1 D Quetiapine SS 800 MG, 1 IN 1 D Date:04/12/04ISR Number: 4337203-0Report Type:Direct Company Report #CTU 216468 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Quetiapine PS ORAL 100 MG BID ORAL Quetiapine Fumarate C Date:04/12/04ISR Number: 4337411-9Report Type:Direct Company Report #CTU 216453 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Autoimmune Disorder Seroquel 25 Mg PS ORAL 3 X 25MG Intervention to Salivary Gland DAILY ORAL Prevent Permanent Enlargement Seroquel 25mg SS ORAL 2 X 25MG Impairment/Damage DAILY ORAL Depakote Er C 22-Feb-2006 08:31 AM Page: 957 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/04ISR Number: 4339222-7Report Type:Expedited (15-DaCompany Report #2004UW06447 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Seroquel PS 50 MG AM, 25 Professional MG PM Date:04/12/04ISR Number: 4339225-2Report Type:Expedited (15-DaCompany Report #2004UW02506 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Seroquel PS Intervention to Professional Remeron C Prevent Permanent Impairment/Damage Date:04/12/04ISR Number: 4339469-XReport Type:Expedited (15-DaCompany Report #2004205770JP Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Cabaser Initial or Prolonged Delirium Literature (Cabergoline) Hallucination Health Tablet, 1-4mg PS ORAL SEE IMAGE Insomnia Professional Permax (Pergolide Nocturia Other Mesilate) SS ORAL SEE IMAGE Lebocar (Levodopa, Carbidopa, Carbidopa, Levodopa, Carbidopa, Levodopa) Tablet SS ORAL SEE IMAGE Selegiline Hydrochloride (Selegiline Hydrochloride) SS SEE IMAGE Tofranil (Imipramine Hydrochloride) SS ORAL 10 MG, ORAL Paroxetine Hydrochloride (Paroxetine Hydrochloride) SS 10 MG, Bromocriptina Dorom (Bromocriptine Mesilate, Bromocriptine Mesilate, SS ORAL SEE IMAGE Seroquel (Quetiapine) SS ORAL SEE IMAGE Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Date:04/12/04ISR Number: 4339846-7Report Type:Expedited (15-DaCompany Report #2004GB00811 Age: Gender: I/FU:I Outcome PT Report Source Other Neutropenia Foreign Health Professional 22-Feb-2006 08:31 AM Page: 958 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel PS Clozaril SS Date:04/13/04ISR Number: 4340714-5Report Type:Expedited (15-DaCompany Report #2004UW06809 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Health Seroquel PS Initial or Prolonged Professional Date:04/13/04ISR Number: 4340733-9Report Type:Expedited (15-DaCompany Report #HQWYE605910SEP03 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Metoclopramide Apathy (Metoclopramide Asthenia Hydrochloride, Condition Aggravated Tablet) PS ORAL ESI LABERLE, Dry Mouth ORAL Dysphagia Metoclopramide Dystonia (Metoclopramide) SS ORAL ORAL Essential Tremor Regland(Metocloprami Fatigue de Hydrochloride, Gastrooesophageal Reflux Tablet) SS ORAL ORAL Disease Seroquel Hallucination (Quetiapine) SS SEE IMAGE Hypersomnia Zantac (Ranitidine Insomnia Hydrochloride) C Mood Altered Drixoral Social Avoidant Behaviour (Dexbrompheniramine Speech Disorder Maleate/Pseudoephedr Tardive Dyskinesia ine Sulfate) C Throat Tightness Bayer Children'S Tongue Disorder Aspirin Weight Loss Poor (Acetylsalicylic Acid) C Ativan (Lorazepam) C Lithobid (Lithium Carbonate) C Premarin (Conjugated Estrogens) C Senokot (Senna Fruit) C Humalog (Insulin Lispro) C Effexor Xr (Venlafaxine Hydrochloride) C Verelan (Verpamil Hydrochloride) C Procardia Xl (Nifedipine) C Lantus (Insulin Glargine) C Prevacid (Lansoprazole) C 22-Feb-2006 08:31 AM Page: 959 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft (Sertraline Hydrochloride) C Detrol (Tolterodine L-Tartrate) C Neurontin (Gabapentin) C Cipro (Ciprofloxacin Hydrochloride) C Altace (Ramipril) C Prandin "Kuhn" (Repaglinide) C Maalox (Aluminium Hydroxide Gel/Magnesium Hydroxide) C Bentyl (Dicycloverine Hydrochloride) C Benadryl (Diphenhydramine Hydrochloride) C Date:04/13/04ISR Number: 4341021-7Report Type:Expedited (15-DaCompany Report #IN-JNJFOC-20040103396 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Risperidone- Blinded Initial or Prolonged Phosphatase Increased Study (Risperidone) Other Blood Bilirubin Increased Health Tablets PS ORAL 2 DOSE(S), 2 Blood Bilirubin Professional IN 1 DAY, Unconjugated Increased ORAL Blood Chloride Increased Quetiapine Diarrhoea (Quetiapine) Duodenal Ulcer Capsules SS ORAL 2 DOSE(S), 2 Eosinophilia IN 1 DAY, Haematochezia ORAL Helicobacter Infection Placebo (Placebo) Helminthic Infection Capsules SS ORAL 2 DOSE(S), 2 Hypochromic Anaemia IN 1 DAY, Jaundice ORAL Leukopenia Fefol (Capsules) Marrow Hyperplasia Fefol C Microcytic Anaemia Pain In Extremity Pallor Palpitations Stomach Discomfort Transfusion Reaction Date:04/14/04ISR Number: 4339179-9Report Type:Direct Company Report #CTU 216595 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Seroquel (300mg) Required Diabetes Mellitus (Astra-Zeneca) Intervention to Manufacturers PS Astra-Zeneca 300 MG AT Prevent Permanent BEDTIME Impairment/Damage Glucophage C Amaryl C 22-Feb-2006 08:31 AM Page: 960 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/04ISR Number: 4342268-6Report Type:Expedited (15-DaCompany Report #2004UW02498 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anticonvulsant Drug Level Health Seroquel PS ORAL 25 MG DAILY Increased Professional PO Drug Interaction Seroquel SS ORAL 50 MG DAILY Drug Toxicity PO Lethargy Seroquel SS ORAL 75 MG DAILY PO Seroquel SS ORAL 100 MG DAILY PO Seroquel SS ORAL 150 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 250 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 150 MG DAILY PO Seroquel SS ORAL 100 MG DAILY PO Seroquel SS ORAL 50 MG DAILY PO Tegretol SS Tegretol SS 1200 MG DAILY Tegretol SS 1400 MG DAILY Tegretol SS 1600 MG DAILY Tegretol SS 1800 MG DAILY Tegretol SS 2000 MG DAILY Tegretol SS 2000 MG DAILY Risperidone C Haldol C Librium C Bentyl C Bethanechol C Lithium C Nadolol C Colace C Psyllium C Synthroid C 22-Feb-2006 08:31 AM Page: 961 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/04ISR Number: 4342277-7Report Type:Expedited (15-DaCompany Report #2004UW07010 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Other Seroquel PS ORAL 25 MG BID PO Required Complete Digoxin C Intervention to Cardio-Respiratory Arrest Calcium Channel Prevent Permanent Cardioactive Drug Level Blocker C Impairment/Damage Decreased Beta Blocker C Date:04/15/04ISR Number: 4342278-9Report Type:Expedited (15-DaCompany Report #2004UW06817 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Affective Disorder Consumer Seroquel PS ORAL 25 MG DAILY Intervention to Arrhythmia PO Prevent Permanent Bronchitis Acute Impairment/Damage C-Reactive Protein Increased Chest Pain Dyspnoea Exertional Herpes Zoster Lung Neoplasm Malignant Muscle Disorder Neuroleptic Malignant Syndrome Pneumonia Tachycardia Date:04/15/04ISR Number: 4342279-0Report Type:Expedited (15-DaCompany Report #2004UW06643 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS White Blood Cell Count Professional Clozaril C Decreased Depakote C Date:04/15/04ISR Number: 4342297-2Report Type:Expedited (15-DaCompany Report #2004UW05965 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Health Seroquel PS ORAL 100 MG QAM PO Initial or Prolonged Haemoglobin Decreased Professional Seroquel SS ORAL 200 MG HS PO White Blood Cell Count Cogentin C Decreased Aricept C Nizoral C Date:04/16/04ISR Number: 4340572-9Report Type:Direct Company Report #CTU 216810 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abasia Seroquel PS Myalgia 22-Feb-2006 08:31 AM Page: 962 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/04ISR Number: 4341790-6Report Type:Expedited (15-DaCompany Report #2004UW07291 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS ORAL 50 MG TID PO Professional Ativan C Prevacid C Zosyn C Albuterol C Mephyton C Neomycin C Folic Acid C Lactulose C Nicotine Patch C Thiamin C Multivitamins C Date:04/16/04ISR Number: 4341816-XReport Type:Expedited (15-DaCompany Report #2004UW02477 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Seroquel PS Coronary Artery Professional Neurontin SS Atherosclerosis Lexapro SS Therapeutic Agent Clonazepam SS Toxicity Oxycontin C Date:04/16/04ISR Number: 4342837-3Report Type:Expedited (15-DaCompany Report #200417570BWH Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Mycelex Initial or Prolonged Drug Interaction Health (Clotrimazole) PS ORAL 30 MG, TOTAL Other Muscle Tightness Professional DAILY, ORAL Other Seroquel (Quetiapine Fumarate) SS ORAL ORAL Zyprexa C Date:04/19/04ISR Number: 4342501-0Report Type:Direct Company Report #CTU 216899 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel 300 Mg X 2 PS 2 TIME DAY Neurontin 600 Mg X 3 SS 3 TIMES DAY Date:04/19/04ISR Number: 4343430-9Report Type:Expedited (15-DaCompany Report #2004UW07234 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Seroquel PS ORAL 50 MG TID PO Intervention to Professional Ativan C Prevent Permanent Mucomyst C Impairment/Damage Reglan C Albuterol C Atrovent C Prevacid C Medrol C Actigall C 22-Feb-2006 08:31 AM Page: 963 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fentanyl C Lasix /Swe/ C Levaquin C Albumin "Behring" C Date:04/19/04ISR Number: 4343431-0Report Type:Expedited (15-DaCompany Report #2004UW07545 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS ORAL 250 MG QD PO Professional Paxil C Trileptal C Date:04/19/04ISR Number: 4343532-7Report Type:Expedited (15-DaCompany Report #200417570BWH Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Mycelex Initial or Prolonged Drug Interaction Health (Clotrimazole) PS ORAL 30 MG, TOTAL Other Muscle Tightness Professional DAILY, ORAL Other Seroquel (Quetiapine Fumarate) SS ORAL ORAL Zyprexa C Date:04/19/04ISR Number: 4343658-8Report Type:Expedited (15-DaCompany Report #2004AP02110 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Circulatory Collapse Foreign Seroquel PS ORAL 25 MG PO Intervention to Loss Of Consciousness Health Prevent Permanent Professional Impairment/Damage Other Date:04/20/04ISR Number: 4342301-1Report Type:Direct Company Report #CTU 216960 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Seroquel 100 Mg PS ORAL 100 MG Q DAY Initial or Prolonged Fall ORAL Gait Disturbance Synthroid C Hallucinations, Mixed Mobic C Tramadol C Zoloft C Lorazepam C Asa C Metoprolol C Furoseamide C Klor-Con C Nexium C Stool Softener C 22-Feb-2006 08:31 AM Page: 964 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/04ISR Number: 4342389-8Report Type:Direct Company Report #CTU 216985 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Lexapro PS LEXAPRO 15 Multiple Drug Overdose QD, OVER 1 YEAR Seroquel SS Carbamazepine SS CARBAMAZEPINE 800 QD Date:04/20/04ISR Number: 4345033-9Report Type:Expedited (15-DaCompany Report #2004SE01944 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Health PO Professional Tenox C Other Cipralex C Date:04/20/04ISR Number: 4345034-0Report Type:Expedited (15-DaCompany Report #2004GB00806 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Quetiapine PS ORAL 300 MG DAILY Initial or Prolonged Cerebrovascular Accident Health PO Dysarthria Professional Amlodipine C Haemoglobin Decreased Other Warfarin C International Normalised Captopril C Ratio Decreased Co-Dydramol C Melaena Fenofibrate C Somnolence Date:04/20/04ISR Number: 4345198-9Report Type:Expedited (15-DaCompany Report #2003AP01034 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Seroquel PS ORAL 100 MG QD PO Constipation Study Seroquel SS ORAL 50 MG TID PO Diabetes Mellitus Health Seroquel SS ORAL 100 MG TID PO Drug Ineffective Professional Ms Poultice C Hypertension Other Impromen C Myofascitis Serenace C Stress Akineton C Tension Basen C Tinea Pedis Lexotan C Toothache Risperdal C Tegretol C Lendormin C Rohypnol C Date:04/20/04ISR Number: 4345288-0Report Type:Expedited (15-DaCompany Report #2004UW07427 Age:21 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:31 AM Page: 965 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 Chest Pain Consumer Seroquel PS Drug Interaction Mycelex SS 10 MIG TID Trismus Zyprexa C Date:04/22/04ISR Number: 4345260-0Report Type:Direct Company Report #CTU 217206 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Upper Quetiapine 100 Mg Intervention to Astra Zeneca PS Astra Zeneca ORAL 100 MG PO HS Prevent Permanent Impairment/Damage Date:04/22/04ISR Number: 4347443-2Report Type:Expedited (15-DaCompany Report #2004AP01504 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Seroquel PS ORAL 500 MG DAILY Sudden Death Health PO Professional Linton C Other Tamsulosin C Levotomin C Propitan C Flunitrazepam C Benzalin C Sennoside C Date:04/22/04ISR Number: 4347654-6Report Type:Expedited (15-DaCompany Report #2004UW07442 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Seroquel PS ORAL 25 MG DAILY Professional PO Date:04/22/04ISR Number: 4347656-XReport Type:Expedited (15-DaCompany Report #2004UW07583 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Seroquel PS Professional Date:04/22/04ISR Number: 4347923-XReport Type:Expedited (15-DaCompany Report #2004UW04402 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Seroquel PS ORAL 50 MG BID PO Initial or Prolonged Pelvic Fracture Professional Upper Limb Fracture 22-Feb-2006 08:31 AM Page: 966 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/04ISR Number: 4348243-XReport Type:Expedited (15-DaCompany Report #2004UW04395 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Foreign Seroquel PS ORAL 100 MG BID PO Intervention to Lens Disorder Health Seroquel SS ORAL 800 MG DAILY Prevent Permanent Professional PO Impairment/Damage Other Fluoxetine C Haldol C Glyburide C Date:04/26/04ISR Number: 4349481-2Report Type:Expedited (15-DaCompany Report #2004AP02038 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Foreign Seroquel PS ORAL 100 MG TID PO Intervention to Increased Health Seroquel SS ORAL 150 MG TID PO Prevent Permanent Aspartate Professional Seroquel SS ORAL 50 MG TID PO Impairment/Damage Aminotransferase Other Tolopelon C Increased Lullan C Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Hyperglycaemia Date:04/26/04ISR Number: 4349488-5Report Type:Expedited (15-DaCompany Report #2004UW01286 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchospasm Health Seroquel PS ORAL 300 MG PO Initial or Prolonged Dizziness Professional Claritin-D SS ORAL 120 MG PO Other Dyspnoea Fall Headache Medication Error Muscular Weakness Nausea Pharmaceutical Product Complaint Syncope Vomiting Date:04/26/04ISR Number: 4349490-3Report Type:Expedited (15-DaCompany Report #2004UW07853 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Seroquel PS Date:04/27/04ISR Number: 4349059-0Report Type:Direct Company Report #CTU 217400 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Seroquel PS ORAL 25 MG PO HS Tic Adderall Xr C Weight Increased Adderall C 22-Feb-2006 08:31 AM Page: 967 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/04ISR Number: 4350483-0Report Type:Expedited (15-DaCompany Report #2004UW07848 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Health Seroquel PS ORAL 200 MG TID PO Initial or Prolonged Decreased Professional White Blood Cell Count Decreased Date:04/27/04ISR Number: 4350484-2Report Type:Expedited (15-DaCompany Report #2004UW07785 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Seroquel PS Initial or Prolonged Parkinson'S Disease Professional Date:04/27/04ISR Number: 4350486-6Report Type:Expedited (15-DaCompany Report #2004UW08037 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cholelithiasis Health Seroquel PS Intervention to Pancreatitis Professional Geodon C Prevent Permanent Impairment/Damage Date:04/27/04ISR Number: 4350565-3Report Type:Expedited (15-DaCompany Report #2004UW02496 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anticonvulsant Drug Level Health Seroquel PS UNSPECIFIED Intervention to Decreased Professional LOWER DOSES Prevent Permanent Drug Interaction OF SEROQUEL Impairment/Damage Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 700 MG DAILY PO Tegretol - Slow Release SS 800 MG DAILY Lithium Citrate C Chlorpromazine C Levothyroxine C Multivitamin C Pyridoxine C Vitamin E C Date:04/27/04ISR Number: 4350598-7Report Type:Expedited (15-DaCompany Report #2004UW07234 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Seroquel PS ORAL 50 MG TID PO Intervention to Pancytopenia Professional Ativan C Prevent Permanent Mucomyst C Impairment/Damage Reglan C Albuterol C Atrovent C Prevacid C Medrol C Actigall C 22-Feb-2006 08:31 AM Page: 968 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fentanyl C Lasix C Levaquin C Albumin "Behring" C Date:04/27/04ISR Number: 4350722-6Report Type:Expedited (15-DaCompany Report #DSA_24214_2004 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Foreign Tavor PS ORAL 20 MG ONCE PO Initial or Prolonged Intentional Overdose Health Seroquel SS Somnolence Professional Tachycardia Date:04/27/04ISR Number: 4351057-8Report Type:Expedited (15-DaCompany Report #2004GB00707 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 200 MG BID PO Health Diazepam C Professional Other Date:04/28/04ISR Number: 4349427-7Report Type:Expedited (15-DaCompany Report #PHBS2004DK05379 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Leponex PS Novartis Sector: Grand Mal Convulsion Pharma ORAL Seroquel SS 800 mg, BID 587 DAY Antabus C UNKNOWN 400 mg, QW3 Buspar C UNKNOWN 10 mg, BID Zoloft C UNKNOWN 100 mg, QD Oxazepam C UNKNOWN 15 mg, QD Risperdal C UNKNOWN 3 mg, BID Egazil Duretter C UNKNOWN .6 mg, BID Nozinan C UNKNOWN 50 mg, QD Date:04/29/04ISR Number: 4352793-XReport Type:Expedited (15-DaCompany Report #2004UW08031 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Health Seroquel PS Professional Alcohol C Celexa C Date:04/29/04ISR Number: 4352814-4Report Type:Expedited (15-DaCompany Report #2004UW08168 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bone Disorder Health Seroquel PS ORAL 1000 MG DAILY Intervention to Cough Professional PO Prevent Permanent Rib Fracture Impairment/Damage 22-Feb-2006 08:31 AM Page: 969 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/04ISR Number: 4352820-XReport Type:Expedited (15-DaCompany Report #2004UW04212 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Seroquel PS Initial or Prolonged Aggression Professional Date:04/29/04ISR Number: 4352822-3Report Type:Expedited (15-DaCompany Report #2004UW08038 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Health Seroquel PS Intervention to Phosphokinase Increased Professional Haldol C Prevent Permanent Hepatic Enzyme Increased Impairment/Damage Muscle Rigidity White Blood Cell Count Increased Date:04/29/04ISR Number: 4353098-3Report Type:Expedited (15-DaCompany Report #2004UW08059 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 400 MG HS PO Initial or Prolonged Aggression Health Anafranil C Food Interaction Professional Kemadrin C Other Synthroid C Date:04/29/04ISR Number: 4353100-9Report Type:Expedited (15-DaCompany Report #2004SE02195 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 800 MG BID PO Intervention to Grand Mal Convulsion Health Leponex SS ORAL 300 MG DAILY Prevent Permanent Professional PO Impairment/Damage Other Antabus C Buspar C Zoloft C Risperdal C Egazil Duretter C Nozinan C Oxazepam C Date:04/29/04ISR Number: 4353102-2Report Type:Expedited (15-DaCompany Report #2004GB00925 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Seroquel PS ORAL 300 MG DAILY Decreased Health PO White Blood Cell Count Professional Seroquel SS ORAL 450 MG DAILY Decreased Other PO Zopiclone C 22-Feb-2006 08:31 AM Page: 970 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/04ISR Number: 4353103-4Report Type:Expedited (15-DaCompany Report #2004AP02202 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocyte Count Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Decreased Health PO Haematocrit Decreased Professional Seroquel SS ORAL 50 MG DAILY Haemoglobin Decreased Other PO Red Blood Cell Count Seroquel SS ORAL 25 MG DAILY Decreased PO White Blood Cell Count Cleanal SS ORAL 1200 MG DAILY Decreased PO Date:04/29/04ISR Number: 4353110-1Report Type:Expedited (15-DaCompany Report #2004PK00259 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Foreign Seroquel PS Intervention to Increased Health Fluanxol C Prevent Permanent Aspartate Professional Olanzapin C Impairment/Damage Aminotransferase Other Melperon C Increased Ziprasidon C Gamma-Glutamyltransferase Chlorprothixen C Increased Leukopenia Date:04/29/04ISR Number: 4353111-3Report Type:Expedited (15-DaCompany Report #2004AP02184 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ano-Rectal Stenosis Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Aphthous Stomatitis Health PO Colitis Ulcerative Professional Seroquel SS ORAL 200 MG DAILY Ileus Other PO Megacolon Seroquel SS ORAL 500 MG DAILY Rectal Haemorrhage PO Subileus Seroquel SS ORAL 200 MG TID PO Lodopin C Barnetil C Neuleptil C Linton C Ferromia C Artane C Valerin C Date:04/30/04ISR Number: 4353526-3Report Type:Expedited (15-DaCompany Report #2004SE02249 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Tonsillitis Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Study PO Health Naltrexone SS ORAL 50 MG DAILY Professional PO Other 22-Feb-2006 08:31 AM Page: 971 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/04ISR Number: 4353537-8Report Type:Expedited (15-DaCompany Report #2004SE02277 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel PS ORAL 400 MG DAILY Health PO Professional Cipramil C Other Rivotril C Truxal C Date:04/30/04ISR Number: 4353676-1Report Type:Expedited (15-DaCompany Report #2004UW06257 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conjunctivitis Bacterial Health Seroquel PS ORAL 300 MG TID PO Initial or Prolonged Dehydration Professional Clozapine SS ORAL 150 MG BID PO Hypoxia Cyanocobalamin C Mental Status Changes Ferrous Sulfate C Pneumonia Senokot C Docusate C Benzatropine C Celexa C Clozapine C Haloperidol C Date:04/30/04ISR Number: 4353677-3Report Type:Expedited (15-DaCompany Report #2004UW08065 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Antinuclear Antibody Health Seroquel PS 25 MG T ID & Intervention to Positive Professional 150-200 HS Prevent Permanent Arthralgia Adderall C Impairment/Damage Blood Creatine Trileptal C Phosphokinase Increased Joint Swelling Myalgia Pain Parvovirus Infection Date:04/30/04ISR Number: 4353678-5Report Type:Expedited (15-DaCompany Report #2004UW05737 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Seroquel PS 200 MG Initial or Prolonged Fall Professional TID-QID Mental Disorder Clozaril SS 200-300 MG Abilify C Ativan C Lexapro C Date:05/03/04ISR Number: 4352546-2Report Type:Direct Company Report #CTU 2171837 Age:60 YR Gender:Male I/FU:I Outcome PT Hospitalization - Confusional State Initial or Prolonged Dysarthria Medication Error Nervous System Disorder 22-Feb-2006 08:31 AM Page: 972 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Report Source Product Role Manufacturer Route Dose Duration Seroquel (Serzone Precribed) PS ORAL 200 ,G PO BID Lithium Xl C Atenolol C Lipitor C Asa C Allopinnol C Date:05/03/04ISR Number: 4354288-6Report Type:Expedited (15-DaCompany Report #2004UW08428 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diaphragmatic Disorder Consumer Seroquel PS 25 MG PLUS Initial or Prolonged Discomfort 1.4 OF A 25 MG Ativan C Synthroid C Celexa C Date:05/03/04ISR Number: 4354408-3Report Type:Expedited (15-DaCompany Report #2004GB00950 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Foreign Seroquel PS ORAL 25 MG QD PO Intervention to Rash Health Aspirin C Prevent Permanent Urine Analysis Abnormal Professional Zoton C Impairment/Damage Other Reminyl C Date:05/03/04ISR Number: 4354412-5Report Type:Expedited (15-DaCompany Report #2004GB01012 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Health PO Professional Diazepam C Other Clozapine C Date:05/03/04ISR Number: 4354418-6Report Type:Expedited (15-DaCompany Report #2004AC00073 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Seroquel PS ORAL 300 MG BID PO Initial or Prolonged Grand Mal Convulsion Literature Nefazodone SS ORAL 200 MG BID PO Medication Error Health Lamotrigine C Overdose Professional Other Date:05/03/04ISR Number: 4354561-1Report Type:Expedited (15-DaCompany Report #2004UW04214 Age:8 YR Gender:Male I/FU:F Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 973 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Health Seroquel PS 25 MG-100 MG Neutrophil Count Professional Depakote C Decreased White Blood Cell Count Decreased Date:05/04/04ISR Number: 4355044-5Report Type:Expedited (15-DaCompany Report #2004UW08360 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Disease Progression Consumer Seroquel PS ORAL 400 MG HS PO Intervention to Myopathy Synthroid C Prevent Permanent Combivent C Impairment/Damage Prevacid C Date:05/04/04ISR Number: 4355205-5Report Type:Expedited (15-DaCompany Report #2004PK00741 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening C-Reactive Protein Foreign Seroquel PS ORAL 400 MG DAILY Hospitalization - Increased Health PO Initial or Prolonged Cholecystitis Professional Jodid C Hepatic Steatosis Other Hepatocellular Damage Hepatosplenomegaly Inflammation Lipomatosis Pancreatitis Necrotising Transaminases Increased Date:05/04/04ISR Number: 4355229-8Report Type:Expedited (15-DaCompany Report #2004SE01142 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Atrophy Foreign Seroquel PS ORAL 400 MG DAILY Status Epilepticus Health PO Professional Modecate C Other Date:05/04/04ISR Number: 4355231-6Report Type:Expedited (15-DaCompany Report #2004AP02038 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Foreign Seroquel PS ORAL 100 MG TID PO Intervention to Increased Health Seroquel SS ORAL 150 MG TID PO Prevent Permanent Aspartate Professional Seroquel SS ORAL 50 MG TID PO Impairment/Damage Aminotransferase Other Tolopelon SS Increased Lullan C Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Hyperglycaemia 22-Feb-2006 08:31 AM Page: 974 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/04ISR Number: 4355241-9Report Type:Expedited (15-DaCompany Report #2004SE01815 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Foreign Seroquel PS Initial or Prolonged Increased Health Seroquel SS ORAL 800 MG DAILY Lipids Increased Professional PO Pneumonia Other Alopam C Pulmonary Embolism Cipramil C Imovane C Date:05/05/04ISR Number: 4355242-0Report Type:Expedited (15-DaCompany Report #2004AC00073 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Seroquel PS ORAL 100 MG SID PO Initial or Prolonged Grand Mal Convulsion Literature Seroquel SS ORAL 300 MG BID PO Medication Error Health Nefazodone SS ORAL 200 MG BID PO Overdose Professional Lamotrigine C Other Date:05/05/04ISR Number: 4355248-1Report Type:Expedited (15-DaCompany Report #2004AP01859 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Foreign Seroquel PS ORAL 400 MG DAILY Prolonged Health PO Hyperglycaemia Professional Risperdal C Palpitations Other Magnesium Oxide C Tachycardia Solon C Date:05/05/04ISR Number: 4355250-XReport Type:Expedited (15-DaCompany Report #2003GB01240 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Foreign Seroquel PS ORAL 400 MG DAILY Intervention to Drug Exposure During Health PO Prevent Permanent Pregnancy Professional Impairment/Damage Pregnancy Other Date:05/06/04ISR Number: 4354635-5Report Type:Direct Company Report #CTU 218024 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Seroquel 100 Mg Hospitalization - Syndrome (Astra Zeneca) PS Astra Zeneca ORAL 100 MG PO TID Initial or Prolonged Haldol 2 Mg Tab Required (Geneva); 5 Mg/Ml Intervention to Vial American Prevent Permanent Pharmaceutical Impairment/Damage Partner SS American Pharmaceutical Partner ORAL 2 MG PO X 1, 2 MG IM X 1 Neurontin C Albuterol C Vitamin C C Aspirin C 22-Feb-2006 08:31 AM Page: 975 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan C Avelox C Colace C Duragesic C Lidaderm Patch C Myticon C Calcium C Prevacid C Synthroid C Mvi C Toprol Xl C Ultram C A & D C Zocor C Ambien C Catapres C Imodium C Minalax C Mom C Senokot C Tylenol C Date:05/06/04ISR Number: 4354636-7Report Type:Direct Company Report #CTU 218022 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Seroquel 50 Mg Hospitalization - Syndrome (Astra Zeneca) PS Astra Zeneca 50 MG QHS Initial or Prolonged Seroquel 100 Mg Required (Astra Zeneca) SS Astra Zeneca 100 MG QHS Intervention to Versed C Prevent Permanent Toradol C Impairment/Damage Demerol C Marcaine C Duramorph C Benadryl C Dilaudid C Coumadin C Ancef C Toprol Xl C Synthroid C Glucophage C Xanax C Cozaar C K-Dur C Vicodin C Ativan C Restoril C Anzemet C Durogesic Patch C Norvasc C Avelox C Catapres Tts-1 C 22-Feb-2006 08:31 AM Page: 976 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/04ISR Number: 4354661-6Report Type:Direct Company Report #CTU 218025 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Adverse Event Seroquel (1600 Mg # Congenital Anomaly Daily !!) PS ORAL 600 MG BID Other ORAL/MAINTENA Required NCE FOR LIFE 6 WK Intervention to Prevent Permanent Impairment/Damage Date:05/06/04ISR Number: 4356366-4Report Type:Expedited (15-DaCompany Report #HQWYE143426MAR04 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Effexor Xr Condition Aggravated Professional (Venlafaxine Disturbance In Attention Hydrochloride, Feeling Abnormal Capsule, PS ORAL SEE IMAGE Hallucination, Auditory Seroquel Panic Attack (Quetiapine,) SS 50 MG 1 X PER Somnolence 1 DAY Zyprexa (Olanzapine) C Xanax (Alprazolam) C Date:05/06/04ISR Number: 4356386-XReport Type:Expedited (15-DaCompany Report #2004UW07103 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Foreign Seroquel PS ORAL 800 MG, PO Required Dystonia Health Seroquel SS ORAL 700 MG PO Intervention to Speech Disorder Professional Seroquel SS ORAL 400 MG PO Prevent Permanent Tobacco User Other Zyprexa C Impairment/Damage Date:05/06/04ISR Number: 4356713-3Report Type:Expedited (15-DaCompany Report #2004AP02369 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Cardio-Respiratory Arrest Health PO Initial or Prolonged Loss Of Consciousness Professional Zyprexia C Disability Other Horizon C Akineton C Landsen C Selenase C Haloperidol C Date:05/07/04ISR Number: 4356086-6Report Type:Direct Company Report #CTU 218141 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Tylenol 1000mg PS 1 X Initial or Prolonged Medication Error ADMINISTRATIO Self-Medication N (OVER DOSE Somnolence OF ANOTHERS Vomiting MEDS) 22-Feb-2006 08:31 AM Page: 977 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Colace 100 Mg SS Geodon 40 Mg SS Mvi SS Risperidone 3 Mg SS Seroquel 100 Mg SS Sertraline 150 Mg SS Date:05/07/04ISR Number: 4356636-XReport Type:Expedited (15-DaCompany Report #2004UW08844 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Disorder Foreign Seroquel PS Intervention to Psychotic Disorder Health Clozapine SS Prevent Permanent Professional Haloperidol C Impairment/Damage Other Nozinan C Date:05/07/04ISR Number: 4356637-1Report Type:Expedited (15-DaCompany Report #2004GB01014 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Foreign Quetiapine PS ORAL 50 MG BID PO Health Donepezil C Professional Other Date:05/07/04ISR Number: 4356638-3Report Type:Expedited (15-DaCompany Report #2004SE02414 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocardial Infarction Foreign Seroquel PS ORAL 300 MG BID PO Health Paxil C Professional Akineton C Other Date:05/07/04ISR Number: 4356731-5Report Type:Expedited (15-DaCompany Report #2004UW08726 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coma Health Seroquel PS ORAL 1000 MG DAILY Intervention to Electrocardiogram Qt Professional PO Prevent Permanent Corrected Interval Depakote C Impairment/Damage Prolonged Overdose Date:05/07/04ISR Number: 4356734-0Report Type:Expedited (15-DaCompany Report #2004UW07545 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS ORAL 250 MG QD PO Professional Risperdal SS Paxil C Trileptal C 22-Feb-2006 08:31 AM Page: 978 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/04ISR Number: 4356739-XReport Type:Expedited (15-DaCompany Report #2004UW08168 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bone Neoplasm Malignant Health Seroquel PS ORAL 700 MG DAILY Intervention to Cough Professional PO Prevent Permanent Ill-Defined Disorder Trazodone C Impairment/Damage Rib Fracture Haldol C Klonopin C Date:05/07/04ISR Number: 4361167-7Report Type:Periodic Company Report #PHEH2003US10701 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Tegretol Hospitalization - Intentional Overdose Professional (Carbamazepine) PS ORAL ORAL Initial or Prolonged Tachycardia Lamictal Required "Glaxosmithkline" Intervention to (Lamotrigine) SS ORAL ORAL Prevent Permanent Seroquel(Quetiapine Impairment/Damage Fumarate) SS ORAL 50MG, ORAL Klonopin (Clonazepam) SS Date:05/10/04ISR Number: 4357379-9Report Type:Expedited (15-DaCompany Report #DSA_24214_2004 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Foreign Tavor PS ORAL 20 MG ONCE PO Initial or Prolonged Intentional Overdose Health Seroquel SS Somnolence Professional Tachycardia Other Date:05/10/04ISR Number: 4357403-3Report Type:Expedited (15-DaCompany Report #2004UW08647 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Seroquel PS ORAL 12000 MG PO Required Feeling Abnormal Other Intervention to Medication Error Prevent Permanent Overdose Impairment/Damage Self-Medication Date:05/11/04ISR Number: 4356199-9Report Type:Expedited (15-DaCompany Report #2004UW08711 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Health Seroquel PS ORAL 25 MG PO Intervention to Corrected Interval Professional Prevent Permanent Prolonged Impairment/Damage Ventricular Tachycardia 22-Feb-2006 08:31 AM Page: 979 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/04ISR Number: 4356200-2Report Type:Expedited (15-DaCompany Report #2004UW08789 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Health Seroquel PS Initial or Prolonged Hepatic Failure Professional Paxil C Date:05/11/04ISR Number: 4356201-4Report Type:Expedited (15-DaCompany Report #2000UW00375 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuropathy Peripheral Health Seroquel"Zeneca" PS Zeneca ORAL 1200 MG DAILY Intervention to Professional PO Prevent Permanent Cogentin C Impairment/Damage Klonopin C Date:05/11/04ISR Number: 4358829-4Report Type:Expedited (15-DaCompany Report #2004UW08948 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bipolar Disorder Health Seroquel PS ORAL 100 MG PO Intervention to Blood Glucose Fluctuation Professional Lithium C Prevent Permanent Condition Aggravated Tegretol C Impairment/Damage Gabitril C Date:05/11/04ISR Number: 4358939-1Report Type:Expedited (15-DaCompany Report #2004PK00782 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Decreased Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Blood Pressure Systolic Health PO Prevent Permanent Increased Professional Valium SS ORAL 25 MG DAILY Impairment/Damage Coma PO Prazina C Quilonorm Retard C Date:05/11/04ISR Number: 4358940-8Report Type:Expedited (15-DaCompany Report #2004SE00729 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colonic Haemorrhage Foreign Seroquel PS ORAL 300 MG DAILY Disseminated Health PO Intravascular Coagulation Professional Zoloft SS 50 MG DAILY Liver Disorder Other Temazepanum C Neuroleptic Malignant Ranitidinum C Syndrome Oxazepam C Pulmonary Oedema Date:05/11/04ISR Number: 4358947-0Report Type:Expedited (15-DaCompany Report #20040400291 Age: Gender: I/FU:I Outcome PT Other Agitation Craniosynostosis Drug Withdrawal Syndrome Neonatal Feeding Disorder Neonatal 22-Feb-2006 08:31 AM Page: 980 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertonia Nasal Flaring Neonatal Respiratory Report Source Product Role Manufacturer Route Dose Duration Distress Syndrome Foreign Ativan (Lorazepam) Pyrexia Other Baxter PS Seroquel (Quetiapine Fumarate) SS Date:05/12/04ISR Number: 4358858-0Report Type:Expedited (15-DaCompany Report #2004006684 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colonic Haemorrhage Foreign Zoloft (Sertraline) PS ORAL 50 MG Hospitalization - Disseminated Health (DAILY), ORAL Initial or Prolonged Intravascular Coagulation Professional Quetiapine Fumarate Other Hepatic Congestion (Quetiapine Neuroleptic Malignant Fumarate) SS ORAL 200 MG (BID), Syndrome ORAL Pulmonary Oedema Temazepam Serotonin Syndrome (Temazepam) C Ranitidine (Ranitidine) C Date:05/12/04ISR Number: 4359127-5Report Type:Expedited (15-DaCompany Report #2004GB00806 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Quetiapine PS ORAL 300 MG DAILY Initial or Prolonged Cerebrovascular Accident Health PO Dysarthria Professional Amlodipine C Haemoglobin Decreased Other Warfarin C International Normalised Captopril C Ratio Decreased Co-Dydramol C Medication Error Fenofibrate C Melaena Somnolence Transient Ischaemic Attack Date:05/12/04ISR Number: 4359276-1Report Type:Expedited (15-DaCompany Report #DSA_24302_2004 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Tavor PS ORAL 1 MG QD PO Initial or Prolonged Blood Pressure Diastolic Health Seroquel SS ORAL 25 MG QD PO Decreased Professional Seroquel SS ORAL 50 MG QD PO Bundle Branch Block Right Other Lasix SS ORAL 20 MG QD PO Heart Rate Increased Lopirin SS ORAL 25 MG QD PO Orthostatic Hypotension Acetylsalicylic Acid C Somnolence Syncope 22-Feb-2006 08:31 AM Page: 981 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/04ISR Number: 4359290-6Report Type:Expedited (15-DaCompany Report #2004050002 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Literature Carisoprodol PS ORAL 700 MG TID, Initial or Prolonged Amnesia Health PO 1 MON Required Drug Screen Positive Professional Seroquel Intervention to Drug Tolerance Increased (Quetiapine) SS ORAL 25 MG HS, PO 1 MON Prevent Permanent Loss Of Consciousness Ambien (Zolpidem Impairment/Damage Restlessness Tartrate) SS ORAL 10 MG HS, PO Zoloft (Setraline Hydrochloride) SS ORAL 200 MG HS, PO 1 MON Neurontin (Gabapentin) C ORAL 600 MG TID, PO 1 MON Ibuprofen Tablets C Date:05/12/04ISR Number: 4359656-4Report Type:Expedited (15-DaCompany Report #2004UW08966 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abasia Consumer Seroquel PS ORAL 25 MG PO Dyskinesia Seroquel SS ORAL 100 MG PO Monoplegia Cozaar C Tremor Lasix C Potassium Chloride C Coumadin "Boots" C Pravachol C Prevacid C Allegra C Mexiletine C Toprol C Lotensin C Darvocet-N C Date:05/13/04ISR Number: 4359871-XReport Type:Expedited (15-DaCompany Report #2004PK00802 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Constipation Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Drug Withdrawal Syndrome Health PO Prevent Permanent Nightmare Professional Interferon C Impairment/Damage Psychomotor Hyperactivity Other Restlessness Tic Date:05/13/04ISR Number: 4359872-1Report Type:Expedited (15-DaCompany Report #2004PK00798 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Granulocytopenia Foreign Seroquel PS ORAL 500 MG DAILY Intervention to Leukopenia Health PO Prevent Permanent Professional Seroquel SS Impairment/Damage Other Mirtazapine C Flupentixol C 22-Feb-2006 08:31 AM Page: 982 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/04ISR Number: 4359873-3Report Type:Expedited (15-DaCompany Report #2004PK00790 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 700 MG DAILY Intervention to Health PO Prevent Permanent Professional Impairment/Damage Other Date:05/13/04ISR Number: 4359945-3Report Type:Expedited (15-DaCompany Report #2004AC00102 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Literature Quetiapine PS ORAL 400 MG BID PO Intervention to Drug Effect Decreased Health Haloperidol SS 20 MG DAILY Prevent Permanent Metabolic Acidosis Professional Haloperidol SS 5 MG BID Impairment/Damage Psychotic Disorder Treatment Noncompliance Weight Decreased Weight Increased Date:05/13/04ISR Number: 4359964-7Report Type:Expedited (15-DaCompany Report #2004UW03165 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Consumer Seroquel PS 400 TO 600 MG Blood Alcohol Increased Klonopin C Coma Lexapro C Completed Suicide Thorazine C Gastrointestinal Trazodone C Haemorrhage Ambien C Multiple Drug Overdose Propoxyphene Sudden Death Napsylate C Treatment Noncompliance Synthroid C Acetaminophen W/Codeine C Contraceptive C Protonix C Antabuse C Metoclopramide C Date:05/13/04ISR Number: 4360057-3Report Type:Expedited (15-DaCompany Report #DSA_24352_2004 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Neonatal Foreign Ativan PS TRANSPLACENTAL 6 MG Q DAY Required Caesarean Section Health Seroquel SS TRANSPLACENTAL 600 MG Q DAY Intervention to Craniosynostosis Professional Prevent Permanent Drug Exposure During Other Impairment/Damage Pregnancy Drug Withdrawal Syndrome Feeding Disorder Neonatal Hypertonia Neonatal Neonatal Respiratory Distress Syndrome Pyrexia 22-Feb-2006 08:31 AM Page: 983 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/04ISR Number: 4359405-XReport Type:Direct Company Report #CTU 218698 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Somnolence Quetiapine PS 75 MG QD Initial or Prolonged Diphenhydramine SS 25 MG QID Omeprazole C Ziprasidone C Furosemide C Estrogens C Lamotrigone C Date:05/14/04ISR Number: 4360342-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500945 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Study Risperidone Initial or Prolonged Gastrointestinal Necrosis Health (Risperidone) Intestinal Ischaemia Professional Unspecified PS Mental Status Changes Olanzapine Pneumonia (Olanzapine) SS Quetiapine (Quetiapine) SS Trazodone (Trazodone) C Mvi (Multivitamins) C Feso4 (Ferrous Sulfate) C Carbamazepine (Carbamazepine) C Date:05/14/04ISR Number: 4360469-8Report Type:Expedited (15-DaCompany Report #2004UW09577 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Diabetic Coma Professional PO Lexapro C Norvasc C Diovan C Date:05/17/04ISR Number: 4360865-9Report Type:Expedited (15-DaCompany Report #2004PK00821 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Autoimmune Thyroiditis Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Body Temperature Health PO Prevent Permanent Increased Professional Seroquel SS ORAL 200 MG DAILY Impairment/Damage Drug Withdrawal Syndrome Other PO Dry Mouth Amitriptyline C Heart Rate Increased Hypothyroidism Insomnia Micturition Urgency 22-Feb-2006 08:31 AM Page: 984 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/04ISR Number: 4360867-2Report Type:Expedited (15-DaCompany Report #2004SE02609 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Foreign Seroquel PS ORAL 75 MG DAILY Life-Threatening Increased Health PO Dysarthria Professional Zyprexia SS ORAL 5 MG DAILY PO Neuroleptic Malignant Other Zyprexia SS ORAL 7.5 MG DAILY Syndrome PO Fluanxol C Date:05/17/04ISR Number: 4361928-4Report Type:Expedited (15-DaCompany Report #2004UW06455 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Seroquel PS Initial or Prolonged Agitation Professional Blood Pressure Increased Date:05/17/04ISR Number: 4362165-XReport Type:Expedited (15-DaCompany Report #2003UW09578 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Seroquel PS ORAL 2400 MG DAILY Initial or Prolonged Anxiety Health PO Required Delusion Professional Seroquel SS ORAL 900 MG DAILY Intervention to Dry Skin PO Prevent Permanent Nervousness Seroquel SS ORAL 1800 MG DAILY Impairment/Damage Overdose PO Self-Medication Benadryl C Skin Warm Lorazepam C Tachycardia Urinary Hesitation Urinary Retention Date:05/18/04ISR Number: 4362971-1Report Type:Expedited (15-DaCompany Report #2004PK00822 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel Zeneca PS Zeneca ORAL 200 MG QD PO Intentional Overdose Health Citalopram SS Professional Other Date:05/18/04ISR Number: 4362973-5Report Type:Expedited (15-DaCompany Report #2004GB01160 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Quetiapine PS ORAL 600 MG DAILY Health PO Professional Other 22-Feb-2006 08:31 AM Page: 985 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/04ISR Number: 4362975-9Report Type:Expedited (15-DaCompany Report #2004AP02671 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Seroquel PS ORAL 200 MG PO Health Professional Other Date:05/18/04ISR Number: 4363007-9Report Type:Expedited (15-DaCompany Report #ZANA001309 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Sirdalud (Tizanidine Coordination Abnormal Health Hydrochloride) PS ORAL 2-4 MG/DAY Disorientation Professional ORAL Drug Interaction Other Entumin (Clotiapine) SS ORAL 40-80 MG/DAY Gait Disturbance ORAL Lorazepam (Lorazepam) SS ORAL 4.5 MG/DAY ORAL Seroquel (Quetiapine Fumarate) SS ORAL 50-700 MG/DAY ORAL Nozinan (Levomepromazine) SS ORAL 50 MG, QD ORAL Orfiril (Valproate Sodium) SS 1000 MG/DAY Date:05/19/04ISR Number: 4361048-9Report Type:Direct Company Report #CTU 218988 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Seroquel 50mg Astra Initial or Prolonged Crying Zenica PS Astra Zenica ORAL 50 MG / NIGHT Dizziness / MOUTH Feeling Abnormal Zoloft C Vaginal Haemorrhage Nasonex C Date:05/19/04ISR Number: 4364106-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040501699 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucinations, Mixed Consumer Topamax (Topiramate) PS ORAL ORAL Initial or Prolonged Insomnia Effexor (Venlafaxine Overdose Hydrochloride) SS Seroquel (Quetiapine Fumarate) SS Date:05/20/04ISR Number: 4362617-2Report Type:Expedited (15-DaCompany Report #2004UW09918 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS ORAL 13800 MG ONCE Overdose Professional PO 22-Feb-2006 08:31 AM Page: 986 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/04ISR Number: 4365438-XReport Type:Expedited (15-DaCompany Report #2004UW09823 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Study Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Drug Effect Decreased Other PO Schizophrenia Seroquel SS ORAL 600 MG DAILY PO Date:05/20/04ISR Number: 4365791-7Report Type:Expedited (15-DaCompany Report #2004SE02414 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocardial Infarction Foreign Seroquel PS ORAL 300 MG BID PO Health Paxil C Professional Akineton C Other Date:05/21/04ISR Number: 4361390-1Report Type:Expedited (15-DaCompany Report #PHEH2004US05427 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Trileptal PS Novartis Sector: Hepatic Steatosis Pharma Seroquel SS Date:05/21/04ISR Number: 4365861-3Report Type:Expedited (15-DaCompany Report #2004AP02038 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Foreign Seroquel PS ORAL 100 MG TID PO Intervention to Increased Health Seroquel SS ORAL 150 MG TID PO Prevent Permanent Aspartate Professional Seroquel SS ORAL 50 MG TID PO Impairment/Damage Aminotransferase Other Tolopelon SS Increased Lullan C Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Hyperglycaemia Date:05/21/04ISR Number: 4365871-6Report Type:Expedited (15-DaCompany Report #2004PK00582 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Brief Psychotic Disorder, Health PO Required With Postpartum Onset Professional Seroquel SS ORAL 300 MG DAILY Intervention to Drug Ineffective Other PO Prevent Permanent Hypomania Seroquel SS ORAL 1000 MG DAILY Impairment/Damage PO Leponex Novartis C Novartis Orfiril Desitin C Desitin Bromocriptin C 22-Feb-2006 08:31 AM Page: 987 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/04ISR Number: 4368773-4Report Type:Expedited (15-DaCompany Report #2004UW08844 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Full Blood Count Foreign Seroquel PS Intervention to Decreased Health Clozapine SS Prevent Permanent Professional Celebrex SS Impairment/Damage Other Haloperidol C Nozinan C Date:05/25/04ISR Number: 4368774-6Report Type:Expedited (15-DaCompany Report #2004AP02587 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Decreased Foreign Seroquel PS ORAL 50 MG DAILY Intervention to Loss Of Consciousness Health PO Prevent Permanent Professional Impairment/Damage Other Date:05/25/04ISR Number: 4369181-2Report Type:Expedited (15-DaCompany Report #2004UW10253 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gastrointestinal Health Seroquel PS ORAL 800 MG DAILY Intervention to Haemorrhage Professional PO Prevent Permanent Pharmaceutical Product Impairment/Damage Complaint Date:05/25/04ISR Number: 4369279-9Report Type:Expedited (15-DaCompany Report #2004UW09835 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Seroquel PS Initial or Prolonged Drug Withdrawal Syndrome Professional Klonopin C Irritability Restlessness Date:05/26/04ISR Number: 4366251-XReport Type:Direct Company Report #CTU 219550 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Faecaloma Quetiapine 50 Mg Intervention to Astra-Zeneca PS Astra-Zeneca ORAL 50 MG BID Prevent Permanent ORAL Impairment/Damage Quetiapine 300 Mg Astra-Zeneca SS Astra-Zeneca ORAL 300 MG BID ORAL Aricept C Bisacodyl C Docusate Na C Folic Acid C Lexapro C Mom C Thiamine C Multi-Vit C Apap C Haloperidol C Maalox C 22-Feb-2006 08:31 AM Page: 988 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C Date:05/26/04ISR Number: 4372721-0Report Type:Expedited (15-DaCompany Report #2004UW10601 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Depakote SS Date:05/27/04ISR Number: 4369440-3Report Type:Expedited (15-DaCompany Report #2004UW10387 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Suicidal Ideation Consumer Seroquel PS ORAL 25 MG DAILY Intervention to PO Prevent Permanent Zyprexa C Impairment/Damage Zoloft C Soma C Ultram C Hydrocodone C Klonopin C Date:05/27/04ISR Number: 4370057-5Report Type:Expedited (15-DaCompany Report #2004SE02277 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel PS ORAL 400 MG DAILY Circulatory Collapse Health PO Discomfort Professional Cipramil C Dyspnoea Company Rivotril C Loss Of Consciousness Representative Truxal C Pulse Absent Other Date:05/28/04ISR Number: 4368567-XReport Type:Expedited (15-DaCompany Report #2004UW10204 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS 2-3 TABS OF Intervention to Blood Pressure Decreased Consumer 25 MG QAM AND Prevent Permanent Depressed Level Of Other 75 MG QHS Impairment/Damage Consciousness Risperidone C Dyspnoea Ativan C Musculoskeletal Stiffness Speech Disorder Upper Limb Deformity Visual Disturbance Date:05/28/04ISR Number: 4369764-XReport Type:Expedited (15-DaCompany Report #2004UW10357 Age:87 YR Gender:Male I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Blood Glucose Decreased Breath Odour Ketosis Muscle Spasms 22-Feb-2006 08:31 AM Page: 989 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychomotor Hyperactivity Screaming Report Source Product Role Manufacturer Route Dose Duration Consumer Seroquel PS ORAL 25 MG QD PO Date:05/28/04ISR Number: 4369765-1Report Type:Expedited (15-DaCompany Report #2004UW08038 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Seroquel PS Initial or Prolonged Phosphokinase Increased Professional Haldol "Janseen" C Blood Glucose Increased Hepatic Enzyme Increased Muscle Rigidity White Blood Cell Count Increased Date:06/01/04ISR Number: 4367870-7Report Type:Direct Company Report #CTU 219804 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Seroquel 100 Mg Initial or Prolonged Back Injury Astro/Zenica PS Astro/Zenica ORAL 100 MG AM Contusion ORAL Delirium Seroquel 200 Mg Fall Astro/Zenica SS Astro/Zenica ORAL 200 MG PM Head Injury ORAL Joint Injury Venlafaxine Xr C Limb Injury Divalproex C Neck Injury Paroxetine C Nightmare Hydroxyzine C Polytraumatism Treatment Noncompliance Wound Date:06/01/04ISR Number: 4367884-7Report Type:Direct Company Report #CTU 219792 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Seroquel 200 Mg Astra Zeneca PS Astra Zeneca ORAL 200 MG 2 X DAILY ORAL Seroquel 200 Mg Astra Zeneca SS Astra Zeneca Date:06/01/04ISR Number: 4370778-4Report Type:Expedited (15-DaCompany Report #2004PK00912 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Foreign Seroquel PS INCREASING Septic Shock Health DOSAGE UPTO Thrombocytopenia Professional 600 MG Other Seroquel SS ORAL 600 MG DAILY PO 22-Feb-2006 08:31 AM Page: 990 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/04ISR Number: 4370783-8Report Type:Expedited (15-DaCompany Report #2004SE02575 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Activities Of Daily Foreign Seroquel PS <800 MG Intervention to Living Impaired Health Seroquel SS ORAL 800 MG DAILY Prevent Permanent Fatigue Professional PO Impairment/Damage Sinus Tachycardia Other Seroquel SS ORAL 1000 MG DAILY PO Seroquel SS ORAL 1400 MG DAILY PO Seroquel SS ORAL 1000 MG DAILY PO Date:06/02/04ISR Number: 4372205-XReport Type:Expedited (15-DaCompany Report #2004SE02910 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Foreign Quetiapine PS ORAL 300 MG DAILY Initial or Prolonged Cytolytic Hepatitis Health PO Hypercholesterolaemia Professional Chlordimethyldiazepa Hypertriglyceridaemia Other m C Lipid Metabolism Disorder Lormetazepam C Neuleptil C Date:06/02/04ISR Number: 4372211-5Report Type:Expedited (15-DaCompany Report #2004AP02772 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Foreign Seroquel PS Glycosuria Literature Lodopin SS Glycosylated Haemoglobin Health Barnetil SS Increased Professional Contomin SS Urine Ketone Body Present Other Impromen SS White Blood Cell Count Akineton SS Increased Halomonth SS Xanthoma Date:06/02/04ISR Number: 4372219-XReport Type:Expedited (15-DaCompany Report #2004UW10928 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Micturition Urgency Foreign Seroquel PS ORAL 150 MG QD PO Health Seroquel SS ORAL 100 MG QD PO Professional Other Date:06/02/04ISR Number: 4372295-4Report Type:Expedited (15-DaCompany Report #2004AP02335 Age:69 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased 22-Feb-2006 08:31 AM Page: 991 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Lactate Dehydrogenase Increased Hepatic Function Abnormal Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Foreign Seroquel PS ORAL 100 MG TID PO Health Seroquel SS ORAL 100 MG DAILY Professional PO Other Lodopin SS ORAL 100 MG TID PO Lodopin SS ORAL 100 MG DAILY PO Risperdal SS ORAL 1 MG TID PO Risperdal SS ORAL 1 MG DAILY PO Tasmolin SS ORAL 3 MG DAILY PO Tasmolin SS ORAL 1 MG DAILY PO Rohypnol SS Vegetamin SS Date:06/02/04ISR Number: 4372441-2Report Type:Expedited (15-DaCompany Report #04P-087-0261443-00 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Akineton (Biperiden) Initial or Prolonged Exercise Lack Of Literature (Biperiden) PS ORAL ORAL Hyperphagia Health Lodopin (Zotepine) Inadequate Diet Professional (Zotepine) SS ORAL ORAL Type V Hyperlipidaemia Quetiapine SS ORAL ORAL Xanthoma Sultopride SS ORAL ORAL Chlorpromazine Hydrochloried SS ORAL ORAL Bromperidol SS ORAL ORAL Haloperidol Decanoate SS INTRAMUSCULAR INTRAMUSCULAR Date:06/03/04ISR Number: 4370380-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12515797 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 15 mg/day initiated March 2003; incr to 30 mg soon 1 YR Seroquel SS init 50 mg/day June 2003;100 mg/day(no date Mirtazapine C Clonazepam C Haloperidol C Date:06/03/04ISR Number: 4370422-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498341 Age:27 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 992 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Abilify PS Otsuka Neuroleptic Malignant Pharmaceutical Syndrome Company, Ltd. ORAL 2 DAY Seroquel SS Risperdal SS Effexor C Date:06/03/04ISR Number: 4373351-7Report Type:Expedited (15-DaCompany Report #2004UW11035 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Seroquel PS ORAL 25 MG QD; PO Initial or Prolonged Decreased Professional Date:06/03/04ISR Number: 4373361-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040400186 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Mycelex Troche Initial or Prolonged Drug Interaction (Clotriamazole) Other Muscle Tightness Troche PS 10 MG, 3 IN 1 DAY Seroquel (Quetiapine Fumarate) SS Zyprexa (Olanzapine) C Date:06/04/04ISR Number: 4374912-1Report Type:Expedited (15-DaCompany Report #2004AP02334 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Hyponatraemia Health PO Prevent Permanent Status Epilepticus Professional Seroquel SS ORAL 25 MG BID PO Impairment/Damage Other Seroquel SS ORAL 25 MG DAILY PO Magnesium Oxide C Amoban C Levotomin C Norvasc C Linton C Quazepam C Date:06/04/04ISR Number: 4374952-2Report Type:Expedited (15-DaCompany Report #2004PK00946 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS Health Leponex "Novartis" C Professional Other 22-Feb-2006 08:31 AM Page: 993 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/04ISR Number: 4374953-4Report Type:Expedited (15-DaCompany Report #2004PK00937 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Foreign Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Lacrimal Gland Health PO Enlargement Professional Orfiril "Desitin" SS ORAL 600 MG DAILY Parkinsonism Other PO Restless Legs Syndrome Orfiril "Desitin" SS ORAL 1050 MG DAILY PO Orfiril "Desitin" SS ORAL 1800 MG DAILY PO Orfiril "Desitin" SS ORAL 2400 MG DAILY PO Orfiril "Desitin" SS ORAL 2100 MG DAILY PO Orfiril "Desitin" SS ORAL 1800 MG DAILY PO Orfiril "Desitin" SS ORAL 1300 MG DAILY PO Orfiril "Desitin" SS ORAL 1200 MG DAILY PO Orfiril "Desitin" SS ORAL 1050 MG DAILY PO Quilonorm Retard SS 12.2 MMOL DAILY Quilonorm Retard SS 18.3 MMOL DAILY Truxal C Coaprovel C Temesta C Sortis "Goedecke" C Aspirin Protect C Date:06/07/04ISR Number: 4375484-8Report Type:Expedited (15-DaCompany Report #2004UW10950 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Health Seroquel PS ORAL 800 MG PO Intervention to White Blood Cell Count Professional Zestril C Prevent Permanent Decreased Lasix C Impairment/Damage Actos C Date:06/07/04ISR Number: 4375486-1Report Type:Expedited (15-DaCompany Report #2004UW11073 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Seroquel PS Initial or Prolonged Dependence Professional Alcohol SS Depression Sustiva SS Multiple Drug Overdose Reglan SS Myocardial Infarction Phenergan SS Suicide Attempt Viread SS Trazodone SS Depakote SS 3tc SS 22-Feb-2006 08:31 AM Page: 994 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/04ISR Number: 4376147-5Report Type:Expedited (15-DaCompany Report #2004006684 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disseminated Foreign Zoloft (Sertraline) PS ORAL 50 MG Hospitalization - Intravascular Coagulation Health (DAILY), ORAL Initial or Prolonged Enterocolitis Professional Quetiapine Fumarate Other Haemorrhagic (Quetiapine Gastrointestinal Disorder Fumarate) SS ORAL 200 MG, BID, General Physical Health ORAL Deterioration Temazepam Hepatic Congestion (Temazepam) C Hepatomegaly Ranitidine Malaise (Ranitidine) C Neuroleptic Malignant Oxazepam (Oxazepam) C Syndrome Pulmonary Oedema Serotonin Syndrome Date:06/08/04ISR Number: 4376587-4Report Type:Expedited (15-DaCompany Report #2004UW09823 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Disease Recurrence Health PO Schizophrenia Professional Seroquel SS ORAL 600 MG DAILY Underdose PO Date:06/08/04ISR Number: 4376685-5Report Type:Expedited (15-DaCompany Report #04P-163-0262263-00 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Consumer Biaxin 500mg Intervention to Aphasia Health (Biaxin) Prevent Permanent Drug Interaction Professional (Clarithromycin) Impairment/Damage Musculoskeletal Stiffness (Clarithromycin) PS ORAL 500 MG, 2 IN 1 D, PER ORAL Quetipaine SS ORAL 200 MG, 1 IN 1 D, PER ORAL Clonazepam C Date:06/09/04ISR Number: 4375987-6Report Type:Direct Company Report #CTU 220406 Age:33 YR Gender:Female I/FU:I Outcome PT Other Abdominal Pain Lower Abnormal Dreams Diarrhoea Dyspareunia Dyspepsia Feeling Hot Flatulence Hyperhidrosis Insomnia Loss Of Consciousness Pollakiuria Rhinorrhoea Sneezing Stress Incontinence 22-Feb-2006 08:31 AM Page: 995 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Prolixin SS Date:06/09/04ISR Number: 4378353-2Report Type:Expedited (15-DaCompany Report #2004UW11571 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Seroquel PS NI Trazodone C Date:06/09/04ISR Number: 4378354-4Report Type:Expedited (15-DaCompany Report #2004UW03227 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Health Seroquel PS ORAL 400 MG DAILY; Intervention to Alcohol Use Professional PO Prevent Permanent Alopecia Seroquel SS ORAL 50 MG DAILY; Impairment/Damage Asthenia PO Back Pain Effexor-Xr C Blepharospasm Soma C Body Temperature Stelazine C Decreased Mellaril C Body Temperature Increased Cheilitis Condition Aggravated Dehydration Dry Skin Emotional Disorder Epistaxis Erythema Hair Texture Abnormal Hypoaesthesia Hypotrichosis Myalgia Pruritus Pruritus Generalised Rash Rhinorrhoea Urticaria Date:06/10/04ISR Number: 4379114-0Report Type:Expedited (15-DaCompany Report #2004UW11794 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Health Seroquel PS 25 TO 50 MG Initial or Prolonged Pregnancy Professional PER DAY Pregnancy Zoloft C Premature Baby 22-Feb-2006 08:31 AM Page: 996 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/04ISR Number: 4379654-4Report Type:Expedited (15-DaCompany Report #2004SE03127 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Health PO Prevent Permanent Professional Impairment/Damage Other Date:06/14/04ISR Number: 4379660-XReport Type:Expedited (15-DaCompany Report #2004AP03100 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Seroquel PS ORAL 50 MG BID PO Health Professional Other Date:06/14/04ISR Number: 4379663-5Report Type:Expedited (15-DaCompany Report #2004SE03156 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Discomfort Foreign Seroquel PS Constipation Health Flatulence Professional Haematochezia Other Leukocytosis Date:06/14/04ISR Number: 4379910-XReport Type:Expedited (15-DaCompany Report #2004UW10470 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Foreign Seroquel PS ORAL 50 MG DAILY Intervention to Increased Health PO Prevent Permanent Aspartate Professional Seroquel SS ORAL 75 MG DAILY Impairment/Damage Aminotransferase PO Increased Seroquel SS ORAL 150 MG DAILY Coordination Abnormal PO Gamma-Glutamyltransferase Seroquel SS ORAL 250 MG DAILY Increased PO Hepatic Function Abnormal Seroquel SS ORAL 75 MG DAILY Intentional Overdose PO Migraine Without Aura Seroquel SS Luvox SS 75 MG DAILY Luvox SS 150 MG DAILY Myslee SS 10 MG DAILY Myslee SS 40 MG ONCE Zyprexa C Rohypnol C Date:06/14/04ISR Number: 4380959-1Report Type:Expedited (15-DaCompany Report #2004UW11874 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Seroquel PS Hospitalization - Syndrome Professional Initial or Prolonged 22-Feb-2006 08:31 AM Page: 997 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/04ISR Number: 4381002-0Report Type:Expedited (15-DaCompany Report #NLWYE810508JUN04 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Benign Prostatic Study Efexor Xr Hyperplasia (Venlafaxine Condition Aggravated Hydrochloride, 0) PS ORAL 75 MG 5X PER Urinary Retention 1 DAY 35 DAY Quetiapine (Quetiapine, , 0) SS ORAL 600 MG 1X PER 1 DAY 35 DAY Omnic (Tamsulosin Hydrochloride) C Date:06/15/04ISR Number: 4377778-9Report Type:Direct Company Report #CTU 220763 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Seroquel 200 Mg PS ORAL 200 MG 5 Initial or Prolonged TIMES ORAL Fluoxetine 40 Mg SS ORAL 20 MG 1 BID ORAL Topamax C Trazodone C Singulair C Nasonex C Gabitril C Date:06/15/04ISR Number: 4377917-XReport Type:Direct Company Report #CTU 220771 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Seroquel 25 Mg Movement Disorder Astrazeneca Orthostatic Hypotension Pharmaceuticals Lp PS Astrazeneca Tardive Dyskinesia Pharmaceuticals Lp ORAL 25-100MG 1X AT NIGHT ORAL Date:06/15/04ISR Number: 4380322-3Report Type:Direct Company Report #USP 56586 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel PS Astra Zeneca Rhabdomyolysis Wheelchair User Date:06/15/04ISR Number: 4381898-2Report Type:Expedited (15-DaCompany Report #2004UW07103 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Foreign Seroquel PS ORAL 800 MG PO; Required Dystonia Health 700 MG PO; Intervention to Laryngeal Disorder Professional 400 MG PO Prevent Permanent Nasopharyngeal Disorder Zyprexa C Impairment/Damage 22-Feb-2006 08:31 AM Page: 998 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/04ISR Number: 4382175-6Report Type:Expedited (15-DaCompany Report #2004036973 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acne Consumer Geodon (Ziprasidone) PS ORAL 1 IN 1 D, Initial or Prolonged Condition Aggravated ORAL Confusional State Quetiapine Fumarate Crying (Quetiapine Cyst Fumarate) SS ORAL 200 MG, ORAL Dry Mouth Gabapentin Haemorrhage (Gabapentin) C Headache Paracetamol Muscle Twitching (Paracetamol) C Nervousness Schizophrenia Weight Increased Date:06/16/04ISR Number: 4380693-8Report Type:Expedited (15-DaCompany Report #2004AP02587 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Hypotension Health PO Required Loss Of Consciousness Professional Gaster C Intervention to Other Sepamit C Prevent Permanent Pantosin C Impairment/Damage Magnesium Oxide C Date:06/17/04ISR Number: 4379740-9Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0335046A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Consumer Paroxetine PS Glaxosmithkline UNKNOWN 20MG Per day Initial or Prolonged Hypoglycaemia Quetiapine SS UNKNOWN 25MG Twice per day Gliclazide SS UNKNOWN 80MG Twice per day Ibuprofen C Glaxosmithkline UNKNOWN 400MG Three times per day Loperamide C UNKNOWN 2MG As required White Soft Paraffin C UNKNOWN Liquid Paraffin C UNKNOWN Trimovate C Glaxosmithkline TOPICAL Voltarol C Glaxosmithkline TOPICAL Chlorpheniramine C UNKNOWN 4MG Twice per day Calamine C UNKNOWN Ascorbic Acid C Glaxosmithkline UNKNOWN 500MG Per day Zinc Sulphate C Glaxosmithkline UNKNOWN 125MG Twice per day Gliclazide C UNKNOWN 80MG Twice per day Furosemide C Glaxosmithkline UNKNOWN 40MG Twice per day Paracetamol C Glaxosmithkline UNKNOWN 500MG Four times per day Allopurinol C Glaxosmithkline UNKNOWN 100MG Per day Aqueous Cream Bp C TOPICAL Carmellose Sodium C OPHTHALMIC 1DROP As 22-Feb-2006 08:31 AM Page: 999 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report directed Date:06/17/04ISR Number: 4382450-5Report Type:Expedited (15-DaCompany Report #2004AP03109 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Aspiration Foreign Seroquel PS ORAL 50 MG DAILY Health PO Professional Doral C Other Date:06/17/04ISR Number: 4382452-9Report Type:Expedited (15-DaCompany Report #2004UW10928 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Micturition Urgency Foreign Seroquel PS ORAL 150 MG QD PO Health Seroquel SS ORAL 100 MG QD PO Professional Apo-Hydro C Other Theodur C Vasotec C Alprazolam C Date:06/17/04ISR Number: 4382453-0Report Type:Expedited (15-DaCompany Report #2004PK00822 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Zeneca ORAL 200 MG QD PO Intentional Overdose Health Citalopram SS ORAL 20 MG DAILY Professional PO Other Date:06/17/04ISR Number: 4382704-2Report Type:Expedited (15-DaCompany Report #2003004038 Age:44 YR Gender:Female I/FU:F Outcome PT Hospitalization - Adenoma Benign Initial or Prolonged Anxiety Other Candidiasis Cervical Myelopathy Chromaturia Cough Diplopia Diverticulitis Dry Skin Dysphagia Dysuria Economic Problem Emotional Distress Fall Fibromyalgia Fungal Cystitis Genital Ulceration Herpes Simplex Hydronephrosis Hypertension Hypoglycaemia Hypokalaemia Increased Appetite 22-Feb-2006 08:31 AM Page: 1000 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inflammation Insomnia Irritable Bowel Syndrome Report Source Product Role Manufacturer Route Dose Duration Myositis Consumer Lipitor Neuralgia (Atorvastatin) PS 20 MG Neuropathy Quetiapine Fumarate Oedema (Quetiapine Osteopetrosis Fumarate) SS Palpitations Rofecoxib Pruritus (Rofecoxib) SS Psychomotor Hyperactivity Azithromycin Rash (Azithromycin) C Respiratory Disorder Vicodin Rhabdomyolysis (Paracetamol, Rhinitis Allergic Hydrocodone Spinal Cord Disorder Bitartrate) C Stress Incontinence Sertraline Temperature Intolerance Hydrochloride Thirst (Sertraline Urinary Tract Infection Hydrochloride) C Weight Increased Torasemide White Blood Cell Count (Torasemide) C Increased Potassium Chloride Xerosis (Potassium Chloride) C Salbutamol (Salbutamol) C Chromagen (Ascorbic Acid, Cyanocobalamin, Ferrous Fumarate, Stomach Desiccated) C Omeprazole (Omeprazole) C Estrogens Conjugated (Estrogens Conjugated) C Buspirone Hydrochloride (Buspirone Hydrochloride) C Citalopram Hydrobromide (Citalopram Hydrobromide) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Clonazepam (Clonazepam) C Prednisone (Prednisone) C Estratest Hs (Methyltestosterone, Estrogens Esterified) C Ranitidine (Ranitidine) C Furosemide (Furosemide) C Gabapentin 22-Feb-2006 08:31 AM Page: 1001 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Gabapentin) C Metaxalone (Metaxalone) C Valaciclovir Hydrochloride (Valaciclovir Hydrochloride) C Diazepam (Diazepam) C Librax (Chlordiazepoxide Hydrochloride, Clidinium Bromide) C Pseudoephedrine Hydrochloride (Pseudoephedrine Hydrochloride) C Metronidazole (Metronidazole) C Dicycloverine (Dicycloverine) C Clarithromycin (Clarithromycin) C Estrates Hs (Methyltestosterone, Estrogens Esterified) C Alprazolam (Alprazolam) C Theophylline (Theophylline) C Ketoconazole (Ketoconazole) C Histex Hc (Pseudoephedrine Hydrochloride, Hydrocodone Bitartrate, C Guaifenesin (Guaifenesin) C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Lansoprazole (Lansoprazole) C Fexofenadine Hydrochloride (Fexofenadine Hydrochloride) C Orlistat (Orlistat) C Arthrotec (Diclofenac Sodium, Misoprostol) C Aerobid-M (Flunisolide, Menthol) C 22-Feb-2006 08:31 AM Page: 1002 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/04ISR Number: 4383129-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031102715 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Study Risperidone Weight Increased Health (Risperidone) Professional Unspecified PS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS Ziprasidone (Ziprasidone) SS Perphenazine (Perphenazine) SS Date:06/18/04ISR Number: 4383227-7Report Type:Expedited (15-DaCompany Report #04P-087-0261443-00 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Akineton (Biperiden) Initial or Prolonged Type V Hyperlipidaemia Literature (Biperiden) PS ORAL 1 MG, 3 IN 1 Xanthoma Health D, ORAL Professional Lodopin (Zotepine) (Zotepine) SS ORAL 100 MG, 3 IN 1 D; ORAL Quetiapine SS ORAL 100 MG, 3 IN 1 D; ORAL Sultopride SS ORAL 600 MG, 2 IN 1 D, ORAL Chlorpromazine Hydrochloride SS ORAL 100 MG, 3 IN 1 D; ORAL Bromperidol SS ORAL 7 MG, 3 IN 1 D; ORAL Haloperidol Decanoate SS INTRAMUSCULAR 100 MG, 1 IN 1 M, INTRAMUSCULAR Date:06/18/04ISR Number: 4383433-1Report Type:Expedited (15-DaCompany Report #200412822BCC Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Foreign Aleve (Naproxen Initial or Prolonged Coordination Abnormal Other Sodium) PS Drug Abuser Quilonorm Retard Drug Interaction (Lithium Carbonate) SS ORAL 450 MG, TOTAL Drug Level Increased DAILY, ORAL Drug Toxicity Brufen (Ibuprofen) SS ORAL 1200 MG, Dysarthria TOTAL DAILY, Dysstasia ORAL Haemoconcentration Seroquel (Quetiapine Haemodialysis Fumarate) SS ORAL 25 MG, TOTAL Nervous System Disorder DAILY, ORAL Renal Failure Acute Bekunis Bisacodyl C Somnolence Novalgine C Urine Analysis Abnormal Zelmac C Buscopan C Demetrin C 22-Feb-2006 08:31 AM Page: 1003 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Panadol C Solatran C Xanax C Date:06/21/04ISR Number: 4383921-8Report Type:Expedited (15-DaCompany Report #2004UW11965 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucinations, Mixed Health Seroquel PS Initial or Prolonged Insomnia Professional Topamax SS Required Multiple Drug Overdose Effexor SS Intervention to Prevent Permanent Impairment/Damage Date:06/21/04ISR Number: 4384399-0Report Type:Expedited (15-DaCompany Report #2004AC00138 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Quetiapine PS ORAL 9000 MG PO Initial or Prolonged Agitation Literature Oxcarbazepine SS ORAL 36000 MG PO Alcohol Use Health Atomoxetine SS 1200 MG Depressed Level Of Professional Acetaminophen C Consciousness Other Salicylate C Drug Screen Positive Ethanol C Electrocardiogram Qt Corrected Interval Prolonged Intentional Overdose Intentional Self-Injury Laceration Multiple Drug Overdose Self Injurious Behaviour Somnolence Suicide Attempt Vomiting Date:06/21/04ISR Number: 4391151-9Report Type:Periodic Company Report #USA-2003-0011606 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Professional Hydrochloride Other (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS Naproxen (Naproxen) SS Trazodone (Trazodone) SS Diclofenac Sodium (Diclofenac Sodium) SS Propoxyphene (Dextropropoxyphene) SS Cogentin (Benzatropine Mesilate) SS Vistaril (Hydroxyzine 22-Feb-2006 08:31 AM Page: 1004 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Embonate) SS Zyprexa (Olanzapine) SS Sertraline (Sertraline) SS Quetiapine (Quetiapine) SS Temazepam (Temazepam) SS Acetaminophen (Paracetamol) SS Caffeine (Caffeine) SS Nicotine (Nicotine) SS Valproic Acid (Valproic Acid) SS Date:06/21/04ISR Number: 4396063-2Report Type:Periodic Company Report #USA-2003-0011073 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin PS ORAL ORAL Multiple Drug Overdose Professional Hydrocodone Other Bitartrate SS Alpazolam (Alpazolam) SS Diphenhydramine (Diphenhydramine) SS Acetaminophen (Paracetamol) SS Gemfibrozil (Gemfibrozil) SS Nadolol (Nadolol) SS Quetiapine (Quetiapine) SS Fentanyl (Fentanyl) SS Gabapentin (Gabapentin) SS Date:06/21/04ISR Number: 4398882-5Report Type:Periodic Company Report #USA-2003-0007239 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Professional Hydrochloride Other (Oxycodone Hydrochloride) PS Morphine Sulfate (Similar To Nda 19-516) (Morphine Sulfate) SS Meperidine Hydrochloride (Pethidine Hydrochloride) SS Trimethobenzamide (Trimethobenzamide) SS Quetiapine (Quetiapine) SS Citalopram (Citalopram) SS 22-Feb-2006 08:31 AM Page: 1005 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nicotine (Nicotine) SS Lidocaine (Lidocaine) SS Date:06/21/04ISR Number: 4414570-0Report Type:Periodic Company Report #USA-2003-0012008 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin Tablets Other Drug Dependence Professional (Oxycodone Multiple Drug Overdose Other Hydrochloride) PS Methadone (Methadone) SS Alprazlam (Alprazolam) SS Quetiapine (Quetiapine) SS Date:06/22/04ISR Number: 4385380-8Report Type:Expedited (15-DaCompany Report #2004UW12511 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Health Seroquel PS Intervention to Phosphokinase Increased Professional Lithium SS Prevent Permanent Drug Interaction Impairment/Damage Date:06/22/04ISR Number: 4385382-1Report Type:Expedited (15-DaCompany Report #2004UW12540 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 500 MG QD PO Decreased Professional Zyprexa C Date:06/22/04ISR Number: 4385383-3Report Type:Expedited (15-DaCompany Report #2004UW12369 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Seroquel PS ORAL 200 MG PO; Initial or Prolonged Cardiac Arrest Professional 100 MG PO Lamictal C Date:06/22/04ISR Number: 4385384-5Report Type:Expedited (15-DaCompany Report #2004UW12429 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Seroquel PS Professional Date:06/22/04ISR Number: 4385398-5Report Type:Expedited (15-DaCompany Report #2004UW09918 Age:47 YR Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS ORAL 13800 MG ONCE Overdose Professional PO 22-Feb-2006 08:31 AM Page: 1006 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/04ISR Number: 4385399-7Report Type:Expedited (15-DaCompany Report #2004AC00142 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Literature Quetiapine PS ORAL 400 MG DAILY Bipolar Disorder Health PO Condition Aggravated Professional Valproic Acid SS ORAL 1000 MG BID Dehydration PO; 2250 MG Pancreatitis Acute DAILY PO Platelet Count Decreased Haloperidol C Sudden Death Haloperidol Treatment Noncompliance Decanoate Injection C Acetaminophen C Date:06/22/04ISR Number: 4385920-9Report Type:Expedited (15-DaCompany Report #2004UW12254 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Eye Disorder Foreign Seroquel PS ORAL 200 MG TID PO Intervention to Paralysis Health Remeron Sch C Prevent Permanent Professional Impairment/Damage Other Date:06/23/04ISR Number: 4383884-5Report Type:Direct Company Report #CTU 221265 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Seroquel 300 Mg'S Disability Daily Astra Zeneca-Manufacter PS Astra-Zencea 200 MGS BEDTIME Neurontin C Paxil C Seroquel C Celexa C Date:06/23/04ISR Number: 4385795-8Report Type:Expedited (15-DaCompany Report #2004AP02671 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Seroquel PS ORAL 50 MG BID PO Health Professional Other Date:06/23/04ISR Number: 4385796-XReport Type:Expedited (15-DaCompany Report #2004AP02772 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Red Blood Cell Foreign Seroquel PS ORAL 100 MG TID PO Initial or Prolonged Sedimentation Rate Literature Lodopin SS ORAL 100 MG TID PO Increased Health Barnetil SS ORAL 600 MG BID PO White Blood Cell Count Professional Contomin SS ORAL 100 MG TID PO Increased Other Impromen SS ORAL 7 MG TID PO Xanthoma Akineton /Aus/ SS ORAL 1 MG TID PO Halomonth SS 100 MG MONTH IM 22-Feb-2006 08:31 AM Page: 1007 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/04ISR Number: 4385798-3Report Type:Expedited (15-DaCompany Report #2004AP03028 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Seroquel PS Initial or Prolonged Coma Health Depressed Level Of Professional Consciousness Other Intentional Overdose Miosis Paralysis Flaccid Suicide Attempt Date:06/25/04ISR Number: 4384971-8Report Type:Expedited (15-DaCompany Report #PHNR2004AU01096 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Tegretol PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 200 mg, QD Bradycardia Felodur Er SS ORAL 10 mg, QD Circulatory Collapse Tenormin SS ORAL 100 mg, QD Dehydration Seroquel SS ORAL 400 mg, QD 37440MIN Dizziness Lithium C Gastrointestinal Motility Largactil C Disorder Modecate C Hyperkalaemia Tazac C Hypotension Lipitor C Renal Impairment Date:06/28/04ISR Number: 4385347-XReport Type:Expedited (15-DaCompany Report #PHEH2004US04070 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Diovan PS Novartis Sector: Drug Level Increased Professional Pharma UNK, QD Drug Toxicity Alprazolam SS Overdose Paxil SS Pulmonary Congestion Seroquel SS Pulmonary Oedema Ethanol SS Ventricular Hypertrophy Date:06/28/04ISR Number: 4385443-7Report Type:Expedited (15-DaCompany Report #PHBS2004ES08155 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Trileptal PS Novartis Sector: Initial or Prolonged Asthenia Professional Pharma ORAL 600 mg/d 25920MIN Sleep Apnoea Syndrome Depakine SS ORAL 1 g/d 25920MIN Somnolence Risperdal SS ORAL 3 ml/d 25920MIN Seroquel SS ORAL 400 mg/d 25920MIN Deprax SS ORAL 100 mg/d 25920MIN Seroxat "Smithkline Beecham" SS ORAL 40 mg/d 25920MIN 22-Feb-2006 08:31 AM Page: 1008 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/04ISR Number: 4385615-1Report Type:Expedited (15-DaCompany Report #PHEH2004US06560 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Health Zelnorm PS Novartis Sector: Hospitalization - Agitation Professional Pharma ORAL 6 mg, BID Initial or Prolonged Autonomic Nervous System Effexor-Xr SS 75 mg, QD Other Imbalance Effexor-Xr SS 75 mg/qam, Blood Creatine 150 mg/qhs Phosphokinase Increased Mirapex "Boehringer Coma Ingelheim" SS 5 mg, QHS Electrocardiogram St Quetiapine SS 25 mg, BID Segment Abnormal Mirtazapine SS Electromechanical Sinemet SS UNK, TID Dissociation Duragesic SS Heart Injury Neurontin SS Hypertension Pantoprazole C Hypotension Advair C Hypoxia Lipitor C Intubation Furosemide C Leukocytosis Lantus C Lung Infiltration Plavix C Mental Status Changes Imdur C Metabolic Acidosis Allegra C Myocardial Infarction Atenolol C Myoclonus Opisthotonus Pneumonia Pneumonia Aspiration Pulmonary Oedema Renal Failure Renal Tubular Necrosis Respiratory Failure Restless Legs Syndrome Rhabdomyolysis Serotonin Syndrome Troponin Increased Date:06/28/04ISR Number: 4389102-6Report Type:Expedited (15-DaCompany Report #2004UW06035 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abasia Consumer Seroquel PS Required Dysstasia Serzone SS Intervention to Fall Wellbutrin SS Prevent Permanent Medication Error Motrin C Impairment/Damage Musculoskeletal Stiffness Heparin C Rhabdomyolysis Ultram C Prednisone C Cellcept C Sleeping Pill C Date:06/28/04ISR Number: 4389103-8Report Type:Expedited (15-DaCompany Report #2004UW10166 Age:75 YR Gender:Female I/FU:I Outcome PT Death Acute Prerenal Failure Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate 22-Feb-2006 08:31 AM Page: 1009 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Blood Alkaline Phosphatase Increased Report Source Product Role Manufacturer Route Dose Duration Disease Progression Health Seroquel PS Escherichia Urinary Tract Professional Norvasc C Infection Aspirin C Hypoxia Klonopin C Pericardial Effusion Aricept C Pneumonia Synthroid C Pneumonia Aspiration Theravite C Scleroderma Isosource C Urinary Tract Infection Beta Protein C Fungal Date:06/28/04ISR Number: 4389133-6Report Type:Expedited (15-DaCompany Report #2004AC00142 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Literature Quetiapine PS ORAL 400 MG DAILY Drug Level Increased Health PO Pancreatitis Acute Professional Valproic Acid SS ORAL 1000 MG BID Platelet Count Decreased PO Valproic Acid SS ORAL 2250 MG DAILY PO Haloperidol C Haloperidol Decanoate Injection C Acetaminophen C Date:06/28/04ISR Number: 4389521-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040604426 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Study Reminyl Initial or Prolonged Orthostatic Decreased Health (Galantamine) Cerebrovascular Disorder Professional Unspecified PS ORAL SEE IMAGE Confusional State Seroquel (Quetiapine Delirium Fumarate) Dizziness Unspecified SS ORAL ORAL Gait Disturbance Celexa (Citalopram Hallucination, Visual Hydrobromide) C Muscle Twitching Cartia Nausea (Acetylsalicylic Nervous System Disorder Acid) C Vomiting Lipitor (Atorvastatin) C Isosorbide (Isosorbide) C Lecithin (Lecithin) C Glucosamine (Glucosamine) C Colace (Docusate Sodium) C Asa (Acetylsalicylic Acid) C 22-Feb-2006 08:31 AM Page: 1010 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/04ISR Number: 4390629-1Report Type:Expedited (15-DaCompany Report #2004GB01406 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Quetiapine PS ORAL 25 MG BID PO Initial or Prolonged Drug Interaction Health Paroxetine SS 1 DF DAILY Hallucination Professional Ibuprofen C Hypoglycaemia Other Loperamide C White Soft Paraffin C Liquid Paraffin C Trimovate C Voltarol C Chlorpheniramine C Calamine C Ascorbic Acid C Zinc Sulphate C Frusemide C Paracetamol C Allopurinol C Aqueous Cream C Carmellose Sodium C Date:06/29/04ISR Number: 4386305-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12618500 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Abilify PS Otsuka Initial or Prolonged Decreased Pharmaceutical Company, Ltd. ORAL Seroquel SS Depakote C Date:06/30/04ISR Number: 4390610-2Report Type:Expedited (15-DaCompany Report #2004UW06440 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Enuresis Health Seroquel PS ORAL 50 MG PO Intervention to Somnolence Professional Flexeril C Prevent Permanent Phenergan C Impairment/Damage Prednisone C Oxycontin C Ativan C Lortab C Ultram C Date:06/30/04ISR Number: 4390611-4Report Type:Expedited (15-DaCompany Report #2004AC00147 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Lower Literature Quetiapine PS Initial or Prolonged Decreased Appetite Health Mirtazapine C Diverticulum Intestinal Professional Temazepam C Pancreatitis Acute Lansoprazole C Pancreatitis Chronic Promethazine C Pseudocyst 22-Feb-2006 08:31 AM Page: 1011 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/04ISR Number: 4415365-4Report Type:Periodic Company Report #2003031728 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Consumer Zoloft (Sertraline) PS ORAL ORAL Dyskinesia Quetiapine Fumarate Feeling Abnormal (Quetiapine Tremor Fumarate) SS Risperidone (Risperidone) SS ORAL ORAL Date:07/01/04ISR Number: 4391516-5Report Type:Expedited (15-DaCompany Report #2004UW13226 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Musculoskeletal Stiffness Health Seroquel PS Intervention to Restless Legs Syndrome Professional Prevent Permanent Impairment/Damage Date:07/01/04ISR Number: 4391732-2Report Type:Expedited (15-DaCompany Report #2003116181 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Im) Electromechanical Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Dissociation Company Quetiapine Fumarate Representative (Quetiapine Fumarate) SS 25 MG Pip/Tazo (Piperacillin Sodium, Tazobactam Sodium) C Metoprolol Tartrate (Metoprolol Tartrate) C Haloperidol (Haloperidol) C Date:07/01/04ISR Number: 4392321-6Report Type:Expedited (15-DaCompany Report #2004UW13140 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Health Seroquel PS ORAL 900 MG HS PO Initial or Prolonged Sensory Loss Professional Tardive Dyskinesia Date:07/01/04ISR Number: 4393960-9Report Type:Expedited (15-DaCompany Report #2004PK01092 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Seroquel PS ORAL 75 MG DAILY Sudden Cardiac Death Health PO Professional Seroquel SS ORAL 150 MG DAILY Other PO Seroquel SS ORAL 300 MG DAILY PO Seroquel SS ORAL 400 MG DAILY 22-Feb-2006 08:31 AM Page: 1012 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 700 MG DAILY PO Seroquel SS ORAL 800 MG DAILY PO Seroquel SS ORAL 1000 MG DAILY PO Ciatyl-Z SS 20-110 MG Ciatyl-Z SS ORAL 120 MG DAILY PO Ciatyl-Z SS ORAL 150 MG DAILY PO Ciatyl-Z SS ORAL 160 MG DAILY PO Ciatyl-Z SS ORAL 140 MG DAILY PO Ciatyl-Z SS ORAL 130 MG DAILY PO Ciatyl-Z SS ORAL 140 MG DAILY PO Ciatyl-Z SS ORAL 145 MG DAILY PO Ciatyl-Z SS ORAL 150 MG DAILY PO Ciatyl-Z SS ORAL 155 MG DAILY PO Ciatyl-Z SS ORAL 160 MG DAILY PO Ciatyl-Z SS ORAL 165 MG DAILY PO Ergenyl C Diazepam C Nexium Mups C Acc C Minirin C Glucophage C Bifiteral C Clexane C Date:07/01/04ISR Number: 4393963-4Report Type:Expedited (15-DaCompany Report #2004AP02534 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 1200 MG DAILY Neutrophil Count Health PO Decreased Professional Seroquel SS Other Venlafaxine SS Venlafaxine SS Carbamazepine SS Carbamazepine SS Mirtazapine SS Mirtazapine SS 22-Feb-2006 08:31 AM Page: 1013 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/04ISR Number: 4393964-6Report Type:Expedited (15-DaCompany Report #2004UW12254 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ophthalmoplegia Foreign Seroquel PS ORAL 200 MG TID PO Intervention to Strabismus Health Remeron /Sch/ C Prevent Permanent Professional Impairment/Damage Other Date:07/01/04ISR Number: 4393965-8Report Type:Expedited (15-DaCompany Report #2004AP03100 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Seroquel PS ORAL 50 MG BID PO Health Professional Other Date:07/01/04ISR Number: 4393967-1Report Type:Expedited (15-DaCompany Report #2004AP03278 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Seroquel PS ORAL 200 MG DAILY Required Antidepressant Drug Level Health PO Intervention to Increased Professional Seroquel SS 25 TO 50 MG Prevent Permanent Completed Suicide Other AS REQUIRED Impairment/Damage Aripiprazole C Fluvoxamine C Topiramate C Thyroxine C Seretide Allen & Hanburys Ltd C Allen & Hanburys Ltd Ventolin C Date:07/01/04ISR Number: 4393968-3Report Type:Expedited (15-DaCompany Report #2004UW12832 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Seroquel PS Health Professional Other Date:07/02/04ISR Number: 4390860-5Report Type:Direct Company Report #CTU 222008 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dry Mouth Seroquel 100 Mg PS ORAL 100 MG AT Intervention to Pharyngolaryngeal Pain BEDTIME ORAL Prevent Permanent Seroquel 25 Mg SS ORAL 100 MG AT Impairment/Damage BEDTIME ORAL Lithium C Effexor C Paxil C Lorazepam C 22-Feb-2006 08:31 AM Page: 1014 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/04ISR Number: 4392957-2Report Type:Expedited (15-DaCompany Report #2004PK01106 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coagulopathy Foreign Seroquel PS ORAL 500 MG DAILY Intervention to Drug Effect Increased Health PO Prevent Permanent Drug Interaction Professional Marcumar SS Impairment/Damage Other Ergenyl Chrono C Tavor C Date:07/02/04ISR Number: 4393852-5Report Type:Expedited (15-DaCompany Report #2004UW13449 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Health Seroquel PS Treatment Noncompliance Professional Date:07/02/04ISR Number: 4414487-1Report Type:Periodic Company Report #352306 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clonazepam Initial or Prolonged Depression Professional (Clonazepam) PS Multiple Drug Overdose Other Lamictal Tachycardia (Lamotrigine) SS ORAL ORAL 21 DAY Quetapine Fumarate (Quetapine Fumarate) SS Carbamazepine (Carbamazepine) SS Date:07/06/04ISR Number: 4394139-7Report Type:Expedited (15-DaCompany Report #2004UW13406 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Serotonin Syndrome Health Seroquel PS ORAL 400 MG BID PO Intervention to Professional Zoloft SS 150 MG Prevent Permanent Impairment/Damage Date:07/06/04ISR Number: 4394804-1Report Type:Expedited (15-DaCompany Report #2004-06-1964 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Rinderon Increased Health Like Celestone PS Aspartate Professional Salicylamide SS Aminotransferase Other Hirnamin SS Increased Akineton SS Blood Alkaline Serenace SS Phosphatase Increased Aleviatin SS Blood Bilirubin Increased Seroquel (Quetiapine Gamma-Glutamyltransferase Fumarate) SS Increased Gaster SS Liver Disorder Tegretol SS 22-Feb-2006 08:31 AM Page: 1015 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/04ISR Number: 4391464-0Report Type:Expedited (15-DaCompany Report #ES-GLAXOSMITHKLINE-B0337417A Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Seroxat PS Glaxosmithkline ORAL 40MG per day 18 DAY Initial or Prolonged Fatigue Depakine SS ORAL 1G per day 18 DAY Sleep Apnoea Syndrome Trileptal SS ORAL 600MG per day 18 DAY Somnolence Risperdal SS ORAL 3ML per day 18 DAY Seroquel SS ORAL 400MG per day 18 DAY Deprax SS ORAL 100MCG per day 18 DAY Date:07/08/04ISR Number: 4396077-2Report Type:Expedited (15-DaCompany Report #US013354 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Gabitril PS ORAL 2 MG QD ORAL 1 WK Initial or Prolonged Drug Interaction Professional Gabitril SS ORAL 4 MG QD ORAL 1 WK Flashback Company Gabitril SS ORAL 6 MG QD ORAL 1 WK Post-Traumatic Stress Representative Gabitril SS ORAL 8 MG QD ORAL 1 WK Disorder Gabitril SS ORAL 12 MG QD ORAL 1 WK Gabitril SS ORAL 16 MG QD ORAL Seroquel SS ORAL 800 MG QD ORAL Zyprexa C Remeron /Net/ C Celexa C Buspar C Coumadin "Dupont" C Lamictal "Glaxosmithkline" C Diabetic Medication C Date:07/08/04ISR Number: 4396834-2Report Type:Expedited (15-DaCompany Report #2004AP03400 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatitis Fulminant Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Neuroleptic Malignant Health PO Initial or Prolonged Syndrome Professional Lullan C Pyrexia Other Olanzapine C Acetaminophen C Haloperidol C Date:07/08/04ISR Number: 4396837-8Report Type:Expedited (15-DaCompany Report #2004SE03657 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sleep Apnoea Syndrome Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Somnolence Health PO Professional Depakine SS ORAL 1 GR DAILY PO Other Trileptal SS ORAL 600 MG DAILY PO Risperdal SS ORAL 3 MG DAILY PO Deprax SS ORAL 100 UG DAILY PO Seroxat SS ORAL 40 MG DAILY PO 22-Feb-2006 08:31 AM Page: 1016 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/04ISR Number: 4396840-8Report Type:Expedited (15-DaCompany Report #2004GB01531 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 125 MG DAILY Initial or Prolonged Transient Ischaemic Health PO Attack Professional Olanzapine C Other Date:07/08/04ISR Number: 4396842-1Report Type:Expedited (15-DaCompany Report #2004SE03816 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS Neutropenia Health Professional Other Date:07/08/04ISR Number: 4397173-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607450 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Halodol Initial or Prolonged Phosphokinase Increased Health (Haloperidol) Professional Unspecified PS SEE IMAGE Seroquel (Quetiapine Fumarate) SS ORAL SEE IMAGE Date:07/08/04ISR Number: 4397266-3Report Type:Expedited (15-DaCompany Report #2004UW13380 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Drug Level Foreign Zomig PS Initial or Prolonged Increased Health Seroquel SS ORAL 100 MG DAILY Required Depression Professional PO Intervention to Other Epival SS 1500 MG DAILY Prevent Permanent Epival SS 1375 MG DAILY Impairment/Damage Tryptophan C Effexor-Xr C Risperidone C Lopressor C Imovane C Lithium C Date:07/12/04ISR Number: 4394341-4Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12629689 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sleep Apnoea Syndrome Health Deprax PS Apothecon ORAL Initial or Prolonged Somnolence Professional Depakine SS ORAL Trileptal SS ORAL Risperdal SS ORAL Seroquel SS ORAL Seroxat SS ORAL 22-Feb-2006 08:31 AM Page: 1017 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/04ISR Number: 4395469-5Report Type:Direct Company Report #CTU 222525 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Celexa 20 Mg PS 20 MG DAY Anxiety Seraquel 25 Mg SS 25 MG 4-6 HR Formication PRN Suicidal Ideation Date:07/12/04ISR Number: 4398657-7Report Type:Expedited (15-DaCompany Report #2004PK01141 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Seroquel PS Initial or Prolonged Drug Interaction Health Reminyl SS Professional Other Date:07/12/04ISR Number: 4398659-0Report Type:Expedited (15-DaCompany Report #2004SE03695 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Seroquel PS Initial or Prolonged Accidental Overdose Other Required Convulsion Intervention to Medication Error Prevent Permanent Impairment/Damage Date:07/12/04ISR Number: 4398662-0Report Type:Expedited (15-DaCompany Report #2004SE03694 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Seroquel PS Initial or Prolonged Convulsion Other Required Medication Error Intervention to Prevent Permanent Impairment/Damage Date:07/12/04ISR Number: 4398880-1Report Type:Expedited (15-DaCompany Report #2004UW08711 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Health Seroquel PS ORAL 25 MG QD PO Intervention to Corrected Interval Professional Labetalol C Prevent Permanent Prolonged Impairment/Damage Electrocardiogram Qt Prolonged Hypotension Ventricular Tachycardia 22-Feb-2006 08:31 AM Page: 1018 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/04ISR Number: 4398881-3Report Type:Expedited (15-DaCompany Report #2004UW07202 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Ineffective Health Seroquel PS ORAL 500 MG PO Required Fall Professional Seroquel SS ORAL 400 MG PO Intervention to Loss Of Consciousness Seroquel SS ORAL 300 MG PO Prevent Permanent Orthostatic Hypotension Tylenol W/Codeine No Impairment/Damage 2 C Tylenol W/Codeine No.3 C Fluoxetine C Fosinopril C Hydrochlorothiazide C Date:07/12/04ISR Number: 4398883-7Report Type:Expedited (15-DaCompany Report #2004UW13704 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gingival Discolouration Consumer Seroquel PS ORAL 400 MG QD PO Intervention to Laceration Lortab C Prevent Permanent Nail Discolouration Klonopin C Impairment/Damage Tongue Injury Tooth Loss Date:07/12/04ISR Number: 4399255-1Report Type:Expedited (15-DaCompany Report #2004044086 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affective Disorder Health Geodon (Ziprasidone) PS ORAL 40 MG (20 MG, Initial or Prolonged Anxiety Professional 2 IN 1 D), Other Arteriosclerosis ORAL Blood Cholesterol Lipitor Increased (Atrovastatin) SS Condition Aggravated Zoloft (Sertraline) SS Depression Valproate Semisodium Eye Disorder (Valproate Fatigue Semisodium) SS Feeling Abnormal Topiramate Headache (Topiramate) SS Insomnia Quetiapine Fumarate Intentional Self-Injury (Quetiapine Medication Error Fumarate) SS 200 MG (UNK, Self-Injurious Ideation 1 IN 1 D) Suicidal Ideation Lithium Carbonate Tongue Ulceration (Lithium Carbonate) SS ORAL ORAL Treatment Noncompliance Docusate (Docusate) C Tremor Trazodone Weight Decreased (Trazodone) C Weight Increased Tocopherol (Tocopherol) C Hydroxyzine Embonate (Hydroxyzine Embonate) C Estradiol (Estradiol) C Estratest Hs (Estrogens Esterified, Methyltestosterone) C 22-Feb-2006 08:31 AM Page: 1019 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Desloratadine (Desloratadine) C Calcium (Calcium) C Centrum (Minerals Nos, Vitamins Nos) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Date:07/12/04ISR Number: 4399363-5Report Type:Expedited (15-DaCompany Report #2004043111 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Zoloft (Sertraline) PS Hospitalization - Affect Lability Quetiapine Fumarate Initial or Prolonged Affective Disorder (Quetiapine Other Anxiety Fumarate) SS Borderline Personality Disorder Completed Suicide Formication Hallucination, Auditory Heart Rate Increased Irritability Middle Insomnia Suicidal Ideation Date:07/14/04ISR Number: 4398182-3Report Type:Direct Company Report #CTU 222780 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Seroquel 25 Mg Drug Effect Decreased Astrazeneca PS Astrazeneca ORAL 25 MG QD-BID ORAL Date:07/14/04ISR Number: 4399908-5Report Type:Expedited (15-DaCompany Report #2004PK00946 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS Health Leponex C Professional Other Date:07/14/04ISR Number: 4401613-3Report Type:Expedited (15-DaCompany Report #2004044086 Age:46 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anxiety Initial or Prolonged Blood Cholesterol Other Increased Depression Eye Disorder Fatigue Feeling Abnormal Headache 22-Feb-2006 08:31 AM Page: 1020 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Intentional Self-Injury Medication Error Report Source Product Role Manufacturer Route Dose Duration Self-Injurious Ideation Health Geodon (Ziprasidone) PS ORAL 40 MG (20 MG, Suicidal Ideation Professional 2 IN 1 D), Tongue Ulceration ORAL Tremor Lipitor Weight Decreased (Atorvastatin) SS Weight Increased Zoloft (Sertraline) SS Valproate Semisodium (Valproate Semisodium) SS Topiramate (Topiramate) SS Quetiapine Fumarate (Quetiapine Fumarate) SS 200 MG (1 IN 1 D) Lithium Carbonate (Lithium Carbonate) SS ORAL ORAL Trazodone (Trazodone) C Tocopherol (Tocopherol) C Hydroxyzine Embonate (Hydroxyzine Embonate) C Estradiol (Estradiol) C Estratest Hs (Estrogens Esterified, Methyltestosterone) C Desloratadine (Desloratadine) C Calcium (Calcium) C Centrum (Minerals Nos, Vitamins Nos) C Docusate (Docusate) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Date:07/14/04ISR Number: 4401837-5Report Type:Expedited (15-DaCompany Report #2004044348 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Cold Consumer Neurontin Headache (Gabapentin) PS Hyperhidrosis Quetiapine Fumarate Muscle Twitching (Quetiapine Musculoskeletal Stiffness Fumarate) SS Nerve Injury Risperidone Suicidal Ideation (Risperidone) SS Tardive Dyskinesia Oxcarbazepine Weight Decreased (Oxcarbazepine) C Zolpidem Tartrate (Zolpidem Tartrate) C 22-Feb-2006 08:31 AM Page: 1021 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/04ISR Number: 4402126-5Report Type:Expedited (15-DaCompany Report #2004UW07200 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Fall Health Seroquel PS ORAL 100 MG PO Required Loss Of Consciousness Professional Seroquel SS ORAL 200 MG PO Intervention to Orthostatic Hypotension Seroquel SS Prevent Permanent Sertraline C Impairment/Damage Clonazepam C Date:07/15/04ISR Number: 4405335-4Report Type:Expedited (15-DaCompany Report #2004AP03466 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Seroquel PS ORAL 25 MG TID; PO Health Depakene C Professional Ubretid C Other Silece C No Match C Akineton C Date:07/15/04ISR Number: 4405337-8Report Type:Expedited (15-DaCompany Report #2004SE03889 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Seroquel PS 200-400 MG Initial or Prolonged Health Seroquel SS ORAL 100 MG DAILY; Professional PO Other Serenase C Seroxat C Date:07/15/04ISR Number: 4406452-5Report Type:Expedited (15-DaCompany Report #2004PK01141 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Seroquel PS ORAL 400 MG DAILY Hospitalization - Syncope Health PO Initial or Prolonged Professional Reminyl C Other Melperon C Date:07/15/04ISR Number: 4406718-9Report Type:Expedited (15-DaCompany Report #2004SE03690 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Seroquel PS Hospitalization - Medication Error Other Initial or Prolonged Overdose Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 1022 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/15/04ISR Number: 4406735-9Report Type:Expedited (15-DaCompany Report #2004AP03466 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Seroquel PS ORAL 25 MG TID PO Health Depakene C Professional Ubretid C Other Silece C No Match C Akineton C Date:07/15/04ISR Number: 4406738-4Report Type:Expedited (15-DaCompany Report #2004UW14222 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Foreign Seroquel PS ORAL 950 MG DAILY Intervention to White Blood Cell Count Health PO Prevent Permanent Decreased Professional Impairment/Damage Other Date:07/16/04ISR Number: 4399236-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB02777 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Overdose Pharma ORAL 1400 mg Self-Medication overdose Quetiapine SS Zopiclone SS Date:07/16/04ISR Number: 4400522-3Report Type:Direct Company Report #CTU 222934 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain Quetiapine 200 Mg Priapism Astra-Zeneca PS Astra-Zeneca ORAL 200 MG BID ORAL Quetiapine 200 Mg Astra-Zeneca SS Astra-Zeneca ORAL 200 MG Q 6 H PRN ORAL Docusate C Lamotrigine C Omeprazole C Olanzapine C Senna C Date:07/16/04ISR Number: 4405090-8Report Type:Expedited (15-DaCompany Report #2004UW01459 Age:28 YR Gender:Male I/FU:F Outcome PT Death Disseminated Hospitalization - Intravascular Coagulation Initial or Prolonged Generalised Oedema Medication Error Neuroleptic Malignant Syndrome Pulmonary Haemorrhage Renal Failure Acute 22-Feb-2006 08:31 AM Page: 1023 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rhabdomyolysis Treatment Noncompliance Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS 200 MG IN THE Professional AM/600 MG HS Zoloft C Date:07/16/04ISR Number: 4406291-5Report Type:Expedited (15-DaCompany Report #2004SE04008 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Haemorrhage Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Health PO Professional Other Date:07/16/04ISR Number: 4406412-4Report Type:Expedited (15-DaCompany Report #2004SE03958 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Seroquel PS ORAL 300 MG BID PO Hospitalization - Cardiac Arrest Health Haldol C Initial or Prolonged Professional Tegretol C Other Lysanxia C Trisequens C Zocor C Movicol C Venoruton C Date:07/16/04ISR Number: 4406445-8Report Type:Expedited (15-DaCompany Report #2004AP03456 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Seroquel PS ORAL 150 MG DAILY Initial or Prolonged Liver Disorder Health PO Pyrexia Professional Contomin SS ORAL 75 MG DAILY Other PO Date:07/20/04ISR Number: 4404295-XReport Type:Expedited (15-DaCompany Report #2004GB01699 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Foreign Seroquel PS ORAL 400 MG DAILY Disability Dysphasia Health PO Hemiparesis Professional Metformin C Other Thyroxine C Furosemide C Date:07/20/04ISR Number: 4404296-1Report Type:Expedited (15-DaCompany Report #2004UW09772 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Movement Disorder Health Seroquel PS ORAL 600 MG DAILY Intervention to Screaming Professional PO Prevent Permanent Seroquel SS ORAL 50 MG BID PO Impairment/Damage Zoloft C 22-Feb-2006 08:31 AM Page: 1024 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote - Slow Release C Remeron C Date:07/20/04ISR Number: 4404311-5Report Type:Expedited (15-DaCompany Report #2004UW10204 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS 2-3 OF 25 MG Intervention to Aphasia Health TABLETS QAM Prevent Permanent Depressed Level Of Professional AND 75 MG QHS Impairment/Damage Consciousness Other Seroquel SS ORAL 112.5 MG Dyskinesia DAILY PO Dyspnoea Risperidone C Hypotension Ativan C Visual Disturbance Date:07/20/04ISR Number: 4404451-0Report Type:Expedited (15-DaCompany Report #2004UW13380 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Drug Level Foreign Zomig PS Initial or Prolonged Increased Health Seroquel SS ORAL 100 MG DAILY Required Depression Professional PO Intervention to Other Epival SS 1500 MG DAILY Prevent Permanent Epival SS 1375 MG DAILY Impairment/Damage Effexor C Tryptophan C Risperidone C Lopressor C Imovane C Lithium C Date:07/20/04ISR Number: 4404572-2Report Type:Expedited (15-DaCompany Report #2004UW14066 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatocellular Damage Health Seroquel PS ORAL 200 MG PO Intervention to Tachycardia Professional Prevent Permanent Impairment/Damage Date:07/20/04ISR Number: 4404573-4Report Type:Expedited (15-DaCompany Report #2004UW14018 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Seroquel PS Initial or Prolonged Supraventricular Singulair Tachycardia "Dieckmann" C Synthroid C Valium C Carbidopa C Vitamin B6 C Prazosin C Zantac C Multivitamin "Lappe" C Reglan C 22-Feb-2006 08:31 AM Page: 1025 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Meclizine C Albuterol "Deu-Lute" C Date:07/20/04ISR Number: 4404575-8Report Type:Expedited (15-DaCompany Report #2004UW14420 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Seroquel PS Initial or Prolonged Dehydration Zyprexa C Hypovolaemia Depakote C Date:07/21/04ISR Number: 4407086-9Report Type:Expedited (15-DaCompany Report #2004UW14727 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Health Seroquel PS ORAL 50 MG PO Initial or Prolonged Professional Seroquel SS ORAL 100 MG PO Lipitor C Antihypertensive C Date:07/21/04ISR Number: 4407422-3Report Type:Expedited (15-DaCompany Report #2004SE04062 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenia Foreign Seroquel PS ORAL 75 MG DAILY Required Chest Pain Health PO Intervention to Dizziness Professional Seroquel SS ORAL 75 MG DAILY Prevent Permanent Headache Other PO Impairment/Damage Myalgia Nightmare Sleep Disorder Tremor Date:07/21/04ISR Number: 4407672-6Report Type:Expedited (15-DaCompany Report #2004SE04008 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Haemorrhage Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Depression Health PO Professional Remeron C Other Risperidone C Date:07/21/04ISR Number: 4407674-XReport Type:Expedited (15-DaCompany Report #2004SE03958 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Seroquel PS ORAL 300 MG BID PO Hospitalization - Cardiac Arrest Health Haldol C Initial or Prolonged Professional Tegretol C Other Lysanxia C Trisequens C Zocor C Movicol C Venoruton C 22-Feb-2006 08:31 AM Page: 1026 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/04ISR Number: 4407920-2Report Type:Expedited (15-DaCompany Report #2004AP03489 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Foreign Seroquel PS Intervention to Increased Other Prohance "Bracco" SS Bracco Prevent Permanent Aspartate Hirnamin SS Impairment/Damage Aminotransferase Pl Gran. SS Increased Akineton SS Blood Alkaline Selenase SS Phosphatase Increased Aleviatin SS Blood Lactate Gaster SS Dehydrogenase Increased Tegretol SS Gamma-Glutamyltransferase Increased Liver Disorder Date:07/21/04ISR Number: 4408028-2Report Type:Expedited (15-DaCompany Report #2004UW13380 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Zomig PS Initial or Prolonged Drug Level Increased Health Seroquel SS ORAL 100 MG DAILY Required Professional PO Intervention to Other Epival SS 1500 MG DAILY Prevent Permanent Epival SS 1375 MG DAILY Impairment/Damage Effexor C Effexor Xr C Tryptophan C Risperidone C Lopressor C Imovane C Lithium C Date:07/21/04ISR Number: 4431666-8Report Type:Periodic Company Report #2004024715 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Health Relpax (Eletriptan) PS Drug Interaction Professional Quetiapine Fumarate Company (Quetiapine Representative Fumarate) SS Nadolol (Nadolol) SS Date:07/22/04ISR Number: 4408202-5Report Type:Expedited (15-DaCompany Report #2004SE04115 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Cerebrovascular Accident Health PO Hypotonia Professional Seroquel SS ORAL 75 MG DAILY Ventricular Tachycardia Other PO Alopam C Lasix Retard C Seloken C Madopar C 22-Feb-2006 08:31 AM Page: 1027 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/22/04ISR Number: 4408349-3Report Type:Expedited (15-DaCompany Report #2004UW14801 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lower Limb Fracture Health Seroquel PS ORAL 800 MG PO Initial or Prolonged Muscle Spasms Professional Seroquel SS ORAL 1400 MG PO Myoclonus Seroquel SS ORAL 600 MG PO Prozac C Date:07/23/04ISR Number: 4405256-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12641056 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Abilify PS Otsuka Hyperthermia Pharmaceutical Company, Ltd. Started at 15 mg/day on 16-Jun-03, inc to 20 mg/day in 5 MON Seroquel SS Dose increased from 600 mg to 800 mg/day on 11-Jun-04. Aciphex C Trazodone Hcl C Apothecon Lisinopril + Hctz C 10/12.5 mg Androgen C Dostinex C Date:07/23/04ISR Number: 4408666-7Report Type:Expedited (15-DaCompany Report #2004UW14898 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Health Professional Other Date:07/23/04ISR Number: 4409731-0Report Type:Expedited (15-DaCompany Report #2004UW14954 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Consumer Seroquel PS 25 MG DAILY Norvasc C Lipitor C Pradin C Cozaar C Date:07/26/04ISR Number: 4409935-7Report Type:Expedited (15-DaCompany Report #04P-163-0267056-00 Age:35 YR Gender:Female I/FU:I Outcome PT Death Dehydration Drug Level Above Therapeutic Pancreatitis Acute 22-Feb-2006 08:31 AM Page: 1028 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sudden Death Report Source Product Role Manufacturer Route Dose Duration Literature Valproic Acid Health (Depakene) (Valproic Professional Acid) (Valproic Acid) PS 500 MG MORNING, 1750 BEDTIME; 1000 MG, 2 IN 1 D Quetiapine SS 100MG MORNING, 300MG BEDTIME Haloperidol C Haloperidol Decanoate C Paracetamol C Date:07/26/04ISR Number: 4410533-XReport Type:Expedited (15-DaCompany Report #2004UW14977 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Seroquel PS ORAL 25 MG PO Decreased Professional Risperdal C White Blood Cell Count Decreased Date:07/26/04ISR Number: 4410534-1Report Type:Expedited (15-DaCompany Report #2004UW09577 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Diabetes Mellitus Professional PO Diabetic Coma Seroquel SS ORAL 800 MG DAILY Feeling Abnormal PO Hypertension Lexapro C Insomnia Norvasc C Painful Respiration Diovan C Self Esteem Decreased Celexa C Speech Disorder Ambien C Unspecified Hypertension Medication C Unspecified Inhalers C Insulin C Date:07/26/04ISR Number: 4411017-5Report Type:Expedited (15-DaCompany Report #2004UW15101 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Seroquel PS ORAL 1000 MG PO Professional Lithium C 22-Feb-2006 08:31 AM Page: 1029 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/04ISR Number: 4408759-4Report Type:Expedited (15-DaCompany Report #PHEH2004US07276 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Clozaril PS Novartis Sector: Chest Pain Pharma ORAL 400 mg/day 1825 DAY Drug Level Increased Prevacid C Drug Toxicity Albuterol C Advair C Miralax C Seroquel I Fluvoxamine I Date:07/27/04ISR Number: 4409703-6Report Type:Direct Company Report #CTU 223645 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Compulsions Seroquel PS ORAL 400 MG QD Suicide Attempt ORAL Effexor C Date:07/27/04ISR Number: 4411391-XReport Type:Expedited (15-DaCompany Report #2004AP02110 Age:94 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Loss Of Consciousness Foreign Seroquel PS ORAL 25 MG DAILY Health PO Professional Norvasc /Den/ C Other Serenace C Astrix C Coloxyl With Senna C Panadeine C Panadol C Date:07/27/04ISR Number: 4413043-9Report Type:Expedited (15-DaCompany Report #S04-USA-04304-01 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Lexapro Professional (Escitalopram) PS Company Seroquel (Quetiapine Representative Fumarate) SS Date:07/28/04ISR Number: 4410526-2Report Type:Direct Company Report #CTU 223755 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Seroquel 25-50 Mg PS ORAL 25 MG AM PO Intervention to AND 25-50 HS Prevent Permanent Klonopin C Impairment/Damage Zoloft C 22-Feb-2006 08:31 AM Page: 1030 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/04ISR Number: 4413995-7Report Type:Expedited (15-DaCompany Report #NLWYE824214JUN04 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Foreign Efexor Cardiac Murmur Health (Venlafaxine Cardiomyopathy Professional Hydrochloride) PS Chest Pain Other Seroquel Conduction Disorder (Quetiapine) SS Coronary Artery Disease Dyspnoea Fatigue Gallop Rhythm Present Mitral Valve Incompetence Tachycardia Ventricular Dysfunction Date:07/28/04ISR Number: 4414113-1Report Type:Expedited (15-DaCompany Report #2004SE04115 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Depressed Level Of Health PO Consciousness Professional Seroquel SS ORAL 75 MG DAILY Hypotonia Other PO Ventricular Tachycardia Alopam C Lasix Retard C Seloken C Madopar C Date:07/29/04ISR Number: 4411799-2Report Type:Direct Company Report #CTU 223853 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Zoloft PS 1 PILL AT Intervention to Fatigue BEDTIME Prevent Permanent Feeling Abnormal Seroquel SS Impairment/Damage Feeling Hot Hunger Hyperhidrosis Date:07/29/04ISR Number: 4414608-0Report Type:Expedited (15-DaCompany Report #2004SE04099 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Seroquel PS ORAL 600 MG DAILY Increased Health PO Thrombocytopenia Professional Other Date:07/29/04ISR Number: 4414609-2Report Type:Expedited (15-DaCompany Report #2004AP03456 Age:60 YR Gender:Male I/FU:F Outcome PT Hospitalization - Biliary Tract Disorder Initial or Prolonged Biopsy Liver Abnormal Cholecystitis Cholelithiasis 22-Feb-2006 08:31 AM Page: 1031 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Gallbladder Disorder Jaundice Report Source Product Role Manufacturer Route Dose Duration Liver Disorder Foreign Seroquel PS ORAL 25 MG TID PO Lymphocytic Infiltration Health Contomin SS ORAL 100 MG TID PO Pyrexia Professional Tryptanol C Viral Infection Other Rohypnol C Lendormin C Date:07/29/04ISR Number: 4414610-9Report Type:Expedited (15-DaCompany Report #2004SE04162 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypotension Foreign Seroquel PS 100-800 MG Loss Of Consciousness Health DAILY Pulmonary Embolism Professional Rivotril C Tachycardia Other Hormonal Contraception C Date:07/29/04ISR Number: 4414689-4Report Type:Expedited (15-DaCompany Report #2004UW15084 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Health Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Living Impaired Professional PO Required Affect Lability Seroquel SS ORAL 40 MG HS PO Intervention to Condition Aggravated Seroquel SS ORAL 50 MG BID PO Prevent Permanent Dementia Exelon C Impairment/Damage Faecal Incontinence Zoloft C Incoherent Xanax C Urinary Incontinence Amen C Date:07/29/04ISR Number: 4414690-0Report Type:Expedited (15-DaCompany Report #2004AC00185 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Literature Quetiapine PS ORAL 14000 MG PO Initial or Prolonged Hepatic Enzyme Increased Health Divalproex C Lethargy Professional Gabapentin C Overdose Sertraline C Somnolence Date:07/29/04ISR Number: 4443710-2Report Type:Periodic Company Report #US-JNJFOC-20040202060 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone) Pneumonia Unspecified PS ORAL ORAL Seroquel (Quetiapine Fumarate) SS 500MG @ HS ; 100MG PRN FOR AGITATION Lithium (Lithium) C Inderal (Propranolol Hydrochloride) C 22-Feb-2006 08:31 AM Page: 1032 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443713-8Report Type:Periodic Company Report #US-JNJFOC-20040200880 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Risperdal Syndrome Professional (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL; 1 MG, 2 IN 1 DAY, ORAL Geodon (Ziprasidone Hydrochloride) SS 20 MG Seroquel (Quetiapine Fumarate) SS 100 MG Date:07/30/04ISR Number: 4412445-4Report Type:Expedited (15-DaCompany Report #JP-MERCK-0406USA02451 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Eruption Pepcid Rpd PS Merck & Co., Inc ORAL 35 DAY Initial or Prolonged Liver Disorder Pl Gran SS ORAL 3 DAY Lymphocyte Stimulation Akineton SS ORAL 46 DAY Test Positive Prohance SS INTRAVENOUS Serenace SS ORAL 10 DAY Serenace SS ORAL 7 DAY Levomepromazine SS ORAL 7 DAY Levomepromazine SS ORAL 44 DAY Aleviatin SS ORAL 2 DAY Arasena-A SS INTRAVENOUS 10 DAY Seroquel SS ORAL 29 DAY Seroquel SS ORAL Aleviatin SS ORAL 59 DAY Levomepromazine SS ORAL 6 DAY Levomepromazine SS ORAL 2 DAY Serenace SS ORAL 4 DAY Serenace SS ORAL 32 DAY Tegretol SS ORAL 19 DAY Tegretol SS ORAL 26 DAY Date:07/30/04ISR Number: 4415631-2Report Type:Expedited (15-DaCompany Report #2004UW15495 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel PS ORAL 100 MG PO 4 MON Initial or Prolonged Diabetic Ketoacidosis Professional Required Intervention to Prevent Permanent Impairment/Damage Date:07/30/04ISR Number: 4415634-8Report Type:Expedited (15-DaCompany Report #2004UW15662 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Seroquel PS ORAL 100 MG TID PO Decreased Appetite Professional Abilify SS Sleep Disorder Zyprexa SS Paxil SS Zantac SS 22-Feb-2006 08:31 AM Page: 1033 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/04ISR Number: 4415637-3Report Type:Expedited (15-DaCompany Report #2004UW15638 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Xanax SS 0.5 MG TID Hydrocodone SS 7.5/500 Q8H Date:07/30/04ISR Number: 4415639-7Report Type:Expedited (15-DaCompany Report #2004UW15424 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Seroquel PS ORAL 700- MG DAILY Initial or Prolonged Blood Glucose Increased Professional PO Ativan SS Buspar SS Tegretol C Strattera C Date:07/30/04ISR Number: 4415642-7Report Type:Expedited (15-DaCompany Report #2004UW13527 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Intentional Self-Injury Health Seroquel PS Intervention to Overdose Professional Prevent Permanent Suicidal Ideation Impairment/Damage Date:07/30/04ISR Number: 4416107-9Report Type:Expedited (15-DaCompany Report #2004AP02110 Age:94 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Loss Of Consciousness Foreign Seroquel PS ORAL 25 MG DAILY Health PO Professional Norvasc /Den/ C Other Serenace C Astrix C Coloxyl With Senna C Panadeine C Panadol C Date:07/30/04ISR Number: 4416109-2Report Type:Expedited (15-DaCompany Report #2004AP03400 Age:50 YR Gender:Male I/FU:F Outcome PT Death Disseminated Life-Threatening Intravascular Coagulation Hospitalization - Haemodialysis Initial or Prolonged Haemoglobin Decreased Required Hepatitis Fulminant Intervention to Loss Of Consciousness Prevent Permanent Neuroleptic Malignant Impairment/Damage Syndrome Overdose Red Blood Cell Count Decreased Renal Failure Upper Respiratory Tract 22-Feb-2006 08:31 AM Page: 1034 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inflammation Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 200 MG DAILY Health PO Professional Selenase SS ORAL 3 MG BID PO Other Lullan SS ORAL 16 MG DAILY PO Lullan SS ORAL 32 MG DAILY PO Lullan SS ORAL 8 MG BID PO Kyufu SS Date:08/02/04ISR Number: 4413066-XReport Type:Direct Company Report #CTU 224038 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Chest Pain Seroquel 25 Mg PS ORAL 25 MG PO QD, Intervention to Dyspnoea 50 MG PO HS Prevent Permanent Hypoaesthesia Lexapro C Impairment/Damage Nitrofurantoin C Acetaminophen C Ambien C Milk Of Magnesia C Date:08/02/04ISR Number: 4416682-4Report Type:Expedited (15-DaCompany Report #2004UW15549 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Consumer Seroquel PS Intervention to Increased Atenolol C Prevent Permanent Visual Disturbance Norvasc C Impairment/Damage Captopril C Digitek C Gemfibrozil C Date:08/02/04ISR Number: 4417061-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040400186 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Mycelex Troche Initial or Prolonged Drug Interaction (Clotrimazole) Other Muscle Tightness Troche PS 10 MG, 3 IN 1 DAY Seroquel (Quetiapine Fumarate) SS Zyprexa (Olanzapine) C Date:08/03/04ISR Number: 4417392-XReport Type:Expedited (15-DaCompany Report #2004UW01459 Age:28 YR Gender:Male I/FU:F Outcome PT Death Disseminated Hospitalization - Intravascular Coagulation Initial or Prolonged Drug Screen Positive Generalised Oedema Hyperthermia 22-Feb-2006 08:31 AM Page: 1035 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Pulmonary Haemorrhage Report Source Product Role Manufacturer Route Dose Duration Renal Failure Acute Health Seroquel PS 200 MG IN THE Rhabdomyolysis Professional AM/600 MG HS Zoloft C Date:08/03/04ISR Number: 4417932-0Report Type:Expedited (15-DaCompany Report #2004PK01141 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Seroquel PS ORAL 400 MG DAILY Hospitalization - Drug Interaction Health PO Initial or Prolonged Drug Level Increased Professional Reminyl C Hypotension Other Melperon C Syncope Reminyl C Melperon C Date:08/03/04ISR Number: 4417942-3Report Type:Expedited (15-DaCompany Report #2004UW12832 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Seroquel PS Health Professional Other Date:08/04/04ISR Number: 4421127-4Report Type:Expedited (15-DaCompany Report #2004UW15497 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coma Consumer Seroquel PS ORAL 100 MG QD PO Intervention to Sensory Disturbance Seroquel SS ORAL 25 MG QD PO Prevent Permanent Somnolence Ativan SS Impairment/Damage Depakote C Date:08/05/04ISR Number: 4416384-4Report Type:Expedited (15-DaCompany Report #2004014467 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Tagonis PS Glaxosmithkline ORAL 90TAB Single Intentional Overdose dose 1 DAY Suicide Attempt Tramal Long SS ORAL 10TAB Single Vomiting dose 1 DAY Chloralhydrat SS ORAL 26TAB Single dose 1 DAY Seroquel SS ORAL 10TAB Single dose 1 DAY Date:08/05/04ISR Number: 4416510-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB02777 Age:28 YR Gender:Female I/FU:F Outcome PT Hospitalization - Accidental Exposure Initial or Prolonged Agitation Alanine Aminotransferase 22-Feb-2006 08:31 AM Page: 1036 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Dystonia Hallucination, Auditory Intentional Overdose Report Source Product Role Manufacturer Route Dose Duration Self-Injurious Ideation Health Clozaril PS Novartis Sector: Suicidal Ideation Professional Pharma ORAL 1400 mg overdose Quetiapine SS Zopiclone SS Thyroxin C ORAL 50 ug/day Quetiapine C ORAL 200mg/day Ventolin /00139501/ C 2 Pufffs PRN Date:08/05/04ISR Number: 4422030-6Report Type:Expedited (15-DaCompany Report #2004UW09577 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Diabetes Mellitus Professional PO Diabetic Coma Seroquel SS ORAL 800 MG DAILY Hypertension PO Insomnia Lexapro C Pain Norvasc C Psychiatric Symptom Diovan C Speech Disorder Celexa C Ambien C Unspecified Hypertension Medication C Unspecified Inhalers C Insulin C Date:08/05/04ISR Number: 4422033-1Report Type:Expedited (15-DaCompany Report #2004UW15892 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Consumer Seroquel PS ORAL 125 MG HS PO Initial or Prolonged Wellbutrin C Date:08/06/04ISR Number: 4420109-6Report Type:Direct Company Report #CTU 224411 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Somnolence Xanax 1 Mg PS ORAL 1 MG Q 2 HOURS ORAL Seroquel 200 Mg SS ORAL 200 MG QID ORAL Ritalin C Prozac C Date:08/06/04ISR Number: 4421886-0Report Type:Expedited (15-DaCompany Report #2004AP03978 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Death Myocarditis Foreign Health 22-Feb-2006 08:31 AM Page: 1037 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Seroquel PS Zyprexa SS ORAL 20 MG DAILY PO Date:08/06/04ISR Number: 4421892-6Report Type:Expedited (15-DaCompany Report #2004GB01814 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperventilation Foreign Seroquel PS ORAL 100 MG BID PO Intervention to Mobility Decreased Health Gliclazide C Prevent Permanent Professional Frusemide C Impairment/Damage Other Ramipril C Simvastatin C Terbinafine C Viazem Xl C Procyclidine C Date:08/06/04ISR Number: 4422039-2Report Type:Expedited (15-DaCompany Report #2004UW16445 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS ORAL 600 MG PO Hyperthermia Professional Seroquel SS 800 MG Abilify C Trazodone C Lisinopril C Dostinex C Date:08/06/04ISR Number: 4422043-4Report Type:Expedited (15-DaCompany Report #2004UW10950 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Full Blood Count Abnormal Health Seroquel PS 600-800 Intervention to Neutropenia Professional MG/DAILY Prevent Permanent Platelet Count Decreased Zestril C Impairment/Damage White Blood Cell Count Lasix C Decreased Actos C Date:08/06/04ISR Number: 4422252-4Report Type:Expedited (15-DaCompany Report #S04-USA-04304-01 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Lexapro Coma Professional (Escitalopram) PS ORAL 30 MG QD PO Company Lexapro Representative (Escitalopram) SS ORAL 10 MG QD PO Lexapro (Escitalopram) SS ORAL 20 MG QD PO Seroquel (Quetiapine Fumarate) SS 25 MG QD Neurontin (Gabapentin) C 22-Feb-2006 08:31 AM Page: 1038 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/04ISR Number: 4423745-6Report Type:Expedited (15-DaCompany Report #2003AP00923 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Foreign Seroquel PS ORAL 700 MG DAILY Alcohol Use Health PO Crying Professional Cipramil SS ORAL 40 MG DAILY Depressed Mood Other PO Fall Erythromycin C Injury Intentional Overdose Oral Infection Date:08/09/04ISR Number: 4420530-6Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0504223A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nightmare Paxil Cr PS Glaxosmithkline ORAL Lexapro SS Seroquel SS Date:08/09/04ISR Number: 4424693-8Report Type:Expedited (15-DaCompany Report #2004UW16160 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Colitis Ischaemic Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:08/09/04ISR Number: 4424694-XReport Type:Expedited (15-DaCompany Report #2004SE04319 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS Breath Sounds Abnormal Health Seroquel SS ORAL 300 MG BID PO Cough Professional Seroquel SS ORAL 1000 MG DAILY Pharyngeal Erythema Other PO Pyrexia Nozinan C Sepsis Phenergan C White Blood Cell Count Imovane C Decreased Akineton C Date:08/09/04ISR Number: 4425233-XReport Type:Expedited (15-DaCompany Report #2004UW12429 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Seroquel PS ORAL 100 MG HS PO Professional Unithroid C Carbidopa C Levodopa C Mirapex "Boehringer Ingelheim" C Lupron C 22-Feb-2006 08:31 AM Page: 1039 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/04ISR Number: 4425237-7Report Type:Expedited (15-DaCompany Report #2004UW08789 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Health Seroquel PS Medication Error Professional Paxil C Date:08/10/04ISR Number: 4423283-0Report Type:Direct Company Report #CTU 224625 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Learning Disability Seroquel 100 Mg Mental Impairment Astrazeneca PS Astrazeneca ORAL 200 MG DAY Speech Disorder ORAL Developmental Visual Disturbance Date:08/10/04ISR Number: 4425093-7Report Type:Expedited (15-DaCompany Report #2004AC00138 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Literature Quetiapine PS ORAL 9000 MG PO Initial or Prolonged Agitation Health Oxcarbazepine SS ORAL 36000 MG PO Cardiac Murmur Professional Atomoxetine SS 1200 MG Depressed Level Of Acetaminophen C Consciousness Salicylate C Electrocardiogram Qt Ethanol C Corrected Interval Marijuana C Prolonged Paroxetine C Excoriation Albuterol C Hallucinations, Mixed Montelukast C Head Banging Intentional Self-Injury Joint Injury Medication Error Multiple Drug Overdose Intentional Self Injurious Behaviour Somnolence Suicidal Ideation Suicide Attempt Vomiting Date:08/10/04ISR Number: 4426052-0Report Type:Expedited (15-DaCompany Report #2004AP03456 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Foreign Seroquel PS ORAL 25 MG TID PO Initial or Prolonged Cholelithiasis Health Contomin SS ORAL 100 MG TID PO Condition Aggravated Professional Tryptanol C Depression Other Rohypnol C Jaundice Lendormin C Liver Disorder Viral Infection 22-Feb-2006 08:31 AM Page: 1040 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/04ISR Number: 4426226-9Report Type:Expedited (15-DaCompany Report #2004SE04319 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS C-Reactive Protein Health Seroquel SS ORAL 300 MG BID Increased Professional PO Cough Other Seroquel SS ORAL 1000 MG DAILY Feeling Abnormal PO Pyrexia Nozinan C Sepsis Phenergan C Imovane C Akineton C Date:08/11/04ISR Number: 4426302-0Report Type:Expedited (15-DaCompany Report #04P-062-0268476-00 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bowel Sounds Abnormal Foreign Akineton (Biperiden) Initial or Prolonged Fatigue Health (Biperiden) PS ORAL 2 MG, 3O IN 1 Suicide Attempt Professional D, PER ORAL Tachycardia Other Quetiapine SS ORAL 300 MG, 100 IN 1 D, PER ORAL Lorazepam SS ORAL 1 MG, 50 IN 1 D, PER ORAL Date:08/11/04ISR Number: 4426323-8Report Type:Expedited (15-DaCompany Report #2004AP04116 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Foreign Seroquel PS ORAL 50 MG QD PO Increased Health Pyrexia Professional White Blood Cell Count Other Increased Date:08/11/04ISR Number: 4427111-9Report Type:Expedited (15-DaCompany Report #2004UW16588 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS ORAL 50 MG TID PO Professional Ativan C Klonopin C Depakote C Zyprexa C Date:08/11/04ISR Number: 4427113-2Report Type:Expedited (15-DaCompany Report #2004UW16205 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pseudoparalysis Consumer Seroquel PS ORAL 200 MG PO Intervention to Seroquel SS ORAL 25 MG PO Prevent Permanent Remeron C Impairment/Damage Activan C Ambien C 22-Feb-2006 08:31 AM Page: 1041 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/04ISR Number: 4424449-6Report Type:Expedited (15-DaCompany Report #PHEH2004US08464 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Health Exelon PS Novartis Sector: Catatonia Professional Pharma ORAL 1.5 mg, QD 7200 MIN Drug Interaction Exelon SS Novartis Sector: Hypokinesia Pharma ORAL 1.5 mg, BID 21600MIN Seroquel SS Haldol "Janssen" SS Trazodone SS Estrogens SS TRANSDERMAL Ativan C Folic Acid C Combivent C Date:08/12/04ISR Number: 4426614-0Report Type:Direct Company Report #CTU 224900 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Seroquel Zeneca PS Zeneca PRESCRIPTION Headache # 0703 292 - Hyperhidrosis 02564 DATE Nausea 7/6/04 Pyrexia Tongue Paralysis Date:08/12/04ISR Number: 4427459-8Report Type:Expedited (15-DaCompany Report #2004PK01332 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Increased Foreign Seroquel PS ORAL 1000 MG DAILY Hospitalization - Blood Glucose Increased Study PO Initial or Prolonged C-Reactive Protein Health Ergenyl SS ORAL 2400 MG DAILY Increased Professional PO Deep Vein Thrombosis Other Rivotril SS ORAL 4 MG DAILY PO Pulmonary Embolism Xanef SS ORAL 20 MG DAILY PO Date:08/12/04ISR Number: 4427478-1Report Type:Expedited (15-DaCompany Report #2004UW15823 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Seroquel PS ORAL 600 MG HS PO Decreased Appetite Consumer Hallucination, Auditory Other Platelet Count Decreased Somnolence Weight Decreased Date:08/12/04ISR Number: 4427547-6Report Type:Expedited (15-DaCompany Report #2004AP04093 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eosinophil Count Foreign Seroquel PS Increased Health Professional Other 22-Feb-2006 08:31 AM Page: 1042 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/04ISR Number: 4427548-8Report Type:Expedited (15-DaCompany Report #2004GB01434 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS ORAL 150 MG BID PO Initial or Prolonged Alcohol Interaction Health Diazepam C Required Professional Venlafaxine C Intervention to Other Olanzapine C Prevent Permanent Impairment/Damage Date:08/12/04ISR Number: 4427656-1Report Type:Expedited (15-DaCompany Report #2004UW16742 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS Cardiovascular Disorder Professional Geodon SS Date:08/12/04ISR Number: 4427658-5Report Type:Expedited (15-DaCompany Report #2004UW16809 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS Cardiovascular Disorder Professional Date:08/12/04ISR Number: 4427659-7Report Type:Expedited (15-DaCompany Report #2004UW16810 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS Cardiovascular Disorder Professional Amitriptyline SS OVERDOSE Overdose Date:08/13/04ISR Number: 4428241-8Report Type:Expedited (15-DaCompany Report #2004UW16434 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Amnesia Consumer Seroquel PS ORAL 50 MG DAILY Intervention to Drug Ineffective PO Prevent Permanent Imprisonment Seroquel SS ORAL 125 MG DAILY Impairment/Damage Loss Of Consciousness PO Medication Error Seroquel SS ORAL 50 MG DAILY PO Date:08/13/04ISR Number: 4428367-9Report Type:Expedited (15-DaCompany Report #2004GB01892 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Test Abnormal Foreign Seroquel PS ORAL 500 MG DAILY Health PO Professional Cannabis C Other 22-Feb-2006 08:31 AM Page: 1043 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/04ISR Number: 4428593-9Report Type:Expedited (15-DaCompany Report #2004AP03980 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dilatation Atrial Foreign Seroquel PS ORAL 1 DAILY PO Initial or Prolonged Headache Health Clozaril SS ORAL 125 MG DAILY Hepatitis C Positive Professional PO Mitral Valve Incompetence Other Myocarditis Pyrexia Red Blood Cell Sedimentation Rate Increased Tachycardia Troponin Increased Virus Serology Test Positive Date:08/16/04ISR Number: 4427355-6Report Type:Direct Company Report #CTU 224977 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Seroquel PS 400 MG BID Initial or Prolonged [SEVERAL MONTHS] Depakene C Cozaar C Humulin C Date:08/16/04ISR Number: 4427608-1Report Type:Direct Company Report #CTU 225044 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Haldol 5 Mg Im PS INTRAMUSCULAR 5 MG IM Q 4H Initial or Prolonged Labile Blood Pressure PRN Required Musculoskeletal Stiffness Seroquel 200 Mg Po SS 200 MG BID Intervention to Neuroleptic Malignant Protonix C Prevent Permanent Syndrome Dantrolene C Impairment/Damage Paranoia Pyrexia Tachycardia Treatment Noncompliance Date:08/16/04ISR Number: 4429583-2Report Type:Expedited (15-DaCompany Report #DSA_24764_2004 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bowel Sounds Abnormal Foreign Tavor PS ORAL 50 MG ONCE PO Initial or Prolonged Fatigue Health Akineton SS ORAL 60 MG ONCE PO Intentional Overdose Professional Seroquel SS ORAL 30000 MG ONCE Multiple Drug Overdose Other PO Tachycardia 22-Feb-2006 08:31 AM Page: 1044 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/04ISR Number: 4429961-1Report Type:Expedited (15-DaCompany Report #2004UW16477 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Haemorrhage Consumer Seroquel PS ONE DOSE Initial or Prolonged Cerebrovascular Accident Coma Date:08/17/04ISR Number: 4429962-3Report Type:Expedited (15-DaCompany Report #2004UW16878 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Health Seroquel PS ORAL 25 MG QD PO Cardiac Arrest Professional Lexapro SS ORAL 30 MG QD PO Coma Lexapro SS ORAL 10 MG QD PO Respiratory Arrest Lexapro SS ORAL 20 MG QD PO Sudden Death Neurontin C Date:08/17/04ISR Number: 4429963-5Report Type:Expedited (15-DaCompany Report #2004UW14727 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Health Seroquel PS ORAL SEE IMAGE Hospitalization - Diabetes Mellitus Professional Gabapentin C Initial or Prolonged Non-Insulin-Dependent Tramadol C Diabetic Hyperosmolar Lipitor C Coma Rofecoxib C Diabetic Ketoacidosis Singulair C Dizziness Tamoxifen C Fatigue Nexium C Cozaar C Date:08/17/04ISR Number: 4429964-7Report Type:Expedited (15-DaCompany Report #2004UW09823 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Study Seroquel PS ORAL SEE IMAGE Initial or Prolonged Schizophrenia Health Professional Date:08/17/04ISR Number: 4429971-4Report Type:Expedited (15-DaCompany Report #2004UW16636 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Health Seroquel PS Initial or Prolonged Orthostatic Decreased Professional Promethazine Confusional State Hydrochloride SS Delirium Reminyl SS ORAL 24 MG DAILY Dizziness PO Drug Interaction Reminyl SS ORAL 4 MG BID PO Gait Disturbance Celexa C Hallucination, Visual Cartia C Muscle Twitching Lipitor C Nausea Isosorbide C Nervous System Disorder Lecithin C Vomiting Glucosamine C Colace C Asa C 22-Feb-2006 08:31 AM Page: 1045 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/04ISR Number: 4429974-XReport Type:Expedited (15-DaCompany Report #2004UW16731 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Visual Disturbance Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:08/17/04ISR Number: 4429976-3Report Type:Expedited (15-DaCompany Report #2004UW16769 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Consumer Seroquel PS Initial or Prolonged Drug Effect Decreased Haloperidol SS ORAL 1 MG PRN PO Drug Withdrawal Syndrome Haloperidol SS ORAL 1 MG TID PO Eating Disorder Haloperidol SS ORAL 0.5 MG TID PO Parkinsonism Zyprexa SS Tremor Lisinopril Weight Decreased W/Hydrochlorothiazid Weight Increased e C Zestril C Date:08/17/04ISR Number: 4430178-5Report Type:Expedited (15-DaCompany Report #2004AP03992 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Seroquel PS Initial or Prolonged Consciousness Health Abilify SS ORAL 15 MG DAILY Drug Interaction Professional PO Other Diazepam SS ORAL 20 MG DAILY PO Droperidol SS INTRAMUSCULAR 5 MG PRN IM Lamictal "Burroughs Wellcome" SS Burroughs Wellcome ORAL 137 MG DAILY PO Midazolam SS INTRAMUSCULAR 10 MG PRN IM Epilim SS ORAL 1000 MG DAILY PO Levlen C Ferro-Gradumet /Aus/ C Nicabate C Mylanta C Date:08/17/04ISR Number: 4431053-2Report Type:Expedited (15-DaCompany Report #2004GB01912 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Foreign Quetiapine PS ORAL 325 MG PO Myocardial Ischaemia Health Tranylcypromine C Neuroleptic Malignant Professional Aspirin C Syndrome Other Senna C Viscotears C 22-Feb-2006 08:31 AM Page: 1046 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/04ISR Number: 4431063-5Report Type:Expedited (15-DaCompany Report #2004PK01352 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cerebellar Infarction Foreign Seroquel PS ORAL 300 MG DAILY Hypertension Health PO Pulmonary Embolism Professional Cipramil SS 30 MG DAILY Thrombocythaemia Other Risperdal SS 4 MG DAILY Remergil SS 45 MG DAILY Date:08/17/04ISR Number: 4431065-9Report Type:Expedited (15-DaCompany Report #2004UW16675 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Haematocrit Decreased Foreign Seroquel PS Intervention to Haemoglobin Decreased Health Prevent Permanent Platelet Count Decreased Professional Impairment/Damage Red Blood Cell Count Other Decreased White Blood Cell Count Decreased Date:08/17/04ISR Number: 4431067-2Report Type:Expedited (15-DaCompany Report #2004UW16160 Age:40 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Colitis Ischaemic Foreign Seroquel PS ORAL 450 MG QD PO Intervention to Haematochezia Health Seroquel SS ORAL 600 MG QD PO Prevent Permanent Professional Clozapine SS 720 NMOL/L Impairment/Damage Other Clozaril C Celexa C Epival C Date:08/17/04ISR Number: 4431085-4Report Type:Expedited (15-DaCompany Report #2004SE04319 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS ORAL 25 MG BID PO Breath Sounds Abnormal Health Seroquel SS ORAL 50 MG BID PO C-Reactive Protein Professional Seroquel SS ORAL 100 MG BID PO Increased Other Seroquel SS ORAL 150 MG BID Cough PO Dysphonia Seroquel SS ORAL 200 MG BID Feeling Abnormal PO Neutrophil Count Seroquel SS ORAL 300 MG BID PO Decreased Seroquel SS ORAL 1000 MG BID Pharyngeal Erythema PO Pyrexia Nozinan C Sepsis Phenergan C Sputum Discoloured Imovane C Akineton C Date:08/17/04ISR Number: 4431092-1Report Type:Expedited (15-DaCompany Report #2004AP03994 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Other Neutropenia Foreign Health 22-Feb-2006 08:31 AM Page: 1047 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 300 MG DAILY PO Clozaril C Solian C Date:08/18/04ISR Number: 4429830-7Report Type:Direct Company Report #CTU 225212 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Venlafaxine 150 Mg PS Abdominal Pain Upper Quetiapine 25 Mg SS Abnormal Dreams Anxiety Clumsiness Crying Decreased Appetite Depressed Mood Diarrhoea Difficulty In Walking Fatigue Feeling Abnormal Frequent Bowel Movements Headache Hyperacusis Insomnia Irritability Lethargy Movement Disorder Nausea Nightmare Panic Disorder Scratch Skin Haemorrhage Suicidal Ideation Tremor Visual Disturbance Date:08/18/04ISR Number: 4430634-XReport Type:Expedited (15-DaCompany Report #04P-087-0269008-00 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Contrast Media Reaction Foreign Akineton (Biperiden) Initial or Prolonged Drug Eruption Health (Biperiden) PS 3 MG 1 IN 1 D Hepatic Enzyme Increased Professional Phenytoin SS SEE IMAGE Hepatic Function Abnormal Haloperidol SS SEE IMAGE Influenza Like Illness Levomepromazine SS ORAL SEE IMAGE Scab Carbamazepine SS ORAL SEE IMAGE Famotidine SS OPHTHALMIC 40 MG, ORAL Quetiapine SS ORAL SEE IMAGE Vidarabine SS INTRAVENOUS 600 MG, INTRAVENOUS Gadoteridol SS INTRAVENOUS INTRAVENOUS Pl Gran. SS ORAL 3 GM, ORAL Teprenone SS ORAL ORAL 22-Feb-2006 08:31 AM Page: 1048 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/04ISR Number: 4430661-2Report Type:Expedited (15-DaCompany Report #2004AP04162 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Foreign Seroquel PS ORAL 75 MG DAILY Initial or Prolonged Health PO Professional Paxil C Other Toledomin C Anafranil C Date:08/18/04ISR Number: 4430663-6Report Type:Expedited (15-DaCompany Report #2004AP04095 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatic Function Abnormal Foreign Seroquel PS Intervention to Jaundice Health Prevent Permanent Professional Impairment/Damage Other Date:08/18/04ISR Number: 4430665-XReport Type:Expedited (15-DaCompany Report #2004SE04561 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Seroquel PS ORAL 300 MG DAILY Cardiac Arrest Health PO Fear Professional Seroquel SS ORAL 800 MG DAILY Psychological Factor Other PO Affecting Medical Seroquel SS ORAL 1200 MG DAILY Condition PO Lormetazapam C Pentazol C Akineton C Cisordinol-Acutard C Cisordinol - Slow Release C Date:08/19/04ISR Number: 4429598-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12671673 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Serzone Tabs PS Bristol-Myers Squibb Initial or Prolonged Company ORAL started at Other 150mg am, 300mg pm;increased to 150mg am Clonazepam SS Mirtazapine SS reduced to 15mg daily Ranitidine SS Omeprazole SS Quetiapine SS Hydrocodone + Acetaminophen C 22-Feb-2006 08:31 AM Page: 1049 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/04ISR Number: 4431873-4Report Type:Expedited (15-DaCompany Report #2004UW16877 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Seroquel PS ORAL 300 MG BID PO Initial or Prolonged Disease Progression Health Seroquel SS ORAL 400 MG BID PO Hypotension Professional Depakote C Hypothermia Cogentin C Mental Status Changes Clonidine C Paranoia Physical Assault Psychotic Disorder Suspiciousness Date:08/19/04ISR Number: 4431894-1Report Type:Expedited (15-DaCompany Report #2004UW13007 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grip Strength Decreased Health Seroquel PS 600 TO 700 MG Intervention to Professional DAILY Prevent Permanent Depakote C Impairment/Damage Date:08/19/04ISR Number: 4431895-3Report Type:Expedited (15-DaCompany Report #2004UW16913 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Health Seroquel PS ORAL 900 MG HS; PO Intervention to Drug Exposure During Professional Xanax SS NI Prevent Permanent Pregnancy Zoloft SS NI Impairment/Damage Date:08/19/04ISR Number: 4431897-7Report Type:Expedited (15-DaCompany Report #2004UW16877 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Seroquel PS ORAL 300 MG BID; Initial or Prolonged Hypotension Health PO Hypothermia Professional Seroquel SS ORAL 400 MG BID; Psychotic Disorder PO Depakote C Cogentin C Clonidine C Date:08/19/04ISR Number: 4432012-6Report Type:Expedited (15-DaCompany Report #2002GB00361 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Elevated Mood Foreign Quetiapine PS ORAL 400 MG DAILY Intervention to Euphoric Mood Literature PO Prevent Permanent Paranoia Health Quetiapine SS ORAL 600 MG DAILY Impairment/Damage Psychomotor Hyperactivity Professional PO Thinking Abnormal Other Clomipramine C 22-Feb-2006 08:31 AM Page: 1050 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/04ISR Number: 4431359-7Report Type:Expedited (15-DaCompany Report #2004PK01366 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Seroquel PS ORAL 12.5 MG QD PO Initial or Prolonged Health Heparin SS Professional Other Date:08/20/04ISR Number: 4432432-XReport Type:Expedited (15-DaCompany Report #2004AP03489 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Eruption Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Hepatic Enzyme Increased Health PO Hepatic Function Abnormal Professional Seroquel SS ORAL 300 MG DAILY Lymphocyte Stimulation Other PO Test Positive Prohance "Bracco" SS Nasopharyngitis Hirnamin SS ORAL 50 MG PO Hirnamin SS ORAL 75 MG PO Hirnamin SS ORAL 150 MG PO Hirnamin SS ORAL 200 MG PO Pl Gran. SS ORAL 3 G PO Akineton /Aus/ SS ORAL 3 MG PO Selenase SS ORAL 2 MG PO Selenase SS ORAL 6 MG PO Selenase SS ORAL 12 MG PO Selenase SS ORAL 9 MG PO Aleviatin SS ORAL 500 MG PO Aleviatin SS ORAL 300 MG PO Gaster SS ORAL 40 MG PO Tegretol SS ORAL 400 MG PO Tegretol SS ORAL 600 MG PO Arasena A SS INTRAVENOUS 600 MG IV Date:08/20/04ISR Number: 4432437-9Report Type:Expedited (15-DaCompany Report #2004SE04443 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS 600 MG DAILY Health Seroquel SS 400 MG DAILY Professional Depakin Chrono C Other Rivotril C Date:08/20/04ISR Number: 4432547-6Report Type:Expedited (15-DaCompany Report #2004UW17103 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Dysphoria Health Seroquel SS ORAL 600 MG DAILY Hallucination, Auditory Professional PO Insomnia Rabeprazole C Schizophrenia, Paranoid Tylenol C Type Glyburide C Speech Disorder Lovastatin C Treatment Noncompliance Risperidone C 22-Feb-2006 08:31 AM Page: 1051 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/04ISR Number: 4432610-XReport Type:Expedited (15-DaCompany Report #2004UW16936 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Consumer Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Dysphagia PO Eye Irritation Topamax C Keratoconjunctivitis Depakote C Sicca Celebrex C Ocular Hyperaemia Multivitamin "Lappe" C Oyster Shell Calcium C Date:08/20/04ISR Number: 4432627-5Report Type:Expedited (15-DaCompany Report #2004UW16822 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fall Consumer Seroquel PS ORAL 150 MG HS PO Intervention to Hypoaesthesia Prevent Permanent Loss Of Consciousness Impairment/Damage Penis Disorder Date:08/20/04ISR Number: 4432637-8Report Type:Expedited (15-DaCompany Report #2004UW17067 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS Professional Depakote C Date:08/24/04ISR Number: 4431141-0Report Type:Expedited (15-DaCompany Report #PHEH2004US08464 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Health Exelon PS Novartis Sector: Catatonia Professional Pharma ORAL 1.5 mg, QD 7200 MIN Drug Interaction Exelon SS Novartis Sector: Hypokinesia Pharma ORAL 1.5 mg, BID 21600MIN Seroquel SS Haldol "Janssen" SS Trazodone SS Estrogens SS TRANSDERMAL Ativan C Folic Acid C Combivent C Date:08/24/04ISR Number: 4431445-1Report Type:Expedited (15-DaCompany Report #2004014467 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Tagonis PS Glaxosmithkline ORAL 90TAB Single Initial or Prolonged Intentional Overdose dose Somnolence Tramal Long SS ORAL 10TAB Single Suicide Attempt dose Vomiting Chloralhydrat SS ORAL 26TAB Single dose Seroquel SS ORAL 10TAB Single dose 22-Feb-2006 08:31 AM Page: 1052 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/04ISR Number: 4433239-XReport Type:Expedited (15-DaCompany Report #2004UW17154 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Consumer Seroquel PS ORAL 50 MG PO Intervention to Deafness Prevent Permanent Hypersensitivity Impairment/Damage Muscle Atrophy Date:08/24/04ISR Number: 4433244-3Report Type:Expedited (15-DaCompany Report #2004UW17434 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Seroquel PS ORAL 300 MG PO Initial or Prolonged Ileus Professional Date:08/24/04ISR Number: 4433246-7Report Type:Expedited (15-DaCompany Report #2004AC00230 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Quetiapine PS Health Professional Date:08/24/04ISR Number: 4433497-1Report Type:Expedited (15-DaCompany Report #2004AP03400 Age:50 YR Gender:Male I/FU:F Outcome PT Death Alanine Aminotransferase Life-Threatening Increased Hospitalization - Ascites Initial or Prolonged Aspartate Required Aminotransferase Intervention to Increased Prevent Permanent Blood Bilirubin Increased Impairment/Damage Blood Creatine Phosphokinase Increased C-Reactive Protein Decreased Coagulation Factor Decreased Coma Delusion Depressed Level Of Consciousness Disseminated Intravascular Coagulation Encephalopathy Haematemesis Haemodialysis Hepatic Atrophy Hepatic Function Abnormal Hepatitis Fulminant Hyperhidrosis Hypoproteinaemia Hypotension Jaundice Loss Of Consciousness Mental Status Changes 22-Feb-2006 08:31 AM Page: 1053 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multi-Organ Failure Myoglobinuria Neuroleptic Malignant Report Source Product Role Manufacturer Route Dose Duration Syndrome Foreign Seroquel PS ORAL 100 MG BID PO Ocular Icterus Health Haloperidol SS Overdose Professional Haloperidol SS ORAL 3 MG BID PO Purpura Other Lullan SS ORAL 16 MG DAILY Pyrexia PO Renal Failure Lullan SS ORAL 32 MG DAILY Tachycardia PO Vomiting Lullan SS ORAL 8 MG BID PO White Blood Cell Count Kyufu Gold SS Decreased Tasmolin C Silece C Amoban C Vegetamin A C Circanetten C Borraginol A C Date:08/24/04ISR Number: 4433499-5Report Type:Expedited (15-DaCompany Report #2004PK01377 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Circulatory Collapse Foreign Seroquel PS ORAL 500 MG DAILY Intervention to Fall Health PO Prevent Permanent Head Injury Professional Zoloft SS ORAL 50 MG DAILY Impairment/Damage Hypotension Other PO Loss Of Consciousness Syncope Date:08/24/04ISR Number: 4433500-9Report Type:Expedited (15-DaCompany Report #2004GB01793 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Autoimmune Thyroiditis Foreign Seroquel PS STARTED ON A Intervention to Health LOWER DOSE Prevent Permanent Professional Seroquel SS ORAL 150 MG BID PO Impairment/Damage Other Cipramol C Iron C Date:08/24/04ISR Number: 4433502-2Report Type:Expedited (15-DaCompany Report #2004GB01923 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Panic Reaction Foreign Quetiapine PS ORAL 25 MG BID PO Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:08/24/04ISR Number: 4433503-4Report Type:Expedited (15-DaCompany Report #2004PK01374 Age:17 YR Gender:Male I/FU:I Outcome PT Required Fall Intervention to Hypotension Prevent Permanent Limb Injury Impairment/Damage Loss Of Consciousness 22-Feb-2006 08:31 AM Page: 1054 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syncope Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 500 MG DAILY Health PO Professional Efexor SS ORAL 75 MG DAILY Other PO Date:08/24/04ISR Number: 4433569-1Report Type:Expedited (15-DaCompany Report #HQWYE285816AUG04 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Efexor Xr Initial or Prolonged Hypotension Professional (Venlafaxine Disability Limb Injury Other Hydrochloride, Loss Of Consciousness Capsule, Extended Syncope Release) PS ORAL 75 MG 1X PER 1 DAY,ORAL Seroquel (Quetiapine, ) SS 500 MG 1X PER 1 DAY Date:08/25/04ISR Number: 4433633-7Report Type:Direct Company Report #CTU 225559 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Seroquel 300 Mg PS ORAL 300 MG PO Initial or Prolonged Hummilin 70/30 C Required Synthroid C Intervention to Toprol Xl C Prevent Permanent K+ Clor C Impairment/Damage Bumex C Allegra C Rhinocort C Singulair C O2 C Albuterol C Date:08/25/04ISR Number: 4434397-3Report Type:Expedited (15-DaCompany Report #04P-087-0270005-00 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Tasmolin (Akineton) Initial or Prolonged Consciousness Health (Biperiden) Hepatic Function Abnormal Professional (Biperiden) PS ORAL 2 MG, 1 IN 1 Hypoglycaemia D, PER ORAL : Pneumonia Aspiration 3 MG, PER Protein Total Decreased ORAL Lodopin(Zotepine) (Zotepine) (Zotepine) SS ORAL 100 MG, 1 IN 1 D, PER ORAL Quetiapine SS ORAL 300 MG, 1 IN 1 D, PER ORAL SEE IMAGE Risperidone SS ORAL 3 MG, 1 IN 1 D, PER ORAL Flunitrazepam SS ORAL 2 MG , 1 IN 1 22-Feb-2006 08:31 AM Page: 1055 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report D, PER ORAL Vegetamin SS ORAL PER ORAL Date:08/26/04ISR Number: 4435100-3Report Type:Expedited (15-DaCompany Report #2004UW16877 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Agitation Health Seroquel SS ORAL 50 MG BID PO Condition Aggravated Professional Seroquel SS ORAL 100 MG BID PO Hypotension Seroquel SS ORAL 150 MG BID PO Hypothermia Seroquel SS ORAL 200 MG BID PO Mental Status Changes Seroquel SS ORAL 300 MG BID PO Paranoia Seroquel SS ORAL 400 MG BID PO Psychotic Disorder Depakote C Suspiciousness Cogentin C Clonidine C Date:08/26/04ISR Number: 4435161-1Report Type:Expedited (15-DaCompany Report #2004UW17233 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Disorientation Consumer Seroquel PS ORAL 900 MG DAILY Intervention to Fall PO Prevent Permanent Gait Disturbance Baclofen C Impairment/Damage Somnolence Vistaril C Suicidal Ideation Gabatril C Date:08/26/04ISR Number: 4435164-7Report Type:Expedited (15-DaCompany Report #2004UW17484 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Health Seroquel PS 25 OR 50 MG Initial or Prolonged Pregnancy Professional DAILY Required Neonatal Respiratory Intervention to Distress Syndrome Prevent Permanent Premature Baby Impairment/Damage Date:08/26/04ISR Number: 4435170-2Report Type:Expedited (15-DaCompany Report #2004UW17483 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Developmental Delay Health Seroquel PS TRANSPLACENTAL 75 MG QD TPL Initial or Prolonged Drug Exposure During Professional Prenatal Vitamins C Required Pregnancy Intervention to Hypotonia Neonatal Prevent Permanent Neonatal Respiratory Impairment/Damage Distress Syndrome Premature Baby Date:08/26/04ISR Number: 4435455-XReport Type:Expedited (15-DaCompany Report #2004GB02008 Age: Gender:Female I/FU:I Outcome PT Report Source Death Myocardial Infarction Foreign Health 22-Feb-2006 08:31 AM Page: 1056 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Seroquel PS TITRATED UP SLOWLY Seroquel SS ORAL 25 MG BID PO Date:08/26/04ISR Number: 4435785-1Report Type:Expedited (15-DaCompany Report #2004UW17103 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Study Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Condition Aggravated Health Seroquel SS ORAL 600 MG DAILY Medication Error Professional PO Psychotic Disorder Seroquel SS ORAL 400 MG BID PO Treatment Noncompliance Rabeprazole C Tylenol C Glyburide C Date:08/26/04ISR Number: 4435996-5Report Type:Expedited (15-DaCompany Report #2004UW08948 Age:7 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Health Seroquel PS ORAL 300 MG DAILY Intervention to Hyperglycaemia Professional PO Prevent Permanent Hypoglycaemia Lithium C Impairment/Damage Lipids Increased Tegretol C Gabitril C Date:08/26/04ISR Number: 4435997-7Report Type:Expedited (15-DaCompany Report #2004UW11794 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Exposure During Health Seroquel PS ORAL 300 MG PO Intervention to Pregnancy Professional Seroquel SS 25 TO 50 MG Prevent Permanent Pregnancy PER DAY Impairment/Damage Premature Labour Zoloft SS 100 MG DAILY Prenatal Vitamins C Date:08/26/04ISR Number: 4435998-9Report Type:Expedited (15-DaCompany Report #2004UW09823 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Study Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Schizophrenia Health PO Underdose Professional Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 600 MG DAILY PO 22-Feb-2006 08:31 AM Page: 1057 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/04ISR Number: 4437613-7Report Type:Expedited (15-DaCompany Report #2002GB00361 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Mania Foreign Quetiapine PS ORAL 400 MG DAILY Intervention to Paranoia Literature PO Prevent Permanent Health Quetiapine SS ORAL 600 MG DAILY Impairment/Damage Professional PO Other Clomipramine C Date:08/30/04ISR Number: 4436375-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498341 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Abilify PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Other Syndrome Company, Ltd. ORAL 2 DAY Seroquel SS Risperdal SS Effexor C Date:08/30/04ISR Number: 4436383-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12569737 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL 2.5 mg in AM and 5 mg in PM Depakote SS chronic use Seroquel SS 200 mg and 400 mg Date:08/30/04ISR Number: 4437414-XReport Type:Direct Company Report #CTU 225841 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ammonia Increased Seroquel 200 Mg PS 20 TABS Drug Abuser (4,000 MG) Overdose Geodon C Depakote C Cogentin C Date:08/30/04ISR Number: 4437426-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB02707 Age:64 YR Gender:Male I/FU:F Outcome PT Death Adrenal Adenoma Arrhythmia Circulatory Collapse Coronary Artery Atherosclerosis Coronary Artery Disease Drug Level Increased Gastritis Haemorrhagic Liver Disorder Myocardial Ischaemia 22-Feb-2006 08:31 AM Page: 1058 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paralysis Pulmonary Congestion Pulmonary Oedema Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Clozaril PS Novartis Sector: Urinary Incontinence Pharma ORAL 450 mg/day Clozaril SS Novartis Sector: Pharma ORAL 400 mg/day Quetiapine SS 150mg & 50 mg Sinemet C Amitriptyline C 10 mg/day Date:08/30/04ISR Number: 4438755-2Report Type:Expedited (15-DaCompany Report #2004UW17514 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alcohol Use Health Seroquel PS ORAL 200 MG PO Intervention to Overdose Professional Prevent Permanent Impairment/Damage Date:08/30/04ISR Number: 4438756-4Report Type:Expedited (15-DaCompany Report #2003UW14496 Age:47 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anxiety Initial or Prolonged Aphasia Arachnoid Cyst Arterial Thrombosis Cardiomegaly Complicated Migraine Condition Aggravated Dilatation Ventricular Disturbance In Attention Dizziness Drug Ineffective Dyskinesia Dysphasia Dyspnoea Ejection Fraction Decreased Fatigue Impulse-Control Disorder Major Depression Migraine Myoclonic Epilepsy Pain Personality Change Pollakiuria Self-Injurious Ideation Self-Medication Sleep Disorder Somnolence Suicidal Ideation Systemic Lupus Erythematosus Thirst Transient Ischaemic Attack Tremor 22-Feb-2006 08:31 AM Page: 1059 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventricular Hypertrophy Weight Decreased Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS ORAL 25 MG BID - Professional 100 MG BID PO Celexa C Trazodone C Neurontin C Celebrex C Wellbutrin C Advil C Hydroxyzine C Nexium C Fiorinal C Darvocet-N C Keppra C Steroid C Advair Diskus C Prednisone C Tylenol C Pravachol C Medrol C Vistaril C Depakote C Plaquenil C Date:08/30/04ISR Number: 4438946-0Report Type:Expedited (15-DaCompany Report #2004GB01905 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Quetiapine PS Hospitalization - Alanine Aminotransferase Health Clozaril SS ORAL 1400 MG PO Initial or Prolonged Increased Professional Zopiclone SS Dystonia Other Thyroxine C Hallucination, Auditory Ventolin C Multiple Drug Overdose Intentional Self-Injurious Ideation Suicide Attempt Date:08/30/04ISR Number: 4438950-2Report Type:Expedited (15-DaCompany Report #2004PK00937 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Foreign Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Living Impaired Health PO Chills Professional Orfiril "Desytin" SS ORAL 600 MG DAILY Lacrimal Disorder Other PO Musculoskeletal Stiffness Orfiril "Desytin" SS ORAL 1050 MG DAILY Oedema PO Parkinsonism Orfiril "Desytin" SS ORAL 1800 MG DAILY Psychiatric Symptom PO Restless Legs Syndrome Orfiril "Desytin" SS ORAL 2400 MG DAILY Tremor PO Orfiril "Desytin" SS ORAL 2100 MG DAILY PO Orfiril "Desytin" SS ORAL 1800 MG DAILY PO Orfiril "Desytin" SS ORAL 1300 MG DAILY 22-Feb-2006 08:31 AM Page: 1060 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Orfiril "Desytin" SS ORAL 1200 MG DAILY PO Orfiril "Desytin" SS ORAL 1050 MG DAILY PO Quilonorm Retard SS 450 MG DAILY Quilonorm Retard SS 675 MG DAILY Quilonorm Retard SS ORAL 450 MG DAILY PO Coaprovel C Temesta C Sortis C Aspirin Protect C Date:08/30/04ISR Number: 4438960-5Report Type:Expedited (15-DaCompany Report #2004SE03889 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Seroquel PS 200-400 MG Initial or Prolonged Health Seroquel SS ORAL 100 MG DAILY Professional PO Other Serenase C Seroxat C Date:08/30/04ISR Number: 4438965-4Report Type:Expedited (15-DaCompany Report #2004AP02335 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Increased Health PO Aspartate Professional Seroquel SS ORAL 250 MG DAILY Aminotransferase Other PO Increased Seroquel SS ORAL 100 MG DAILY Asthenia PO Blood Alkaline Seroquel SS ORAL 50 MG DAILY Phosphatase Increased PO Blood Lactate Lodopin SS ORAL 100 MG DAILY Dehydrogenase Increased PO Hepatic Function Abnormal Risperdal SS ORAL 3 MG DAILY PO Hypoglycaemia Tasmolin SS ORAL 3 MG DAILY PO Pneumonia Aspiration Tasmolin SS ORAL 2 MG DAILY PO Protein Total Decreased Rohypnol SS ORAL 2 MG DAILY PO Vegetamin SS Zyprexa C Date:08/31/04ISR Number: 4439680-3Report Type:Expedited (15-DaCompany Report #2004AP03109 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Foreign Seroquel PS ORAL 50 MG DAILY Foreign Body Aspiration Health PO Professional Doral C Other 22-Feb-2006 08:31 AM Page: 1061 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/04ISR Number: 4439691-8Report Type:Expedited (15-DaCompany Report #NLWYE771519MAY04 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Efexor Xr Initial or Prolonged Extrapyramidal Disorder Professional (Venlafaxine Nonspecific Reaction Hydrochloride, Capsule, Extended Release, 0) PS ORAL 300 MG 1X PER 1 DAY, ORAL 172 DAY Seroquel (Quetiapine, 0) SS 200 MG 1X PER 1 DAY 17 DAY Date:08/31/04ISR Number: 4439705-5Report Type:Expedited (15-DaCompany Report #2004AC00250 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Seroquel PS ORAL 900 MG DAILY Hospitalization - Coma Health PO Initial or Prolonged Dystonia Professional Temesta C Paralysis Other Anafranyl C Date:08/31/04ISR Number: 4439706-7Report Type:Expedited (15-DaCompany Report #2004PK01408 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertension Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Pseudophaeochromocytoma Health PO Prevent Permanent Tachycardia Professional Clopixol Impairment/Damage Other /00876701/ SS ORAL 125 MG DAILY PO Truxal SS ORAL 300 MG DAILY PO Zyprexa Velotab SS ORAL 10 MG DAILY PO Valium C Akineton C Date:08/31/04ISR Number: 4439707-9Report Type:Expedited (15-DaCompany Report #2004PK01416 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Foreign Seroquel PS ORAL 1200 MG DAILY Leukopenia Health PO Neutropenia Professional Seroquel SS ORAL 800 MG DAILY Other PO Seroquel SS ORAL 1200 MG DAILY PO Clozapin C Fluvoxamin C Depakine C 22-Feb-2006 08:31 AM Page: 1062 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/04ISR Number: 4439709-2Report Type:Expedited (15-DaCompany Report #2004PK01405 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Potentiation Health PO Leukopenia Professional Fluctine SS ORAL 10 MG DAILY Neutropenia Other PO Fluctine SS ORAL 20 MG DAILY PO Temesta C Supradyn C Date:08/31/04ISR Number: 4439732-8Report Type:Expedited (15-DaCompany Report #2004UW18032 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Contusion Health Seroquel PS ORAL 12000 MG ONCE Initial or Prolonged Fall Professional PO Intentional Overdose Monoplegia Rhabdomyolysis Sedation Spinal Disorder Date:08/31/04ISR Number: 4439734-1Report Type:Expedited (15-DaCompany Report #2004AC00230 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Ethanol Increased Literature Quetiapine PS Completed Suicide Health Cocaine SS Coronary Artery Professional Ethanol C Atherosclerosis Overdose Pulmonary Oedema Therapeutic Agent Toxicity Date:08/31/04ISR Number: 4440860-1Report Type:Expedited (15-DaCompany Report #2004UW18123 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Seroquel PS Convulsion Haldol C Tegretol C Date:09/01/04ISR Number: 4439733-XReport Type:Direct Company Report #CTU 226070 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Seroquel 25 Mg Astra Headache Zeneca PS Astra Zeneca ORAL 25 MG TWICE A Nausea DA ORAL Photosensitivity Reaction Seroquel 100 Mg Astra Zeneca SS Astra Zeneca ORAL 100 MG BEDTIME ORAL Cyclobenzaprine Hcl C Olanzapine C 22-Feb-2006 08:31 AM Page: 1063 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benztropine Mesylate C Chlordiazepoxide C Diazepam C Haloperidol Lactate C Trazadone Hcl C Trimethobenzamide C Folic Acid C Pantoprazole C Thiamine C Acetaminophen C Maalox Plus C Immodium C Magnesium Hydroxide C Date:09/01/04ISR Number: 4441802-5Report Type:Expedited (15-DaCompany Report #2004SE04751 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Foreign Quetiapine PS ORAL 800 MG DAILY Diabetic Ketoacidosis Literature PO 8 MON Drug Level Decreased Health Venlafaxine C Foreign Body Aspiration Professional Gastritis Other Hepatic Steatosis Poisoning Date:09/01/04ISR Number: 4441803-7Report Type:Expedited (15-DaCompany Report #DSA_23863-2004 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Temesta PS ORAL 2.5 MG Q DAY Initial or Prolonged Increased Health PO Aspartate Professional Temesta SS ORAL 2 MG QD PO Aminotransferase Other Seroquel SS ORAL 800 MG Q DAY Increased PO Drug Level Above Seroquel SS ORAL 50 MG Q DAY Therapeutic PO Seroquel SS ORAL 100 MG Q DAY PO Seroquel SS ORAL 200 MG QD DAY PO Seroquel SS ORAL 300 MG QD DAY PO Seroquel SS ORAL 400 MG QD DAY PO Seroquel SS ORAL 600 MG QD DAY PO Seroquel SS ORAL 600 MG Q DAY PO Seroquel SS ORAL 200 MG Q DAY PO Seroquel SS ORAL 100 MG Q DAY PO Truxal SS ORAL VAR Q D PO 22-Feb-2006 08:31 AM Page: 1064 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/04ISR Number: 4443398-0Report Type:Expedited (15-DaCompany Report #2004AC00230 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Quetiapine PS Health Professional Date:09/01/04ISR Number: 4443474-2Report Type:Expedited (15-DaCompany Report #2004UW15638 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Seroquel PS Brain Oedema Professional Xanax SS 0.5 MG TID Pulmonary Oedema Hydrocodone SS 7.5/500 Q8H Spleen Congestion Date:09/01/04ISR Number: 4443476-6Report Type:Expedited (15-DaCompany Report #2004UW17614 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS ORAL 500 MG PO Professional Date:09/01/04ISR Number: 4443478-XReport Type:Expedited (15-DaCompany Report #2004UW18075 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Professional Date:09/01/04ISR Number: 4443555-3Report Type:Expedited (15-DaCompany Report #B0342642A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Paxil (Paroxetine Inhibition Literature Hydrochloride) PS Extrapyramidal Disorder Health Quetiapine Parkinsonism Professional (Formulation Unknown) (Quetiapine) SS ORAL VARIABLE DOSE / ORAL Nizatidine (Formulation Unknown) (Nizatidine) SS ORAL VARIABLE DOSE / ORAL Date:09/03/04ISR Number: 4442377-7Report Type:Periodic Company Report #2004UW09268 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Seroquel PS ORAL 600 MG HS PO Fatigue Professional Crestor /Unk/ SS Somnolence Depakote C Lexapro C Lamictal C 22-Feb-2006 08:31 AM Page: 1065 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/04ISR Number: 4442380-7Report Type:Periodic Company Report #2004UW09268 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Seroquel PS ORAL 600 MG HS PO Fatigue Professional Crestor /Unk/ SS Somnolence Depakote - Slow Release C Lexapro C Lamictal C Date:09/03/04ISR Number: 4444842-5Report Type:Expedited (15-DaCompany Report #2004PK01436 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Foreign Seroquel PS ORAL 700 MG DAILY Intervention to Coordination Abnormal Health PO Prevent Permanent Drug Interaction Professional Sirdalud SS ORAL 4 MG DAILY PO Impairment/Damage Other Entumin SS ORAL 80 MG DAILY PO Orfiril SS ORAL 1 G DAILY PO Lorazepam SS ORAL 4.5 MG DAILY PO Date:09/03/04ISR Number: 4444843-7Report Type:Expedited (15-DaCompany Report #2004UW16675 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Haematocrit Decreased Foreign Seroquel PS ORAL 550 MG PO Intervention to Haemoglobin Decreased Health Citalopram C Prevent Permanent Platelet Count Decreased Professional Sinemet C Impairment/Damage Red Blood Cell Count Other Decreased White Blood Cell Count Decreased Date:09/03/04ISR Number: 4444845-0Report Type:Expedited (15-DaCompany Report #2004SE04749 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Lymphocyte Count Foreign Seroquel PS ORAL 1200 MG DAILY Intervention to Decreased Health PO Prevent Permanent Professional Solian C Impairment/Damage Other Date:09/03/04ISR Number: 4445845-7Report Type:Expedited (15-DaCompany Report #2004UW18156 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drooling Consumer Seroquel PS Intervention to Speech Disorder Lithium C Prevent Permanent Tongue Disorder Tegretol C Impairment/Damage Provigil C Neurontin C 22-Feb-2006 08:31 AM Page: 1066 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/04ISR Number: 4445858-5Report Type:Expedited (15-DaCompany Report #2004UW12429 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anaemia Health Seroquel PS ORAL 100 MG HS PO Professional Unithroid C Carbidopa C Levodopa C Mirapex "Boehringe Ringelheim" C Date:09/07/04ISR Number: 4444674-8Report Type:Expedited (15-DaCompany Report #2004AP04599 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Exposure During Foreign Seroquel PS Intervention to Pregnancy Health Prevent Permanent Drug Withdrawal Syndrome Professional Impairment/Damage Neonatal Other Neonatal Disorder Premature Baby Date:09/07/04ISR Number: 4444817-6Report Type:Direct Company Report #CTU 226500 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dysuria Seroquel 300 Mg Urinary Retention Astra/Zeneca PS Astra/Zeneca 300 MG AT BEDTIME Lexapro C Lorazepam C Date:09/07/04ISR Number: 4444976-5Report Type:Direct Company Report #CTU 226492 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Seroquel PS 300 MG Q PM Initial or Prolonged Depression Placebo SS Wellbutrin C Topomax C Effexor Xr C Trazadone C Singular C Albuterol C Date:09/07/04ISR Number: 4445060-7Report Type:Expedited (15-DaCompany Report #04P-087-0270005-00 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Tasmolin (Akineton) Initial or Prolonged Consciousness Health (Biperiden) Hepatic Function Abnormal Professional (Biperiden) PS ORAL 3 MG, 1 IN 1 Hypoglycaemia D, PER ORAL Pneumonia Aspiration Lodopin (Zotepine) SS ORAL 100 MG, 3 IN Protein Total Decreased 1 D, PER ORAL Quetiapine SS ORAL 100 MG, 3 IN 1 D, PER ORAL Risperidone SS ORAL 1 MG, 3 IN 1 22-Feb-2006 08:31 AM Page: 1067 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report D, PER ORAL Flunitrazepam SS ORAL 2 MG, 1 IN 1 D, PER ORAL Vegetamin SS ORAL PER ORAL Olanzapine C Date:09/07/04ISR Number: 4445644-6Report Type:Expedited (15-DaCompany Report #2004PK01437 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Beloc-Zok PS ORAL 200 MG QD PO Initial or Prolonged Anticholinergic Syndrome Health Seroquel SS ORAL 50 MG DAILY Confusional State Professional PO Drug Interaction Other Deroxat SS ORAL 30 MG DAILY Drug Level Increased PO Mydriasis Zyprexa SS ORAL 10 MG DAILY Tachycardia PO Temesta SS ORAL 2.5 MG DAILY PO Eltroxin "Glaxo" C Torem C Co-Diovan C Selipran C Aldactone C Marcoumar C Date:09/07/04ISR Number: 4446226-2Report Type:Expedited (15-DaCompany Report #2004UW18179 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Health Seroquel PS ORAL 300 MG PO Intervention to Fall Professional Prevent Permanent Impairment/Damage Date:09/07/04ISR Number: 4446227-4Report Type:Expedited (15-DaCompany Report #2004UW18395 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Seroquel PS Professional Date:09/07/04ISR Number: 4455138-XReport Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0344069A Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Deroxat PS Glaxosmithkline ORAL 30MG Per day 7 MON Initial or Prolonged Anticholinergic Syndrome Beloc Zok SS ORAL 200MG Per day 9 MON Confusional State Zyprexa SS ORAL 10MG Per day 9 MON Disorientation Temesta SS ORAL 2.5MG Per day 9 MON Drug Interaction Seroquel SS ORAL 50MG Per day Mydriasis Eltroxin C Glaxosmithkline ORAL .01MG Per day MON Perseveration Torem C ORAL 10MG Per day MON Tachycardia Co-Diovan C ORAL MON Selipran C ORAL 40MG Per day MON Aldactone C ORAL 25MG Per day Marcoumar C ORAL MON 22-Feb-2006 08:31 AM Page: 1068 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/04ISR Number: 4445646-XReport Type:Expedited (15-DaCompany Report #2004AC00250 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Seroquel PS ORAL 900 MG DAILY Hospitalization - Coma Health PO Initial or Prolonged Paralysis Professional Temesta C Other Anafranyl C Date:09/08/04ISR Number: 4446714-9Report Type:Expedited (15-DaCompany Report #2004IC000854 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Dalmadorm "Icn" Initial or Prolonged Consciousness Health (Flurazepam Respiratory Failure Professional Hydrochloride) (30 Sleep Apnoea Syndrome Mg) PS ORAL 30 MG;DAILY;ORAL Seroquel (Quetiapine Fumarate) SS ORAL 200 MG;X1;ORAL Zyprexa (Olanzapine)(10 Mg) SS ORAL 10MG;DAILY;OR AL Temesta (Lorazepam) (2.5mg) SS ORAL 2.5MG; 3 TIMES A DAY; ORAL Lithiofor C Depakine Chrono C Akineton C Date:09/08/04ISR Number: 4447223-3Report Type:Direct Company Report #CTU 226581 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Seroquel 50 Mg PS ORAL 50-100 MG Required Dizziness BEDTIME ORAL Intervention to Drug Ineffective Paxil SS ORAL 10 MG ONE Prevent Permanent Epistaxis PILL ORAL Impairment/Damage Impaired Work Ability Loss Of Employment Nausea Psychiatric Symptom Vision Blurred Date:09/09/04ISR Number: 4448489-6Report Type:Direct Company Report #CTU 226759 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Seroquel 25 Mg PS ORAL 2 TABS DAILY Initial or Prolonged ORAL Abilify 10 Mg SS OROPHARINGEAL 1 TAB DAILY OROPHARINGEAL 22-Feb-2006 08:31 AM Page: 1069 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/04ISR Number: 4448802-XReport Type:Expedited (15-DaCompany Report #2004AP04093 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS ORAL 100 MG TID PO Hospitalization - Increased Health Seroquel SS Initial or Prolonged Anorexia Professional Pl Gran. SS ORAL 1 G TID PO Aspartate Other Cefzon SS ORAL 100 MG TID PO Aminotransferase Hirnamin C Increased Blood Lactate Dehydrogenase Increased Bronchitis Acute Condition Aggravated Eosinophil Count Increased Eosinophilic Pneumonia Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Nasopharyngitis Pneumonia Mycoplasmal Date:09/09/04ISR Number: 4448804-3Report Type:Expedited (15-DaCompany Report #2004AP04162 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Seroquel PS ORAL 25 MG TID PO Initial or Prolonged Hypokalaemia Health Paxil SS ORAL 40 MG DAILY Serotonin Syndrome Professional PO Other Toledomin SS ORAL 25 MG DAILY PO Anafranil SS 50 MG DAILY Lexotan C Date:09/09/04ISR Number: 4448805-5Report Type:Expedited (15-DaCompany Report #2004GB02064 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 25 MG QD PO Intervention to Dyskinesia Health Seroquel SS ORAL 25 MG BID PO Prevent Permanent Eating Disorder Professional Risperidone SS 500 MG BID Impairment/Damage Emotional Distress Other Risperidone SS 500 MG QD Paranoia Tongue Disorder Tremor Date:09/09/04ISR Number: 4448809-2Report Type:Expedited (15-DaCompany Report #2004UW18223 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Foreign Seroquel PS ORAL SEE IMAGE Intervention to Anxiety Health Rivotril C Prevent Permanent Hypermetabolism Professional Paxil C Impairment/Damage Insomnia Other Remeron C Major Depression Celexa C Restlessness Trazodone C Tremor Imovane C Ativan C 22-Feb-2006 08:31 AM Page: 1070 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Interferon C Zyprexa C Date:09/09/04ISR Number: 4448811-0Report Type:Expedited (15-DaCompany Report #2004UW17434 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Motility Health Seroquel PS ORAL 300 MG PO Initial or Prolonged Disorder Professional Ileus Irritable Bowel Syndrome Megacolon Treatment Noncompliance Date:09/09/04ISR Number: 4448815-8Report Type:Expedited (15-DaCompany Report #2004AP04615 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Seroquel PS ORAL 25 MG DAILY Shock Health PO Professional Serenace C Other Date:09/09/04ISR Number: 4448816-XReport Type:Expedited (15-DaCompany Report #2004GB02074 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Foreign Seroquel PS Intervention to Decreased Health Prevent Permanent White Blood Cell Count Professional Impairment/Damage Decreased Other Date:09/10/04ISR Number: 4449138-3Report Type:Expedited (15-DaCompany Report #2004PK01482 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Consciousness Health PO Gaze Palsy Professional Zyprexa SS ORAL 10 MG DAILY Pupil Fixed Other PO Respiratory Failure Dalmadorm SS ORAL 30 MG DAILY PO Temesta SS ORAL 2.5 MG TID PO Lithiofor C Depakene Chrono C Akineton C Date:09/10/04ISR Number: 4449140-1Report Type:Expedited (15-DaCompany Report #2004PK01456 Age:62 YR Gender:Male I/FU:I Outcome PT Hospitalization - Drug Toxicity Initial or Prolonged Electrocardiogram Qt Prolonged Hypotension Overdose 22-Feb-2006 08:31 AM Page: 1071 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Suicide Attempt Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 1800 MG DAILY Health PO Professional Seroquel SS ORAL 14 G DAILY PO Other Imovane SS ORAL 7.5 MG DAILY PO Imovane SS ORAL 40 DF ONCE PO Daonil C Glucophage C Concor C Seropram C Date:09/10/04ISR Number: 4449143-7Report Type:Expedited (15-DaCompany Report #2004GB02157 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Liver Disorder Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Menstruation Irregular Consumer PO Prevent Permanent Thyroid Disorder Other Impairment/Damage Weight Increased Date:09/10/04ISR Number: 4449983-4Report Type:Periodic Company Report #S04-USA-03012-01 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Lexapro Initial or Prolonged Increased Professional (Escitalopram) PS ORAL 10 MG QD PO Aspartate Company Seroquel (Quetiapine Aminotransferase Representative Fumarate) SS ORAL 100 MG BID PO Increased Neurontin Gamma-Glutamyltransferase (Gabapentin) C Increased Lithium C Rhabdomyolysis Date:09/13/04ISR Number: 4448810-9Report Type:Expedited (15-DaCompany Report #2004UW18430 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abasia Consumer Seroquel PS Required Dysarthria Methylphenidate C Intervention to Insomnia Clonazepam C Prevent Permanent Intentional Overdose Ambien C Impairment/Damage Serotonin Syndrome Depo Provera C Fentanyl C Date:09/13/04ISR Number: 4449720-3Report Type:Direct Company Report #CTU 226893 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Ineffective Seroquel 25 Mg PS I TOOK 1 25 Tardive Dyskinesia MG TAB DAILY BY MOUTH 22-Feb-2006 08:31 AM Page: 1072 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/04ISR Number: 4449393-XReport Type:Expedited (15-DaCompany Report #2004UW18413 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Health Seroquel PS Initial or Prolonged Abnormal Professional Seroquel SS ORAL 800 MG PO Mental Disorder Depakote C Date:09/14/04ISR Number: 4449394-1Report Type:Expedited (15-DaCompany Report #2004UW18394 Age:97 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Constipation Consumer Seroquel PS ORAL 25 MG QD PO Intervention to Dysphagia Seroquel SS ORAL 25 MG PRN PO Prevent Permanent Eating Disorder Impairment/Damage Mental Impairment Tremor Date:09/14/04ISR Number: 4449395-3Report Type:Expedited (15-DaCompany Report #2004UW18452 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coordination Abnormal Health Seroquel PS 25 MG BID Intervention to Fall Professional Seroquel SS 50 MG BID Prevent Permanent Tremor Seroquel SS 400 MG DAILY Impairment/Damage Seroquel SS 600 MG DAILY Ativan C Lamictal "Glaxosmithkline" C Date:09/14/04ISR Number: 4450325-9Report Type:Expedited (15-DaCompany Report #04P-087-0271922-00 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Foreign Cefzon Capsules Hospitalization - Bronchitis Acute Health (Omnicef) (Cefdinir) Initial or Prolonged Chills Professional (Cefdinir) PS ORAL 100 MG, 3 IN Required Eosinophil Count 1 D, PER ORAL Intervention to Increased Clarith (Biaxin) Prevent Permanent Eosinophilic Pneumonia (Clarithromycin) Impairment/Damage Hepatic Function Abnormal (Clarithromycin) SS Lung Crepitation Seroquel Nasopharyngitis (Quetiapine) SS ORAL 100 MG, 3 IN Oxygen Saturation 1 D, PER ORAL Decreased : 600 MG , 1 Pneumonia Mycoplasmal IN 1 D , PER ORAL Pl Gran. SS ORAL 1 GM, 3 IN 1 D, PER ORAL Levomepromazine C Ciprofloxacin C Minocycline Hydrochloride C 22-Feb-2006 08:31 AM Page: 1073 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/04ISR Number: 4450354-5Report Type:Expedited (15-DaCompany Report #2004AP04671 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Foreign Seroquel PS Health Flucloxicillin C Professional Other Date:09/14/04ISR Number: 4450356-9Report Type:Expedited (15-DaCompany Report #2004GB01905 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Quetiapine PS NI Hospitalization - Alanine Aminotransferase Health Clozaril SS ORAL 1400 MG PO Initial or Prolonged Increased Professional Zopiclone SS Dystonia Other Thyroxine C Hallucination, Auditory Ventolin C Multiple Drug Overdose Intentional Self-Injurious Ideation Self-Medication Suicidal Ideation Suicide Attempt Date:09/14/04ISR Number: 4450508-8Report Type:Expedited (15-DaCompany Report #2004UW11874 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Seroquel PS ORAL 25 MG QAM PO Hospitalization - Syndrome Professional Seroquel SS ORAL 12.5 MG PO Initial or Prolonged Pneumonia Seroquel SS ORAL 100 MG HS PO Amitriptyline C Zyprexia C Haldol C Date:09/15/04ISR Number: 4450430-7Report Type:Expedited (15-DaCompany Report #2004AP04579 Age:28 YR Gender:Male I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Agitation Arthralgia Coma Communication Disorder Delusion Dysphagia Erythema Hip Swelling Hyperkinesia Induration Insomnia Neuroleptic Malignant Syndrome Poverty Of Speech Pyrexia Repetitive Speech Salivary Gland Disorder Screaming 22-Feb-2006 08:31 AM Page: 1074 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Wound Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 400 MG DAILY Health PO Professional Seroquel SS ORAL 300 MG DAILY Other PO Barnetil SS Barnetil SS ORAL 400 MG TID PO Barnetil SS ORAL 200 MG TID PO Valerin SS ORAL 400 MG TID PO Lodopin SS ORAL 100 MG TID PO Vegetamin A SS Levotomin SS Levotomin SS ORAL 67 MG TID PO Isomytal SS ORAL 0.2 G DAILY PO Risperdal C Date:09/15/04ISR Number: 4451548-5Report Type:Expedited (15-DaCompany Report #2004UW19062 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS ORAL 300 MG PO Overdose Professional Seroquel SS ORAL 8000 MG ONCE PO Lamictal SS Date:09/15/04ISR Number: 4452042-8Report Type:Direct Company Report #CTU 227244 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Seroquel PS 100 MG QHS Initial or Prolonged Head Injury 25MG AM Required Headache Albuterol C Intervention to Hypotension Hydroxychloroquine C Prevent Permanent Loss Of Consciousness Alprazolam C Impairment/Damage Pain In Extremity Vomiting Date:09/15/04ISR Number: 4452325-1Report Type:Expedited (15-DaCompany Report #ZANA001309 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Sirdalud (Tizanidine Coordination Abnormal Health Hydrochloride) PS ORAL 2-4 MG/DAY Depressive Delusion Professional ORAL Disease Recurrence Other Entumin (Clotiapine) SS ORAL 40-80 MG/DAY Disorientation ORAL Drug Interaction Lorazepam Gait Disturbance (Lorazepam) SS ORAL 4.5 MG/DAY Sleep Disorder ORAL Seroquel (Quetiapine Fumarate) SS ORAL 100 - 700 MG/DAY ORAL Nozinan (Levomepromazine) SS ORAL 50 MG DAILY ORAL 22-Feb-2006 08:31 AM Page: 1075 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Orfiril (Valproate Sodium) SS ORAL 1000 MG/DAY ORAL Date:09/16/04ISR Number: 4452442-6Report Type:Expedited (15-DaCompany Report #2004AP04095 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cholelithiasis Foreign Seroquel PS ORAL 200 MG TID PO Intervention to Pyrexia Health Prevent Permanent Professional Impairment/Damage Other Date:09/16/04ISR Number: 4452870-9Report Type:Expedited (15-DaCompany Report #2004UW18692 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Seroquel PS ORAL 600 MG HS PO Initial or Prolonged Depressed Level Of Professional Seroquel SS ORAL 900 MG ONCE Consciousness PO Drug Interaction Erythromycin SS 333 MG QD Hypotension Medication Error Tachycardia Date:09/16/04ISR Number: 4452875-8Report Type:Expedited (15-DaCompany Report #2004UW18894 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Health Seroquel PS Intervention to Dystonia Professional Paxil C Prevent Permanent Impairment/Damage Date:09/16/04ISR Number: 4452876-XReport Type:Expedited (15-DaCompany Report #2004UW19005 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Renal Failure Professional Diabetic Medications C Lithium C Date:09/16/04ISR Number: 4452877-1Report Type:Expedited (15-DaCompany Report #2004UW19041 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS Treatment Noncompliance Professional Date:09/16/04ISR Number: 4454302-3Report Type:Direct Company Report #CTU 227404 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Quetiapine PS Initial or Prolonged Sedation 22-Feb-2006 08:31 AM Page: 1076 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/04ISR Number: 4455652-7Report Type:Expedited (15-DaCompany Report #2004UW18973 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Communication Disorder Health PO Prevent Permanent Fall Professional Seroquel SS 100 MG DAILY Impairment/Damage Fracture Other Seroquel SS 25 MG DAILY Seroquel SS 100 MG DAILY Immovane C Acetaminophen Extra Strength C Dilantin C Date:09/17/04ISR Number: 4455653-9Report Type:Expedited (15-DaCompany Report #2004AP04093 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS ORAL 100 MG TID PO Hospitalization - Increased Health Seroquel SS ORAL 600 MG DAILY Initial or Prolonged Anorexia Professional PO Aspartate Other Pl Gran. SS ORAL 1 G TID PO Aminotransferase Cefzon SS ORAL 100 MG TID PO Increased Hirnamin C Blood Lactate Dehydrogenase Increased Bronchitis Acute Eosinophilic Pneumonia Gamma-Glutamyltransferase Increased Pneumonia Mycoplasmal Therapy Non-Responder Date:09/17/04ISR Number: 4456370-1Report Type:Expedited (15-DaCompany Report #DSA_24962_2004 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Temesta PS ORAL 2.5 MG Q DAY Initial or Prolonged Anticholinergic Syndrome Health PO Confusional State Professional Beloc Zok SS ORAL 200 MG QD PO Drug Interaction Other Deroxat SS ORAL 30 MG QD PO Drug Level Increased Deroxat SS ORAL 5 MG QD PO Mydriasis Seroquel SS ORAL 50 MG QD PO Tachycardia Zyprexa SS ORAL 10 MG QD PO Zyprexa SS ORAL 2.5 MG QD PO Eltroxin C Torem C Co-Diovan C Selipran C Aldactone C Marcoumar C Date:09/17/04ISR Number: 4456374-9Report Type:Expedited (15-DaCompany Report #DSA_24963_2004 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Other Confusional State Foreign Coordination Abnormal Health Sleep Disorder Professional 22-Feb-2006 08:31 AM Page: 1077 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Temesta PS ORAL 4.5 MG Q DAY PO Seroquel SS ORAL 700 MG Q DAY PO Sirdalud SS ORAL 4 MG Q DAY PO Entumin SS ORAL 80 MG Q DAY PO Orfiril "Desitin" SS ORAL 1 G QD PO Date:09/21/04ISR Number: 4456702-4Report Type:Expedited (15-DaCompany Report #2004UW18846 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Accident Consumer Seroquel PS ORAL 200 MG PO 1 YR Intervention to Arrhythmia Cogentin C Prevent Permanent Bradykinesia Klonopin C Impairment/Damage Bradyphrenia Cardiac Murmur Difficulty In Walking Muscle Tightness Panic Attack Throat Tightness Tremor Date:09/21/04ISR Number: 4456703-6Report Type:Expedited (15-DaCompany Report #2004UW19212 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Seroquel PS ORAL 6000 MG PO Professional Date:09/21/04ISR Number: 4456706-1Report Type:Expedited (15-DaCompany Report #2004UW19194 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Flutter Health Seroquel PS ORAL 1200 MG DAILY Intervention to Fall Professional PO Prevent Permanent Syncope Seroquel SS ORAL 600 MG DAILY Impairment/Damage PO Seroquel SS ORAL 300 MG DAILY PO Date:09/21/04ISR Number: 4456970-9Report Type:Expedited (15-DaCompany Report #2004SE05002 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Hypotension Health PO Somnolence Professional Seroquel SS ORAL 500 MG DAILY Tachycardia Other PO Hydrochlorthiazide C 22-Feb-2006 08:31 AM Page: 1078 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/04ISR Number: 4457206-5Report Type:Expedited (15-DaCompany Report #2004UW19158 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Fluctuation Consumer Seroquel PS ORAL 200 MG BID PO 3 MON Intervention to Depression Lithium C Prevent Permanent Economic Problem Lamictal C Impairment/Damage Syncope Propoxyphene C Tremor Glucovance C Visual Acuity Reduced Lorazepam C Ultrafix C Ambien C Furinol C Date:09/21/04ISR Number: 4457207-7Report Type:Expedited (15-DaCompany Report #2004UW19017 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bradycardia Health Seroquel PS ORAL 700 MG DAILY Intervention to Hepatic Failure Professional PO Prevent Permanent Renal Failure Tigan C Impairment/Damage Lasix C Epogen C Date:09/21/04ISR Number: 4457232-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040903663 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Literature Motrin Ib Other Phosphokinase Increased Health (Ibuprofen) PS ORAL ORAL Blood Fibrinogen Professional Quetiapine Increased (Quetiapine) SS ORAL ORAL Blood Ph Decreased Effexor (Venlafaxine Blood Pressure Decreased Hydrochloride) SS ORAL ORAL Convulsion Haematocrit Decreased Haemodialysis Haemoglobin Decreased Heart Rate Increased Intentional Overdose Platelet Count Decreased Red Blood Cell Count Decreased Renal Impairment Date:09/22/04ISR Number: 4457355-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040903511 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Ph Decreased Literature Acetaminophen Other Cardiac Arrest Health (Acetaminophen) PS ORAL ASPIRIN+CAFFE Hyperhidrosis Professional INE (ANACIN) Mental Impairment Aspirin+Caffeine Multiple Drug Overdose (Anacin) SS ORAL ORAL Vomiting Quetiapine (Quetiapine) SS ORAL ORAL Sertraline (Sertraline) SS 22-Feb-2006 08:31 AM Page: 1079 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/04ISR Number: 4458181-XReport Type:Expedited (15-DaCompany Report #2004SE05049 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Visual Acuity Reduced Foreign Seroquel PS ORAL 800 MG DAILY Health PO Professional Trileptal C Other Date:09/22/04ISR Number: 4458183-3Report Type:Expedited (15-DaCompany Report #2004SE05057 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dizziness Foreign Seroquel PS ORAL 300 MG DAILY Fatigue Study PO Health Zoloft C Professional Other Date:09/23/04ISR Number: 4459860-0Report Type:Expedited (15-DaCompany Report #DSA_24954_2004 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Temesta PS ORAL 2.5 MG TID PO Initial or Prolonged Consciousness Health Seroquel SS ORAL 200 MG Q DAY Eye Movement Disorder Professional PO Miosis Other Zyprexa C Pupillary Light Reflex Dalmadorm C Tests Abnormal Lithiofor C Respiratory Failure Depakin C Akineton C Date:09/24/04ISR Number: 4458173-0Report Type:Expedited (15-DaCompany Report #CA-ABBOTT-04P-028-0272719-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Epival Tablets PS ORAL 370 DAY Initial or Prolonged Condition Aggravated Epival Tablets SS ORAL 370 DAY Hepatic Enzyme Increased Ritonavir Soft Hepatotoxicity Gelatin Capsules SS ORAL 786 DAY Hypomania Ritonavir Soft Nausea Gelatin Capsules SS ORAL 786 DAY Psychotic Disorder Tipranavir SS ORAL 787 DAY Schizophrenia Procyclidine SS ORAL 151 DAY Vomiting Olanzapine SS ORAL 3 YR Olanzapine SS ORAL 3 YR Risperidone SS ORAL 46 DAY Trazodone SS ORAL Quetiapine SS ORAL 23 DAY Lamivudine C ORAL Abacavir C ORAL Paracetamol C ORAL 618 DAY Atovaquone C ORAL Calcium Carbonate C ORAL Magic Mouthwash C Nystatin C ORAL Megavim C ORAL 22-Feb-2006 08:31 AM Page: 1080 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/04ISR Number: 4462050-9Report Type:Expedited (15-DaCompany Report #2004GB02205 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Foreign Seroquel PS ORAL 200 MG BID; Initial or Prolonged Drug Toxicity Health PO Muscular Weakness Professional Seroquel SS ORAL 100 MG BID; Pallor Other PO Depakote C Date:09/27/04ISR Number: 4459403-1Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-A0525765A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Paxil PS Glaxosmithkline ORAL Confusional State Seroquel SS UNKNOWN Feeling Abnormal Unspecified Mania Medication C UNKNOWN Overdose Personality Change Suicidal Ideation Date:09/27/04ISR Number: 4459479-1Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-04P-167-0273657-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Valproate Sodium PS Initial or Prolonged Increased Quetiapine SS ORAL Pancreatitis Date:09/27/04ISR Number: 4462682-8Report Type:Expedited (15-DaCompany Report #2003UW16014 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Seroquel PS Required Blood Chloride Increased Professional Zyprexa SS ORAL 7.5 MG DAILY Intervention to Blood Potassium Increased PO Prevent Permanent Blood Sodium Increased Zyprexa SS ORAL 15 MG DAILY Impairment/Damage Blood Urea Increased PO Coma Ativan C Confusional State Vistaril C Hepatic Steatosis Metabolic Disorder Obsessive-Compulsive Disorder Pancreatic Necrosis Pancreatitis Haemorrhagic Pressure Of Speech Repetitive Speech Steatorrhoea Toxicologic Test Abnormal Date:09/27/04ISR Number: 4462685-3Report Type:Expedited (15-DaCompany Report #2004UW19322 Age:45 YR Gender:Male I/FU:I Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Hallucination, Auditory 22-Feb-2006 08:31 AM Page: 1081 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Study Seroquel PS ORAL 300 MG BID PO Health Risperdal SS ORAL 1.5 MG BID PO Professional Zoloft C Ativan C Aspirin C Date:09/27/04ISR Number: 4464574-7Report Type:Expedited (15-DaCompany Report #2004UW19372 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Disorder Foreign Seroquel PS ORAL 50 MG HS; PO Haemoglobin Decreased Consumer Seroquel SS ORAL 75 MG BID; PO Haemorrhage Other Lamotrigine C Olanzapine C Hydroxyurea C Effexor Xr C Date:09/28/04ISR Number: 4463000-1Report Type:Expedited (15-DaCompany Report #2004SE05160 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Insomnia Foreign Seroquel PS 100 MG IN THE Irritability Health MORNING AND Professional 300 AT NIGHT Other Xanor C Remeron C Date:09/28/04ISR Number: 4463002-5Report Type:Expedited (15-DaCompany Report #2004SE05193 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Foreign Seroquel PS 400 MG DIALY Intervention to Neuroleptic Malignant Health Prevent Permanent Syndrome Professional Impairment/Damage Other Date:09/28/04ISR Number: 4463003-7Report Type:Expedited (15-DaCompany Report #2004AP02335 Age:69 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased Asthenia Azotaemia Blood Alkaline Phosphatase Increased Blood Lactate Dehydrogenase Increased Hepatic Function Abnormal Hypoglycaemia Hypotension 22-Feb-2006 08:31 AM Page: 1082 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Aspiration Protein Total Decreased Weight Decreased Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Seroquel PS ORAL 300 MG DAILY Decreased Health PO Professional Seroquel SS ORAL 200 MG DAILY Other PO Seroquel SS ORAL 100 MG DAILY PO Seroquel SS ORAL 50 MG DAILY PO Lodopin SS ORAL 100 MG DAILY PO Risperdal SS ORAL 3 MG DAILY PO Tasmolin SS ORAL 3 MG DAILY PO Tasmolin SS ORAL 2 MG DAILY PO Rohypnol SS ORAL 2 MG DAILY PO Vegetamin SS Zyprexa C Date:09/28/04ISR Number: 4463012-8Report Type:Expedited (15-DaCompany Report #2004GB01912 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Foreign Quetiapine PS ORAL 325 MG PO Required Blood Creatinine Health Tranylcypromine C Intervention to Increased Professional Aspirin C Prevent Permanent Blood Pressure Decreased Other Senna C Impairment/Damage Central Venous Pressure Viscotears C Decreased Coma Convulsion Coronary Artery Atherosclerosis Cystitis Noninfective Drug Ineffective Electromechanical Dissociation Epistaxis Hepatic Congestion Mucosal Inflammation Myocardial Fibrosis Neuroleptic Malignant Syndrome Pulmonary Oedema Renal Tubular Necrosis Respiratory Failure Therapy Non-Responder Urine Output Decreased Ventricular Tachycardia Date:09/28/04ISR Number: 4463150-XReport Type:Expedited (15-DaCompany Report #2004AC00346 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 200 MG HS PO Health Effexor C Professional Corvatard C Other Fosamax C 22-Feb-2006 08:31 AM Page: 1083 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolopa C Imovane C Dulcolax C Aacifemine C Motilium C Date:09/28/04ISR Number: 4463151-1Report Type:Expedited (15-DaCompany Report #2004GB02233 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 400 MG BID PO Health Sodium Valproate SS SIMILAR DOSE Professional TO QUETIAPINE Other Date:09/29/04ISR Number: 4463814-8Report Type:Expedited (15-DaCompany Report #2004UW19849 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS Asthenia Health Clozaril SS Atherosclerosis Professional Orap SS Cardiac Arrest Other Carbamazepine C Hepatic Steatosis Clonazepam C Myocardial Ischaemia Flurazepam Obesity Hydrochloride C Pulmonary Congestion Kemadrin C Pulmonary Oedema Nova-Gabapentin C Pulmonary Thrombosis Topamax C Respiratory Arrest Somnolence Date:09/29/04ISR Number: 4465351-3Report Type:Expedited (15-DaCompany Report #2004UW14318 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Condition Aggravated Health PO Extrapyramidal Disorder Professional Seroquel SS ORAL 500 MG DAILY Insomnia PO Schizoaffective Disorder Tums C Urine Cannabinoids Cogentin C Increased Depakote C Nicoderm C Date:09/29/04ISR Number: 4465356-2Report Type:Expedited (15-DaCompany Report #2004UW19212 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Seroquel PS ORAL 6000 MG PO Therapeutic Agent Professional Celexa C Toxicity Wellbutrin C Hydroxyzine C Neurontin C 22-Feb-2006 08:31 AM Page: 1084 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/04ISR Number: 4465362-8Report Type:Expedited (15-DaCompany Report #2004UW19780 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Seroquel PS Required Professional Multiple Medications C Intervention to Prevent Permanent Impairment/Damage Date:09/29/04ISR Number: 4465370-7Report Type:Expedited (15-DaCompany Report #2004UW19583 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Other Seroquel PS ORAL 750 MG QD PO Depakote C Lorazepam C Luvox C Albuterol C Date:09/30/04ISR Number: 4465946-7Report Type:Direct Company Report #CTU 228426 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Quetiapine PS ORAL 100 MG ORAL Drug Withdrawal Syndrome Lamotrigine C Headache Clonazepam C Nausea Date:09/30/04ISR Number: 4466006-1Report Type:Expedited (15-DaCompany Report #2004GB02296 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Seroquel PS ORAL 25 MG TID PO Dilatation Ventricular Health Professional Other Date:09/30/04ISR Number: 4466025-5Report Type:Direct Company Report #CTU 228413 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Quetiapine PS ORAL 150 MG AM Hospitalization - Dehydration ORAL Initial or Prolonged Diabetic Ketoacidosis Quetiapine SS ORAL 350 MG HS ORAL Lorazepam C Levothyroxine C Valproic Acid C Rabeprazole C Citalopram C Primidone C Oxybutinin C Phenytoin C Trazodone C 22-Feb-2006 08:31 AM Page: 1085 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/04ISR Number: 4464117-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908714 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Haldol PS OROPHARINGEAL Overdose Quetiapine SS OROPHARINGEAL Phenelzine SS OROPHARINGEAL Date:10/01/04ISR Number: 4464279-2Report Type:Expedited (15-DaCompany Report #PHBS2004JP12941 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaphylactic Reaction Health Melleril PS Novartis Sector: Blood Pressure Systolic Professional Pharma ORAL Decreased Quetiapine Fumarate SS ORAL Flushing Biperiden Obstructive Airways Hydrochloride SS ORAL Disorder Eperisone Oxygen Saturation Hydrochloride SS ORAL Decreased Pco2 Decreased Tachycardia Date:10/01/04ISR Number: 4467667-3Report Type:Expedited (15-DaCompany Report #2004UW19829 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Seroquel PS Professional Date:10/01/04ISR Number: 4467799-XReport Type:Expedited (15-DaCompany Report #2004AP04599 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Exposure During Foreign Seroquel PS 600 MG DAILY Intervention to Pregnancy Health TPL Prevent Permanent Drug Withdrawal Syndrome Professional Impairment/Damage Neonatal Other Premature Baby Date:10/01/04ISR Number: 4467801-5Report Type:Expedited (15-DaCompany Report #2004UW20270 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 1200 MG DAILY Neutropenia Health PO 9 WK Professional Carbamazepine C Other Date:10/01/04ISR Number: 4467802-7Report Type:Expedited (15-DaCompany Report #2004UW20187 Age:45 YR Gender:Male I/FU:I Outcome PT Required Blood Creatine Intervention to Phosphokinase Increased Prevent Permanent Drug Withdrawal Syndrome Impairment/Damage Dysphagia 22-Feb-2006 08:31 AM Page: 1086 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Pyrexia Foreign Seroquel PS Health Sinemet SS Professional Timentin C Other Tylenol C Nitrofurantoin C Date:10/04/04ISR Number: 4467638-7Report Type:Direct Company Report #CTU 228578 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Vasovagal Seroquel 25mg PS 25MG AM Initial or Prolonged /RECENT 3 DAY Seroquel SS 100MG PM/ RECENT 3 DAY Date:10/04/04ISR Number: 4467950-1Report Type:Expedited (15-DaCompany Report #2004UW17956 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aggression Foreign Seroquel PS 1 YR Other Agitation Health Axid SS Required Medication Error Professional Intervention to Other Prevent Permanent Impairment/Damage Date:10/04/04ISR Number: 4467955-0Report Type:Expedited (15-DaCompany Report #2004UW20218 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Balance Disorder Foreign Seroquel PS ORAL 300 MG QD PO 1 MON Intervention to Difficulty In Walking Health Novo-Divalproex SS 750 MG QD 90 MON Prevent Permanent Professional Glyburide SS 10 MG BID Impairment/Damage Other Ratio-Metformin SS 2500 MG QD 2 YR Zocor Dieckmann SS Dieckmann 18 MON Date:10/05/04ISR Number: 4469756-6Report Type:Expedited (15-DaCompany Report #2004UW20190 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypotension Foreign Seroquel PS ORAL 6 G PO Intervention to Loss Of Consciousness Health Alprazolam SS ORAL 22 MG PO Prevent Permanent Multiple Drug Overdose Professional Effexor-Xr SS ORAL 9 G PO Impairment/Damage Intentional Other Date:10/05/04ISR Number: 4469758-XReport Type:Expedited (15-DaCompany Report #2004GB02251 Age:37 YR Gender:Male I/FU:I Outcome PT Required Blood Pressure Increased Intervention to Condition Aggravated Prevent Permanent Disorientation Impairment/Damage Dysarthria 22-Feb-2006 08:31 AM Page: 1087 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Mobility Decreased Neuroleptic Malignant Report Source Product Role Manufacturer Route Dose Duration Syndrome Foreign Quetiapine PS UP TO 150 MG Tachycardia Health Abilify SS UP TO 20MG Tremor Professional Paracetamol C Other Procyclidine C Melatonin C Lithium C Movicol C Date:10/05/04ISR Number: 4469762-1Report Type:Expedited (15-DaCompany Report #2004AC00397 Age:24 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Conjunctival Haemorrhage Foreign Quetiapine PS FORCED Contusion Literature ADMINISTRATIO Excoriation Health N Injury Asphyxiation Professional Medication Error Other Mouth Injury Overdose Petechiae Date:10/05/04ISR Number: 4470459-2Report Type:Direct Company Report #CTU 228903 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Geodon 30 Mg Im/Po Circulatory Collapse Pfizer PS Pfizer INTRAMUSCULAR 20 MG IM, 20 Heart Rate Increased MG PO Seroquel 100 Mg Zeneca SS Zeneca Haldol C Date:10/06/04ISR Number: 4470701-8Report Type:Expedited (15-DaCompany Report #2004AC00346 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 200 MG HS PO Health Effexor C Professional Corvatard C Other Fosamax C Prolopa C Imovane C Dulcolax C Aacifemine C Motilium C Date:10/06/04ISR Number: 4470702-XReport Type:Expedited (15-DaCompany Report #2004UW17956 Age:15 YR Gender:Female I/FU:F Outcome Disability Other Required Intervention to 22-Feb-2006 08:31 AM Page: 1088 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Aggression Foreign Seroquel PS 1 YR Agitation Health Seroquel SS ORAL 50 MG DAILY Medication Error Professional PO Other Seroquel SS 250-300 MG Axid SS Axid SS Date:10/06/04ISR Number: 4470710-9Report Type:Expedited (15-DaCompany Report #2004UW20262 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Foreign Seroquel PS 25 MG DAILY 10 DAY Consciousness Health Zyprexa SS 3.75 MG DAILY 60 DAY Musculoskeletal Stiffness Professional Phenytoin SS ORAL 300 MG DAILY Opisthotonus Other PO Citalopram SS ORAL 40 MG DAILY PO Aricept SS ORAL 10 MG DAILY PO Crestor C Acetaminophen C Aspirin (E.C.) C Multivitamins C Senna C Date:10/06/04ISR Number: 4470714-6Report Type:Expedited (15-DaCompany Report #2004UW20185 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS 106 DAY Intervention to Neutropenia Health Clozaril SS ORAL 575 MG DAILY Prevent Permanent Professional PO 3 YR Impairment/Damage Other Epival SS 89 DAY Date:10/06/04ISR Number: 4470715-8Report Type:Expedited (15-DaCompany Report #2004UW20278 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dehydration Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Urinary Retention Health PO 5 MON Prevent Permanent Urinary Tract Infection Professional Zopiclone C Impairment/Damage Other Date:10/06/04ISR Number: 4470716-XReport Type:Expedited (15-DaCompany Report #2004UW20222 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Foreign Seroquel PS ORAL 450 MG DAILY Intervention to Colitis Health PO Prevent Permanent Gastrointestinal Professional Celexa SS ORAL 10 MG DAILY Impairment/Damage Haemorrhage Other PO Divalproex Sodium SS ORAL 1375 MG DAILY PO Clozaril C ORAL 450 MG DAILY 22-Feb-2006 08:31 AM Page: 1089 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO 3 YR Date:10/06/04ISR Number: 4471353-3Report Type:Expedited (15-DaCompany Report #2004AC00424 Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Multiple Drug Overdose Health Venlafaxine SS Professional Zaleplon SS Date:10/07/04ISR Number: 4471993-1Report Type:Expedited (15-DaCompany Report #2004UW20246 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fall Foreign Seroquel PS ORAL 325 MG QD PO Intervention to Pathological Fracture Health Lorazepam SS ORAL 5 MG QD PO Prevent Permanent Professional Sertraline SS ORAL 100 MG QD PO Impairment/Damage Other Slow-K C Date:10/07/04ISR Number: 4471997-9Report Type:Expedited (15-DaCompany Report #2004UW20279 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depressed Level Of Foreign Seroquel PS ORAL 25 MG PO Intervention to Consciousness Health Citalopram SS 40 MG Prevent Permanent Sinus Tachycardia Professional Impairment/Damage Somnolence Other Date:10/07/04ISR Number: 4471999-2Report Type:Expedited (15-DaCompany Report #2004PK01601 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Phosphokinase Increased Health PO Clostridium Colitis Professional Hypotension Other Overdose Postrenal Failure Somnolence Staphylococcal Infection Urinary Retention Date:10/07/04ISR Number: 4472408-XReport Type:Expedited (15-DaCompany Report #2004UW20363 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Health Seroquel PS ORAL 25 MG PO Initial or Prolonged Dysarthria Professional Seroquel SS ORAL 50 MG PO Fatigue Schizophrenia 22-Feb-2006 08:31 AM Page: 1090 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/04ISR Number: 4472409-1Report Type:Expedited (15-DaCompany Report #2004UW20369 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Contusion Health Seroquel PS ORAL 275 MG QD PO Platelet Function Test Professional Lamictal C Abnormal Verapamil C Provigil C Ranitidine C Date:10/07/04ISR Number: 4472410-8Report Type:Expedited (15-DaCompany Report #2004UW19780 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Seroquel PS ORAL 25 MG BID PO Dementia Professional Ativan C Feeling Abnormal Aricept C Hyperhidrosis Ace Inhibitor C Resuscitation Date:10/07/04ISR Number: 4472411-XReport Type:Expedited (15-DaCompany Report #2004UW20712 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS ORAL 400 MG HS PO Professional Paxil C Abilify C Wellbutrin C Darvocet-N C Date:10/08/04ISR Number: 4469480-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041001031 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Test Risperdal PS OROPHARINGEAL Drug Interaction Quetiapine Fumarate SS OROPHARINGEAL Drug Screen Positive Zotepine SS OROPHARINGEAL Murder Etizolam SS OROPHARINGEAL Suicide Attempt Rilmazafone Hydrochloride SS OROPHARINGEAL Date:10/08/04ISR Number: 4471492-7Report Type:Direct Company Report #CTU 229180 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Seroquel 25 Mg PS ORAL 25 MG ONCE Muscle Twitching ORAL Somnolence Date:10/08/04ISR Number: 4471504-0Report Type:Direct Company Report #CTU 229183 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Seroquel 300 Mg/Day Astrazenica PS Astrazenica ORAL 300 MG DAILY ORAL 22-Feb-2006 08:31 AM Page: 1091 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/04ISR Number: 4472853-2Report Type:Expedited (15-DaCompany Report #2004UW20198 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dysphemia Foreign Seroquel PS ORAL 25 MG DIALY Intervention to Speech Disorder Health PO 2 MON Prevent Permanent Professional Gabapentin SS 300 MG DAILY 2 MON Impairment/Damage Other Date:10/08/04ISR Number: 4473876-XReport Type:Direct Company Report #CTU 229116 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Seroquel PS ORAL 1000 MG PO Sexual Dysfunction Date:10/08/04ISR Number: 4474192-2Report Type:Expedited (15-DaCompany Report #2004UW16445 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS ORAL 25 MG TID PO Hyperthermia Professional Seroquel SS ORAL 600 MG QD PO Seroquel SS ORAL 800 MG QD PO Abilify C Dostinex C Lisinopril W/Hydrochlorothiazid e C Aciphex C Androgel C Trazodone C Date:10/08/04ISR Number: 4474193-4Report Type:Expedited (15-DaCompany Report #2004UW19706 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depression Health Seroquel PS Intervention to Nightmare Professional Prevent Permanent Suicidal Ideation Impairment/Damage Date:10/08/04ISR Number: 4474304-0Report Type:Expedited (15-DaCompany Report #2004UW20543 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Event Health Seroquel PS Initial or Prolonged Drug Interaction Professional Buspar SS Date:10/11/04ISR Number: 4471057-7Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12670543 Age:61 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anaemia Macrocytic Initial or Prolonged Chronic Obstructive Pulmonary Disease Hypertension Nephrolithiasis 22-Feb-2006 08:31 AM Page: 1092 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pancreatitis Acute Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel SS ORAL Temesta C Cosaar C Norvasc C Nexium C Benerva C Becozym C Vioxx C Symbicort C Date:10/12/04ISR Number: 4474305-2Report Type:Direct Company Report #CTU 229437 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hunger Seroquel PS SEE IMAGE Hypoglycaemia Tegretol C Increased Appetite Vitamin C C Date:10/12/04ISR Number: 4474650-0Report Type:Expedited (15-DaCompany Report #2004UW20532 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemolytic Anaemia Foreign Seroquel PS ORAL 900 MG DAILY Initial or Prolonged Health PO Required Professional Lithium C Intervention to Other Neurontin C Prevent Permanent Celexa C Impairment/Damage Synthroid C Kemadrin C Date:10/12/04ISR Number: 4474686-XReport Type:Expedited (15-DaCompany Report #2004SE05160 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Insomnia Foreign Seroquel PS 100 MG IN THE Irritability Health MORNING AND Professional 300 MG AT Other NIGHT Xanor C Remeron /Net/ C Date:10/12/04ISR Number: 4474687-1Report Type:Expedited (15-DaCompany Report #2004AC00453 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Multiple Drug Overdose Literature Naproxen SS Health Topiramate SS Professional Tecnal SS Other 22-Feb-2006 08:31 AM Page: 1093 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/04ISR Number: 4474689-5Report Type:Expedited (15-DaCompany Report #2004AC00451 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Overdose Literature Health Professional Other Date:10/12/04ISR Number: 4474690-1Report Type:Expedited (15-DaCompany Report #2004AC00452 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Overdose Literature Health Professional Other Date:10/12/04ISR Number: 4475249-2Report Type:Expedited (15-DaCompany Report #2003UW16014 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Seroquel PS Required Asthenia Professional Seroquel SS 175 MG DAILY Intervention to Blood Chloride Increased Zyprexa SS ORAL 7.5 MG DAILY Prevent Permanent Blood Glucose Increased PO Impairment/Damage Blood Pressure Zyprexa SS ORAL 15 MG DAILY Immeasurable PO Blood Sodium Increased Zyprexa SS 10 MG HS Blood Urea Increased Zyprexa SS 3 DF QD Cardio-Respiratory Arrest Ativan C Coma Vistaril C Coronary Artery Disease Depo-Provera C Drug Level Increased Advil C Headache Ambien C Hepatic Steatosis Septra Ds C Metabolic Disorder Metronidazole C Pancreatic Necrosis Doxycycline C Pancreatitis Acute Temazepam C Pancreatitis Haemorrhagic Roxicet C Pulse Absent Pupil Fixed Treatment Noncompliance Urinary Tract Infection Vomiting Date:10/12/04ISR Number: 4476021-XReport Type:Expedited (15-DaCompany Report #2004070491 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Phenytoin Suspension Multiple Drug Overdose Health (Phenytoin Sodium) PS ORAL ORAL Intentional Professional .. SS Mirtazapine (Mirtazapine) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL 22-Feb-2006 08:31 AM Page: 1094 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report All Other Therapeutic Products (All Other Therapeutic Products) SS ORAL ORAL Date:10/12/04ISR Number: 4476483-8Report Type:Expedited (15-DaCompany Report #2004070519 Age:45 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Phenytoin Suspension Multiple Drug Overdose Health (Phenytoin Sodium) PS ORAL ORAL Intentional Professional Quetiapine (Quetiapine) SS ORAL ORAL Metoprolol SS ORAL ORAL Allother Therapeutic Products SS ORAL ORAL Date:10/12/04ISR Number: 4476489-9Report Type:Expedited (15-DaCompany Report #2004070501 Age:50 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Gabapentin Multiple Drug Overdose Health (Gabapentin) PS ORAL ORAL Professional Chlorpromazine (Chlorpromazine) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL All Other Therapeutic Products (All Other Therapeutic Products) SS ORAL ORAL Date:10/12/04ISR Number: 4476536-4Report Type:Expedited (15-DaCompany Report #2004071261 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Phenelzine Sulfate Other Completed Suicide Health (Phenelzine Sulfate) PS Multiple Drug Overdose Professional Haloperidol Intentional (Haloperidol) SS Quetiapine (Quetiapine) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Date:10/13/04ISR Number: 4475127-9Report Type:Direct Company Report #CTU 229515 Age:49 YR Gender:Male I/FU:I Outcome PT Hospitalization - Depressed Level Of Initial or Prolonged Consciousness Hypersomnia 22-Feb-2006 08:31 AM Page: 1095 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mental Status Changes Somnolence Report Source Product Role Manufacturer Route Dose Duration Quetiapine -Seroquel- PS ORAL 900 MG QHS ORAL Clonazepam -Klonopin- SS ORAL 0.5MG TID ORAL Risperidone -Risperdal- C Clonazepam -Klonopin- C Oxcarbazepine -Trileptal- C Quetiapine -Seroquel- C Divalproex Sodium -Depakote- C Date:10/13/04ISR Number: 4476725-9Report Type:Expedited (15-DaCompany Report #2004UW20615 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Health Seroquel PS 25-50 MG Intervention to Drug Exposure During Professional Klonopin C Prevent Permanent Pregnancy Impairment/Damage Date:10/13/04ISR Number: 4476935-0Report Type:Expedited (15-DaCompany Report #2004068910 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Zoloft (Sertraline) PS ORAL 250 MG, ORAL Initial or Prolonged Multiple Sclerosis Health Lorazepam Other Professional (Lorazepam) SS ORAL 3 MG, ORAL Company Quetiapine Representative (Quetiapine) SS ORAL 50 MG, ORAL Lorazepam (Lorazepam) C Quetiapine (Quetiapine) C Date:10/13/04ISR Number: 4477226-4Report Type:Expedited (15-DaCompany Report #A01200404816 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dermatitis Bullous Literature Iscover - Hepatic Failure Health (Clopidogrel Professional Sulfate) - Tablet 75 Mg PS ORAL 75 MG QD, ORAL (Valproate Sodium) - Tablet SS ORAL 400 MG QD, ORAL 5 DAY Augmentin Duo Forte - (Amoxicillin/Clavula 22-Feb-2006 08:31 AM Page: 1096 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report nic Acid) - Tablet SS ORAL 2 UNIT QD, ORAL 3 DAY Karvea - (Irbesartan) - Tablet SS ORAL 150 MG QD, ORAL (Quetiapine) - Tablet SS ORAL 50 MG QD, ORAL 1 WK (Calcitonin, Salmon) - Solution SS SUBCUTANEOUS 100 IU QD, SUBCUTANEOUS 6 DAY Caltrate (Calcium Carbonate) C Ostelin (Ergocalciferol) C Date:10/13/04ISR Number: 4477362-2Report Type:Expedited (15-DaCompany Report #2004AC00451 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Overdose Literature Health Professional Other Date:10/13/04ISR Number: 4477364-6Report Type:Expedited (15-DaCompany Report #2004AC00452 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Overdose Literature Health Professional Other Date:10/13/04ISR Number: 4477365-8Report Type:Expedited (15-DaCompany Report #2004AC00453 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Multiple Drug Overdose Literature Naproxen SS Health Topiramate SS Professional Tecnal SS Other Date:10/13/04ISR Number: 4477366-XReport Type:Expedited (15-DaCompany Report #2004AP04095 Age:53 YR Gender:Female I/FU:F Outcome PT Required Alanine Aminotransferase Intervention to Increased Prevent Permanent Aspartate Impairment/Damage Aminotransferase Increased Blood Alkaline Phosphatase Increased 22-Feb-2006 08:31 AM Page: 1097 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cholelithiasis Gamma-Glutamyltransferase Increased Report Source Product Role Manufacturer Route Dose Duration Hepatic Function Abnormal Foreign Seroquel PS ORAL 200 MG TID PO Jaundice Health Pyrexia Professional Other Date:10/13/04ISR Number: 4477400-7Report Type:Expedited (15-DaCompany Report #2004-06-1964 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Rinderon "Like Initial or Prolonged Increased Health Celestone Syrup" Other Aspartate Professional Tablets PS ORAL 3-5- 3MG QD Aminotransferase Other ORAL : 5MG QD Increased ORAL : 4MG QD Blood Alkaline ORAL : 3MG QD Phosphatase Increased ORAL Blood Lactate Salicylamide Oral SS ORAL 3G/D ORAL Dehydrogenase Increased Hirnamin Oral SS ORAL 50-200MG QD Drug Eruption ORAL : 50MG , Gamma-Glutamyltransferase 75MG, 150MG, Increased 200MG Hepatic Function Abnormal Akineton Oral SS ORAL 3MG QD ORAL Liver Disorder Serenace Oral SS ORAL 2-12 - 9MG QD Lymphocyte Stimulation ORAL : 2MG , Test Positive 6MG , 9MG , Scab 12 MG Aleviatin Oral SS ORAL 500-300MG QD ORAL : 500MG, 300MG Seroquel (Quetiapine Fumurate) Oral SS ORAL 200-300MG QD ORAL ; 200 MG, 300 MG Gaster Oral SS ORAL 40MG QD ORAL Tergretol Oral SS ORAL 400-600MG QD ORAL ; 400MG, 600MG Arasena A Injectable SS 600MG Contrast Dye Injectable SS Date:10/14/04ISR Number: 4475569-1Report Type:Direct Company Report #CTU 229625 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Quetiapine 100 Mg PS ORAL 100-400 MG Initial or Prolonged Blood Glucose Increased QHS ORAL Required Fatigue Citalopram C Intervention to Hyperglycaemic Hydrochlorothiazide C Prevent Permanent Hyperosmolar Nonketotic Ibuprofen C Impairment/Damage Syndrome Mirtazapine C Polydipsia Oxcarbazepine C Polyuria Simvastatin C Weight Decreased 22-Feb-2006 08:31 AM Page: 1098 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/14/04ISR Number: 4477724-3Report Type:Expedited (15-DaCompany Report #S04-USA-04304-01 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Health Lexapro Cardiac Arrest Professional (Escitalopram) PS ORAL 30 MG QD PO Coma Company Lexapro Drug Screen Positive Representative (Escitalopram) SS ORAL 10 MG QD PO Dyspnoea Lexapro Pulmonary Oedema (Escitalopram) SS ORAL 20 MG QD PO Seroquel (Quetiapine Fumarate) SS 25 MG QD Neurontin (Gabapentin) C Date:10/14/04ISR Number: 4477770-XReport Type:Expedited (15-DaCompany Report #2004073296 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Deterioration Health Geodon (Ziprasidone) PS 160 MG Pain Professional Neurontin Paraesthesia Company (Gabapentin) SS Speech Disorder Representative Quetiapine Fumarate (Quetiapine Fumarate) SS 100 MG Cannabis (Cannabis) SS Date:10/15/04ISR Number: 4475262-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041001031 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal PS OROPHARINGEAL Drug Interaction Professional Quetiapine Fumarate SS OROPHARINGEAL Overdose Zotepine SS OROPHARINGEAL Victim Of Crime Etizolam C OROPHARINGEAL Rilmazafone Hydrochloride C OROPHARINGEAL Date:10/15/04ISR Number: 4479232-2Report Type:Expedited (15-DaCompany Report #2004AP05119 Age:55 YR Gender:Male I/FU:I Outcome PT Life-Threatening Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Lactate Dehydrogenase Increased Depressed Level Of Consciousness Gamma-Glutamyltransferase Increased Hepaplastin Abnormal Hypoglycaemic Coma Liver Disorder Malnutrition 22-Feb-2006 08:31 AM Page: 1099 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prothrombin Time Prolonged Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 25 MG DAILY Health PO Professional Amoban SS ORAL 7.5 MG DAILY Other PO Wypax C Menesit C Cabaser C Permax C Metlifine C Risumic C Date:10/15/04ISR Number: 4479262-0Report Type:Expedited (15-DaCompany Report #2004AC00250 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Foreign Seroquel PS ORAL 900 MG DAILY Hospitalization - Atrioventricular Block Health PO Initial or Prolonged Bundle Branch Block Left Professional Seroquel SS ORAL 200 MG BID PO Required Coma Other Temesta C Intervention to Cyanosis Anafranyl C Prevent Permanent Paralysis Omeprazole C Impairment/Damage Dehydrobenzperidol C Date:10/15/04ISR Number: 4479265-6Report Type:Expedited (15-DaCompany Report #2004AC00453 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Multiple Drug Overdose Literature Naproxen SS Health Topiramate SS Professional Tecnal SS Other Date:10/15/04ISR Number: 4479524-7Report Type:Expedited (15-DaCompany Report #2004UW21119 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Seroquel PS Suicide Attempt Professional Oxycontin SS Surgery Date:10/15/04ISR Number: 4479527-2Report Type:Expedited (15-DaCompany Report #2004UW14830 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Health Seroquel PS ORAL 300 MG DAILY Intervention to Anger Professional PO Prevent Permanent Anxiety Concerta C Impairment/Damage Bipolar Disorder Ritalin C Depression Disease Recurrence Mood Swings Obsessive Thoughts Suicide Attempt 22-Feb-2006 08:31 AM Page: 1100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/04ISR Number: 4479529-6Report Type:Expedited (15-DaCompany Report #2004UW21097 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Myocardial Infarction Consumer Seroquel PS ORAL 200 MG DAILY Intervention to PO 2 DAY Prevent Permanent Insulin C Impairment/Damage Norvasc C Metoprolol C Unspecified Medications C Date:10/15/04ISR Number: 4511082-0Report Type:Periodic Company Report #2004012512 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Neurontin Initial or Prolonged Convulsion (Gabapentin) PS ORAL 900 MG (300 Other Hot Flush MG, TID), Panic Disorder ORAL Phenobarbital (Phenobarbital) SS ORAL 60 MG (60 MG, DAILY), ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS Oxcarbazepine (Oxcarbazepine) SS Escitalopram (Escitalopram) C Alprazolam (Alprazolam) C Clonazepam (Clonazepam) C Date:10/18/04ISR Number: 4480110-3Report Type:Expedited (15-DaCompany Report #K200401534 Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Sonata (Zaleplon) Multiple Drug Overdose Health Capsule, 5 Mg PS ORAL ORAL Intentional Professional Quetiapine (Quetiapine) SS ORAL ORAL Venlafaxine (Venlafaxine) SS ORAL ORAL Date:10/18/04ISR Number: 4480398-9Report Type:Expedited (15-DaCompany Report #2004068910 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Disorder Foreign Zoloft (Sertraline) PS ORAL 250 MG, ORAL Initial or Prolonged Demyelination Health Lorazepam Other Epilepsy Professional (Lorazepam) SS ORAL 3 MG,ORAL Multiple Sclerosis Company Quetiapine Prescribed Overdose Representative (Quetiapine) SS ORAL 50 MG,ORAL Lorazepam (Lorazepam) C Quetiapine (Quetiapine) C 22-Feb-2006 08:31 AM Page: 1101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/04ISR Number: 4480541-1Report Type:Expedited (15-DaCompany Report #2004UW20186 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Foreign Seroquel PS ORAL 100 MG PO Balance Disorder Health Apo-Doxepin C Lethargy Professional Clonazepam C Palpitations Other Date:10/19/04ISR Number: 4480542-3Report Type:Expedited (15-DaCompany Report #2004AC00452 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Overdose Literature Acetaminophen C Health Bupropion C Professional Topiramate C Other Oxycodone C Paroxetine C Date:10/19/04ISR Number: 4480543-5Report Type:Expedited (15-DaCompany Report #2004GB02407 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS ORAL 750 MG DAILY Health PO Professional Carbamazepine C Other Date:10/19/04ISR Number: 4480545-9Report Type:Expedited (15-DaCompany Report #2004AC00451 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Overdose Literature Pneumonia Viral Health Pneumonitis Professional Self-Medication Other Date:10/19/04ISR Number: 4480554-XReport Type:Expedited (15-DaCompany Report #2004PK01673 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Seroquel PS 50 T0 400 MG Initial or Prolonged Disease Recurrence Health Seroquel SS 500 TO 600 MG Galactorrhoea Professional Seroquel SS ORAL 700 MG DAILY Psychiatric Symptom Other PO Suicidal Ideation Seroquel SS ORAL 800 MG DAILY PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 400 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Clopixol SS ORAL 20 MG DAILY PO Clopixol SS ORAL 15 MG DAILY 22-Feb-2006 08:31 AM Page: 1102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Clopixol SS ORAL 10 MG DAILY PO Efexor C Topamax C Akineton Retard C Date:10/19/04ISR Number: 4480555-1Report Type:Expedited (15-DaCompany Report #2004GB02429 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Quetiapine PS 100MG - 350 Hypertension Health MG Professional Terbutaline C Other Budesonide C Date:10/19/04ISR Number: 4480556-3Report Type:Expedited (15-DaCompany Report #2004UW19607 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Health Seroquel SS ORAL 100 MG HS PO Professional Other Date:10/19/04ISR Number: 4480755-0Report Type:Expedited (15-DaCompany Report #2004UW19194 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Flutter Health Seroquel PS ORAL 1200 MG DAILY Intervention to Fall Professional PO Prevent Permanent Hypotension Seroquel SS ORAL 600 MG DAILY Impairment/Damage Syncope PO Seroquel SS ORAL 300 MG DAILY PO Date:10/19/04ISR Number: 4480763-XReport Type:Expedited (15-DaCompany Report #2004UW21280 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Consumer Seroquel PS ORAL 300 MG HS PO Required Overdose Neurontin C Intervention to Risperdal C Prevent Permanent Ativan C Impairment/Damage Remeron C Lithium C Lisinopril C Prevacid C Dilantin C Date:10/19/04ISR Number: 4480765-3Report Type:Expedited (15-DaCompany Report #2004UW18156 Age:46 YR Gender:Female I/FU:F Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 1103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Drooling Consumer Seroquel PS Dyskinesia Lithium C Food Intolerance Tegretol C Nasopharyngitis Provigil C Oral Discomfort Neurontin C Speech Disorder Nexium C Swollen Tongue Lorazepam C Lortab C Ambien C Date:10/19/04ISR Number: 4480905-6Report Type:Expedited (15-DaCompany Report #2004UW21215 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Seroquel PS ORAL 1500 MG DAILY Required Prescribed Overdose PO Intervention to Prevent Permanent Impairment/Damage Date:10/20/04ISR Number: 4482231-8Report Type:Expedited (15-DaCompany Report #2004SE05665 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS White Blood Cell Count Health Temetsa C Decreased Professional Other Date:10/20/04ISR Number: 4482234-3Report Type:Expedited (15-DaCompany Report #2004GB02395 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Seroquel PS Decreased Health Professional Other Date:10/20/04ISR Number: 4483427-1Report Type:Expedited (15-DaCompany Report #2004UW19212 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS ORAL 6000 MG PO Overdose Professional Seroquel SS ORAL 600 MG DAILY PO Celexa C Wellbutrin C Neurontin C Vistaril C Arthrotec C 22-Feb-2006 08:31 AM Page: 1104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/04ISR Number: 4483474-XReport Type:Expedited (15-DaCompany Report #S04-USA-06784-01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Health Lexapro Initial or Prolonged Priapism Professional (Escitalopram) PS ORAL 10 MG QD PO Required Company Seroquel (Quetiapine Intervention to Representative Fumarate) SS 400 MG QD Prevent Permanent Impairment/Damage Date:10/21/04ISR Number: 4483681-6Report Type:Expedited (15-DaCompany Report #2004AL000904 Age:58 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Children'S Apap Multiple Drug Overdose Elixir (Acetaminophen) (Alpharma) PS Alpharma ORAL PO Infants' Apap Drops (Acetaminophen) (Alpharma) SS Alpharma ORAL PO Aspirin/Caffeine SS ORAL PO Quetiapine SS ORAL PO Date:10/21/04ISR Number: 4484177-8Report Type:Expedited (15-DaCompany Report #2004AL000810 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Chlorpromazine Multiple Drug Overdose Hydrochloride Oral Intentional Concentrate Usp, 100mg/Ml (Alpharma) PS Alpharma ORAL PO Quetiapine SS ORAL PO Gabapentin SS ORAL PO Date:10/21/04ISR Number: 4484338-8Report Type:Expedited (15-DaCompany Report #2004AL000836 Age:32 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ibuprofen Oral Multiple Drug Overdose Suspension PS Alpharma ORAL PO Venlafaxine SS ORAL PO Quetiapine SS ORAL PO Date:10/21/04ISR Number: 4484413-8Report Type:Expedited (15-DaCompany Report #2004AL000838 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Phenytoin Oral Multiple Drug Overdose Health Suspension PS Alpharma ORAL PO Professional Quetiapine SS ORAL PO Metoprolol (Long Acting) SS ORAL PO 22-Feb-2006 08:31 AM Page: 1105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/04ISR Number: 4484425-4Report Type:Expedited (15-DaCompany Report #2004AL000670 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Phenytoin Oral Multiple Drug Overdose Suspension Usp, 125mg/5ml (Alpharma) PS Alpharma ORAL PO Mirtazapine SS ORAL PO Quetiapine SS ORAL PO Date:10/22/04ISR Number: 4484685-XReport Type:Expedited (15-DaCompany Report #2004AL000664 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Carbamazepine Completed Suicide Tablets Usp, 200mg Multiple Drug Overdose (Purepac) PS Purepac ORAL PO Respiratory Arrest Clonazepam Tablets Usp, 0.5 Mg, 1 Mg And 2 Mg (Purepac) SS Purepac ORAL PO Quetiapine SS ORAL PO Date:10/22/04ISR Number: 4485035-5Report Type:Direct Company Report #CTU 230340 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Quetiapine Fumarate PS ORAL 300MG, 100MG Initial or Prolonged AM ORAL Required Quetiapine Fumarate C Intervention to Metformin Hcl C Prevent Permanent Propranolol Hcl C Impairment/Damage Naproxen C Gemfibrozil C Hydrochlorothiazide C Paroxentine Hcl C Glipizide C Rosiglitazone Maleate C Lisinopril C Sildenafil Citrate C Date:10/22/04ISR Number: 4485435-3Report Type:Expedited (15-DaCompany Report #2004AL000694 Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Diazepam Tablets Completed Suicide Usp, 10 Mg (Purepac) PS Purepac ORAL PO Multiple Drug Overdose Bupropion SS ORAL PO Intentional Quetiapine SS ORAL PO Date:10/22/04ISR Number: 4485503-6Report Type:Expedited (15-DaCompany Report #2004AL000837 Age:15 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Fluvoxamine Maleate Multiple Drug Overdose Tablets, 25 Mg, 50 Mg And 100 Mg (Purepac) PS ORAL PO 22-Feb-2006 08:31 AM Page: 1106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydramine Cough Syrup (Diphenhydramine Hydrochloride Cough Syrup ) (Alpharma) SS Alpharma ORAL PO Hydramine Elixir (Diphenhydramine Hydrochloride Elixir) SS OPHTHALMIC PO Quetiapine SS ORAL PO Date:10/22/04ISR Number: 4485853-3Report Type:Expedited (15-DaCompany Report #2004UW15495 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Seroquel PS ORAL 100 MG HS PO Initial or Prolonged Non-Insulin-Dependent Professional Gabapentin C Required Diabetic Hyperosmolar Tramadol C Intervention to Coma Atorvastatin C Prevent Permanent Diabetic Ketoacidosis Rofecoxib C Impairment/Damage Singulair C Tamoxifen C Nexium C Cozaar C Date:10/25/04ISR Number: 4487832-9Report Type:Expedited (15-DaCompany Report #S04-CAN-07034-01 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Foreign Celexa (Citalopram Consciousness Health Hydrobromide) PS ORAL 40 MG QD PO Opisthotonus Professional Aricept (Donepezil Other Hydrochloride) SS ORAL 10 MG QD PO Seroquel (Quetiapine Fumarate) SS ORAL 25 MG QD PO Zyprexa (Olanzapine) SS ORAL 3.75 MG QD PO Phenytoin SS ORAL 300 MG QD PO Acetaminophen C Crestor (Rosuvastatin) C Asa (Acetylsalicylic Acid) C Senna C Multivitamins C Date:10/25/04ISR Number: 4488630-2Report Type:Expedited (15-DaCompany Report #2004GB02064 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dyskinesia Foreign Seroquel PS ORAL 50 MG BID PO Required Emotional Distress Health Seroquel SS ORAL 25 MG BID PO Intervention to Oral Intake Reduced Professional Thyroxine C Prevent Permanent Paranoia Other Calcium Supplements C Impairment/Damage Tremor Sulphasalazine C Lanzoprazole C 22-Feb-2006 08:31 AM Page: 1107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/04ISR Number: 4488631-4Report Type:Expedited (15-DaCompany Report #2004GB02441 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Circulatory Collapse Foreign Seroquel PS Intervention to Palpitations Health Prevent Permanent Professional Impairment/Damage Other Date:10/25/04ISR Number: 4488632-6Report Type:Expedited (15-DaCompany Report #2004GB02296 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Seroquel PS ORAL 25 MG BID PO Dilatation Ventricular Health Professional Other Date:10/25/04ISR Number: 4488633-8Report Type:Expedited (15-DaCompany Report #2004AP04095 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cholelithiasis Foreign Seroquel PS ORAL 200 MG TID PO Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:10/26/04ISR Number: 4486558-5Report Type:Direct Company Report #CTU 230486 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Geodon 80 Mg PS ORAL BID PO Intervention to Quetiapine 300 Mg SS ORAL 3 PO QHS Prevent Permanent Impairment/Damage Date:10/26/04ISR Number: 4488423-6Report Type:Expedited (15-DaCompany Report #2004043111 Age:16 YR Gender:Female I/FU:F Outcome PT Death Affect Lability Hospitalization - Affective Disorder Initial or Prolonged Anxiety Other Completed Suicide Depression Educational Problem Formication Haemorrhage Hallucination, Auditory Heart Rate Increased Injury Asphyxiation Intentional Self-Injury Irritability Laceration Overdose Parent-Child Problem Partner Stress Personality Disorder 22-Feb-2006 08:31 AM Page: 1108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharyngolaryngeal Pain Pyrexia Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Thinking Abnormal Consumer Zoloft (Sertraline) PS Quetiapine Fumarate (Quetiapine Fumarate) SS Date:10/26/04ISR Number: 4489138-0Report Type:Expedited (15-DaCompany Report #2004AC00605 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Foreign Quetiapine PS ORAL 10.7 G ONCE Hospitalization - Poisoning Literature PO Initial or Prolonged Rhabdomyolysis Health Somnolence Professional Other Date:10/26/04ISR Number: 4489228-2Report Type:Expedited (15-DaCompany Report #2004AC00606 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Quetiapine PS ORAL 19 G ONCE PO Overdose Literature Respiratory Failure Health Somnolence Professional Suicide Attempt Other Date:10/26/04ISR Number: 4489231-2Report Type:Expedited (15-DaCompany Report #2004AC00607 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Quetiapine PS ORAL 36 G ONCE PO Coma Literature Confusional State Health Drug Toxicity Professional Hyperglycaemia Other Hypotension Overdose Respiratory Acidosis Rhabdomyolysis Tachycardia Date:10/26/04ISR Number: 4489275-0Report Type:Expedited (15-DaCompany Report #2004AL000863 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Disorder Foreign Sera (Oxazepam) Initial or Prolonged Electroencephalogram Health Capsules, 30 Mg Abnormal Professional (Alpharma) PS Alpharma SEE IMAGE Simple Partial Seizures Other Seroquel SS SEE IMAGE Somnolence Depakine SS SEE IMAGE 22-Feb-2006 08:31 AM Page: 1109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/04ISR Number: 4487106-6Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0349154A Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Augmentin PS Glaxosmithkline ORAL 1000MG Twice Cerebral Haematoma per day 1 DAY Coordination Abnormal Trittico SS ORAL Cyanosis Seroquel SS ORAL Fall Temesta C ORAL Grand Mal Convulsion Zestril C ORAL Hypotonia Torem C ORAL Mouth Haemorrhage Marcumar C ORAL Respiratory Arrest Tongue Biting Date:10/27/04ISR Number: 4487621-5Report Type:Direct Company Report #CTU 230625 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Risperidone 4 Mg PS ORAL 4 MG QD ORAL Initial or Prolonged Blood Glucose Increased Quetiapine 200mg SS ORAL 400 MG QHS Required Nausea ORAL Intervention to Weight Increased Prevent Permanent Impairment/Damage Date:10/27/04ISR Number: 4490217-2Report Type:Expedited (15-DaCompany Report #2004079230 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Foreign Zeldox (Capsules) Cardiomegaly Health (Ziprasidone) PS ORAL ORAL Drug Effect Decreased Professional Quetiapine Fumarate Drug Interaction Company (Quetiapine Dyskinesia Representative Fumarate) SS ORAL 600 MG (1 IN Electrocardiogram Qt 1 D), ORAL Shortened Herbal Preparation (Herbal Preparation) SS Date:10/27/04ISR Number: 4490240-8Report Type:Expedited (15-DaCompany Report #2004AC00593 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alcohol Use Foreign Quetiapine PS ORAL 6 G ONCE PO Hospitalization - Chest X-Ray Abnormal Literature Alcohol C Initial or Prolonged Crackles Lung Health Required Electrocardiogram Qt Professional Intervention to Prolonged Prevent Permanent Extensor Plantar Response Impairment/Damage Hypotension Intentional Overdose Non-Cardiogenic Pulmonary Oedema Po2 Increased Sinus Tachycardia Strabismus 22-Feb-2006 08:31 AM Page: 1110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/04ISR Number: 4490241-XReport Type:Expedited (15-DaCompany Report #2004AP04615 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Seroquel PS ORAL 25 MG DAILY Bradycardia Health PO Cold Sweat Professional Serenace C Unresponsive To Verbal Other Alfarol C Stimuli Aspara-Ca C Loxonin C Ternelin C Toughmac E C Dops C Menesit C Date:10/27/04ISR Number: 4490742-4Report Type:Expedited (15-DaCompany Report #2004AP05093 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Cholesterol Foreign Seroquel PS ORAL 50 MG BID PO Required Increased Health Seroquel SS ORAL 75 MG DAILY Intervention to Drug Interaction Professional PO Prevent Permanent Hypertriglyceridaemia Other Seroquel SS ORAL 50 MG DAILY Impairment/Damage Increased Appetite PO Weight Increased Paxil SS ORAL 20 MG BID PO Depas C Silece C Pariet C Pursennid C Date:10/27/04ISR Number: 4490794-1Report Type:Expedited (15-DaCompany Report #2004UW21574 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Health Seroquel PS ORAL 1300 MG PO Intervention to Decreased Professional Depakote C Prevent Permanent Sinusitis Clindamycin C Impairment/Damage Skin Infection Urinary Tract Infection Date:10/27/04ISR Number: 4490795-3Report Type:Expedited (15-DaCompany Report #2004UW21581 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Health Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Poisoning Professional PO Somnolence Seroquel SS ORAL 300 MG DAILY PO Date:10/28/04ISR Number: 4490100-2Report Type:Expedited (15-DaCompany Report #2004UW21718 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Seroquel PS ORAL 450 MG DAILY Initial or Prolonged Headache PO Heart Rate Increased Seroquel SS ORAL 800 MG DAILY Muscle Rigidity PO 1 MON Schizophrenia Seroquel SS ORAL 1000 MG DAILY 22-Feb-2006 08:31 AM Page: 1111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Prolixin SS 3 DAY Abilify SS 5 DAY Risperdal C Haldol C Zyprexa C Date:10/28/04ISR Number: 4490101-4Report Type:Expedited (15-DaCompany Report #2004UW21991 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Other Seroquel PS Other Drug Toxicity Fall Hypertensive Heart Disease Medication Error Date:10/28/04ISR Number: 4490103-8Report Type:Expedited (15-DaCompany Report #2004UW21528 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Seroquel PS Initial or Prolonged Renal Failure Professional Respiratory Failure Date:10/28/04ISR Number: 4490104-XReport Type:Expedited (15-DaCompany Report #2004UW21708 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Contusion Consumer Seroquel PS ORAL 25 MG DAILY Intervention to Fall PO Prevent Permanent Sedation Namenda SS ORAL 5 MG DAILY PO Impairment/Damage Namenda SS ORAL 10 MG DAILY PO Warfarin C Multivitamins C Date:10/28/04ISR Number: 4490456-0Report Type:Expedited (15-DaCompany Report #2004SE05866 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Foreign Seroquel PS ORAL 50 MG DAILY Hospitalization - Convulsion Health PO Initial or Prolonged General Physical Health Professional Amikacina C Deterioration Other Velamox C Meningitis Bacterial Claforan C Myocardial Infarction Amplital C Myocardial Ischaemia Rocefin C Pyrexia Troponin Increased 22-Feb-2006 08:31 AM Page: 1112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/04ISR Number: 4490462-6Report Type:Expedited (15-DaCompany Report #2004UW19590 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Movement Disorder Foreign Seroquel PS ORAL 400 MG QD PO Initial or Prolonged Tic Health Epival C Disability Professional Other Date:10/28/04ISR Number: 4490540-1Report Type:Expedited (15-DaCompany Report #2004AC00250 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Foreign Seroquel PS ORAL 900 MG DAILY Hospitalization - Atrioventricular Block Health PO Initial or Prolonged Bundle Branch Block Left Professional Seroquel SS ORAL 200 MG BID PO Required Coma Other Temesta C Intervention to Cyanosis Anafranyl C Prevent Permanent Paralysis Omeprazole C Impairment/Damage Treatment Noncompliance Dehydrobenzperidol C Date:10/28/04ISR Number: 4491274-XReport Type:Expedited (15-DaCompany Report #2004PK01743 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel PS 400 TO 800 MG Initial or Prolonged Neutropenia Health Seroquel SS ORAL 400 MG DAILY Professional PO Other Leponex SS 200 TO 300 MG Leponex SS 100 TO 150 MG Leponex SS ORAL 75 MG DAILY PO Leponex SS ORAL 50 MG DAILY PO Leponex SS ORAL 25 MG DAILY PO Leponex SS ORAL 0 MG DAILY PO Leponex SS ORAL 12.5 MG DAILY PO Abilify SS ORAL 7.5 MG DAILY PO Abilify SS ORAL 15 MG DAILY PO Abilify SS ORAL 22.5 MG DAILY PO Abilify SS ORAL 30 MG DAILY PO Abilify SS ORAL 30.75 MG DAILY PO Abilify SS ORAL 0 MG DAILY PO Abilify SS ORAL 15 MG DAILY PO Abilify SS ORAL 30 MG DAILY PO Abilify SS ORAL 37.5 MG DAILY PO Madopar SS ORAL 62.5 MG DAILY PO Madopar SS ORAL 125 MG DAILY PO 22-Feb-2006 08:31 AM Page: 1113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Madopar SS ORAL 187.5 MG DAILY PO Madopar SS ORAL 250 MG DAILY PO Madopar SS ORAL 187.5 MG DAILY PO Madopar SS ORAL 125 MG DAILY PO Madopar SS ORAL 67.5 MG DAILY PO Madopar SS ORAL 0 MG DAILY PO Madopar SS ORAL 187.5 MG DAILY PO Madopar SS ORAL 250 MG DAILY PO Sinemet-Cr SS 200 DAILY Sinemet-Cr SS 400 DAILY Sinemet-Cr SS 600 DAILY Date:10/29/04ISR Number: 4488989-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741369 Age:58 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Apap + Aspirin + Professional Caffeine PS Bristol-Myers Squibb Company Quetiapine SS ORAL Date:10/29/04ISR Number: 4488990-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741401 Age:51 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Drug Reaction Health Buspirone Hcl PS Bristol-Myers Squibb Professional Company ORAL Lamotrigine SS ORAL Quetiapine SS ORAL Date:10/29/04ISR Number: 4492422-8Report Type:Expedited (15-DaCompany Report #2004GB02463 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Seroquel PS Health Professional Other Date:10/29/04ISR Number: 4492490-3Report Type:Expedited (15-DaCompany Report #2004AP-05119 Age:55 YR Gender:Male I/FU:F Outcome PT Life-Threatening Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Anti-Hbc Antibody Positive Aspartate Aminotransferase Increased 22-Feb-2006 08:31 AM Page: 1114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Alkaline Phosphatase Increased Blood Lactate Report Source Product Role Manufacturer Route Dose Duration Dehydrogenase Increased Foreign Seroquel PS ORAL 25 MG DAILY Gamma-Glutamyltransferase Health PO Increased Professional Amoban SS ORAL 7.5 MG DAILY Hepaplastin Decreased Other PO Hypoglycaemic Coma Wypax C Liver Disorder Menesit C Malnutrition Cabaser C Prothrombin Time Permax C Prolonged Metligine C Prothrombin Time Risumic C Shortened Date:10/29/04ISR Number: 4492589-1Report Type:Expedited (15-DaCompany Report #2004UW13004 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Health Seroquel PS 300 MG Intervention to Grip Strength Decreased Professional Seroquel SS 200 MG Prevent Permanent Loss Of Control Of Legs Seroquel SS 150 MG Impairment/Damage Prozac C Date:10/29/04ISR Number: 4492764-6Report Type:Expedited (15-DaCompany Report #2004S1003078 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Abnormal Consumer Apokyn (Aphmorphien Initial or Prolonged Blood Pressure Systolic Health Hcl Injection) 10 Other Decreased Professional Mg/Ml Mylan Bertex Pharmaceuticals (A Subsidiary Of Mylan PS Mylan Bertek Pharmaceuticals (A Subsidiary Of Mylan Laboratories) SUBCUTANEOUS 0.2ML - 0.4ML QID PM, SUBCUTANEOUSL Y 3 DAY Requip Tablets 5mg Glaxosmithkline SS Glaxosmithkline ORAL 5MG, QID, ORAL Seroquel Tablets 25mg Astrazeneca SS ORAL 25MG, BID, ORAL Date:11/01/04ISR Number: 4492061-9Report Type:Expedited (15-DaCompany Report #HQWYE007622OCT04 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Literature Pantozol(Pantoprazol Antipsychotic Drug Level e) PS 40 MG 1X PER Increased 1 DAY Drug Effect Decreased Doxepin (Doxepin) SS SEE IMAGE Drug Interaction Quetiapine Gastrointestinal Disorder (Quetiapine,) SS SEE IMAGE Reflux Oesophagitis Lorazepam Restlessness (Lorazepam) C 22-Feb-2006 08:31 AM Page: 1115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ofloxacin (Ofloxacin) C Date:11/01/04ISR Number: 4492088-7Report Type:Expedited (15-DaCompany Report #2004067358 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Zoloft(Sertraline) PS 100 MG (1 IN1 Disability Bipolar Ii Disorder Professional D) 1 YR Depression Escitalopram Feelings Of Worthlessness (Escitalopram) SS 10 MG (10 MG, Irritability 1 IN 1 D) 1 MON Panic Attack Valproate Semisodium Paranoia (Valproate Psychotic Disorder Semisodium) SS Sleep Disorder Olanzapine Speech Disorder (Olanzapine) SS Stress Topiramate Suicidal Ideation (Topiramate) SS 50 MG Weight Increased Quetiapine Fumarate (Quetiapine Fumarate) SS 50 MG Date:11/02/04ISR Number: 4492417-4Report Type:Direct Company Report #CTU 230960 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Seroquel 300 Mg PS 2 NIGHT Pharmaceutical Product Complaint Therapeutic Response Decreased Date:11/02/04ISR Number: 4493348-6Report Type:Expedited (15-DaCompany Report #2004UW21682 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Cancer Consumer Seroquel PS 12.5 TO 50 Intervention to Hyperthyroidism MG Prevent Permanent Loss Of Consciousness Vitamins C Impairment/Damage Narcolepsy Depakote C Road Traffic Accident Lamictal C Syncope Eskalith C Tachycardia Topamax C Date:11/02/04ISR Number: 4493349-8Report Type:Expedited (15-DaCompany Report #2004UW21888 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Seroquel PS ORAL 400 MG TID PO Professional 22-Feb-2006 08:31 AM Page: 1116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/04ISR Number: 4493876-3Report Type:Expedited (15-DaCompany Report #2004UW03638 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Menometrorrhagia Foreign Seroquel PS ORAL 25 MG BID PO Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:11/02/04ISR Number: 4493877-5Report Type:Expedited (15-DaCompany Report #2004GB02485 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agitation Foreign Quetiapine PS ORAL 100 MG DAILY Confusional State Health PO Professional Quetiapine SS DOSE REDUCED Other ON 01 OCT 2004 Date:11/02/04ISR Number: 4493878-7Report Type:Expedited (15-DaCompany Report #2004GB02508 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Foreign Seroquel PS 50-200 MG PER Intervention to Fluctuation Health DAY Prevent Permanent Bradycardia Professional Madopar SS ORAL 812.5 UG Impairment/Damage Depressed Level Of Other DAILY PO Consciousness Thyroxine C Drug Interaction Lactulose C Date:11/02/04ISR Number: 4493879-9Report Type:Expedited (15-DaCompany Report #2004UW22090 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS ORAL 300 MG PO Health Lithium C Professional Other Date:11/03/04ISR Number: 4492159-5Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0531945A Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dizziness Lamictal PS Glaxosmithkline ORAL Fall Lithium SS Glaxosmithkline Seroquel SS Date:11/03/04ISR Number: 4494627-9Report Type:Expedited (15-DaCompany Report #2004AC00591 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Quetiapine PS ORAL 750 MG DAILY Initial or Prolonged Akathisia Literature PO 6 DAY Drug Interaction Health Quetiapine SS ORAL 900 MG DAILY Drug Level Increased Professional PO Gastrointestinal Disorder Other Doxepin SS 100 MG DAILY Restlessness Lorazepam SS 4.5 MG DAILY 22-Feb-2006 08:31 AM Page: 1117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam SS 2 MG DAILY Lorazepam SS 0.5 MG DAILY Pantoprazole SS 40 MG DAILY Date:11/03/04ISR Number: 4494628-0Report Type:Expedited (15-DaCompany Report #2004GB02407 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Foreign Seroquel PS ORAL 700 MG DAILY Corrected Interval Health PO Prolonged Professional Epilim Chrono SS Pulmonary Haemorrhage Other Carbamazepine C Sudden Death Levetiracetam C Date:11/03/04ISR Number: 4494629-2Report Type:Expedited (15-DaCompany Report #2004GB02008 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel PS TITRATED UP Circulatory Collapse Health SLOWLY Deep Vein Thrombosis Professional Seroquel SS ORAL 25 MG BID PO Pulmonary Embolism Lorazepam C Treatment Noncompliance Baclofen C Clonazepam C Mirtazepine C Date:11/03/04ISR Number: 4494633-4Report Type:Expedited (15-DaCompany Report #2004UW17956 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aggression Foreign Seroquel PS 1 YR Other Agitation Health Seroquel SS ORAL 50MG DAILY PO Required Drug Interaction Professional Seroquel SS 250-300 MG Intervention to Medication Error Other Axid SS Prevent Permanent Axid SS Impairment/Damage Date:11/03/04ISR Number: 4494635-8Report Type:Expedited (15-DaCompany Report #2004IC000854 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Dalmadorm "Icn" Initial or Prolonged Consciousness Health (Flurazepam Disturbance In Attention Professional Hydrochloride) 930 Eye Movement Disorder Mg) PS ORAL 20 MG; DAILY; Miosis ORAL Pupillary Reflex Impaired Seroquel (Quetiapine Respiratory Failure Fumarate) SS ORAL 200 MG;XL; Sleep Apnoea Syndrome ORAL Zyprexa (Olanzapine) (10 Mg) SS ORAL 10 MG; DAILY; ORAL Temesta (Lorazepam) (2.5 Mg) SS ORAL 2.5 MG; 2 TIMES A DAY; ORAL Lithiofor C 22-Feb-2006 08:31 AM Page: 1118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakine Chrono C Akineton C Date:11/03/04ISR Number: 4494653-XReport Type:Expedited (15-DaCompany Report #2004UW22087 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Accidental Exposure Foreign Seroquel PS Intervention to Depressed Level Of Health Rosuvastatin C Prevent Permanent Consciousness Professional Metformn C Impairment/Damage Dizziness Other Lisinopril C Dry Mouth Dyspepsia Hypertension Inner Ear Disorder Medication Error Nausea Paraesthesia Paraesthesia Oral Date:11/03/04ISR Number: 4494654-1Report Type:Expedited (15-DaCompany Report #2004AC00666 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Coma Foreign Seroquel PS ORAL 1100 MG DAILY Hospitalization - Ketoacidosis Health PO Initial or Prolonged Pancreatitis Professional Seroquel SS ORAL 600 MG DAILY Required Weight Increased Other PO Intervention to Staurodorm C Prevent Permanent Etumine C Impairment/Damage Inderal C Xalatan C Timoptol C Aldactazine C Date:11/03/04ISR Number: 4494656-5Report Type:Expedited (15-DaCompany Report #2004AP05472 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Seroquel PS Flushing Literature Levomepromazine SS Oxygen Saturation Health Propofol C Decreased Professional Vecuronium C Other Fentanyl C Nitrous Oxide C Oxygen C Sevoflurane C Lidocaine C Date:11/03/04ISR Number: 4494658-9Report Type:Expedited (15-DaCompany Report #2004AC00250 Age:62 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:31 AM Page: 1119 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 Abnormal Behaviour Foreign Seroquel PS ORAL 900 MG DAILY Atrioventricular Block Health PO Bundle Branch Block Left Professional Seroquel SS ORAL 200 MG BID PO Coma Other Temesta C Cyanosis Anafranyl C Paralysis Omeprazole C Dehydrobenzperidol C Date:11/03/04ISR Number: 4494805-9Report Type:Expedited (15-DaCompany Report #2004-BP-10340RO Age:52 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Diazepam Intensol Completed Suicide Oral Solution Multiple Drug Overdose (Concentrate), 5 Intentional Mg/Ml (Diazepam) PS Bupropion (Bupropion) SS Quetiapine (Quetiapine) SS Date:11/03/04ISR Number: 4494826-6Report Type:Expedited (15-DaCompany Report #2004-BP-10326RO Age:47 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Mirtazapine Tablets, Multiple Drug Overdose 15 Mg (Mirtazapine) PS Intentional Phenytoin (Phenytoin) SS Quetiapine (Quetiapine) SS Date:11/04/04ISR Number: 4498334-8Report Type:Expedited (15-DaCompany Report #2004068910 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Zoloft (Sertraline) PS ORAL 250 MG (50 Initial or Prolonged Multiple Sclerosis Health MG, 1 D), Other Professional ORAL Company Lorazepam Representative (Lorazepam) SS ORAL 5 MG, ORAL Quetiapine (Quetiapine) SS ORAL 50 MG, ORAL Date:11/05/04ISR Number: 4493651-XReport Type:Expedited (15-DaCompany Report #US-ABBOTT-04P-163-0279336-00 Age:18 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Valproic Acid PS ORAL Colchicine SS ORAL Quetiapine SS ORAL 22-Feb-2006 08:31 AM Page: 1120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/04ISR Number: 4493762-9Report Type:Expedited (15-DaCompany Report #US-ABBOTT-04P-163-0279319-00 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Valproic Acid (Depakote Er) PS ORAL Venlafaxine SS ORAL Quetiapine SS ORAL Date:11/05/04ISR Number: 4497954-4Report Type:Expedited (15-DaCompany Report #2004UW22388 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Seroquel PS ORAL 200 MG PO 6 WK Initial or Prolonged Dyskinesia Professional Serzone SS 200 MG Other Feeling Hot And Cold Wellbutrin C Medication Error Restlessness Tic Date:11/05/04ISR Number: 4497955-6Report Type:Expedited (15-DaCompany Report #2004UW13226 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Seroquel PS ORAL 900 MG DAILY Blood Creatine Professional PO Phosphokinase Increased Neurontin C Musculoskeletal Stiffness Effexor C Myalgia Nausea Restless Legs Syndrome Vomiting Date:11/05/04ISR Number: 4498436-6Report Type:Expedited (15-DaCompany Report #2004AC00666 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bronchopneumonia Foreign Seroquel PS ORAL 1100 MG DAILY Hospitalization - Diabetic Coma Health PO Initial or Prolonged Diabetic Ketoacidosis Professional Seroquel SS ORAL 600 MG DAILY Required Pancreatitis Other PO Intervention to Upper Respiratory Tract Staurodorm C Prevent Permanent Infection Etumine C Impairment/Damage Weight Increased Inderal C Xalatan C Timoptol C Aldactazine C Date:11/05/04ISR Number: 4498437-8Report Type:Expedited (15-DaCompany Report #2004GB02540 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bilirubin Conjugated Foreign Seroquel PS ORAL 25 MG BID PO Intervention to Increased Health Zopiclone C Prevent Permanent Professional Lactulose C Impairment/Damage Other Donepezil C 22-Feb-2006 08:31 AM Page: 1121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/04ISR Number: 4498482-2Report Type:Expedited (15-DaCompany Report #2004GB02468 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Dizziness Study PO Fall Health Atenolol SS ORAL 20 MG QD PO Upper Limb Fracture Professional Aspirin C Other Paracetamol C Amitriptyline C Senna C Atorvastatin C Date:11/08/04ISR Number: 4495498-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908714 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxia Haldol PS OROPHARINGEAL Cardio-Respiratory Arrest Quetiapine SS OROPHARINGEAL Coma Phenelzine SS OROPHARINGEAL Completed Suicide Clonazepam SS Multiple Drug Overdose Intentional Date:11/08/04ISR Number: 4498725-5Report Type:Expedited (15-DaCompany Report #2004UW22508 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Other Seroquel PS Victim Of Homicide Alprazolam SS Date:11/08/04ISR Number: 4498970-9Report Type:Expedited (15-DaCompany Report #2004AC00625 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Quetiapine PS ORAL 200 MG DAILY Initial or Prolonged Schizophrenia Health PO Professional Lithium Carbonate C Other Date:11/09/04ISR Number: 4500793-9Report Type:Expedited (15-DaCompany Report #HQWYE165129OCT04 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Health Effexor (Venlafaxine Cardiac Failure Professional Hydrochloride) PS ORAL 150 MG TWICE Cardiomegaly DAILY AND 75 Disease Recurrence MG AT HS, Drug Interaction ORAL Drug Level Increased Seroquel Electrocardiogram Qt (Quetiapine) SS 100 MG 1 X Prolonged PER 1 DAY Pelvic Pain Trazodone Pulmonary Oedema (Trazodone) C Topamax (Topiramate) C Flexeril (Cyclobenzaprine Hydrochloride) C 22-Feb-2006 08:31 AM Page: 1122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zetia (Ezetimibe) C Singulair (Montelukast Sodium) C Metformin (Metformin) C Actos (Pioglitazone Hydrochloride) C Cozaar (Losartan Potassium) C Lovastatin (Lovastatin) C Vicodin (Hydrocodone Bitartrate/Paracetam ol) C Morphine Sulfate (Morphine Sulfate) C Date:11/09/04ISR Number: 4501684-XReport Type:Expedited (15-DaCompany Report #2004AC00675 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS ORAL 200 MG QID PO Intervention to Diabetes Mellitus Health Seroquel SS ORAL 200 MG QID PO Prevent Permanent Fatigue Professional Effexor C Impairment/Damage Other No Match C Maniprex C Asaflow C Trazolan C Loramet C Lantus C Date:11/09/04ISR Number: 4501685-1Report Type:Expedited (15-DaCompany Report #2004AC00641 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Epilepsy Health PO Hyperprolactinaemia Professional Seroquel SS ORAL 500 MG DAILY Other PO Sreoquel SS ORAL 200 MG BID PO Redomex C Impromen C Akineton C Effortil C Seroxat C Xanax Retard C Date:11/09/04ISR Number: 4501873-4Report Type:Expedited (15-DaCompany Report #2004068910 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Zoloft (Sertraline) PS ORAL 250 MG (50 Initial or Prolonged Multiple Sclerosis Health MG, 1 D), Other Professional ORAL Company Lorazepam Representative (Lorazepam) SS ORAL 5 MG, ORAL Quetiapine (Quetiapine) SS ORAL 50 MG, ORAL 22-Feb-2006 08:31 AM Page: 1123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/04ISR Number: 4501409-8Report Type:Expedited (15-DaCompany Report #2004UW21718 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Consumer Seroquel PS ORAL 450 MG DAILY Initial or Prolonged Drug Ineffective PO Dysuria Seroquel SS ORAL 800 MG DAILY Headache PO 1 MON Heart Rate Increased Seroquel SS ORAL 1000 MG DAILY Joint Stiffness PO Schizophrenia Seroquel SS ORAL 1100 MG DAILY Tongue Disorder PO Prolixin SS 3 DAY Abilify SS 5 DAY Risperdal C Haldol C Zyprexa C Date:11/10/04ISR Number: 4502446-XReport Type:Expedited (15-DaCompany Report #2004AC00606 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Quetiapine PS ORAL 19 G ONCE PO Overdose Literature Respiratory Failure Health Somnolence Professional Suicide Attempt Other Date:11/10/04ISR Number: 4502617-2Report Type:Expedited (15-DaCompany Report #DEWYE165502NOV04 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Foreign Trevilor Retard Initial or Prolonged Intentional Overdose Health Loss Of Consciousness Professional (Venlafaxine Other Hydrochloride) PS ORAL ORAL 1 DAY Remergil (Mirtazapine) SS ORAL ORAL 1 DAY Seroquel (Quetiapine Fumarate) SS ORAL ORAL 1 DAY Unspecified Antidepressant (Unspecified Antidepressant) SS ORAL ORAL Unspecified Benzodiazepine (Unspecified Benzodiazepine) SS ORAL ORAL 1 DAY Date:11/11/04ISR Number: 4499223-5Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0350871A Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Augmentin PS Glaxosmithkline ORAL 2G Per day 2 DAY Grand Mal Convulsion Seroquel SS ORAL 300MG Per day Periorbital Haematoma Trittico SS ORAL 100MG Per day Zestril C ORAL 5MG Per day Torem C ORAL 10MG Per day 22-Feb-2006 08:31 AM Page: 1124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Marcoumar C ORAL Date:11/12/04ISR Number: 4502715-3Report Type:Expedited (15-DaCompany Report #2004UW20464 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Cold Health Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Hot Flush Professional PO Night Sweats Date:11/12/04ISR Number: 4502909-7Report Type:Expedited (15-DaCompany Report #2004UW03389 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Cholesterol Health Seroquel PS ORAL 600 MG QD PO Required Increased Professional Lexaro C Intervention to Blood Triglycerides Zyprexa C Prevent Permanent Increased Impairment/Damage Cataract Face Oedema Impaired Healing Oedema Peripheral Retinal Detachment Weight Increased Date:11/12/04ISR Number: 4502912-7Report Type:Expedited (15-DaCompany Report #2004UW18123 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Seroquel PS ORAL 25 MG BID - Hospitalization - Anxiety Professional 250 MG TID PO Initial or Prolonged Coma Tegretol SS ORAL 400 MG 2 TABS Convulsion BID- 400 MG 3 Personality Change TABS QPM PO Haladol C Keppra C Date:11/12/04ISR Number: 4502915-2Report Type:Expedited (15-DaCompany Report #2004UW19322 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Seroquel PS ORAL 300 MG BID PO Initial or Prolonged Hallucination, Auditory Health Risperdal SS ORAL 1.5 MG BID PO Psychotic Disorder Professional Zoloft C Suicidal Ideation Ativan C Aspirin C Date:11/12/04ISR Number: 4502916-4Report Type:Expedited (15-DaCompany Report #2004UW16205 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Paralysis Consumer Seroquel PS ORAL 200 MG PO Required Seroquel SS ORAL 25 MG PO Intervention to Remeron C Prevent Permanent Ativan C Impairment/Damage Ambien C 22-Feb-2006 08:31 AM Page: 1125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/04ISR Number: 4503083-3Report Type:Expedited (15-DaCompany Report #2004SE06147 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS ORAL 500 MG DAILY Health PO Professional Subutex SS Other Rivotril C Truxal C Buronil C Imovane C Date:11/12/04ISR Number: 4503151-6Report Type:Expedited (15-DaCompany Report #2004AP05093 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 50 MG BID PO Intervention to Hypertriglyceridaemia Health Seroquel SS ORAL 75 MG DAILY Prevent Permanent Increased Appetite Professional PO Impairment/Damage Weight Increased Other Seroquel SS ORAL 50 MG DAILY PO Paxil SS ORAL 20 MG BID PO Depas C Silece C Pariet C Date:11/12/04ISR Number: 4503155-3Report Type:Expedited (15-DaCompany Report #2004AP05119 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS ORAL 25 MG DAILY Hospitalization - Increased Health PO Initial or Prolonged Anti-Hbc Antibody Professional Amoban SS ORAL 7.5 MG DAILY Positive Other PO Aspartate Wypax C Aminotransferase Menesit C Increased Cabaser C Blood Alkaline Permax C Phosphatase Increased Metligine C Blood Lactate Risumic C Dehydrogenase Increased Depressed Level Of Consciousness Gamma-Glutamyltransferase Increased Hepaplastin Abnormal Hypoglycaemic Coma Liver Disorder Malnutrition Prothrombin Time Prolonged Date:11/12/04ISR Number: 4503369-2Report Type:Expedited (15-DaCompany Report #2004AC00669 Age:48 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 1126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Foreign Seroquel PS ORAL 100 MG BID PO Constipation Health Fevarin C Decreased Activity Professional Decreased Interest Other Depression Disturbance In Attention Fatigue Feeling Abnormal Muscular Weakness Trismus Weight Increased Date:11/15/04ISR Number: 4500620-XReport Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12753075 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Abilify PS Otsuka Initial or Prolonged Consciousness Pharmaceutical Drug Interaction Company, Ltd. ORAL Levlen C Mylanta C Seroquel I Midazolam I INTRAMUSCULAR Droperidol I INTRAMUSCULAR Lamictal I ORAL Diazepam I ORAL Epilim I ORAL Date:11/15/04ISR Number: 4501747-9Report Type:Direct Company Report #CTU 231996 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Seroquel PS Intervention to Celexa C Prevent Permanent Xanax C Impairment/Damage Date:11/15/04ISR Number: 4501842-4Report Type:Direct Company Report #CTU 231962 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Seroquel 300 Mg Tab PS Hospitalization - Supraventricular Methocarbamol C Initial or Prolonged Tachycardia Ranitidine C Required Sertraline C Intervention to Timolol 0.5% Ophth Prevent Permanent Sol C Impairment/Damage Tramadol C Fentanyl C Morphine Sulfate C Salsalate C Albuterol Oral Ihn C Gabapentin C Methocarbamol C Omeprazole C 22-Feb-2006 08:31 AM Page: 1127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Etodolac C Gabapentin C Baclofen C Mutlivitamin C Piroxicam C Senna C Travoprost 0.004% Ophth Sol C Docusate C Nicotine Chewing Gum C Diphenhydramine C Cyclobenzaprine C Diazepam C Hydrocodone 5.0 Mg/Acetaminophen C Date:11/15/04ISR Number: 4504127-5Report Type:Expedited (15-DaCompany Report #2003UW16014 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Seroquel PS Abdominal Pain Upper Professional Seroquel SS 175 MG DAILY Asthenia Zyprexa SS ORAL 7.5 MG DAILY Back Pain PO Cardio-Respiratory Arrest Zyprexa SS ORAL 15 MG DAILY Coma PO Coronary Artery Disease Zyprexa SS 10 MG HS Dizziness Zyprexa SS 3 DF QD Drug Level Increased Ativan C Headache Vistaril C Hepatic Steatosis Depo-Provera C Impaired Work Ability Not Match C Metabolic Disorder Advil C Pancreatic Necrosis Ambien C Pancreatitis Haemorrhagic Septra Ds C Paracentesis Eye Abnormal Metronidazole C Vomiting Doxycycline C Temazepam C Roxicet C Date:11/16/04ISR Number: 4502896-1Report Type:Direct Company Report #CTU 232013 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Euphoric Mood Paxil PS Apotex Pharmaceutical Product Seroquel SS Complaint Somnolence Date:11/16/04ISR Number: 4502948-6Report Type:Direct Company Report #CTU 232172 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Seroquel PS ORAL 200 MG AM Hospitalization - Syndrome ORAL : 600 Initial or Prolonged MG HS ORAL Zoloft C 22-Feb-2006 08:31 AM Page: 1128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/04ISR Number: 4505025-3Report Type:Expedited (15-DaCompany Report #2004SE06150 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Quetiapine PS ORAL 800 MG DAILY Initial or Prolonged Schizophrenia Health PO Professional Quetiapine SS ORAL 1000 MG DAILY Other PO Quetiapine SS ORAL 1200 MG DAILY PO Quetiapine SS ORAL 1400 MG DAILY PO Quetiapine SS ORAL 1600 MG DAILY PO Quetiapine SS ORAL 1200 MG DAILY PO Date:11/16/04ISR Number: 4505027-7Report Type:Expedited (15-DaCompany Report #2004SE06134 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Quetiapine PS ORAL 600 MG QD PO Initial or Prolonged Schizophrenia Health Professional Other Date:11/16/04ISR Number: 4505180-5Report Type:Expedited (15-DaCompany Report #2004UW18413 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Health Seroquel PS Intervention to Aggression Professional Seroquel SS ORAL 50 MG QID PO Prevent Permanent Alcoholism Seroquel SS ORAL 100 MG BID PO Impairment/Damage Anxiety Seroquel SS ORAL 50 MG PO Asthenia Seroquel SS ORAL 400 MG PO Confusional State Seroquel SS ORAL 600 MG PO Delusion Seroquel SS ORAL 800 MG PO Disturbance In Attention Depakote SS ORAL 1000 MG QD PO Drug Toxicity Alcohol SS MG Haematospermia Hepatic Function Abnormal Hepatic Steatosis Hyperkinesia Liver Function Test Abnormal Loss Of Consciousness Paraesthesia Paranoia Psychotic Disorder Radial Nerve Palsy Speech Disorder Treatment Noncompliance Date:11/16/04ISR Number: 4525583-2Report Type:Periodic Company Report #S04-USA-06452-01 Age:78 YR Gender:Female I/FU:I Outcome PT Contusion Fall 22-Feb-2006 08:31 AM Page: 1129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Report Source Product Role Manufacturer Route Dose Duration Consumer Namenda (Memantine) PS ORAL 10 MG QD PO Namenda (Memantine) SS ORAL 5 MG QD PO Seroquel (Quetiapine Fumarate) SS 25 MG QD Warfarin C Multivitamins C Date:11/17/04ISR Number: 4504355-9Report Type:Direct Company Report #CTU 232347 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Seroquel 100 Mg PS ORAL 100 MG PO QHS Hospitalization - Increased Abilify C Initial or Prolonged Myalgia Zoloft C Neuroleptic Malignant Wellbutrin C Syndrome Clonazepam C Date:11/17/04ISR Number: 4504434-6Report Type:Direct Company Report #CTU 232346 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Seroquel 100 Mg PS ORAL 100 MG PO BID 6 MON Initial or Prolonged Communication Disorder Risperdal 2 Mg SS ORAL 2 MG PO QHS 6 MON Neuroleptic Malignant Zoloft C Syndrome Valproic Acid C Date:11/17/04ISR Number: 4504471-1Report Type:Direct Company Report #CTU 232322 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Seroquel 100mg Initial or Prolonged Mental Status Changes Tablet PS ORAL 100MG HS, BY MOUTH Prednisone Tab C Chlordiazepoxide Cap C Nicotine Transdermal Patch C Insulin, Human Reg, Novolin-R C Oxycodone/Acetaminop hen C Trazodone Hcl (Desyrel) Tab C Sertraline Hcl (Zoloft) Tab C Gabapentin Cap C Simvastatin (Zocor) Tab C Lisinopril Tab C Omeprazole (Prilosec For Inpatient Use) Cap, Sa C Thiamine Hcl Tab C Folic Acid Tab C Metoprolol Tartrate 22-Feb-2006 08:31 AM Page: 1130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tab C Diazepam Inj C Clopidogrel Bisulfate Tab C Aspirin Tab C Date:11/17/04ISR Number: 4505145-3Report Type:Direct Company Report #CTU 232218 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Quetinpine PS 400 ML QHS Initial or Prolonged Methadone SS 5 ML Q 8 H Lorazepam SS 0.5 ML BID 1M Q HS Asa C Plavix C Lopid C Lisinopril C Metoprolol C Naproxen C Date:11/17/04ISR Number: 4506760-3Report Type:Expedited (15-DaCompany Report #2004UW23116 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Other Seroquel PS ORAL 500 MG PO Required Medication Error Ferro-Sequels SS 500 MG Intervention to Mental Disorder Prevent Permanent Impairment/Damage Date:11/17/04ISR Number: 4506763-9Report Type:Expedited (15-DaCompany Report #2004UW22782 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Mydriasis Consumer Seroquel PS ORAL 50 MG PO 5 DAY Intervention to Myopia Prevent Permanent Nervousness Impairment/Damage Date:11/17/04ISR Number: 4506953-5Report Type:Expedited (15-DaCompany Report #2004AP04095 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Foreign Seroquel PS ORAL 200 MG TID PO Intervention to Increased Health Prevent Permanent Aspartate Professional Impairment/Damage Aminotransferase Other Increased Blood Alkaline Phosphatase Increased Cholelithiasis Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Jaundice Pyrexia 22-Feb-2006 08:31 AM Page: 1131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4506985-7Report Type:Expedited (15-DaCompany Report #2004AP04615 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Seroquel PS ORAL 25 MG DAILY Bradycardia Health PO Cold Sweat Professional Serenace C Shock Other Alfarol C Unresponsive To Verbal Aspra-Ca C Stimuli Loxonin C Ternelin C Toughmac E C Dops C Menesit C Date:11/17/04ISR Number: 4506988-2Report Type:Expedited (15-DaCompany Report #2004SE06199 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Obsessive-Compulsive Foreign Seroquel PS ORAL 1400 MG DAILY Disorder Health PO Prescribed Overdose Professional Rivotril C Other Yasmin C Nozinan C Date:11/18/04ISR Number: 4505330-0Report Type:Direct Company Report #CTU 232354 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Seroquel 25mg / Initial or Prolonged Fall Astra Zeneca PS Astra Zeneca ORAL 25 MG PO HS Head Injury Hyzaar C Hyperglycaemia Ekelon C Date:11/18/04ISR Number: 4507091-8Report Type:Expedited (15-DaCompany Report #B0349825A Age:52 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Wellbutrin Sr Completed Suicide Health Tablet-Controlled Drug Screen Positive Professional Release (Bupropion Hydrochloride) PS ORAL ORAL Quetiapine (Formulation Unknown) (Quetiapine) SS ORAL ORAL Diazepam (Formulation Unknown) (Diazepam) SS ORAL ORAL Date:11/18/04ISR Number: 4507845-8Report Type:Expedited (15-DaCompany Report #2004PK01919 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS 100 - 600 MG Intervention to Neutropenia Health Seroquel SS ORAL 900 MG DAILY Prevent Permanent Professional PO Impairment/Damage Other Seroquel SS ORAL 1200 MG DAILY 22-Feb-2006 08:31 AM Page: 1132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Seroquel SS ORAL 1350 MG DAILY PO Seroquel SS ORAL 1200 MG DAILY PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 700 MG DAILY PO Date:11/18/04ISR Number: 4507851-3Report Type:Expedited (15-DaCompany Report #2004PK01930 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Seroquel PS ORAL 600 MG DAILY Life-Threatening Health PO Professional Other Date:11/18/04ISR Number: 4508035-5Report Type:Expedited (15-DaCompany Report #2004PK01913 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Corrected Interval Health PO Prolonged Professional Seroquel SS ORAL 100 MG DAILY Fibrin D Dimer Increased Other PO Hyperthermia Seroquel SS ORAL 600 MG DAILY Hypoaesthesia PO Sensation Of Heaviness Seroquel SS ORAL 450 MG DAILY Venous Thrombosis PO Melneurin SS ORAL 25 MG DAILY PO Akineton Retard C Date:11/18/04ISR Number: 4512888-4Report Type:Direct Company Report #CTU 232456 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Nervous System Disorder Seroquel 100 Mg Tabs Required Sensory Disturbance (Qd + Bid Depending Intervention to Visual Acuity Reduced On Her Prevent Permanent Record)*Dosing Impairment/Damage Directions Were PS Astra Zeneca ORAL 100 MG QD PO; 200MG QD, PO .. C Lac-Hydrin 12% C Synthroid C Tampon Use C Celexa C Date:11/19/04ISR Number: 4510037-XReport Type:Expedited (15-DaCompany Report #2004UW10204 Age:88 YR Gender:Female I/FU:F Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 1133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Foreign Seroquel PS ORAL 112.5 MG - Aggression Health 150 MG DAILY Agitation Professional PO Condition Aggravated Other Gentamicin SS Confusional State Risperidone C Depressed Level Of Ativan C Consciousness Dysarthria Dyskinesia Dyspnoea Hypertension Hypotension Speech Disorder Stupor Thinking Abnormal Urinary Tract Infection Visual Disturbance Weight Increased Date:11/19/04ISR Number: 4510039-3Report Type:Expedited (15-DaCompany Report #2004AC00675 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS ORAL 200 MG QID PO Intervention to Diabetes Mellitus Health Seroquel SS ORAL 200 MG TID PO Prevent Permanent Fatigue Professional Effexor C Impairment/Damage Treatment Noncompliance Other Maniprex C Asaflow C Trazolan C Loramet C Lantus C Date:11/22/04ISR Number: 4509007-7Report Type:Direct Company Report #CTU 232578 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Quetiapine PS ORAL 25 MG QHS Initial or Prolonged Fall ORAL Mental Status Changes Amantadine SS ORAL 100 MG DAILY Tardive Dyskinesia ORAL Metformin -Glucophage C Valproic Acid -Depakote C Benztropine -Cogentin C Rivastigmine -Exelon C Amlodipine C Date:11/22/04ISR Number: 4510200-8Report Type:Direct Company Report #USP 56932 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Ferro-Sequels PS Inverness Medical TABLET Seroquel SS Astra Zeneca TABLET 22-Feb-2006 08:31 AM Page: 1134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/04ISR Number: 4510527-XReport Type:Expedited (15-DaCompany Report #2004UW23116 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Seroquel PS ORAL 500 MG PO Required Medication Error Professional Ferro-Sequels SS 500 MG Intervention to Psychiatric Symptom Prevent Permanent Impairment/Damage Date:11/22/04ISR Number: 4511273-9Report Type:Expedited (15-DaCompany Report #2004GB02295 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemodilution Foreign Seroquel PS Post Procedural Health Complication Professional White Blood Cell Count Other Decreased Date:11/22/04ISR Number: 4511274-0Report Type:Expedited (15-DaCompany Report #2004GB02689 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Exposure During Foreign Seroquel PS TRANSPLACENTAL Intervention to Pregnancy Health Lustral C Prevent Permanent Ectopic Pregnancy Professional Impairment/Damage Other Date:11/22/04ISR Number: 4511276-4Report Type:Expedited (15-DaCompany Report #2004GB02382 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Spontaneous Foreign Seroquel PS ORAL 350 MG DAILY Drug Exposure During Health PO Pregnancy Professional Pregnancy Other Date:11/23/04ISR Number: 4511860-8Report Type:Expedited (15-DaCompany Report #2004S1003078 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Abnormal Health Apokyn (Apomorphine Initial or Prolonged Blood Pressure Decreased Professional Hcl Injection) PS Bertek SUBCUTANEOUS 0.2ML - 0.4ML Other Drug Ineffective EVERY 3 HOURS General Physical Health QID PM, Deterioration SUBCUTANEOUSL Mental Status Changes Y Requip SS Glaxosmithkline ORAL 5MG QID, ORAL Seroquel SS Astrazeneca ORAL 50MG Q HS, ORAL Carbidopa/Levodopa C Amantadine C Metoprolol C Furosemide C Potassium Chloride C Losartan C Amiodipine C 22-Feb-2006 08:31 AM Page: 1135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Alendronate C Zolpidem C Calcium With Vitamin D C Acetaminophen/Diphen hydramine (Prn) C Vitamins With Iron C Pantoprazole C Refecoxib C Amoxicillin C Date:11/23/04ISR Number: 4512025-6Report Type:Expedited (15-DaCompany Report #2004UW23235 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dizziness Health Seroquel PS 75 MG Fall Professional Lamictal Glaxo Wellcome SS Glaxo Wellcome ORAL 100 MG PO Lithium Salt SS 900 MG Date:11/23/04ISR Number: 4512355-8Report Type:Expedited (15-DaCompany Report #2004AP05470 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ammonia Increased Foreign Seroquel PS ORAL 100 MG TID PO Required Aphagia Health Horizon SS ORAL 5 MG QID PO Intervention to Blood Pressure Decreased Professional Silece SS ORAL 2 MG BID PO Prevent Permanent Bradycardia Other Vegetamin A SS Impairment/Damage Disease Recurrence Dogmatyl SS ORAL 100 MG TID PO Hepatitis Acute Chlopromazine C Hypercapnia Impromen C Hypoxia Pyrethia C Ill-Defined Disorder Bicamol C Immunosuppression Glycyron C Multi-Organ Failure Dasen C Pneumonia Bacterial Renal Impairment Sepsis Sputum Retention Stupor Viral Infection Date:11/23/04ISR Number: 4512380-7Report Type:Expedited (15-DaCompany Report #2004AC00641 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Epilepsy Health PO Hyperprolactinaemia Professional Seroquel SS ORAL 500 MG DAILY Other PO Seroquel SS ORAL 200 MG BID PO Redomex C Impromen C Akineton C Effortil C Seroxat C Xanax Retard C 22-Feb-2006 08:31 AM Page: 1136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/04ISR Number: 4512381-9Report Type:Expedited (15-DaCompany Report #2004AP05702 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 200 MG DAILY Health PO Professional Other Date:11/24/04ISR Number: 4509973-XReport Type:Expedited (15-DaCompany Report #AU-ABBOTT-04P-008-0280886-00 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dry Mouth Epilim Tablets PS Hypertonia Epilim Tablets SS Immobile Quetiapine SS ORAL 5 DAY Neuroleptic Malignant Coloxyl With Senna C Syndrome Lactulose C Tachycardia Tachypnoea Date:11/24/04ISR Number: 4510608-0Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-04P-167-0281088-00 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Haemorrhage Epilim Chrono Sudden Death Tablets PS Quetiapine SS ORAL Quetiapine SS ORAL Carbamazepine C UNKNOWN Levetiracetam C ORAL Date:11/24/04ISR Number: 4514195-2Report Type:Expedited (15-DaCompany Report #2004UW20226 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fatigue Foreign Seroquel PS Intervention to Hallucination Health Lopressor SS Prevent Permanent Professional M-Eslon SS Impairment/Damage Other No Match SS Methotrexate SS Nozinan SS 200 MG Pariet SS Prometrium SS Septra SS Sulfasalazine SS Trazodone SS Date:11/26/04ISR Number: 4515385-5Report Type:Expedited (15-DaCompany Report #2004UW23852 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Choking Health Seroquel PS ORAL 600 MG QD PO Dry Mouth Professional Zyprexa C 22-Feb-2006 08:31 AM Page: 1137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/04ISR Number: 4515390-9Report Type:Expedited (15-DaCompany Report #2004UW23788 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Health Seroquel PS Intervention to Visual Acuity Reduced Professional Prevent Permanent Impairment/Damage Date:11/26/04ISR Number: 4515414-9Report Type:Expedited (15-DaCompany Report #2004066266 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Geodon (Ziprasidone) PS ORAL 60 MG (1 IN 1 Initial or Prolonged Increased Professional D), ORAL Other Aspartate Company Quetiapine Fumarate Aminotransferase Representative (Quetiapine Increased Fumarate) SS ORAL ORAL Blood Electrolytes Escitalopram Abnormal (Escitalopram) C Blood Pressure Increased Oxcarbazepine Bradycardia (Oxcarbazepine) C Cardiac Arrest Clonazepam Coma (Clonazepam) C Cyanosis Levothyroxine Sodium Diarrhoea (Levothyroxine Electrocardiogram Qt Sodium) C Corrected Interval Antihypertensives Electrocardiogram Qt (Antihypertensives) C Prolonged Co-Diovan Fall (Hydrochlorothiazide Heart Rate Decreased , Valsartan) C Heart Rate Increased Estradiol Hypertriglyceridaemia (Estradiol) C Hypokalaemia Diltiazem Laboratory Test Abnormal Hydrochloride Leukocytosis (Diltiazem Long Qt Syndrome Hydrochloride) C Pneumonia Aspiration Oxcarbazepine Respiratory Arrest (Oxcarbazepine) C Torsade De Pointes Temazepam Ventricular Fibrillation (Temazepam) C Nicotinic Acid (Nicotinic Acid) C Clindamycin (Clindamycin) C Clonidine (Clonidine) C Isradipine (Isradipine) C Potassium Chloride (Potassium Chloride) C Quinapril Hydrochloride (Quinapril Hydrochloride) C Aripiprazole (Aripiprazole) C 22-Feb-2006 08:31 AM Page: 1138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511677-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12768065 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Professional Pharmaceutical Disturbance In Attention Company, Ltd. ORAL Increased to Hallucination 30 mg/day Muscle Rigidity after one Schizophrenia week. Social Avoidant Behaviour Clozapine SS Tardive Dyskinesia Quetiapine SS Date:11/29/04ISR Number: 4515030-9Report Type:Direct Company Report #CTU 233165 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Delsym 30mg/5ml Cough Celltech Dizziness Pharmaceuticals PS Celltech Nasopharyngitis Pharmaceuticals ORAL 60MG/10ML Nausea ONCE ORAL Somnolence Seroquel 100mg Zeneca SS Zeneca ORAL 300MG ONCE ORAL Levothyroxine C Celexa C Lipitor C Clonazepam C Seroquel C Alcohol C Date:11/30/04ISR Number: 4515252-7Report Type:Direct Company Report #CTU 233217 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Haloperidol PS INTRAMUSCULAR 10 MG IM X 2 Hospitalization - Agitation Quetiapine SS 200 MG [PRIOR Initial or Prolonged Blood Creatine TO ADMIT] Required Phosphokinase Increased Paroxetine C Intervention to Blood Pressure Increased Simvastatin C Prevent Permanent Chest Pain Impairment/Damage Electrocardiogram Qt Corrected Interval Prolonged Heart Rate Increased Neuroleptic Malignant Syndrome White Blood Cell Count Increased Date:11/30/04ISR Number: 4518248-4Report Type:Expedited (15-DaCompany Report #2004UW23677 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrolyte Imbalance Health Seroquel PS ORAL 9000 MG ONCE Initial or Prolonged Intentional Overdose Professional PO Somnolence Seroquel SS DENTAL 600 MG QD PO 22-Feb-2006 08:31 AM Page: 1139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4518250-2Report Type:Expedited (15-DaCompany Report #2004UW23687 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Consumer Seroquel PS ORAL 600 MG PO Decreased Ativan C Depakote C Date:12/01/04ISR Number: 4518907-3Report Type:Expedited (15-DaCompany Report #2004UW23847 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS Professional Zyprexa SS Date:12/01/04ISR Number: 4518908-5Report Type:Expedited (15-DaCompany Report #2004UW15424 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Asthenia Professional PO Blood Glucose Increased Tegretol C Dizziness Ativan C Fatigue Buspar C Hyperphagia Strattera C Polydipsia Prozac C Polyuria Zithromax C Vision Blurred Albuterol C Weight Increased Remeron C Ddavp C Depakote C Date:12/01/04ISR Number: 4518921-8Report Type:Expedited (15-DaCompany Report #DSA_25436_2004 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Foreign Temesta PS ORAL 1 MG Q DAY PO Depressed Level Of Health Prazine SS ORAL 50 MG Q DAY Consciousness Professional PO Drug Interaction Other Deroxat SS ORAL 20 MG Q DAY Extensor Plantar Response PO Somnolence Seroquel SS ORAL 300 MG Q DAY Tachycardia PO Seroquel SS ORAL 150 MG Q DAY PO Seroquel SS ORAL 150 MG BID PO Seroquel SS ORAL 200 MG BID PO Seroquel SS ORAL 600 MG Q DAY PO Date:12/01/04ISR Number: 4519034-1Report Type:Expedited (15-DaCompany Report #2004AC00641 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Hospitalization - Circulatory Collapse Foreign Initial or Prolonged Epilepsy Health Hyperprolactinaemia Professional 22-Feb-2006 08:31 AM Page: 1140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 200 MG DAILY PO Seroquel SS ORAL 500 MG DAILY PO Seroquel SS ORAL 200 MG BID PO Redomex C Impromen C Akineton C Effortil C Seroxat C Xanax Retard C Date:12/01/04ISR Number: 4519035-3Report Type:Expedited (15-DaCompany Report #2004GB02522 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Seroquel PS ORAL 250 MG DAILY Epilepsy Health PO Palpitations Professional Seroquel SS ORAL 600 MG DAILY Tachycardia Other PO Seroquel SS ORAL 300 MG DAILY PO Date:12/01/04ISR Number: 4519036-5Report Type:Expedited (15-DaCompany Report #2004GB02737 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Quetiapine PS ORAL 250 MG PO Initial or Prolonged Phosphokinase Increased Health Clozapine SS Condition Aggravated Professional Abilify SS ORAL 15 MG HS PO Disturbance In Attention Other Abilify SS ORAL 30 MG HS PO Hallucination Mental Impairment Muscle Rigidity Social Avoidant Behaviour Tardive Dyskinesia Date:12/01/04ISR Number: 4519037-7Report Type:Expedited (15-DaCompany Report #2004PK02003 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 100 MG DAILY Health PO Professional Other Date:12/01/04ISR Number: 4519130-9Report Type:Expedited (15-DaCompany Report #2004SE06501 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS Life-Threatening Multiple Drug Overdose Health Other Drugs Not Intentional Professional Specified SS Other 22-Feb-2006 08:31 AM Page: 1141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/04ISR Number: 4519257-1Report Type:Expedited (15-DaCompany Report #2004079230 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Foreign Zeldox (Capsules) Cardiomegaly Health (Ziprasidone) PS ORAL ORAL Drug Effect Decreased Professional Quetiapine Fumarate Drug Interaction Company (Quetiapine Representative Fumarate) SS ORAL 600 MG (1 IN Other 1 D), ORAL Herbal Preparation (Herbal Preparation) C Date:12/02/04ISR Number: 4519534-4Report Type:Expedited (15-DaCompany Report #2004SE06199 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Obsessive-Compulsive Foreign Seroquel PS ORAL 1400 MG DAILY Disorder Health PO Professional Seroquel SS ORAL 600 MG DAILY Other PO Rivotril C Yasmin C Mozinan C Date:12/06/04ISR Number: 4520916-5Report Type:Direct Company Report #CTU 233682 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Lexapro Forest Imprisonment Laboratories PS Forest Laboratories ORAL ORAL Self Mutilation Seroquel Suicidal Ideation Astrazeneca SS Astrazeneca ORAL ORAL Seroquel C Lexapro C Date:12/06/04ISR Number: 4520920-7Report Type:Direct Company Report #CTU 233686 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Seroquel Hospitalization - Respiratory Failure Astrazeneca Initial or Prolonged Suicide Attempt Pharmaceuticals Lp PS Astrazeneca Pharmaceuticals Lp ORAL 6,000MG OVERDOSE ORAL Effexor Xr C Wellbutrin Xl C Geodon C Trileptal C Klonopin C Albuterol C Serevent Diskus C Naproxen C 22-Feb-2006 08:31 AM Page: 1142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/04ISR Number: 4521567-9Report Type:Expedited (15-DaCompany Report #2004UW23940 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Consumer Seroquel PS Intervention to Drug Abuser Lexapro C Prevent Permanent Sexual Activity Increased Impairment/Damage Suicidal Ideation Date:12/06/04ISR Number: 4521568-0Report Type:Expedited (15-DaCompany Report #2004UW24455 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS ORAL 100 MG DAILY Professional PO Date:12/06/04ISR Number: 4521569-2Report Type:Expedited (15-DaCompany Report #2004UW24380 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Seroquel PS Professional Risperdal C Carbatrol C Zithromax C Date:12/06/04ISR Number: 4521570-9Report Type:Expedited (15-DaCompany Report #2004UW24014 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aneurysm Consumer Seroquel PS ORAL 100 MG HS PO Initial or Prolonged Cerebrovascular Accident Levothyroxine C Lotrel C Estratest C Date:12/06/04ISR Number: 4521656-9Report Type:Expedited (15-DaCompany Report #2004SE06491 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS ORAL 100 MG DAILY Decreased Health PO Professional Haldol SS ORAL 2 MG DAILY PO Other Date:12/06/04ISR Number: 4521657-0Report Type:Expedited (15-DaCompany Report #2004UW24375 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Seroquel PS Health Seroquel SS ORAL 300 MG DAILY Professional PO Other Clonazepam C Synthroid C 22-Feb-2006 08:31 AM Page: 1143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/04ISR Number: 4521659-4Report Type:Expedited (15-DaCompany Report #2004GB02800 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Decreased Foreign Quetiapine PS ORAL 25 MG DAILY Intervention to Blood Prolactin Increased Health PO Prevent Permanent Dizziness Professional Sertraline C Impairment/Damage Heart Rate Decreased Other Risperidone C Hyperhidrosis Muscle Twitching Date:12/06/04ISR Number: 4521686-7Report Type:Expedited (15-DaCompany Report #2003AP03972 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Seroquel PS ORAL 100 MG DAILY Phosphokinase Increased Health PO Fracture Professional Cravit C Platelet Count Decreased Other Telesmin C Pneumonia Risperdal C Pyrexia Gramalil C Date:12/06/04ISR Number: 4521703-4Report Type:Expedited (15-DaCompany Report #2004GB02779 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Foreign Seroquel PS Intervention to Phosphokinase Increased Health Prevent Permanent Disease Recurrence Professional Impairment/Damage Polymyalgia Rheumatica Other Date:12/06/04ISR Number: 4521795-2Report Type:Expedited (15-DaCompany Report #L04-USA-07403-18 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Carbamazepine PS Multiple Drug Overdose Health Quetiapine SS Professional Clonazepam SS Date:12/06/04ISR Number: 4521993-8Report Type:Expedited (15-DaCompany Report #2004UW24228 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombotic Health Seroquel PS Initial or Prolonged Thrombocytopenic Purpura Professional Date:12/06/04ISR Number: 4521996-3Report Type:Expedited (15-DaCompany Report #2004UW23884 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Seroquel PS Required Medication Error Professional Intervention to Overdose Prevent Permanent Respiratory Depression Impairment/Damage Self-Medication 22-Feb-2006 08:31 AM Page: 1144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/04ISR Number: 4522124-0Report Type:Expedited (15-DaCompany Report #2004UW19462 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Study Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Drug Toxicity Health Seroquel SS ORAL 600 MG ONCE Dyspnoea Professional PO Intentional Overdose Iron C Suicidal Ideation Ibuprofen C Valproic Acid C Phentermine C Darvocet-N C Date:12/07/04ISR Number: 4522650-4Report Type:Expedited (15-DaCompany Report #2004GB02808 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arthralgia Foreign Seroquel PS ORAL 100 MG PO Intervention to Hypersensitivity Health Olanzapine C Prevent Permanent Paraesthesia Oral Professional Venlafaxine C Impairment/Damage Rash Macular Other Chlorpromazine C Swollen Tongue Carbamazepine C Tachypnoea Date:12/07/04ISR Number: 4522651-6Report Type:Expedited (15-DaCompany Report #2004PK02024 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Symptom Foreign Seroquel PS ORAL 900 MG DAILY Intervention to Agranulocytosis Health PO Prevent Permanent Leukopenia Professional Haldol C Impairment/Damage Other Date:12/07/04ISR Number: 4522653-XReport Type:Expedited (15-DaCompany Report #2004SE06147 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS ORAL 600 MG DAILY Health PO Professional Subutex SS Other Rivotril C Truxal C Buronil C Imovane C Date:12/07/04ISR Number: 4523107-7Report Type:Direct Company Report #CTU 233749 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Seroquel 100 Mg Tremor (Astra Zeneca) PS Astra Zeneca 13 DAY 22-Feb-2006 08:31 AM Page: 1145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/04ISR Number: 4523212-5Report Type:Expedited (15-DaCompany Report #2004SE06648 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Seroquel PS ORAL 50 MG DAILY Sudden Death Health PO Professional Zeldox SS ORAL 20 MG BID PO Other Renitec C Imdur C Calcium C Triobe C Fosamax C Digitoxin C Marevan C Date:12/08/04ISR Number: 4523217-4Report Type:Expedited (15-DaCompany Report #2004AC00853 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coagulopathy Foreign Seroquel PS ORAL 400 MG DAILY Intervention to Health PO Prevent Permanent Professional Seroquel SS ORAL 100 MG DAILY Impairment/Damage Other PO Prozac C Date:12/08/04ISR Number: 4523219-8Report Type:Expedited (15-DaCompany Report #2004AC00902 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Prolactin Increased Foreign Seroquel PS ORAL 200 MG DAILY Completed Suicide Health PO Professional Loramet C Other Prozac C Prothiaden C Uni-Trauxene C Date:12/08/04ISR Number: 4523245-9Report Type:Expedited (15-DaCompany Report #2004SE06654 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Seroquel PS ORAL 100 MG DAILY Required Sedation Health PO Intervention to Professional Seroquel SS ORAL 200 MG DAILY Prevent Permanent Other PO Impairment/Damage Haloperidol C Biperiden C Date:12/08/04ISR Number: 4523671-8Report Type:Expedited (15-DaCompany Report #2004UW24644 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Health Seroquel PS ORAL 400 MG DAILY Professional ORAL Prozac C Cocaine C 22-Feb-2006 08:31 AM Page: 1146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/04ISR Number: 4523712-8Report Type:Expedited (15-DaCompany Report #2004AC00869 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Literature Quetiapine PS ORAL 400 MG DAILY Intervention to Laboratory Test Abnormal Health PO Prevent Permanent Laboratory Test Professional Quetiapine SS ORAL 250 MG BID PO Impairment/Damage Interference Luvox C Lithium C Docusate C Imipramine C Date:12/09/04ISR Number: 4523930-9Report Type:Expedited (15-DaCompany Report #SUS1-2004-00783 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Carbatrol Cough Professional (Carbamazepine) Xr PS 300 MG, EVERY Dizziness 12 HOURS, Feeling Abnormal Seroquel (Quetiapine Loss Of Consciousness Fumarate) SS 200 MG, EVERY Pain In Extremity HS, Pulmonary Embolism Risperdal Treatment Noncompliance (Risperidone) SS 1 MG, 1X/DAY; QD IN AM, Depo Provera (Medroxyprogesterone Acetate) C Date:12/09/04ISR Number: 4524212-1Report Type:Expedited (15-DaCompany Report #2004UW24443 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Foreign Seroquel PS ORAL 25 MG BID PO Initial or Prolonged Condition Aggravated Health Seroquel SS ORAL 100 MG TID PO Electrocardiogram Qt Professional Pravachol C Prolonged Other Lithium C Lamotrigine C Clonazepam C Temazepam C Bupropion C Eltroxin C Premarin C Mobicox C Date:12/09/04ISR Number: 4524216-9Report Type:Expedited (15-DaCompany Report #2004UW24590 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged General Physical Health Health PO Deterioration Professional Seroquel SS 25 MG DAILY Hypoxia Other GE Pneumonia Lamotrigina C 22-Feb-2006 08:31 AM Page: 1147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/04ISR Number: 4525349-3Report Type:Expedited (15-DaCompany Report #2004066266 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Geodon (Ziprasidone) PS ORAL 06 MG (1 IN 1 Initial or Prolonged Increased Professional D), ORAL Other Arrhythmia Company Quetiapine Fumarate Aspartate Representative (Quetiapine Fumrate) SS ORAL ORAL Aminotransferase Escitalopram Increased (Escitalopram) C Blood Pressure Increased Oxcarbazepine Cardio-Respiratory Arrest (Oxcarbazepine) C Coma Clonazepam Cyanosis (Clonazepam) C Diarrhoea Levothyroxine Sodium Electrocardiogram Qt (Levothyroxine Prolonged Sodium) C Heart Rate Irregular Antihypertensives Hypertriglyceridaemia (Antihypertensives) C Hypokalaemia Co-Diovan Loss Of Consciousness (Hydrochlorothiazide Pneumonia Aspiration , Valsartarn) C Torsade De Pointes Estradiol Ventricular Fibrillation (Estradiol) C Diltazem Hydrochloride (Diltazem Hydrochloride) C Temazepam (Temazepam) C Nicotinic Acid (Nicotinic Acid) C Clindamycin (Clindamycin) C Clonidine (Clonidine) C Isradipine (Isradipine) C Potassium Chloride (Potassium Chloride) C Quinapril Hydrochloride (Quinapril Hydcrochloride) C Aripiprazole (Aripiprazole) C Date:12/10/04ISR Number: 4526259-8Report Type:Expedited (15-DaCompany Report #2004SE06679 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Foreign Seroquel PS ORAL 125 MG BID; Initial or Prolonged Decreased Health PO Professional Leponex C Other Hydrex Semi C Heksavit C Minifom C Movicol C Temesta C Tenox C 22-Feb-2006 08:31 AM Page: 1148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/04ISR Number: 4526263-XReport Type:Expedited (15-DaCompany Report #2004AP05832 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Seroquel PS ORAL 25 MG DAILY; Initial or Prolonged Blood Potassium Increased Health PO Condition Aggravated Professional Rhythmy C Dizziness Other Azeptin C Renal Failure Chronic Talion C Urinary Retention Zyloric "Glaxo Wellcome" C Glaxo Wellcome Micardis C Lac B C Perdipine C Date:12/10/04ISR Number: 4526538-4Report Type:Expedited (15-DaCompany Report #2004UW24380 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Seroquel PS ORAL 200 MG HS PO Circulatory Collapse Professional Risperdal C Dizziness Carbatrol C Malaise Zithromax C Pulmonary Embolism Date:12/10/04ISR Number: 4526539-6Report Type:Expedited (15-DaCompany Report #2004UW24585 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Seroquel PS ORAL 200 MG HS PO Initial or Prolonged Neuroleptic Malignant Professional Morphine C Syndrome Parnate C Overdose Renal Failure Respiratory Failure Date:12/10/04ISR Number: 4526540-2Report Type:Expedited (15-DaCompany Report #2004UW09561 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Consumer Seroquel PS ORAL 200 MG QD PO Initial or Prolonged Hallucinations, Mixed Seroquel SS ORAL 100 MG QD PO Required Sleep Disorder Topamax C Intervention to Suicide Attempt Alprazolam C Prevent Permanent Oxycontin C Impairment/Damage Carisoprodol C Date:12/13/04ISR Number: 4526790-5Report Type:Expedited (15-DaCompany Report #2002UW16050 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Circadian Rhythm Sleep Consumer Seroquel PS 200 TO 400 MG Required Disorder Lithium C Intervention to Dependence Prevent Permanent Faeces Discoloured Impairment/Damage Hepatic Fibrosis Insomnia 22-Feb-2006 08:31 AM Page: 1149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/04ISR Number: 4526791-7Report Type:Expedited (15-DaCompany Report #2004UW22782 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myopia Health Seroquel PS ORAL 50 MG BID PO Nervousness Professional Date:12/13/04ISR Number: 4527019-4Report Type:Expedited (15-DaCompany Report #2004103897 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hallucination Foreign Zeldox (Capsules) Myocardial Infarction Health (Ziprasidone) PS ORAL 40 MG (20 MG, Osteoporosis Professional 2 IN 1 D), Sudden Death ORAL Seroquel (Quetiapine Fumarate) SS ORAL 50 MG (50 MG, 1 IN 1 D), ORAL Enalapril Maleate (Enalapril Maleate) C Isosorbide Mononitrate (Isosorbide Mononitrate) C Calcium Carbonate (Calcium Carbonate) C Triobe (Cyanocobalamin, Folic Acid, Pyridoxine) C Alendronate Sodium (Alandronate Sodium) C Digitoxin (Digitoxin) C Warfarin (Warfarin) C Date:12/14/04ISR Number: 4528923-3Report Type:Expedited (15-DaCompany Report #SUSI-2004-00841 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Carbamazepine Multiple Drug Overdose Health Extended-Release(Car Professional bamazepine) Capsule Xr PS Quetiapine (Quetiapine) SS Clonazepam (Clonazepam) SS Date:12/14/04ISR Number: 4529389-XReport Type:Expedited (15-DaCompany Report #2004AP06165 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Foreign Seroquel PS Hospitalization - Status Epilepticus Health Initial or Prolonged Professional 22-Feb-2006 08:31 AM Page: 1150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/04ISR Number: 4529390-6Report Type:Expedited (15-DaCompany Report #2004UW24538 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hallucination Foreign Seroquel PS NI Intervention to Medication Error Study Seroquel SS INCREASED Prevent Permanent Mental Impairment Health DOSE Impairment/Damage Restlessness Professional Zopiclone C Sleep Disorder Date:12/14/04ISR Number: 4529391-8Report Type:Expedited (15-DaCompany Report #2004GB02689 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Exposure During Foreign Seroquel PS ORAL 150 MG DAILY Intervention to Pregnancy Health PO Prevent Permanent Ectopic Pregnancy Professional Lustral SS ORAL 200 MG DAILY Impairment/Damage PO Date:12/14/04ISR Number: 4529392-XReport Type:Expedited (15-DaCompany Report #2004SE06654 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Seroquel PS ORAL 100 MG DAILY Required Azotaemia Health PO Intervention to Cardiac Disorder Professional Seroquel SS ORAL 200 MG DAILY Prevent Permanent Electrolyte Imbalance PO Impairment/Damage Ketoacidosis Myocardial Infarction Sedation Date:12/14/04ISR Number: 4533939-7Report Type:Periodic Company Report #S04-USA-03012-01 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Lexapro Initial or Prolonged Increased Professional (Escitalopram) PS ORAL 10 MG QD PO Aspartate Company Seroquel (Quetiapine Aminotransferase Representative Fumarate) SS ORAL 300 MG BID PO Increased Neurontin Gamma-Glutamyltransferase (Gabapentin) C Increased Rhabdomyolysis Date:12/15/04ISR Number: 4529726-6Report Type:Direct Company Report #CTU 234420 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Seroquel PS ORAL SEE IMAGE Initial or Prolonged Sedation Sinemet C Sinemet Cr C Cogentin C Aivan C Prozac C Glucosamin C 22-Feb-2006 08:31 AM Page: 1151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/04ISR Number: 4529727-8Report Type:Direct Company Report #CTU 234419 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Seroquel PS Convulsion Levoflox C Laceration Loss Of Consciousness Tongue Disorder Date:12/15/04ISR Number: 4529728-XReport Type:Direct Company Report #CTU 234418 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nausea Seroquel PS ORAL 1 TAB PO BID Initial or Prolonged Vomiting Furosemide C Spironolactone C Lithium C Lortab C Neomycin C Date:12/15/04ISR Number: 4530348-1Report Type:Expedited (15-DaCompany Report #2004105845 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Lustral (Sertraline) PS ORAL (2 IN 1 D), Initial or Prolonged Delusional Disorder, Health ORAL Disability Persecutory Type Professional Quetiapine Other Dysphagia (Quetiapine) SS 25 MG (25 MG, Dystonia 1 IN 1 D) Gait Disturbance Lactulose Hallucination (Lactulose0 C Mobility Decreased Co-Amilofruse(Amilor Pain ide Hydrochloride, Tardive Dyskinesia Furosemide) C Tremor Co-Codamol (Codeine Phosphate, Paracetamol) C Senna (Senna) C Date:12/15/04ISR Number: 4530415-2Report Type:Expedited (15-DaCompany Report #2004GB03011 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Transient Ischaemic Foreign Quetiapine PS Intervention to Attack Health Exelon SS Prevent Permanent Professional Impairment/Damage Other Date:12/15/04ISR Number: 4530416-4Report Type:Expedited (15-DaCompany Report #2004GB02958 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Quetiapine PS ORAL 25 MG BID PO Intervention to Inadequate Control Health Haloperidol C Prevent Permanent Glycosylated Haemoglobin Professional Procyclidine C Impairment/Damage Increased Other Insulin C 22-Feb-2006 08:31 AM Page: 1152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/04ISR Number: 4530418-8Report Type:Expedited (15-DaCompany Report #2004AC00902 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Prolactin Increased Foreign Seroquel PS ORAL 200 MG DAILY Completed Suicide Health PO Professional Loramet C Other Prozac C Prothiadem C Uni-Trauxene C Date:12/15/04ISR Number: 4530421-8Report Type:Expedited (15-DaCompany Report #2004AC00933 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alcohol Withdrawal Foreign Quetiapine PS ORAL 25 MG DAILY Hospitalization - Syndrome Literature PO Initial or Prolonged Alcoholism Health Venlafaxine SS ORAL 225 MG DAILY Amnesia Professional PO Blood Pressure Other Ethanol SS Fluctuation Coma Drug Ineffective Drug Tolerance Decreased Drug Withdrawal Syndrome Electrocardiogram Qrs Complex Prolonged Electrocardiogram Qt Corrected Interval Prolonged Grand Mal Convulsion Hyperthermia Intracranial Pressure Increased Leukocytosis Multiple Drug Overdose Neuroleptic Malignant Syndrome Pneumonia Aspiration Respiratory Depression Serotonin Syndrome Suicide Attempt Treatment Noncompliance Date:12/15/04ISR Number: 4530423-1Report Type:Expedited (15-DaCompany Report #2004GB02944 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Sleep Paralysis Foreign Seroquel PS ORAL 150 MG DAILY Intervention to Health PO Prevent Permanent Professional Impairment/Damage Other Date:12/15/04ISR Number: 4530861-7Report Type:Expedited (15-DaCompany Report #2004UW24885 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Seroquel PS Initial or Prolonged Professional Insulin SS 22-Feb-2006 08:31 AM Page: 1153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal C Date:12/15/04ISR Number: 4530864-2Report Type:Expedited (15-DaCompany Report #2004UW25072 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laryngospasm Health Seroquel PS 200 MG DAILY Initial or Prolonged Professional Hypoglycemic C Date:12/16/04ISR Number: 4531646-8Report Type:Direct Company Report #CTU 234504 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Seroquel 300 Mg, 200 Initial or Prolonged Mg PS 300 MG QID, Required 200 MG QHS Intervention to Prevent Permanent Impairment/Damage Date:12/16/04ISR Number: 4531933-3Report Type:Expedited (15-DaCompany Report #2004UW20340 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Seroquel PS ORAL 100 MG PO Initial or Prolonged Lethargy Professional Date:12/16/04ISR Number: 4531936-9Report Type:Expedited (15-DaCompany Report #2004UW25167 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Seroquel PS Professional Date:12/17/04ISR Number: 4532064-9Report Type:Expedited (15-DaCompany Report #2004UW25180 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Seroquel PS ORAL 400 MG QD PO Initial or Prolonged Psychotic Disorder Health Tylenol C Professional Ambien C Ativan C Date:12/17/04ISR Number: 4532067-4Report Type:Expedited (15-DaCompany Report #2004UW25363 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Arrest Health Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Professional PO Clonopin SS 22-Feb-2006 08:31 AM Page: 1154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/04ISR Number: 4532070-4Report Type:Expedited (15-DaCompany Report #2004UW18156 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drooling Consumer Seroquel PS Intervention to Movement Disorder Lithium C Prevent Permanent Nasopharyngitis Tegretol C Impairment/Damage Oral Intake Reduced Provigil C Speech Disorder Neurontin C Swollen Tongue Nexium C Tongue Disorder Lorazepam C Tongue Ulceration Lortab C Weight Decreased Ambien C Date:12/17/04ISR Number: 4532071-6Report Type:Expedited (15-DaCompany Report #2004UW25001 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Activities Of Daily Consumer Seroquel PS Intervention to Living Impaired Prevent Permanent Dizziness Impairment/Damage Dyspnoea Hypertension Orthopnoea Date:12/17/04ISR Number: 4532073-XReport Type:Expedited (15-DaCompany Report #2004UW11075 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Health Seroquel PS ORAL 400 MG DAILY Intervention to Agitation Professional PO Prevent Permanent Suicidal Ideation Lithium C Impairment/Damage Date:12/17/04ISR Number: 4532077-7Report Type:Expedited (15-DaCompany Report #2004UW24821 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Seroquel PS 300-400 MG Abnormal Professional DAILY Date:12/17/04ISR Number: 4532105-9Report Type:Expedited (15-DaCompany Report #2004UW10204 Age:88 YR Gender:Female I/FU:F Outcome PT Required Aggression Intervention to Agitation Prevent Permanent Confusional State Impairment/Damage Depressed Level Of Consciousness Dysarthria Dyskinesia Dyspnoea Hypotension Movement Disorder Nervous System Disorder Skin Irritation Speech Disorder 22-Feb-2006 08:31 AM Page: 1155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stupor Urinary Tract Infection Visual Disturbance Report Source Product Role Manufacturer Route Dose Duration Weight Increased Foreign Seroquel PS ORAL 112.5 MG - Health 150 MG DAILY Professional PO Other Risperidone C Ativan C Date:12/17/04ISR Number: 4532106-0Report Type:Expedited (15-DaCompany Report #2004PK02100 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 800 MG DAILY Health PO Professional Other Date:12/20/04ISR Number: 4532260-0Report Type:Expedited (15-DaCompany Report #CA-ABBOTT-04P-028-0272719-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Epival Tablets PS ORAL Initial or Prolonged Cholelithiasis Epival Tablets SS ORAL Condition Aggravated Epival Tablets SS Hepatic Enzyme Increased Ritonavir Soft Hepatotoxicity Gelatin Capsules SS ORAL 786 DAY Hypomania Ritonavir Soft Jaundice Cholestatic Gelatin Capsules SS ORAL 786 DAY Nausea Tipranavir SS ORAL 787 DAY Pneumonia Procyclidine SS ORAL 151 DAY Psychotic Disorder Olanzapine SS ORAL 3 YR Schizophrenia Olanzapine SS ORAL 3 YR Vomiting Risperidone SS ORAL 46 DAY Trazodone SS ORAL Trazodone SS ORAL Quetiapine SS ORAL 23 DAY Clonazepam SS ORAL Carbamazepine SS 9 DAY Paracetamol SS ORAL 642 DAY Paracetamol SS 642 DAY Lamivudine C ORAL 128 DAY Lamivudine C 128 DAY Abacavir C ORAL 128 DAY Abacavir C 128 DAY Atovaquone C ORAL 154 DAY Atovaquone C 154 DAY Calcium Carbonate C ORAL 4 YR Magic Mouthwash C 204 DAY Nystatin C ORAL 12 YR Megavim C ORAL Enfuvirtide (T-20) C SUBCUTANEOUS Enfuvirtide (T-20) C Bisacodyl C Bisacodyl C Choral Hydrate C Lactulose C 209 DAY Imodium C 4 YR Diphenhydramine 22-Feb-2006 08:31 AM Page: 1156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C INTRAVENOUS Diphenhydramine Hydrochloride C ORAL Diphenhydramine Hydrochloride C INTRAMUSCULAR Kaletra C 3 DAY Lithium C 4 DAY Date:12/20/04ISR Number: 4533288-7Report Type:Direct Company Report #CTU 234645 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Seroquel (200mg Qd) PS 200 MG QD 2 YR Movement Disorder Tardive Dyskinesia Date:12/20/04ISR Number: 4536632-XReport Type:Expedited (15-DaCompany Report #2004066728 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Drug Effect Decreased Health 2 IN 1 D), Drug Ineffective Professional ORAL 1 MON Electrocardiogram Qt Quetiapine Fumarate Corrected Interval (Quetiapine Prolonged Fumarate) SS Electrocardiogram St-T Topiramate Change (Topiramate) C Electrocardiogram T Wave Citalopram Abnormal Hydrobromide Myocardial Ischaemia (Citalopram Hydrobromide) C Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Methylphenidate Hydrochloride (Medhylphenidate Hydrochloride) C Date:12/21/04ISR Number: 4534433-XReport Type:Direct Company Report #CTU 234840 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Seroquel 25 Mg PS ORAL 25 MG PO BID Facial Palsy Tongue Disorder 22-Feb-2006 08:31 AM Page: 1157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/04ISR Number: 4537110-4Report Type:Expedited (15-DaCompany Report #MK200412-0154-1 Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Fluoxetine Capsules Multiple Drug Overdose Health (Strength Unk) PS Intentional Professional Quetiapine SS Olanzapine SS Date:12/21/04ISR Number: 4537138-4Report Type:Expedited (15-DaCompany Report #MK200412-0125-1 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Oxycodone Hcl Multiple Drug Overdose Health Tablets PS Intentional Professional Quetiapine And Zolpidem SS Date:12/21/04ISR Number: 4538263-4Report Type:Expedited (15-DaCompany Report #2004SE06769 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Atonic Urinary Bladder Foreign Seroquel PS ORAL 750 MG DAILY Constipation Health PO Urinary Retention Professional Other Date:12/21/04ISR Number: 4538267-1Report Type:Expedited (15-DaCompany Report #2004GB02977 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Dystonia Health PO Disability Gait Disturbance Professional Lustral SS 50MG-100MG BD Required Medication Error Other Lactulose C Intervention to Mobility Decreased Co-Amilofruse C Prevent Permanent Tardive Dyskinesia Co-Codamol C Impairment/Damage Tremor Senna C Date:12/21/04ISR Number: 4538268-3Report Type:Expedited (15-DaCompany Report #2004AP06253 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apallic Syndrome Foreign Seroquel PS ORAL 100 MG DAILY Cardio-Respiratory Arrest Health PO Loss Of Consciousness Professional Linton C Shock Other Risperdal C Biperiden Hydrochloride C Hirnamin C Vegetamin B C 22-Feb-2006 08:31 AM Page: 1158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/04ISR Number: 4538272-5Report Type:Expedited (15-DaCompany Report #2004AP06243 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Foreign Seroquel PS ORAL 1200 MG DAILY Endocarditis Health PO Myocarditis Professional Other Date:12/21/04ISR Number: 4538292-0Report Type:Expedited (15-DaCompany Report #2004AP06262 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Increased Appetite Health PO Liver Disorder Professional Seroquel SS ORAL 250 MG DAILY Pyrexia Other PO Date:12/21/04ISR Number: 4538295-6Report Type:Expedited (15-DaCompany Report #2003AP04436 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Seroquel PS ORAL 25 MG TID PO Shock Health Benzalin SS ORAL 5 MG DAILY PO Professional Gramalil SS ORAL 25 MG TID PO Other Neuleptil SS ORAL 3 MG DAILY PO Salipex SS ORAL 20 MG DAILY PO Date:12/22/04ISR Number: 4535649-9Report Type:Direct Company Report #CTU 234908 E Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Abilify PS PLUS Hospitalization - Prescribed Overdose INJECTIONS 2 Initial or Prolonged Suicide Attempt X A DAY Disability Tooth Disorder 2001-2004 Other Zyprexa 40 Mg SS 3 X DAY Required 10/04-PRES Intervention to Risperdal 13 Mg SS Prevent Permanent Prolaxian 20 Mg SS Impairment/Damage Depakote 2500 SS Seraquel 800 Mg SS Cogentin 4 Mg SS Others SS Date:12/22/04ISR Number: 4536880-9Report Type:Expedited (15-DaCompany Report #2004UW25128 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Laryngospasm Health Seroquel PS ORAL 200 MG PO Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 1159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/04ISR Number: 4538673-5Report Type:Expedited (15-DaCompany Report #04-323 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ibuprofen Multiple Drug Overdose Health (Ibuprofen) PS Intentional Professional Fluoxetine (Fluoxetine) SS Quetiapine (Quetiapine) SS Date:12/22/04ISR Number: 4538751-0Report Type:Expedited (15-DaCompany Report #S04-USA-06784-01 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Health Lexapro Initial or Prolonged Post Procedural Professional (Escitalopram) PS ORAL 10 MG QD PO Required Complication Company Seroquel (Quetiapine Intervention to Priapism Representative Fumarate) SS 400 MG QD Prevent Permanent Thrombosis Ambien (Zolpidem Impairment/Damage Treatment Noncompliance Tartrate) C Date:12/22/04ISR Number: 4539045-XReport Type:Expedited (15-DaCompany Report #2004UW25577 Age:28 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Health Seroquel PS ORAL 300 MG PO Initial or Prolonged Convulsion Professional Lamictal SS Required Injury Intervention to Treatment Noncompliance Prevent Permanent Impairment/Damage Date:12/22/04ISR Number: 4539091-6Report Type:Expedited (15-DaCompany Report #2004-05130 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Trazodone Initial or Prolonged Drug Dependence Professional Hydrochloride Drug Hypersensitivity (Watson Drug Withdrawal Syndrome Laboratories) Eosinophilia (Tazodone PS Watson Laboratories ORAL 300 MG, QHS, ORAL Seroquel (Quetiapine Fumarate) SS Topamax (Topiramate) C Lipitor (Atorvastatin) C Clonazepam C Fluoxetine C Date:12/22/04ISR Number: 4539452-5Report Type:Expedited (15-DaCompany Report #2004AC00902 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Death Blood Prolactin Increased Foreign Completed Suicide Health Professional 22-Feb-2006 08:31 AM Page: 1160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seroquel PS ORAL 200 MG DAILY PO Loramet C Prozac C Prothiaden C Uni-Trauxene C Date:12/22/04ISR Number: 4540122-8Report Type:Expedited (15-DaCompany Report #2004SE07007 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Seroquel PS ORAL 200 MG BID PO Life-Threatening Increased Health Truxal C Dyspnoea Professional Akarin C Palpitations Other Remeron C Novynette C Date:12/23/04ISR Number: 4537382-6Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-04P-167-0283834-00 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Thyroid Stimulating Depakene PS ORAL Initial or Prolonged Hormone Increased Depakene SS Leukopenia Quetiapine SS ORAL Neutropenia Date:12/23/04ISR Number: 4537407-8Report Type:Expedited (15-DaCompany Report #JP-ABBOTT-04P-087-0271922-00 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Cefzon Capsules PS ORAL 2 DAY Hospitalization - Bronchitis Acute Clarith SS 4 DAY Initial or Prolonged Chills Seroquel SS ORAL 16 DAY Other Condition Aggravated Seroquel SS ORAL 16 DAY Eosinophil Count Pl Gran. SS ORAL 3 DAY Increased Levomepromazine C 35 DAY Eosinophilic Pneumonia Ciprofloxacin C INTRAVENOUS 3 DAY Hepatic Function Abnormal Minocycline Nasopharyngitis Hydrochloride C 3 DAY Oxygen Saturation Decreased Date:12/23/04ISR Number: 4539290-3Report Type:Expedited (15-DaCompany Report #2004UW25001 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Consumer Seroquel PS ORAL 600 MG PO Intervention to Dyspnoea Xanax C Prevent Permanent Feeling Abnormal Impairment/Damage Hypertension Loss Of Consciousness Lung Disorder Scar 22-Feb-2006 08:31 AM Page: 1161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/04ISR Number: 4539296-4Report Type:Expedited (15-DaCompany Report #2004UW23677 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrolyte Imbalance Health Seroquel PS ORAL 9000 MG ONCE Initial or Prolonged Intentional Overdose Professional PO Somnolence Seroquel SS ORAL 600 MG QD PO Date:12/23/04ISR Number: 4585535-3Report Type:Direct Company Report #USP 57059 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Metformin 500mg PS TABLET Seroquel SS Astra Zeneca TABLET Date:12/27/04ISR Number: 4541675-6Report Type:Expedited (15-DaCompany Report #2004AP04093 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Seroquel PS ORAL 100 MG TID PO Hospitalization - Increased Health Seroquel SS ORAL 600 MG DAILY, Initial or Prolonged Anorexia Professional PO Aspartate Other Pl Gran. SS ORAL 1 G TID, PO Aminotransferase Cefzon SS ORAL 100 MG TID PO Increased Hirnamin C Blood Lactate Dehydrogenase Increased Bronchitis Acute Chills Eosinophil Count Increased Eosinophilic Pneumonia Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Lymphocyte Stimulation Test Positive Pneumonia Mycoplasmal Date:12/27/04ISR Number: 4541677-XReport Type:Expedited (15-DaCompany Report #2004GB02468 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Foreign Seroquel PS ORAL 100 MG DAILY, Initial or Prolonged Fall Study PO Upper Limb Fracture Health Atenolol SS ORAL 20 MG QD PO Professional Aspirin C Other Paracetamol C Amitriptyline C Senna C Atorvastatin C Date:12/27/04ISR Number: 4541739-7Report Type:Expedited (15-DaCompany Report #2004UW25674 Age:33 YR Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 1162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Drug Exposure During Foreign Seroquel PS ORAL 600 MG DAILY Pregnancy Health PO Gestational Diabetes Professional Seroquel SS ORAL 400 MG QD PO 2 WK Pregnancy With Other Seroquel SS ORAL 600 MG DAILY Contraceptive Device PO Hydrochlorothiazide C Labetalol C Date:12/27/04ISR Number: 4541740-3Report Type:Expedited (15-DaCompany Report #2004GB03164 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Loss Of Consciousness Foreign Quetiapine PS ORAL 750 MG DAILY Intervention to Sinus Tachycardia Health PO Prevent Permanent Professional Clozaril SS ORAL 300 MG DAILY Impairment/Damage Other PO Citalopram C Date:12/27/04ISR Number: 4541743-9Report Type:Expedited (15-DaCompany Report #2004UW24375 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Foreign Seroquel PS Interference Health Seroquel SS ORAL 300 MG DAILY Platelet Count Decreased Professional PO Other Clonazepam C Synthroid C Date:12/27/04ISR Number: 4541745-2Report Type:Expedited (15-DaCompany Report #2004AP02184 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphthous Stomatitis Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Colitis Ulcerative Health PO Ileus Professional Seroquel SS ORAL 200 MG DAILY Megacolon Other PO Rectal Ulcer Seroquel SS ORAL 500 MG DAILY Therapy Non-Responder PO Seroquel SS ORAL 200 MG TID PO Lodopin C Barnetil C Neuleptil C Linton C Ferromia C Artane C Valerin C Date:12/27/04ISR Number: 4541748-8Report Type:Expedited (15-DaCompany Report #2003GB01715 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Other Neutropenia Foreign Health Professional 22-Feb-2006 08:31 AM Page: 1163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Quetiapine PS ORAL 25 MG HS PO Efexor C Thyroxine C Date:12/27/04ISR Number: 4541835-4Report Type:Expedited (15-DaCompany Report #2004UW25875 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Seroquel PS Professional Date:12/27/04ISR Number: 4541985-2Report Type:Expedited (15-DaCompany Report #2004UW25647 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Health Seroquel PS ORAL 500 MG PO Initial or Prolonged Professional Clonapin SS 300 MG Effexor C Neurontin C Vioxx C Mobic C Ambien C Date:12/28/04ISR Number: 4539294-0Report Type:Expedited (15-DaCompany Report #PHBS2004JP17256 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Ritalin PS Novartis Sector: Pharma ORAL UNK, UNK Seroquel SS Tecipul C Sepazon C Amoban C Date:12/28/04ISR Number: 4539460-4Report Type:Direct Company Report #USP 57009 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Seroquel PS CAPSULE Date:12/28/04ISR Number: 4540870-XReport Type:Expedited (15-DaCompany Report #2004GB02847 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Foreign Seroquel PS ORAL 700 MG DAILY Intervention to Blood Creatine Health PO Prevent Permanent Phosphokinase Increased Professional Impairment/Damage Blood Pressure Increased Other Confusional State Hallucination Hypothermia Tachycardia 22-Feb-2006 08:31 AM Page: 1164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/04ISR Number: 4540871-1Report Type:Expedited (15-DaCompany Report #2004GB03135 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Seroquel PS ORAL 200 MG BID PO Health Professional Other Date:12/28/04ISR Number: 4540872-3Report Type:Expedited (15-DaCompany Report #2004GB03150 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Artery Occlusion Foreign Quetiapine PS ORAL 200 MG BID PO Initial or Prolonged Hemiparesis Health Venlafaxine C Disability Professional Haloperidol C Required Other Procyclidine C Intervention to Zopiclone C Prevent Permanent Impairment/Damage Date:12/28/04ISR Number: 4541141-8Report Type:Expedited (15-DaCompany Report #2004UW25847 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Huntington'S Chorea Consumer Seroquel PS ORAL 25 MG PO Intervention to Evista C Prevent Permanent Nexium C Impairment/Damage Trazodone C Aricept C Glucosamine C Centrum Silver C Aleve C Zyrtec-D C Lasix C Potassium C Arthrotec C Lorazepam C Astelin C Rhinocort C Depakote C Lortab C Date:12/29/04ISR Number: 4540669-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12799631 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Disturbance In Attention Company, Ltd. 15 then 30 mg Hallucination nocte after Muscle Rigidity one week Schizophrenia Clozapine SS UNKNOWN Social Avoidant Behaviour Quetiapine SS UNKNOWN Tardive Dyskinesia 22-Feb-2006 08:31 AM Page: 1165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/04ISR Number: 4541921-9Report Type:Direct Company Report #CTU 235347 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arteriovenous Fistula Quetiapine 300mg Initial or Prolonged Electrocardiogram St Astra Zeneca PS Astra Zeneca ORAL 1500MG Segment Elevation BEDTIME ORAL Electrocardiogram T Wave Inversion Overdose Date:12/29/04ISR Number: 4543232-4Report Type:Expedited (15-DaCompany Report #2004GB02737 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Quetiapine PS ORAL 350 MG DAILY Initial or Prolonged Phosphokinase Increased Health PO Condition Aggravated Professional Clozapine SS Disturbance In Attention Other Abilify SS 15-30MG NOCTE Hallucination Abilify SS ORAL 30 MG HS PO Muscle Rigidity Social Avoidant Behaviour Tardive Dyskinesia Date:12/29/04ISR Number: 4543329-9Report Type:Expedited (15-DaCompany Report #2004AP04579 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Seroquel PS ORAL 400 MG DAILY; Initial or Prolonged Arthralgia Health PO Coma Professional Seroquel SS ORAL 300 MG DAILY; Communication Disorder Other PO Delusion Seroquel SS NI Dysphagia Barnetil SS NI Erythema Barnetil SS ORAL 400 MG TID; Hip Swelling PO Induration Barnetil SS ORAL 200 MG TID; Insomnia PO Neuroleptic Malignant Valerin SS ORAL 400 MG TID; Syndrome PO Screaming Lodopin SS ORAL 100 MG TID; Somnolence PO Speech Disorder Vegetamin A SS Levotomin SS Levotomin SS ORAL 67 MG TID; PO Isomytal SS ORAL 0.2 G DAILY; PO Risperdal C Date:12/30/04ISR Number: 4544644-5Report Type:Expedited (15-DaCompany Report #2004UW25001 Age: Gender:Male I/FU:F Outcome PT Required Dizziness Intervention to Dysphonia Prevent Permanent Dyspnoea Impairment/Damage Hypertension Loss Of Consciousness Lung Disorder 22-Feb-2006 08:31 AM Page: 1166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Scar Report Source Product Role Manufacturer Route Dose Duration Consumer Seroquel PS ORAL 600 MG PO Xanax C Date:12/30/04ISR Number: 4544649-4Report Type:Expedited (15-DaCompany Report #2004SE06769 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Constipation Foreign Seroquel PS ORAL 750 MG DAILY Neurogenic Bladder Health PO Urinary Retention Professional Rivotril C Other Nozinan C Date:01/03/05ISR Number: 4543965-XReport Type:Expedited (15-DaCompany Report #GXKR2003GB00509 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Diazepam (Ngx) Initial or Prolonged Brain Oedema Health (Diazepam) PS ORAL 70 MG, Clonus Professional ONCE/SINGLE, Coagulation Test Abnormal Other ORAL Decubitus Ulcer Quetiapine Electrocardiogram Qt (Quetiapine) SS ORAL 12000 MG, Prolonged ONCE/SINGLE, Glasgow Coma Scale ORAL Abnormal Antibiotics SS Hyperreflexia Flumazenil C International Normalised Ratio Decreased Leg Amputation Leukocytosis Liver Function Test Abnormal Metabolic Acidosis Miosis Multiple Drug Overdose Intentional Stupor Tachycardia Date:01/03/05ISR Number: 4546370-5Report Type:Expedited (15-DaCompany Report #2004119642 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Foreign Atarax Convulsion Health (Hydroxyzine Suicide Attempt Professional Hydrochloride) PS ORAL Tachycardia Other Zoloft (Setraline) SS Quetiapine Fumarate (Quetiapine Fumarate) SS 22-Feb-2006 08:31 AM Page: 1167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/05ISR Number: 4544437-9Report Type:Direct Company Report #CTU 235577 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Seroquel Life-Threatening Medication Error (Quetiapine) PS UP TO 550 MG Hospitalization - PER DAY Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage Date:01/04/05ISR Number: 4544814-6Report Type:Expedited (15-DaCompany Report #2004AC00666 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bronchopneumonia Foreign Seroquel PS ORAL 1100 MG DAILY Hospitalization - Diabetic Ketoacidotic Health PO Initial or Prolonged Hyperglycaemic Coma Professional Seroquel SS ORAL 200 MG TID PO Required Pancreatitis Other Staurodorm C Intervention to Respiratory Tract Etumine C Prevent Permanent Infection Inderal C Impairment/Damage Weight Increased Xalatan C Timoptol C Aldactazine C Date:01/05/05ISR Number: 4544982-6Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0537765A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Paxil Cr PS Glaxosmithkline ORAL 75MG Per day 5 MON Initial or Prolonged Phosphokinase Increased Seroquel SS Eating Disorder Clonopin C Muscle Twitching Abilify C Pyrexia Tremor Date:01/05/05ISR Number: 4546784-3Report Type:Expedited (15-DaCompany Report #2004SE07205 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tunnel Vision Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Visual Field Defect Health PO Prevent Permanent Professional Litarex C Impairment/Damage Other Date:01/05/05ISR Number: 4547102-7Report Type:Expedited (15-DaCompany Report #2004UW26314 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Seroquel PS STARTER PACK Initial or Prolonged Hallucination Professional Cold Medication SS Nasopharyngitis Overdose Self-Medication Treatment Noncompliance 22-Feb-2006 08:31 AM Page: 1168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/05ISR Number: 4546092-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12809232 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Serzone Tabs 50 Mg PS Bristol-Myers Squibb Initial or Prolonged Abdominal Pain Upper Company ORAL Confusional State Seroquel SS Hallucination Seroquel SS Liver Abscess Liver Function Test Abnormal Medication Error Nausea Psychiatric Symptom Psychotic Disorder Vomiting Date:01/06/05ISR Number: 4548328-9Report Type:Direct Company Report #CTU 235842 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Seroquel PS SEE ITEM B5 Dysarthria Zyprexa C Rhinorrhoea Cogentin C Vomiting Benadryl C Date:01/07/05ISR Number: 4547135-0Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20041207584 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Risperdal PS OROPHARINGEAL Initial or Prolonged Depakin Chrono SS OROPHARINGEAL Seroquel SS OROPHARINGEAL Phenobarbital C OROPHARINGEAL Date:01/07/05ISR Number: 4550063-8Report Type:Expedited (15-DaCompany Report #2004UW18018 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Health Seroquel PS ORAL 50 MG DAILY Intervention to Drug Exposure During Professional PO Prevent Permanent Pregnancy Zoloft C Impairment/Damage Pregnancy Topiramate C Zomig C Date:01/07/05ISR Number: 4550065-1Report Type:Expedited (15-DaCompany Report #2004UW18894 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Health Seroquel PS ORAL 150 MG QOD PO Intervention to Tardive Dyskinesia Professional Paxil C Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 1169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/05ISR Number: 4551367-5Report Type:Expedited (15-DaCompany Report #2004AC01098 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Myeloid Leukaemia Foreign Seroquel PS ORAL 500 MG DAILY Health PO Professional Clozapin Other Neuraxpharm C Neuraxpharm Paroxetin C Date:01/07/05ISR Number: 4551458-9Report Type:Expedited (15-DaCompany Report #2004PK01913 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Electrocardiogram Qt Health PO Corrected Interval Professional Seroquel SS ORAL 100 MG DAILY Prolonged PO Fibrin D Dimer Increased Seroquel SS ORAL 600 MG DAILY Hyperthermia PO Hypoaesthesia Seroquel SS ORAL 450 MG DAILY Sensation Of Heaviness PO Venous Thrombosis Melneurin SS ORAL 25 MG DAILY Weight Decreased PO Akineton Retard C Date:01/10/05ISR Number: 4550082-1Report Type:Expedited (15-DaCompany Report #2005UW00077 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Seroquel PS ORAL 4 G ONCE PO Initial or Prolonged Electrocardiogram Qt Professional Seroquel SS Corrected Interval Klonopin SS Prolonged Multiple Drug Overdose Intentional Suicide Attempt Torsade De Pointes Date:01/10/05ISR Number: 4550095-XReport Type:Expedited (15-DaCompany Report #2004UW23940 Age:9 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Seroquel PS ORAL 150 MG QD PO Condition Aggravated Professional Lexapro C Date:01/11/05ISR Number: 4551575-3Report Type:Expedited (15-DaCompany Report #2003UW15501 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Consumer Seroquel PS ORAL 25 MG QD PO Hospitalization - Cardio-Respiratory Arrest Seroquel SS ORAL 50 MG QD PO Initial or Prolonged Convulsion Seroquel SS ORAL 125 MG QD PO Required Dementia Alzheimer'S Type Seroquel SS ORAL 75 MG QD PO Intervention to Disease Progression Seroquel SS ORAL 100 MG QD PO Prevent Permanent Seroquel SS ORAL 125 MG QD PO Impairment/Damage Seroquel SS ORAL 150 MG QD PO Seroquel SS ORAL 125 MG QD PO 22-Feb-2006 08:31 AM Page: 1170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS ORAL 150 MG QD PO Seroquel SS ORAL 175 MG QD PO Seroquel SS ORAL 225 MG QD PO Seroquel SS ORAL 300 MG QD PO Seroquel SS ORAL 450 MG QD PO Seroquel SS ORAL 550 MG QD PO Seroquel SS ORAL 25 MG QD PO Seroquel SS ORAL 50 MG QD PO Seroquel SS ORAL 25 MG QD PO Aspirin C Lactulose C Levothyroxine C Sertraline C Vitamin E C Galantamine C Lorazepam C Acetaminophen C Date:01/11/05ISR Number: 4551832-0Report Type:Expedited (15-DaCompany Report #2005GB00008 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Quetiapine PS Initial or Prolonged Condition Aggravated Health Exelon SS Liver Function Test Professional Abnormal Other Skin Discolouration Date:01/12/05ISR Number: 4550658-1Report Type:Expedited (15-DaCompany Report #IT-ABBOTT-05P-083-0285874-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bicytopenia Depakine Chrono Initial or Prolonged Tablets PS ORAL 30 DAY Quetiapine SS ORAL 31 DAY Risperidone SS ORAL 2 DAY Phenobarbital Sodium C ORAL 1 DAY Date:01/12/05ISR Number: 4551671-0Report Type:Expedited (15-DaCompany Report #2004UW25875 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Seroquel PS Professional Date:01/12/05ISR Number: 4553383-6Report Type:Expedited (15-DaCompany Report #2004AP06173 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS ORAL 300 MG DAILY Decreased Health PO Professional Other 22-Feb-2006 08:31 AM Page: 1171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/05ISR Number: 4553384-8Report Type:Expedited (15-DaCompany Report #2004AP06174 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS ORAL 350 MG DAILY Decreased Health PO Professional Other Date:01/13/05ISR Number: 4552969-2Report Type:Expedited (15-DaCompany Report #2004UW25167 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Seroquel PS Completed Suicide Professional No Match C Date:01/13/05ISR Number: 4552971-0Report Type:Expedited (15-DaCompany Report #2005AC00016 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antinuclear Antibody Literature Quetiapine PS ORAL 100 MG DAILY Required Positive Health PO Intervention to Anuria Professional Metformin C Prevent Permanent Ascites Ramipril C Impairment/Damage Blood Albumin Decreased Thyroid Replacement Blood Culture Positive Therapy C Bronchopneumonia Lithium C Coma Culture Urine Positive Cystitis Depressed Level Of Consciousness Diabetic Nephropathy Drug Ineffective Encephalopathy Fungal Infection Hepatic Failure Hepatic Necrosis Hepatitis Nephrosclerosis Prothrombin Time Prolonged Pyelonephritis Renal Impairment Staphylococcal Infection Date:01/13/05ISR Number: 4553175-8Report Type:Expedited (15-DaCompany Report #2001AP04758 Age:64 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Blood Osmolarity Required Decreased Intervention to Brain Damage Prevent Permanent Grand Mal Convulsion Impairment/Damage Hyponatraemia Obsessive-Compulsive Disorder Personality Change 22-Feb-2006 08:31 AM Page: 1172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polydipsia Thirst Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel "Zeneca" PS Zeneca ORAL 300 MG BID PO Health Oxybutinin SS 2.5 MG BID Professional Ibuprofen C Other Lactulose C Paracetamol C Temazepam C Quinine Sulphate C Vitamin E C Malic Acid C Glandosane C Benzexol Hydrochloride C Olanzapine C Date:01/13/05ISR Number: 4553177-1Report Type:Expedited (15-DaCompany Report #2004AC00853 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Activated Partial Foreign Seroquel PS ORAL SEE IMAGE Intervention to Thromboplastin Time Health Prozac C Prevent Permanent Prolonged Professional Impairment/Damage Coagulopathy Other Prothrombin Time Prolonged Date:01/14/05ISR Number: 4554806-9Report Type:Expedited (15-DaCompany Report #GXKR2003GB00451 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Neonatal Foreign Lorazepam (Ngx) Initial or Prolonged Caesarean Section Health (Lorazepam) PS TRANSPLACENTAL 6 MG, Congenital Anomaly Drug Exposure During Professional TRANSPLACENTA Pregnancy Other L Drug Withdrawal Syndrome Seroquel (Quetiapine Feeding Disorder Neonatal Fumarate) Tablet SS TRANSPLACENTAL 600 MG/DAY, Hypertonia TRANSPLACENTA Intercostal Retraction L Nasal Flaring Pyrexia Date:01/14/05ISR Number: 4556422-1Report Type:Expedited (15-DaCompany Report #2004SE07287 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Seroquel PS ORAL 1 G DAILY PO Initial or Prolonged Health Depakin Chrono SS ORAL 1 G DAILY PO Professional Risperdal SS ORAL 3 MG DAILY PO Other Gardenale C 22-Feb-2006 08:31 AM Page: 1173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/05ISR Number: 4556423-3Report Type:Expedited (15-DaCompany Report #2005SE00118 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Foreign Seroquel PS ORAL 50 MG QD PO Syncope Vasovagal Health Remeron SS ORAL 15 MG QD PO Professional Meronem C Other Fludex - Slow Release C Date:01/14/05ISR Number: 4556472-5Report Type:Expedited (15-DaCompany Report #2004UW18692 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Seroquel PS ORAL 600 MG HS PO Initial or Prolonged Blood Pressure Decreased Professional Seroquel SS ORAL 900 MG ONCE Depressed Level Of PO Consciousness Erythromycin SS 500 MG QD Disturbance In Sexual Singulair C Arousal Claritin C Drug Interaction False Positive Laboratory Result Somnolence Tachycardia Date:01/14/05ISR Number: 4556473-7Report Type:Expedited (15-DaCompany Report #2005UW00292 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Oesophageal Achalasia Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:01/14/05ISR Number: 4556527-5Report Type:Expedited (15-DaCompany Report #2005AP00145 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Seroquel PS ORAL 1200 MG DAILY Health PO Professional Valproic Acid C Other Date:01/14/05ISR Number: 4556986-8Report Type:Expedited (15-DaCompany Report #2004UW24380 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Seroquel PS ORAL 200 MG HS PO Bronchitis Professional Risperdal SS ORAL 1 MG QAM PO Circulatory Collapse Risperdal SS 0.5 MG QAM Dizziness Carbatrol SS ORAL 300 MG Q12H Fatigue PO Feeling Abnormal Zithromax C Loss Of Consciousness Ortho Tri-Cyclen C Pain In Extremity Flonase C Pulmonary Embolism Maxalt-Mlt C Motrin C 22-Feb-2006 08:31 AM Page: 1174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lidocaine Jelly C Albuterol C Pepcid C Cleocin T C Flexeril C Icy Hot C Depo-Provera C Date:01/18/05ISR Number: 4553932-8Report Type:Expedited (15-DaCompany Report #JP-ABBOTT-05P-087-0285506-00 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ammonia Increased Depakene PS ORAL 15 DAY Life-Threatening Ascites Bicamol SS ORAL 15 DAY Hospitalization - Blood Pressure Decreased Vegetamin SS ORAL 78 DAY Initial or Prolonged Bradycardia Risperidone SS ORAL 15 DAY Other Coma Carbamazepine SS ORAL 15 DAY Condition Aggravated Diazepam SS ORAL 60 DAY Dysphagia Sulpiride SS ORAL 50 DAY Hepatic Function Abnormal Quetiapine SS ORAL 1 DAY Hepatitis Acute Chlorpromazine C ORAL 53 DAY Hypercapnia Flunitrazepam C ORAL 78 DAY Hypoxia Bromperidol C ORAL 53 DAY Jaundice Promethazine Logorrhoea Hydrochloride C ORAL 53 DAY Multi-Organ Failure Neuroleptic Malignant Syndrome Oliguria Pneumonia Pyrexia Renal Impairment Soliloquy Sputum Retention Stupor Unevaluable Event Unresponsive To Verbal Stimuli Date:01/18/05ISR Number: 4555370-0Report Type:Direct Company Report #CTU 237026 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperhidrosis Seroquel PS 25 MG AM 50MG Hospitalization - Muscle Rigidity PM Initial or Prolonged Neuroleptic Malignant Geodon Inj SS INTRAMUSCULAR 10MG 100MG HS Syndrome IM Tachypnoea Paroxetine C Verapamil C Crestor C Prednisone C Date:01/18/05ISR Number: 4555555-3Report Type:Direct Company Report #CTU 237083 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Seroquel PS ORAL 200 MG Q12 H PO 22-Feb-2006 08:31 AM Page: 1175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Glucophage C Zoloft C Date:01/18/05ISR Number: 4556687-6Report Type:Expedited (15-DaCompany Report #SUS1-2004-00783 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Carbatrol Dizziness Professional (Carbamazepine) Loss Of Consciousness Capsule Xr PS ORAL 300 MG, EVERY Pain In Extremity 12 HOURS,ORAL Pulmonary Embolism Seroquel (Quetiapine Fumarate) SS ORAL 200 MG, EVERY HS, ORAL Risperdal(Risperidon e) SS 1 MG, 1X/DAY:QD IN AM Date:01/18/05ISR Number: 4556805-XReport Type:Expedited (15-DaCompany Report #S04-USA-06784-01 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Health Lexapro Initial or Prolonged Post Procedural Professional (Escitalopram) PS ORAL 10 MG QD PO Required Complication Company Seroquel (Quetiapine Intervention to Priapism Representative Fumarate) SS 400 MG QD Prevent Permanent Thrombosis Ambien (Zolpidem Impairment/Damage Tartrate) C Date:01/18/05ISR Number: 4557041-3Report Type:Expedited (15-DaCompany Report #2005GB00019 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Foreign Quetiapine PS ORAL 200 MG PO Initial or Prolonged Influenza Health Semisodium Valproate SS ORAL 500 MG TID PO Required Urticaria Professional Valium C Intervention to Other Prevent Permanent Impairment/Damage Date:01/19/05ISR Number: 4555539-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12768065 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Disturbance In Attention Company, Ltd. ORAL Increased to Hallucination 30 mg/day Muscle Rigidity after one Schizophrenia week. Social Avoidant Behaviour Clozapine SS Tardive Dyskinesia Quetiapine SS 22-Feb-2006 08:31 AM Page: 1176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/05ISR Number: 4556045-4Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0349154A Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Augmentin PS Glaxosmithkline ORAL 1000MG Twice Cerebral Haematoma per day 1 DAY Convulsion Trittico SS ORAL Coordination Abnormal Seroquel SS ORAL Cyanosis Temesta C ORAL Fall Zestril C ORAL Grand Mal Convulsion Torem C ORAL Head Injury Marcumar C ORAL Hypotonia Infected Skin Ulcer Mouth Haemorrhage Respiratory Arrest Sepsis Staphylococcal Infection Streptococcal Infection Tongue Biting Traumatic Haematoma Date:01/19/05ISR Number: 4557125-XReport Type:Direct Company Report #CTU 237225 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Quetiapine 300mg PS ORAL 300MG QBED Initial or Prolonged ORAL Tylenol #3 C Enalapril C Glyburide C Nitroglycerine C Omeprazole C Paroxetine C Date:01/19/05ISR Number: 4558686-7Report Type:Expedited (15-DaCompany Report #2005UW00478 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Seroquel PS ORAL 600 MG DAILY Initial or Prolonged Insomnia Health PO Medication Error Professional Depakote C Muscle Tightness Risperdal C Schizophrenia Cogentin C Prozac C Ambien C Acetaminophen C Date:01/20/05ISR Number: 4556936-4Report Type:Expedited (15-DaCompany Report #PHBS2004JP12941 Age:39 YR Gender:Female I/FU:F Outcome PT Life-Threatening Anaesthetic Complication Anaphylactic Reaction Blood Pressure Systolic Decreased Flushing Hysterectomy Latex Allergy 22-Feb-2006 08:31 AM Page: 1177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Obstructive Airways Disorder Oxygen Saturation Report Source Product Role Manufacturer Route Dose Duration Decreased Melleril PS Novartis Sector: Pco2 Decreased Pharma ORAL Tachycardia General Traction Anaesthetics, Other SS Quetiapine Fumarate SS ORAL Eperisone Hydrochloride SS ORAL Biperiden Hydrochloride SS ORAL Anaesthetics, Local SS Date:01/20/05ISR Number: 4560218-4Report Type:Direct Company Report #CTU 237475 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Quetiapine Initial or Prolonged Schizophrenia (Seroquel) 200 Mg Other Treatment Noncompliance Tab ; Astra -Zeneca Pharmaceuticals PS Astra -Zeneca Pharmaceuticals ORAL 600 MG QD @ HS PO Date:01/21/05ISR Number: 4558642-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500945 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Risperidone PS UNKNOWN 308 DAY Initial or Prolonged Gastrointestinal Necrosis Olanzapine SS UNKNOWN 308 DAY Pneumonia Quetiapine SS UNKNOWN 308 DAY Trazodone C Mvi C Mvi C Mvi C Mvi C Mvi C Mvi C Mvi C Mvi C Feso4 C Carbamazepine C OROPHARINGEAL Date:01/21/05ISR Number: 4558669-7Report Type:Direct Company Report #CTU 237523 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Seroquel 100mg Astra-Zeneca PS Astra-Zeneca ORAL 300MG AT BEDTIME ORAL Serzone 100mg Bristol Myers Squibb SS Bristol Myers Squibb ORAL 200MG TWICE DAILY ORAL 22-Feb-2006 08:31 AM Page: 1178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4558987-2Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-05P-167-0286210-00 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Depakote PS ORAL 9 MON Initial or Prolonged Influenza Quetiapine SS ORAL 9 MON Other Oropharyngeal Swelling Diazepam C ORAL Urticaria Diazepam C Date:01/21/05ISR Number: 4560724-2Report Type:Expedited (15-DaCompany Report #2004AP05470 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ascites Foreign Seroquel PS ORAL 100 MG TID PO Life-Threatening Blood Pressure Decreased Health Tegretol SS ORAL 100 MG TID PO Hospitalization - Bradycardia Professional Horizon SS ORAL 5 MG QID PO Initial or Prolonged Cardiac Disorder Other Silece SS ORAL 2 MG BID PO Dysphagia Hirnamin SS ORAL 5 MG TID PO Hepatitis Vegetamin A SS Hepatitis Acute Risperdal SS ORAL 2 MG TID PO Hypercapnia Dogmatyl SS ORAL 100 MG TID PO Multi-Organ Failure Depakene-R SS ORAL 200 MG TID PO Neuroleptic Malignant Glycyron C Syndrome Dasen C Pneumonia Aspiration Pneumonia Bacterial Renal Impairment Sepsis Stupor Date:01/21/05ISR Number: 4560725-4Report Type:Expedited (15-DaCompany Report #2004SE06769 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Constipation Foreign Seroquel PS ORAL 750 MG DAILY Neurogenic Bladder Health PO Urinary Retention Professional Rivotril C Other Nozinan C Date:01/21/05ISR Number: 4560727-8Report Type:Expedited (15-DaCompany Report #2004AP06253 Age:50 YR Gender:Female I/FU:F Outcome PT Death Abnormal Behaviour Alanine Aminotransferase Increased Anoxic Encephalopathy Aspartate Aminotransferase Increased Bacteria Urine Identified Blood Lactate Dehydrogenase Increased Blood Pressure Decreased Bradycardia Brain Death Cardio-Respiratory Arrest Delirium Diabetes Insipidus 22-Feb-2006 08:31 AM Page: 1179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diverticulitis Inflammation Insomnia Report Source Product Role Manufacturer Route Dose Duration Large Intestine Carcinoma Foreign Seroquel PS ORAL 100 MG DAILY Loss Of Consciousness Health PO Memory Impairment Professional Akineton SS ORAL 1 MG TID PO Pulmonary Artery Other Hirnamin SS ORAL 50 MG TID PO Thrombosis Linton SS ORAL 9 MG TID PO Renal Infarct Risperdal SS ORAL 2 MG TID PO Respiratory Rate Rohypnol SS Decreased Vegetamin B SS ORAL 50 MG DAILY Restlessness PO Shock Pursennid C Supraventricular Extrasystoles Ventricular Fibrillation Date:01/21/05ISR Number: 4560730-8Report Type:Expedited (15-DaCompany Report #2005SE00152 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleurothotonus Foreign Seroquel PS Initial or Prolonged Health Lithium C Professional Other Date:01/21/05ISR Number: 4560731-XReport Type:Expedited (15-DaCompany Report #2005-01-1039 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Gentamicin Sulfate Condition Aggravated Other Injectable Solution PS Depressed Level Of Seroquel (Quetiapine Consciousness Fumurate) Tablets SS ORAL 138 MG QD Dyspnoea ORAL Dystonia Ativan C Hypotension Risperidone C Speech Disorder Visual Disturbance Date:01/21/05ISR Number: 4561104-6Report Type:Expedited (15-DaCompany Report #2005UW00843 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Seroquel PS Drug Toxicity Professional Hepatic Steatosis Date:01/21/05ISR Number: 4561268-4Report Type:Expedited (15-DaCompany Report #2005UW00708 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fall Health Seroquel PS ORAL 200 MG HS PO 1 MON Intervention to Head Injury Professional Lexapro C Prevent Permanent Loss Of Consciousness Vicodin C Impairment/Damage Orthostatic Hypotension 22-Feb-2006 08:31 AM Page: 1180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4561648-7Report Type:Expedited (15-DaCompany Report #2004UW24885 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemia Health Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Loss Of Consciousness Professional PO Insulin SS Parnate C Lisinopril C Risperdal C Date:01/21/05ISR Number: 4561649-9Report Type:Expedited (15-DaCompany Report #2004UW25293 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cough Health Seroquel PS ORAL 300 MG HS PO Intervention to Laryngospasm Professional Trileptal C Prevent Permanent Stridor Impairment/Damage Date:01/21/05ISR Number: 4562763-4Report Type:Expedited (15-DaCompany Report #2005AP00084 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tic Foreign Seroquel PS Intervention to Health Lexapro C Prevent Permanent Professional Edronax C Impairment/Damage Other Epilim C Date:01/21/05ISR Number: 4562766-XReport Type:Expedited (15-DaCompany Report #2004GB02958 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Foreign Quetiapine PS ORAL 25 MG BID PO Required Inadequate Control Health Haloperidol SS 5 MG DAILY Intervention to Drug Interaction Professional Procyclidine C Prevent Permanent Other Insulin C Impairment/Damage Date:01/21/05ISR Number: 4562768-3Report Type:Expedited (15-DaCompany Report #2005PK00082 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Cardiac Failure Health PO Pleural Effusion Professional Trevilor SS ORAL 75 MG DAILY Supraventricular Other PO Tachycardia Solian C Troponin I Increased Date:01/24/05ISR Number: 4559438-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041207553 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Health Risperdal PS OROPHARINGEAL Total daily Sudden Death Professional dose = 3-4 mg/day. 22-Feb-2006 08:31 AM Page: 1181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Litium SS OROPHARINGEAL Litium SS OROPHARINGEAL Quetiapine Fumarate SS OROPHARINGEAL Clonazepam C Date:01/24/05ISR Number: 4560650-9Report Type:Direct Company Report #CTU 237697 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Quetiapine PS ORAL 200 MG PO HS Hospitalization - Syndrome [PRIOR TO Initial or Prolonged ADMISSION TO Other 1/22/05] Required Fluticasone C Intervention to Lansoprazole C Prevent Permanent Amitriptyline C Impairment/Damage Escitalopram C Ipratropium C Mucinex C Montelukast C Albuterol C Midazolam C Phenylephrine C Propofol C Buspirone C Date:01/26/05ISR Number: 4564161-6Report Type:Expedited (15-DaCompany Report #2005014481 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Depression Foreign Lustral (Sertraline) PS ORAL 200 MG (200 Drug Exposure During Health MG, 1 IN 1 Pregnancy Professional D), ORAL Drug Tolerance Decreased Quetiapine Fumarate Ectopic Pregnancy (Quetiapine Fumarate) SS ORAL 150 MG (150 MG, 1 IN 1 D), ORAL Date:01/26/05ISR Number: 4564174-4Report Type:Expedited (15-DaCompany Report #2004GB01310 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Distension Foreign Seroquel PS ORAL 200 MG BID PO Intervention to Dyspnoea Consumer Seroquel SS ORAL 500 MG DAILY Prevent Permanent Eye Swelling Other PO Impairment/Damage Joint Swelling Seroquel SS ORAL 300 MG DAILY Rash Maculo-Papular PO Skin Discolouration Enzyme Tablet C Skin Swelling Swelling Face 22-Feb-2006 08:31 AM Page: 1182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/05ISR Number: 4564176-8Report Type:Expedited (15-DaCompany Report #2004SE06491 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS ORAL 100 MG DAILY Decreased Health PO Professional Haldol SS ORAL 2 MG DAILY PO Other Orfiril C Date:01/26/05ISR Number: 4564384-6Report Type:Expedited (15-DaCompany Report #2005AP00254 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Health PO Professional Other Date:01/26/05ISR Number: 4564392-5Report Type:Expedited (15-DaCompany Report #2005AP00168 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 1000 MG DAILY Intervention to Neutropenia Health PO Prevent Permanent Professional Impairment/Damage Other Date:01/26/05ISR Number: 4564397-4Report Type:Expedited (15-DaCompany Report #2004SE07205 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Strabismus Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Tunnel Vision Health PO Prevent Permanent Visual Disturbance Professional Litarex C Impairment/Damage Visual Field Defect Other Date:01/27/05ISR Number: 4565173-9Report Type:Direct Company Report #CTU 238341 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Seroquel PS SEE ITEM B5 Dizziness Zyprexa C Dysarthria Cogentin C Loss Of Consciousness Benadryl C Nausea Ocular Hyperaemia Rhinorrhoea Somnolence Vomiting Date:01/27/05ISR Number: 4565194-6Report Type:Direct Company Report #CTU 238463 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Quetiapine Initial or Prolonged Treatment Noncompliance (Seroquel) 200 Mg Tab Astra-Zeneca 22-Feb-2006 08:31 AM Page: 1183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals PS Astra-Zeneca Pharmaceuticals ORAL 600 MG QD @HS PO Date:01/27/05ISR Number: 4567266-9Report Type:Expedited (15-DaCompany Report #2005015050 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Literature Ziprasidone (Caps) Full Blood Count Health (Ziprasidone) PS ORAL 120 MG, ORAL Decreased Professional Quetiapine Macrocytosis (Quetiapine) SS ORAL 600 MG, ORAL Myelodysplastic Syndrome Date:01/28/05ISR Number: 4563818-0Report Type:Expedited (15-DaCompany Report #PHBS2004JP12941 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaphylactic Reaction Thioridazine PS Novartis Sector: Blood Pressure Systolic Pharma ORAL Decreased General Flushing Anaesthetics, Other SS Hysterectomy Quetiapine Fumarate SS ORAL Obstructive Airways Anaesthetics, Local SS Disorder Eperisone Oxygen Saturation Hydrochloride SS ORAL Decreased Biperiden Pco2 Decreased Hydrochloride SS ORAL Tachycardia Thiopental C Traction Suxamethonium C UNKNOWN Propofol C UNKNOWN Vecuronium C UNKNOWN Dinitrogen Monoxide C UNKNOWN Oxygen C UNKNOWN Sevoflurane C UNKNOWN Xylocaine C 9 ml/d Fentanyl C UNKNOWN 50 ug/d Date:01/28/05ISR Number: 4565942-5Report Type:Expedited (15-DaCompany Report #2005SE00348 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Hallucination Study PO Insomnia Health Schizoaffective Disorder Professional Other Date:01/28/05ISR Number: 4565952-8Report Type:Expedited (15-DaCompany Report #2005PK00093 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Encephalopathy Other PO Psychiatric Symptom Temesta SS ORAL 3 MG DAILY PO Sedation Temesta SS ORAL 2 MG DAILY PO Vertigo Temesta SS ORAL 1 MG DAILY PO Asasantin - Slow 22-Feb-2006 08:31 AM Page: 1184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Release C Zestril C Tenormin Mite C Aspirin Cardio C Eltroxin "Glaxo" C Nexium Mups C Citalopram C Date:01/28/05ISR Number: 4565998-XReport Type:Expedited (15-DaCompany Report #2004SE04561 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Seroquel PS ORAL 300 MG DAILY Cardiac Arrest Health PO Fear Professional Seroquel SS ORAL 800 MG DAILY Myocarditis Other PO Psychological Factor Seroquel SS ORAL 1200 MG DAILY Affecting Medical PO Condition Lormetazapam C Pentazol C Akineton C Cisordinol-Acutard C Cisordinol-Slow Release C Date:01/28/05ISR Number: 4566487-9Report Type:Expedited (15-DaCompany Report #KII-2005-0014786 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Oxycontin Initial or Prolonged Agitation Health (Oxycodone Other Anion Gap Increased Professional Hydrochloride) Cr PS ORAL ORAL Blood Creatine Other Seroquel Phosphokinase Increased (Quetiapine) SS ORAL ORAL Blood Creatine Thiazolidnedione () SS ORAL ORAL Phosphokinase Mb Antipsychotics () SS ORAL ORAL Increased Benzodiazepines Blood Glucose Decreased Derivatives () SS ORAL ORAL Blood Glucose Increased Confusional State Disorientation Hallucination Heart Rate Increased Hyperhidrosis Loss Of Consciousness Multiple Drug Overdose Polysubstance Abuse Tremor White Blood Cell Count Increased Date:01/28/05ISR Number: 4568085-XReport Type:Expedited (15-DaCompany Report #2005UW01112 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Consumer Seroquel PS ORAL 125 MG DAILY Platelet Count Decreased PO 3 YR 22-Feb-2006 08:31 AM Page: 1185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/05ISR Number: 4568086-1Report Type:Expedited (15-DaCompany Report #2005UW00874 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Seroquel PS ORAL 200 MG PO Required Disorientation Naproxen C Intervention to Dizziness Atenolol C Prevent Permanent Dry Mouth Pravachol C Impairment/Damage Medication Error Myocardial Infarction Speech Disorder Swollen Tongue Date:01/31/05ISR Number: 4568377-4Report Type:Expedited (15-DaCompany Report #2005SE00270 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Electroencephalogram Foreign Seroquel PS ORAL 400 MG QD PO Abnormal Health Zoloft C Narcolepsy Professional Sleep Disorder Other Date:01/31/05ISR Number: 4568378-6Report Type:Expedited (15-DaCompany Report #2005UW01228 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS Professional Date:01/31/05ISR Number: 4569746-9Report Type:Expedited (15-DaCompany Report #2005AC00094 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Literature Quetiapine PS ORAL 100 MG BID PO Intervention to Orthostatic Health Quetiapine SS ORAL 500 MG HS PO Prevent Permanent Body Temperature Professional Quetiapine SS ORAL 50 MG PRN PO Impairment/Damage Increased Quetiapine SS ORAL 100 MG ONCE Electrocardiogram Qt PO Corrected Interval Mirtazipine C Prolonged Heart Rate Increased Intentional Overdose Neutropenia Suicide Attempt Date:02/01/05ISR Number: 4569104-7Report Type:Expedited (15-DaCompany Report #2004UW24585 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Seroquel PS ORAL 600 MG HS PO Hospitalization - Depression Professional Parnate SS ORAL 20 MG TID PO Initial or Prolonged Myoglobinuria Morphine C Neuroleptic Malignant Syndrome Overdose Renal Failure Respiratory Failure 22-Feb-2006 08:31 AM Page: 1186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/05ISR Number: 4569105-9Report Type:Expedited (15-DaCompany Report #2005UW01312 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Seroquel PS Professional Buspar SS Date:02/01/05ISR Number: 4569559-8Report Type:Expedited (15-DaCompany Report #2005AP00293 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Abnormal Health PO Professional Cipramil C Other Venlafaxine C Date:02/01/05ISR Number: 4569560-4Report Type:Expedited (15-DaCompany Report #2005AC00136 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradykinesia Foreign Seroquel PS ORAL 100 MG DAILY Hospitalization - Choking Health PO Initial or Prolonged Dysphagia Professional Sinemet C Parkinsonism Other Mirapexin C Date:02/01/05ISR Number: 4569561-6Report Type:Expedited (15-DaCompany Report #2005GB00187 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Seroquel PS ORAL 25 MG ONCE PO Required Syncope Health Intervention to Professional Prevent Permanent Other Impairment/Damage Date:02/01/05ISR Number: 4569562-8Report Type:Expedited (15-DaCompany Report #2005SE00364 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Autism Study PO Condition Aggravated Health Hypochondriasis Professional Hypokinesia Other Schizophrenia Date:02/01/05ISR Number: 4569598-7Report Type:Expedited (15-DaCompany Report #2005SE00493 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Apathy Foreign Seroquel PS ORAL 300 MG DAILY Intervention to Cerebral Haemorrhage Consumer PO Prevent Permanent Fatigue Other Klomipramin C Impairment/Damage Muscle Spasms Propavan C Stilnoct C Fluanxol C 22-Feb-2006 08:31 AM Page: 1187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/05ISR Number: 4569599-9Report Type:Expedited (15-DaCompany Report #2005AP00453 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neutropenia Foreign Seroquel PS ORAL 1600 MG DAILY Respiratory Failure Health PO Professional Other Date:02/01/05ISR Number: 4569600-2Report Type:Expedited (15-DaCompany Report #2005PK00155 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Micturition Disorder Health PO Urinary Retention Professional Efexor SS ORAL 225 MG DAILY Other PO Date:02/01/05ISR Number: 4576059-8Report Type:Direct Company Report #CTU 238768 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Seroquel PS Initial or Prolonged Date:02/02/05ISR Number: 4570586-5Report Type:Expedited (15-DaCompany Report #2005GB00174 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Somnolence Foreign Quetiapine PS 25-12.5 MG ON Intervention to Thrombocytopenia Health Atenolol C Prevent Permanent Professional Senna C Impairment/Damage Other Temazepam C Amoxicillin Trihydrate C Haloperidol C Date:02/02/05ISR Number: 4570611-1Report Type:Expedited (15-DaCompany Report #2004AP06088 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Foreign Seroquel PS ORAL 25 MG TID PO Intervention to Increased Health Seroquel SS ORAL 150 MG PO Prevent Permanent Anaemia Professional Seroquel SS ORAL 100 MG TID PO Impairment/Damage Aspartate Other Limas C Aminotransferase Bromocriptine C Increased Tasmolin C Blood Creatine Doral C Phosphokinase Increased Magnesium Oxide C Hepatic Function Abnormal Pantethine C Hyperglycaemia Pleural Effusion Pneumonia Vomiting 22-Feb-2006 08:31 AM Page: 1188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4571758-6Report Type:Direct Company Report #CTU 238968 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Seroquel Initial or Prolonged Pyrexia Astrazeneca PS Astrazeneca Zyprexa C Date:02/02/05ISR Number: 4571831-2Report Type:Expedited (15-DaCompany Report #2005UW01150 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Transient Health Seroquel PS ORAL 25 MG ONCE PO Intervention to Drug Withdrawal Syndrome Professional Ativan SS Prevent Permanent Impairment/Damage Date:02/02/05ISR Number: 4578369-7Report Type:Direct Company Report #CTU 238900 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Quetiapine Initial or Prolonged Electrocardiogram Pr (Seroquel) PS 25MG Q AM / Prolongation 50MG QHS Sinus Bradycardia Synthroid C Syncope Aricept C Vitc/Vit E C Selegiline C Date:02/03/05ISR Number: 4572280-3Report Type:Expedited (15-DaCompany Report #2005AP00375 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Azotaemia Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Blood Glucose Increased Health PO Professional Seroquel SS ORAL 50 MG DAILY Other PO Clozaril C Date:02/03/05ISR Number: 4572281-5Report Type:Expedited (15-DaCompany Report #2005AP00613 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Foreign Seroquel PS ORAL 12.5 MG DAILY Health PO Professional Other Date:02/04/05ISR Number: 4576081-1Report Type:Expedited (15-DaCompany Report #2005UW01549 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatotoxicity Foreign Seroquel PS Neutropenia Health Professional Other 22-Feb-2006 08:31 AM Page: 1189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4578527-1Report Type:Direct Company Report #CTU 239301 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fibrosis Seroquel 200mg Initial or Prolonged Penis Disorder Tablet Astrazeneca PS Astrazeneca ORAL 400MG TWICE Required Priapism DAILY ORAL Intervention to Therapeutic Response Seroquel 300mg Prevent Permanent Decreased Tablet Astrazeneca SS Astrazeneca ORAL 300MG TWICE Impairment/Damage DAILY ORAL Depakote Er C Aspirin (Ec) C Lipitor C Date:02/05/05ISR Number: 4571408-9Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-04P-167-0283834-00 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Thyroid Stimulating Valproate Sodium PS ORAL Initial or Prolonged Hormone Increased Valproate Sodium SS Leukopenia Quetiapine SS ORAL Neutropenia Date:02/07/05ISR Number: 4576410-9Report Type:Expedited (15-DaCompany Report #2005AP00683 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Seroquel PS ORAL 200 MG DAILY Required Arrhythmia Health PO Intervention to Blood Sodium Decreased Professional Amlodipine C Prevent Permanent Drug Interaction Other Insulin C Impairment/Damage Hypotension Ambroxol C Hypoventilation Diphenhydramine C Insomnia Obesity Resuscitation Sleep Apnoea Syndrome Date:02/07/05ISR Number: 4576482-1Report Type:Expedited (15-DaCompany Report #2004UW21574 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Health Seroquel PS ORAL 1300 MG PO Intervention to Sinusitis Professional Seroquel SS ORAL 900 MG DAILY Prevent Permanent Skin Infection PO Impairment/Damage Urinary Tract Infection Seroquel SS ORAL 150 MG PO Seroquel SS ORAL 300 MG PO Seroquel SS ORAL 600 MG PO Depakote C Clindamycin C Date:02/07/05ISR Number: 4576488-2Report Type:Expedited (15-DaCompany Report #2005UW01779 Age:41 YR Gender:Female I/FU:I Outcome Death Required Intervention to 22-Feb-2006 08:31 AM Page: 1190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Seroquel PS ORAL 200 MG DAILY Overdose Professional PO Self-Medication Paxil C Cymbalta C Date:02/07/05ISR Number: 4576493-6Report Type:Expedited (15-DaCompany Report #2005UW01728 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Professional Date:02/07/05ISR Number: 4576494-8Report Type:Expedited (15-DaCompany Report #2005AC00142 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Macrocytic Literature Quetiapine PS ORAL 600 MG DAILY Intervention to Blood Disorder Health PO Prevent Permanent Blood Test Abnormal Professional Quetiapine SS ORAL 600 MG DAILY Impairment/Damage Myelodysplastic Syndrome PO Ziprasidone SS ORAL 40 MG DAILY PO Ziprasidone SS 120 MG DAILY PAR Date:02/07/05ISR Number: 4576902-2Report Type:Expedited (15-DaCompany Report #2005UW01504 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Toprol Xl PS ORAL 100 MG PO Initial or Prolonged Neuroleptic Malignant Professional Seroquel SS ORAL 100 MG PO Syndrome Benadryl SS Rash Clonapin C Tapazole C Lexapro C Risperdal C Date:02/07/05ISR Number: 4578533-7Report Type:Direct Company Report #CTU 239379 E Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Abilify Initial or Prolonged Drooling Bristol-Myers Squibb PS Bristol-Myers Squibb ORAL 5 MG DAILY PO Dystonia Seroquel Gait Disturbance Astra-Zeneca SS Astra-Zeneca ORAL 225 MG / DAY Muscle Spasms PO Posture Abnormal Adderall Xr C Tremor Vomiting 22-Feb-2006 08:31 AM Page: 1191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/05ISR Number: 4578606-9Report Type:Direct Company Report #CTU 239464 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Quetiapine PS ORAL PO Initial or Prolonged Date:02/07/05ISR Number: 4578609-4Report Type:Direct Company Report #CTU 239463 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Quetiapine PS ORAL PO Initial or Prolonged Tetrabenazine SS ORAL PO Date:02/08/05ISR Number: 4575090-6Report Type:Expedited (15-DaCompany Report #AT-GLAXOSMITHKLINE-B0369754A Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Lamotrigine PS Glaxosmithkline ORAL 36 DAY Initial or Prolonged Venlafaxine Hydrochloride SS ORAL 31 DAY Mirtazapine SS ORAL 60MG Per day Quetiapine SS ORAL Alprazolam C ORAL 13 DAY Tamsulosin C ORAL .4MG Per day Lactulose C ORAL Seroxat C Glaxosmithkline UNKNOWN 60MG per day Nortriptyline C ORAL 50MG per day 14 DAY Date:02/08/05ISR Number: 4576975-7Report Type:Expedited (15-DaCompany Report #2004UW01147 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Seroquel PS ORAL 37.5 MG DAILY Initial or Prolonged Beta Haemolytic Other PO Required Streptococcal Infection Celexa C Intervention to Blood Sodium Decreased Prevent Permanent Bronchitis Acute Impairment/Damage Decreased Appetite Dehydration Dermatitis Contact Diabetes Mellitus Diabetic Ketoacidosis Dyspnoea Hyperglycaemia Infectious Mononucleosis Ketoacidosis Ketonuria Pharyngitis Sinusitis Tachycardia Urinary Tract Infection Weight Increased 22-Feb-2006 08:31 AM Page: 1192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/05ISR Number: 4576989-7Report Type:Expedited (15-DaCompany Report #2005UW01580 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Health Seroquel PS ORAL 100 MG HS PO Initial or Prolonged Professional Seroquel SS ORAL 25 MG QD PO Anafranil C Zantac C Date:02/08/05ISR Number: 4576991-5Report Type:Expedited (15-DaCompany Report #2005UW01793 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Vision Blurred Consumer Seroquel PS ORAL 50 MG DAILY Intervention to PO 2 MON Prevent Permanent Lithium C Impairment/Damage Lexapro C Date:02/08/05ISR Number: 4576996-4Report Type:Expedited (15-DaCompany Report #2004UW25180 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affect Lability Study Seroquel PS ORAL 400 MG QD PO Initial or Prolonged Agitation Health Tylenol C Condition Aggravated Professional Ambien C Paranoia Ativan C Psychotic Disorder Date:02/08/05ISR Number: 4577105-8Report Type:Expedited (15-DaCompany Report #HQWYE165129OCT04 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Health Effexor (Venlafaxine Blood Chloride Increased Professional Hydrochloride) PS ORAL 150 MG TWICE Blood Glucose Increased DAILY AND 75 Blood Osmolarity MG AT HS, Increased ORAL Cardiac Failure Morphine Sulfate Cardiomegaly (Morphine Sulfate) SS INTRAMUSCULAR 20 MG 1X PER Costovertebral Angle 1 TOT, Tenderness INTRAMUSCULAR Dilatation Ventricular Seroquel Drug Interaction (Quetiapine, ) SS 100 MG 1X PER Drug Level Increased 1 DAY Drug Screen Positive Vicodin (Hydrocodone Electrocardiogram Qt Bitartrate/Paracetam Prolonged ol, ) SS Hepatic Steatosis Trazodone Nausea (Trazodone) C Obesity Topamax (Topiramate) C Pelvic Pain Flexeril Pulmonary Oedema (Cyclobenzaprine Ureteral Stent Insertion Hydrochloride) C Vomiting Zetia (Ezetimibe0 C Singulair (Montelukast Sodium) C Metformin (Metformin) C Actos (Pioglitazone 22-Feb-2006 08:31 AM Page: 1193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Cozaar (Losartan Potassium) C Lovastatin (Lovastatin) C Date:02/08/05ISR Number: 4577568-8Report Type:Expedited (15-DaCompany Report #2004AP06262 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Increased Health PO Aspartate Professional Seroquel SS ORAL 50 MG TID PO Aminotransferase Other Seroquel SS ORAL 150 MG QID PO Increased Seroquel SS ORAL 250 MG QID PO Blood Pressure Decreased Aricept C Blood Test Abnormal Serenace C Cholelithiasis Artane C Hepatic Function Abnormal Neo Dopaston C Hyperplastic Risperdal C Cholecystopathy Zyprexa C Increased Appetite Pursennid C Inflammation Magnesium Oxide C Parkinsonism Pyrexia Date:02/08/05ISR Number: 4579210-9Report Type:Direct Company Report #CTU 239742 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Quetiapine PS 200 MG DAILY Initial or Prolonged AT 0700 - 2100 Date:02/08/05ISR Number: 4579212-2Report Type:Direct Company Report #CTU 239744 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Quetiapine PS ORAL 200 MG PO 9 Initial or Prolonged AM Date:02/08/05ISR Number: 4579213-4Report Type:Direct Company Report #CTU 239745 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Quetiapine 200 Mg PS 200 MG HS Initial or Prolonged Date:02/09/05ISR Number: 4577229-5Report Type:Expedited (15-DaCompany Report #2004AL000721 Age: Gender:Female I/FU:F Outcome PT Death Completed Suicide Hospitalization - Electrocardiogram Poor Initial or Prolonged R-Wave Progression Hypotension Multiple Drug Overdose 22-Feb-2006 08:31 AM Page: 1194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Sedation Septic Shock Report Source Product Role Manufacturer Route Dose Duration Tachycardia Literature Theophylline Elixir, Health 80 Mg/15 Ml Professional (Alpharma) PS Alpharma ORAL PO Acetaminophen/Hydroc odone SS ORAL PO Mirtazapine SS ORAL PO Sertraline SS ORAL PO Quetiapine SS ORAL PO Doxycycline SS ORAL PO Lansoprazole SS ORAL PO Labetalol SS ORAL PO Prochlorperazine SS ORAL PO Date:02/09/05ISR Number: 4577240-4Report Type:Expedited (15-DaCompany Report #2004AL000904 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anion Gap Increased Literature Children'S Apap Blood Bicarbonate Health Elixir Decreased Professional (Acetaminophen) Blood Ph Decreased (Alpharma) PS Alpharma ORAL PO Cardiac Arrest Infants' Apap Drops Completed Suicide (Acetaminophen) Depression (Alpharma) SS Alpharma ORAL PO Electromechanical Aspirin/Caffeine SS ORAL PO Dissociation Quetiapine SS ORAL PO Hyperhidrosis Sertraline SS ORAL PO Multiple Drug Overdose Vomiting Date:02/09/05ISR Number: 4578583-0Report Type:Expedited (15-DaCompany Report #2005-124866-NL Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delirium Mirtazapine PS 8 MG Drug Interaction Quetiapine Fumarate SS 75 MG 1 MON Hallucinations, Mixed Pipamperone Refusal Of Treatment By Hydrochloride SS 100 MG 1 MON Patient Rofecoxib SS 25 MG 1 MON Restlessness Date:02/09/05ISR Number: 4578637-9Report Type:Expedited (15-DaCompany Report #2005GB00221 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Foreign Quetiapine PS ORAL 25 MG BID PO Life-Threatening Deterioration Health Atarax /Can/ SS ORAL 25 MG DAILY Hospitalization - Musculoskeletal Stiffness Professional PO Initial or Prolonged Myalgia Other Donepezil SS ORAL 5 MG DAILY PO Disability Neuroleptic Malignant Memantine C Required Syndrome Aspirin C Intervention to Dipyridamole C Prevent Permanent Prednisolone C Impairment/Damage Oxybutynin C 22-Feb-2006 08:31 AM Page: 1195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4578676-8Report Type:Direct Company Report #CTU 239960 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenia Quetiapine 200 Mg Required Blood Pressure Systolic Astra Zeneca PS Astra Zeneca ORAL SEE IMAGE Intervention to Increased Albuterol Ihhaler C Prevent Permanent Chest Pain Lexapro C Impairment/Damage Diabetes Mellitus Enalapril C Nausea Xanax C Pain Nicotine Gum C Sleep Disorder Ibuprofen C Seroquel C Keflex C Date:02/09/05ISR Number: 4579247-XReport Type:Direct Company Report #CTU 239932 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Arrest Seroquel PS UNKNOWN OVERDOSE - Circulatory Collapse UNKNOWN Completed Suicide Succinylcholine SS MG/KG ( MG) Coronary Artery Atherosclerosis Drug Ineffective Drug Interaction Hyperthermia Malignant Intentional Overdose Neuroleptic Malignant Syndrome Ventricular Tachycardia Date:02/09/05ISR Number: 4579275-4Report Type:Expedited (15-DaCompany Report #2005GB00187 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Seroquel PS ORAL 25 MG ONCE PO Required Feeling Abnormal Health Intervention to Sinus Arrest Professional Prevent Permanent Sinus Bradycardia Other Impairment/Damage Date:02/09/05ISR Number: 4579276-6Report Type:Expedited (15-DaCompany Report #2004AP05472 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Flushing Foreign Seroquel PS Haemodynamic Instability Literature Levomepromazine SS Hypotension Health Thioridazine SS Oxygen Saturation Professional Propofol C Decreased Other Vecuronium C Procedural Complication Fentanyl C Nitrous Oxide C Oxygen C Sevoflurane C Lidocaine C Biperiden C Eperisone C 22-Feb-2006 08:31 AM Page: 1196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4579277-8Report Type:Expedited (15-DaCompany Report #2004SE07007 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Foreign Seroquel PS ORAL 200 MG BID PO Life-Threatening Palpitations Health Truxal SS 50 MG DAILY Sudden Death Professional Akarin SS 40 MG DAILY Other Remeron SS 15 MG DAILY Novynette SS 150+2- UG Date:02/09/05ISR Number: 4579290-0Report Type:Expedited (15-DaCompany Report #2005GB00188 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Seroquel PS ORAL 25 MG ONCE PO Required Bradycardia Health Intervention to Nausea Professional Prevent Permanent Sinus Arrest Other Impairment/Damage Syncope Date:02/10/05ISR Number: 4579610-7Report Type:Expedited (15-DaCompany Report #2004AL000507 Age:51 YR Gender:Female I/FU:F Outcome PT Death Aggression Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Atrioventricular Block First Degree Base Excess Negative Bilirubin Conjugated Increased Blood Albumin Decreased Blood Alkaline Phosphatase Increased Blood Bicarbonate Decreased Blood Bilirubin Increased Blood Chloride Increased Blood Creatine Phosphokinase Increased Blood Glucose Increased Blood Lactate Dehydrogenase Increased Blood Ph Decreased Blood Pressure Decreased Bundle Branch Block Right Completed Suicide Electrocardiogram Pr Prolongation Electrocardiogram Qrs Complex Prolonged Generalised Oedema Grand Mal Convulsion Hepatic Steatosis Multiple Drug Overdose Oxygen Saturation 22-Feb-2006 08:31 AM Page: 1197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Pco2 Decreased Pco2 Increased Po2 Decreased Report Source Product Role Manufacturer Route Dose Duration Pyrexia Literature Propoxyphene Qrs Axis Abnormal Health Napsylate And Splenomegaly Professional Acetaminophen Urine Output Decreased Tablets Usp, 100 Mg/650 Mg (Purepac) PS Purepac ORAL PO Alprazolam Tablets Usp, 2 Mg (Purepac) SS Purepac ORAL PO Zolpidem SS ORAL PO Ethanol SS ORAL PO Bupropion SS ORAL PO Quetiapine SS ORAL PO Date:02/10/05ISR Number: 4579748-4Report Type:Expedited (15-DaCompany Report #2005AP00789 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Seroquel PS ORAL 400 MG DAILY Exercise Capacity Health PO Decreased Professional Solian SS 1 G Fatigue Other Sodium Valproate C Date:02/10/05ISR Number: 4579752-6Report Type:Expedited (15-DaCompany Report #2004AP06112 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacteria Sputum Foreign Seroquel PS ORAL 25 MG TID PO Identified Health Seroquel SS ORAL 50 MG TID PO C-Reactive Protein Professional Voltaren SS 25 MG DAILY Increased Other RC Cardio-Respiratory Arrest Serenace C Depressed Level Of Levotomin C Consciousness Eurodin C Granulocytopenia Bladderon C Haemorrhagic Diathesis Slo-Bid C Infection In An Onon C Immunocompromised Host Mexitil C Klebsiella Infection Bisolvon C Leukopenia Mucosolvan C Multi-Organ Failure Ferromia C Pneumonia Akineton C Renal Failure Acute Gaster C Respiratory Failure Effortil C Septic Shock Dopamine Therapeutic Product Hydrochloride C Ineffective Date:02/10/05ISR Number: 4579753-8Report Type:Expedited (15-DaCompany Report #2005GB00211 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Left Ventricular Failure Foreign Seroquel PS ORAL 200 MG BID PO Intervention to Pulmonary Oedema Consumer Prevent Permanent Other Impairment/Damage 22-Feb-2006 08:31 AM Page: 1198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/05ISR Number: 4579755-1Report Type:Expedited (15-DaCompany Report #2005AP00941 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Seroquel PS ORAL 600 MG DAILY Electrocardiogram Qt Health PO Prolonged Professional Fluoxetine Hypotension Other Hydrochloride SS ORAL 80 MG DAILY Loss Of Consciousness PO Tachyarrhythmia Erythromycin SS 400 MG DAILY Date:02/10/05ISR Number: 4579756-3Report Type:Expedited (15-DaCompany Report #2005AP00951 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Neonatal Foreign Seroquel PS 25 MG DAIL Required Drug Exposure During Health PAR Intervention to Pregnancy Professional Fluoxetine Prevent Permanent Hypothermia Neonatal Other Hydrochloride SS 40 MG DAILY Impairment/Damage Neonatal Apnoeic Attack PAR Premature Baby Syntocinon C Date:02/10/05ISR Number: 4579765-4Report Type:Expedited (15-DaCompany Report #2005SE00746 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatitis Toxic Foreign Seroquel PS ORAL 1200 MG QD; Intervention to Health PO Prevent Permanent Professional Impairment/Damage Other Date:02/10/05ISR Number: 4579875-1Report Type:Expedited (15-DaCompany Report #2004AL000664 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Carbamazepine Hospitalization - Completed Suicide Health Tablets, Usp, 200 Mg Initial or Prolonged Nervous System Disorder Professional (Purepac) PS Purepac ORAL PO Pneumonia Clonazepam Tablets Pupil Fixed Usp, 2 Mg (Purepac) SS Purepac ORAL PO Respiratory Arrest Quetiapine SS ORAL PO Chlordiazepoxide SS ORAL PO Acetaminophen/Hydroc odone SS ORAL PO Lithium SS ORAL PO Date:02/10/05ISR Number: 4579916-1Report Type:Expedited (15-DaCompany Report #2004AL000680 Age:50 YR Gender:Female I/FU:F Outcome PT Death Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Blood Urea Increased 22-Feb-2006 08:31 AM Page: 1199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coma Completed Suicide Drug Ineffective Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram St Literature Alprazolam Tablets Segment Elevation Health Usp, 2 Mg (Purepac) PS Purepac ORAL PO Hepatic Steatosis Professional Propoxyphene Multiple Drug Overdose Napsylate And Pulmonary Oedema Acetaminophen Pupillary Reflex Impaired Tablets Usp, 100 Splenomegaly Mg/650 Mg (Purepac) SS Purepac ORAL PO Bupropion SS ORAL PO Quetiapine SS ORAL PO Date:02/10/05ISR Number: 4580021-9Report Type:Expedited (15-DaCompany Report #2004UW22139 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Professional PO Date:02/10/05ISR Number: 4580032-3Report Type:Expedited (15-DaCompany Report #2005UW02036 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Seroquel PS Professional Date:02/10/05ISR Number: 4582178-2Report Type:Expedited (15-DaCompany Report #2004AL000837 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agonal Rhythm Literature Fluvoxamine Maleate Blood Ph Decreased Health Tablets, 100 Mg Cardio-Respiratory Arrest Professional (Purepac) PS Purepac ORAL PO Coma Hydramine Cough Completed Suicide Syrup Electrocardiogram Qrs (Diphenhydramine Complex Prolonged Hydrochloride Cough Electrocardiogram St Syrup) (Alpharma) SS Alpharma ORAL PO Segment Depression Hydramine Elixir Grand Mal Convulsion (Diphenhydramine Haemoglobin Abnormal Hydrochloride Hypotension Elixir) (Alpharma) SS Alpharma ORAL PO Multiple Drug Overdose Children'S Apap Intentional Elixir Pco2 Increased (Acetaminophen) Po2 Increased (Alpharma) SS Alpharma ORAL PO Pulse Absent Infant'S Apap Drops Ventricular Tachycardia (Acetaminophen) (Alpharma) SS Alpharma ORAL PO Ibuprofen Oral Suspension Usp, 100 Mg/5 Ml (Otc) (Alpharma) SS Alpharma ORAL PO Ibuprofen Oral Suspension Usp, 100 Mg/5 Ml (Rx) (Alpharma) SS Alpharma ORAL PO 22-Feb-2006 08:31 AM Page: 1200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quetiapine SS ORAL PO Brompheniramine SS ORAL PO Date:02/11/05ISR Number: 4578757-9Report Type:Expedited (15-DaCompany Report #PHBS2004JP17256 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Ritalin PS Novartis Sector: Blood Alkaline Pharma ORAL 30 mg/d Phosphatase Increased Rohypnol SS ORAL 2 mg/d Haemoglobin Decreased Seroquel SS ORAL 30 mg/d Malaise Tecipul SS ORAL 6 mg/d 134 DAY Pancytopenia Sepazon SS ORAL 2 mg/d 183 DAY Platelet Count Decreased Amoban C Red Blood Cell Count Decreased White Blood Cell Count Decreased Date:02/11/05ISR Number: 4579930-6Report Type:Direct Company Report #CTU 240277 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Seroquel PS ORAL 100 MG PO Drug Interaction DAILY Hypotension SEVERAL DAYS Pulse Pressure Decreased Clonidine SS ORAL 0.1 MG PO Syncope DAILY IN PM SEVERAL DAYS Date:02/11/05ISR Number: 4583499-XReport Type:Expedited (15-DaCompany Report #2005025058 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Atarax (Tablet) Hospitalization - Phosphokinase Increased Health (Hydroxyzine Initial or Prolonged Eczema Professional Hydrochloride) PS ORAL 25 MG (1 D), Other Musculoskeletal Stiffness ORAL Myalgia Quetiapine Neuroleptic Malignant (Quetiapine) SS ORAL 50 MG (25 MG, Syndrome 2 IN 1 D), Pruritus ORAL Donepezil (Donepezil) SS ORAL 5 MG (1 D), ORAL Memantine (Memantine) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Dipyridamole (Dipyridamole) C Prednisolone (Prednisolone) C Oxybutynin Hydrochloride (Oxybutynin Hydrochloride) C 22-Feb-2006 08:31 AM Page: 1201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/05ISR Number: 4583538-6Report Type:Expedited (15-DaCompany Report #2005AP00812 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Seroquel PS ORAL 100 MG DAILY Electrocardiogram St Health PO Segment Elevation Professional Hypotension Other Tachycardia Vomiting Date:02/11/05ISR Number: 4583592-1Report Type:Expedited (15-DaCompany Report #2005AP00998 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Delusion Health PO Disturbance In Attention Professional Musculoskeletal Stiffness Other Date:02/11/05ISR Number: 4583594-5Report Type:Expedited (15-DaCompany Report #2005PK00220 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 800 MG DAILY Health PO Professional Favistan SS Other Lorazepam C Propanolol C L-Thyroxin C Date:02/11/05ISR Number: 4583862-7Report Type:Expedited (15-DaCompany Report #2005PK00219 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancytopenia Foreign Seroquel PS Health Carbamazepin "Gry" SS Gry Professional Lorazepam "Ayerst" C Other Date:02/14/05ISR Number: 4579687-9Report Type:Expedited (15-DaCompany Report #JP-ABBOTT-05P-087-0285506-00 Age:25 YR Gender:Female I/FU:F Outcome PT Death Ammonia Increased Life-Threatening Ascites Hospitalization - Bradycardia Initial or Prolonged Condition Aggravated Other Hepatic Function Abnormal Hepatitis Acute Hypercapnia Hypoxia Jaundice Logorrhoea Multi-Organ Failure Neuroleptic Malignant Syndrome Oliguria 22-Feb-2006 08:31 AM Page: 1202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Renal Impairment Sputum Retention Report Source Product Role Manufacturer Route Dose Duration Depakene PS ORAL 15 DAY Bicamol SS ORAL 15 DAY Vegetamin SS ORAL 78 DAY Risperidone SS ORAL 15 DAY Carbamazepine SS ORAL 15 DAY Diazepam SS ORAL 60 DAY Sulpiride SS ORAL 50 DAY Quetiapine SS ORAL 1 DAY Chlorpromazine C ORAL 53 DAY Flunitrazepam C ORAL 78 DAY Bromperidol C ORAL 53 DAY Promethazine Hydrochloride C ORAL 53 DAY Date:02/14/05ISR Number: 4580801-XReport Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0513553A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Macular Lamictal PS Glaxosmithkline ORAL 25MG Per day 3 DAY Seroquel SS UNKNOWN Tegretol C Date:02/14/05ISR Number: 4580911-7Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0515864A Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Lamictal PS Glaxosmithkline ORAL 75MG At night Seroquel SS ORAL 100MG At night Hctz C ORAL 25MG Per day Lexapro C ORAL 10MG Per day Date:02/14/05ISR Number: 4581124-5Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0521669A Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Lamictal PS Glaxosmithkline ORAL 150MG Per day 3 MON Seroquel SS Eskalith C Glaxosmithkline Ambien C Ativan C Date:02/14/05ISR Number: 4584812-XReport Type:Expedited (15-DaCompany Report #2005UW02011 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Seroquel PS ORAL 50 MG ONCE Initial or Prolonged Blood Ph Decreased Professional PO Blood Pressure Increased Albuterol C Coma Azithromycin C Heart Rate Increased Ceftriaxone C Heparin C Meclizine C Pantoprazole C 22-Feb-2006 08:31 AM Page: 1203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prednisone C Haldol C Date:02/14/05ISR Number: 4584814-3Report Type:Expedited (15-DaCompany Report #2004UW26314 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Seroquel PS ORAL 100 MG PO Initial or Prolonged Agitation Professional Paxil SS ORAL 25 MG PO Blood Chloride Increased Antihistamine SS Blood Creatinine Increased Fatigue Hallucination Hallucination, Tactile Hallucination, Visual Multiple Drug Overdose Somnolence Tachycardia Date:02/14/05ISR Number: 4584815-5Report Type:Expedited (15-DaCompany Report #2005UW01895 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Retinitis Pigmentosa Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:02/14/05ISR Number: 4584816-7Report Type:Expedited (15-DaCompany Report #2005UW02231 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 500 MG DAILY Decreased Professional PO Risperidone C Depakote C Paxil C Date:02/14/05ISR Number: 4584817-9Report Type:Expedited (15-DaCompany Report #2005UW01731 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Consumer Seroquel PS Intervention to Condition Aggravated Depakote C Prevent Permanent Imprisonment Sleep Medications C Impairment/Damage Mania Suicide Attempt Date:02/14/05ISR Number: 4585329-9Report Type:Expedited (15-DaCompany Report #2005023545 Age: Gender: I/FU:I Outcome PT Hospitalization - Anorgasmia Initial or Prolonged Anxiety Other Condition Aggravated 22-Feb-2006 08:31 AM Page: 1204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Drug Interaction Dry Mouth Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Consumer Nardil (Phenelzine Nervous System Disorder Sulfate) PS ORAL 45 MG (15 MG, Suicidal Ideation 1 IN 1 D), Therapeutic Response ORAL Unexpected Quetiapine Fumarate Tremor (Quetiapine Vision Blurred Fumarate) SS ORAL 50 MG (50 MG, 1 IN 1 D), ORAL Aripiprazole (Aripiprazole) SS ORAL 10 MG (10 MG, 1 IN 1 D), ORAL Lithium (Lithium) C Date:02/14/05ISR Number: 4585445-1Report Type:Expedited (15-DaCompany Report #2005UW01947 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Seroquel PS ORAL 400 MG QD PO Initial or Prolonged Bipolar Disorder Health Risperidone C Condition Aggravated Professional Clonidine C Screaming Aripiprazole C Self Injurious Behaviour Divalproex C Suicidal Ideation Date:02/14/05ISR Number: 4587039-0Report Type:Expedited (15-DaCompany Report #2005AP00938 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dry Mouth Foreign Seroquel PS ORAL 900 MG DAILY Musculoskeletal Stiffness Health PO Neuroleptic Malignant Professional Epilim SS 1 G DAILY Syndrome Other Coloxyl C Pyrexia Senna C Tachycardia Lactulose C Tachypnoea Date:02/14/05ISR Number: 4587042-0Report Type:Expedited (15-DaCompany Report #2005AP01104 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Suicidal Ideation Foreign Seroquel PS Intervention to Suicide Attempt Health Largactil SS Prevent Permanent Professional Impairment/Damage Other Date:02/14/05ISR Number: 4587071-7Report Type:Expedited (15-DaCompany Report #2005AP01083 Age:34 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 1205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Serotonin Syndrome Foreign Seroquel PS ORAL 50 MG DAILY Health PO Professional Aropax SS ORAL 40 MG DAILY Other PO Panadeine Forte C Date:02/15/05ISR Number: 4582581-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB04520 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Exelon PS Novartis Sector: Initial or Prolonged Gamma-Glutamyltransferase Pharma ORAL 3mg/day Disability Increased Quetiapine SS ORAL 100mg/day Other Jaundice Liver Function Test Abnormal Skin Discolouration Date:02/15/05ISR Number: 4587283-2Report Type:Expedited (15-DaCompany Report #2005GB00268 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Quetiapine PS ORAL 50 MG PO Convulsion Health Fall Professional Respiratory Arrest Other Date:02/15/05ISR Number: 4587284-4Report Type:Expedited (15-DaCompany Report #2004AC00073 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Clearance Decreased Foreign Seroquel PS ORAL 100 MG SID PO Initial or Prolonged Drug Interaction Literature Seroquel SS ORAL 300 MG BID PO Grand Mal Convulsion Health Nefazodone SS ORAL 200 MG BID PO Medication Error Professional Lamotrigine C Overdose Other Sedation Date:02/15/05ISR Number: 4587285-6Report Type:Expedited (15-DaCompany Report #2005GB00227 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Quetiapine PS ORAL 50 MG BID PO Intervention to Face Injury Health Fybogel C Prevent Permanent Fall Professional Impairment/Damage Other Date:02/15/05ISR Number: 4587324-2Report Type:Expedited (15-DaCompany Report #2005AP01098 Age: Gender: I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 1206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Homicidal Ideation Foreign Seroquel PS Suicidal Ideation Health Fluoxetine Professional Hydrochloride SS Other Haloperidol SS Efexor SS Date:02/15/05ISR Number: 4587325-4Report Type:Expedited (15-DaCompany Report #2005AP01094 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Foreign Seroquel PS Intervention to Homicidal Ideation Health Prevent Permanent Physical Assault Professional Impairment/Damage Suicidal Ideation Other Date:02/15/05ISR Number: 4587483-1Report Type:Expedited (15-DaCompany Report #2005UW02233 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depression Consumer Seroquel PS Intervention to Drug Interaction Parnate SS Prevent Permanent Hunger Impairment/Damage Suicide Attempt Date:02/16/05ISR Number: 4585807-2Report Type:Expedited (15-DaCompany Report #2004AL000839 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ibuprofen Oral Multiple Drug Overdose Suspension Usp, 100 Intentional Mg/5 Ml (Rx) (Alpharma) PS Alpharma ORAL PO Ibuprofen Oral Suspension Usp, 100 Mg/5 Ml (Otc) (Alpharma) SS Alpharma ORAL PO Venlafaxine SS ORAL PO Quetiapine SS ORAL PO Date:02/16/05ISR Number: 4588263-3Report Type:Expedited (15-DaCompany Report #2005AP01110 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Seroquel PS Intervention to Suicidal Ideation Health Cipramil SS Prevent Permanent Professional Impairment/Damage Other 22-Feb-2006 08:31 AM Page: 1207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/05ISR Number: 4589365-8Report Type:Expedited (15-DaCompany Report #B0349825A Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Wellbutrin Sr Tablet Completed Suicide Health - Controlled Release Drug Toxicity Professional (Bipropion Toxicologic Test Abnormal Hydrochloride) PS ORAL ORAL Quetiapine (Formulation Unknown) (Quetiapine) SS ORAL ORAL Diazepam (Formulation Unknown) (Diazepam) SS ORAL ORAL Date:02/16/05ISR Number: 4589437-8Report Type:Expedited (15-DaCompany Report #2005UW02049 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Health Seroquel PS ORAL 700 MG QD PO Initial or Prolonged Liver Function Test Professional Abnormal Date:02/16/05ISR Number: 4589438-XReport Type:Expedited (15-DaCompany Report #2005UW02241 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Seroquel PS Professional Date:02/16/05ISR Number: 4590024-6Report Type:Expedited (15-DaCompany Report #B0349819A Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Literature Wellbutrin Phosphokinase Increased Health Unspecified Tablet Blood Creatinine Professional (Bupropion Increased Hydrochloride) PS ORAL ORAL Blood Urea Increased Alprazolam Coma (Alprazolam) SS ORAL ORAL Completed Suicide Paracetamol Electrocardiogram St (Acetaminophen) SS ORAL ORAL Segment Elevation Dextropropoxyphene Hepatic Steatosis (Dextropropoxyphene) SS ORAL ORAL Multiple Drug Overdose Quetiapine Pulmonary Oedema (Quetiapine) SS ORAL ORAL Splenomegaly Date:02/17/05ISR Number: 4589687-0Report Type:Expedited (15-DaCompany Report #2005AP01112 Age:39 YR Gender:Male I/FU:I Outcome PT Hospitalization - Dyspnoea Initial or Prolonged Electrocardiogram Abnormal Myocarditis Neuroleptic Malignant 22-Feb-2006 08:31 AM Page: 1208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 600 MG DAILY Health PO Professional Solian SS ORAL 800 MG DAILY Other PO Clozapine C Date:02/17/05ISR Number: 4589695-XReport Type:Expedited (15-DaCompany Report #2005AP01116 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Suicidal Ideation Foreign Seroquel PS Intervention to Health Avanza SS ORAL 60 MG DAILY Prevent Permanent Professional PO Impairment/Damage Other Risperidone SS Date:02/17/05ISR Number: 4590010-6Report Type:Expedited (15-DaCompany Report #2005AP01154 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Glycosuria Health PO Hyperglycaemia Professional Ketonuria Other Polydipsia Polyuria Date:02/17/05ISR Number: 4590011-8Report Type:Expedited (15-DaCompany Report #2005GB00232 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Quetiapine PS ORAL 100 MG QD PO Intervention to Face Injury Health Quetiapine SS ORAL 200 MG QD PO Prevent Permanent Fall Professional Lorazepam C Impairment/Damage Injury Other Folic Acid C Ibuprofen C Haloperidol C Carbamazepine C Flucloxacillin C Date:02/17/05ISR Number: 4590012-XReport Type:Expedited (15-DaCompany Report #2005UW02227 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS Professional Date:02/17/05ISR Number: 4590014-3Report Type:Expedited (15-DaCompany Report #2004AP05470 Age:25 YR Gender:Female I/FU:F Outcome Death Life-Threatening Hospitalization - 22-Feb-2006 08:31 AM Page: 1209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Ascites Foreign Seroquel PS ORAL 100 MG TID PO Cardiac Disorder Health Tegretol SS ORAL 100 MG TID PO Condition Aggravated Professional Horizon SS ORAL 5 MG QID PO Hepatic Function Abnormal Other Silece SS ORAL 2 MG BID PO Hepatitis Acute Hirnamin SS ORAL 5 MG TID PO Mental Disorder Vegetamin A SS Multi-Organ Failure Risperdal SS ORAL 2 MG TID PO Neuroleptic Malignant Dogmatyl SS ORAL 100 ,G TID PO Syndrome Depakene-R SS ORAL 200 MG TID PO Pneumonia Bacterial Glycyron C Psychosomatic Disease Dasen C Date:02/17/05ISR Number: 4590350-0Report Type:Expedited (15-DaCompany Report #2005UW2250 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Health Seroquel PS ORAL 500 MG QD PO Intervention to Dyspnoea Professional Pyridostigmine SS Prevent Permanent Muscular Weakness Parnate SS 30 MG QD Impairment/Damage Ocular Myasthenia Date:02/18/05ISR Number: 4590993-4Report Type:Expedited (15-DaCompany Report #2005AP01133 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Foreign Seroquel PS Initial or Prolonged Health Cipramil SS Professional Other Date:02/18/05ISR Number: 4590994-6Report Type:Expedited (15-DaCompany Report #2005AP01123 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Insipidus Foreign Seroquel PS ORAL 200 MG DAILY Initial or Prolonged Drug Level Increased Health PO Renal Failure Acute Professional Lithium Carbonate SS ORAL 500 MG DAILY Other PO Ostelin C Nexium C Metoprolol C Oxazepam C Venlafaxine C Date:02/18/05ISR Number: 4590996-XReport Type:Expedited (15-DaCompany Report #2005AP01117 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Urine Ketone Body Present Health PO Professional Other 22-Feb-2006 08:31 AM Page: 1210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/05ISR Number: 4590998-3Report Type:Expedited (15-DaCompany Report #2005AP01137 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Foreign Seroquel PS ORAL 1400 MG DAILY Intervention to Abnormal Health PO Prevent Permanent Electrocardiogram Qt Professional Intal C Impairment/Damage Corrected Interval Other Ventolin C Prolonged Luvox C Solian C Date:02/18/05ISR Number: 4591001-1Report Type:Expedited (15-DaCompany Report #2004SE07007 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholelithiasis Foreign Seroquel PS ORAL 200 MG BID PO Life-Threatening Hepatic Congestion Health Truxal SS 50 MG DAILY Palpitations Professional Akarin SS 40 MG DAILY Pulmonary Artery Other Remeron /Net/ SS 15 MG DAILY Thrombosis Noynette SS 150+20 UG Pulmonary Embolism Schizophrenia Sudden Death Tachycardia Thrombosis Tracheal Haemorrhage Date:02/18/05ISR Number: 4591128-4Report Type:Expedited (15-DaCompany Report #2005AP00763 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel Code Not Initial or Prolonged Increased Study Broken PS Aspartate Health Aminotransferase Professional Increased Other Blood Alkaline Phosphatase Increased Cholelithiasis Concomitant Disease Aggravated Gamma-Glutamyltransferase Increased Date:02/18/05ISR Number: 4591131-4Report Type:Expedited (15-DaCompany Report #2005SE00746 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatitis Toxic Foreign Seroquel PS ORAL 1200 MG QD PO Intervention to Health Prevent Permanent Professional Impairment/Damage Other 22-Feb-2006 08:31 AM Page: 1211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/05ISR Number: 4591673-1Report Type:Expedited (15-DaCompany Report #2005UW00843 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Seroquel PS Drug Screen Positive Professional Protonix "Pharmacia" C Hepatic Atrophy Hepatic Steatosis Pickwickian Syndrome Pulmonary Congestion Date:02/18/05ISR Number: 4592736-7Report Type:Expedited (15-DaCompany Report #2004SE07198 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Lymphoma Foreign Seroquel PS ORAL 100 MG DAILY; Intervention to Somnolence Study PO Prevent Permanent Health Seroquel SS ORAL 200 MG DAILY; Impairment/Damage Professional PO Other Seroquel SS ORAL 300 MG DAILY; PO Seroquel SS ORAL 400 MG DAILY; PO Seroquel SS ORAL 500 MG DAILY; PO Seroquel SS ORAL 600 MG DAILY; PO Seroquel SS ORAL 500 MG DAILY; PO Seroquel SS ORAL 400 MG DAILY; PO Seroquel SS ORAL 600 MG DAILY; PO Depakine Chrono C Propranolol C Estazolam C Date:02/22/05ISR Number: 4590615-2Report Type:Direct Company Report #CTU 240920 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Seroquel 200 G Intervention to Astrazeneca PS Astrazeneca ORAL 1 IN AM, 2 Prevent Permanent AT HS PO Impairment/Damage Inderal C Date:02/22/05ISR Number: 4591037-0Report Type:Direct Company Report #CTU 240985 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Seroquel PS Astrazeneca ORAL 100-200 MG Hospitalization - Asthenia 1-2 TIMES/DAY Initial or Prolonged Atrial Fibrillation ORAL Disability Cardiac Arrest Required Cerebrovascular Accident Intervention to Ventricular Fibrillation Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 1212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/05ISR Number: 4592528-9Report Type:Expedited (15-DaCompany Report #2005023545 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorgasmia Consumer Nardil Initial or Prolonged Anxiety (Phenelzine Sulfate) PS ORAL 45 MG (15 MG, Other Depression Suicidal 1 IN 1 D), Dry Mouth ORAL Muscle Rigidity Quetiapin Fumarate Pharmaceutical Product (Quetiapine Complaint Fumarate) SS ORAL 50 MG (50 MG, Tremor 1 IN 1 D), Vision Blurred ORAL Ariprazole (Aripiprazole) SS ORAL 10 MG (10 MG, 1 IN 1 D), ORAL Lithium (Lithium) C Date:02/22/05ISR Number: 4592559-9Report Type:Expedited (15-DaCompany Report #2005AP01114 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Suicidal Ideation Foreign Seroquel PS Intervention to Health Cipramil SS Prevent Permanent Professional Impairment/Damage Other Date:02/22/05ISR Number: 4592560-5Report Type:Expedited (15-DaCompany Report #2005SE00783 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bronchospasm Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Health PO Prevent Permanent Professional Seroquel SS ORAL 100 MG DAILY Impairment/Damage Other PO Effexor Xr C Lamictin C Date:02/22/05ISR Number: 4592561-7Report Type:Expedited (15-DaCompany Report #2004SE04443 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS 600 MG DAILY Health Seroquel SS 400 MG DAILY Professional Depakin Chrono C Other Rivotril C Date:02/22/05ISR Number: 4594173-8Report Type:Expedited (15-DaCompany Report #2005PK00247 Age:43 YR Gender:Female I/FU:I Outcome PT Required Coordination Abnormal Intervention to Drug Interaction Prevent Permanent Drug Toxicity Impairment/Damage Dyspnoea Nausea 22-Feb-2006 08:31 AM Page: 1213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vertigo Visual Disturbance Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 800 MG DAILY Health PO Professional Seroquel SS ORAL 100 MG DAILY Other PO Vps SS ORAL 2000 MG DAILY PO Vps SS ORAL 1000 MG DAILY PO Date:02/23/05ISR Number: 4591747-5Report Type:Direct Company Report #CTU 241093 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Seroquel 100 Mg PS Q HS DAILY Initial or Prolonged Lamictal 125 Mg SS QHS DAILY Orthotricyclen-Lo C Date:02/23/05ISR Number: 4594790-5Report Type:Expedited (15-DaCompany Report #2005UW02692 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention-Seeking Health Seroquel PS Initial or Prolonged Behaviour Professional Xanax SS APPROXIMATELY Multiple Drug Overdose 3 PILLS Intentional Suicide Attempt Date:02/23/05ISR Number: 4594796-6Report Type:Expedited (15-DaCompany Report #2005SE00939 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS OROPHARINGEAL 125 MG DAILY Health PO Professional Tegretol SS 600 MG DAILY Other Benzodiazepine Drops C Date:02/23/05ISR Number: 4594798-XReport Type:Expedited (15-DaCompany Report #2005GB00276 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Foreign Quetiapine PS ORAL 25 MG QD PO Intervention to Complete Health Amiodarone C Prevent Permanent Bradycardia Professional Bisoprolol C Impairment/Damage Sinus Arrest Other Perindopril C Tegretol C Date:02/23/05ISR Number: 4594799-1Report Type:Expedited (15-DaCompany Report #2005GB00277 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Diabetes Mellitus Foreign Initial or Prolonged Inadequate Control Health Disability Urinary Tract Infection Professional 22-Feb-2006 08:31 AM Page: 1214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Quetiapine PS ORAL 600 MG DAILY PO Lithium Carbonate C Zopiclone C Date:02/23/05ISR Number: 4594800-5Report Type:Expedited (15-DaCompany Report #2005GB00280 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Seroquel PS ORAL 25 MG PO Initial or Prolonged Consciousness Health Temazepam C Electrocardiogram Qt Professional Venlafaxine C Prolonged Other Donepezil C Trazodone C Date:02/24/05ISR Number: 4595774-3Report Type:Expedited (15-DaCompany Report #A044-002-005478 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Aricept (Donepezil Initial or Prolonged Haemodialysis Health Hydrochloride) PS ORAL 10 MG, 1 IN 1 Neuroleptic Malignant Professional D, ORAL Syndrome Seroquel (Quetiapine Renal Failure Acute Fumarate) SS 400 MG Rhabdomyolysis Tavor (Lorazepam) SS 6 MG Thombran (Trazodone Hydrochloride) SS 400 MG Quilonum (Lithium Acetate) SS 675 MG Zyprexa (Olanzapine) SS 20 MG Zeldox (Ziprasidone Hydrochloride) SS 80 MG Haldol (Haloperidol) SS 6 MG Date:02/24/05ISR Number: 4595994-8Report Type:Expedited (15-DaCompany Report #2004UW24375 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other False Positive Laboratory Foreign Seroquel PS Result Health Seroquel SS ORAL 300 MG DAILY Platelet Count Decreased Professional PO Other Clonazepam C Synthroid C Date:02/25/05ISR Number: 4595317-4Report Type:Direct Company Report #CTU 241377 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Clonazepam 1mg PS ORAL 1MG PO TID Initial or Prolonged PRN ANXIETY Quetiapine 25mg SS ORAL 50MG PO TID 22-Feb-2006 08:31 AM Page: 1215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/05ISR Number: 4596065-7Report Type:Expedited (15-DaCompany Report #2005PK00278 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS ORAL 50 MG DAILY Life-Threatening Cardiac Failure Health PO Cardiopulmonary Failure Professional Seroquel SS ORAL 100 MG DAILY Coronary Artery Disease Other PO Drug Interaction Seroquel SS ORAL 150 MG DAILY Fall PO Hepatic Congestion Seroquel SS ORAL 200 MG DAILY Skin Laceration PO Seroquel SS ORAL 300 MG DAILY PO Fluanxol SS ORAL 7 MG DAILY PO Fluanxol SS ORAL 3 MG DAILY PO Fluanxol SS ORAL 3 MG DAILY PO Carmen SS 10 MG DAILY Edronax C L-Thyroxin C Ossofortin C Date:02/25/05ISR Number: 4596067-0Report Type:Expedited (15-DaCompany Report #2005AP00168 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Insomnia Foreign Seroquel PS ORAL 1000 MG DAILY Intervention to Leukopenia Health PO Prevent Permanent Neutropenia Professional Temazapam C Impairment/Damage Other Date:02/25/05ISR Number: 4596122-5Report Type:Expedited (15-DaCompany Report #2005-DE-00533GD Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Literature Sertraline Initial or Prolonged Communication Disorder (Sertraline) PS 200 MG, QHS Drug Effect Decreased Lithium (Lithium Drug Resistance Carbonate) SS 1650 MG, QD Mania Quetiapine Paraesthesia (Quetiapine) SS 200 MG, QHS Skin Reaction Clonazepam Suicidal Ideation (Clonazepam) SS 2 MG, QID Treatment Noncompliance Ziprasidone (Ziprasidone) SS 80 MG, QHS Verapamil (Verapamil) SS 160 MG, BID Date:02/25/05ISR Number: 4596218-8Report Type:Expedited (15-DaCompany Report #2005PK00286 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Seroquel PS 250 MG DAILY Initial or Prolonged Micturition Disorder Health Seroquel SS ORAL 125 MG DAILY Professional PO Other Stangyl SS Stangyl SS Stangyl SS 175 MG DAILY Tavor SS 2 MG DAILY 22-Feb-2006 08:31 AM Page: 1216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trevilor C Date:02/25/05ISR Number: 4596230-9Report Type:Expedited (15-DaCompany Report #2005UW02647 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatic Failure Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:02/25/05ISR Number: 4596235-8Report Type:Expedited (15-DaCompany Report #2005PK00291 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Health PO Prevent Permanent Professional Impairment/Damage Other Date:02/25/05ISR Number: 4596243-7Report Type:Expedited (15-DaCompany Report #2005UW02627 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Health Seroquel PS 200 MG, 120 Initial or Prolonged Intentional Professional TABLETS Required Suicide Attempt Clonazepam SS "100 PILLS" Intervention to Xanax SS "100 PILLS" Prevent Permanent Impairment/Damage Date:02/28/05ISR Number: 4595594-XReport Type:Direct Company Report #CTU 241510 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Seroquel 100 Mg Tabs PS ORAL 100 MG PO BID Divalproex C Fluphenazine C Risperidone C Date:02/28/05ISR Number: 4596331-5Report Type:Expedited (15-DaCompany Report #2005PK00290 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Blood Creatinine Health PO Required Increased Professional Tavor SS 6 MG DAILY Intervention to Drug Interaction Other Thombran SS 400 DAILY Prevent Permanent Haemodialysis Aricept SS 10 MG DAILY Impairment/Damage Neuroleptic Malignant Zeldox /Gfr/ SS 80 MG DAILY Syndrome Haldol "Janssen" SS 6 MG DAILY Renal Failure Acute Rhabdomyolysis 22-Feb-2006 08:31 AM Page: 1217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4596878-1Report Type:Expedited (15-DaCompany Report #2005UW02816 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Health Seroquel PS ORAL 100 MG BID Initial or Prolonged Disorientation Professional PO Dysstasia Vicks SS Date:02/28/05ISR Number: 4596882-3Report Type:Expedited (15-DaCompany Report #2004UW22388 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Seroquel PS ORAL 200 MG PO 6 WK Initial or Prolonged Dyskinesia Professional Serzone SS 200 MG Other Feeling Hot And Cold Wellbutrin C Medication Error Asacol C Movement Disorder Parkinsonism Restlessness Tic Date:02/28/05ISR Number: 4597531-0Report Type:Direct Company Report #CTU 241470 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blister Seroquel 100mg PS Astra Zeneca PILL 2X A DAY Initial or Prolonged Chest Pain ( I THINK) 3 DAY Required Crying Intervention to Feeling Abnormal Prevent Permanent Headache Impairment/Damage Hypersensitivity Insomnia Psychomotor Hyperactivity Date:02/28/05ISR Number: 4597595-4Report Type:Direct Company Report #CTU 241598 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Seroquel-Quetiapine- PS Astra Zeneca ORAL 200 MG BID Hospitalization - Ketoacidosis ORAL Initial or Prolonged Mental Status Changes Sertraline C Metocarbamol C Dicyclomine C Divalproex C Augmentin C Guaifenesin With Codeine C Date:03/02/05ISR Number: 4598149-6Report Type:Expedited (15-DaCompany Report #2005SE00152 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleurothotonus Foreign Seroquel PS 600 MG + 60 Initial or Prolonged Health MG AS NEEDED Professional Lithium C Other Litarex C Rivotril C Zeldox C 22-Feb-2006 08:31 AM Page: 1218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/05ISR Number: 4598176-9Report Type:Expedited (15-DaCompany Report #2004AC01032 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 100 MG PO Intervention to Extrapyramidal Disorder Health Seroquel SS ORAL 200 MG PO Prevent Permanent Professional Depakine SS ORAL 1 G DAILY PO Impairment/Damage Other Sipralexa C Edronax C Date:03/02/05ISR Number: 4598179-4Report Type:Expedited (15-DaCompany Report #2005UW02785 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Hip Fracture Professional PO Orthostatic Hypotension Date:03/02/05ISR Number: 4598180-0Report Type:Expedited (15-DaCompany Report #2004UW24691 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Burning Sensation Health Seroquel PS ORAL 300 MG DAILY Intervention to Generalised Oedema Professional PO Prevent Permanent Rash Effexor-Xr C Impairment/Damage Treatment Noncompliance Mirtazapine C Neurontin C Vistaril C Date:03/02/05ISR Number: 4598183-6Report Type:Expedited (15-DaCompany Report #2004UW24585 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Health Seroquel PS ORAL 600 MG HS PO Hospitalization - Azotaemia Professional Parnate SS ORAL 20 MG TID PO Initial or Prolonged Coma Morphine C Required Multiple Drug Overdose Intervention to Myoglobinuria Prevent Permanent Neuroleptic Malignant Impairment/Damage Syndrome Renal Failure Respiratory Failure Date:03/02/05ISR Number: 4598185-XReport Type:Expedited (15-DaCompany Report #2005SE01120 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Haemorrhage Foreign Seroquel PS ORAL 25 MG DAILY Required Tachycardia Health PO Intervention to Professional Seroquel SS ORAL 225 MG DAILY Prevent Permanent Other PO Impairment/Damage 22-Feb-2006 08:31 AM Page: 1219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/05ISR Number: 4598187-3Report Type:Expedited (15-DaCompany Report #2005GB00325 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Foreign Quetiapine PS ORAL 150 MG PO Initial or Prolonged Tremor Health Risperidone SS ORAL 1 MG PO Disability Professional Lithium C Other Cipramil C Zopiclone C Date:03/02/05ISR Number: 4598269-6Report Type:Expedited (15-DaCompany Report #2005UW01581 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Health Seroquel PS Intervention to Abnormal Professional Prevent Permanent Electrocardiogram T Wave Impairment/Damage Abnormal Sinus Arrhythmia Supraventricular Extrasystoles Ventricular Extrasystoles Ventricular Tachycardia Date:03/02/05ISR Number: 4599140-6Report Type:Expedited (15-DaCompany Report #2005-00680 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Lorazepam (Watson Initial or Prolonged Drug Level Increased Literature Laboratories)(Loraze Health pam) Tablet PS Watson Laboratories ORAL 0.5-4.5 MG, Professional DAILY, ORAL Other Doxepin (Watson Laboratories) (Doxewpin Hydrochloride) Capsule SS Watson Laboratories ORAL 100 50MG, DAILY, ORAL Quetiapine (Quetiapine) SS ORAL 750 MG, DAILY, ORAL Pantoprazole (Pantoprazole) SS ORAL 40, ORAL Ofloxacine C Date:03/03/05ISR Number: 4599988-8Report Type:Expedited (15-DaCompany Report #2005UW01895 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Retinal Detachment Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 1220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/05ISR Number: 4599993-1Report Type:Expedited (15-DaCompany Report #2005UW01580 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qrs Health Seroquel PS ORAL 100 MG HS PO Initial or Prolonged Complex Prolonged Professional Seroquel SS ORAL 25 MG QD PO Required Tachycardia Anafranil C Intervention to Zantac C Prevent Permanent Impairment/Damage Date:03/03/05ISR Number: 4599997-9Report Type:Expedited (15-DaCompany Report #2005UW03034 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Liver Function Test Health Seroquel PS ORAL 800 MG PO Intervention to Abnormal Professional Dilantil C Prevent Permanent Haldol C Impairment/Damage Date:03/03/05ISR Number: 4600121-4Report Type:Expedited (15-DaCompany Report #2005SE01050 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Foreign Seroquel PS ORAL 50 MG QD PO Intervention to Crying Health Citalopram Prevent Permanent Nightmare Professional Hydrobromide C Impairment/Damage Parasomnia Other Screaming Sleep Terror Date:03/03/05ISR Number: 4600127-5Report Type:Expedited (15-DaCompany Report #2005PK00297 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Seroquel PS ORAL 150 MG DAILY Initial or Prolonged Corrected Interval Health PO Prolonged Professional Seroquel SS ORAL 75 MG DAILY Electrocardiogram Qt Other PO Prolonged Glucobay C Heart Rate Increased Tavor C Ventricular Extrasystoles Dridase C Furosemid C Iscover C Sortis C Date:03/04/05ISR Number: 4600839-3Report Type:Expedited (15-DaCompany Report #2005UW03189 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Visual Disturbance Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other 22-Feb-2006 08:31 AM Page: 1221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/05ISR Number: 4600841-1Report Type:Expedited (15-DaCompany Report #2005PK00328 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Seroquel PS ORAL 12.5 QD PO Hospitalization - Syndrome Health Dipiperon C Initial or Prolonged Professional Remeron C Other Distraneurin C Co-Reniten C Diamicron C Date:03/04/05ISR Number: 4600845-9Report Type:Expedited (15-DaCompany Report #2005SE01092 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Seroquel PS ORAL 300 MG PO Tachycardia Health Professional Other Date:03/04/05ISR Number: 4601230-6Report Type:Expedited (15-DaCompany Report #2005UW02227 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS Professional Date:03/04/05ISR Number: 4658746-6Report Type:Direct Company Report #USP 57160 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Dispensing Error Serzone PS Bristol Myers TABLET Medication Error Seroquel SS Astra Zeneca TABLET Date:03/07/05ISR Number: 4602526-4Report Type:Expedited (15-DaCompany Report #2005035736 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zeldox Initial or Prolonged Haemodialysis Health Other Neuroleptic Malignant Professional (Ziprasidone) PS ORAL 80 MG (1 D), Syndrome Other ORAL Aricept (Donepezil) SS ORAL 10 MG (1 D), ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS 400 MG (1 D) Lorazepam (Lorazepam) SS 6 MG (1 D) Trazodone Hydrochloride (Trazodone Hydrochloride) SS 400 MG (1 D) Haloperidol (Haloperidol) SS 6 MG (1 D) 22-Feb-2006 08:31 AM Page: 1222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium Acetate (Lithium Acetate) C Olanzapine (Olanzapine) C Date:03/07/05ISR Number: 4602664-6Report Type:Expedited (15-DaCompany Report #2005GB00397 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Seroquel PS Obstructive Airways Health Olanzapine SS 20 MG DAILY Disorder Professional Respiratory Arrest Other Date:03/07/05ISR Number: 4602730-5Report Type:Expedited (15-DaCompany Report #2005AC00369 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bile Duct Obstruction Literature Quetiapine PS ORAL 100 MG BID PO Condition Aggravated Health Fluoxetine SS Hepatic Failure Professional Divalproex Sodium SS Hepatitis Clonazepam SS Pulmonary Embolism Naltrexone SS Date:03/07/05ISR Number: 4602736-6Report Type:Expedited (15-DaCompany Report #2005UW03107 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dialysis Health Seroquel PS Intervention to Renal Disorder Professional Prevent Permanent Impairment/Damage Date:03/07/05ISR Number: 4602829-3Report Type:Expedited (15-DaCompany Report #2005-125695-NL Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mydriasis Health Mirtazapine PS ORAL 45 F, ORAL Professional Venlafaxine SS ORAL 225 DF ORAL Quetiapine SS ORAL 250 DF, ORAL Codeine C Paracetamol C Diclofenac C Bisacodyl C Diazepam C Date:03/07/05ISR Number: 4602936-5Report Type:Expedited (15-DaCompany Report #2005035266 Age:63 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anuria Initial or Prolonged Drug Interaction Haemodialysis Neuroleptic Malignant Syndrome Renal Failure Acute 22-Feb-2006 08:31 AM Page: 1223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Foreign Lithium (Lithium) PS 675 MG Health Lorazepam Professional (Lorazepam) SS ORAL 6 MG, ORAL Trazodone Hydrochloride (Trazodone Hydrochloride) SS 400 MG Ziprasidone (Caps) (Ziprasidone) SS 80 MG Haloperidol (Haloperidol) SS 6 MG Donepezil Hydrochloride (Donepezil Hydrochloride) SS 10 MG (1 IN 1 D) Quetiapine Fumarate (Quetiapine Fumarate) SS 400 MG Olanzapine (Olanzapine) SS 20 MG Date:03/08/05ISR Number: 4603236-XReport Type:Expedited (15-DaCompany Report #2005UW03290 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Seroquel PS 200-400 MG Initial or Prolonged Hypotension Health Metformin C Other Medication Error Professional Other Date:03/08/05ISR Number: 4603565-XReport Type:Expedited (15-DaCompany Report #DEWYE474603MAR05 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Foreign Trevilor Retard Initial or Prolonged Cardiac Failure Health (Venlafaxine Other Ejection Fraction Professional Hydrochloride, Decreased Other Capsule, Extended Electrocardiogram Release, 0) PS ORAL 75 MG PER DAY Abnormal ORAL 13 DAY Pleural Effusion Seroquel Supraventricular (Quetiapine, , 0) SS ORAL 200 MG PER Tachycardia DAY ORAL 20 DAY Solian (Amisulpride) C Date:03/08/05ISR Number: 4603834-3Report Type:Expedited (15-DaCompany Report #2005UW03320 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Seroquel PS ORAL 12.5 MG PO Professional 22-Feb-2006 08:31 AM Page: 1224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/05ISR Number: 4606103-0Report Type:Expedited (15-DaCompany Report #2005UW03330 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Seroquel PS ORAL 50 MG BID PO Increased Professional Gemfibrozil SS Aspartate Depakote C Aminotransferase Lithium C Increased Repaglinide C Hepatic Enzyme Increased Neutropenia Date:03/09/05ISR Number: 4606105-4Report Type:Expedited (15-DaCompany Report #2005UW00487 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Consumer Seroquel PS ORAL 400 MG DAILY Intervention to Agitation PO Prevent Permanent Drug Exposure During Seroquel SS ORAL 50 MG DAILY Impairment/Damage Pregnancy PO Insomnia Seroquel SS ORAL 25 MG DAILY Pregnancy PO Lamictal C Date:03/09/05ISR Number: 4607532-1Report Type:Expedited (15-DaCompany Report #2005AP00613 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Seroquel PS ORAL 12.5 MG DAILY Life-Threatening Apraxia Health PO Cardiac Arrest Professional Cognitive Disorder Depressed Level Of Consciousness Hypokinesia Hypothermia Muscle Rigidity Date:03/09/05ISR Number: 4607535-7Report Type:Expedited (15-DaCompany Report #2004SE06147 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gingival Bleeding Foreign Seroquel PS ORAL 600 MG DAILY Pulmonary Haemorrhage Health PO Self-Medication Professional Subutex SS Splenomegaly Other Rivotril C Truxal C Buronil C Imovane C Date:03/10/05ISR Number: 4604307-4Report Type:Expedited (15-DaCompany Report #US-ABBOTT-04P-163-0279319-00 Age:35 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Valproic Acid (Long Overdose Acting) PS ORAL Venlafaxine SS ORAL Quetiapine SS ORAL 22-Feb-2006 08:31 AM Page: 1225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/10/05ISR Number: 4606835-4Report Type:Expedited (15-DaCompany Report #2005UW03390 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Consumer Seroquel PS ORAL 25 MG PO Initial or Prolonged Aphasia Seroquel SS ORAL 100 MG QD PO Required Arrhythmia Risperdal C Intervention to Asthenia Prevent Permanent Brain Damage Impairment/Damage Dehydration Depression Dyspnoea Fluid Retention Memory Impairment Muscle Atrophy Nasopharyngitis Nervous System Disorder Respiratory Disorder Rhinorrhoea Tardive Dyskinesia Date:03/10/05ISR Number: 4607393-0Report Type:Expedited (15-DaCompany Report #2005PK00370 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Foreign Seroquel "Zeneca" PS Zeneca ORAL 200 MG DAILY Hospitalization - Increased Health PO Initial or Prolonged C-Reactive Protein Professional Seroquel " Zeneca" SS Zeneca ORAL 500 MG DAILY Increased Other PO Deep Vein Thrombosis Seroquel "Zeneca" SS Zeneca ORAL 800 MG DAILY Pulmonary Embolism PO Respiratory Failure Seroquel "Zeneca" SS Zeneca ORAL 1000 MG DAILY PO Ergenyl C Rivotril C Xanef C Date:03/10/05ISR Number: 4607396-6Report Type:Expedited (15-DaCompany Report #2005PK00361 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angina Pectoris Foreign Seroquel PS ORAL 200 MG DAILY Cardiac Arrest Health PO Circulatory Collapse Professional Antra SS ORAL 20 MG DAILY Drug Interaction Other PO Respiratory Arrest Saroten Retard SS ORAL 150 MG DAILY Ventricular Fibrillation PO Ventricular Flutter Tavor SS ORAL 3 MG DAILY PO Stilnox SS ORAL 1 DF DAILY PO Date:03/11/05ISR Number: 4608213-0Report Type:Expedited (15-DaCompany Report #2005AP01213 Age:78 YR Gender:Male I/FU:I Outcome PT Hospitalization - Atrial Fibrillation Initial or Prolonged Coma Constipation Dehydration Haematuria 22-Feb-2006 08:31 AM Page: 1226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypokalaemia Leukocytosis Mania Report Source Product Role Manufacturer Route Dose Duration Productive Cough Foreign Seroquel PS ORAL 25 MG HS PO Urinary Tract Infection Study Eurodin SS ORAL 2 MG HS PO Health Nxy-059 Code Not Professional Broken SS INTRAVENOUS 151 ML/ HR IV Other Nxy-059 Code Not Broken SS INTRAVENOUS 32 ML /HR IV Transamin C Herbesser C Delta Imovane C Sulfatrim C Piroxicam Gel C Cefazoline C Allopurinol C Norvasc C Cough Syrup C Bokey Emc C Mgo C Senokot C Adalat C Cefadroxil C Haloperidol C Lonine C Colchicine C Date:03/11/05ISR Number: 4608214-2Report Type:Expedited (15-DaCompany Report #2005UW03421 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Hallucination Study PO Psychotic Disorder Health Aripiprazole SS Schizophrenia Professional Other Date:03/11/05ISR Number: 4608215-4Report Type:Expedited (15-DaCompany Report #2005PK00386 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Seroquel PS Zeneca ORAL 25 MG DAILY Initial or Prolonged Disorientation Health PO Drug Interaction Professional Seroquel Zeneca SS Zeneca ORAL 25 MG DAILY Feeling Abnormal Other PO Restlessness Taxilan SS 50 MG DAILY Sensation Of Pressure Akineton Retard SS ORAL 4 MG DAILY PO Tranxilium C Tavor C Date:03/11/05ISR Number: 4608216-6Report Type:Expedited (15-DaCompany Report #2005SE00118 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Foreign Seroquel PS ORAL 50 MG QD PO Cardio-Respiratory Arrest Health Remeron SS ORAL 15 MG QD PO Syncope Vasovagal Professional Meronem C Other Fludex - Slow 22-Feb-2006 08:31 AM Page: 1227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Release C Date:03/11/05ISR Number: 4608261-0Report Type:Expedited (15-DaCompany Report #2005PK00377 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel "Zeneca" PS Zeneca DAILY DOSE Intervention to Health RANGE FROM Prevent Permanent Professional 400 TO 600 MG Impairment/Damage Other Date:03/11/05ISR Number: 4609052-7Report Type:Expedited (15-DaCompany Report #2005UW03407 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardio-Respiratory Arrest Health Seroquel PS ORAL 25 MG QD PO 2 DAY Intervention to Electrocardiogram Qt Professional Prevent Permanent Prolonged Impairment/Damage Date:03/11/05ISR Number: 4609079-5Report Type:Expedited (15-DaCompany Report #2004UW24455 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Seroquel PS ORAL 100 MG DAILY Condition Aggravated Professional PO Date:03/14/05ISR Number: 4606751-8Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0293053-00 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Akineton Retard PS ORAL 54 DAY Initial or Prolonged Drug Interaction Clorazepate Dipotassium C ORAL 54 DAY Lorazepam C ORAL Perazine I ORAL 20 DAY Quetiapine I ORAL 1 DAY Date:03/14/05ISR Number: 4609159-4Report Type:Expedited (15-DaCompany Report #DSA_25988_2005 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Tavor PS 2 MG Initial or Prolonged Drug Interaction Health Seroquel SS 125 MG Urinary Retention Professional Stangyl SS 175 MG Other Trevilor C Date:03/14/05ISR Number: 4609172-7Report Type:Expedited (15-DaCompany Report #DSA_25983_2005 Age:63 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Glucose Increased Initial or Prolonged Drug Interaction Haemodialysis Neuroleptic Malignant Syndrome 22-Feb-2006 08:31 AM Page: 1228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Failure Acute Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Foreign Tavor PS 6 MG Q DAY Health Aricept SS 10 MG Q DAY Professional Geodon SS 80 MG Q DAY Other Geodon SS 160 MG Q DAY Haldol "Janssen" SS Janssen 6 MG Q DAY Seroquel SS 400 MG Q DAY Thrombran SS 400 MG Q DAY Zeldox SS DF Quilonum C Zyprexa C Date:03/14/05ISR Number: 4609336-2Report Type:Expedited (15-DaCompany Report #2005035736 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zeldox (Capsules) Initial or Prolonged Diarrhoea Health (Ziprasidone) PS ORAL 80 MG ( 1IN 1 Other Drug Interaction Professional D), ORAL Haemodialysis Aricept (Donepezil) SS ORAL 10 MG (1 IN 1 Neuroleptic Malignant D), ORAL Syndrome Quetiapine Fumarate Renal Failure Acute (Quetiapine Rhabdomyolysis Fumarate) SS 400 MG (1 IN 1 D) Lorazepam (Lorazepam) SS 6 MG (1 D) Trazodone Hydrochloride (Trazodone Hydrochloride) SS 400 MG (1 D) Haloperidol (Haloperidol) C 6 MG (1 IN 1 D) Lithium Acetate (Lithium Acetate) C Olanzapine (Olanzapine) C Date:03/14/05ISR Number: 4609619-6Report Type:Direct Company Report #CTU 243102 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Quetiapine PS 100 MG Consciousness Methadone Oxygen Saturation Hydrochloride C Decreased Date:03/14/05ISR Number: 4609761-XReport Type:Expedited (15-DaCompany Report #2005-DE-00776GD Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Literature Diclofenac (Diclofenac) (Nr) (Diclofenac Sodium) PS Quetiapine 22-Feb-2006 08:31 AM Page: 1229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Quetiapine) (Nr) SS Date:03/15/05ISR Number: 4608485-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0549462A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Wellbutrin Sr PS Glaxosmithkline ORAL Initial or Prolonged Ill-Defined Disorder Lithium SS Glaxosmithkline Cogentin SS Klonopin SS Trazodone SS Prolixin SS Seroquel SS Date:03/15/05ISR Number: 4608486-4Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0549464A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Wellbutrin Sr PS Glaxosmithkline ORAL Initial or Prolonged Cogentin SS Trazodone SS Seroquel SS Klonopin SS Trilafon SS Glaxosmithkline Date:03/15/05ISR Number: 4608612-7Report Type:Expedited (15-DaCompany Report #PHBS2004JP17256 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Ritalin PS Novartis Sector: Blood Alkaline Pharma ORAL 30 mg/d Phosphatase Increased Rohypnol SS ORAL 2 mg/d Haemoglobin Decreased Seroquel SS ORAL 30 mg/d Malaise Tecipul SS ORAL 6 mg/d 134 DAY Pancytopenia Sepazon SS ORAL 2 mg/d 183 DAY Platelet Count Decreased Amoban C Red Blood Cell Count Decreased White Blood Cell Count Decreased Date:03/15/05ISR Number: 4608766-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12809232 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Serzone Tabs 200 Mg PS Bristol-Myers Squibb Initial or Prolonged Confusional State Company ORAL Dose Value: Dementia reported as Hallucination both 50 mg Liver Abscess three times a Liver Function Test day, and 3 x 2 WK Abnormal Seroquel SS Medication Error Seroquel SS Nausea Psychiatric Symptom Psychotic Disorder Sedation Vomiting 22-Feb-2006 08:31 AM Page: 1230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/05ISR Number: 4609976-0Report Type:Expedited (15-DaCompany Report #2005GB00188 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Seroquel PS ORAL 25 MG ONCE PO Required Bradycardia Health Intervention to Cardiac Disorder Professional Prevent Permanent Nausea Other Impairment/Damage Sinus Arrest Supraventricular Extrasystoles Syncope Date:03/15/05ISR Number: 4609982-6Report Type:Expedited (15-DaCompany Report #2004AP06262 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Increased Health PO Aspartate Professional Seroquel SS ORAL 50 MG TID PO Aminotransferase Other Seroquel SS ORAL 150 MG QID PO Increased Seroquel SS ORAL 250 MG QID PO Blood Pressure Decreased Aricept C Cholelithiasis Serenace C Increased Appetite Artane C Liver Disorder Neo Dopaston C Pyrexia Risperdal C Zyprexa C Pursennid C Magnesium Oxide C Date:03/15/05ISR Number: 4610040-5Report Type:Expedited (15-DaCompany Report #2005GB00187 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Disorder Foreign Seroquel PS ORAL 25 MG ONCE PO Required Sinus Arrest Health Intervention to Syncope Vasovagal Professional Prevent Permanent Other Impairment/Damage Date:03/15/05ISR Number: 4610051-XReport Type:Expedited (15-DaCompany Report #2005GB00397 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Seroquel PS ORAL 100 MG PO Communication Disorder Health Diazepam C Foreign Body Aspiration Professional Olanzapine C Respiratory Arrest Other Date:03/15/05ISR Number: 4610053-3Report Type:Expedited (15-DaCompany Report #2005AC00402 Age:64 YR Gender:Male I/FU:I Outcome PT Disability Cerebral Atrophy Difficulty In Walking Electroencephalogram Abnormal 22-Feb-2006 08:31 AM Page: 1231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeding Disorder Myoclonus Posture Abnormal Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Foreign Seroquel PS ORAL 25 MG BID PO Speech Disorder Literature Seroquel SS ORAL 400 MG BID PO Health Seroquel SS ORAL 300 MG BID PO Professional Seroquel SS ORAL 200 MG BID PO Other Seroquel SS ORAL 100 MG BID PO Citalopram C Date:03/15/05ISR Number: 4613298-1Report Type:Expedited (15-DaCompany Report #2005SE01319 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Seroquel PS Decreased Health Professional Other Date:03/15/05ISR Number: 4614238-1Report Type:Expedited (15-DaCompany Report #20050200044 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Ativan (Lorazepam) Initial or Prolonged Drug Interaction Health Baxter PS Baxter 2 MG QD Urinary Retention Professional Stangyl Other (Trimipramine Maleate) SS 175 MG QD Seroquel (Quetiapine) SS 125 MG QD Trevilor (Venlafaxine Hydrochloride) C Date:03/15/05ISR Number: 4614354-4Report Type:Expedited (15-DaCompany Report #2005AP01590 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Quetiapine PS ORAL 800 MG DAILY Neutropenia Health PO Thrombocytopenia Professional Other Date:03/15/05ISR Number: 4614426-4Report Type:Expedited (15-DaCompany Report #2005AC00142 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Macrocytic Literature Quetiapine PS ORAL 600 MG DAILY Intervention to Blood Disorder Health PO Prevent Permanent Full Blood Count Professional Quetiapine SS ORAL 600 MG DAILY Impairment/Damage Decreased PO Myelodysplastic Syndrome Ziprasidone SS ORAL 40 MG DAILY PO Ziprasidone SS 120 MG DAILY PAR 22-Feb-2006 08:31 AM Page: 1232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/05ISR Number: 4612645-4Report Type:Direct Company Report #CTU 243421 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Seroquel PS Astra Zeneca ORAL 300 MG TWICE Initial or Prolonged DAILY ORAL Seroquel SS Astra Zeneca OROPHARINGEAL 200 MG ONCE DAILY OROPHARING Albuterol Mdi C Multivitamin C Celexa C Prevacid C Zyrtec C Actigall C Lipitor C Advair C Wellbutrin Sr C Clonazepam C Trazodone C Date:03/16/05ISR Number: 4613299-3Report Type:Expedited (15-DaCompany Report #2005PK00382 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Oedema Health PO Oedema Peripheral Professional Seroquel SS ORAL 500 MG DAILY Other PO Taxilan SS ORAL 150 MG DAILY PO Taxilan SS ORAL 100 MG DAILY PO Orfiril SS 10000 MG DAILY Saroten Retard SS ORAL 75 MG DAILY PO Truxal SS ORAL 250 MG DAILY PO Risperal SS ORAL 1 MG DAILY PO Risperal SS ORAL 2MG DAILY PO Risperal SS ORAL 3 MG DAILY PO Date:03/16/05ISR Number: 4614070-9Report Type:Expedited (15-DaCompany Report #2005AP00453 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Seroquel PS ORAL 1600 MG DAILY Hospitalization - Agitation Health PO Initial or Prolonged Aspiration Professional Seroquel SS ORAL 400 MG DAILY Required Delirium Other PO Intervention to Neutropenia Benzodiazepine C Prevent Permanent Respiratory Failure Impairment/Damage Respiratory Tract Infection Urinary Tract Infection 22-Feb-2006 08:31 AM Page: 1233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/05ISR Number: 4615342-4Report Type:Expedited (15-DaCompany Report #2005AP00763 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel Code Not Initial or Prolonged Increased Study Broken PS Required Aspartate Health Alusa C Intervention to Aminotransferase Professional Enalapril C Prevent Permanent Increased Other Impairment/Damage Blood Alkaline Phosphatase Increased Blood Cholesterol Increased Blood Lactate Dehydrogenase Increased Gamma-Glutamyltransferase Increased Jaundice Date:03/17/05ISR Number: 4615507-1Report Type:Expedited (15-DaCompany Report #2005UW03764 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS Decreased Professional Date:03/17/05ISR Number: 4615556-3Report Type:Expedited (15-DaCompany Report #2004070501 Age:50 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Gabapentin Multiple Drug Overdose Health (Gabapentin) PS ORAL ORAL Intentional Professional Chlorpromazine (Chlorpromazine) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL All Other Therapeutic Products (All Other Therapeutic Products) SS ORAL ORAL Date:03/17/05ISR Number: 4615698-2Report Type:Expedited (15-DaCompany Report #2004UW24644 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Health Seroquel PS ORAL 300 MG BID PO Professional Prozac SS ORAL 20 MG DAILY PO Klonopin C Synthroid C Date:03/18/05ISR Number: 4614840-7Report Type:Direct Company Report #CTU 243658 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Quetiapine Decreased Astra/Zeneca PS Astra/Zeneca 22-Feb-2006 08:31 AM Page: 1234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/05ISR Number: 4614908-5Report Type:Direct Company Report #CTU 243701 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Seroquel PS 50 MG TID , Initial or Prolonged Overdose 200 MG HS Respiratory Rate Decreased Date:03/18/05ISR Number: 4615890-7Report Type:Expedited (15-DaCompany Report #2005SE00348 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Schizoaffective Disorder Study PO Health Professional Other Date:03/18/05ISR Number: 4615891-9Report Type:Expedited (15-DaCompany Report #2005UW03994 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Foreign Seroquel PS ORAL 1000 MG PO Initial or Prolonged Agitation Study Seroquel SS ORAL 1200 MG PO Required Panic Attack Health Seroquel SS ORAL 1000 MG PO Intervention to Paranoia Professional Seroquel SS ORAL 800 MG PO Prevent Permanent Self Injurious Behaviour Other Clonazepam C Impairment/Damage Somatic Delusion Lorazepam C Ativan C Date:03/18/05ISR Number: 4615892-0Report Type:Expedited (15-DaCompany Report #2005SE01442 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Face Oedema Foreign Seroquel PS 100 MG + 0 + Intervention to Pharyngeal Oedema Health 200 MG Prevent Permanent Professional TABLETS DAILY Impairment/Damage Other Date:03/18/05ISR Number: 4615908-1Report Type:Expedited (15-DaCompany Report #2005SE01280 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Discomfort Health Stilnoct C Hypersensitivity Professional Oral Discomfort Other Tongue Disorder Date:03/18/05ISR Number: 4616465-6Report Type:Expedited (15-DaCompany Report #L04-USA-07403-41 Age: Gender:Female I/FU:F Outcome PT Death Completed Suicide Hypotension Multiple Drug Overdose 22-Feb-2006 08:31 AM Page: 1235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intentional Pneumonia Pyrexia Septic Shock Report Source Product Role Manufacturer Route Dose Duration Tachycardia Literature Theophylline PS Health Acetaminophen/Propox Professional yphene SS Mirtazapine SS Sertraline SS Quetiapine SS Doxycycline SS Lansoprazole SS Labetalol SS Prochlorperazine SS Date:03/18/05ISR Number: 4616556-XReport Type:Expedited (15-DaCompany Report #L04-USA-07403-18 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Abnormal Literature Carbamazepine PS Completed Suicide Health Clonazepam SS Multiple Drug Overdose Professional Hydrocodone Intentional W/Acetaminophen SS Mydriasis Chlordiazepoxide SS Pneumonia Lithium SS Pupil Fixed Quetiapine SS Date:03/18/05ISR Number: 4619075-XReport Type:Direct Company Report #CTU 243572 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Seroquel PS ORAL PO [A FEW Initial or Prolonged DAYS PRIOR] B12 C Isosorbide C Reminyl C Coumadin C Digoxin C Cardizem C Date:03/21/05ISR Number: 4616323-7Report Type:Expedited (15-DaCompany Report #2005UW01947 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Seroquel PS ORAL 400 MG QD PO Initial or Prolonged Agitation Health Risperidone C Bipolar I Disorder Professional Clonidine C Condition Aggravated Aripiprazole C Hostility Divalproex C Screaming Suicidal Ideation Date:03/21/05ISR Number: 4616361-4Report Type:Expedited (15-DaCompany Report #2004UW07853 Age:26 YR Gender:Male I/FU:F Outcome PT Death Chills Feeling Hot 22-Feb-2006 08:31 AM Page: 1236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Insomnia Respiratory Arrest Report Source Product Role Manufacturer Route Dose Duration Consumer Seroquel PS 200-400 MG Lexapro C Neurontin C Restoril C Klonopin C Cephalexin C Percocet C Aspirin "Bayer" C Tylenol C Maalox C Benadryl "Parke Davis" /Isr/ C Milk Of Magnesia C Cogentin C Metamucil "Searle" C Date:03/21/05ISR Number: 4616362-6Report Type:Expedited (15-DaCompany Report #2005UW04153 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Jaundice Health Seroquel PS Intervention to Liver Function Test Professional Prevent Permanent Abnormal Impairment/Damage Date:03/21/05ISR Number: 4616364-XReport Type:Expedited (15-DaCompany Report #2005UW03993 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS ORAL 300 MG PO Pneumonia Professional Avelox C Haldol C Date:03/21/05ISR Number: 4616417-6Report Type:Expedited (15-DaCompany Report #2005042638 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Neurontin Initial or Prolonged Drug Effect Decreased (Gabapentin) PS ORAL 400 MG (100 Other Eczema MG, 4 IN 1 Feeling Abnormal D), ORAL Insomnia Xanax Tablet Mental Disorder (Alprazolam) SS ORAL 0.25 MG, ORAL Post-Traumatic Stress Hydroxyzine Pamoate Disorder (Caps) (Hydroxyzine Weight Fluctuation Pamoate) SS ORAL ORAL Quetiapine Fumarate (Quetiapine Fumarte) SS Propylthiouracil (Propylthiouracil) C Lisinopril (Lisinopril) C Lekovit Ca (Calcium Carbonate, Colecalciferol) C 22-Feb-2006 08:31 AM Page: 1237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/05ISR Number: 4616711-9Report Type:Expedited (15-DaCompany Report #2005AP00941 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Seroquel PS ORAL 600 MG DAILY Electrocardiogram Qt Health PO Prolonged Professional Fluoxetine Hypotension Other Hydrochloride SS ORAL 80 MG DAILY Loss Of Consciousness PO Tachyarrhythmia Erythromycin SS 400 MG DAILY Date:03/21/05ISR Number: 4616713-2Report Type:Expedited (15-DaCompany Report #2005SE01050 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Foreign Seroquel PS ORAL 50 MG QD PO Intervention to Crying Health Citalopram Prevent Permanent Nightmare Professional Hydrobromide C Impairment/Damage Parasomnia Other Screaming Sleep Disorder Sleep Terror Date:03/21/05ISR Number: 4616714-4Report Type:Expedited (15-DaCompany Report #2005AP01213 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Seroquel PS ORAL 25 MG HS PO Initial or Prolonged Coma Study Eurodin SS ORAL 2 MG HS PO Constipation Health Nxy-059 Code Not Dehydration Professional Broken SS INTRAVENOUS 151 ML /HR IV Haematuria Other Nxy-059 Code Not Hypokalaemia Broken SS INTRAVENOUS 32 ML /HR IV Leukocytosis Transamin C Loss Of Consciousness Herbesser C Mania Sulfatrim C Productive Cough Piroxicam C Urinary Tract Infection Cefalozine C Allopurinol C Norvasc C Cough Syrup C Bokey Emc C Mgo C Senokot C Adalat C Cefadroxil C Haloperidol C Lonine C Colchicine C No Match C Date:03/21/05ISR Number: 4616715-6Report Type:Expedited (15-DaCompany Report #2005PK00405 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Seroquel PS ORAL 400 MG BID PO Completed Suicide Health Seroquel SS ORAL 6200 MG ONCE Overdose Professional PO Other 22-Feb-2006 08:31 AM Page: 1238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/05ISR Number: 4616768-5Report Type:Expedited (15-DaCompany Report #2005AC00445 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acetonaemia Foreign Seroquel PS ORAL 300 MG DAILY Hospitalization - Coma Health PO Initial or Prolonged Hyperglycaemia Professional Marvelon C Ketoacidosis Other Shock Date:03/21/05ISR Number: 4619722-2Report Type:Direct Company Report #CTU 243823 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Haldol PS Medication Error Lithuim SS Prolixin SS Seroquel SS .. C .. C Date:03/21/05ISR Number: 4620381-3Report Type:Direct Company Report #CTU 243884 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancytopenia Quetiapine PS Hospitalization - Mirtazepine SS Initial or Prolonged Heparin C Esomeprazole C Clonazepam C Bromocriptine C Date:03/22/05ISR Number: 4617987-4Report Type:Expedited (15-DaCompany Report #2005AP01753 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pupillary Reflex Impaired Foreign Seroquel PS ORAL 50 MG DAILY Intervention to Health PO Prevent Permanent Professional Depromel C Impairment/Damage Other Landsen C Tryptanol C Telesmin C Biofermin C Azucurenin S C Date:03/22/05ISR Number: 4617989-8Report Type:Expedited (15-DaCompany Report #2005SE00783 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bronchospasm Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Dyspnoea Health PO Prevent Permanent Professional Seroquel SS ORAL 100 MG DAILY Impairment/Damage Other PO Effexor Xr C Lamictin C Acurate C 22-Feb-2006 08:31 AM Page: 1239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/22/05ISR Number: 4617990-4Report Type:Expedited (15-DaCompany Report #2005SE00364 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Autism Study PO Delusion Health Seroquel SS ORAL 600 MG DAILY Hyperkinesia Professional PO Hypochondriasis Other Schizophrenia Date:03/22/05ISR Number: 4617991-6Report Type:Expedited (15-DaCompany Report #2004SE07205 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Strabismus Foreign Seroquel PS ORAL 25 MG DAILY Intervention to Tunnel Vision Health PO Prevent Permanent Visual Disturbance Professional Litarex C Impairment/Damage Visual Field Defect Other Date:03/23/05ISR Number: 4618347-2Report Type:Expedited (15-DaCompany Report #2005SE00270 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Depression Foreign Seroquel PS DOSE Electroencephalogram Health TITRATION Abnormal Professional FROM 25 MG QD Narcolepsy Other TO 400 MG QD Sleep Apnoea Syndrome Seroquel SS ORAL 400 MG QD PO Sleep Attacks Zoloft C Date:03/23/05ISR Number: 4618348-4Report Type:Expedited (15-DaCompany Report #2005AP01732 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cluster Headache Foreign Seroquel PS ORAL 75 MG DAILY Intervention to Dysstasia Health PO Prevent Permanent Professional Solanax C Impairment/Damage Other Date:03/23/05ISR Number: 4618350-2Report Type:Expedited (15-DaCompany Report #2003AP04434 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Seroquel PS ORAL 50 MG DAILY Hospitalization - Depressed Level Of Literature PO Initial or Prolonged Consciousness Health Gramalil C Required Diabetic Ketoacidosis Professional Intervention to Hyperglycaemia Other Prevent Permanent Oral Intake Reduced Impairment/Damage Refusal Of Treatment By Patient Somnolence 22-Feb-2006 08:31 AM Page: 1240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/05ISR Number: 4617606-7Report Type:Expedited (15-DaCompany Report #US-MERCK-0503USA03482 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Event Cogentin PS Merck & Co., Inc ORAL Initial or Prolonged Drug Interaction Wellbutrin Sr SS UNKNOWN Lithium Carbonate SS ORAL Klonopin SS UNKNOWN Trazodone Hydrochloride SS UNKNOWN Seroquel SS UNKNOWN Prolixin SS UNKNOWN Date:03/24/05ISR Number: 4618589-6Report Type:Expedited (15-DaCompany Report #2005UW03577 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Seroquel PS ORAL 60 MG DAILY Increased Professional PO Hyperglycaemia Seroquel SS ORAL 400 MG DAILY Leukopenia PO Lymphocyte Count Geodon C Decreased Risperdal C Pyrexia Red Blood Cell Count Decreased Date:03/24/05ISR Number: 4619679-4Report Type:Expedited (15-DaCompany Report #2004103897 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zeldox Sudden Death Health Professional (Ziprasidone) PS ORAL 40 MG (20 MG, Other 2 IN 1 D), ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL 50 MG (50 MG, 1 IN 1 D), ORAL Enalapril Maleate (Enalapril Maleate) C Isosorbide Mononitrate (Isosorbide Mononitrate) C Calcium Carbonate (Calcium Carbonate) C Triobe (Cyanocobalamin, Folic Acid, Pyridoxine) C Alendronate Sodium (Alendronate Sodium) C 22-Feb-2006 08:31 AM Page: 1241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Digitoxin (Digitoxin) C Warfarin (Warfarin) C Date:03/25/05ISR Number: 4620656-8Report Type:Expedited (15-DaCompany Report #A01200501265 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Stilnox Initial or Prolonged Neuroleptic Malignant Health Syndrome Professional (Zolpidem) PS ORAL ORAL Rhabdomyolysis Other Quetiapine SS ORAL 150 MG ORAL Valproate Sodium SS ORAL 1000 MG ORAL Panadol (Paracetamol) C Sandomigran (Pizotifen Maleate) C Mersyndol C Diazepam C Phenergan (Promethazine Hydrochloride) C Ventolin (Salbutamol) C Date:03/25/05ISR Number: 4620712-4Report Type:Expedited (15-DaCompany Report #2005UW04437 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypotension Health Seroquel PS ORAL 25 MG ONCE PO Respiratory Arrest Professional Cozaar C Lasix C Diflucan C Ativan C Cough Syrup C Date:03/25/05ISR Number: 4620929-9Report Type:Expedited (15-DaCompany Report #A04200500249 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angina Pectoris Health Stilnox - (Zolpidem) Arteriospasm Coronary Professional - Tablet - 10 Mg PS ORAL 10 MG 39 DAY Cardiac Arrest Seroquel - Circulatory Collapse (Quetiapine Drug Interaction Fumarate) - Tablet SS ORAL 200 MG 4 DAY Respiratory Arrest Antra - (Omeprazole) Tachycardia - Tablet SS ORAL 20 MG 39 DAY Ventricular Fibrillation Saroten "Bayer Ventricular Flutter Vital" - (Amitriptyline Hydrochloride) SS ORAL 150 MG 12 DAY Tavor - (Lorazepam) SS ORAL 3 MG 39 DAY Plantocur (Plantago Ovata Husk) C 22-Feb-2006 08:31 AM Page: 1242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/05ISR Number: 4621026-9Report Type:Expedited (15-DaCompany Report #2005UW04362 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Facial Palsy Foreign Seroquel PS Intervention to Health Imovane SS Prevent Permanent Professional Impairment/Damage Other Date:03/25/05ISR Number: 4621028-2Report Type:Expedited (15-DaCompany Report #2005AP01805 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Quetiapine PS ORAL 150 MG DAILY Initial or Prolonged Neuroleptic Malignant Health PO Syndrome Professional Stilnox SS Other Valproate Sodium SS ORAL 1000 MG DAILY PO Valproate Sodium SS Venlafaxine SS ORAL 150 MG DAILY PO Venlafaxine SS Panadol C Sandomigran C Mersyndol C Diazepam C Phenergan Aventis Pharma C Ventolin C Date:03/25/05ISR Number: 4621029-4Report Type:Expedited (15-DaCompany Report #2005GB00444 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Muscle Twitching Foreign Seroquel PS 400 - 600MG Intervention to Musculoskeletal Stiffness Health Seroquel SS ORAL 150 MG BID PO Prevent Permanent Pain In Extremity Professional Sodium Valproate C Impairment/Damage Other Insulin C Date:03/25/05ISR Number: 4621030-0Report Type:Expedited (15-DaCompany Report #2004UW25674 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Exposure During Foreign Seroquel PS ORAL 600 MG DAILY Intervention to Pregnancy Health PO Prevent Permanent Gestational Diabetes Professional Seroquel SS ORAL 400 MG QD PO 2 WK Impairment/Damage Induced Labour Other Seroquel SS ORAL 600 MG DAILY Pregnancy Induced PO Hypertension Hydrochlorothiazide C Pregnancy With Labetalol C Contraceptive Device Premature Baby 22-Feb-2006 08:31 AM Page: 1243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/05ISR Number: 4621031-2Report Type:Expedited (15-DaCompany Report #2005AC00445 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acetonaemia Foreign Seroquel PS ORAL 300 MG DAILY Hospitalization - Coma Health PO Initial or Prolonged Hyperglycaemia Professional Marvelon C Ketoacidosis Other Shock Date:03/25/05ISR Number: 4621032-4Report Type:Expedited (15-DaCompany Report #2004SE02277 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Seroquel PS ORAL 400 MG DAILY Circulatory Collapse Health PO Dyspnoea Professional Cipramil C Gastrointestinal Disorder Other Rivotril C Haematemesis Truxal C Loss Of Consciousness Pulmonary Haemorrhage Date:03/28/05ISR Number: 4622272-0Report Type:Expedited (15-DaCompany Report #2005SE01442 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Face Oedema Foreign Seroquel PS 100 MG + 0 + Intervention to Pharyngeal Oedema Health 200 MG Prevent Permanent Professional TABLETS DAILY Impairment/Damage Other Date:03/28/05ISR Number: 4623102-3Report Type:Direct Company Report #CTU 244451 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Olanzapine PS ORAL 5MG QHS + Initial or Prolonged Corrected Interval Q6H PRN ORAL Prolonged Quetiapine SS ORAL 25MG/50MG Electrocardiogram T Wave QAM/QHS ORAL Inversion Date:03/29/05ISR Number: 4621676-XReport Type:Expedited (15-DaCompany Report #2005UW04493 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS Professional Darvocet-N C Date:03/29/05ISR Number: 4621700-4Report Type:Expedited (15-DaCompany Report #2005UW04550 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Seroquel PS Professional 22-Feb-2006 08:31 AM Page: 1244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/05ISR Number: 4621934-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12908679 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Trazodone Hcl PS Apothecon Initial or Prolonged Prolixin I Apothecon Wellbutrin Sr I Lithium I ORAL Benztropine Mesylate I Clonazepam I Quetiapine Fumarate I Date:03/29/05ISR Number: 4622177-5Report Type:Expedited (15-DaCompany Report #2004SE04443 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS ORAL 600 MG DAILY Health PO Professional Seroquel SS ORAL 400 MG DAILY Other PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 300 MG BID PO Depakin Chrono C Rivotril C Date:03/29/05ISR Number: 4623165-5Report Type:Expedited (15-DaCompany Report #DSA_26125_2005 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Foreign Tavor PS 3 MG Atrial Fibrillation Study Saroten Retard SS Cardiac Arrest Health Antra SS 20 MG Chest Pain Professional Stilnox SS ORAL DF DAILY PO Circulatory Collapse Other Seroquel SS 200 MG Conduction Disorder Plantocur C Coronary Artery Stenosis Drug Interaction Transient Psychosis Ventricular Flutter Date:03/30/05ISR Number: 4625871-5Report Type:Expedited (15-DaCompany Report #2005UW04518 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Foreign Seroquel PS Initial or Prolonged Health Professional Other Date:03/30/05ISR Number: 4626642-6Report Type:Expedited (15-DaCompany Report #HQWYE331924MAR05 Age:37 YR Gender:Male I/FU:I Outcome PT Death Completed Suicide Hospitalization - Drug Withdrawal Syndrome Initial or Prolonged Medication Error Panic Attack 22-Feb-2006 08:31 AM Page: 1245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Treatment Noncompliance Unevaluable Event Report Source Product Role Manufacturer Route Dose Duration Consumer Effexor Xr (Venlafaxine Hydrochloride, Capsule, Extended Release) PS ORAL 187.5 MG 1X PER 1 DAY, ORAL Lamictal (Lamotrigine) SS Seroquel (Quetiapine) SS Tegretol (Carbamazepine) SS Vistaril (Hydroxyzine Hydrochloride) SS Xanax - Slow Release (Alprazolam) SS Date:03/31/05ISR Number: 4627008-5Report Type:Expedited (15-DaCompany Report #2004UW25576 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Study Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Atrioventricular Block Health Albuterol C Required First Degree Professional Lopressor C Intervention to Blood Glucose Increased Prevent Permanent Cough Impairment/Damage Disorientation Dizziness Drug Abuser Echocardiogram Abnormal Electrocardiogram Qt Corrected Interval Prolonged Fall Hyperhidrosis Lower Respiratory Tract Infection Mean Cell Haemoglobin Decreased Red Blood Cell Count Decreased Sinus Bradycardia Somnolence Toxicologic Test Abnormal Tricuspid Valve Incompetence Ventricular Hypertrophy Wheezing 22-Feb-2006 08:31 AM Page: 1246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/05ISR Number: 4627071-1Report Type:Expedited (15-DaCompany Report #2005SE01757 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 800 MG DAILY Intentional Overdose Health PO Professional Seroquel SS ORAL 12 GR ONCE PO Oxazepam C Citalopram C Nimadorm Zolpidem C Date:03/31/05ISR Number: 4627220-5Report Type:Expedited (15-DaCompany Report #2005UW04517 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Seroquel PS Initial or Prolonged Professional Wellbutrin - Slow Release SS Lithium SS Cogentin SS Klonopin SS Trazodone SS Prolixin SS Date:04/01/05ISR Number: 4627744-0Report Type:Expedited (15-DaCompany Report #141651USA Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dystonia Health Pimozide PS Gait Disturbance Professional Zotepine SS Quetiapine SS 1 MON Date:04/01/05ISR Number: 4627913-XReport Type:Expedited (15-DaCompany Report #2005GB00585 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Supraventricular Foreign Quetiapine PS ORAL 10 MG PO Hospitalization - Tachycardia Health Thyroxine C Initial or Prolonged Professional Atorvastatin C Other Date:04/01/05ISR Number: 4627915-3Report Type:Expedited (15-DaCompany Report #2005UW04330 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Seroquel PS ORAL 850 MG DAILY Initial or Prolonged Hyperhidrosis Consumer PO Nausea Other Seroquel SS ORAL 750 MG DAILY Pain In Extremity PO Schizophrenia Trazodone C Vomiting 22-Feb-2006 08:31 AM Page: 1247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/05ISR Number: 4628180-3Report Type:Expedited (15-DaCompany Report #HQWYE340624MAR05 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Efexor (Venlafaxine Initial or Prolonged Agitation Professional Hydrochloride, Depressive Delusion Tablet) PS ORAL 225-375 MG; Hypothyroidism ORAL 971 DAY Postpartum Efexor (Venlafaxine Hypopituitarism Hydrochloride, Tablet) SS ORAL 450 MG 1X PER 1 DAY; ORAL (SEE IMAGE) 22 DAY Seroquel (Quetiapine, ) SS ORAL 200-400 MG; ORAL (SEE IMAGE) 61 DAY Orfiril (Valproate Sodium) C Sortis (Atorvastatin Calcium) C Parke-Davis Paroxetine C Lorazepam C Date:04/01/05ISR Number: 4628398-XReport Type:Expedited (15-DaCompany Report #2005UW04537 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Seroquel PS Intervention to Professional Geodon C Prevent Permanent Wellbutrin C Impairment/Damage Date:04/01/05ISR Number: 4628406-6Report Type:Expedited (15-DaCompany Report #2005UW04498 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 250 MG DAILY Decreased Professional PO Clonidine C Bupropion C Date:04/04/05ISR Number: 4628426-1Report Type:Expedited (15-DaCompany Report #2005UW04759 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Health Seroquel PS ORAL 25 MG BID PO Intervention to Cardiac Arrest Professional Prevent Permanent Hypertension Impairment/Damage Date:04/04/05ISR Number: 4628427-3Report Type:Expedited (15-DaCompany Report #2005UW04564 Age: Gender: I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 1248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Health Seroquel PS Professional Geodon C Wellbutrin C Avandia C Date:04/04/05ISR Number: 4628566-7Report Type:Expedited (15-DaCompany Report #2005UW04518 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleural Effusion Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Pulmonary Embolism Health PO Professional Lorazepam C Other Date:04/04/05ISR Number: 4629242-7Report Type:Direct Company Report #CTU 245128 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Seroquel = Pregnancy Quetiapine PS ORAL 50 MG PO BID Polyhydramnios Prenatal Vitamins C Premature Separation Of Placenta Date:04/05/05ISR Number: 4627155-8Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0375961A Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Paxil PS Glaxosmithkline ORAL 20MG Per day 240 DAY Initial or Prolonged Extrapyramidal Disorder Desyrel SS ORAL 25MG Per day 181 DAY Gait Disturbance Huscode SS ORAL 3.33ML Three Hallucination, Auditory times per day 2 DAY Headache Hokunalin SS ORAL .5MG Three Intentional Overdose times per day 2 DAY Muscle Rigidity Zithromac SS ORAL 250MG Twice Overdose per day 2 DAY Panic Reaction Depakene R SS ORAL 200MG Twice Suicide Attempt per day 22 DAY Tremor Seroquel SS ORAL 50MG Three times per day Bakumondo-To C ORAL 3G per day 2 DAY Shimotsu-To C ORAL 2.5G per day 2 DAY Date:04/05/05ISR Number: 4629014-3Report Type:Direct Company Report #CTU 245281 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chest Pain Seroquel 20 Mg PS ORAL 20 MG 3X Other Dyspnoea DAILY ORAL Erythema Seroquel 100 Mg SS ORAL 100 MG 1X Feeling Abnormal DAILY ORAL Flushing 22-Feb-2006 08:31 AM Page: 1249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4629415-3Report Type:Expedited (15-DaCompany Report #DSA_26168_2005 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Foreign Tavor PS OPHTHALMIC 2 TAB ONCE PO Initial or Prolonged Intentional Health White Wine SS ORAL 1 BOTTLE ONCE Somnolence Professional PO Tachycardia Other Dominal Forte SS ORAL 960 MG ONCE PO Seroquel SS ORAL 800 MG ONCE PO Seroquel SS VAR ONCE Date:04/05/05ISR Number: 4657371-0Report Type:Periodic Company Report #2004034907 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Vision Blurred Professional Quetiapine Fumarate Company (Quetiapine Representative Fumarate) SS Valsartan (Valsartan) SS Date:04/05/05ISR Number: 4657619-2Report Type:Periodic Company Report #2003121405 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Other Corrected Interval Professional ORAL Prolonged Haloperidol SS ORAL 5 MG (DAILY), ORAL Quetiapine Fumarate SS ORAL 1100 MG, ORAL Hydroxyzine Embonate C Gemfibrozil C Lorazepam C Levothyroxine Sodium C Ferrous Sulfate C Gabapentin C Nordette (Ethinylestradiol, Levonorgestrel) C Date:04/07/05ISR Number: 4631418-XReport Type:Expedited (15-DaCompany Report #2005UW04887 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Electrolytes Consumer Seroquel PS ORAL 100 MG PO Initial or Prolonged Decreased Atenolol C Dehydration Heparin C Pneumonia Protonix "Wyeth-Ayerst" C Senna C Colace C Lactulose C Amantadine C 22-Feb-2006 08:31 AM Page: 1250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/05ISR Number: 4631419-1Report Type:Expedited (15-DaCompany Report #2005UW04889 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fall Consumer Seroquel PS ORAL 100 MG QOD PO Intervention to Hallucination Blood Pressure Prevent Permanent Loss Of Consciousness Medication C Impairment/Damage Ketamine C Date:04/07/05ISR Number: 4631421-XReport Type:Expedited (15-DaCompany Report #2004UW18156 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drooling Consumer Seroquel PS Intervention to Dysgeusia Lithium C Prevent Permanent Dyskinesia Tegretol C Impairment/Damage Food Intolerance Provigil C Nasopharyngitis Neurontin C Speech Disorder Nexium C Swollen Tongue Lorazepam C Tongue Disorder Lortab C Tongue Ulceration Ambien C Weight Decreased Date:04/07/05ISR Number: 4631613-XReport Type:Expedited (15-DaCompany Report #2005GB00628 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuropathy Peripheral Foreign Seroquel PS ORAL 400 MG DAILY Intervention to Health PO Prevent Permanent Professional Impairment/Damage Other Date:04/07/05ISR Number: 4631614-1Report Type:Expedited (15-DaCompany Report #2005SE01892 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Foreign Seroquel PS ORAL 600 MG DAILY Confusional State Health PO Disorientation Professional Disipal SS ORAL 150 MG DAILY Drug Level Increased Other PO Eye Infection Risperdal C Sudden Death Xanor C Ceradroxil C Theralen C Date:04/07/05ISR Number: 4631615-3Report Type:Expedited (15-DaCompany Report #2005PK00521 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Foreign Seroquel PS ORAL 12.5 MG TID Intervention to Electrocardiogram Pq Health PO Prevent Permanent Interval Prolonged Professional Seroquel SS ORAL 50 MG DAILY Impairment/Damage Other PO Digimerck C Delix C Dilatrend C Isdn C 22-Feb-2006 08:31 AM Page: 1251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Corvaton C Furosemid C Ass C Date:04/07/05ISR Number: 4631616-5Report Type:Expedited (15-DaCompany Report #2005SE01927 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Abdomen Health Seroquel PS ORAL 300 MG BID PO Cardio-Respiratory Arrest Professional Clozapine SS ORAL 100 MG QID PO Epistaxis Other Valproic Acid C Hypotension Fluphenazine C Thrombocytopenia Date:04/07/05ISR Number: 4631626-8Report Type:Expedited (15-DaCompany Report #2005SE01442 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Face Oedema Foreign Seroquel PS 300 MG DAILY Intervention to Pharyngeal Oedema Health Prevent Permanent Professional Impairment/Damage Other Date:04/07/05ISR Number: 4631627-XReport Type:Expedited (15-DaCompany Report #2005SE01889 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Foreign Seroquel PS 1200 MG DAILY Leukopenia Health Seroquel SS 1000 MG DAILY Neutropenia Professional Seroquel SS 800 MG DAILY Other Nozinan C Date:04/07/05ISR Number: 4631628-1Report Type:Expedited (15-DaCompany Report #2004SE03625 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Increased Health PO Aspartate Professional Heminevrin C Aminotransferase Other Propavan C Increased Theralen C Blood Alkaline Orudis C Phosphatase Increased Cisordinol C Blood Bilirubin Increased Oxascand C Gamma-Glutamyltransferase Emconcor C Increased Trombyl C Liver Disorder Allopurinol C Torem C Zopiklon Nm Pharma C Pharma Date:04/07/05ISR Number: 4631779-1Report Type:Expedited (15-DaCompany Report #2005UW04787 Age:44 YR Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 1252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Study Seroquel PS ORAL 500 MG QD PO Health Depakote C Professional Multivitamin C Excedrin C Date:04/07/05ISR Number: 4631780-8Report Type:Expedited (15-DaCompany Report #2005UW02712 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Study Seroquel PS ORAL 600 MG HS PO Initial or Prolonged Apnoea Health Tessalon Perle C Aspiration Professional Bronchospasm Convulsion Drug Abuser Fall Lung Infiltration Metabolic Acidosis Muscle Twitching Nicotine Dependence Treatment Noncompliance Vomiting Date:04/08/05ISR Number: 4630058-6Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0295895-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Akineton Tabletten PS ORAL Four 2 mg Initial or Prolonged Intentional tablets once Overdose Citalopram SS Ten 30 mg Suicide Attempt tablets once Quetiapine SS ORAL Ten 300 mg tablets once Date:04/08/05ISR Number: 4630123-3Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0375961A Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Paxil PS Glaxosmithkline ORAL 20MG Per day 34 DAY Initial or Prolonged Phosphokinase Increased Desyrel SS ORAL 25MG Per day 181 DAY Delusion Huscode SS ORAL 3.33ML Three Extrapyramidal Disorder times per day 2 DAY Gait Disturbance Hokunalin SS ORAL .5MG Three Hallucination, Auditory times per day 2 DAY Headache Zithromac SS ORAL 250MG Twice Mood Swings per day 2 DAY Muscle Rigidity Depakene R SS ORAL 200MG Twice Overdose per day Panic Reaction Seroquel SS ORAL Suicidal Ideation Bakumondo-To C ORAL Suicide Attempt Shimotsu-To C ORAL Tremor Mobic C 21 DAY 22-Feb-2006 08:31 AM Page: 1253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/05ISR Number: 4630755-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-400153 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Klonopin PS Roche UNKNOWN Initial or Prolonged Wellbutrin Sr I ORAL Lithium Salt I UNKNOWN Cogentin I UNKNOWN Trazodone I Roche UNKNOWN Prolixin I UNKNOWN Seroquel I UNKNOWN Date:04/08/05ISR Number: 4630775-8Report Type:Expedited (15-DaCompany Report #US-ROCHE-400318 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Klonopin PS Roche UNKNOWN Initial or Prolonged Wellbutrin Sr I ORAL Benztropine I UNKNOWN Trazodone I Roche UNKNOWN Seroquel I UNKNOWN Trilafon I UNKNOWN Date:04/08/05ISR Number: 4633261-4Report Type:Expedited (15-DaCompany Report #2005UW03994 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Foreign Seroquel PS ORAL 1000 MG PO Initial or Prolonged Agitation Study Seroquel SS ORAL 1200 MG PO Required Panic Attack Health Seroquel SS ORAL 1000 MG PO Intervention to Paranoia Professional Seroquel SS ORAL 800 MG PO Prevent Permanent Self-Injurious Ideation Other Clonazepam C Impairment/Damage Somatic Delusion Lorazepam C Ativan C Date:04/08/05ISR Number: 4633448-0Report Type:Expedited (15-DaCompany Report #2005UW04762 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Agitation Health Lithium Carbonate C Irritability Professional Risperidone C Mania Tenex C Thirst Adderall C Diphenhydramine Hcl C Lorazepam C Ziprasidone C Hydroxyzine C Ibuprofen C Stridex Topical C Date:04/11/05ISR Number: 4634397-4Report Type:Expedited (15-DaCompany Report #2005AC00523 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Disability Drug Interaction Foreign Extrapyramidal Disorder Literature Health 22-Feb-2006 08:31 AM Page: 1254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Quetiapine PS Oxcarbacepine SS Date:04/12/05ISR Number: 4634751-0Report Type:Direct Company Report #CTU 245894 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Seroquel PS ORAL 200 MG ORAL Hospitalization - Feeling Hot Trazodone C Initial or Prolonged Hyperkinesia Ambien C Trileptal C Paroxetine C Date:04/12/05ISR Number: 4634754-6Report Type:Expedited (15-DaCompany Report #2005UW05320 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Health Seroquel PS ORAL 200 MG QD PO Blood Cholesterol Professional Lipitor C Increased Zoloft C Hepatic Enzyme Increased Myocardial Infarction Weight Increased Date:04/12/05ISR Number: 4634916-8Report Type:Expedited (15-DaCompany Report #2005AP02056 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alopecia Foreign Seroquel PS ORAL 100 MG DAILY Intervention to Health PO Prevent Permanent Professional Seroquel SS ORAL 50 MG DAILY Impairment/Damage Other PO Seroquel SS ORAL 25 MG DAILY PO Lamotrigine C Escitalopram C Date:04/12/05ISR Number: 4634917-XReport Type:Expedited (15-DaCompany Report #2005GB00660 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperglycaemia Foreign Quetiapine PS Metabolic Disorder Health Professional Other Date:04/12/05ISR Number: 4634933-8Report Type:Expedited (15-DaCompany Report #DSA_26125_2005 Age:55 YR Gender:Male I/FU:F Outcome PT Life-Threatening Apnoea Arrhythmia Atrial Fibrillation 22-Feb-2006 08:31 AM Page: 1255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Arrest Chest Pain Circulatory Collapse Report Source Product Role Manufacturer Route Dose Duration Conduction Disorder Foreign Tavor PS 3 MG Coronary Artery Stenosis Study Saroten Retard SS Delirium Health Antra SS 20 MG Ventricular Flutter Professional Stilnox /Fra/ SS ORAL DF DAILY PO Other Seroquel SS 200 MG Plantocur C Date:04/13/05ISR Number: 4635624-XReport Type:Expedited (15-DaCompany Report #2005UW02884 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Difficulty In Walking Foreign Seroquel PS ORAL 600 MG BID PO Required Disease Recurrence Health Seroquel SS ORAL 100 MG QID PO Intervention to Orthostatic Hypotension Professional Trileptal Prevent Permanent Pneumonia Other "Ciba-Geigy" C Impairment/Damage Date:04/13/05ISR Number: 4635841-9Report Type:Expedited (15-DaCompany Report #2005UW04926 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS Required Increased Professional Intervention to Prevent Permanent Impairment/Damage Date:04/13/05ISR Number: 4635852-3Report Type:Expedited (15-DaCompany Report #2005UW05371 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 50 MG PO Decreased Professional Ativan C Buspar C Date:04/14/05ISR Number: 4635091-6Report Type:Expedited (15-DaCompany Report #PHBS2005JP04450 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Carbamazepine PS Novartis Sector: Drug Interaction Pharma ORAL Drug Level Decreased Quetiapine Fumarate SS ORAL 50 mg/day Date:04/14/05ISR Number: 4635267-8Report Type:Expedited (15-DaCompany Report #PHBS2005JP04451 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Carbamazepine PS Novartis Sector: Convulsion Pharma ORAL Drug Interaction Quetiapine SS ORAL 50 mg/day 22-Feb-2006 08:31 AM Page: 1256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/05ISR Number: 4635521-XReport Type:Expedited (15-DaCompany Report #2005UW05382 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Facial Nerve Disorder Health Seroquel PS ORAL 25 MG PO Intervention to Hypoaesthesia Professional Depakote C Prevent Permanent Hypoaesthesia Oral Lithium C Impairment/Damage Lamictal C Neurontin C Ambien C Paxil C Risperdal C Date:04/14/05ISR Number: 4635522-1Report Type:Expedited (15-DaCompany Report #2005UW02233 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Amnesia Consumer Seroquel PS Intervention to Anxiety Parnate SS Prevent Permanent Asthenia Paxil SS Impairment/Damage Cerebrovascular Accident Coordination Abnormal Depressed Level Of Consciousness Depression Drug Interaction Hunger Suicide Attempt Thinking Abnormal Date:04/14/05ISR Number: 4635684-6Report Type:Expedited (15-DaCompany Report #HQWYE646304APR05 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Homicidal Ideation Foreign Efexor (Venlafaxine Suicidal Ideation Health Hydrochloride, Professional Tablet) PS ORAL ORAL Other Fluoxetine (Fluoxetine,) SS ORAL ORAL Haloperidol (Haloperidol,) SS ORAL ORAL Haloperidol (Haloperidol,) SS ORAL ORAL Quetiapine (Quetiapine,) SS ORAL ORAL Date:04/14/05ISR Number: 4636646-5Report Type:Expedited (15-DaCompany Report #2005UW04518 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleural Effusion Foreign Seroquel PS ORAL 100 MG DAILY Initial or Prolonged Pulmonary Embolism Health PO Professional Lorazepam C Other 22-Feb-2006 08:31 AM Page: 1257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/05ISR Number: 4636842-7Report Type:Expedited (15-DaCompany Report #2005SE02093 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaphylactic Shock Foreign Seroquel PS ORAL 200 MG ONCE Hospitalization - Health PO Initial or Prolonged Professional Flupidol C Other Akineton C Date:04/14/05ISR Number: 4636971-8Report Type:Expedited (15-DaCompany Report #2005UW04564 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Seroquel PS Intervention to Professional Geodon C Prevent Permanent Wellbutrin C Impairment/Damage Avandia C Date:04/15/05ISR Number: 4637961-1Report Type:Expedited (15-DaCompany Report #2005GB00686 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Seroquel PS Initial or Prolonged Leukopenia Health Ssri C Professional Depakote C Other Date:04/15/05ISR Number: 4637963-5Report Type:Expedited (15-DaCompany Report #2005AC00563 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Quetiapine PS Hospitalization - Drug Toxicity Literature Verapamil SS Initial or Prolonged Haemodialysis Health Doxepin SS Intentional Misuse Professional Diazepam SS Metabolic Acidosis Temazepam SS Shock Clonazepam SS Therapy Non-Responder Date:04/15/05ISR Number: 4638667-5Report Type:Direct Company Report #CTU 246324 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Metoprolol PS Initial or Prolonged Decreased Quetiapine SS Heart Rate Decreased Hypotension Date:04/15/05ISR Number: 4638668-7Report Type:Direct Company Report #CTU 246326 Age:25 YR Gender:Male I/FU:I Outcome PT Required Alanine Aminotransferase Intervention to Increased Prevent Permanent Aspartate Impairment/Damage Aminotransferase Increased 22-Feb-2006 08:31 AM Page: 1258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bipolar Disorder Hepatotoxicity Report Source Product Role Manufacturer Route Dose Duration Valproate PS Quetiapine SS Date:04/15/05ISR Number: 4639148-5Report Type:Direct Company Report #CTU 246306 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Disorientation Seroquel PS 200 MG - 1 A Intervention to Dizziness DAY (PILL) Prevent Permanent Headache Impairment/Damage Hyperhidrosis Sedation Date:04/18/05ISR Number: 4638748-6Report Type:Direct Company Report #CTU 246434 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Seroquel 25 Mg Life-Threatening Syndrome Astrazeneca PS Astrazeneca ORAL 25 MG 1 OR Hospitalization - 2 DAILY Initial or Prolonged ORAL Prednisone C Xanax C Albuterol C Date:04/18/05ISR Number: 4638839-XReport Type:Direct Company Report #CTU 246453 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Seroquel 12.5 Mg Headache Astra Zeneca PS Astra Zeneca ORAL 12.5 TID Muscle Twitching ORAL Vistaril C Date:04/18/05ISR Number: 4639189-8Report Type:Expedited (15-DaCompany Report #2001SE02468 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cholestasis Foreign Seroquel "Zeneca" PS Zeneca ORAL 200 MG DAILY Intervention to Hyperglycaemia Health PO Prevent Permanent Hypertriglyceridaemia Professional Rexer C Impairment/Damage Other Idalprem C Somnovit C Akineton Retard C Date:04/18/05ISR Number: 4639190-4Report Type:Expedited (15-DaCompany Report #2005SE02082 Age:84 YR Gender:Male I/FU:I Outcome PT Hospitalization - Adverse Drug Reaction Initial or Prolonged Alanine Aminotransferase Increased Aspartate 22-Feb-2006 08:31 AM Page: 1259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Blood Alkaline Phosphatase Increased Report Source Product Role Manufacturer Route Dose Duration Gamma-Glutamyltransferase Foreign Seroquel PS ORAL 25 MG QD PO Increased Health Lasix Retard C Jaundice Professional Movicol C Other Citalopram Alpharma C Folacin C Alvedon C Stesolid C Betolvex C Trombyl C Oxascand C Acetylcysteine Astrazeneca C Madopark C Zopiklon Nm Pharma C Date:04/18/05ISR Number: 4639191-6Report Type:Expedited (15-DaCompany Report #2005SE01927 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Seroquel PS ORAL 300 MG BID PO Acute Abdomen Health Clozapine SS ORAL 100 MG QID PO Cardio-Respiratory Arrest Professional Valproic Acid C Epistaxis Other Fluphenazine C Hypotension Thrombocytopenia Date:04/18/05ISR Number: 4639329-0Report Type:Expedited (15-DaCompany Report #2005055621 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Appetite Disorder Consumer Zoloft (Sertraline) PS ORAL 100 MG (100 Dehydration MG, 1 IN 1 Dental Caries D), ORAL Depression Geodon (Ziprasidone) SS ORAL 60 MG (60 MG, Dry Mouth 1 IN 1 D), Gastric Disorder ORAL Headache Quetiapine Fumarate Mood Swings (Quetiapine Nausea Fumarate) SS ORAL 300 MG (1 IN Post Procedural 1 D), ORAL Haemorrhage Folic Acid (Folic Procedural Pain Acid) C Vomiting Weight Decreased Date:04/19/05ISR Number: 4639484-2Report Type:Expedited (15-DaCompany Report #2005UW05585 Age:30 YR Gender:Male I/FU:I Outcome PT Death Abdominal Pain Cardiac Arrest Constipation Drug Toxicity Respiratory Arrest Therapy Non-Responder 22-Feb-2006 08:31 AM Page: 1260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Seroquel PS Professional Depakote C Lithium C Ativan C Bleach C Date:04/19/05ISR Number: 4640310-6Report Type:Expedited (15-DaCompany Report #2005UW02011 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Seroquel PS ORAL 50 MG ONCE PO Initial or Prolonged Blood Pressure Increased Professional Albuterol C Heart Rate Increased Azithromycin C Loss Of Consciousness Ceftriaxone C Respiratory Acidosis Heparin C Meclizine C Pantoprazole C Prednisone C Haldol C Date:04/19/05ISR Number: 4640328-3Report Type:Expedited (15-DaCompany Report #2004UW10253 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gastrointestinal Health Seroquel PS ORAL 800 MG DAILY Intervention to Haemorrhage Professional PO Prevent Permanent Impairment/Damage Date:04/19/05ISR Number: 4640329-5Report Type:Expedited (15-DaCompany Report #2005UW05691 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Seroquel PS ORAL 125 MG DAILY Hospitalization - Drug Ineffective Professional PO Initial or Prolonged Haldol C Ativan C Date:04/19/05ISR Number: 4640331-3Report Type:Expedited (15-DaCompany Report #2005UW05487 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Health Seroquel PS ORAL 500 MG DAILY Haemoglobin Decreased Professional PO Red Blood Cell Count Interferon C Decreased Wellbutrin C White Blood Cell Count Buspar C Decreased Cogentin C Protonix C 22-Feb-2006 08:31 AM Page: 1261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/05ISR Number: 4640332-5Report Type:Expedited (15-DaCompany Report #2005UW05576 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Thinking Abnormal Date:04/19/05ISR Number: 4640605-6Report Type:Expedited (15-DaCompany Report #2005GB00413 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Major Depression Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Mydriasis Health PO Prevent Permanent Visual Disturbance Professional Venlafaxine SS ORAL 225 MG DAILY Impairment/Damage Other PO Mirtazapine SS Paracetamol SS Codeine C Diclofenac C Bisacodyl C Diazepam C Date:04/19/05ISR Number: 4641219-4Report Type:Direct Company Report #CTU 246584 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dry Skin Lamictal 50 Mg Am & Initial or Prolonged Dystonia Hs PS 50 MG AM AND HS Seroquel 25 Mg Am And 200 Mg Hs SS 25 MG AM AND 200 MG HS Date:04/20/05ISR Number: 4642046-4Report Type:Expedited (15-DaCompany Report #2005UW05531 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abasia Health Seroquel PS Intervention to Confusional State Professional Xanax C Prevent Permanent Dysarthria Impairment/Damage Dysstasia Fall Date:04/20/05ISR Number: 4642129-9Report Type:Expedited (15-DaCompany Report #2005UW03764 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Health Seroquel PS Intervention to Decreased Professional Seroquel SS ORAL 125 MG DAILY Prevent Permanent PO Impairment/Damage Aricept C Ambien C Lexapro C Asacol C 22-Feb-2006 08:31 AM Page: 1262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/05ISR Number: 4642150-0Report Type:Expedited (15-DaCompany Report #2004SE03625 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Increased Health PO Aspartate Professional Heminevrin C Aminotransferase Other Propavan C Increased Theralen C Blood Alkaline Orudis C Phosphatase Increased Cisordinol C Blood Bilirubin Increased Oxascand C Gamma-Glutamyltransferase Emconcor C Increased Trombyl C Liver Disorder Allopurinol C Transaminases Increased Torem C Zopiklon Nm Pharma C Date:04/20/05ISR Number: 4642154-8Report Type:Expedited (15-DaCompany Report #2005UW05801 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Suicide Attempt Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:04/20/05ISR Number: 4642500-5Report Type:Direct Company Report #CTU 246666 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Seroquel PS Astrazeneca ORAL 25 MG 1 OR 2 Life-Threatening Syndrome DAILY ORAL Hospitalization - Prednisone C Initial or Prolonged Xanax C Albuterol C Date:04/21/05ISR Number: 4642112-3Report Type:Expedited (15-DaCompany Report #2005AP000320 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alpha-1 Anti-Trypsin Literature Fluoxetine Other Increased Health Hydrochloride Oral Biliary Dilatation Professional Solution PS 60 MG; QD; Ceruloplasmin Divalproex Sodium SS 1000 MG; BID 4 YR Ceruloplasmin Increased Quetiapine SS 100 MG; BID Electromechanical Naltrexone SS 50 MG; QD Dissociation Clonazepam C Haematocrit Decreased Hepatic Steatosis Hepatitis Hepatitis Cholestatic Pulmonary Embolism Resuscitation Sinus Bradycardia Ventricular Fibrillation 22-Feb-2006 08:31 AM Page: 1263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/05ISR Number: 4643059-9Report Type:Expedited (15-DaCompany Report #2004079230 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Foreign Zeldox (Capsules) Cardiomegaly Health (Ziprasidone) PS ORAL ORAL Drug Ineffective Professional Quetiapine Fumarate Drug Interaction Company (Quetiapine Representative Fumarate) SS ORAL 600 MG (1 IN 1 D), ORAL Herbal Preparation (Herbal Preparation) C Date:04/21/05ISR Number: 4643101-5Report Type:Expedited (15-DaCompany Report #2005UW05561 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Health Seroquel PS ORAL 100 MG PO Intervention to Dysphemia Professional Seroquel SS ORAL 600 MG PO Prevent Permanent Fall Impairment/Damage Fatigue Feeling Abnormal Thinking Abnormal Date:04/21/05ISR Number: 4643103-9Report Type:Expedited (15-DaCompany Report #2005UW05851 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Febrile Convulsion Health Seroquel PS Professional Date:04/21/05ISR Number: 4643106-4Report Type:Expedited (15-DaCompany Report #2005UW05609 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Seroquel PS Initial or Prolonged Drug Interaction Professional Date:04/21/05ISR Number: 4643371-3Report Type:Expedited (15-DaCompany Report #2004029509 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zoloft (Sertraline) PS ORAL 100 MG (100 Other Drug Interaction Professional MG, 1 IN 1 Drug Toxicity D), ORAL Vomiting Olanzapine (Olanzapine) SS ORAL 20 MG (5 MG, 1 IN 1 D), ORAL Valproate Semisodium (Valproate Semisodium) SS ORAL 1000 MG (500 MG, 2 IN 1 D), ORAL Quetiapine (Quetiapine) SS 400 MG (1 IN 1 D) 22-Feb-2006 08:31 AM Page: 1264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/05ISR Number: 4643806-6Report Type:Direct Company Report #CTU 246930 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Quetiapine PS Lorazepam C Sodium Fluoride C Omeprazole C Ketorolac Tromethamine C Dorzolamide 2%/Timolol 0.5% C Docusate Sodium C Brimonidine C Milk Of Magnesia C Acetaminophen C Date:04/25/05ISR Number: 4645524-7Report Type:Expedited (15-DaCompany Report #2005UW04330 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Seroquel PS Initial or Prolonged Gastric Disorder Health Seroquel SS ORAL 850 MG DAILY Hyperhidrosis Professional PO Pain In Extremity Other Seroquel SS ORAL 750 MG DAILY Schizophrenia PO Vomiting Seroquel SS ORAL 725 MG DAILY PO Trazodone C Date:04/25/05ISR Number: 4645525-9Report Type:Expedited (15-DaCompany Report #2005PK00521 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required C-Reactive Protein Foreign Seroquel PS ORAL 12.5 MG TID Intervention to Increased Health PO Prevent Permanent Electrocardiogram Pq Professional Seroquel SS ORAL 50 MG DAILY Impairment/Damage Interval Prolonged Other PO Digimerck C Delix C Dilatrend C Isoket C Corvaton C Furosemid C Ass C Date:04/25/05ISR Number: 4645763-5Report Type:Expedited (15-DaCompany Report #2005AP02184 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Irritability Study PO Physical Assault Health Chlorpromazine C Professional Paracetamol C Other Akineton /Aus/ C 22-Feb-2006 08:31 AM Page: 1265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/05ISR Number: 4646053-7Report Type:Expedited (15-DaCompany Report #2005UW05982 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram T Wave Study Seroquel PS Intervention to Abnormal Health Ativan C Prevent Permanent Loss Of Consciousness Professional Impairment/Damage Date:04/25/05ISR Number: 4646055-0Report Type:Expedited (15-DaCompany Report #2005UW05807 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gynaecomastia Health Seroquel PS Intervention to Sexual Dysfunction Professional Robaxin C Prevent Permanent Soma C Impairment/Damage Baclofen C Kadian C Oxycodone C Sinequan C Xanax C Aricept C Remeron C Levitra C Neurontin C Prilosec C Lipitor C Amitriptyline C Midrin C Zanaflex C Flexeril C Valium C Protonix C Alprazolam C Date:04/26/05ISR Number: 4647197-6Report Type:Expedited (15-DaCompany Report #2005059817 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Consumer Bextra (Valdecoxib) PS ORAL 20 MG (10 MG, Increased 2 IN 1 D), Blood Glucose Increased ORAL Drug Ineffective Quetiapine Fumarate Paranoia (Quetiapine Schizoaffective Disorder Fumarate) SS ORAL 4 IN 1 D), Weight Increased ORAL Topiramate (Topiramate) C Clonazepam (Clonazepam) C Escitalopram (Escitalopram) C Tiagabine Hydrochloride (Tiagabine Hydrochloride) C Bupropion Hydrochloride (Bupropion Hydrochloride) C 22-Feb-2006 08:31 AM Page: 1266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone (Trazodone) C Aripiprazole (Aripiprazole) C Date:04/26/05ISR Number: 4647333-1Report Type:Expedited (15-DaCompany Report #2005SE02267 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Toxic Skin Eruption Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Health PO Required Professional Paroxat SS ORAL 20 MG DAILY Intervention to Other PO Prevent Permanent Rivotril C Impairment/Damage Akineton C Trental C Tisasen C Date:04/26/05ISR Number: 4647335-5Report Type:Expedited (15-DaCompany Report #2005AC00563 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Foreign Quetiapine PS 10 G Hospitalization - Atrioventricular Block Literature Verapamil SS 7.2 G Initial or Prolonged First Degree Health Doxepin SS 1.6 G Cardiac Arrest Professional Diazepam SS 2 G Drug Toxicity Other Temazepam SS 200 MG Ejection Fraction Clonazepam SS 100 MG Decreased Haemodialysis Intentional Misuse Loss Of Consciousness Metabolic Acidosis Myocardial Ischaemia Overdose Shock Date:04/26/05ISR Number: 4647337-9Report Type:Expedited (15-DaCompany Report #2005UW03994 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Foreign Seroquel PS ORAL 1000 MG PO Initial or Prolonged Agitation Study Seroquel SS ORAL 1200 MG PO Required Condition Aggravated Health Seroquel SS ORAL 1000 MG PO Intervention to Panic Attack Professional Seroquel SS ORAL 800 MG PO Prevent Permanent Paranoia Other Clonazepam C Impairment/Damage Self-Injurious Ideation Lorazepam C Somatic Delusion Ativan C Date:04/26/05ISR Number: 4647929-7Report Type:Direct Company Report #CTU 247129 Age:63 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:31 AM Page: 1267 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 Hyperthermia Seroquel 25 Mg And Neuroleptic Malignant 100mg PS 50MG HS , Syndrome 200MG HS , 25MG BID & 300 MG HS Amantadine C Toprol Xl C Lisinopril C Protonix C Asa C Synthroid C Date:04/27/05ISR Number: 4647377-XReport Type:Direct Company Report #CTU 247277 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cheilitis Prazosin 1 Mg PS ORAL 3-5 CAPS AT Pharyngeal Oedema BEDTIME PM Stomatitis ORAL Tongue Disorder Quetiapine 100 Mg SS OPHTHALMIC 1 TAB AT BEDTIME ORAL Ammonium Lactate C Aspirin C Cromolyn C Divalproex C Hydrochlorothiazide C Hydroxyzine Pamoate C Lisinopril C Loratadine C Miconazole Nitrate C Ranitidine Hcl C Simvastatin C Venlafaxine Xr C Date:04/27/05ISR Number: 4648702-6Report Type:Expedited (15-DaCompany Report #2005UW05930 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Literature Seroquel PS HIGH DOSE Initial or Prolonged Health Prozac C Professional Date:04/27/05ISR Number: 4648826-3Report Type:Expedited (15-DaCompany Report #2005AC00609 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agitation Foreign Seroquel PS ORAL 50 MG DAILY Confusional State Health PO Feeling Jittery Professional Orfidal SS ORAL 1 MG DAILY PO Hallucination Other 22-Feb-2006 08:31 AM Page: 1268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/05ISR Number: 4648841-XReport Type:Expedited (15-DaCompany Report #2005UW06136 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Foreign Seroquel PS ORAL 700 MG DAILY Intervention to Drug Exposure During Health PO Prevent Permanent Pregnancy Professional Impairment/Damage Other Date:04/28/05ISR Number: 4647900-5Report Type:Expedited (15-DaCompany Report #PHBS2005JP04451 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anticonvulsant Drug Level Tegretol PS Novartis Sector: Increased Pharma ORAL Complex Partial Seizures Tegretol SS Novartis Sector: Convulsion Pharma ORAL 1000 Drug Interaction Tegretol SS Novartis Sector: Drug Level Decreased Pharma ORAL 800 mg/day Quetiapine SS ORAL 25 mg/day Quetiapine SS ORAL 50 mg/day Date:04/28/05ISR Number: 4647901-7Report Type:Expedited (15-DaCompany Report #PHBS2005JP04450 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Tegretol PS Novartis Sector: Drug Interaction Pharma ORAL Drug Level Decreased Tegretol SS Novartis Sector: Hallucination, Auditory Pharma ORAL 500 mg/day Persecutory Delusion Quetiapine Fumarate SS ORAL 50 mg/day Quetiapine Fumarate SS ORAL 25 mg/day Date:04/28/05ISR Number: 4650523-5Report Type:Expedited (15-DaCompany Report #2005UW06158 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Seroquel PS Initial or Prolonged Hypersomnia Professional Renal Failure Date:04/28/05ISR Number: 4650526-0Report Type:Expedited (15-DaCompany Report #2005UW06364 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fear Other Seroquel PS Required Hallucination, Auditory Intervention to Mental Disorder Prevent Permanent Murder Impairment/Damage Persecutory Delusion Regressive Behaviour 22-Feb-2006 08:31 AM Page: 1269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/05ISR Number: 4650532-6Report Type:Expedited (15-DaCompany Report #2005UW6257 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Health Seroquel PS ORAL 600 MG PO Intervention to Professional Seroquel SS ORAL 400 MG PO Prevent Permanent Risperdal SS 6 MG Impairment/Damage Depakote SS Wellbutrin SS Strattera SS Trileptal "Ciba-Geigy" SS Trileptal "Ciba-Geigy" SS DECREASING Date:04/29/05ISR Number: 4649048-2Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20050405525 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Risperdal PS OROPHARINGEAL Risperdal Consta SS INTRAMUSCULAR Quetiapine SS OROPHARINGEAL 900 mg/ 2x1 Quetiapine SS OROPHARINGEAL 600 mg /2 x 1 Quetiapine SS OROPHARINGEAL 400 mg /2 X 1 Chlorpromazine SS OROPHARINGEAL 100 mg/ 4 X 1 Biperidene SS OROPHARINGEAL 6 mg/ 3X1 Date:04/29/05ISR Number: 4650373-XReport Type:Expedited (15-DaCompany Report #2005PK00220 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel PS ORAL 800 MG DAILY Initial or Prolonged Health PO Professional Tavor C Other Propanolol C L-Thyroxin C Favistan C Date:04/29/05ISR Number: 4650374-1Report Type:Expedited (15-DaCompany Report #2005SE01927 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Abdomen Foreign Seroquel PS ORAL 300 MG BID PO Cardio-Respiratory Arrest Health Clozapine SS ORAL 100 MG QID PO Epistaxis Professional Valproic Acid C Hypotension Other Fluphenazine C Thrombocytopenia Date:04/29/05ISR Number: 4650375-3Report Type:Expedited (15-DaCompany Report #2005AP02307 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Intentional Self-Injury Foreign Quetiapine PS ORAL 200 MG BID PO Intervention to Libido Increased Health Lorazepam C Prevent Permanent Self-Injurious Ideation Professional Moclobemide C Impairment/Damage Other Temazepam C 22-Feb-2006 08:31 AM Page: 1270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/05ISR Number: 4650376-5Report Type:Expedited (15-DaCompany Report #2005AP02495 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Aspiration Foreign Seroquel PS ORAL 750 MG DAILY Required Health PO Intervention to Professional Prevent Permanent Other Impairment/Damage Date:04/29/05ISR Number: 4650377-7Report Type:Expedited (15-DaCompany Report #2004PK02024 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel PS ORAL 300 MG DAIILY Intervention to Colitis Health PO Prevent Permanent Professional Seroquel SS ORAL 900 MG DAILY Impairment/Damage Other PO Haldol-Janssen Decanoat C Acerbon "Zeneca" C Date:04/29/05ISR Number: 4650500-4Report Type:Expedited (15-DaCompany Report #2005-DE-01433GD Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Mirtazapine Literature (Mirtazapine) PS Quetiapine (Quetiapine) SS Bupropion (Bupropion) SS Amitriptyline (Amitriptyline) SS Valproate (Valproic Acid) C Date:05/02/05ISR Number: 4652306-9Report Type:Expedited (15-DaCompany Report #141890USA Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Air Embolism Literature Fluoxetine PS 60 MILLIGRAM Alpha-1 Anti-Trypsin Health QD Increased Professional Divalproex Sodium SS 10000 Bile Duct Cancer MILLIGRAM BID Carbon Dioxide Decreased Quetiapine SS 100 MILLIGRAM Ceruloplasmin Increased BID Electromechanical Naltrexone SS 50 MILLIGRAM Dissociation QD Haematocrit Decreased Clonzepam C Hepatic Steatosis Hepatitis Hepatitis Cholestatic Procedural Complication Pulmonary Embolism Pulmonary Hypertension Sinus Bradycardia Ventricular Fibrillation 22-Feb-2006 08:31 AM Page: 1271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/05ISR Number: 4652521-4Report Type:Expedited (15-DaCompany Report #DSA_26313_2005 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agitation Foreign Orfidal PS ORAL 1 MG Q DAY PO 1 MON Confusional State Health Seroquel SS ORAL 50 MG Q DAY Hallucination Professional PO Nervousness Other Date:05/02/05ISR Number: 4652867-XReport Type:Expedited (15-DaCompany Report #2005SE02284 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 500 MG DAILY, Initial or Prolonged Schizophrenia Study PO Treatment Noncompliance Health Professional Other Date:05/02/05ISR Number: 4652868-1Report Type:Expedited (15-DaCompany Report #2005PK00665 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Seroquel PS ORAL 950 MG DAILY, Initial or Prolonged Drug Interaction Health PO Hallucination Professional Lasix /Swe/ SS Hallucination, Auditory Other Haloperidol SS 1.3 ML DAILY Metabolic Syndrome Oedema Peripheral Psychotic Disorder Schizophrenia Weight Increased Date:05/03/05ISR Number: 4650809-4Report Type:Expedited (15-DaCompany Report #080305-02 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Quilonorm Retard PS Glaxosmithkline ORAL Initial or Prolonged Dizziness Carbamazepine SS ORAL 15 DAY Drug Interaction Quetiapine SS ORAL 50MG per day Drug Level Increased Fluvoxamine SS ORAL 200MG per day Gait Disturbance Posture Abnormal Date:05/03/05ISR Number: 4650811-2Report Type:Expedited (15-DaCompany Report #2004-0480 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Quilonorm Retard PS Glaxosmithkline ORAL 450MG Per day MON Initial or Prolonged Drug Interaction Brufen SS Glaxosmithkline ORAL 400MG Unknown MON Dysarthria Aleve SS ORAL MON Renal Failure Acute Seroquel SS ORAL 25MG Per day MON Novalgine C Buscopan C Demetrin C Panadol C Glaxosmithkline Solatran C Glaxosmithkline Xanax C 22-Feb-2006 08:31 AM Page: 1272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/05ISR Number: 4653166-2Report Type:Direct Company Report #CTU 247667 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Potassium Decreased Seroquel PS Aztrazenteca 300 MG'S Hospitalization - Cardiac Disorder TWICE DAY Initial or Prolonged Diabetes Mellitus Other Pneumonia Required Intervention to Prevent Permanent Impairment/Damage Date:05/03/05ISR Number: 4655078-7Report Type:Expedited (15-DaCompany Report #2005SE01757 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seroquel PS ORAL 800 MG DAILY Intentional Misuse Health PO Multiple Drug Overdose Professional Seroquel SS ORAL 12 G ONCE PO Other Citalopram SS ORAL 60 MG DAILY PO Citalopram SS Oxazepam SS ORAL 15 MG TID PO Oxazepam SS Nimadorm Zolpidem C Oxapax C Klopoxid C Date:05/03/05ISR Number: 4655079-9Report Type:Expedited (15-DaCompany Report #2005GB00797 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Arrest Foreign Seroquel PS ORAL 25 MG BID PO Health Combivent C Professional Furosemide C Other Ramipril C Benclomethasone C Date:05/03/05ISR Number: 4655080-5Report Type:Expedited (15-DaCompany Report #2005AC00653 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Foreign Seroquel PS Fat Tissue Increased Health Diazepam C Gastrointestinal Disorder Professional Pancreatitis Other Date:05/03/05ISR Number: 4655081-7Report Type:Expedited (15-DaCompany Report #2005AC00647 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 200 MG DAILY Intervention to Tardive Dyskinesia Health PO Prevent Permanent Professional Seroquel SS ORAL 400 MG DAILY Impairment/Damage Other PO Zyprexa SS Lithium SS 22-Feb-2006 08:31 AM Page: 1273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/05ISR Number: 4655083-0Report Type:Expedited (15-DaCompany Report #2005UW06454 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Professional Clozapine SS Date:05/03/05ISR Number: 4655084-2Report Type:Expedited (15-DaCompany Report #2005UW06278 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Seroquel PS Intervention to Epistaxis Professional Allergy Medications C Prevent Permanent Impairment/Damage Date:05/03/05ISR Number: 4655085-4Report Type:Expedited (15-DaCompany Report #2005UW04498 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS ORAL 200 MG DAILY Decreased Professional PO Clonidine C Bupropion C Date:05/03/05ISR Number: 4655086-6Report Type:Expedited (15-DaCompany Report #2004UW23847 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Seroquel PS Professional Zyprexa SS Date:05/04/05ISR Number: 4656454-9Report Type:Expedited (15-DaCompany Report #2005PK00219 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Ineffective Foreign Seroquel PS ORAL 600 MG DAILY Drug Interaction Health PO Pancytopenia Professional Carbamazepin SS ORAL 600 MG DAILY Transaminases Increased Other PO Lorazepam C Date:05/04/05ISR Number: 4656506-3Report Type:Expedited (15-DaCompany Report #2005UW03390 Age:17 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Anorexia Disability Aphasia Required Arrhythmia Intervention to Asthenia Prevent Permanent Convulsion Impairment/Damage Dehydration Depression Drug Ineffective Dyspnoea Feeding Disorder 22-Feb-2006 08:31 AM Page: 1274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluid Retention Memory Impairment Mental Impairment Report Source Product Role Manufacturer Route Dose Duration Monoplegia Consumer Seroquel PS ORAL 25 MG PO Muscle Atrophy Seroquel SS ORAL 100 MG QD PO Nasopharyngitis Risperdal C Nervous System Disorder Obstructive Airways Disorder Respiratory Disorder Rhinorrhoea Tardive Dyskinesia Weight Decreased Date:05/04/05ISR Number: 4656508-7Report Type:Expedited (15-DaCompany Report #2005UW06595 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Myocardial Infarction Health Seroquel PS Intervention to Professional Prevent Permanent Impairment/Damage Date:05/04/05ISR Number: 4656509-9Report Type:Expedited (15-DaCompany Report #2005UW06647 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Damage Health Seroquel PS ORAL 25000 MG PO Hospitalization - Dyspnoea Professional Initial or Prolonged Intentional Misuse Loss Of Consciousness Overdose Status Epilepticus Suicide Attempt Date:05/05/05ISR Number: 4656819-5Report Type:Expedited (15-DaCompany Report #2005SE02352 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Quetiapine PS ORAL 400 MG DAILY Initial or Prolonged Schizophrenia Study PO Health Clonazepam C Professional Carbamazepine C Other Lithium Carbonate C Date:05/05/05ISR Number: 4656820-1Report Type:Expedited (15-DaCompany Report #2005SE02546 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Foreign Seroquel PS ORAL 400 MG DAILY Health PO Professional Seroquel SS ORAL 600 MG DAILY Other PO Seroquel SS ORAL 800 MG DAILY PO Seroquel SS ORAL 300 MG TID PO Risperidon C 22-Feb-2006 08:31 AM Page: 1275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal C Largactil C Mellaril C Akineton C Date:05/05/05ISR Number: 4656821-3Report Type:Expedited (15-DaCompany Report #2005PK00370 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Foreign Seroquel "Zeneca" PS Zeneca ORAL 200 MG DAILY Hospitalization - Increased Health PO Initial or Prolonged C-Reactive Protein Professional Seroquel "Zeneca" SS Zeneca ORAL 500 MG DAILY Increased Other PO Deep Vein Thrombosis Seroquel "Zeneca" SS Zeneca ORAL 800 MG DAILY Dehydration PO Pulmonary Embolism Seroquel "Zeneca" SS Zeneca ORAL 1000 MG DAILY Respiratory Failure PO Ergenyl C Rivotril C Xanef C Date:05/05/05ISR Number: 4656822-5Report Type:Expedited (15-DaCompany Report #2005AP02418 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Seroquel PS ORAL 25 MG DAILY Initial or Prolonged Delusion Health PO Dystonia Professional Seroquel SS ORAL 150 MG DAILY Gait Disturbance Other PO Hallucination, Auditory Paxil SS ORAL 20 MG DAILY Headache PO Laceration Tasmolin SS Muscle Rigidity Cercine SS Overdose Cercine SS Panic Disorder Cercine SS Psychotic Disorder Cercine SS INTRAMUSCULAR 5 MG DAILY IM Suicidal Ideation Depakene-R C Suicide Attempt Flunitrazepam C Tremor Desyrel C Artane C Flucam C Colonel C Maglax C Bakumonduouto C Solanax C Calonal C Date:05/05/05ISR Number: 4656823-7Report Type:Expedited (15-DaCompany Report #2005AP02414 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Foreign Seroquel PS ORAL 75 MG DAILY Initial or Prolonged Decreased Health PO Professional Serenace C Other Akineton C Levotomin C Halcion C Laxoberon C 22-Feb-2006 08:31 AM Page: 1276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diovan "Ciba-Geigy" C Date:05/06/05ISR Number: 4656772-4Report Type:Expedited (15-DaCompany Report #2005AP02184 Age:14 YR Gender:Male 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 Irritability Study PO Health Chlorpromazine C Professional Paracetamol C Other Akineton C Date:05/06/05ISR Number: 4656776-1Report Type:Expedited (15-DaCompany Report #2005SE02516 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Quetiapine PS ORAL 400 MG DAILY Intervention to Schizophrenia Study PO Prevent Permanent Health Quetiapine SS ORAL 600 MG DAILY Impairment/Damage Professional PO Other Date:05/06/05ISR Number: 4656777-3Report Type:Expedited (15-DaCompany Report #2005SE02515 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Quetiapine PS ORAL 400 MG DAILY Initial or Prolonged Schizophrenia Study PO Health Quetiapine SS ORAL 600 MG DAILY Professional PO Other Date:05/06/05ISR Number: 4657121-8Report Type:Expedited (15-DaCompany Report #2005042638 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Neurontin Initial or Prolonged Eczema (Gabapentin) PS ORAL 400 MG (100 Other Insomnia MG, 4 IN 1 Mental Disorder D), ORAL Post-Traumatic Stress Xanax Tablet Disorder (Alprazolam) SS ORAL (0.25 MG), Weight Fluctuation ORAL Hydroxyzine Pamoate (Caps) (Hydroxyzine Pamoate) SS ORAL ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS Propylthiouracil (Propylthiouracil) C Lisinopril (Lisinopril) C Lekovit Ca (Calcium Carbonate, Colecalciferol) C 22-Feb-2006 08:31 AM Page: 1277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/05ISR Number: 4662645-3Report Type:Periodic Company Report #2004UW23136 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Seroquel PS Initial or Prolonged Professional Nexium SS Duragesic C Risperadol C Cogentin C Zoloft C Tryleptal C No Match C Date:05/09/05ISR Number: 4656614-7Report Type:Expedited (15-DaCompany Report #2005UW04321 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activities Of Daily Seroquel PS Zeneca Living Impaired Pharmaceutical ORAL 2 YR Asthenia Seroquel SS Zeneca Balance Disorder Pharmaceutical ORAL Bruxism Effexor-Xr C ORAL Confusional State Effexor-Xr C ORAL Coordination Abnormal Effexor-Xr C ORAL Depression Lamotrigine C ORAL Difficulty In Walking Lamotrigine C ORAL Disturbance In Attention Ativan C ORAL 10 YR Dyskinesia Nozinan C ORAL 10 YR Dysstasia Hypokinesia Impaired Work Ability Memory Impairment Mental Disorder Motor Dysfunction Muscle Twitching Musculoskeletal Stiffness Parkinsonism Date:05/09/05ISR Number: 4656617-2Report Type:Expedited (15-DaCompany Report #2005UW06680 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Dispensing Error Seroquel PS Zeneca Dyskinesia Pharmaceutical ORAL Restless Legs Syndrome Serzone SS ORAL Thinking Abnormal Risperdal C Tongue Disorder Lortab C Tremor Xanax C Wrong Drug Administered Zocor C Nitroglycerin C Anti-Inflammatory Medication C Other Medications C 22-Feb-2006 08:31 AM Page: 1278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/05ISR Number: 4658663-1Report Type:Expedited (15-DaCompany Report #S05-USA-02250-01 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Consumer Lexapro Hospitalization - Depression (Escitalopram) PS ORAL 20 MG QD PO Initial or Prolonged Drug Ineffective Lithium SS 600 MG QD Mania Lamictal Multiple Drug Overdose (Lamotrigine) SS 50 MG BID Personality Change Abilify Suicide Attempt (Aripiprazole) SS 15 MG QD Weight Increased Seroquel (Quetiapine Fumarate) SS Trazodone SS Date:05/09/05ISR Number: 4658966-0Report Type:Expedited (15-DaCompany Report #2005UW06731 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS ORAL 600 MG DAILY Professional PO Seroquel SS ORAL 500 MG DAILY PO Clonazepam C Gabitril C Lamictal "Burroughs Wellcome" C "Burroughs Wellcome" Date:05/09/05ISR Number: 4659071-XReport Type:Expedited (15-DaCompany Report #2005AP02414 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Foreign Seroquel PS ORAL 75 MG DAILY Initial or Prolonged Decreased Health PO Professional Seroquel SS ORAL 400 MG DAILY Other PO Serenace C Akineton C Levotomin C Halcion C Laxoberon C Diovan C "Ciba-Geigy" Date:05/09/05ISR Number: 4659084-8Report Type:Expedited (15-DaCompany Report #2005SE02518 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS Intervention to Psychotic Disorder Health Methotrexate SS Prevent Permanent Professional Impairment/Damage Other Date:05/09/05ISR Number: 4659085-XReport Type:Expedited (15-DaCompany Report #2005UW01745 Age: Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:31 AM Page: 1279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abortion Spontaneous Foreign Seroquel PS Drug Exposure During Health Pregnancy Professional Other Date:05/09/05ISR Number: 4659086-1Report Type:Expedited (15-DaCompany Report #2005PK00770 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Foreign Seroquel PS Intervention to Health Prevent Permanent Professional Impairment/Damage Other Date:05/10/05ISR Number: 4657942-1Report Type:Expedited (15-DaCompany Report #2005AC00691 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Quetiapine PS Zeneca Dizziness Pharmaceutical ORAL Drug Withdrawal Syndrome Quetiapine SS Zeneca Headache Pharmaceutical ORAL 1 DAY Nausea Quetiapine SS Zeneca Weight Increased Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL TAPER OF 12.5MG EVERY 5 DAYS Lamotrigine C Lamotrigine C Clonazepam C Clonazepam C Date:05/10/05ISR Number: 4657955-XReport Type:Expedited (15-DaCompany Report #2005UW06747 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Wellbutrin Sr Tablet Controlled Release I Cogentin I Trazodone I Klonopin I Trilafon I Date:05/10/05ISR Number: 4657957-3Report Type:Expedited (15-DaCompany Report #2005UW06878 Age:6 YR Gender: I/FU:I Outcome PT Other Heart Rate Increased Oxygen Saturation 22-Feb-2006 08:31 AM Page: 1280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Wheezing Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL Date:05/10/05ISR Number: 4657961-5Report Type:Expedited (15-DaCompany Report #2005PK00784 Age:25168 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Seroquel PS Zeneca Pharmaceutical ORAL 54 DAY Seroquel SS Zeneca Pharmaceutical ORAL Edronax C ORAL Date:05/10/05ISR Number: 4658647-3Report Type:Direct Company Report #CTU 248129 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Quetiapine 100 Mg PS ORAL 100 MG BID ORAL Tylenol C Novlin R C Novolin N C Atrovent/Proventil C Senocot C Heparin C Ativan C Lopressor C Vitamin C C Zinc Sulfate C Folic Acid C Date:05/10/05ISR Number: 4659291-4Report Type:Expedited (15-DaCompany Report #2005UW06735 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Health Seroquel PS Initial or Prolonged Dementia Professional Depakote SS Disorientation Date:05/10/05ISR Number: 4659293-8Report Type:Expedited (15-DaCompany Report #2005UW06680 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Dispensing Error Consumer Seroquel PS ORAL 200 MG PO Required Dyskinesia Serzone SS Intervention to Judgement Impaired Risperdal C Prevent Permanent Restless Legs Syndrome Lortab C Impairment/Damage Tongue Disorder Xanax C Tremor Zocor "Dieckmann" C Nitroglycerin "A.L." C Anti-Inflammatory Medication C Other Medications C 22-Feb-2006 08:31 AM Page: 1281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/05ISR Number: 4659306-3Report Type:Expedited (15-DaCompany Report #2005UW04321 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Activities Of Daily Foreign Seroquel PS ORAL 100 MG BID PO 2 YR Intervention to Living Impaired Health Seroquel SS ORAL 250 MG DAILY Prevent Permanent Asthenia Professional PO Impairment/Damage Balance Disorder Other Effexor-Xr C Bruxism Lamotrigine C Confusional State Ativan C Coordination Abnormal Nozinan C Depression Disturbance In Attention Dysstasia Memory Impairment Motor Dysfunction Muscle Twitching Musculoskeletal Stiffness Date:05/11/05ISR Number: 4659218-5Report Type:Expedited (15-DaCompany Report #2005AP02506 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Seroquel PS Zeneca Initial or Prolonged White Blood Cell Count Pharmaceutical ORAL Decreased Gramalil SS ORAL Date:05/11/05ISR Number: 4659220-3Report Type:Expedited (15-DaCompany Report #2005AP02539 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Seroquel PS Zeneca Multiple Drug Overdose Pharmaceutical ORAL Suicide Attempt Seroquel SS Zeneca Pharmaceutical ORAL PATIENT PROBABLY TOOK A MONTH'S SUPPLY OF QUETIAPINE Risperdal SS ORAL Risperdal SS ORAL PATIENT PROBABLY TOOK A MONTH'S SUPPLY OF RISPERIDONE Date:05/11/05ISR Number: 4659229-XReport Type:Expedited (15-DaCompany Report #2005PK00665 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Hallucination, Auditory Pharmaceutical ORAL Oedema Peripheral Haldol Decanoat C INTRAMUSCULAR Psychotic Disorder Citalopram C ORAL Schizophrenia Citalopram C ORAL Weight Increased Citalopram C ORAL Lasix I 22-Feb-2006 08:31 AM Page: 1282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/05ISR Number: 4659231-8Report Type:Expedited (15-DaCompany Report #2005UW07052 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Seroquel PS Zeneca Initial or Prolonged Hypotension Pharmaceutical ORAL Multiple Drug Overdose Alcohol SS ORAL 1/5 TH OF BOTTLE Date:05/11/05ISR Number: 4661123-5Report Type:Expedited (15-DaCompany Report #2005068722 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Doxepin (Caps) Initial or Prolonged Cardiac Arrest Literature (Doxepin) PS ORAL 1.6 GRAM, Other Haemodialysis ORAL Hypotension Diazepam (Diazepam) SS ORAL 2 GRAM, ORAL Loss Of Consciousness Temazepam Metabolic Acidosis (Temazepam) SS 200 MG, ORAL Multiple Drug Overdose Clonazepam Subendocardial Ischaemia (Clonazepam) SS ORAL 100 MG, ORAL Verapamil Hydrochloride Caplet (Verapamil Hydrochloride) SS ORAL 7.2 GRAM, ORAL Quetiapine (Quetiapine) SS 10 GRAM, ORAL Date:05/11/05ISR Number: 4661686-XReport Type:Direct Company Report #CTU 248219 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Warfarin PS 4 MG QD Initial or Prolonged International Normalised Quetiapine SS 100 MG QHS Ratio Increased Metoprolol SS 25 MG BID Syncope Ntg C Omeprazole C Date:05/11/05ISR Number: 4661963-2Report Type:Expedited (15-DaCompany Report #HQWYE641211MAY05 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Sclerosis Consumer Effexor Xr (Venlafaxine Hydrochloride, Capsule, Extended Release) PS ORAL 150 MG 2X PER 1 DAY, ORAL Seroquel (Quetiapine, ) SS SEE IMAGE Date:05/12/05ISR Number: 4660613-9Report Type:Expedited (15-DaCompany Report #2005AP02538 Age:72 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 1283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Infection Seroquel PS Zeneca Platelet Count Decreased Pharmaceutical ORAL 12 DAY Pruritus Cravit SS ORAL 13 DAY Psychiatric Symptom Madopar C ORAL Pyrexia Depas C ORAL Restlessness Magnesium Oxide C ORAL Urticaria White Blood Cell Count Decreased Date:05/13/05ISR Number: 4661792-XReport Type:Expedited (15-DaCompany Report #2005SE02664 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Pharmaceutical 1 YR Seroquel SS Zeneca Pharmaceutical ORAL 400 MG + 500 MG DAILY Risperdal C ORAL Orsanil Ret C 50 MG + 200 MG DAILY Date:05/13/05ISR Number: 4661795-5Report Type:Expedited (15-DaCompany Report #2005UW05801 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Misuse Seroquel PS Zeneca Overdose Pharmaceutical ORAL Suicide Attempt Date:05/13/05ISR Number: 4661796-7Report Type:Expedited (15-DaCompany Report #2005UW06735 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Seroquel PS Zeneca Initial or Prolonged Encephalopathy Pharmaceutical ORAL Depakote SS Date:05/13/05ISR Number: 4661799-2Report Type:Expedited (15-DaCompany Report #2005UW07199 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Seroquel PS Zeneca Hospitalization - Depression Pharmaceutical ORAL 3 YR Initial or Prolonged Drug Ineffective Lexapro SS ORAL Intentional Misuse Lithium SS Mania Lamictal SS Multiple Drug Overdose Abilify SS Personality Change Trazodone SS 3 YR Social Avoidant Behaviour Suicide Attempt Weight Increased 22-Feb-2006 08:31 AM Page: 1284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/05ISR Number: 4661802-XReport Type:Expedited (15-DaCompany Report #2005UW07271 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Seroquel PS Zeneca Hospitalization - Pharmaceutical ORAL Initial or Prolonged Date:05/16/05ISR Number: 4662594-0Report Type:Expedited (15-DaCompany Report #2005AP02728 Age:420 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blister Seroquel PS Zeneca Malnutrition Pharmaceutical ORAL Oral Mucosal Blistering Date:05/16/05ISR Number: 4662614-3Report Type:Expedited (15-DaCompany Report #2005SE02815 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Seroquel PS Zeneca Other Increased Pharmaceutical ORAL UNKNOWN DOSE Aspartate Seroquel SS Zeneca Aminotransferase Pharmaceutical ORAL 290 DAY Increased Seroquel SS Zeneca Hepatic Enzyme Increased Pharmaceutical ORAL Jaundice Seroquel SS Zeneca Pharmaceutical ORAL DECREASED GRADUALLY Deprakine Depot C ORAL 289 DAY Orgametril C ORAL Risolid C ORAL Date:05/16/05ISR Number: 4664211-2Report Type:Direct Company Report #CTU 248670 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Depakote PS 25 MG , 2X, Cerebrovascular Accident Seroquel SS 600 MG , X1 Myocardial Infarction Date:05/16/05ISR Number: 4664764-4Report Type:Expedited (15-DaCompany Report #STA-AE-05-012 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Diazepam PS 2000 MG PER Hospitalization - Cardiac Arrest Literature DAY, UNK Initial or Prolonged Glasgow Coma Scale Health Verapamil SS 7200 MG PER Abnormal Professional DAY, UNK Haemodialysis Distributor Doxepin SS 1600 MG PER Hypotension Other DAY, UNK Loss Of Consciousness Temazepam SS 10000 MG PER Metabolic Acidosis DAY, UNK Multiple Drug Overdose Clonazepam SS 100 MG PER Plasmapheresis DAY Subendocardial Ischaemia Quetiapine SS 22-Feb-2006 08:31 AM Page: 1285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/05ISR Number: 4663502-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0558030A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antisocial Behaviour Lamictal PS Glaxosmithkline ORAL Initial or Prolonged Depression Lithium SS Glaxosmithkline UNKNOWN 600MG Per day Drug Ineffective Lexapro SS ORAL 20MG Per day Intentional Misuse Abilify SS UNKNOWN 15MG Per day Mania Seroquel SS UNKNOWN Overdose Trazodone SS UNKNOWN Personality Change Suicidal Ideation Suicide Attempt Weight Increased Date:05/17/05ISR Number: 4664693-6Report Type:Direct Company Report #CTU 248846 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Quetiapine PS Date:05/17/05ISR Number: 4664891-1Report Type:Direct Company Report #CTU 248812 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Quetiapine PS Hypotension Somnolence Date:05/18/05ISR Number: 4664340-3Report Type:Expedited (15-DaCompany Report #2005UW07274 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Seroquel PS Zeneca Initial or Prolonged Drug Interaction Pharmaceutical ORAL Strattera I Date:05/18/05ISR Number: 4664347-6Report Type:Expedited (15-DaCompany Report #2005UW07441 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Pharmaceutical ORAL 200 MG AM, 400 MG PM 6 MON Date:05/18/05ISR Number: 4664357-9Report Type:Expedited (15-DaCompany Report #2004UW01147 Age:5275 DY Gender:Female I/FU:F Outcome PT Hospitalization - Bronchitis Acute Initial or Prolonged Dehydration Other Dermatitis Contact Diabetes Mellitus Insulin-Dependent Diabetic Ketoacidosis Hyperglycaemia Infectious Mononucleosis 22-Feb-2006 08:31 AM Page: 1286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ketonuria Pharyngitis Sinusitis Report Source Product Role Manufacturer Route Dose Duration Urinary Tract Infection Seroquel PS Zeneca Vomiting Pharmaceutical ORAL 11 MON Weight Increased Seroquel SS Zeneca Pharmaceutical ORAL 11 MON Seroquel SS Zeneca Pharmaceutical ORAL 11 MON Seroquel SS Zeneca Pharmaceutical ORAL HALF TAB IN AM, 1 TAB IN PM 6 MON Seroquel SS Zeneca Pharmaceutical ORAL HALF TAB IN AM, 1 TAB IN PM 6 MON Seroquel SS Zeneca Pharmaceutical ORAL HALF TAB IN AM, 1 TAB IN PM 6 MON Seroquel SS Zeneca Pharmaceutical ORAL 25 MG IN AM, 50 MG IN PM 4 MON Seroquel SS Zeneca Pharmaceutical ORAL 25 MG IN AM, 50 MG IN PM 4 MON Seroquel SS Zeneca Pharmaceutical ORAL 25 MG IN AM, 50 MG IN PM 4 MON Celexa C Celexa C Date:05/18/05ISR Number: 4664921-7Report Type:Expedited (15-DaCompany Report #2005AP02495 Age:16196 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Seroquel PS Zeneca Choking Pharmaceutical ORAL Respiratory Arrest Wypax C ORAL Silece C ORAL Benzalin C ORAL Pursennid C ORAL Date:05/18/05ISR Number: 4664926-6Report Type:Expedited (15-DaCompany Report #2005AP02792 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Seroquel PS Zeneca Death Pharmaceutical ORAL Huntington'S Chorea Serenace SS Date:05/18/05ISR Number: 4664934-5Report Type:Expedited (15-DaCompany Report #2005UW02233 Age:46 YR Gender:Male I/FU:F Outcome PT Other Amnesia Anxiety 22-Feb-2006 08:31 AM Page: 1287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asthenia Brain Damage Coordination Abnormal Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Paxil PS Consciousness Klonopin C ORAL Depression Klonopin C ORAL Disturbance In Attention Lexapro C ORAL Drug Dependence Seroquel I Zeneca Drug Interaction Pharmaceutical ORAL Hepatic Enzyme Abnormal Parnate I Increased Appetite Suicide Attempt Date:05/18/05ISR Number: 4664938-2Report Type:Expedited (15-DaCompany Report #2005UW03421 Age:21699 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Seroquel PS Zeneca Initial or Prolonged Hallucination Pharmaceutical ORAL 162 DAY Schizophrenia Date:05/18/05ISR Number: 4665656-7Report Type:Direct Company Report #CTU 248974 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Quetiapine 100mg Initial or Prolonged Miosis Astra Zeneca PS Astra Zeneca ORAL 100MG HS ORAL Selegiline C Pramipexole C Metoprolol C Clonazepam C Digoxin C Sinemet Cr C Albuterol C Atorvastatin C Date:05/18/05ISR Number: 4666262-0Report Type:Direct Company Report #CTU 249046 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Seroquel 50 Mg PS ORAL 50 MG PO BID Initial or Prolonged Prilosec C Date:05/18/05ISR Number: 4666344-3Report Type:Expedited (15-DaCompany Report #8010447 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Keppra PS ORAL 1000 MG /D PO Exposure To Therapeutic Professional Keppra SS ORAL 1500 MG/D PO Drugs Company Lexapro SS ORAL 20 MG /D PO Placenta Praevia Representative Seroquel SS ORAL 100 MG /D PO Pregnancy Baby Asprin C Prenatal Vitamins C 22-Feb-2006 08:31 AM Page: 1288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/05ISR Number: 4666389-3Report Type:Expedited (15-DaCompany Report #2005AC00723 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Pharmaceutical ORAL Akineton C ORAL Depakine C ORAL Nocatamid C ORAL Stilnox C ORAL Omeprazole C ORAL Zyprexa C ORAL Date:05/19/05ISR Number: 4666397-2Report Type:Expedited (15-DaCompany Report #2005SE02899 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fluid Retention Seroquel PS Zeneca Initial or Prolonged Pleural Effusion Pharmaceutical ORAL Pulmonary Arterial Diclofenak SS ORAL 9 DAY Pressure Increased Tikacillin SS ORAL 1 MON Tonsillitis Citalopram C ORAL Alvedon C Date:05/19/05ISR Number: 4666400-XReport Type:Expedited (15-DaCompany Report #2005SE02900 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Seroquel PS Zeneca Metastases To Bone Pharmaceutical ORAL 7 MON Metastases To Liver Seroquel SS Zeneca Metastases To Pleura Pharmaceutical ORAL Haldol SS ORAL Inderal C Zoloft C Date:05/19/05ISR Number: 4666403-5Report Type:Expedited (15-DaCompany Report #2005UW05561 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Seroquel PS Zeneca Confusional State Pharmaceutical ORAL DAY 1 Dysphemia Seroquel SS Zeneca Fall Pharmaceutical ORAL DAY 5 Fatigue Feeling Abnormal Limb Discomfort Mental Impairment Date:05/19/05ISR Number: 4666875-6Report Type:Expedited (15-DaCompany Report #JP-SANOFI-SYNTHELABO-A01200503194 Age:78 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Liver Disorder Myslee PS ORAL Hospitalization - Seroquel SS ORAL Initial or Prolonged Blopress SS ORAL UNK Loxonin SS ORAL UNK Mobic C ORAL UNK 22-Feb-2006 08:31 AM Page: 1289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/05ISR Number: 4668516-0Report Type:Expedited (15-DaCompany Report #2005-01660 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Trazodone Initial or Prolonged Drug Ineffective Other Hydrochloride Other Intentional Misuse (Watson Required Mania Laboratories)(Trazod Intervention to Multiple Drug Overdose one Hydrochloride) PS Watson Laboratories ORAL ORAL Prevent Permanent Off Label Use Lexapro Impairment/Damage Personality Change (Escitalopram) SS ORAL 20 MG, DAILY, Suicide Attempt ORAL Weight Increased Lithium (Lithium) SS ORAL 600 MG, DAILY, ORAL Lamictal "Glaxo Welcome" SS Glaxo Welcome ORAL 50 MG, BID, ORAL Ariprazole (Apirprazole) SS ORAL 15 MG, DAILY, ORAL Seroquel (Quetiapine Fumarate) SS ORAL ORAL Date:05/19/05ISR Number: 4668684-0Report Type:Expedited (15-DaCompany Report #2005071563 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Consumer Neurontin Initial or Prolonged Convulsion (Gabapentin) PS ORAL 400 MG (1D), Other Difficulty In Walking ORAL Dizziness Lamictal Drug Ineffective (Lamotrigine) SS Gait Disturbance Zyprexa (Olanzapine) SS Increased Appetite Seroquel (Quetiapine Insomnia Fumarate) SS Metabolic Disorder Depakote (Valproate Migraine Sodium) SS Suicidal Ideation Depakene (Valproate Weight Increased Sodium) C Claritin (Loratadine) C Date:05/19/05ISR Number: 4669268-0Report Type:Expedited (15-DaCompany Report #2005-125695-NL Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mydriasis Health Mirtazapine PS ORAL 45 DF Visual Disturbance Professional Venlafaxine SS ORAL 225 MG/DF 2 MON Quetiapine SS ORAL 250 MG Codeine C Paracetamol C Diclofenac C Bisacodyl C Diazepam C 22-Feb-2006 08:31 AM Page: 1290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/05ISR Number: 4667973-3Report Type:Expedited (15-DaCompany Report #2005UW07385 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intestinal Functional Seroquel PS Zeneca Disorder Pharmaceutical ORAL Iron Deficiency Anaemia Date:05/20/05ISR Number: 4667974-5Report Type:Expedited (15-DaCompany Report #2005UW07487 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Malabsorption Pharmaceutical ORAL Prothrombin Time Coumadin I Prolonged Date:05/20/05ISR Number: 4672361-XReport Type:Expedited (15-DaCompany Report #2005-01596 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Foreign Verapamil (Watson Initial or Prolonged Metabolic Acidosis Literature Laboratories) Other Multiple Drug Overdose Health (Verapamil Required Shock Professional Hydrochloride) Intervention to Tablets PS Watson Laboratories ORAL 7.2 GRAM Prevent Permanent SINGLE ORAL Impairment/Damage Diazepam (Watson Laboratories) (Diazepam, Diazepam) Tablet SS Watson Laboratories ORAL 2 G SINGLE ORAL Clonazepam (Watson Laboratories) (Clonazepam, Clonazepam) Tablets SS Watson Laboratories ORAL 100 MG SINGLE ORAL Temazepam (Temazepam) SS ORAL 200 MG SINGLE ORAL Doxepin (Doxepin) SS ORAL 1.6 SINGLE ORAL Quetiapine (Quetiapine) SS ORAL 10 G SINGLE ORAL Date:05/23/05ISR Number: 4672835-1Report Type:Expedited (15-DaCompany Report #KII-2005-0016584 Age:75 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Blood Creatine Phosphokinase Mb Increased Blood Urine Present Coma Confusional State Loss Of Consciousness 22-Feb-2006 08:31 AM Page: 1291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multiple Drug Overdose Nervousness Somnolence Report Source Product Role Manufacturer Route Dose Duration Tachycardia Study Oxycodone Troponin Increased Health Hydrochloride(Simila Professional r To Nda Other 20-553)(Oxycodone Hydrochloride) PS ORAL ORAL Seroquel (Quetiapine) SS ORAL ORAL Diazepam (Diazepam) SS Lisinopril C Serumlipidreducing Agents C Date:05/23/05ISR Number: 4672916-2Report Type:Expedited (15-DaCompany Report #2005073197 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Geodon (Ziprasidone) PS 160 MG 980 Abnormal Professional MG, 2 IN 1 Neuroleptic Malignant Company D), Syndrome Representative Lithium (Lithium) SS Pneumonia Quetiapine (Quetiapine) SS Date:05/23/05ISR Number: 4695542-8Report Type:Expedited (15-DaCompany Report #2005AP02791 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Seroquel PS Zeneca Loss Of Consciousness Pharmaceutical ORAL DOSE RANGED FROM 25-50 MG Zoloft C Antibiotics C Cholesterol Lowering Drugs C Date:05/23/05ISR Number: 4695543-XReport Type:Expedited (15-DaCompany Report #2005AP02801 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL Date:05/23/05ISR Number: 4695558-1Report Type:Expedited (15-DaCompany Report #2005PK00093 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Seroquel PS Zeneca Initial or Prolonged Psychiatric Symptom Pharmaceutical ORAL 2 DAY Sedation Asasantin C Vertigo Zestril C Tenormin C Aspirin Protect C Eltroxin C Nexium Mups C 22-Feb-2006 08:31 AM Page: 1292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Citalopram C Lorazepam C ORAL 2 DAY Lorazepam C ORAL 2 DAY Lorazepam C ORAL 2 DAY Date:05/23/05ISR Number: 4695561-1Report Type:Expedited (15-DaCompany Report #2005PK00838 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Seroquel PS Zeneca Drug Dependence Pharmaceutical ORAL Fatigue Seroquel SS Zeneca Fracture Pharmaceutical BUCCAL Insomnia Seroquel SS Zeneca Multiple Fractures Pharmaceutical ORAL Date:05/23/05ISR Number: 4695563-5Report Type:Expedited (15-DaCompany Report #2005PK00842 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Erectile Dysfunction Pharmaceutical ORAL 5 DAY Seroquel I Zeneca Pharmaceutical ORAL 6 DAY Seroquel I Zeneca Pharmaceutical ORAL 22 DAY Seroquel I Zeneca Pharmaceutical ORAL 13 DAY Seroquel I Zeneca Pharmaceutical ORAL 37 DAY Seroquel I Zeneca Pharmaceutical ORAL Abilify I ORAL 40 DAY Abilify I ORAL Date:05/23/05ISR Number: 4695564-7Report Type:Expedited (15-DaCompany Report #2005PK00843 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Seroquel PS Zeneca Initial or Prolonged Drug Interaction Pharmaceutical ORAL 1 DAY Speech Disorder Lithiofor C ORAL Adalat C ORAL 17 DAY Nitroderm Tts C TRANSDERMAL 32 DAY Lexotanil 6 C ORAL Beloc-Zok C ORAL 7 DAY Seroquel I Zeneca Pharmaceutical ORAL 1 DAY Valium I ORAL 4 DAY Valium I ORAL 1 DAY Valium I ORAL 1 DAY 22-Feb-2006 08:31 AM Page: 1293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/05ISR Number: 4695567-2Report Type:Expedited (15-DaCompany Report #2005SE02961 Age:18809 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Quetiapine PS Zeneca Initial or Prolonged Pharmaceutical ORAL Allopurinol C Fenofibrate C Date:05/23/05ISR Number: 4695573-8Report Type:Expedited (15-DaCompany Report #2005UW07571 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Seroquel PS Zeneca Initial or Prolonged Blood Urea Decreased Pharmaceutical ORAL Dysarthria Seroquel SS Zeneca Hallucination Pharmaceutical ORAL Heart Rate Increased Neuroleptic Malignant Syndrome Platelet Disorder Salivary Hypersecretion Date:05/24/05ISR Number: 4672575-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0559750A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anger Eskalith PS Glaxosmithkline ORAL 450MG Twice Hospitalization - Crying per day 3 WK Initial or Prolonged Depression Paxil SS Glaxosmithkline ORAL 20MG Per day 9 YR Disability Poisoning Wellbutrin Xl SS Glaxosmithkline ORAL 150MG Per day 2 WK Other Psychotic Disorder Seroquel SS UNKNOWN Suicide Attempt Risperdal C Klonopin C Date:05/24/05ISR Number: 4672793-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12965893 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Abilify PS Otsuka Hospitalization - Drug Ineffective Pharmaceutical Initial or Prolonged Intentional Misuse Company, Ltd. Mania Trazodone Hcl SS Apothecon Suicide Attempt Lexapro SS ORAL Weight Increased Lithium SS Lamictal SS Seroquel SS Date:05/24/05ISR Number: 4673140-XReport Type:Direct Company Report #CTU 249311 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Eyeball Rupture Seriquil 200 Ml Thinking Abnormal Region 2, Region 2 Omh PS HEMODIALYSIS 100ML MORNING HEMODIALYS ; 400ML NIGHT 22-Feb-2006 08:31 AM Page: 1294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report HEMODIALYS Date:05/24/05ISR Number: 4695580-5Report Type:Expedited (15-DaCompany Report #2005AC00729 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Quetiapine PS Zeneca Initial or Prolonged Intentional Misuse Pharmaceutical ORAL Overdose Quetiapine SS Zeneca Suicide Attempt Pharmaceutical ORAL Risperidone SS Risperidone SS BETWEEN 90 MG TO 120 MG Lithium Carbonate C Date:05/24/05ISR Number: 4695585-4Report Type:Expedited (15-DaCompany Report #2005AP02913 Age:78 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Liver Disorder Seroquel PS Zeneca Hospitalization - Pharmaceutical ORAL Initial or Prolonged Myslee SS ORAL Blopress SS Astrazeneca Pharmaceuticals ORAL Loxonin SS ORAL Mobic SS ORAL Date:05/24/05ISR Number: 4695588-XReport Type:Expedited (15-DaCompany Report #2005PK00839 Age:230 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myopia Seroquel PS Zeneca Pharmaceutical ORAL Date:05/24/05ISR Number: 4695590-8Report Type:Expedited (15-DaCompany Report #2005UW06382 Age:25304 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Seroquel PS Zeneca Initial or Prolonged Hepatic Function Abnormal Pharmaceutical ORAL Disability Jaundice Date:05/24/05ISR Number: 4695592-1Report Type:Expedited (15-DaCompany Report #2005UW07520 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Seroquel PS Zeneca Blood Glucose Increased Pharmaceutical ORAL 5 MON Dystonia Duragesic C Thinking Abnormal Percocet C Visual Acuity Reduced Somazapam C Robaxin C Ranitidine C Lithium C Amitriptyline C Bentyl C Glucosamine C 22-Feb-2006 08:31 AM Page: 1295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Isoflavins C Date:05/24/05ISR Number: 4695593-3Report Type:Expedited (15-DaCompany Report #2005UW07559 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Seroquel PS Zeneca Intentional Misuse Pharmaceutical ORAL Loss Of Consciousness Seroquel SS Zeneca Overdose Pharmaceutical ORAL Self-Injurious Ideation Methadone C Weight Decreased Xanax C Crack C All Kinds Of Drugs C Date:05/24/05ISR Number: 4695595-7Report Type:Expedited (15-DaCompany Report #2005UW07673 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Seroquel PS Zeneca Other Deafness Pharmaceutical ORAL Zoloft C Propanolol C Date:05/25/05ISR Number: 4673639-6Report Type:Expedited (15-DaCompany Report #2005PK00073 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Seroquel PS Zeneca Initial or Prolonged Drug Interaction Pharmaceutical ORAL Drug Level Increased Quilonorm SS ORAL 2 YR Gait Disturbance Quilonorm SS ORAL 4 DAY Vertigo Quilonorm SS ORAL 4 DAY Tegretol I ORAL 12 DAY Tegretol I ORAL 3 DAY Floxyfral I ORAL Date:05/25/05ISR Number: 4673650-5Report Type:Expedited (15-DaCompany Report #2005PK00863 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Seroquel PS Zeneca Hospitalization - Overdose Pharmaceutical ORAL Initial or Prolonged Poisoning Date:05/25/05ISR Number: 4677093-XReport Type:Direct Company Report #CTU 249526 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Quetiapine PS Initial or Prolonged Overdose Required Tremor Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:31 AM Page: 1296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/05ISR Number: 4674760-9Report Type:Expedited (15-DaCompany Report #2005UW07817 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Conduction Disorder Seroquel PS Zeneca Pharmaceutical ORAL Date:05/26/05ISR Number: 4674763-4Report Type:Expedited (15-DaCompany Report #2005UW04889 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysstasia Seroquel PS Zeneca Fall Pharmaceutical ORAL Hallucination Blood Pressure Hallucination, Visual Medication C Loss Of Consciousness Ketamine C TOPICAL Doxepin C 100 MG UP TO QID Miralax C Ativan C 2 MG UP TO TID Ambien C Lidocaine C Bumex C Inderal C Lipitor C Monopril C Date:05/26/05ISR Number: 4674772-5Report Type:Expedited (15-DaCompany Report #2005UW07490 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Seroquel PS Zeneca Initial or Prolonged Suicidal Ideation Pharmaceutical ORAL TITRATION 100-600 MG Seroquel SS Zeneca Pharmaceutical ORAL TITRATION 100-600 MG Effexor C Date:05/26/05ISR Number: 4676527-4Report Type:Direct Company Report #CTU 249676 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Quetiapine PS 75MG BID Aspirin C Calcium Carbonate C Darbepoetin C Docusate C Ferrous Sulfate C Furosemide C Levothyroxine C Lisinopril C Metoprolol C Pantoprazole C Simvastatin C 22-Feb-2006 08:31 AM Page: 1297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/05ISR Number: 4677355-6Report Type:Expedited (15-DaCompany Report #HQWYE828520MAY05 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Efexor (Venlafaxine Initial or Prolonged Dyskinesia Health Hydrochloride, Other Professional Tablet) PS ORAL SEE IMAGE 45 DAY Quilonorm Retard (Lithium Carbonate, ) SS ORAL SEE IMAGE 2 DAY Seroquel (Quetiapine, ) SS ORAL SEE IMAGE 5 DAY Date:05/27/05ISR Number: 4675404-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12872206 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Abilify PS Otsuka Initial or Prolonged Drooling Pharmaceutical Dystonia Company, Ltd. ORAL Muscle Spasms Seroquel SS ORAL Tremor Adderall Xr C Vomiting Date:05/27/05ISR Number: 4676395-0Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0548259A Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Wellbutrin Xl PS Glaxosmithkline ORAL 450MG Per day Other Ativan SS ORAL 1MG Twice per day Remeron SS ORAL 7.5MG Per day Zofran SS Glaxosmithkline ORAL 8MG As required Seroquel SS ORAL 150MG At night Prozac SS UNKNOWN 100MG Per day Date:05/27/05ISR Number: 4676643-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-405250 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Klonopin PS Roche ORAL Confusional State Gabitril I ORAL AT BEDTIME 1 WK Delusion Gabitril I ORAL AT BEDTIME Disorientation Lithium I ORAL Drug Interaction Trileptal I ORAL Sedation Seroquel I ORAL Clozaril I ORAL Date:05/27/05ISR Number: 4676680-2Report Type:Expedited (15-DaCompany Report #2005UW07650 Age: Gender:Female I/FU:I Outcome PT Other Akinesia Defaecation Urgency Ill-Defined Disorder Immobile 22-Feb-2006 08:31 AM Page: 1298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Micturition Urgency Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL Depakote C Date:05/27/05ISR Number: 4676763-7Report Type:Expedited (15-DaCompany Report #US-MERCK-0505USA02903 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Event Cogentin PS Merck & Co., Inc ORAL Initial or Prolonged Drug Interaction Wellbutrin Sr SS ORAL Trazodone Hydrochloride SS UNKNOWN Seroquel SS UNKNOWN Klonopin SS UNKNOWN Trilafon SS UNKNOWN Date:05/27/05ISR Number: 4676885-0Report Type:Expedited (15-DaCompany Report #2005073197 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Geodon (Ziprasidone) PS 160 MG (80 Abnormal Professional MG, 2 IN 1 D) Neuroleptic Malignant Company Lithium (Lithium) SS Syndrome Representative Quetiapine Pneumonia (Quetiapine) SS Unevaluable Event Date:05/27/05ISR Number: 4677417-3Report Type:Direct Company Report #CTU 249768 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Simvastatin 80mg PS ORAL 40MG HS ORAL Initial or Prolonged Phosphokinase Increased Quetiapine 100mg SS ORAL 100-200MG Blood Creatinine DAILY ORAL Increased Confusional State Hypovolaemia International Normalised Ratio Increased Rhabdomyolysis Date:05/31/05ISR Number: 4677974-7Report Type:Expedited (15-DaCompany Report #2005AP02538 Age:26460 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Seroquel PS Zeneca Initial or Prolonged Pigmentation Disorder Pharmaceutical ORAL 12 DAY Other Platelet Count Decreased Cravit SS ORAL 13 DAY Pruritus Madopar C ORAL Pyrexia Depas C ORAL Rash Magnesium Oxide C ORAL Urticaria White Blood Cell Count Decreased 22-Feb-2006 08:31 AM Page: 1299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/31/05ISR Number: 4677977-2Report Type:Expedited (15-DaCompany Report #2005AC00777 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Pharmaceutical ORAL Lithium C Serozat C Sleeping Medication C Date:05/31/05ISR Number: 4677998-XReport Type:Expedited (15-DaCompany Report #2005GB00961 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Seroquel PS Zeneca Corrected Interval Pharmaceutical ORAL 1 MON Prolonged Prozac C ORAL Priadel C ORAL Date:05/31/05ISR Number: 4678002-XReport Type:Expedited (15-DaCompany Report #2005UW05526 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fibromyalgia Seroquel PS Zeneca Myalgia Pharmaceutical ORAL Renal Failure Benadryl C Nifedipine C Celebrex C Lorazepam C Toradol C Date:05/31/05ISR Number: 4678008-0Report Type:Expedited (15-DaCompany Report #2005AP02878 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Seroquel PS Zeneca Leukopenia Pharmaceutical ORAL 2 MON Pneumonia Contmin C Gramalil C Date:05/31/05ISR Number: 4678009-2Report Type:Expedited (15-DaCompany Report #2005GB00966 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Disorder Quetiapine PS Zeneca Initial or Prolonged Drug Interaction Pharmaceutical ORAL Disability Drug Level Increased Bendrofluazide C ORAL Gastroenteritis Omeprazole C ORAL Therapeutic Agent Tamsulosin C ORAL Toxicity Lorazepam C ORAL Priadel I ORAL Priadel I ORAL 22 DAY 22-Feb-2006 08:31 AM Page: 1300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/31/05ISR Number: 4679250-5Report Type:Direct Company Report #CTU 249980 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Seroquel PS 800 MG DAILY Initial or Prolonged Cerebrovascular Accident Depakote C Disability Drug Exposure During Pregnancy Hypertension Myocardial Infarction Pregnancy Date:05/31/05ISR Number: 4679274-8Report Type:Direct Company Report #CTU 249935 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Cholesterol Seroquel 100 Mg PS Disability Increased Required Cataract Intervention to Low Density Lipoprotein Prevent Permanent Increased Impairment/Damage Night Blindness Date:05/31/05ISR Number: 4679707-7Report Type:Expedited (15-DaCompany Report #2005073197 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Geodon (Ziprasidone) PS 160 MG (80 Liver Function Test Professional MG, 2 IN 1 D) Abnormal Company Lithium (Lithium) SS Neuroleptic Malignant Representative Quetiapine Syndrome (Quetiapine) SS Pneumonia Date:05/31/05ISR Number: 4679715-6Report Type:Expedited (15-DaCompany Report #PAR_0049_2005 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ibuprofen PS ORAL DF PO Multiple Drug Overdose Health Quetiapine SS DF Professional Venlafaxine SS DF Date:06/02/05ISR Number: 4679418-8Report Type:Expedited (15-DaCompany Report #2005UW07559 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Seroquel PS Zeneca Loss Of Consciousness Pharmaceutical ORAL Self-Injurious Ideation Methadone C Weight Decreased Xanax C Crack C All Kinds Of Drugs C 22-Feb-2006 08:31 AM Page: 1301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/05ISR Number: 4679420-6Report Type:Expedited (15-DaCompany Report #2005UW07385 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intestinal Functional Seroquel PS Zeneca Disorder Pharmaceutical ORAL Iron Deficiency Anaemia Date:06/02/05ISR Number: 4679425-5Report Type:Expedited (15-DaCompany Report #2005PK00843 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Seroquel PS Zeneca Initial or Prolonged Dizziness Pharmaceutical ORAL 1 DAY Drug Interaction Lithiofor C ORAL Dry Mouth Adalat C ORAL 17 DAY Flushing Nitroderm Tts C TRANSDERMAL 32 DAY Speech Disorder Lexotanil 6 C ORAL Tongue Disorder Beloc-Zok C ORAL 7 DAY Seroquel I Zeneca Pharmaceutical ORAL 1 DAY Valium I ORAL 4 DAY Valium I ORAL 1 DAY Valium I ORAL 1 DAY Date:06/02/05ISR Number: 4679654-0Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20050505721 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Metastatic Haldol PS OROPHARINGEAL Metastases To Bone Seroquel SS OROPHARINGEAL Metastases To Liver Metastases To Pleura Date:06/02/05ISR Number: 4680226-2Report Type:Expedited (15-DaCompany Report #JP-SANOFI-SYNTHELABO-A01200503194 Age:1006 MONGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Myslee PS ORAL 13 DAY Hospitalization - Hepatitis Seroquel SS ORAL 13 DAY Initial or Prolonged Hypersensitivity Blopress SS ORAL 4 mg 13 DAY Jaundice Novastan SS UNKNOWN 60 mg 8 DAY Pain Mobic SS ORAL 10 mg 6 DAY Sepsis Loxonin C ORAL 120 mg 6 DAY Lanirapid C ORAL 0.5 mg Itorol C ORAL 20 mg Lasix C ORAL 20 mg Aspirin C ORAL 0.1 g Aspirin C ORAL 0.1 g Warfarin C ORAL 1.5 mg Gaster C ORAL 20 mg Date:06/02/05ISR Number: 4681304-4Report Type:Direct Company Report #CTU 250193 Age:67 YR Gender:Female I/FU:I Outcome Life-Threatening Required 22-Feb-2006 08:31 AM Page: 1302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Arrest Seroquel 25mg PS ORAL TWO TABS Ventricular Fibrillation DAILY ORAL Prozac 20mg SS ORAL ONE TAB DAILY ORAL Altace C Date:06/02/05ISR Number: 4682419-7Report Type:Direct Company Report #CTU 250249 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Seroquel PS ORAL 500 MG PO HS Initial or Prolonged Date:06/03/05ISR Number: 4680675-2Report Type:Expedited (15-DaCompany Report #2005UW06647 Age:536 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Damage Seroquel PS Zeneca Hospitalization - Intentional Misuse Pharmaceutical ORAL Initial or Prolonged Loss Of Consciousness Fluoxetine C ORAL 213 DAY Respiratory Arrest Risperdal C ORAL Status Epilepticus Clonazepam C ORAL Suicide Attempt Ambien C ORAL Unresponsive To Verbal Stimuli Date:06/03/05ISR Number: 4680687-9Report Type:Expedited (15-DaCompany Report #2005AP02792 Age:930 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Infarction Seroquel PS Zeneca Other Delirium Pharmaceutical ORAL 14 DAY Huntington'S Chorea Seroquel SS Zeneca Pharmaceutical ORAL 14 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL 14 DAY Seroquel SS Zeneca Pharmaceutical ORAL 14 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Harnal C ORAL Gramalil C ORAL 14 DAY Gramalil C ORAL 14 DAY Gramalil C ORAL Gramalil C ORAL Eurodin C ORAL Eurodin C ORAL Lendormin D C ORAL Lendormin D C ORAL 22-Feb-2006 08:31 AM Page: 1303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Excegran C ORAL Depakene C ORAL Methycobal C ORAL Serenace C ORAL 14 DAY Serenace C ORAL 14 DAY Serenace C ORAL Serenace C ORAL Date:06/03/05ISR Number: 4680698-3Report Type:Expedited (15-DaCompany Report #2005UW08180 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Overdose Seroquel PS Zeneca Hospitalization - Dependence Pharmaceutical ORAL 6 YR Initial or Prolonged Depression Peg-Intron SS SUBCUTANEOUS Other Intentional Misuse Rebetol SS ORAL Dilaudid SS Effexor Xr C ORAL Trazodone Hydrochloride C ORAL Analgesic C ORAL Topamax C ORAL Prevacid C ORAL Date:06/03/05ISR Number: 4681410-4Report Type:Expedited (15-DaCompany Report #2005UW08430 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Seroquel PS Zeneca Pharmaceutical ORAL Levodopa SS ORAL Date:06/06/05ISR Number: 4682798-0Report Type:Expedited (15-DaCompany Report #2005SE03210 Age:13288 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Neutropenia Pharmaceutical ORAL 184 DAY Seroquel SS Zeneca Pharmaceutical ORAL 184 DAY Seroquel SS Zeneca Pharmaceutical ORAL LOWER DOSE Seroquel SS Zeneca Pharmaceutical ORAL LOWER DOSE Lamictal SS ORAL 61 DAY Kalcipos-D C ORAL Multi-Tabs C ORAL Efexor Depot C ORAL Duroferon C ORAL Movicol C ORAL Date:06/06/05ISR Number: 4682799-2Report Type:Expedited (15-DaCompany Report #2005PK00917 Age:52 YR Gender:Female I/FU:I Outcome PT Death Blood Creatine Phosphokinase Increased 22-Feb-2006 08:31 AM Page: 1304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sudden Death Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL Nexium SS Astrazeneca Pharmaceuticals Lamictal SS Zoloft SS Euthyrox SS Kreon SS Date:06/06/05ISR Number: 4682804-3Report Type:Expedited (15-DaCompany Report #2005GB01028 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Quetiapine PS Zeneca Drug Ineffective Pharmaceutical ORAL 13 DAY Hallucination Stalevo C ORAL Sinemet C ORAL Sinemet Cr C ORAL Cabergoline C ORAL Cabergoline C ORAL Madopar C ORAL Oxybutynin C ORAL Date:06/06/05ISR Number: 4682805-5Report Type:Expedited (15-DaCompany Report #2005SE02284 Age:13927 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Seroquel PS Zeneca Initial or Prolonged Schizophrenia Pharmaceutical ORAL 142 DAY Treatment Noncompliance Date:06/06/05ISR Number: 4682811-0Report Type:Expedited (15-DaCompany Report #2005AC00804 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Quetiapine PS Zeneca Neutropenia Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL Lithium C Valproic Acid C Omeprazole C Lormatazepam C Bezafibrate C Tyrosine C Date:06/06/05ISR Number: 4682812-2Report Type:Expedited (15-DaCompany Report #2005AC00798 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Seroquel PS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/05ISR Number: 4682817-1Report Type:Expedited (15-DaCompany Report #2005AC00797 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Seroquel PS Zeneca Hospitalization - Sudden Death Pharmaceutical ORAL Initial or Prolonged Date:06/06/05ISR Number: 4682827-4Report Type:Expedited (15-DaCompany Report #2005SE02546 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL 19 DAY Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Risperidon C ORAL Risperdal Consta C INTRAMUSCULAR Largactil C ORAL Mellaril C Akineton C Tolvon C INTRAMUSCULAR 1 DAY Date:06/06/05ISR Number: 4682829-8Report Type:Expedited (15-DaCompany Report #2005GB01020 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Quetiapine PS Zeneca Initial or Prolonged Confusional State Pharmaceutical ORAL Disability Drug Interaction Omeprazole C UNKNOWN Facial Paresis Prostap C UNKNOWN Gastroenteritis Tamsulosin C UNKNOWN Hemiparesis Lorazepam C UNKNOWN Zopiclone C UNKNOWN Priadel I ORAL INCREASED TO 600MG Priadel I ORAL INCREASED FROM 400MG Bendrofluazide I UNKNOWN Date:06/06/05ISR Number: 4683512-5Report Type:Direct Company Report #CTU 250382 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Autoimmune Hepatitis Quetiapine PS ORAL 175 QHS Hepatitis ORAL Liver Disorder Topiramate SS ORAL 50 BID ORAL Date:06/06/05ISR Number: 4683514-9Report Type:Direct Company Report #CTU 250381 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Seroquel 200mg PS ORAL 200MG 4 TIMES A DAY ORAL 22-Feb-2006 08:31 AM Page: 1306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/05ISR Number: 4686965-1Report Type:Expedited (15-DaCompany Report #2005068722 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Doxepin (Caps) Initial or Prolonged Atrioventricular Block Literature (Doxepin) PS ORAL 1.6 GRAM, Other First Degree ORAL Bradycardia Diazepam (Diazepam) SS ORAL 2 GRAM, ORAL Cardiac Arrest Clonazepam Depression (Clonazepam) SS ORAL 100 MG, ORAL Drug Ineffective Quetiapine Ejection Fraction (Quetiapine) SS ORAL 10 GRAM, ORAL Decreased Verapamil Haemodialysis Hydrochloride Caplet Haemodynamic Instability (Verapamil Hypotension Hydrochloride) SS ORAL 7.2 GRAM, Intentional Misuse ORAL Loss Of Consciousness Temazepam Metabolic Acidosis (Temazepam) C ORAL 200 MG, ORAL Multiple Drug Overdose Shock Subendocardial Ischaemia Therapy Non-Responder Troponin I Increased Date:06/07/05ISR Number: 4684310-9Report Type:Expedited (15-DaCompany Report #2005PK00951 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Injury Seroquel PS Zeneca Facial Bones Fracture Pharmaceutical ORAL 3 DAY Fall Seroquel SS Zeneca Hypotension Pharmaceutical ORAL 3 DAY Hypothyroidism Seroquel SS Zeneca Leukopenia Pharmaceutical ORAL 3 DAY Loss Of Consciousness Seroquel SS Zeneca Weight Decreased Pharmaceutical ORAL 4 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL Somnubene C ORAL 20 DAY Somnubene C ORAL 8 DAY Somnubene C ORAL 9 DAY Zyprexa C ORAL 3 DAY Zyprexa C ORAL 3 DAY Zyprexa C ORAL 3 DAY Zyprexa C ORAL 4 DAY Forlax C Date:06/07/05ISR Number: 4684316-XReport Type:Expedited (15-DaCompany Report #2005SE03193 Age:9904 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Quetiapine PS Zeneca Initial or Prolonged Pharmaceutical ORAL NEW DOSE NOT SPECIFIED 1 MON Quetiapine SS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/05ISR Number: 4684317-1Report Type:Expedited (15-DaCompany Report #2005PK00950 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Seroquel PS Zeneca Psychotic Disorder Pharmaceutical ORAL 24 DAY Serum Serotonin Increased Seroquel SS Zeneca Sleep Disorder Pharmaceutical ORAL 4 DAY Seroquel SS Zeneca Pharmaceutical ORAL Cipralex SS ORAL 18 DAY Cipralex SS ORAL Trittico C ORAL Zoldem C ORAL 15 DAY Gewalcam C ORAL 18 DAY Gewalcam C ORAL Date:06/07/05ISR Number: 4684318-3Report Type:Expedited (15-DaCompany Report #2005AP03049 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecaloma Seroquel PS Zeneca Initial or Prolonged Therapy Non-Responder Pharmaceutical ORAL 25MG-600MG Other MAINTENANCE DOSE SINCE 2001 Seroquel SS Zeneca Pharmaceutical ORAL Aropax C Valium C Date:06/07/05ISR Number: 4684320-1Report Type:Expedited (15-DaCompany Report #2005PK00939 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Seroquel PS Zeneca Fall Pharmaceutical ORAL 4 DAY Haemorrhage Seroquel SS Zeneca Head Injury Pharmaceutical ORAL Hypotension Dominal SS ORAL 6 DAY Laceration Dominal SS ORAL 8 DAY Loss Of Consciousness Dominal SS ORAL Temesta SS ORAL 4 DAY Temesta SS ORAL 2 DAY Temesta SS ORAL 7 DAY Temesta SS ORAL 1 DAY Depakine SS ORAL Ebixa C ORAL 17 DAY Ebixa C ORAL Date:06/07/05ISR Number: 4684327-4Report Type:Expedited (15-DaCompany Report #2005AP02495 Age:16196 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Seroquel PS Zeneca Choking Pharmaceutical ORAL Respiratory Arrest Wypax C ORAL Silece C ORAL Benzalin C ORAL 22-Feb-2006 08:31 AM Page: 1308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pursennid C ORAL Date:06/07/05ISR Number: 4684336-5Report Type:Expedited (15-DaCompany Report #2005AC00792 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemolytic Anaemia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL SCALATING DOSE Meleril C Date:06/08/05ISR Number: 4685533-5Report Type:Expedited (15-DaCompany Report #2005GB01084 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Pharmaceutical ORAL Date:06/08/05ISR Number: 4685535-9Report Type:Expedited (15-DaCompany Report #2005SE03199 Age:9728 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Quetiapine PS Zeneca Initial or Prolonged Psychotic Disorder Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL DOSE NOT SPECIFIED Buspirone C ORAL Lergigan C ORAL Ibumetin C ORAL Ibumetin C ORAL Ibumetin C ORAL Paracetamol C ORAL Paracetamol C ORAL Xyloproct C Echinagard C ORAL Date:06/08/05ISR Number: 4687401-1Report Type:Expedited (15-DaCompany Report #2005073197 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Coronary Syndrome Health Geodon (Ziprasidone) PS 160 MG (80 Neuroleptic Malignant Professional MG, 2 IN 1 Syndrome Company D), Pneumonia Representative Lithium (Lithium) SS Quetiapine (Quetiapine) SS Date:06/09/05ISR Number: 4686651-8Report Type:Expedited (15-DaCompany Report #2005PK00964 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS ORAL 19 DAY Promethazin SS 45 DAY 22-Feb-2006 08:31 AM Page: 1309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bisoprolol SS Date:06/09/05ISR Number: 4686653-1Report Type:Expedited (15-DaCompany Report #2005AP03126 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Headache Seroquel PS Zeneca Hypermetropia Pharmaceutical ORAL Dothiepin Hydrohcloride C Date:06/09/05ISR Number: 4687434-5Report Type:Direct Company Report #CTU 250807 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatinine Linezolid 600 Mg Intervention to Increased Pharmacia PS Pharmacia INTRAVENOUS 600 MG Q12H Prevent Permanent Drug Interaction INTRAVENOU Impairment/Damage Haemodialysis Quetiapine 25 Mg Rhabdomyolysis Astra-Zeneca SS Astra-Zeneca ORAL 25 MG BID Serotonin Syndrome ORAL Pyridoxine C Lisinopril C Ceftriaxone C Doxazosin C Vitamin B Complex W/C C Iron Polysaccharides C Diltiazem C Nystatin C Pantoprazole C Docusate C Labetalol C Calcium Carobonate C Sodium Bicarbonate C Insulin C Erythropoeitin C Date:06/10/05ISR Number: 4687734-9Report Type:Expedited (15-DaCompany Report #JP-SANOFI-SYNTHELABO-A01200503194 Age:1006 MONGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Myslee PS ORAL 13 DAY Hospitalization - Hepatitis Seroquel SS ORAL 13 DAY Initial or Prolonged Jaundice Blopress SS ORAL 4 mg 13 DAY Sepsis Novastan SS UNKNOWN 60 mg 8 DAY Mobic SS ORAL 10 mg 6 DAY Loxonin C ORAL 120 mg 6 DAY Lanirapid C ORAL 0.5 mg Itorol C ORAL 20 mg Lasix C ORAL 20 mg Aspirin C ORAL 0.1 g Aspirin C ORAL 0.1 g Warfarin C ORAL 1.5 mg Gaster C ORAL 20 mg 22-Feb-2006 08:31 AM Page: 1310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/05ISR Number: 4687917-8Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-A0561911A Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asterixis Paxil PS Glaxosmithkline 60MG Per day Gait Disturbance Asa SS Glaxosmithkline Overdose Quetiapine SS 700MG Per day Respiratory Alkalosis Amitriptyline C 25MG Per day Tremor Amoxicillin C Glaxosmithkline Citalopram C 20MG Twice per day Clonazepam C Naproxen C Omeprazole C Glaxosmithkline Oxazepam C 30MG Per day Starnoc C 7.5MG Per day Thyroid C Date:06/10/05ISR Number: 4688015-XReport Type:Expedited (15-DaCompany Report #2005UW08741 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Pharmaceutical ORAL Date:06/10/05ISR Number: 4688018-5Report Type:Expedited (15-DaCompany Report #2005UW08423 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Seroquel PS Zeneca Crying Pharmaceutical ORAL Depression Wellbutrin Xl SS ORAL Intentional Self-Injury Risperdal C Laceration Klonopin C Poisoning Paxil C ORAL 9 YR Psychotic Disorder Suicide Attempt Date:06/10/05ISR Number: 4688662-5Report Type:Direct Company Report #CTU 250897 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Weight Increased Quetiapine 300 Mg Intervention to Astra PS Astra ORAL 600 MG DAILY Prevent Permanent ORAL Impairment/Damage Lac Hydrin C Celexa C Risperidone C Urea 20% Cream C Date:06/13/05ISR Number: 4689128-9Report Type:Expedited (15-DaCompany Report #2005AP03162 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Seroquel PS Zeneca Initial or Prolonged Menstrual Disorder Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakene-R SS ORAL Benzodiazepine C ORAL Rivotril C ORAL Date:06/13/05ISR Number: 4689130-7Report Type:Expedited (15-DaCompany Report #2005AP02538 Age:26460 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocyte Count Seroquel PS Zeneca Initial or Prolonged Decreased Pharmaceutical ORAL 12 DAY Other Infection Seroquel SS Zeneca Platelet Count Decreased Pharmaceutical ORAL 12 DAY Pyrexia Cravit SS ORAL 13 DAY Rash Cefozopran Urticaria Hydrochloride SS INTRAVENOUS White Blood Cell Count Madopar C ORAL Decreased Depas C ORAL Magnesium Oxide C ORAL Date:06/13/05ISR Number: 4689135-6Report Type:Expedited (15-DaCompany Report #2004UW01147 Age:5275 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Beta Haemolytic Seroquel PS Zeneca Initial or Prolonged Streptococcal Infection Pharmaceutical ORAL 11 MON Other Bronchitis Acute Seroquel SS Zeneca Dehydration Pharmaceutical ORAL 11 MON Dermatitis Contact Seroquel SS Zeneca Diabetes Mellitus Pharmaceutical ORAL 11 MON Insulin-Dependent Seroquel SS Zeneca Diabetic Ketoacidosis Pharmaceutical ORAL HALF TAB IN Hyperglycaemia AM, 1 TAB IN Hypokalaemia PM 6 MON Infectious Mononucleosis Seroquel SS Zeneca Influenza Like Illness Pharmaceutical ORAL HALF TAB IN Ketonuria AM, 1 TAB IN Malaise PM 6 MON Pharyngitis Seroquel SS Zeneca Pyrexia Pharmaceutical ORAL HALF TAB IN Self Injurious Behaviour AM, 1 TAB IN Sinusitis PM 6 MON Somnolence Seroquel SS Zeneca Tachycardia Pharmaceutical ORAL 25 MG IN AM, Urinary Tract Infection 50 MG IN PM 4 MON Vaginitis Bacterial Seroquel SS Zeneca Vomiting Pharmaceutical ORAL 25 MG IN AM, Weight Increased 50 MG IN PM 4 MON Seroquel SS Zeneca Pharmaceutical ORAL 25 MG IN AM, 50 MG IN PM 4 MON Celexa C Celexa C Celexa C Remeron C 22-Feb-2006 08:31 AM Page: 1312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/05ISR Number: 4689151-4Report Type:Expedited (15-DaCompany Report #2005UW05585 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Seroquel PS Zeneca Antipsychotic Drug Level Pharmaceutical ORAL LOW DOSE Above Therapeutic Seroquel SS Zeneca Apnoea Pharmaceutical ORAL 300 QAM, 500 Cardiac Arrest QHS Constipation Depakote C ORAL Drug Ineffective Lithium C ORAL Drug Toxicity Ativan C ORAL Fall Abilify C ORAL Loss Of Consciousness Klonopin C Pulse Absent Respiratory Arrest Ventricular Extrasystoles Vomiting Date:06/13/05ISR Number: 4689160-5Report Type:Expedited (15-DaCompany Report #2005UW04842 Age:23510 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Seroquel PS Zeneca Hospitalization - Atrioventricular Block Pharmaceutical ORAL Initial or Prolonged Complete Doxepin SS ORAL Other Atrioventricular Block Digoxin SS ORAL First Degree Nxy-059 Code Not Atrioventricular Block Broken SS INTRAVENOUS LOADING DOSE 67 MIN Second Degree Nxy-059 Code Not Atrophy Broken SS INTRAVENOUS MAINTENANCE Cerebral Artery Stenosis DOSE 4253 MIN Cerebral Infarction Tpa C 60 MIN Diverticular Perforation Lipitor C ORAL Electrocardiogram Qt Coumadin C ORAL Prolonged Zestril C ORAL Peritonitis Keflex C ORAL Date:06/13/05ISR Number: 4689162-9Report Type:Expedited (15-DaCompany Report #2005UW05775 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Seroquel PS Zeneca Initial or Prolonged Aggression Pharmaceutical ORAL TITRATED TO Other Agitation 300 MG IN THE Tardive Dyskinesia EVENING, 200 MG IN THE MORNING AND 11 MON Seroquel SS Zeneca Pharmaceutical ORAL TITRATED TO 300 MG IN THE EVENING, 200 MG IN THE MORNING AND 11 MON Seroquel SS Zeneca Pharmaceutical ORAL TITRATED DOWN 1 MON Seroquel SS Zeneca Pharmaceutical ORAL TITRATED DOWN 1 MON Seroquel SS Zeneca Pharmaceutical ORAL TITRATED UP 22-Feb-2006 08:31 AM Page: 1313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS Zeneca Pharmaceutical ORAL TITRATED UP Seroquel SS Zeneca Pharmaceutical ORAL TITRATED DOWN Seroquel SS Zeneca Pharmaceutical ORAL TITRATED DOWN Vitamins C Stool Softener C Prilosec C ORAL Date:06/13/05ISR Number: 4689164-2Report Type:Expedited (15-DaCompany Report #2005UW08563 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Potentiation Pharmaceutical ORAL Pancytopenia Combivir I Depakote I Date:06/13/05ISR Number: 4689165-4Report Type:Expedited (15-DaCompany Report #2005UW08430 Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Seroquel PS Zeneca Pharmaceutical ORAL Levodopa SS ORAL Date:06/13/05ISR Number: 4689167-8Report Type:Expedited (15-DaCompany Report #2005UW08656 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ill-Defined Disorder Seroquel PS Zeneca Initial or Prolonged Weight Increased Pharmaceutical ORAL Risperdal C Blood Pressure Medication C Insulin C Stelazine C Zoloft C Date:06/13/05ISR Number: 4689170-8Report Type:Expedited (15-DaCompany Report #2005UW07087 Age:63 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Balance Disorder Blood Chloride Decreased Blood Creatinine Increased Blood Sodium Decreased Blood Urea Increased Depressed Level Of Consciousness Difficulty In Walking Dizziness Dyspnoea Exertional Fall 22-Feb-2006 08:31 AM Page: 1314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haematocrit Decreased Haemoglobin Decreased Hypertension Report Source Product Role Manufacturer Route Dose Duration Hypotension Seroquel PS Zeneca Hypothermia Pharmaceutical ORAL 492 DAY Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Haldol C INTRAMUSCULAR EVERY 28 DAYS Haldol C INTRAMUSCULAR Trileptal C ORAL 300 MG AM; 600 MG PM Enalapril C ORAL 342 DAY Hctz C ORAL 342 DAY Aspirin C ORAL Lipitor C ORAL Trazodone C Clonazepam C Cogentin C Geodon C INTRAMUSCULAR Vistaril C ORAL Ativan C INTRAMUSCULAR Date:06/13/05ISR Number: 4689174-5Report Type:Expedited (15-DaCompany Report #2005UW08489 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Seroquel PS Zeneca Initial or Prolonged Overdose Pharmaceutical ORAL Rhabdomyolysis Seroquel SS Zeneca Pharmaceutical ORAL 3000 - 4000 MG Date:06/13/05ISR Number: 4689807-3Report Type:Direct Company Report #CTU 251046 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Incorrect Dose Neurontin Disability Administered Pfizer PS Pfizer Suicide Attempt Seroquel Astra Senteca SS Astra Senteca Date:06/14/05ISR Number: 4690864-9Report Type:Direct Company Report #CTU 251127 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Seroquel PS 700MG TOTAL Initial or Prolonged Extrapyramidal Disorder DAILY DOSE Renal Failure Risperdal SS 6 MG TOTAL DAILY DOSE Zoloft C Hydrochlorothiazide C Clonidine C 22-Feb-2006 08:31 AM Page: 1315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/05ISR Number: 4691913-4Report Type:Direct Company Report #CTU 251160 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Seroquel PS Somnolence Date:06/15/05ISR Number: 4690416-0Report Type:Expedited (15-DaCompany Report #2005PK01009 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Seroquel PS Zeneca Anxiety Pharmaceutical ORAL Blood Pressure Zoloft SS ORAL 8 DAY Fluctuation Zoloft SS ORAL 9 DAY Delusion Zoloft SS ORAL 26 DAY Excitability Temesta C ORAL 1 DAY Loss Of Consciousness Temesta C ORAL 4 DAY Psychotic Disorder Temesta C ORAL 2 DAY Serotonin Syndrome Temesta C ORAL 1 DAY Temesta C ORAL 5 DAY Temesta C ORAL 1 DAY Temesta C ORAL 4 DAY Temesta C ORAL 2 DAY Temesta C ORAL 4 DAY Tenoretic C Eltroxin C ORAL Date:06/15/05ISR Number: 4690421-4Report Type:Expedited (15-DaCompany Report #2005UW08382 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Headache Pharmaceutical ORAL Lithium I Date:06/15/05ISR Number: 4690440-8Report Type:Expedited (15-DaCompany Report #2005UW07169 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Seroquel PS Zeneca Hospitalization - Somnolence Pharmaceutical 25 MG QAM, 25 Initial or Prolonged MG NOON, 50 MG HS 35 MON Seroquel SS Zeneca Pharmaceutical 25 MG QAM, 25 MG NOON, 50 MG HS 35 MON Date:06/15/05ISR Number: 4690454-8Report Type:Expedited (15-DaCompany Report #2005SE03402 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Pharmaceutical ORAL Remeron SS Stilnoct SS 22-Feb-2006 08:31 AM Page: 1316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/05ISR Number: 4690466-4Report Type:Expedited (15-DaCompany Report #2005AP02878 Age:22481 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Seroquel PS Zeneca Hospitalization - Pyrexia Pharmaceutical ORAL 66 DAY Initial or Prolonged Contmin C ORAL DIVIDED INTO Other 4 DOSES, COMMENCED BEFORE 2004 Gramalil C ORAL COMMENCED BEFORE 2004 Lithium Carbonate C COMMENCED BEFORE 2004 Wypax C ORAL DIVIDED INTO 4 DOSES, COMMENCED BEFORE 2004 Akineton C ORAL DIVIDED INTO 4 DOSES, COMMENCED BEFORE 2004 Brotizolam C ORAL COMMENCED BEFORE 2004 Sennoside C ORAL COMMENCED BEFORE 2004 Date:06/15/05ISR Number: 4690602-XReport Type:Expedited (15-DaCompany Report #JP-SOLVAY-00305001218 Age:26015 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Depromel 25 PS ORAL Daily dose: Hospitalization - Neuroleptic Malignant 150 Initial or Prolonged Syndrome milligram(s) 1 YR Pneumonia Depromel 25 SS ORAL Daily dose: Respiratory Failure 50 Tachycardia milligram(s) 14 DAY Sediel SS ORAL Daily dose: 20 milligram(s) Symmetrel SS ORAL Daily dose: 150 milligram(s) Depromel 25 I ORAL Daily dose: 100 milligram(s) 8 DAY Seroquel I ORAL Daily dose: 200 milligram(s) 2 MON Date:06/15/05ISR Number: 4690641-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0562394A Age: Gender:Female I/FU:I Outcome PT Disability Arthralgia Arthritis Drug Interaction Joint Swelling Monarthritis Movement Disorder 22-Feb-2006 08:31 AM Page: 1317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Photophobia Report Source Product Role Manufacturer Route Dose Duration Lamictal PS Glaxosmithkline ORAL 4 MON Seroquel SS ORAL 100MG At night 1 YR Synthroid C Glaxosmithkline Rocaltrol C Aleve C Ibuprofen C Glaxosmithkline Date:06/15/05ISR Number: 4691047-9Report Type:Expedited (15-DaCompany Report #2005UW08999 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Pulmicort PS RESPIRATORY (INHALATION) Seroquel SS Zeneca Pharmaceutical ORAL Date:06/15/05ISR Number: 4691050-9Report Type:Expedited (15-DaCompany Report #2005UW06918 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Seroquel PS Zeneca Diabetes Mellitus Pharmaceutical ORAL 15 MON Increased Appetite Seroquel SS Zeneca Musculoskeletal Disorder Pharmaceutical ORAL 15 MON Weight Increased Seroquel SS Zeneca Pharmaceutical ORAL 50-75 MG Seroquel SS Zeneca Pharmaceutical ORAL 50-75 MG Glucophage SS Serax C ORAL Prilosec C ORAL Paxil C ORAL Date:06/15/05ISR Number: 4691051-0Report Type:Expedited (15-DaCompany Report #2005UW08704 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Seroquel PS Zeneca Nasopharyngeal Disorder Pharmaceutical ORAL Paralysis Seroquel SS Zeneca Pharmaceutical ORAL Ambien C Bipolar Disorder Medicine C Date:06/15/05ISR Number: 4691863-3Report Type:Direct Company Report #CTU 251232 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Seroquel PS 50 MG TID 200 Initial or Prolonged Overdose MG HS 22-Feb-2006 08:31 AM Page: 1318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/05ISR Number: 4692003-7Report Type:Direct Company Report #CTU 251369 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Prescribing Error Seroquel PS 1000 MG DAY Date:06/16/05ISR Number: 4693622-4Report Type:Expedited (15-DaCompany Report #141651USA Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Condition Aggravated Health Pimozide PS ORAL 100 MILLIGRAM 87 DAY Dystonia Professional Zotepine SS Gait Disturbance Quetiapine SS 1 MON Date:06/16/05ISR Number: 4695747-6Report Type:Direct Company Report #CTU 251300 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hallucinations, Mixed Seroquel PS 612 MGS Disability Benztropine SS Haloperidol SS Date:06/17/05ISR Number: 4692537-5Report Type:Expedited (15-DaCompany Report #2005AC00536 Age:22363 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Sediel PS Hospitalization - Aspiration Symmetrel SS Initial or Prolonged Depressed Mood Quetiapine I Zeneca Drug Interaction Pharmaceutical ORAL Extrapyramidal Disorder Quetiapine I Zeneca Irritability Pharmaceutical ORAL Jaundice Quetiapine I Zeneca Neuroleptic Malignant Pharmaceutical ORAL Syndrome Depromel I ORAL 1 WK Pneumonia Depromel I ORAL 1 WK Respiratory Failure Depromel I ORAL Depromel I ORAL Date:06/17/05ISR Number: 4692781-7Report Type:Expedited (15-DaCompany Report #2005AC00875 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Quetiapine PS Zeneca Drug Toxicity Pharmaceutical ORAL Fluvoxamine SS Date:06/17/05ISR Number: 4692807-0Report Type:Expedited (15-DaCompany Report #2005AC00870 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Drug Toxicity Pharmaceutical ORAL Ibuprofen SS Tricyclic Antidepressants SS Verapamil SS 22-Feb-2006 08:31 AM Page: 1319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/05ISR Number: 4692815-XReport Type:Expedited (15-DaCompany Report #2005AC00871 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Drug Toxicity Pharmaceutical ORAL Diazepam SS Cyclobenzaprine SS Fluoxetine SS Tramadol SS Norfluoxetine C Date:06/17/05ISR Number: 4692816-1Report Type:Expedited (15-DaCompany Report #2005AC00876 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Quetiapine PS Zeneca Drug Toxicity Pharmaceutical ORAL Carbamazepine C Loxapine C Date:06/17/05ISR Number: 4692825-2Report Type:Expedited (15-DaCompany Report #2005UW07559 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Seroquel PS Zeneca Self-Injurious Ideation Pharmaceutical ORAL Weight Decreased Methadone SS Xanax SS Percoset SS Illegal Drugs SS Crack C All Kinds Of Drugs C Date:06/17/05ISR Number: 4692828-8Report Type:Expedited (15-DaCompany Report #2005UW09046 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Pneumonia Pharmaceutical ORAL Date:06/17/05ISR Number: 4692844-6Report Type:Expedited (15-DaCompany Report #2005AC00873 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Drug Toxicity Pharmaceutical ORAL Diphenhydramine SS Paroxetine SS Date:06/17/05ISR Number: 4692848-3Report Type:Expedited (15-DaCompany Report #2005AC00860 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Quetiapine PS Zeneca Drug Toxicity Pharmaceutical ORAL Haloperidol C 22-Feb-2006 08:31 AM Page: 1320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/05ISR Number: 4692850-1Report Type:Expedited (15-DaCompany Report #2005UW08505 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL Depakote C Wellbutrin Xl C Synthroid C Lithium C Date:06/17/05ISR Number: 4693657-1Report Type:Expedited (15-DaCompany Report #2005GB01096 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Quetiapine PS Zeneca White Blood Cell Count Pharmaceutical ORAL 61 DAY Decreased Sodium Valproate C ORAL Ranitidine C ORAL Omeprazole C ORAL Lorazepam C ORAL Date:06/17/05ISR Number: 4693659-5Report Type:Expedited (15-DaCompany Report #2005AP02801 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL 674 DAY Epilim C Oxazepam C Oxazepam C Date:06/17/05ISR Number: 4693660-1Report Type:Expedited (15-DaCompany Report #2005UW07487 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Malabsorption Pharmaceutical ORAL 11 MON Prothrombin Time Diflucan C Prolonged Tracleer C Levbid C Spironolactone C Prednisone C Novolog Insulin 70/30 C SUBCUTANEOUS 30 U IN AM + 20 U AT NIGHT Micro-K C Lexapro C Percocet C Albuterol C RESPIRATORY (INHALATION) Singulair C Advair 250/50 C RESPIRATORY (INHALATION) Zyrtec C Flonase C NASAL Prilosec C Topamax C Iron C 22-Feb-2006 08:31 AM Page: 1321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel I Zeneca Pharmaceutical ORAL 11 MON Seroquel I Zeneca Pharmaceutical ORAL 3 MON Seroquel I Zeneca Pharmaceutical ORAL 3 MON Seroquel I Zeneca Pharmaceutical ORAL 50 MG AM, 50 MG @ 4PM, 600 MG AT NIGHT Seroquel I Zeneca Pharmaceutical ORAL 50 MG AM, 50 MG @ 4PM, 600 MG AT NIGHT Coumadin I ORAL Date:06/17/05ISR Number: 4693675-3Report Type:Expedited (15-DaCompany Report #2005UW08788 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Seroquel PS Zeneca Initial or Prolonged Convulsion Pharmaceutical ORAL TITRATED TO Hepatic Pain 800 MG/DAY, Liver Function Test THEN REDUCED Abnormal TO 200MG/DAY 2 WK Nausea Norvasc C ORAL Nephrolithiasis Toprol C ORAL Pyrexia Hydrochlorothiazide C ORAL Xanax C ORAL Date:06/17/05ISR Number: 4694939-XReport Type:Expedited (15-DaCompany Report #DSA_26557_2005 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Temesta PS 5 MG Q DAY Initial or Prolonged Haemorrhage Health Temesta SS 7.5 MG Q DAY Other Head Injury Professional Temesta SS 3.75 MG Q DAY Loss Of Consciousness Other Temesta SS 2.5 MG Q DAY Seroquel SS 100 MG Q DAY Seroquel SS 50 MG DAILY Depakine Crono SS 1000 MG DAILY Dominal Forte SS 160 MG DAILY Dominal Forte SS 120 MG DAILY Dominal Forte SS 80 MG DAILY Exiba C Date:06/20/05ISR Number: 4694796-1Report Type:Expedited (15-DaCompany Report #2005AP02414 Age:23010 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 8 DAY 22-Feb-2006 08:31 AM Page: 1322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Seroquel SS Zeneca Pharmaceutical ORAL 34 DAY Seroquel SS Zeneca Pharmaceutical ORAL 5 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Tasmolin SS ORAL 104 DAY Tasmolin SS ORAL DIVIDED INTO 3 DOSES 1 DAY Tasmolin SS ORAL DIVIDED INTO 2 DOSES Serenace C ORAL 5-20 MG DAILY 61 DAY Serenace C ORAL DIVIDED INTO 3 DOSES 2 DAY Serenace C ORAL 13 DAY Serenace C ORAL DIVIDED INTO 3 DOSES 8 DAY Serenace C ORAL 8 DAY Serenace C ORAL DIVIDED INTO 3 DOSES 8 DAY Serenace C ORAL 7 DAY Serenace C ORAL DIVIDED INTO 2 DOSES 8 DAY Serenace C ORAL DIVIDED INTO 2 DOSES 8 DAY Akineton C ORAL 6-3 MG DAILY Levotomin C ORAL Halcion C ORAL Laxoberon C ORAL Diovan C ORAL Date:06/20/05ISR Number: 4694830-9Report Type:Expedited (15-DaCompany Report #2005AP02913 Age:30640 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Seroquel PS Zeneca Hospitalization - Central Venous Pressure Pharmaceutical ORAL 13 DAY Initial or Prolonged Decreased Myslee SS ORAL 13 DAY Hepatitis Blopress SS Astrazeneca Sepsis Pharmaceuticals ORAL 13 DAY Staphylococcal Infection Loxonin SS ORAL 6 DAY Mobic SS ORAL 6 DAY Novastan SS INTRAVENOUS DRIP 8 DAY Aspirin C ORAL Aspirin C ORAL Warfarin C ORAL Gaster C ORAL Lanirapid C ORAL HALF A TABLET Itorol C ORAL Lasix C ORAL 22-Feb-2006 08:31 AM Page: 1323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/05ISR Number: 4694838-3Report Type:Expedited (15-DaCompany Report #2005GB01084 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Pharmaceutical ORAL 10 DAY Date:06/20/05ISR Number: 4694840-1Report Type:Expedited (15-DaCompany Report #2005SE02664 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL 1 YR Seroquel SS Zeneca Pharmaceutical ORAL 400 MG + 500 MG DAILY Seroquel SS Zeneca Pharmaceutical ORAL 200MG + 300MG Risperdal C ORAL Orsanil Ret C 50 MG + 200 MG DAILY Date:06/20/05ISR Number: 4696116-5Report Type:Expedited (15-DaCompany Report #DSA_26567_2005 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Temesta PS 0.5 MG Q DAY Increased Health Temesta SS 1 MG Q DAY Aspartate Professional Temesta SS 1.5 MG Q DAY Aminotransferase Other Temesta SS 2 MG Q DAY Increased Temesta SS 1.5 MG Q DAY Blood Alkaline Temesta SS 1 MG Q DAY Phosphatase Increased Seroquel SS 800 MG Q DAY Gamma-Glutamyltransferase Seroquel SS 700 MG Q DAY Increased Seroquel SS 600 MG Q DAY Glutamate Dehydrogenase Seroquel SS 400 MG Q DAY Increased Seroquel SS 300 MG Q DAY Seroquel SS 200 MG Q DAY Seroquel SS 10 MG Q DAY Dominal C Date:06/21/05ISR Number: 4695915-3Report Type:Expedited (15-DaCompany Report #2005AC00874 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Drug Toxicity Pharmaceutical ORAL Date:06/21/05ISR Number: 4695925-6Report Type:Expedited (15-DaCompany Report #2005AP03278 Age:28760 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Seroquel PS Zeneca Consciousness Pharmaceutical ORAL 1 DAY Glossoptosis Pam C INTRAVENOUS DRIP 1 DAY Atropine Sulfate C INTRAVENOUS 2 DAY Propofol C INTRAVENOUS 22-Feb-2006 08:31 AM Page: 1324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DRIP 2 DAY Date:06/21/05ISR Number: 4695946-3Report Type:Expedited (15-DaCompany Report #PHBS2005JP04451 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Tegretol PS Novartis Sector: Akathisia Pharma ORAL 900 mg/day Anxiety Tegretol SS Novartis Sector: Complex Partial Seizures Pharma ORAL 1000 mg/day Drug Interaction Tegretol SS Novartis Sector: Drug Level Decreased Pharma ORAL 800 mg/day Irritability Quetiapine SS ORAL 25 mg/day Lactation Disorder Quetiapine SS ORAL 50 mg/day Psychotic Disorder Sulpiride SS 150 mg/day Self-Injurious Ideation Date:06/21/05ISR Number: 4695953-0Report Type:Expedited (15-DaCompany Report #PHBS2005JP04450 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Tegretol PS Novartis Sector: Delusion Pharma ORAL 400 mg/day Drug Interaction Tegretol SS Novartis Sector: Drug Level Decreased Pharma ORAL 500 mg/day Hallucination, Auditory Quetiapine Fumarate SS ORAL 50 mg/day Psychotic Disorder Quetiapine Fumarate SS ORAL 25 mg/day Date:06/21/05ISR Number: 4696224-9Report Type:Expedited (15-DaCompany Report #2005UW09153 Age:17884 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticoagulation Drug Quetiapine PS Zeneca Initial or Prolonged Level Below Therapeutic Pharmaceutical ORAL 97 DAY Blood Glucose Increased Quetiapine SS Zeneca Disease Recurrence Pharmaceutical ORAL 97 DAY Drug Ineffective Coumadin C Dyspnoea Coumadin C Haematocrit Decreased Hydrochlorothiazide C Haemoglobin Decreased Hypertension International Normalised Ratio Decreased Psychotic Disorder Pulmonary Embolism Red Blood Cell Count Decreased Refusal Of Treatment By Patient Schizophrenia Date:06/21/05ISR Number: 4696226-2Report Type:Expedited (15-DaCompany Report #2005UW09228 Age:78 YR Gender:Male I/FU:I Outcome PT Death Cerebrovascular Accident Communication Disorder Gastrointestinal Tube 22-Feb-2006 08:31 AM Page: 1325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insertion General Physical Health Deterioration Pneumonia Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Seroquel PS Zeneca Pharmaceutical ORAL 262.5 MG AM; 337.5 MG PM Seroquel SS Zeneca Pharmaceutical ORAL 262.5 MG AM; 337.5 MG PM Seroquel SS Zeneca Pharmaceutical ORAL 187.5 MG AM; 225 MG PM Seroquel SS Zeneca Pharmaceutical ORAL 187.5 MG AM; 225 MG PM Vioxx C ORAL Glyburide C Adalat C Losec C Bextra C Date:06/21/05ISR Number: 4696227-4Report Type:Expedited (15-DaCompany Report #2005UW09207 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Seroquel PS Zeneca Initial or Prolonged Medication Error Pharmaceutical ORAL Date:06/21/05ISR Number: 4696235-3Report Type:Expedited (15-DaCompany Report #2005UW09025 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Seroquel PS Zeneca Tooth Injury Pharmaceutical ORAL Date:06/22/05ISR Number: 4697274-9Report Type:Expedited (15-DaCompany Report #2005UW09308 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Seroquel PS Zeneca Heart Rate Increased Pharmaceutical ORAL Mydriasis Dexclorfeniramine Somnolence Maleate C Suicide Attempt Clonazepam C Fluvoxamine C Sertraline C Date:06/22/05ISR Number: 4697277-4Report Type:Expedited (15-DaCompany Report #2005UW09294 Age:92 YR Gender:Male I/FU:I Outcome PT Death Hypotension Hospitalization - Oedema Peripheral Initial or Prolonged Pneumonia Pneumonia Aspiration Sepsis Swelling Face 22-Feb-2006 08:31 AM Page: 1326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL 1 MON Seroquel SS Zeneca Pharmaceutical ORAL 1 MON Date:06/22/05ISR Number: 4697278-6Report Type:Expedited (15-DaCompany Report #2005UW09205 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Seroquel PS Zeneca Initial or Prolonged Pulse Absent Pharmaceutical ORAL Syncope Seroquel SS Zeneca Pharmaceutical ORAL Prozac C ORAL Date:06/22/05ISR Number: 4698499-9Report Type:Expedited (15-DaCompany Report #2005088294 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Consumer Zoloft (Sertraline) PS ORAL 75 MG (1 D) Agitation ORAL Alcohol Use Seroquel (Quetiapine Bipolar Disorder Fumarate) SS ORAL ORAL Caesarean Section All Other Depression Therapeutic Products C Drug Exposure During Synthroid Pregnancy (Levothyroxine Feeling Abnormal Sodium) C Hallucination, Auditory Ortho Evra Hyperphagia (Ethinylestradiol Hypersomnia Norelgestromin) C Intentional Self-Injury Laceration Mood Swings Pregnancy Premature Labour Psychomotor Hyperactivity Suicidal Ideation Suicide Attempt Weight Decreased Weight Increased Date:06/22/05ISR Number: 4698948-6Report Type:Direct Company Report #CTU 251703 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Exfoliation Seroquel 300mg PS ORAL 300MG PO IN Sunburn EVENING SEE IMAGE 22-Feb-2006 08:31 AM Page: 1327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/05ISR Number: 4698211-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050603246 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Haloperidol PS UNKNOWN Depression Risperdal Consta SS INTRAMUSCULAR Seroquel SS Solian SS Cipralex SS OROPHARINGEAL Start date = End of APR-2005 Date:06/23/05ISR Number: 4699137-1Report Type:Direct Company Report #CTU 251799 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Seroquel 100 Mg Astra /Zeneca PS Astra /Zeneca BUCCAL 100 MG /HS PO BUCCAL Seroquel 25 Mg Astra /Zeneca SS Astra /Zeneca BUCCAL 50 MG/HS PO BUCCAL Prozac C Date:06/23/05ISR Number: 4699749-5Report Type:Expedited (15-DaCompany Report #2005UW09308 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Increased Foreign Seroquel PS Intervention to Heart Rate Increased Health No Match C Prevent Permanent Mydriasis Professional Clonazepam C Impairment/Damage Somnolence Fluvoxamine C Suicide Attempt Sertraline C Date:06/23/05ISR Number: 4699791-4Report Type:Expedited (15-DaCompany Report #2005UW09205 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Health Seroquel PS ORAL 500 MG PO Initial or Prolonged Imprisonment Professional Seroquel SS ORAL 100 MG PO Overdose Prozac C Pulse Absent Syncope Date:06/23/05ISR Number: 4699820-8Report Type:Expedited (15-DaCompany Report #2005089492 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Attention Initial or Prolonged Deficit/Hyperactivity Other Disorder Back Disorder Back Pain Blood Cholesterol Increased Fall Heart Rate Increased Hypertension 22-Feb-2006 08:31 AM Page: 1328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Migraine Post Procedural Complication Report Source Product Role Manufacturer Route Dose Duration Surgery Consumer Lipitor Weight Increased (Atorvastatin) PS ORAL ORAL Neurontin (Gabapentin) SS ORAL 1200 MG (600 MG, 2 IN 1 D),ORAL Zoloft (Sertraline) SS ORAL 100 MG (100 MG, 1 IN 1 D), ORAL Seroquel (Quetiapine Fumarate) SS ORAL ORAL Ambien (Zolpidem Tartrate) C Nexium (Esomeprazole) C Date:06/24/05ISR Number: 4699558-7Report Type:Expedited (15-DaCompany Report #2005UW09331 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Fluctuation Seroquel PS Zeneca Initial or Prolonged Blood Prolactin Increased Pharmaceutical ORAL 75 MG QAM, 75 Depression MG @ 1600, Lactation Disorder 100 MG HS 1 YR Weight Increased Lithium SS Mellaril C Effexor Xr C Clonazepam C Ativan C Lopressor C Pariet C Pariet C Date:06/24/05ISR Number: 4699572-1Report Type:Expedited (15-DaCompany Report #2005PK01090 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Seroquel PS Zeneca Initial or Prolonged Myopathy Pharmaceutical ORAL 50 TABLETS Overdose Rhabdomyolysis Suicide Attempt Date:06/24/05ISR Number: 4699575-7Report Type:Expedited (15-DaCompany Report #2005AP03291 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/05ISR Number: 4699576-9Report Type:Expedited (15-DaCompany Report #2005UW03034 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Seroquel PS Zeneca Increased Pharmaceutical OTHER Aspartate Dilantin C Aminotransferase Haldol C Increased Ativan C OTHER Blood Alkaline Ultracal C OTHER DOSAGE - Phosphatase Increased VARIES Hepatic Enzyme Abnormal Date:06/24/05ISR Number: 4699579-4Report Type:Expedited (15-DaCompany Report #2005AP03297 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Granulocyte Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Date:06/24/05ISR Number: 4700175-0Report Type:Direct Company Report #CTU 251906 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Seroquel 600 Down Disability Dyskinesia To 300 Congenital Anomaly Thinking Abnormal Astrazeneca PS Astrazeneca ORAL 400 1 AT Weight Increased NIGHT ORAL Date:06/24/05ISR Number: 4700991-5Report Type:Expedited (15-DaCompany Report #2005AC00871 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Drug Toxicity Health Diazepam SS Intentional Misuse Professional Cyclobenzaprine SS Multiple Drug Overdose Fluoxetine SS Tramadol SS Date:06/24/05ISR Number: 4700993-9Report Type:Expedited (15-DaCompany Report #2005AC00860 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Literature Quetiapine PS Drug Toxicity Health Haloperidol C Professional Date:06/24/05ISR Number: 4701216-7Report Type:Expedited (15-DaCompany Report #2005SE03517 Age:26 YR Gender:Male I/FU:I Outcome PT Disability Akathisia Delusion Extrapyramidal Disorder Hallucination 22-Feb-2006 08:31 AM Page: 1330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Musculoskeletal Stiffness Psychotic Disorder Restlessness Report Source Product Role Manufacturer Route Dose Duration Tremor Foreign Quetiapine PS ORAL 300 MG DAILY Study PO Health Quetiapine SS ORAL 600 MG DAILY Professional PO Other Risperidone C Fluoxetine C Date:06/27/05ISR Number: 4700482-1Report Type:Expedited (15-DaCompany Report #2005PK01069 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Cardiac Death Seroquel PS Zeneca Sudden Death Pharmaceutical ORAL 1 TO 4 TABLETS PER DAY Date:06/27/05ISR Number: 4701903-0Report Type:Expedited (15-DaCompany Report #2004244052US Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Consumer Bextra (Valdecoxib) PS Apathy Albuterol Arthralgia (Salbutamol) SS RESPIRATORY Balance Disorder (INHALATION) INHALATION Coordination Abnormal Seroquel (Quetiapine Dizziness Fumarate0 SS Fall Cortisone Fear (Cortisone) SS Feeling Abnormal Heart Rate Increased Loss Of Control Of Legs Medication Error Memory Impairment Pneumonia Pneumonia Primary Atypical Polydipsia Throat Tightness Date:06/28/05ISR Number: 4701563-9Report Type:Expedited (15-DaCompany Report #2005PK01089 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Seroquel PS Zeneca Hospitalization - Escherichia Sepsis Pharmaceutical ORAL 11 DAY Initial or Prolonged General Physical Health Leponex SS ORAL 0-37,5 MG 11 DAY Deterioration Leponex SS ORAL 4 DAY Leponex SS ORAL 3 DAY Leponex SS ORAL 7 DAY Leponex SS ORAL 16 DAY Remergil C ORAL Cipralex C ORAL 24 DAY Madopar C ORAL Alna C 22-Feb-2006 08:31 AM Page: 1331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/05ISR Number: 4701571-8Report Type:Expedited (15-DaCompany Report #2005AP03296 Age:12401 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Seroquel PS Zeneca Neutrophil Percentage Pharmaceutical ORAL 649 DAY Decreased Gaster SS ORAL 716 DAY White Blood Cell Count Luvox SS ORAL 631 DAY Decreased Evamyl SS ORAL 743 DAY Constan C ORAL 719 DAY Lendormin C ORAL Dogmatyl C ORAL 673 DAY Date:06/28/05ISR Number: 4701573-1Report Type:Expedited (15-DaCompany Report #2005AP02506 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Gramalil SS ORAL Date:06/28/05ISR Number: 4703027-5Report Type:Direct Company Report #CTU 252097 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucinations, Mixed Paxil 40 Mgs 1 PS Malaise Seroquel 100 Mg SS TWICE Weight Increased Date:06/29/05ISR Number: 4703181-5Report Type:Expedited (15-DaCompany Report #2005PK01069 Age:12988 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Cardiac Death Seroquel PS Zeneca Sudden Death Pharmaceutical ORAL 1 TO 4 TABLETS PER DAY 37 DAY Date:06/29/05ISR Number: 4703182-7Report Type:Expedited (15-DaCompany Report #2005UW09441 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Arthralgia Seroquel PS Zeneca Arthritis Pharmaceutical ORAL Drug Interaction Thyroxine C Joint Swelling Calcitriol C Monarthritis Naproxen Sodium C Movement Disorder Ibuprofen C Photophobia Lamictal I ORAL 4 MON Lamictal I ORAL Date:06/29/05ISR Number: 4703183-9Report Type:Expedited (15-DaCompany Report #2005UW09324 Age:58 YR Gender:Female I/FU:I Outcome PT Hospitalization - Diabetes Mellitus Initial or Prolonged Infection 22-Feb-2006 08:31 AM Page: 1332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ketoacidosis Weight Increased Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL Date:06/29/05ISR Number: 4703185-2Report Type:Expedited (15-DaCompany Report #2005PK01103 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Erectile Dysfunction Pharmaceutical ORAL 5 DAY Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Seroquel SS Zeneca Pharmaceutical ORAL 22 DAY Seroquel SS Zeneca Pharmaceutical ORAL 13 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL Abilify SS ORAL 39 DAY Abilify SS ORAL Date:06/29/05ISR Number: 4705365-9Report Type:Expedited (15-DaCompany Report #23100223 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Novastan PS INTRAVENOUS 60 MG QD IV Depressed Level Of Health Radicut (Edaravone) SS INTRAVENOUS 30 MG BID IV Consciousness Professional Blopress Jaundice Other (Candesartan Liver Disorder Cilexetil) SS Pneumonia Myslee (Zolpidem Respiratory Arrest Tartrate) SS Skin Inflammation Mobic (Meloxicam) SS Seroquel (Quetiapine Fumarate) SS ORAL 25 MG QD PO Lenoxin SS ORAL 60 MG BID PO Glucose C Solita-T No. 3 C Lanirapid C Itorol C Acetylsalicylic Acid C Warfarin C Gaster D (Famotidine) C Lasix C Date:06/29/05ISR Number: 4705661-5Report Type:Expedited (15-DaCompany Report #MAG-2005-0000365 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other International Normalised Foreign Theophylline 200 Ratio Increased Health Mg(Theophylline) Cr Professional Tablet PS ORAL 200 MG, Other DAILY, ORAL 22-Feb-2006 08:31 AM Page: 1333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Warfarin Potassium (Warfarin Potassium) SS ORAL 3.5 MG, DAILY, ORAL Quetiapine (Fumarate Quetiapine Fumarate) SS ORAL SEE IMAGE, ORAL Date:06/30/05ISR Number: 4704262-2Report Type:Expedited (15-DaCompany Report #2005AP03335 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperammonaemia Seroquel PS Zeneca Initial or Prolonged Loss Of Consciousness Pharmaceutical ORAL 8 DAY Sodium Valproate SS ORAL 8 DAY Haloperidol C ORAL Artane C ORAL Rohypnol C ORAL Date:06/30/05ISR Number: 4704275-0Report Type:Expedited (15-DaCompany Report #2004UW01147 Age:5275 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Seroquel PS Zeneca Initial or Prolonged Bronchitis Acute Pharmaceutical ORAL 11 MON Other Dehydration Seroquel SS Zeneca Depression Pharmaceutical ORAL 11 MON Dermatitis Contact Seroquel SS Zeneca Diabetes Mellitus Pharmaceutical ORAL 11 MON Insulin-Dependent Seroquel SS Zeneca Diabetic Ketoacidosis Pharmaceutical ORAL HALF TAB IN Hyperglycaemia AM, 1 TAB IN Hypokalaemia PM 6 MON Impulse-Control Disorder Seroquel SS Zeneca Infectious Mononucleosis Pharmaceutical ORAL HALF TAB IN Influenza Like Illness AM, 1 TAB IN Ketonuria PM 6 MON Pharyngitis Seroquel SS Zeneca Self Injurious Behaviour Pharmaceutical ORAL HALF TAB IN Sinusitis AM, 1 TAB IN Treatment Noncompliance PM 6 MON Urinary Tract Infection Seroquel SS Zeneca Urinary Tract Infection Pharmaceutical ORAL 25 MG IN AM, Bacterial 50 MG IN PM 4 MON Vaginitis Bacterial Seroquel SS Zeneca Vomiting Pharmaceutical ORAL 25 MG IN AM, Weight Increased 50 MG IN PM 4 MON Seroquel SS Zeneca Pharmaceutical ORAL 25 MG IN AM, 50 MG IN PM 4 MON Celexa C Celexa C Celexa C Remeron C 22-Feb-2006 08:31 AM Page: 1334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/05ISR Number: 4704292-0Report Type:Expedited (15-DaCompany Report #2005UW09340 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematemesis Seroquel PS Zeneca Haematochezia Pharmaceutical Cymbalta C Date:06/30/05ISR Number: 4704295-6Report Type:Expedited (15-DaCompany Report #2005UW09467 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradykinesia Seroquel PS Zeneca Initial or Prolonged Disorientation Pharmaceutical ORAL 100 AND 200 Extrapyramidal Disorder MG Date:06/30/05ISR Number: 4704306-8Report Type:Expedited (15-DaCompany Report #2005UW06680 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Dispensing Error Seroquel PS Zeneca Dyskinesia Pharmaceutical ORAL Hypersomnia Serzone SS ORAL Judgement Impaired Risperdal C Medication Error Lortab C Restless Legs Syndrome Xanax C Sleep Apnoea Syndrome Zocor C Tremor Nitroglycerin C Anti-Inflammatory Medication C Other Medications C Date:06/30/05ISR Number: 4704307-XReport Type:Expedited (15-DaCompany Report #2005SE03767 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Seroquel PS Zeneca Hospitalization - Electrocardiogram Qt Pharmaceutical ORAL Initial or Prolonged Corrected Interval Compendium SS ORAL 1 BOTTLE, Prolonged DOSE UNKNOWN Heart Rate Increased Sereupin SS ORAL Intentional Misuse Alprazolam SS ORAL 2 BOTTLES, Pneumonia Aspiration DOSE UNKNOWN Respiratory Failure Suicide Attempt Date:06/30/05ISR Number: 4704309-3Report Type:Expedited (15-DaCompany Report #2005PK01091 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 5 DAY Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Seroquel SS Zeneca Pharmaceutical ORAL 5 DAY 22-Feb-2006 08:31 AM Page: 1335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS Zeneca Pharmaceutical ORAL 700 MG GRADUALLY WITHDRAWN Date:06/30/05ISR Number: 4704310-XReport Type:Expedited (15-DaCompany Report #2005PK01108 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Seroquel PS Zeneca Initial or Prolonged Dizziness Pharmaceutical ORAL Drug Interaction Lithiofor C ORAL FOR YEARS Dry Mouth Adalat C ORAL Speech Disorder Nitroderm Tts C TRANSDERMAL Tongue Disorder Lexotanil C ORAL FOR YEARS Beloc-Zok C ORAL 7 DAY Seroquel I Zeneca Pharmaceutical ORAL Valium I ORAL 4 DAY Valium I ORAL Valium I ORAL Date:06/30/05ISR Number: 4704311-1Report Type:Expedited (15-DaCompany Report #2005GB00884 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharyngolaryngeal Pain Pharmaceutical ORAL Date:06/30/05ISR Number: 4704317-2Report Type:Expedited (15-DaCompany Report #2005PK01098 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Seroquel PS Zeneca Initial or Prolonged Urinary Retention Pharmaceutical ORAL 21 DAY Seroquel SS Zeneca Pharmaceutical ORAL 5 DAY Saroten SS ORAL 2 DAY Saroten SS ORAL 5 DAY Saroten SS ORAL 20 DAY Saroten SS ORAL 3 DAY Saroten SS ORAL 5 DAY Saroten SS ORAL 2 DAY Saroten SS ORAL 24 DAY Saroten SS ORAL 4 DAY Saroten SS ORAL 4 DAY Lamictal C ORAL LONG TERM MEDICATION Quilonum Retard C ORAL LONG TERM MEDICATION Euthyrox C ORAL LONG TERM MEDICATION Gelomyrtol C ORAL Acc 200 C ORAL Ass C ORAL LONG TERM MEDICATION Valiquid C ORAL Movicol C LONG TERM 22-Feb-2006 08:31 AM Page: 1336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MEDICATION Date:06/30/05ISR Number: 4704713-3Report Type:Expedited (15-DaCompany Report #2005077982 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Hospitalization - Pulmonary Embolism Professional MG, 2 IN 1 Initial or Prolonged D), ORAL Other Quetiapine (Quetiapine) SS ORAL 400 MG (200 MG, 2 IN 1 D), ORAL Clomipramine (Clomipramine) C Seroquel (Quetiapine Fumarate) C Date:07/01/05ISR Number: 4704840-0Report Type:Expedited (15-DaCompany Report #2005SE03402 Age:24869 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Intentional Misuse Pharmaceutical ORAL Multiple Drug Overdose Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Ramipril SS ORAL Remeron SS ORAL Stilnoct SS ORAL Nozinan SS ORAL Date:07/01/05ISR Number: 4704940-5Report Type:Expedited (15-DaCompany Report #2005UW08999 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Pulmicort PS RESPIRATORY (INHALATION) Seroquel SS Zeneca Pharmaceutical ORAL Date:07/01/05ISR Number: 4705060-6Report Type:Expedited (15-DaCompany Report #2005AP03435 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Seroquel PS Zeneca Initial or Prolonged Coordination Abnormal Pharmaceutical ORAL COMMENCED IN Depressed Level Of JANUARY OF AN Consciousness UNSPECIFIED Hypothermia YEAR Unresponsive To Verbal Seroquel SS Zeneca Stimuli Pharmaceutical ORAL COMMENCED 13 DECEMBER OF UNSPEDIFIED YEAR Bromperidol C ORAL Risperidone C ORAL 22-Feb-2006 08:31 AM Page: 1337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phenytoin C Sodium Valproate C Date:07/01/05ISR Number: 4705062-XReport Type:Expedited (15-DaCompany Report #2005AC00922 Age:11262 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychomotor Hyperactivity Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 5 DAY Date:07/01/05ISR Number: 4707210-4Report Type:Direct Company Report #CTU 252414 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Transaminases Increased Quetiapine Intervention to -Seroquel- PS ORAL 50 MG QHS Prevent Permanent ORAL; 50 MG Impairment/Damage BID ORAL Date:07/01/05ISR Number: 4707239-6Report Type:Expedited (15-DaCompany Report #GBWYE936829JUL04 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Health Efexor (Venlafaxine Caesarean Section Professional Hydrochloride, Drug Exposure During Capsule, Extended Pregnancy Release) PS ORAL 225MG ORAL Gestational Diabetes Amitriptyline Pregnancy (Amitriptyline,, 0) SS AT TIME OF GIVING BIRTH Olanzapine (Olanzapine,, 0) SS AT TIME OF GIVING BIRTH Quetipaine (Quetiapine, , 0) SS ORAL 600MG ORAL Date:07/01/05ISR Number: 4707279-7Report Type:Expedited (15-DaCompany Report #GBWYE775427JUN05 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Neonatal Health Efexor Xl Caesarean Section Professional (Venlafaxine Drug Exposure During Hydrochloride, Pregnancy Capsule, Extended Feeding Disorder Neonatal Release) PS TRANSPLACENTAL 225MG Large For Dates Baby TRANSPLACENTA L Amitriptyline (Amitriptyline) SS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS ORAL 600 MG 1X PER 1 DAY ORAL 22-Feb-2006 08:31 AM Page: 1338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/05ISR Number: 4706337-0Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-13015938 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Abilify PS Otsuka Initial or Prolonged Prescribed Overdose Pharmaceutical Company, Ltd. ORAL Increased to 45 mg/d on 31-Dec-04 and continuing. Seroquel SS ORAL Initiated at 400mg on 08-Oct-04/350 mg(13-18-Oct) /300mg(19-09- Date:07/05/05ISR Number: 4706507-1Report Type:Expedited (15-DaCompany Report #2005012763 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Lamotrigine PS Glaxosmithkline ORAL Restlessness Rivotril SS ORAL Somnolence Seroquel SS UNKNOWN Suicide Attempt Date:07/05/05ISR Number: 4706676-3Report Type:Expedited (15-DaCompany Report #2005SE03683 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Seroquel PS Zeneca Neutropenia Pharmaceutical ORAL Epilim C Zopimed C Eltroxin C Date:07/05/05ISR Number: 4706678-7Report Type:Expedited (15-DaCompany Report #2005AP03278 Age:28760 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Seroquel PS Zeneca Consciousness Pharmaceutical ORAL 1 DAY Pam C INTRAVENOUS DRIP 1 DAY Atropine Sulfate C INTRAVENOUS 2 DAY Propofol C INTRAVENOUS DRIP 2 DAY Date:07/05/05ISR Number: 4709108-4Report Type:Expedited (15-DaCompany Report #2005071563 Age:6 YR Gender:Female I/FU:F Outcome PT Hospitalization - Arthralgia Initial or Prolonged Bipolar Disorder Other Convulsion Coordination Abnormal Difficulty In Walking Disease Recurrence Dizziness 22-Feb-2006 08:31 AM Page: 1339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Ineffective Increased Appetite Insomnia Report Source Product Role Manufacturer Route Dose Duration Mania Consumer Neurontin Metabolic Disorder Health (Gabapentin) PS ORAL 400 MG, ORAL Migraine Professional Lamictal Speech Disorder (Lamotrigine) SS Suicidal Ideation Zyprexa (Olanzapine) SS Weight Increased Seroquel (Quetiapine Fumarate) SS Depakote (Valproate Semisodium) SS Depakene (Valproate Sodium) C Claritin (Loratadine) C Date:07/06/05ISR Number: 4707408-5Report Type:Expedited (15-DaCompany Report #2005PK00917 Age:18996 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Seroquel PS Zeneca Blood Creatine Pharmaceutical ORAL Phosphokinase Increased Nexium SS Astrazeneca Cardiac Arrest Pharmaceuticals ORAL Sudden Death Lamictal SS ORAL Tachycardia Zoloft SS ORAL Euthyrox SS Kreon SS Date:07/06/05ISR Number: 4707409-7Report Type:Expedited (15-DaCompany Report #2005PK01129 Age:30786 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Seroquel PS Zeneca Hospitalization - Fluctuation Pharmaceutical ORAL 44 DAY Initial or Prolonged Confusional State Lisinopril C ORAL 44 DAY Embolism Verapamil C ORAL Infection Torasemid C ORAL Pulmonary Oedema Amaryl C ORAL Restlessness Date:07/06/05ISR Number: 4707410-3Report Type:Expedited (15-DaCompany Report #2005GB01230 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL ON SEROQUEL AT LEAST ONE YEAR Date:07/06/05ISR Number: 4707421-8Report Type:Expedited (15-DaCompany Report #2005AP03505 Age:25318 DYGender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:31 AM Page: 1340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration International Normalised Seroquel PS Zeneca Ratio Abnormal Pharmaceutical ORAL 17 DAY Prothrombin Time Seroquel SS Zeneca Prolonged Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Warfarin SS ORAL Uniphyl SS ORAL Amoban C ORAL Furosemide C ORAL Lanirapid C ORAL Magnesium Oxide C ORAL Acardi C ORAL Kodesoruvan C ORAL Aspara K C ORAL Aldactone C ORAL Date:07/06/05ISR Number: 4707432-2Report Type:Expedited (15-DaCompany Report #2005UW09532 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Increased Pharmaceutical ORAL Date:07/06/05ISR Number: 4707437-1Report Type:Expedited (15-DaCompany Report #2005UW06731 Age:6782 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Cannabinoids SS Diazepam SS Citalopram SS Benzoylegonine SS Benzodiazepines C Clonazepam C Gabitril C Lamictal C Date:07/06/05ISR Number: 4707438-3Report Type:Expedited (15-DaCompany Report #2005SE03558 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Seroquel PS Zeneca Chills Pharmaceutical ORAL START DOSE, Dizziness INCREASED BY Hyperhidrosis 50 MG TO MAX Hypotension 450 MG DURING Nausea 4-5 WEEKS OF Paraesthesia Mucosal Seroquel SS Zeneca Psychotic Disorder Pharmaceutical ORAL 150 MG + 300 MG Seroquel SS Zeneca 22-Feb-2006 08:31 AM Page: 1341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical ORAL 150 MG + 100 MG 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Zyprexa SS ORAL Zyprexa SS ORAL Zyprexa SS ORAL 2.5 MG + 5 MG 1 DAY Zyprexa SS ORAL 1 DAY Date:07/06/05ISR Number: 4709224-7Report Type:Expedited (15-DaCompany Report #23100223 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Bilirubin Increased Foreign Novastan PS INTRAVENOUS 60 MG QD IV Blood Pressure Decreased Health Radicut (Edaravone) SS INTRAVENOUS 30 MG BID IV Depressed Level Of Professional Blopress Consciousness Other (Candesartan Jaundice Cilexetil) SS Liver Disorder Myslee (Zolpidem Pneumonia Tartrate) SS Respiratory Arrest Mobic (Meloxicam) SS Skin Inflammation Seroquel (Quetiapine Fumarate) SS ORAL 25 MG QD PO Loxonin SS ORAL 60 MG BID PO Glucose C Solita-T No. 3 C Lanirapid C Itorol C Acetylsalicylic Acid C Warfarin C Gaster D (Famotidine) C Lasix C Date:07/06/05ISR Number: 4709379-4Report Type:Direct Company Report #CTU 252624 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Seroquel 100mg PS ORAL 100MG Hospitalization - Syndrome BEDTIME ORAL Initial or Prolonged Haldol 10mg SS INTRAVENOUS 10 MG PRN INTRAVENOU Date:07/07/05ISR Number: 4708124-6Report Type:Expedited (15-DaCompany Report #2005PK01130 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL Date:07/07/05ISR Number: 4708170-2Report Type:Expedited (15-DaCompany Report #JP-SOLVAY-00305001218 Age:57 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:31 AM Page: 1342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Sediel PS ORAL Daily dose: Neuroleptic Malignant 20 Syndrome milligram(s) Pneumonia Depromel 25 SS ORAL Daily dose: Respiratory Failure 150 milligram(s) 1 YR Depromel 25 SS ORAL Daily dose: 50 milligram(s) 14 DAY Symmetrel SS ORAL Daily dose: 150 milligram(s) Depromel 25 SS ORAL Daily dose: 100 milligram(s) 8 DAY Seroquel SS ORAL Daily dose: 200 milligram(s) 2 MON Date:07/07/05ISR Number: 4708356-7Report Type:Expedited (15-DaCompany Report #2005AP00683 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Other Drug Interaction Pharmaceutical ORAL Hypotension Amlodipine C Sleep Apnoea Syndrome Insulin C UNKNOWN Paracetamol C Irbesartan + Hydrochlorothiazide C Azithromycin C Cefuroxime C Diphenhydramine I Diphenhydramine I Date:07/07/05ISR Number: 4710578-6Report Type:Expedited (15-DaCompany Report #PAR_0040_2005 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Foreign Verapamil - Slow Hospitalization - Atrioventricular Block Literature Release PS 7.2 G ONCE 1 DAY Initial or Prolonged First Degree Health Doxepin SS 1.6 G ONCE 1 DAY Required Cardiac Arrest Professional Quetiapine SS 10 G ONCE 1 DAY Intervention to Depression Other Temazepam SS 200 MG ONCE 1 DAY Prevent Permanent Drug Ineffective Clonazepam SS 100 MG ONCE 1 DAY Impairment/Damage Drug Toxicity General Physical Health Deterioration Haemodialysis Haemodynamic Instability Hypotension Loss Of Consciousness Metabolic Acidosis Miosis Multiple Drug Overdose Subendocardial Ischaemia 22-Feb-2006 08:31 AM Page: 1343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/05ISR Number: 4709072-8Report Type:Expedited (15-DaCompany Report #2005UW09787 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Seroquel PS Zeneca Phosphokinase Increased Pharmaceutical ORAL Compartment Syndrome Valproic Acid C Hepatic Enzyme Increased Muscle Necrosis Date:07/08/05ISR Number: 4709271-5Report Type:Expedited (15-DaCompany Report #2005UW03398 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Carpal Tunnel Syndrome Seroquel PS Zeneca Initial or Prolonged Dyskinesia Pharmaceutical ORAL 4 YR Hypoaesthesia Seroquel SS Zeneca Lung Neoplasm Pharmaceutical ORAL Psoriasis Inhaler C Schizophrenia Tremor Date:07/08/05ISR Number: 4709275-2Report Type:Expedited (15-DaCompany Report #2005PK00770 Age:14740 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Seroquel PS Zeneca Convulsion Pharmaceutical ORAL 16 DAY Hypoxia Tavor C ORAL 16 DAY Ventricular Fibrillation Date:07/08/05ISR Number: 4711054-7Report Type:Direct Company Report #CTU 252846 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Seroquel 200 Mg Required Neutropenia Astrazeneca PS Astrazeneca ORAL 200 MG ONCE A Intervention to DAY ORAL Prevent Permanent Depakote Er C Impairment/Damage Divalproex C Quetiapine C Date:07/08/05ISR Number: 4711057-2Report Type:Direct Company Report #CTU 252847 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Seroquel 200 Mg Initial or Prolonged Astrazeneca PS Astrazeneca ORAL 400 MG HS ORAL Divaloproex Er C Date:07/08/05ISR Number: 4711060-2Report Type:Direct Company Report #CTU 252848 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Depakote Er 500 Mg Neutropenia Abbott PS Abbott ORAL 1000 MG HS 22-Feb-2006 08:31 AM Page: 1344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Seroquel 200 Mg, 300 Mg Astrazeneca SS Astrazeneca ORAL 800 MG/DAY BID ORAL Protonix C Date:07/08/05ISR Number: 4711152-8Report Type:Expedited (15-DaCompany Report #GBWYE775427JUN05 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Neonatal Foreign Efexor Xl PS TRANSPLACENTAL 225MG, Drug Exposure During Health FREQUENCY NOT Pregnancy Professional STATED Feeding Disorder Neonatal Other TRANSPLACENTA Large For Dates Baby L Amitriptyline (Amitriptyline) SS Olanzapine (Olanzapine ) SS Quetiapine (Quetiapine) SS TRANSPLACENTAL 600 MG 1X PER 1 DAY TRANSPLACENTA L Date:07/08/05ISR Number: 4711159-0Report Type:Expedited (15-DaCompany Report #GBWYE936829JUL04 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Efexor Xl PS ORAL 225 MG ORAL Caesarean Section Health Amitriptyline Drug Exposure During Professional Pregnancy Other (Amitriptyline) SS AT TIME OF Gestational Diabetes GIVING BIRTH Pregnancy Olanzapine (Olanzapine, , 0) SS AT TIME OF GIVING BIRTH Quetiapine (Quetiapine) SS ORAL 600MG ORAL Date:07/11/05ISR Number: 4710388-XReport Type:Expedited (15-DaCompany Report #JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BAge:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depressed Level Of Mobic PS B.I. Consciousness Pharmaceuticals,Inc. Hepatitis /Ridgefield ORAL 5 DAY Sepsis Myslee SS ORAL 12 DAY Skin Inflammation Loxonin SS ORAL 5 DAY Novastatan SS INTRAVENOUS 5 DAY Radicut SS INTRAVENOUS 2 DAY Blopress SS ORAL 12 DAY Seroquel SS ORAL 12 DAY Dextrose C INTRAVENOUS 2 DAY Solita-T No. 3 C INTRAVENOUS 5 DAY Lanirapid C ORAL Itorol C ORAL Aspirin C ORAL 22-Feb-2006 08:31 AM Page: 1345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Warfarin C ORAL Gaster D C ORAL Lasix C ORAL Date:07/11/05ISR Number: 4710517-8Report Type:Expedited (15-DaCompany Report #2005GB00851 Age:469 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pitting Oedema Seroquel PS Zeneca Pharmaceutical ORAL Clopixol C INTRAMUSCULAR Lithium Carbonate C Paroxetine C Insulin C Other Medications C Date:07/11/05ISR Number: 4710519-1Report Type:Expedited (15-DaCompany Report #2005PK00838 Age:20552 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Seroquel PS Zeneca Dizziness Pharmaceutical ORAL LONG TERM Drug Level Decreased MEDICATION Fatigue Seroquel SS Zeneca Fracture Pharmaceutical ORAL Injury Orfiril Long SS ORAL LONG TERM Multiple Fractures MEDICAITON Orthostatic Hypotension Ciatyl Acuphase C Surgery Ciatyl Acuphase C Treatment Noncompliance Date:07/11/05ISR Number: 4710895-XReport Type:Expedited (15-DaCompany Report #PHEH2005US07458 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Metabolic Acidosis Trileptal PS Novartis Sector: Pharma Unk, Unk Seroquel SS Date:07/12/05ISR Number: 4713095-2Report Type:Direct Company Report #CTU 253094 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Quetiapine PS ORAL 50 MG , 25 MG Hospitalization - Body Temperature BID , ORAL Initial or Prolonged Increased Acetaminophen C Required Muscle Rigidity Enoxaparin C Intervention to Neuroleptic Malignant Diazepam C Prevent Permanent Syndrome Propoxyphene N 100 Impairment/Damage Tachycardia Mg/Acetaminophen C Tremor Ferrpis Sulfate C Quetiapine Flumarate C Metronidazole C Thiamine Hcl C Folic Acid C Cyanocobalamin C Acetaminophen C 22-Feb-2006 08:31 AM Page: 1346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/05ISR Number: 4714269-7Report Type:Expedited (15-DaCompany Report #GBWYE936829JUL04 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Efexor Xl Caesarean Section Health (Venlafaxine Drug Exposure During Professional Hydrochloride, Pregnancy Capsule, Extended Gestational Diabetes Release, 0) PS ORAL 225MG ORAL Pregnancy Amitriptyline (Amitriptyline, , 0) SS AT TIME OF GIVING BIRTH Olanzapine (Olanzapine, , 0) SS AT TIME OF GIVING BIRTH Quetiapine (Quetiapine, , 0) SS ORAL 600MG ORAL Date:07/13/05ISR Number: 4713054-XReport Type:Expedited (15-DaCompany Report #2005SE03683 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Seroquel PS Zeneca Neutropenia Pharmaceutical ORAL Epilim C Zopimed C Eltroxin C Date:07/13/05ISR Number: 4713055-1Report Type:Expedited (15-DaCompany Report #2005UW10015 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Seroquel PS Zeneca Initial or Prolonged Schizophrenia, Paranoid Pharmaceutical ORAL 27 DAY Type Allegra C ORAL Omeprazole C ORAL Date:07/13/05ISR Number: 4713126-XReport Type:Expedited (15-DaCompany Report #2005UW10222 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Seroquel PS Zeneca Anger Pharmaceutical ORAL Drug Administration Error Seroquel SS Zeneca Sedation Pharmaceutical ORAL 200 MG QAM, 600 MG QHS Seroquel SS Zeneca Pharmaceutical ORAL Fluanxol C INTRAMUSCULAR Olanzapine C Effexor C Date:07/13/05ISR Number: 4713463-9Report Type:Expedited (15-DaCompany Report #2005UW10081 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Metabolic Acidosis Seroquel PS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trileptal C Date:07/13/05ISR Number: 4713880-7Report Type:Expedited (15-DaCompany Report #S05-USA-02250-01 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Consumer Lexapro Hospitalization - Depression (Escitalopram) PS ORAL 20 MG QD PO Initial or Prolonged Drug Ineffective Lithium SS 600 MG QD Mania Lamictal Multiple Drug Overdose (Lamotrigine) SS 50 MG BID Personality Change Abilify Suicide Attempt (Aripiprazole) SS 15 MG QD Weight Increased Seroquel (Quetiapine Fumarate) SS Trazodone SS Date:07/13/05ISR Number: 4715556-9Report Type:Expedited (15-DaCompany Report #2005073197 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Geodon (Ziprasidone) PS 160 MG (80 Abnormal Professional MG, 2 IN 1 D) Neuroleptic Malignant Company Lithium (Lithium) SS Syndrome Representative Quetiapine Pneumonia (Quetiapine) SS Pyrexia Date:07/14/05ISR Number: 4714039-XReport Type:Expedited (15-DaCompany Report #2005UW10318 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Seroquel PS Zeneca Pharmaceutical ORAL Benzodiazepines SS Opiates SS Date:07/14/05ISR Number: 4714173-4Report Type:Expedited (15-DaCompany Report #2005PK00842 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Erectile Dysfunction Pharmaceutical ORAL 5 DAY Seroquel I Zeneca Pharmaceutical ORAL 6 DAY Seroquel I Zeneca Pharmaceutical ORAL 22 DAY Seroquel I Zeneca Pharmaceutical ORAL 13 DAY Seroquel I Zeneca Pharmaceutical ORAL 37 DAY Seroquel I Zeneca Pharmaceutical ORAL Abilify I ORAL 40 DAY Abilify I ORAL 22-Feb-2006 08:31 AM Page: 1348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/05ISR Number: 4714214-4Report Type:Expedited (15-DaCompany Report #2005AC00957 Age:11956 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Seroquel PS Zeneca Priapism Pharmaceutical ORAL 2 DAY Seroquel I Zeneca Pharmaceutical ORAL 2 DAY Cipramil I ORAL Cipramil I ORAL Cipramil I ORAL Date:07/14/05ISR Number: 4714218-1Report Type:Expedited (15-DaCompany Report #2005UW10304 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL Several Medications C Date:07/14/05ISR Number: 4714425-8Report Type:Expedited (15-DaCompany Report #2005UW07520 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Seroquel PS Zeneca Blood Glucose Increased Pharmaceutical ORAL 5 MON Condition Aggravated Duragesic C Depression Percocet C Dyskinesia Somazapam C Formication Robaxin C Insomnia Ranitidine C Mental Disorder Lithium C Migraine Amitriptyline C Tremor Bentyl C Visual Acuity Reduced Glucosamine C Isoflavins C Date:07/14/05ISR Number: 4716449-3Report Type:Expedited (15-DaCompany Report #MAG-2005-0000365 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other International Normalised Foreign Theophylline 200 Mg Ratio Increased Health (Theophylline) Cr Professional Tablet PS ORAL 200 MG, Other DAILY, ORAL Warfarin Potassium (Warfarin Potassium) SS ORAL 3.5 MG, DAILY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL SEE IMAGE Zopiclone (Zopiclone) C Furosemide (Furosemide) C Metildigoxin (Metildigoxin) C Magnesium Oxide (Magnesium Oxide) C 22-Feb-2006 08:31 AM Page: 1349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pimobendan (Pimobendan) C Ambroxol Hydrochloride (Ambroxol Hydrochloride) C L-Aspartate Potassium C Spironolactone (Spironolactone) C Date:07/14/05ISR Number: 4716659-5Report Type:Expedited (15-DaCompany Report #GBWYE936829JUL04 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Efexor Xl PS ORAL 225MG ORAL Caesarean Section Health Amitriptyline Drug Exposure During Professional (Amitriptyline) SS AT TIME OF Pregnancy Other GIVING BIRTH Gestational Diabetes Olanzapin Pregnancy (Olanzapine., 0) SS AT TIME OF GIVING BIRTH Quetipaine (Quetiapine, , 0) SS ORAL 600MG ORAL Date:07/15/05ISR Number: 4714652-XReport Type:Expedited (15-DaCompany Report #2005GB01346 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Seroquel PS Zeneca Hospitalization - Transient Ischaemic Pharmaceutical ORAL 6 MON Initial or Prolonged Attack Seroquel SS Zeneca Pharmaceutical ORAL Date:07/15/05ISR Number: 4714913-4Report Type:Expedited (15-DaCompany Report #2005UW10111 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Seroquel PS Zeneca Initial or Prolonged Intentional Misuse Pharmaceutical ORAL Pancytopenia Lithium SS White Blood Cell Count Decreased Date:07/15/05ISR Number: 4714921-3Report Type:Expedited (15-DaCompany Report #2005SE02516 Age:14626 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Quetiapine PS Zeneca Initial or Prolonged Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/15/05ISR Number: 4715265-6Report Type:Expedited (15-DaCompany Report #2005UW10319 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Movement Disorder Seroquel PS Zeneca Pharmaceutical ORAL Date:07/15/05ISR Number: 4715266-8Report Type:Expedited (15-DaCompany Report #2005UW10280 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Movement Disorder Seroquel PS Zeneca Pharmaceutical ORAL Date:07/15/05ISR Number: 4715272-3Report Type:Expedited (15-DaCompany Report #2005GB01278 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Corneal Reflex Decreased Quetiapine PS Zeneca Initial or Prolonged Dizziness Postural Pharmaceutical ORAL Disability Fall Sodium Valproate C ORAL 500MG + Nystagmus 1200MG Syncope Camcolit C ORAL Date:07/15/05ISR Number: 4717449-XReport Type:Expedited (15-DaCompany Report #2005071563 Age:6 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Consumer Neurontin Initial or Prolonged Arthralgia Health (Gabapentin) PS ORAL 300 MG (300 Other Bedridden Professional MG, 1 IN 1 Bipolar Disorder D), ORAL Condition Aggravated Lamictal Convulsion (Lamotrigine) SS Dizziness Zyprexa (Olanzapine) SS Drug Ineffective Seroquel (Quetiapine Increased Appetite Fumarate) SS ORAL ORAL Insomnia Depakote (Valproate Mania Semisodium) SS ORAL ORAL Metabolic Disorder Depakene (Valproate Migraine Sodium) C Speech Disorder Claritin Suicidal Ideation (Loratadine) C Weight Increased Valproic Acid (Valproic Acid) C Date:07/18/05ISR Number: 4715643-5Report Type:Expedited (15-DaCompany Report #2005PK01108 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Seroquel PS Zeneca Initial or Prolonged Drug Interaction Pharmaceutical ORAL Speech Disorder Lithiofor C ORAL FOR YEARS Adalat C ORAL Nitroderm Tts C TRANSDERMAL Lexotanil C ORAL FOR YEARS Beloc-Zok C ORAL 7 DAY Seroquel I Zeneca 22-Feb-2006 08:31 AM Page: 1351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical ORAL Valium I ORAL 4 DAY Valium I ORAL Valium I ORAL Date:07/18/05ISR Number: 4715644-7Report Type:Expedited (15-DaCompany Report #2005PK01103 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Erectile Dysfunction Pharmaceutical ORAL 5 DAY Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Seroquel SS Zeneca Pharmaceutical ORAL 22 DAY Seroquel SS Zeneca Pharmaceutical ORAL 13 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL Abilify SS ORAL 39 DAY Abilify SS ORAL Date:07/18/05ISR Number: 4715655-1Report Type:Expedited (15-DaCompany Report #2005UW10321 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Scan Abnormal Seroquel PS Zeneca Initial or Prolonged Depressed Level Of Pharmaceutical ORAL Consciousness Study Medication SS 5 DAY Somnolence Keppra C Urinary Tract Infection Dilantin C Bacterial Effexor C Zantac C Risperdal C Baclofen C Atacand Hct C Ditropan Xl C Ativan C Decadron C Date:07/18/05ISR Number: 4715824-0Report Type:Expedited (15-DaCompany Report #2005UW10303 Age:17116 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Seroquel PS Zeneca Initial or Prolonged Disorientation Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 266 DAY Risperidone SS INTRAMUSCULAR Lithium C ORAL Depakote C ORAL Premarin C ORAL Levothroid C ORAL Flexeril C Lunesta C 22-Feb-2006 08:31 AM Page: 1352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/05ISR Number: 4715825-2Report Type:Expedited (15-DaCompany Report #2005AP03435 Age:17069 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypothermia Seroquel PS Zeneca Hospitalization - Shock Pharmaceutical ORAL 322 DAY Initial or Prolonged Seroquel SS Zeneca Pharmaceutical ORAL 8 DAY Bromperidol C ORAL Risperidone C ORAL 544 DAY Aleviatin C ORAL Selenica R C ORAL Akineton C ORAL Artane C Cholexamin C Lendormin C ORAL Date:07/18/05ISR Number: 4715829-XReport Type:Expedited (15-DaCompany Report #2005SE04049 Age:6036 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diet Refusal Seroquel PS Zeneca Initial or Prolonged Leukopenia Pharmaceutical ORAL Weight Decreased Levozin C ORAL DAILY DOSE 0-100 MG (25 MG WHEN NEEDED) 1 YR Date:07/18/05ISR Number: 4715953-1Report Type:Expedited (15-DaCompany Report #JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BAge:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatitis Mobic (Meloxicam) Sepsis Tablets PS B.I. Pharmaceuticals,Inc. /Ridgefield ORAL 5 DAY Novastatan SS INTRAVENOUS 5 DAY Radicut SS INTRAVENOUS 2 DAY Blopress SS ORAL 12 DAY Seroquel SS ORAL 12 DAY Myslee SS ORAL 12 DAY Loxonin SS ORAL 5 DAY Solita-T No. 3 C INTRAVENOUS 5 DAY Lanirapid C ORAL Itorol C ORAL Aspirin C ORAL Warfarin C ORAL Gaster D C ORAL Lasix C ORAL Dextrose C INTRAVENOUS 2 DAY Date:07/18/05ISR Number: 4716044-6Report Type:Expedited (15-DaCompany Report #2005AC00777 Age:18267 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Injury Asphyxiation Pharmaceutical ORAL Paroxetine SS ORAL Lithium Carbonate C ORAL 22-Feb-2006 08:31 AM Page: 1353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sleeping Medication C Propranolol C ORAL Date:07/19/05ISR Number: 4716725-4Report Type:Expedited (15-DaCompany Report #2005UW10385 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Seroquel PS Zeneca Increased Pharmaceutical ORAL Jaundice Seroquel SS Zeneca Liver Function Test Pharmaceutical ORAL Abnormal Risperdal SS Risperdal SS Singulair SS Remeron SS Methadone SS Date:07/19/05ISR Number: 4716761-8Report Type:Expedited (15-DaCompany Report #US-KINGPHARMUSA00001-K200500930 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Altace Capsules PS King Multiple Drug Overdose Pharmaceuticals, Inc. ORAL 2.5 mg, qd Seroquel SS ORAL 400 mg, qd 111 DAY Mirtazapine SS ORAL 45 mg, qd Stilnoct SS ORAL 20 mg, qd Nozinan /Net/ SS ORAL 25 mg, qd Date:07/19/05ISR Number: 4716777-1Report Type:Expedited (15-DaCompany Report #2005UW10561 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Seroquel PS Zeneca Initial or Prolonged Overdose Pharmaceutical ORAL Rhabdomyolysis Seroquel SS Zeneca Pharmaceutical ORAL TOOK AN OVERDOSE OF SEROQUEL Cocaine SS TOOK A COCAINE OVERDOSE Date:07/19/05ISR Number: 4716778-3Report Type:Expedited (15-DaCompany Report #2005PK01217 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL Date:07/19/05ISR Number: 4716812-0Report Type:Expedited (15-DaCompany Report #2005AC00902 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paraesthesia Oral Seroquel PS Zeneca Skin Hyperpigmentation Pharmaceutical ORAL 34 DAY 22-Feb-2006 08:31 AM Page: 1354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paroxetine C Priadel C Etynilestradiol C Diazepam C Depakines C Flurazepam C Euthyrox C Date:07/19/05ISR Number: 4716813-2Report Type:Expedited (15-DaCompany Report #2005PK01225 Age:31937 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachyarrhythmia Seroquel PS Zeneca Pharmaceutical ORAL 50 DAY Date:07/19/05ISR Number: 4716814-4Report Type:Expedited (15-DaCompany Report #2005UW09228 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Seroquel PS Zeneca Communication Disorder Pharmaceutical ORAL 262.5 MG AM; Gastrointestinal Tube 337.5 MG PM Insertion Seroquel SS Zeneca Pneumonia Pharmaceutical ORAL 262.5 MG AM; Urinary Incontinence 337.5 MG PM Seroquel SS Zeneca Pharmaceutical ORAL 187.5 MG AM; 225 MG PM Seroquel SS Zeneca Pharmaceutical ORAL 187.5 MG AM; 225 MG PM Vioxx C ORAL Glyburide C Adalat C Losec C Bextra C Date:07/19/05ISR Number: 4718766-XReport Type:Expedited (15-DaCompany Report #A109802 Age:45 YR Gender:Female I/FU:F Outcome PT Hospitalization - Ageusia Initial or Prolonged Agitation Required Akathisia Intervention to Asthenia Prevent Permanent Cognitive Disorder Impairment/Damage Cogwheel Rigidity Contusion Coordination Abnormal Drug Ineffective Dysphagia Dystonia Extrapyramidal Disorder Fall Hallucination Hallucination, Auditory Hot Flush Hypertrophy 22-Feb-2006 08:31 AM Page: 1355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypomania Incontinence Logorrhoea Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Geodon (Ziprasidone) PS ORAL 40 MG (20 MG, Muscle Rigidity Professional 2 IN 1 D), Muscle Spasms ORAL Muscle Twitching Lithium (Lithium) SS ORAL 1200 MG, ORAL Myoclonus Seroquel (Quetiapine Neuroleptic Malignant Fumarate) SS ORAL 200 MG, ORAL Syndrome Propranolol Oral Intake Reduced (Propranolol) SS ORAL 60 MG, ORAL Parkinsonian Gait Paxil (Paroxetine Restlessness Hydrochloride) C Serotonin Syndrome Nortriptyline Sleep Disorder (Nortriptyline) C Sleep Talking Thiamine (Thiamine) C Tongue Discolouration Folic Acid (Folic Tongue Disorder Acid) C Tremor Clonazepam (Clonazepam) C Benadryl C Date:07/19/05ISR Number: 4719121-9Report Type:Expedited (15-DaCompany Report #S05-CAN-02440-01 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Foreign Citalopram Consciousness Health Hydrobromide PS 40 MG QD Sinus Tachycardia Professional Seroquel (Quetiapine Somnolence Other Fumarate) SS 25 MG QD Zopiclone SS 7.5 MG QD Date:07/19/05ISR Number: 4719518-7Report Type:Expedited (15-DaCompany Report #2005088294 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Consumer Zoloft (Sertraline) PS ORAL 75 MG (1 D) Alcohol Use Health ORAL Bipolar Disorder Professional Seroquel (Quetiapine Caesarean Section Fumarate) SS ORAL ORAL Chlamydial Infection All Other Depression Therapeutic Products C Drug Exposure During Synthroid Pregnancy (Levothyroxine Feeling Abnormal Sodium) C Hallucination, Auditory Ortho Evra Laceration (Ethinylestradiol, Mood Swings Norelgestromin) C Oral Intake Reduced Pregnancy Psychomotor Hyperactivity Somnolence Suicidal Ideation Suicide Attempt Weight Decreased Weight Increased 22-Feb-2006 08:31 AM Page: 1356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/05ISR Number: 4719520-5Report Type:Direct Company Report #CTU 253636 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Duloxetine PS ORAL 60MG PO QD Initial or Prolonged Meningitis Quetiapine SS 300MG QHS Required Pyrexia Cymbalta C Intervention to Methadone C Prevent Permanent Synthroid C Impairment/Damage Omeprazole C Clonazepam C Seroquel C Motrin C Felxeril C Neurontin C Date:07/20/05ISR Number: 4718645-8Report Type:Expedited (15-DaCompany Report #2005013672 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Lamictal PS Glaxosmithkline ORAL 1 DAY Initial or Prolonged Suicide Attempt Buscopan SS ORAL 1 DAY Vomiting Dolormin Extra SS Glaxosmithkline ORAL 400MG Unknown 1 DAY Doxepine SS ORAL 1 DAY Movicol SS ORAL 1 DAY Novaminsulfon SS ORAL 1 DAY Pantozol SS ORAL 1 DAY Paracodin N SS Glaxosmithkline ORAL 10MGG Unknown 1 DAY Pinimenthol SS ORAL 1 DAY Seroquel SS ORAL 300MG Unknown 1 DAY Silomat SS ORAL 1 DAY Simvastatin SS ORAL 1 DAY Vomacur SS ORAL 50MG Unknown 1 DAY Date:07/20/05ISR Number: 4724939-2Report Type:Direct Company Report #CTU 253718 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Quetiapine 25 Mg PS ORAL 25MG/50 MG Initial or Prolonged Nausea AM/HS ORAL Polydipsia Simvastatin C Polyuria Asa C Vomiting Prazosin C Tramadol C Nefazodone C Hydroxyzine C Date:07/21/05ISR Number: 4719970-7Report Type:Expedited (15-DaCompany Report #2005AP03791 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Seroquel PS Zeneca Initial or Prolonged Hemiplegia Pharmaceutical ORAL 14 DAY Seroquel SS Zeneca Pharmaceutical ORAL 28 DAY Seroquel SS Zeneca Pharmaceutical ORAL 43 DAY Rocaltrol C ORAL Cardenalin C ORAL 22-Feb-2006 08:31 AM Page: 1357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Perdipine C ORAL Aricept C ORAL Gaster C ORAL Tilcotil C ORAL Bayaspirin C ORAL Date:07/21/05ISR Number: 4724505-9Report Type:Expedited (15-DaCompany Report #S05-CAN-02456-01 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Foreign Citalopram Suicide Attempt Health Hydrobromide Professional (Citalopram) PS Other Clozapine SS Gabapentin SS Seroquel (Quetiapine Fumarate) SS Date:07/22/05ISR Number: 4721988-5Report Type:Expedited (15-DaCompany Report #2005UW10522 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatic Insufficiency Seroquel PS Zeneca Initial or Prolonged Pancreatitis Acute Pharmaceutical ORAL Minocycline Hcl SS Date:07/22/05ISR Number: 4722041-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-400261 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ammonia Increased Xeloda PS Roche ORAL 2 DAY Disability Colon Cancer Metastatic Lexapro SS ORAL DOSAGE Mental Status Changes REGIMEN Metastases To Liver REPORTED AS EVERY DAY Seroquel SS ORAL DOSAGE REGIMEN REPORTED AS EVERY NIGHT Methadone SS ORAL Oxaliplatin C Avastin C Megace C ORAL Protonix C DOSAGE REGIMEN REPORTED AS DAILY Senokot C Colace C Combivent Inhaler C Compazine Suppositories C DOSAGE REGIMEN REPORTED AS PRN 22-Feb-2006 08:31 AM Page: 1358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/22/05ISR Number: 4724016-0Report Type:Expedited (15-DaCompany Report #USA-2005-0020370 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Oxycodone Other Hepatic Steatosis Health Hydrochloride Multiple Drug Overdose Professional (Similar To Nda Polysubstance Abuse Other 20-553) (Oxycodone Pulmonary Congestion Hydrochloride) PS Pulmonary Oedema Morphine Sulfate Schizoaffective Disorder (Similar To Nda Self-Medication 19-516) (Morphine Sulfate) SS Sertraline (Sertraline) SS Mirtazapine (Mirtazapine) SS Quetiapine (Quetiapine) SS Date:07/22/05ISR Number: 4724949-5Report Type:Direct Company Report #CTU 254040 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Quetiapine PS Initial or Prolonged Indifference Date:07/25/05ISR Number: 4723431-9Report Type:Expedited (15-DaCompany Report #2005AP03278 Age:28760 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Seroquel PS Zeneca Consciousness Pharmaceutical ORAL 1 DAY Pam C INTRAVENOUS DRIP 1 DAY Atropine Sulfate C INTRAVENOUS 2 DAY Propofol C INTRAVENOUS DRIP 2 DAY Date:07/25/05ISR Number: 4723546-5Report Type:Expedited (15-DaCompany Report #2005AP03296 Age:12240 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Seroquel PS Zeneca Haemoglobin Decreased Pharmaceutical ORAL 649 DAY Transaminases Increased Gaster SS ORAL 716 DAY Luvox SS ORAL 631 DAY Evamyl SS ORAL 743 DAY Constan C ORAL 719 DAY Lendormin C ORAL Dogmatyl C ORAL 673 DAY Date:07/25/05ISR Number: 4726887-0Report Type:Direct Company Report #CTU 254188 Age:57 YR Gender: I/FU:I Outcome PT Hospitalization - Blood Glucose Increased Initial or Prolonged Dizziness 22-Feb-2006 08:31 AM Page: 1359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glycosylated Haemoglobin Increased Polydipsia Report Source Product Role Manufacturer Route Dose Duration Polyuria Quetiapine 200mg PS ORAL 200MG QHS ORAL Enalapril C Simvastatin C Hydrochlorothiazide C Ranitidine C Trazadone C Travoprost C Dorzolamide/Timolol C Meclizine C Azithromycin C Felodipine C Citalopram C Quetiapine C Guaifenesin/Codeine C Flovent C Tylenol C Tramadol C Date:07/25/05ISR Number: 4733190-1Report Type:Periodic Company Report #USA-2004-0016560 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Consumer Morphine Sulfate Other Polysubstance Abuse Health (Similar To Nda Professional 19-516) (Morphine Other Sulfate) PS Quetiapine (Quetiapine) SS Sertraline (Sertraline) SS Bupropion (Amfebutamone) SS Date:07/26/05ISR Number: 4724339-5Report Type:Expedited (15-DaCompany Report #2005PK01284 Age:23918 DYGender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL 39 DAY Seroquel SS Zeneca Pharmaceutical ORAL 14 DAY Seroquel SS Zeneca Pharmaceutical ORAL 22 DAY Doxepin C Mirtazapin C Zolpidem C Lorzaar Plus C Ass 100 C 22-Feb-2006 08:31 AM Page: 1360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/05ISR Number: 4724465-0Report Type:Expedited (15-DaCompany Report #2005UW10753 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Seroquel PS Zeneca Initial or Prolonged Overdose Pharmaceutical ORAL Suicide Attempt Zoloft SS Date:07/26/05ISR Number: 4724795-2Report Type:Expedited (15-DaCompany Report #2005AP03854 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Seroquel PS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 3 DAY Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Seroquel SS Zeneca Pharmaceutical ORAL 29 DAY Risperdal C ORAL 19 DAY Risperdal C ORAL Aleviatin C ORAL Date:07/26/05ISR Number: 4724964-1Report Type:Expedited (15-DaCompany Report #JP-ROCHE-410845 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Horizon PS Roche UNKNOWN Initial or Prolonged Flunitrazepam SS Roche UNKNOWN Seroquel SS ORAL 4 MON Paxil SS ORAL Sermion SS ORAL Tetramide SS ORAL Brotizolam SS Roche ORAL DRUG NAME REPORTED AS RONFLEMAN Innolet 30r C SUBCUTANEOUS DRUG NAME REPORTED AS INNOLET R (INSULIN HUMAN Date:07/26/05ISR Number: 4727639-8Report Type:Direct Company Report #CTU 254473 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Seroquel 25 Mg PS ORAL 25 MG HS ORAL Fall Skin Laceration Date:07/27/05ISR Number: 4726053-9Report Type:Expedited (15-DaCompany Report #2005SE04172 Age:8874 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Quetiapine PS Zeneca Initial or Prolonged Pharmaceutical ORAL 1 YR 22-Feb-2006 08:31 AM Page: 1361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/05ISR Number: 4727197-8Report Type:Expedited (15-DaCompany Report #2005AP03905 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Seroquel PS Zeneca Initial or Prolonged Hypokalaemia Pharmaceutical ORAL Hyponatraemia Metabolic Acidosis Date:07/28/05ISR Number: 4727265-0Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0384748A Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Paxil PS Glaxosmithkline ORAL 70 DAY Extrapyramidal Disorder Limas SS Glaxosmithkline ORAL 600MG Per day 121 DAY Parkinsonism Lullan SS ORAL 9 DAY Seroquel SS ORAL 8 DAY Zyprexa SS ORAL Date:07/28/05ISR Number: 4727537-XReport Type:Expedited (15-DaCompany Report #2005PK01345 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Seroquel PS Zeneca Pharmaceutical ORAL Date:07/28/05ISR Number: 4728140-8Report Type:Direct Company Report #CTU 254608 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Feeling Abnormal Seroquil 100 X 5 Heart Rate Increased Days, Then 200 For 1 Vision Blurred Mth. PS 3 Date:07/28/05ISR Number: 4730158-6Report Type:Expedited (15-DaCompany Report #DSA_26761_2005 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Tavor PS Initial or Prolonged Miosis Health Seroquel SS ORAL 30000 MG ONCE Multiple Drug Overdose Professional PO Sopor Other Taxilan SS Date:07/29/05ISR Number: 4728372-9Report Type:Expedited (15-DaCompany Report #2005SE03193 Age:9904 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Quetiapine PS Zeneca Initial or Prolonged Pharmaceutical ORAL 49 DAY Date:07/29/05ISR Number: 4728373-0Report Type:Expedited (15-DaCompany Report #2005GB01394 Age: Gender:Male I/FU:I Outcome PT Other Agitation Neonatal Caesarean Section 22-Feb-2006 08:31 AM Page: 1362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Exposure During Pregnancy Feeding Disorder Neonatal Report Source Product Role Manufacturer Route Dose Duration Large For Dates Baby Quetiapine PS Zeneca Premature Baby Pharmaceutical TRANSPLACENTAL Venlafaxine SS TRANSPLACENTAL Venlafaxine SS TRANSPLACENTAL Amitriptyline SS TRANSPLACENTAL Olanzapine SS TRANSPLACENTAL Date:07/29/05ISR Number: 4728621-7Report Type:Expedited (15-DaCompany Report #2005UW08712 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Seroquel PS Zeneca Priapism Pharmaceutical ORAL Several Other Medications I Date:07/29/05ISR Number: 4728719-3Report Type:Expedited (15-DaCompany Report #2005UW09622 Age:15130 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Seroquel PS Zeneca Drug Interaction Pharmaceutical ORAL Electrocardiogram Qt Lamictal C ORAL Prolonged Toprol Xl C ORAL Mood Altered Prilosec C ORAL Doxepin I Doxepin I Doxepin I REDUCED Date:07/29/05ISR Number: 4728720-XReport Type:Expedited (15-DaCompany Report #2005UW10948 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Seroquel PS Zeneca Abnormal Pharmaceutical ORAL Extrapyramidal Disorder Depakote C Gait Disturbance Depakote C Somnolence Speech Disorder Date:07/29/05ISR Number: 4728724-7Report Type:Expedited (15-DaCompany Report #2005UW11013 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL Depakote SS 22-Feb-2006 08:31 AM Page: 1363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/05ISR Number: 4729331-2Report Type:Expedited (15-DaCompany Report #2005UW07729 Age:8496 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Seroquel PS Zeneca Initial or Prolonged Aggression Pharmaceutical ORAL 125 DAY Agitation Risperdal C ORAL 2 DAY Fall Trazodone C ORAL Infection Insomnia Psychotic Disorder Wound Dehiscence Date:07/29/05ISR Number: 4729977-1Report Type:Direct Company Report #CTU 254799 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Quetiapine 200mg Somnolence Astrazeneca PS Astrazeneca ORAL 200MG PO BID Date:07/29/05ISR Number: 4734144-1Report Type:Expedited (15-DaCompany Report #2005100498 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Zoloft (Sertraline) PS ORAL 50 MG (50 MG, Other Insomnia Professional 1 IN 1 D), Respiratory Depression ORAL Seroquel (Quetiapine Fumarate) SS ORAL 100 MG (100 MG, 1 IN 1 D), ORAL Alcohol (Ethanol) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Date:08/01/05ISR Number: 4729962-XReport Type:Expedited (15-DaCompany Report #2005GB01395 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Quetiapine PS Zeneca Caesarean Section Pharmaceutical ORAL Drug Exposure During Efexor Xl SS ORAL Pregnancy Amitriptyline SS UNKNOWN Gestational Diabetes Olanzapine SS UNKNOWN Pregnancy Premature Baby Date:08/01/05ISR Number: 4730094-5Report Type:Expedited (15-DaCompany Report #2005AC01091 Age:25 YR Gender:Male I/FU:I Outcome PT Other Microangiopathic Haemolytic Anaemia Renal Failure Acute Thrombotic 22-Feb-2006 08:31 AM Page: 1364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thrombocytopenic Purpura Report Source Product Role Manufacturer Route Dose Duration Quetiapine PS Zeneca Pharmaceutical ORAL Date:08/01/05ISR Number: 4730378-0Report Type:Expedited (15-DaCompany Report #2005PK01362 Age:472 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Seroquel PS Zeneca Pregnancy Pharmaceutical ORAL Intra-Uterine Death Seroquel SS Zeneca Pharmaceutical ORAL Cipralex SS ORAL Date:08/01/05ISR Number: 4730380-9Report Type:Expedited (15-DaCompany Report #2005AP01094 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Seroquel PS Zeneca Hallucination, Auditory Pharmaceutical ORAL Homicidal Ideation Physical Assault Suicidal Ideation Suicide Attempt Date:08/01/05ISR Number: 4730381-0Report Type:Expedited (15-DaCompany Report #2005AP04092 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Seroquel PS Zeneca Life-Threatening Aspiration Pharmaceutical ORAL Delirium Efexor SS ORAL LONG TERM USE Hallucination, Auditory Overdose Suicidal Ideation Suicide Attempt Date:08/01/05ISR Number: 4730382-2Report Type:Expedited (15-DaCompany Report #2005PK01351 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Quetiapine PS Zeneca Hospitalization - Miosis Pharmaceutical ORAL Initial or Prolonged Tachycardia Difiperone SS ORAL Other Valproic Acid SS ORAL Zopiclone SS ORAL Date:08/01/05ISR Number: 4730634-6Report Type:Expedited (15-DaCompany Report #2005UW10991 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Neurontin SS 22-Feb-2006 08:31 AM Page: 1365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/05ISR Number: 4730638-3Report Type:Expedited (15-DaCompany Report #2005AP02414 Age:23010 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 8 DAY Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Seroquel SS Zeneca Pharmaceutical ORAL 34 DAY Seroquel SS Zeneca Pharmaceutical ORAL 5 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Tasmolin SS ORAL 104 DAY Tasmolin SS ORAL DIVIDED INTO 3 DOSES 1 DAY Tasmolin SS ORAL DIVIDED INTO 2 DOSES Serenace C ORAL 5-20 MG DAILY 61 DAY Serenace C ORAL DIVIDED INTO 3 DOSES 2 DAY Serenace C ORAL 13 DAY Serenace C ORAL DIVIDED INTO 3 DOSES 8 DAY Serenace C ORAL 8 DAY Serenace C ORAL DIVIDED INTO 3 DOSES 8 DAY Serenace C ORAL 7 DAY Serenace C ORAL DIVIDED INTO 2 DOSES 8 DAY Serenace C ORAL DIVIDED INTO 2 DOSES 8 DAY Akineton C ORAL 6-3 MG DAILY Levotomin C ORAL Halcion C ORAL Laxoberon C ORAL Diovan C ORAL Date:08/01/05ISR Number: 4733092-0Report Type:Direct Company Report #CTU 254840 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Baclofen PS Initial or Prolonged Headache Buspirone SS Required Hyperhidrosis Mirtazapine SS Intervention to Hypotension Quetiapine SS Prevent Permanent Hypoxia Sertraline SS Impairment/Damage Insomnia Tramadol SS Pyrexia Sepsis Serotonin Syndrome Tremor 22-Feb-2006 08:31 AM Page: 1366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/05ISR Number: 4731289-7Report Type:Expedited (15-DaCompany Report #2005AP03505 Age:25318 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged International Normalised Pharmaceutical ORAL 17 DAY Other Ratio Abnormal Amoban C ORAL Prothrombin Time Lanirapid C ORAL Prolonged Furosemide C ORAL Magnesium Oxide C ORAL Kodesoruvan C ORAL Aldactone C ORAL Uniphyl C ORAL Aspara K C ORAL Acardi C ORAL Seroquel I Zeneca Pharmaceutical ORAL Seroquel I Zeneca Pharmaceutical ORAL Warfarin I ORAL Date:08/02/05ISR Number: 4731448-3Report Type:Expedited (15-DaCompany Report #2005AC01096 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Quetiapine PS Zeneca Dizziness Pharmaceutical ORAL Drug Withdrawal Syndrome Quetiapine SS Zeneca Headache Pharmaceutical ORAL Nausea Quetiapine SS Zeneca Weight Increased Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL GRADUAL TAPER OF 12.5 MG EVERY 5 DAYS Quetiapine SS Zeneca Pharmaceutical ORAL GRADUAL TAPER OF 12.5 MG EVERY 5 DAYS Lamotrigine C ORAL Lamotrigine C ORAL Clonazepam C ORAL Clonazepam C ORAL Date:08/02/05ISR Number: 4731897-3Report Type:Expedited (15-DaCompany Report #2005PK01284 Age:23918 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL 39 DAY Seroquel SS Zeneca Pharmaceutical ORAL 14 DAY Seroquel SS Zeneca Pharmaceutical ORAL 22 DAY 22-Feb-2006 08:31 AM Page: 1367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Doxepin C Mirtazapin C Zolpidem C Lorzaar Plus C Ass 100 C Date:08/03/05ISR Number: 4732422-3Report Type:Expedited (15-DaCompany Report #2005UW10224 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Confusional State Seroquel PS Zeneca Delirium Pharmaceutical ORAL Disorientation Seroquel I Zeneca Drug Interaction Pharmaceutical ORAL Dysarthria Apokyn I INTRAMUSCULAR NOT USED IN Somnolence EVENINGS Date:08/03/05ISR Number: 4732581-2Report Type:Expedited (15-DaCompany Report #2005UW11126 Age:12178 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Seroquel PS Zeneca Initial or Prolonged Condition Aggravated Pharmaceutical ORAL Psychotic Disorder Atomoxetine Sleep Disorder Hydrochloride SS 41 DAY Hydrochlorothiazide C Date:08/03/05ISR Number: 4732582-4Report Type:Expedited (15-DaCompany Report #2005UW11301 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Seroquel PS Zeneca Initial or Prolonged Overdose Pharmaceutical ORAL Respiratory Arrest Buspar C Suicide Attempt Alcohol I Date:08/03/05ISR Number: 4732674-XReport Type:Expedited (15-DaCompany Report #2005AP03791 Age:30778 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 14 DAY Disability Seroquel SS Zeneca Pharmaceutical ORAL 14 DAY Seroquel SS Zeneca Pharmaceutical ORAL 28 DAY Seroquel SS Zeneca Pharmaceutical ORAL 28 DAY Seroquel SS Zeneca Pharmaceutical ORAL 43 DAY Seroquel SS Zeneca Pharmaceutical ORAL 43 DAY Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Rocaltrol C ORAL 22-Feb-2006 08:31 AM Page: 1368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardenalin C ORAL Perdipine C ORAL Aricept C ORAL Gaster C ORAL Tilcotil C ORAL Bayaspirin C ORAL Celgotin S C Date:08/03/05ISR Number: 4732720-3Report Type:Expedited (15-DaCompany Report #2005SE04295 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Panic Attack Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 16 DAY Date:08/03/05ISR Number: 4733169-XReport Type:Expedited (15-DaCompany Report #2005UW11037 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL Date:08/03/05ISR Number: 4733250-5Report Type:Expedited (15-DaCompany Report #JP-ROCHE-410845 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glycosylated Haemoglobin Horizon PS Roche ORAL Initial or Prolonged Increased Flunitrazepam SS Roche ORAL Hyperglycaemia Seroquel SS ORAL 113 DAY Hyperphagia Paxil SS ORAL Polydipsia Sermion SS ORAL Polyuria Tetramide SS ORAL Thirst Brotizolam SS Roche ORAL DRUG NAME Wrong Technique In Drug REPORTED AS Usage Process RONFLEMAN Innolet 30r C SUBCUTANEOUS DRUG NAME REPORTED AS INNOLET R (INSULIN HUMAN Date:08/03/05ISR Number: 4734588-8Report Type:Direct Company Report #CTU 255223 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myalgia Quetiapine PS Date:08/03/05ISR Number: 4734784-XReport Type:Direct Company Report #CTU 255291 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Palpitations Seroquel 100mg Tablet PS 22-Feb-2006 08:31 AM Page: 1369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/03/05ISR Number: 4738261-1Report Type:Expedited (15-DaCompany Report #HQWYE240122MAR05 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Efexor Xr Initial or Prolonged Amenorrhoea (Venlafaxine Blood Cholesterol Hydrochloride, Increased Capsule, Extended Bruxism Release) PS ORAL 150 MG 1X PER Candidiasis 1 DAY ORAL; Condition Aggravated 75 MG1X PER 1 Dermatitis Exfoliative DAY ORAL 1 WK Drug Dependence Efexor (Venlafaxine Drug Withdrawal Syndrome Hydrochloride, Flushing Tablet) SS ORAL 37.5 MG 1X Gallbladder Operation PER 1 DAY Hypomania ORAL 2 WK Memory Impairment Seroquel Menopause (Quetiapine) SS ORAL 100 MG 1X PER Poor Peripheral 1 DAY ORAL Circulation Neurontin Psoriasis (Gabapentin) C Skin Discolouration Valium (Diazepam) C Skin Exfoliation Xanax (Alprazolam) C Skin Haemorrhage Pariet (Rabeprazole) C Suicidal Ideation Renitec (Enalapril Tongue Biting Maleate) C Tooth Disorder Di-Gesic (Dextropropoxyphene/ Paracetamol) C Pethidine (Pethidine) C Vitamins (Vitamins) C Date:08/04/05ISR Number: 4734125-8Report Type:Expedited (15-DaCompany Report #2005UW11176 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Seroquel PS Zeneca Loss Of Consciousness Pharmaceutical ORAL Methadone C Unspecified Ssri C Lithobid C Klonopin C Date:08/04/05ISR Number: 4734602-XReport Type:Expedited (15-DaCompany Report #2005UW11346 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cyanosis Neonatal Seroquel PS Zeneca Drug Exposure During Pharmaceutical ORAL 186 DAY Pregnancy Premature Baby 22-Feb-2006 08:31 AM Page: 1370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/05ISR Number: 4734605-5Report Type:Expedited (15-DaCompany Report #2005AP03435 Age:17069 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypothermia Seroquel PS Zeneca Hospitalization - Shock Pharmaceutical ORAL 322 DAY Initial or Prolonged Seroquel SS Zeneca Pharmaceutical ORAL 8 DAY Bromperidol C ORAL Risperidone C ORAL 544 DAY Aleviatin C ORAL Selenica R C ORAL Akineton C ORAL Artane C Cholexamin C Lendormin C ORAL Date:08/04/05ISR Number: 4734614-6Report Type:Expedited (15-DaCompany Report #2005GB01084 Age:13699 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Injury Asphyxiation Pharmaceutical ORAL Olanzapine C Date:08/04/05ISR Number: 4734794-2Report Type:Expedited (15-DaCompany Report #2005UW10015 Age:18244 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Seroquel PS Zeneca Initial or Prolonged Incoherent Pharmaceutical ORAL 27 DAY Insomnia Allegra C ORAL Irritability Omeprazole C ORAL Schizophrenia, Paranoid Type Treatment Noncompliance Urinary Casts Urine Abnormality Urine Bilirubin Increased Urine Ketone Body Present Urine Leukocyte Esterase Positive Date:08/04/05ISR Number: 4734796-6Report Type:Expedited (15-DaCompany Report #2005UW11335 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Seroquel PS Zeneca Pharmaceutical ORAL TITRATING UP TO 300 MG HS Seroquel SS Zeneca Pharmaceutical ORAL Illicit Drugs SS Xanax Xr C 22-Feb-2006 08:31 AM Page: 1371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/05ISR Number: 4735469-6Report Type:Expedited (15-DaCompany Report #2005UW11202 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Increased Seroquel PS Zeneca Pharmaceutical ORAL Depakote C Date:08/05/05ISR Number: 4735476-3Report Type:Expedited (15-DaCompany Report #2005AP02791 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Seroquel PS Zeneca Loss Of Consciousness Pharmaceutical ORAL DOSE RANGED FROM 25-50 MG Zoloft SS ORAL Antibiotics C Cholesterol Lowering Drugs C Date:08/05/05ISR Number: 4735782-2Report Type:Expedited (15-DaCompany Report #2005UW11346 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cyanosis Neonatal Seroquel PS Zeneca Drug Exposure During Pharmaceutical ORAL 186 DAY Pregnancy Premature Baby Date:08/05/05ISR Number: 4737415-8Report Type:Expedited (15-DaCompany Report #A001-002-006598 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Health Aricept (Donepezil Intervention to Dyskinesia Professional Hydrochloride) PS ORAL 10 MG, 1 IN Prevent Permanent Gait Disturbance 1D, ORAL Impairment/Damage Infection Seroquel (Quetiapine Fumarate) SS ORAL SEE IMAGE Diovan Hct (Co-Diovan) C Lipitor (Atorvastatin) C Ginkgo Biloba (Ginkgo Biloba) C Occuvite (Vitamins) C Vitamins E (Tocopherol) C Bactrim (Bactrim) C Levagquin (Levofloxacin) C Date:08/08/05ISR Number: 4736313-3Report Type:Expedited (15-DaCompany Report #2005UW10320 Age:19330 DYGender:Female I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Cardiac Failure Other Congestive 22-Feb-2006 08:31 AM Page: 1372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Delusion Gait Disturbance Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Seroquel PS Zeneca Pharmaceutical ORAL 6 MON Effexor C ORAL Neurontin C ORAL 16 MON Hydrocodone C ORAL 4 YR Restoril C ORAL 15-30 MG 381 DAY Date:08/08/05ISR Number: 4736337-6Report Type:Expedited (15-DaCompany Report #2005UW07441 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Seroquel PS Zeneca Death Pharmaceutical ORAL 200 MG AM, 400 MG PM 6 MON Date:08/08/05ISR Number: 4736338-8Report Type:Expedited (15-DaCompany Report #2005GB01461 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL Date:08/08/05ISR Number: 4736339-XReport Type:Expedited (15-DaCompany Report #2005AP04049 Age:9099 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Seroquel PS Zeneca Initial or Prolonged Drug Ineffective Pharmaceutical ORAL 28 DAY Seroquel SS Zeneca Pharmaceutical ORAL Date:08/08/05ISR Number: 4736347-9Report Type:Expedited (15-DaCompany Report #2005AP04258 Age:20412 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Quetiapine PS Zeneca Initial or Prolonged Hepatic Enzyme Increased Pharmaceutical ORAL Leukocytosis Clozaril SS ORAL Neutrophilia Clozaril SS ORAL Psychotic Disorder Valium SS Tardive Dyskinesia Efexor SS ORAL Treatment Noncompliance Vomiting Date:08/08/05ISR Number: 4736536-3Report Type:Expedited (15-DaCompany Report #2005AP04257 Age:12767 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Oral Mucosal Blistering Seroquel PS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/05ISR Number: 4736540-5Report Type:Expedited (15-DaCompany Report #2005AP04218 Age:21579 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Seroquel PS Zeneca Cheyne-Stokes Respiration Pharmaceutical ORAL 2 DAY Confusional State Pravastatin Sodium C Delirium Magmin C Dysarthria Ramipril C Hallucination Digoxin C Hypotension Temazepam C Sedation Sotalol Hydrochloride C Slow-K C Frusemide C Clexane C Warfarin Sodium C Quinine C Spironolactone C Date:08/08/05ISR Number: 4736636-8Report Type:Expedited (15-DaCompany Report #2005UW11342 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Furuncle Seroquel PS Zeneca Staphylococcal Infection Pharmaceutical ORAL White Blood Cell Count Lexapro C Decreased Tenormin C Multivitamins C Nexium C Date:08/08/05ISR Number: 4736637-XReport Type:Expedited (15-DaCompany Report #2005UW11402 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Seroquel PS Zeneca Confusional State Pharmaceutical ORAL Insomnia Stelazine C 5-6 MG/DAY 16 YR Suicidal Ideation Stelazine C Date:08/08/05ISR Number: 4736640-XReport Type:Expedited (15-DaCompany Report #2005UW11472 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Seroquel PS Zeneca Pharmaceutical ORAL Donepezil C ORAL Date:08/08/05ISR Number: 4736643-5Report Type:Expedited (15-DaCompany Report #2005SE04467 Age:29290 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Seroquel PS Zeneca Bronchopneumonia Pharmaceutical ORAL Cardiac Arrest Seroquel SS Zeneca Cerebral Disorder Pharmaceutical ORAL 25 + 50 MG Hallucination Sereprile SS ORAL Sereprile SS ORAL 22-Feb-2006 08:31 AM Page: 1374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trittico SS INTRAMUSCULAR Trittico SS ORAL 50 + 100 + 150 MG Cardirene C ORAL Nimotop C ORAL Folinic Acid C ORAL Citicoline C ORAL Rivotril C ORAL Date:08/08/05ISR Number: 4736646-0Report Type:Expedited (15-DaCompany Report #2005AP04216 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL 674 DAY Epilim C ORAL Oxazepam C ORAL Date:08/08/05ISR Number: 4736648-4Report Type:Expedited (15-DaCompany Report #2005AP04260 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Headache Seroquel PS Zeneca Hypermetropia Pharmaceutical ORAL Dothiepin Hydrochloride C ORAL Date:08/08/05ISR Number: 4736652-6Report Type:Expedited (15-DaCompany Report #2005AP04197 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL 48 DAY Date:08/08/05ISR Number: 4736723-4Report Type:Direct Company Report #CTU 255606 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Amitriptyline PS 25 MG Hospitalization - Anxiety Seroquel SS 100 MG Initial or Prolonged Arthralgia Lisinopril C Chromaturia Estrazolam C Completed Suicide Diclofenac C Constipation Lipitor C Feeling Abnormal Levaquin C Flushing Medrol C Headache Allegra C Insomnia Rhinocort C Nervousness Restlessness 22-Feb-2006 08:31 AM Page: 1375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/05ISR Number: 4736842-2Report Type:Expedited (15-DaCompany Report #2005AP04223 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Seroquel PS Zeneca Drug Withdrawal Pharmaceutical ORAL Convulsions Xanax SS ORAL Aurorix SS ORAL Date:08/08/05ISR Number: 4736947-6Report Type:Expedited (15-DaCompany Report #2005AP04263 Age:10027 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Quetiapine PS Zeneca Pharmaceutical ORAL 99 DAY Date:08/09/05ISR Number: 4737451-1Report Type:Expedited (15-DaCompany Report #2005UW11544 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ill-Defined Disorder Seroquel PS Zeneca Initial or Prolonged Neutrophil Count Abnormal Pharmaceutical ORAL White Blood Cell Count Seroquel SS Zeneca Abnormal Pharmaceutical ORAL White Blood Cell Disorder Seroquel SS Zeneca Pharmaceutical ORAL Depakote C Date:08/09/05ISR Number: 4737999-XReport Type:Expedited (15-DaCompany Report #2005PK01445 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Seroquel PS Zeneca Initial or Prolonged Pregnancy Pharmaceutical ORAL TOOK 600 Intra-Uterine Death TABLETS OF Overdose 200 MG Date:08/09/05ISR Number: 4738046-6Report Type:Expedited (15-DaCompany Report #2005GB00966 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Quetiapine PS Zeneca Initial or Prolonged Cerebrovascular Disorder Pharmaceutical ORAL Disability Drug Interaction Bendrofluazide C ORAL Drug Level Increased Omeprazole C ORAL Therapeutic Agent Tamsulosin C ORAL Toxicity Lorazepam C ORAL Transient Ischaemic Priadel I ORAL Attack Priadel I ORAL 22 DAY Date:08/09/05ISR Number: 4738311-2Report Type:Expedited (15-DaCompany Report #2005GB01461 Age:10408 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL 300 MG MANE, 450 MG NOCTE 98 DAY 22-Feb-2006 08:31 AM Page: 1376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/05ISR Number: 4744539-8Report Type:Periodic Company Report #2005-126682-NL Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Mirtazapine PS ORAL 7.5 MG DAILY Required Professional ORAL Intervention to Wellbutrin Xl SS ORAL 450 MG DAILY Prevent Permanent ORAL Impairment/Damage Lorazepam SS ORAL 1 MG BID ORAL Zofran SS ORAL 8 MG DAILY ORAL Quetiapine Fumarate SS ORAL 150 MG DAILY ORAL, AT NIGHT Prozac SS ORAL 100 MG DAILY ORAL Date:08/10/05ISR Number: 4739151-0Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0556057A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Crying Paxil Cr PS Glaxosmithkline ORAL 25MG Per day Dizziness Paxil SS Glaxosmithkline ORAL 10 YR Irritability Seroquel SS ORAL 100MG Per day 2 MON Memory Impairment Date:08/10/05ISR Number: 4739883-4Report Type:Expedited (15-DaCompany Report #2004UW01147 Age:5275 DY Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Abdominal Pain Upper Other Acidosis Back Pain Bronchitis Acute Decreased Appetite Dehydration Depression Dermatitis Contact Diabetes Mellitus Insulin-Dependent Diabetic Ketoacidosis Ear Pain Hyperglycaemia Hypokalaemia Impulse-Control Disorder Infectious Mononucleosis Influenza Like Illness Ketonuria Pain Pharyngitis Pharyngitis Streptococcal Road Traffic Accident Self Injurious Behaviour Sinusitis Somnolence Tachycardia Urinary Tract Infection Vaginitis Bacterial Vomiting 22-Feb-2006 08:31 AM Page: 1377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL 11 MON Seroquel SS Zeneca Pharmaceutical ORAL 11 MON Seroquel SS Zeneca Pharmaceutical ORAL 11 MON Seroquel SS Zeneca Pharmaceutical ORAL HALF TAB IN AM, 1 TAB IN PM 6 MON Seroquel SS Zeneca Pharmaceutical ORAL HALF TAB IN AM, 1 TAB IN PM 6 MON Seroquel SS Zeneca Pharmaceutical ORAL HALF TAB IN AM, 1 TAB IN PM 6 MON Seroquel SS Zeneca Pharmaceutical ORAL 25 MG IN AM, 50 MG IN PM 4 MON Seroquel SS Zeneca Pharmaceutical ORAL 25 MG IN AM, 50 MG IN PM 4 MON Seroquel SS Zeneca Pharmaceutical ORAL 25 MG IN AM, 50 MG IN PM 4 MON Celexa C Celexa C Celexa C Remeron C Date:08/10/05ISR Number: 4740437-4Report Type:Expedited (15-DaCompany Report #2005UW11612 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fracture Seroquel PS Zeneca Initial or Prolonged Tremor Pharmaceutical ORAL Date:08/10/05ISR Number: 4740438-6Report Type:Expedited (15-DaCompany Report #2005GB01521 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angina Pectoris Seroquel PS Zeneca Bloody Discharge Pharmaceutical ORAL Chest Pain Lung Infection Malaise Nausea Rectal Discharge Vertigo 22-Feb-2006 08:31 AM Page: 1378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/10/05ISR Number: 4741094-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-405250 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Klonopin PS Roche ORAL Confusional State Gabitril I ORAL AT BEDTIME 1 WK Coordination Abnormal Gabitril I ORAL AT BEDTIME Delusion Lithium I ORAL Disorientation Trileptal I ORAL Drug Interaction Seroquel I ORAL Sedation Clozaril I ORAL Date:08/11/05ISR Number: 4742144-0Report Type:Expedited (15-DaCompany Report #2005UW11635 Age:97 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL Date:08/11/05ISR Number: 4742146-4Report Type:Expedited (15-DaCompany Report #2005UW06878 Age:6 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Increased Seroquel PS Zeneca Oxygen Saturation Pharmaceutical ORAL Wheezing Date:08/11/05ISR Number: 4742439-0Report Type:Expedited (15-DaCompany Report #2005UW11543 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Transient Ischaemic Seroquel PS Zeneca Initial or Prolonged Attack Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Depakote C Date:08/11/05ISR Number: 4742850-8Report Type:Expedited (15-DaCompany Report #2005UW11556 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Seroquel PS Zeneca Initial or Prolonged Abdominal Pain Pharmaceutical ORAL Obstruction Date:08/11/05ISR Number: 4742853-3Report Type:Expedited (15-DaCompany Report #2005SE04419 Age:26735 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoalbuminaemia Seroquel PS Zeneca Initial or Prolonged Leukopenia Pharmaceutical ORAL 104 DAY Myelodysplastic Syndrome Tiklid SS ORAL 128 DAY Neutropenia Eutirox C ORAL Pariet C ORAL Laroxil C ORAL 22-Feb-2006 08:31 AM Page: 1379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/05ISR Number: 4742866-1Report Type:Expedited (15-DaCompany Report #2005AP04113 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Epilim C Date:08/11/05ISR Number: 4742867-3Report Type:Expedited (15-DaCompany Report #2005PK01477 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Subileus Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 4 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL Date:08/11/05ISR Number: 4744321-1Report Type:Direct Company Report #CTU 256005 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acne Quetiapine 25mg PS ORAL 25 MG QHS Initial or Prolonged Blister ORAL Rash Rash Pruritic Skin Infection Date:08/12/05ISR Number: 4743477-4Report Type:Expedited (15-DaCompany Report #2005UW11126 Age:12178 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Seroquel PS Zeneca Initial or Prolonged Extrapyramidal Disorder Pharmaceutical ORAL Nausea Atomoxetine Psychotic Disorder Hydrochloride SS 41 DAY Upper Respiratory Tract Hydrochlorothiazide C Infection Wheezing Date:08/12/05ISR Number: 4743531-7Report Type:Expedited (15-DaCompany Report #2005GB01532 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Quetiapine PS Zeneca Disability Mobility Decreased Pharmaceutical ORAL Obesity Warfarin C UNKNOWN PER INR 22-Feb-2006 08:31 AM Page: 1380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Warfarin C UNKNOWN PER INR Co-Amilofruse C ORAL Diazepam C ORAL Diazepam C ORAL Frusemide C ORAL Procyclidine C ORAL Date:08/12/05ISR Number: 4743767-5Report Type:Expedited (15-DaCompany Report #2005013672 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Lamictal PS Glaxosmithkline ORAL 1 DAY Initial or Prolonged Suicide Attempt Buscopan SS ORAL 1 DAY Vomiting Dolormin Extra SS Glaxosmithkline ORAL 400MG Unknown 1 DAY Doxepine SS ORAL 1 DAY Movicol SS ORAL 1 DAY Novaminsulfon SS ORAL 1 DAY Pantozol SS ORAL 1 DAY Paracodin N SS Glaxosmithkline ORAL 10MGG Unknown 1 DAY Pinimenthol SS ORAL 1 DAY Seroquel SS ORAL 300MG Unknown 1 DAY Silomat SS ORAL 1 DAY Simvastatin SS ORAL 1 DAY Vomacur SS ORAL 50MG Unknown 1 DAY Date:08/12/05ISR Number: 4744062-0Report Type:Expedited (15-DaCompany Report #2005GB01238 Age:817 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Formication Seroquel PS Zeneca Pharmaceutical ORAL 6 MON Lithium Carbonate C ORAL Phenelzine C ORAL Zopiclone C ORAL Date:08/12/05ISR Number: 4744566-0Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0307413-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Ergenyl Tablets PS ORAL Initial or Prolonged Miosis Zopiclone SS ORAL Tachycardia Pipamperone SS ORAL Quetiapine SS ORAL Date:08/12/05ISR Number: 4744637-9Report Type:Direct Company Report #CTU 256108 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypotension Seroquel 25 Mg PS ORAL 25 MG ONCE Intestinal Gangrene -NIGHT- ORAL Lethargy Oxygen Saturation Decreased Respiratory Distress Septic Shock 22-Feb-2006 08:31 AM Page: 1381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/05ISR Number: 4745789-7Report Type:Direct Company Report #CTU 256188 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Quetiapine 200mg PS ORAL 400MG QAM Gait Disturbance ORAL Lethargy Quetiapine 100mg SS ORAL 500MG QHS Pollakiuria ORAL Sluggishness Thirst Date:08/15/05ISR Number: 4745842-8Report Type:Direct Company Report #CTU 256207 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Seroquel 100mg Initial or Prolonged Non-Insulin-Dependent Then To 200 Mg Disability Hypertension Astra Zeneca ? PS Astra Zeneca ? ORAL 100/200 MG Insomnia ONCE PER DAY Pancreatitis OR Date:08/16/05ISR Number: 4745865-9Report Type:Expedited (15-DaCompany Report #2005AP03335 Age:5181 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 8 DAY Depakene R SS ORAL Haloperidol C ORAL Tremin C ORAL Rohypnol C ORAL Eurodin C ORAL 8 DAY Date:08/16/05ISR Number: 4745867-2Report Type:Expedited (15-DaCompany Report #2005AP03876 Age:26933 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Seroquel PS Zeneca C-Reactive Protein Pharmaceutical ORAL Increased Seroquel SS Zeneca Delirium Pharmaceutical ORAL Drug Ineffective Seroquel SS Zeneca Hypercreatininaemia Pharmaceutical ORAL RESUMED AT A Pyrexia DECREASED Sedation DOSAGE 21 DAY White Blood Cell Count Seroquel SS Zeneca Increased Pharmaceutical ORAL RESUMED AT A DECREASED DOSAGE 21 DAY Tetramide C ORAL Tetramide C ORAL 40 DAY Tetramide C ORAL Halcion C ORAL Atarax-P C ORAL Pursennid C ORAL Tecipul C ORAL 5 MON Amoxan C ORAL Reslin C ORAL Gramalil C ORAL 90 DAY 22-Feb-2006 08:31 AM Page: 1382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Serenace C ORAL 40 DAY Antidepressant (Unspecified) C Unspecified Drug C Date:08/16/05ISR Number: 4745871-4Report Type:Expedited (15-DaCompany Report #2005UW11828 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL Date:08/16/05ISR Number: 4746376-7Report Type:Direct Company Report #CTU 256261 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Seroquel 25 PS ORAL 50 MG QHS Initial or Prolonged Chromaturia ORAL Rhabdomyolysis Suprapubic Pain Date:08/17/05ISR Number: 4746559-6Report Type:Expedited (15-DaCompany Report #2005UW11937 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thyroid Gland Cancer Seroquel PS Zeneca Tremor Pharmaceutical ORAL Date:08/17/05ISR Number: 4746626-7Report Type:Expedited (15-DaCompany Report #2005UW11680 Age:80 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Seroquel PS Zeneca Back Pain Pharmaceutical ORAL 1 DAY Contusion Seroquel SS Zeneca Coordination Abnormal Pharmaceutical ORAL HALF THE Dizziness TABLET Fall Toprol C ORAL Flank Pain Norvasc C Loss Of Consciousness Hctz C Myalgia Mozic C Pain In Extremity Date:08/17/05ISR Number: 4746627-9Report Type:Expedited (15-DaCompany Report #2005AP03791 Age:30778 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 14 DAY Disability Seroquel SS Zeneca Pharmaceutical ORAL 14 DAY Seroquel SS Zeneca Pharmaceutical ORAL 28 DAY Seroquel SS Zeneca Pharmaceutical ORAL 28 DAY Seroquel SS Zeneca 22-Feb-2006 08:31 AM Page: 1383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical ORAL 43 DAY Seroquel SS Zeneca Pharmaceutical ORAL 43 DAY Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Rocaltrol C ORAL Cardenalin C ORAL Perdipine C ORAL Aricept C ORAL Gaster C ORAL Tilcotil C ORAL Bayaspirin C ORAL Celgotin S C Date:08/17/05ISR Number: 4746628-0Report Type:Expedited (15-DaCompany Report #2005PK01508 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nervousness Seroquel PS Zeneca Initial or Prolonged Restlessness Pharmaceutical ORAL Schizophrenia Seroquel SS Zeneca Tension Pharmaceutical ORAL DOSE ADJUSTED Melperone SS ORAL Melperone SS ORAL DOSE ADJUSTED Risperdal Consta C INTRAMUSCULAR 141 DAY Date:08/17/05ISR Number: 4746630-9Report Type:Expedited (15-DaCompany Report #2005GB01302 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Disorder Seroquel PS Zeneca Hyperglycaemia Pharmaceutical ORAL Liver Function Test Clozaril C ORAL Abnormal Anafranil C ORAL White Blood Cell Count Decreased Date:08/17/05ISR Number: 4747020-5Report Type:Expedited (15-DaCompany Report #PHBS2005BR11887 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Exelon PS Novartis Sector: Agitation Pharma ORAL 3 mg, Q12H Condition Aggravated Seroquel SS Drug Interaction Cataflam SS 2880 MIN Erythema Levodopa C Pharyngolaryngeal Pain Calcort C Skin Reaction Date:08/17/05ISR Number: 4747049-7Report Type:Expedited (15-DaCompany Report #2005UW11740 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pericardial Effusion Seroquel PS Zeneca Pharmaceutical 22-Feb-2006 08:31 AM Page: 1384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/05ISR Number: 4747801-8Report Type:Expedited (15-DaCompany Report #2005AP04376 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Seroquel PS Zeneca Hospitalization - Rash Pharmaceutical ORAL 48 DAY Initial or Prolonged Limas SS ORAL 48 DAY Hirnamin C ORAL Silece C ORAL Vegatamin A C ORAL Date:08/18/05ISR Number: 4748027-4Report Type:Expedited (15-DaCompany Report #2005UW12031 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Furuncle Seroquel PS Zeneca Leukopenia Pharmaceutical ORAL Lexapro C Date:08/18/05ISR Number: 4748029-8Report Type:Expedited (15-DaCompany Report #2005GB01523 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Quetiapine PS Zeneca Decreased Pharmaceutical ORAL Zaponex SS ORAL 100 AM AND 125 MG PM Diazepam C UNKNOWN 20 MG/DAY /PRN Ibuprofen C UNKNOWN Haloperidol C UNKNOWN Hyoscine C UNKNOWN Date:08/18/05ISR Number: 4748033-XReport Type:Expedited (15-DaCompany Report #2005UW12154 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Seroquel PS Zeneca Completed Suicide Pharmaceutical ORAL 25 MG AND 100 MG SAMPLES 20 DAY Alcohol C Wellbutrin C Zoloft C 4 Other Antidepressants C Date:08/18/05ISR Number: 4748144-9Report Type:Expedited (15-DaCompany Report #2004PK01332 Age:21658 DYGender:Male I/FU:F Outcome PT Life-Threatening Blood Creatine Increased Hospitalization - Blood Glucose Increased Initial or Prolonged C-Reactive Protein Increased Deep Vein Thrombosis Dehydration Embolism Mania 22-Feb-2006 08:31 AM Page: 1385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Embolism Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL Ergenyl SS ORAL Rivotril SS ORAL Xanef SS ORAL PERMANENT MEDICATION Date:08/19/05ISR Number: 4748736-7Report Type:Expedited (15-DaCompany Report #2005UW11953 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Abnormal Seroquel PS Zeneca Bulimia Nervosa Pharmaceutical ORAL OFF AND ON 7 MON Incontinence Klonopin C Multiple Sclerosis Zanaflex C Avelox C Methotrexate C Date:08/19/05ISR Number: 4748737-9Report Type:Expedited (15-DaCompany Report #2005UW12137 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinitis Pigmentosa Seroquel PS Zeneca Pharmaceutical ORAL Neurontin C Date:08/19/05ISR Number: 4748739-2Report Type:Expedited (15-DaCompany Report #2005SE04641 Age:10260 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Quetiapine PS Zeneca Initial or Prolonged Pharmaceutical ORAL 154 DAY Haloperidol C UNKNOWN Date:08/19/05ISR Number: 4748843-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0558797A Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Affective Disorder Wellbutrin PS Glaxosmithkline ORAL 426 DAY Amnesia Seroquel SS ORAL 17 DAY Aura Synthroid C Glaxosmithkline ORAL .05MG Per day Bipolar Ii Disorder Menest C Glaxosmithkline ORAL 1TAB Per day Confusional State Doxepin C ORAL 20MG At night 310 DAY Convulsion Ambien C ORAL 10MG As Fall required 496 DAY Fatigue Lorazepam C ORAL .5MG As Loss Of Consciousness required Memory Impairment Zomig C Nausea Neck Pain Paraesthesia Tonic Convulsion Tremor 22-Feb-2006 08:31 AM Page: 1386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/05ISR Number: 4748894-4Report Type:Expedited (15-DaCompany Report #2005UW10522 Age:7173 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agonal Rhythm Seroquel PS Zeneca Hospitalization - Blood Glucose Increased Pharmaceutical ORAL Initial or Prolonged Blood Pressure Increased Minocycline Hcl SS Bradycardia Tegretol C Disseminated Risperdal C Intravascular Coagulation Luvox C Drug Screen Positive Trileptal C Hepatic Steatosis Tenex C Hyperhidrosis Ritalin C Hyperthermia Hypotension Metabolic Acidosis Pancreatitis Acute Respiratory Failure Septic Shock Tachycardia Date:08/19/05ISR Number: 4748898-1Report Type:Expedited (15-DaCompany Report #2005UW08180 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Overdose Seroquel PS Zeneca Hospitalization - Dehydration Pharmaceutical ORAL 6 YR Initial or Prolonged Dependence Seroquel SS Zeneca Other Depression Pharmaceutical ORAL Drug Abuser Peg-Intron SS SUBCUTANEOUS 165 DAY Feeling Abnormal Rebetol SS ORAL 165 DAY Intentional Misuse Dilaudid SS Loss Of Consciousness Effexor Xr C ORAL Self Mutilation Trazodone Hydrochloride C ORAL Analgesic C ORAL Topamax C ORAL Prevacid C ORAL Date:08/19/05ISR Number: 4748902-0Report Type:Expedited (15-DaCompany Report #2005AP03232 Age:28937 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epilepsy Seroquel PS Zeneca Loss Of Consciousness Pharmaceutical ORAL 530 DAY Refusal Of Treatment By Gramalil C ORAL 388 DAY Patient One Alfa C ORAL Tonic Convulsion Date:08/19/05ISR Number: 4748906-8Report Type:Expedited (15-DaCompany Report #2005AP04335 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Seroquel PS Zeneca Initial or Prolonged Dehydration Pharmaceutical ORAL 6 MON Pyrexia Silece C ORAL Pyrethia C ORAL Limas C ORAL 22-Feb-2006 08:31 AM Page: 1387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/22/05ISR Number: 4749434-6Report Type:Expedited (15-DaCompany Report #2005UW12188 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Road Traffic Accident Seroquel PS Zeneca Sedation Pharmaceutical ORAL Date:08/22/05ISR Number: 4749435-8Report Type:Expedited (15-DaCompany Report #2005UW12195 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Seroquel PS Zeneca Initial or Prolonged Hip Fracture Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Date:08/22/05ISR Number: 4751460-8Report Type:Expedited (15-DaCompany Report #SUS1-2005-00602 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Study Equetro Priapism Health (Carbamazepine Professional Extended Release 200mg) Capsule PS ORAL 200 MG, 1X/DAY. QD, ORAL Seroquel (Quetiapine Fumarate) SS ORAL 300 MG, 1X/DAY: QD, ORAL Lantus (Insulin Glargine) C Date:08/22/05ISR Number: 4751704-2Report Type:Expedited (15-DaCompany Report #DSA_26761_2005 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Tavor PS ORAL 5 MG ONCE PO Initial or Prolonged Miosis Health Seroquel SS ORAL 30000 MG ONCE Multiple Drug Overdose Professional PO Somnolence Other Taxilan SS ORAL 5 TAB ONCE PO Sopor Date:08/23/05ISR Number: 4750359-0Report Type:Expedited (15-DaCompany Report #2005GB01558 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Apnoea Syndrome Seroquel PS Zeneca Pharmaceutical ORAL 4 DAY Date:08/23/05ISR Number: 4750360-7Report Type:Expedited (15-DaCompany Report #2005PK01527 Age:43 YR Gender:Male I/FU:I Outcome PT Atrioventricular Block Complete Electrocardiogram Qt 22-Feb-2006 08:31 AM Page: 1388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL Date:08/23/05ISR Number: 4750369-3Report Type:Expedited (15-DaCompany Report #2005AP03854 Age:21317 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Seroquel PS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 3 DAY Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Seroquel SS Zeneca Pharmaceutical ORAL 29 DAY Risperdal C ORAL 19 DAY Risperdal C ORAL Aleviatin C ORAL Lendormin C ORAL Depas C ORAL Hirnamin C ORAL Date:08/23/05ISR Number: 4750377-2Report Type:Expedited (15-DaCompany Report #2005UW12005 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abasia Seroquel PS Zeneca Other Irritability Pharmaceutical ORAL 3 MON Speech Disorder Detrol La C Asa C Synthroid C Omega 3 C Exelon C Doxycycline C Metrogel C Date:08/23/05ISR Number: 4750434-0Report Type:Expedited (15-DaCompany Report #2005SE04116 Age:34192 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL 94 DAY Akarin C Furix C Imdur C Heart Magnyl C Oxapax C Date:08/23/05ISR Number: 4750497-2Report Type:Expedited (15-DaCompany Report #2005AC01188 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clozapine C Date:08/23/05ISR Number: 4750583-7Report Type:Expedited (15-DaCompany Report #2005UW12026 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Quetiapine PS Zeneca Pharmaceutical ORAL 15 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 15 DAY Date:08/23/05ISR Number: 4751213-0Report Type:Direct Company Report #CTU 256814 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Seroquel, 300 Mg PS ORAL 300 MG, Hospitalization - Hallucination NIGHT, ORAL Initial or Prolonged Physical Assault Depakote , 250 Mg SS ORAL 250 MG , MOM Other , ORAL Date:08/23/05ISR Number: 4751215-4Report Type:Direct Company Report #CTU 256816 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Seroquel PS ORAL 200 MG BID PO Musculoskeletal Stiffness Date:08/23/05ISR Number: 4751327-5Report Type:Direct Company Report #CTU 256802 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Seroquel PS SEE IMAGE Intervention to Prevent Permanent Impairment/Damage Date:08/23/05ISR Number: 4751766-2Report Type:Direct Company Report #CTU 256782 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Seroquel PS Fear Of Weight Gain Hypersomnia Oral Intake Reduced Sedation Weight Increased Date:08/24/05ISR Number: 4751241-5Report Type:Expedited (15-DaCompany Report #2005AC01188 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Clozapine C 22-Feb-2006 08:31 AM Page: 1390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/05ISR Number: 4751261-0Report Type:Expedited (15-DaCompany Report #2005AP04380 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Seroquel PS Zeneca Initial or Prolonged Overdose Pharmaceutical ORAL 2 DAY Myslee SS ORAL 2 DAY Date:08/24/05ISR Number: 4751289-0Report Type:Expedited (15-DaCompany Report #2005PK01477 Age:24614 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Subileus Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Eunerpan C ORAL Eunerpan C ORAL Sab Simplex C ORAL Calcivit D C ORAL Supracyclin C ORAL Galikly C Date:08/24/05ISR Number: 4751589-4Report Type:Expedited (15-DaCompany Report #NO-GLAXOSMITHKLINE-B0391524A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Lamictal PS Glaxosmithkline ORAL 25MG per day 2 WK Increased Seroquel SS ORAL 6 WK Arthralgia Aspartate Aminotransferase Increased Gamma-Glutamyltransferase Increased Haematuria Myalgia Neuroleptic Malignant Syndrome Neurological Examination Abnormal Pyrexia Date:08/24/05ISR Number: 4751763-7Report Type:Expedited (15-DaCompany Report #2005UW12217 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Breast Pain Initial or Prolonged Dyskinesia Dyspnoea Feeling Abnormal Menstruation Irregular Nasal Congestion Panic Attack Pharyngolaryngeal Pain 22-Feb-2006 08:31 AM Page: 1391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thinking Abnormal Throat Tightness Thyroid Function Test Report Source Product Role Manufacturer Route Dose Duration Abnormal Seroquel PS Zeneca Vertigo Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical Date:08/24/05ISR Number: 4752131-4Report Type:Direct Company Report #CTU 256879 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Proinsulin Quetiapine 300mg Increased And 200mg Glycosylated Haemoglobin Astra-Zeneca PS Astra-Zeneca ORAL 800MG EVERY Increased NIGHT PO Pantoprazole C Topiramate C Atorvastatin C Metoprolol C Isosorbide Mononitrate C Date:08/25/05ISR Number: 4752259-9Report Type:Expedited (15-DaCompany Report #2005UW12218 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Enzyme Increased Seroquel PS Zeneca Hospitalization - Hyperglycaemia Pharmaceutical ORAL 300 MG TID, Initial or Prolonged Hyperkalaemia 1000 MG HS Life Support Seroquel SS Zeneca Pancreatitis Pharmaceutical ORAL 300 MG TID, Renal Failure 1000 MG HS Ventricular Extrasystoles Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Fenofibrate SS 12 DAY Fenofibrate SS 12 DAY Topamax C ORAL 25 MG AM, 125 MG HS Topamax C ORAL 25 MG AM, 125 MG HS Chlorpromazine C Chlorpromazine C Clonazepam C Clonazepam C Clonazepam C 4 DAY Clonazepam C 4 DAY Zopiclone C ORAL Alendronate C ORAL EVERY WEDNESDAY Pantoprazole C ORAL Senokot C ORAL Soflax C ORAL Calcium With Vitamin D C ORAL CALCIUM 500 MG, VIT D 125 UNITS 22-Feb-2006 08:31 AM Page: 1392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin D C ORAL Date:08/25/05ISR Number: 4752260-5Report Type:Expedited (15-DaCompany Report #2005GB01595 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Seroquel PS Zeneca Abnormal Pharmaceutical ORAL Date:08/25/05ISR Number: 4752275-7Report Type:Expedited (15-DaCompany Report #2005SE04116 Age:34192 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Seroquel PS Zeneca Neutropenia Pharmaceutical ORAL 94 DAY Akarin C Furix C Imdur C Heart Magnyl C Oxapax C Date:08/25/05ISR Number: 4752336-2Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0390885A Age:68 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Paroxetine PS Glaxosmithkline ORAL 600MG per day 0 DAY Paracetamol SS Glaxosmithkline ORAL 15G per day 0 DAY Quetiapine SS ORAL 3000MG per day 0 DAY Alcohol C 1 DAY Date:08/25/05ISR Number: 4754732-6Report Type:Direct Company Report #CTU 256953 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Seroquel PS ORAL 400MG TID Initial or Prolonged Malaise PO Pollakiuria Thirst Vision Blurred Date:08/26/05ISR Number: 4753321-7Report Type:Expedited (15-DaCompany Report #2005AP04475 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/05ISR Number: 4753323-0Report Type:Expedited (15-DaCompany Report #2005SE04735 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Seroquel PS Zeneca Gamma-Glutamyltransferase Pharmaceutical ORAL 2 MON Increased Seroquel SS Zeneca Hepatic Enzyme Increased Pharmaceutical ORAL Lipids Increased Seroquel SS Zeneca Weight Increased Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Date:08/26/05ISR Number: 4753324-2Report Type:Expedited (15-DaCompany Report #2005SE04802 Age:14264 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Seroquel PS Zeneca Infarction Pharmaceutical ORAL Sudden Death Cisordinol C Zoloft C Disipal C Date:08/26/05ISR Number: 4753474-0Report Type:Expedited (15-DaCompany Report #2005UW12154 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Somnolence Pharmaceutical ORAL 20 25 MG AND 20 100 MG Alcohol SS Wellbutrin C Zoloft C 4 Other Antidepressants C Date:08/26/05ISR Number: 4753546-0Report Type:Expedited (15-DaCompany Report #2005UW12485 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antipsychotic Drug Level Seroquel PS Zeneca Above Therapeutic Pharmaceutical ORAL Convulsion Gastrointestinal Disorder Panic Attack Renal Failure Acute Date:08/26/05ISR Number: 4753548-4Report Type:Expedited (15-DaCompany Report #2005UW12458 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/05ISR Number: 4753549-6Report Type:Expedited (15-DaCompany Report #2005UW12253 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Seroquel PS Zeneca Drug Exposure During Pharmaceutical ORAL Pregnancy Topamax C Ovarian Cyst Wellbutrin C Pregnancy Clonazepam C Premature Separation Of Placenta Progesterone Decreased Pyrexia Date:08/26/05ISR Number: 4753759-8Report Type:Expedited (15-DaCompany Report #2005UW12322 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Seroquel PS Zeneca Infection Pharmaceutical ORAL Musculoskeletal Stiffness Baby Aspirin C Weight Increased White Blood Cell Count Decreased Date:08/26/05ISR Number: 4760859-5Report Type:Periodic Company Report #USA-2004-0017815 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Health Oxycodone Professional Hydrochloride Other (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS Hydrocodone (Hydrocodone) SS Valproic Acid (Valproic Acid) SS Acetaminophen (Paracetamol) SS Quetiapine (Quetiapine) SS Venlafaxine (Venlafaxine) SS Date:08/26/05ISR Number: 4760867-4Report Type:Periodic Company Report #USA-2004-0017821 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Health Oxycontin Tablets Professional (Oxycodone Other Hydrochloride) PS UNK MG, SEE TEXT Oxymorphone (Oxymorphone) SS Venlafaxine (Venlafaxine) SS Carbamazepine (Carbamazepine) SS 22-Feb-2006 08:31 AM Page: 1395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gabapentin (Gabapentin) SS Mirtazapine (Mirtazapine) SS Quetiapine (Quetiapine) SS Temazepam (Temazepam) SS Diphenhydramine (Diphenhydramine) SS Lamotrigine (Lamotrigine) SS Coumadine C Date:08/29/05ISR Number: 4754284-0Report Type:Expedited (15-DaCompany Report #2004UW21231 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Seroquel PS Zeneca Initial or Prolonged Increased Pharmaceutical ORAL 1-4 TABS 10 DAY Aspartate Darvocet SS ORAL 1-2 TABS PRN 3 DAY Aminotransferase Increased Atelectasis Blood Urine Diverticulum Intestinal Hypotension Lung Infiltration Syncope Date:08/29/05ISR Number: 4754285-2Report Type:Expedited (15-DaCompany Report #2005UW10753 Age:6513 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Seroquel PS Zeneca Initial or Prolonged Intentional Misuse Pharmaceutical ORAL AMOUNT OF Overdose OVERDOSE Pneumonia Aspiration Seroquel SS Zeneca Suicide Attempt Pharmaceutical ORAL PRESCRIBED DOSE Zoloft SS ORAL AMOUNT OF OVERDOSE Zoloft SS ORAL PRESCRIBED DOSE Date:08/29/05ISR Number: 4754496-6Report Type:Expedited (15-DaCompany Report #2005PK01554 Age:23545 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Seroquel PS Zeneca Hospitalization - Convulsion Pharmaceutical ORAL 59 DAY Initial or Prolonged Disturbance In Attention Iscover C Hyponatraemia Polydipsia Psychogenic Restlessness 22-Feb-2006 08:31 AM Page: 1396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/05ISR Number: 4754631-XReport Type:Expedited (15-DaCompany Report #NO-GLAXOSMITHKLINE-B0391524A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Lamictal PS Glaxosmithkline ORAL 25MG per day 2 WK Increased Seroquel SS ORAL 6 WK Arthralgia Aspartate Aminotransferase Increased Gamma-Glutamyltransferase Increased Haematuria Myalgia Neuroleptic Malignant Syndrome Pyrexia Date:08/29/05ISR Number: 4754775-2Report Type:Expedited (15-DaCompany Report #2005AC01240 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Seroquel PS Zeneca Pharmaceutical ORAL Date:08/29/05ISR Number: 4754776-4Report Type:Expedited (15-DaCompany Report #2005AC01241 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Seroquel PS Zeneca Pharmaceutical ORAL Date:08/29/05ISR Number: 4754777-6Report Type:Expedited (15-DaCompany Report #2005UW12501 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL Depakote C Strattera C Trileptal C Chloral Hydrate C Date:08/29/05ISR Number: 4754780-6Report Type:Expedited (15-DaCompany Report #2005UW12399 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Date:08/29/05ISR Number: 4754782-XReport Type:Expedited (15-DaCompany Report #2005AC01226 Age:7787 DY Gender:Female I/FU:I Outcome PT Other Back Pain Coordination Abnormal Miosis 22-Feb-2006 08:31 AM Page: 1397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Tongue Disorder Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL 3 DAY Oxazepam SS 1 MON Date:08/29/05ISR Number: 4754784-3Report Type:Expedited (15-DaCompany Report #2005AC01239 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Seroquel PS Zeneca Pharmaceutical ORAL Date:08/29/05ISR Number: 4754793-4Report Type:Expedited (15-DaCompany Report #2005UW12315 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Seroquel PS Zeneca Agitation Pharmaceutical ORAL Akinesia Namenda SS Drug Interaction Carbidopa W/Levodopa C Insomnia Excelon C Speech Disorder Levothyroxine C Vitamin E C Remeron C 30 MG 1/2 TABLET EVERY OTHER NIGHT Date:08/30/05ISR Number: 4755548-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12965893 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Abilify PS Otsuka Hospitalization - Drug Ineffective Pharmaceutical Initial or Prolonged Intentional Misuse Company, Ltd. Mania Trazodone Hcl SS Apothecon Suicide Attempt Lexapro SS ORAL Weight Increased Lithium SS Lamictal SS Seroquel SS Date:08/30/05ISR Number: 4756915-8Report Type:Expedited (15-DaCompany Report #2005UW12747 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Seroquel PS Zeneca Hospitalization - Liver Disorder Pharmaceutical ORAL Initial or Prolonged Multi-Organ Failure Lithium SS Renal Failure Acute Vistaril SS Lexapro SS 22-Feb-2006 08:31 AM Page: 1398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4757841-0Report Type:Expedited (15-DaCompany Report #2005-131810-NL Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Galactorrhoea Foreign Mirtazapine PS 15 MG/30 MG 207 DAY Initial or Prolonged Sinus Tachycardia Risperidone SS 4 WK Weight Increased Quetiapine Fumarate SS MG 81 DAY Olanzapine C Aripiprazole C Date:08/30/05ISR Number: 4758413-4Report Type:Direct Company Report #CTU 257222 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lactation Disorder Seroquel 300mg Astrazeneca PS Astrazeneca Seroquel 200mg Astrazeneca SS Astrazeneca (TAPERED DOWN THRU 7/16/05) Valtrex C Allegra C Effexor Xr C Eskalith Cr C Buspar C Depo Provera C Date:08/30/05ISR Number: 4758432-8Report Type:Direct Company Report #CTU 257233 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Quetiapine PS ORAL 100MG Initial or Prolonged THREE TIMES DAILY PO Olanzapine SS ORAL 10MG THREE TIMES DAILY PO Date:08/31/05ISR Number: 4757594-6Report Type:Expedited (15-DaCompany Report #2005SE04779 Age:529 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Seroquel PS Zeneca Initial or Prolonged Increased Pharmaceutical ORAL 6 WK Arthralgia Lamictal SS ORAL 2 WK Aspartate Aminotransferase Increased Gamma-Glutamyltransferase Increased Haematuria Myalgia Pyrexia 22-Feb-2006 08:31 AM Page: 1399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/05ISR Number: 4757596-XReport Type:Expedited (15-DaCompany Report #2005SE04772 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Seroquel PS Zeneca Initial or Prolonged Blood Prolactin Increased Pharmaceutical ORAL 300+400 MG Galactorrhoea DAILY 81 DAY Headache Remeron SS ORAL 207 DAY Nausea Risperdal SS ORAL 0.5-1 MG Orthostatic Hypotension TWICE DAILY 28 DAY Sinus Tachycardia Zyprexa SS ORAL 15-20 MG IN Syncope THE EVENING Weight Increased Date:08/31/05ISR Number: 4757599-5Report Type:Expedited (15-DaCompany Report #2005PK01130 Age:8028 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL 100 MG TO 800 MG 29 DAY Risperdal SS ORAL 2 MG TO 4 MG 10 DAY Solian SS ORAL 100 MG TO 400 MG 44 DAY Abilify SS ORAL Date:08/31/05ISR Number: 4757636-8Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0562394A Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Lamictal PS Glaxosmithkline ORAL 4 MON Initial or Prolonged Arthritis Seroquel SS ORAL 100MG At Disability Convulsion night 1 YR Drug Interaction Synthroid C Glaxosmithkline Joint Swelling Rocaltrol C Monarthritis Aleve C Movement Disorder Ibuprofen C Glaxosmithkline Muscle Atrophy Prednisone C Myalgia Atenolol C Photophobia Viacin C Photosensitivity Reaction Date:08/31/05ISR Number: 4757930-0Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-05P-167-0307656-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hot Flush Depakote PS ORAL Hypoglycaemia Quetiapine SS ORAL Levothyroxine C Losartan C Insulin Glargine C Insulin Lispro C 22-Feb-2006 08:31 AM Page: 1400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/05ISR Number: 4759160-5Report Type:Expedited (15-DaCompany Report #S05-CAN-03153-01 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Citalopram PS Depression Health Neurontin Drug Interaction Professional (Gabapentin) SS 1800 MG DAILY Pathological Fracture Other Risperdal Psychotic Disorder (Risperidone) SS Seroquel (Quetiapine Fumarate) SS Loxapine C Date:08/31/05ISR Number: 4759795-XReport Type:Direct Company Report #CTU 257272 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Seroquel PS 200 MG QHS + Feeling Abnormal 25 MG PRN Restlessness Hydrocodone SS 7.5/500 Q4-6 PRN Date:08/31/05ISR Number: 4759796-1Report Type:Direct Company Report #CTU 257274 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Seroquel PS 25 MG AM, Blood Pressure Systolic NOON + 150MG Increased QHS Body Temperature Hydrocodone SS 10 MG Decreased Zyprexa C Disorientation Phenergan C Muscle Spasms Clonidine C Nausea Librium C Psychomotor Hyperactivity Neurontin C Respiratory Rate Robaxin C Increased Restlessness Vomiting Date:08/31/05ISR Number: 4759797-3Report Type:Direct Company Report #CTU 257275 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Seroquel PS ORAL SEE IMAGE Muscle Spasms Vicodin SS 10/325 BID X Psychomotor Hyperactivity 48 HOURS Restlessness Date:08/31/05ISR Number: 4762239-5Report Type:Direct Company Report #CTU 257273 Age:56 YR Gender:Male I/FU:I Outcome PT Other Abnormal Behaviour Blood Pressure Systolic Increased Disorientation Dysarthria 22-Feb-2006 08:31 AM Page: 1401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyskinesia Restlessness Report Source Product Role Manufacturer Route Dose Duration Seroquel PS 100 MG QHS AND 25 MG PRN Lortab 10 SS 10 MG Librium C Catapress C Robaxin C Bentyl C Immodium C Date:09/01/05ISR Number: 4758759-XReport Type:Expedited (15-DaCompany Report #2005GB01636 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Quetiapine PS Zeneca Other Drug Interaction Pharmaceutical ORAL Myocardial Infarction Fluoxetine I ORAL Date:09/02/05ISR Number: 4760348-8Report Type:Expedited (15-DaCompany Report #2005PK01554 Age:23545 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Seroquel PS Zeneca Hospitalization - Convulsion Pharmaceutical ORAL 59 DAY Initial or Prolonged Electrolyte Imbalance Iscover C Hyponatraemia Marital Problem Polydipsia Psychogenic Restlessness Date:09/02/05ISR Number: 4760421-4Report Type:Expedited (15-DaCompany Report #2005AP00763 Age:30254 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Placebo PS ORAL 35 DAY Initial or Prolonged Increased Alusa C Other Aspartate Enalapril C Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Blood Cholesterol Increased Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Date:09/02/05ISR Number: 4760422-6Report Type:Expedited (15-DaCompany Report #2005GB01461 Age:10408 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL 300 MG MANE, 450 MG NOCTE 98 DAY 22-Feb-2006 08:31 AM Page: 1402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/05ISR Number: 4760423-8Report Type:Expedited (15-DaCompany Report #2005PK01362 Age:472 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Incomplete Seroquel PS Zeneca Abortion Missed Pharmaceutical 50 MG UP TO Drug Exposure During 400 MG Pregnancy Seroquel SS Zeneca Pregnancy Pharmaceutical 50 MG UP TO 400 MG Seroquel SS Zeneca Pharmaceutical Seroquel SS Zeneca Pharmaceutical Seroquel SS Zeneca Pharmaceutical 7 DAY Seroquel SS Zeneca Pharmaceutical 7 DAY Seroquel SS Zeneca Pharmaceutical Seroquel SS Zeneca Pharmaceutical Seroquel SS Zeneca Pharmaceutical Seroquel SS Zeneca Pharmaceutical Cipralex SS ORAL Cipralex SS ORAL Cipralex SS ORAL 5 DAY Cipralex SS ORAL 5 DAY Cipralex SS ORAL Cipralex SS ORAL Cipralex SS ORAL Cipralex SS ORAL Cipralex SS ORAL Cipralex SS ORAL Date:09/02/05ISR Number: 4761398-8Report Type:Direct Company Report #CTU 257569 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Quetiapine Fumarate Skin Hypertrophy 25 Mg Va-Unk Weight Increased Rx8347158 PS ORAL 1 TAB BED TIME, WHE PO Date:09/06/05ISR Number: 4761520-3Report Type:Expedited (15-DaCompany Report #2005GB01656 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperkalaemia Seroquel PS Zeneca Initial or Prolonged Overdose Pharmaceutical ORAL 100MG OR Other 150MG TWICE A DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Paracetamol SS ORAL 1 DAY Paroxetine SS ORAL 1 DAY Vodka SS ORAL A BOTTLE OF 22-Feb-2006 08:31 AM Page: 1403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report VODKA 1 DAY Date:09/06/05ISR Number: 4761526-4Report Type:Expedited (15-DaCompany Report #2005AP03905 Age:10945 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Seroquel PS Zeneca Initial or Prolonged Diabetic Ketoacidosis Pharmaceutical ORAL Hypokalaemia Risperdal SS ORAL 339 DAY Risperdal SS ORAL 338 DAY Tegretol SS ORAL 318 DAY Toledomin C ORAL Acinon C ORAL 31 DAY Rohypnol C ORAL Primperan C ORAL 8 DAY Akineton C ORAL Amoban C ORAL Date:09/06/05ISR Number: 4761529-XReport Type:Expedited (15-DaCompany Report #2005AP04638 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Other Overdose Pharmaceutical ORAL Date:09/06/05ISR Number: 4761534-3Report Type:Expedited (15-DaCompany Report #2005AC00723 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Condition Aggravated Pharmaceutical ORAL Schizophrenia, Akineton C ORAL Disorganised Type Depakine C ORAL Treatment Noncompliance Nocatamid C ORAL Stilnox C ORAL Omeprazole C ORAL Zyprexa C ORAL Date:09/06/05ISR Number: 4761574-4Report Type:Expedited (15-DaCompany Report #2005PK01445 Age:9275 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Seroquel PS Zeneca Hospitalization - Drug Exposure During Pharmaceutical ORAL TOOK 60 Initial or Prolonged Pregnancy TABLETS OF Intra-Uterine Death 200 MG Overdose Respiratory Failure Status Epilepticus Date:09/06/05ISR Number: 4761873-6Report Type:Expedited (15-DaCompany Report #2005AP04335 Age:24498 DYGender:Male I/FU:F Outcome PT Hospitalization - Dehydration Initial or Prolonged Granulocyte Count Decreased 22-Feb-2006 08:31 AM Page: 1404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutrophil Count Decreased Pyrexia Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL 8 MON Seroquel SS Zeneca Pharmaceutical ORAL 3 DAY Silece SS ORAL Silece SS ORAL 3 DAY Pyrethia SS ORAL Limas C ORAL Limas C ORAL 3 DAY Akineton C ORAL Akineton C ORAL 3 DAY Pursennid C ORAL Pursennid C ORAL 3 DAY Date:09/06/05ISR Number: 4765160-1Report Type:Expedited (15-DaCompany Report #2005120764 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zoloft (Sertraline) PS ORAL 25 MG (25 MG, Initial or Prolonged Drug Ineffective 1 IN 1 D), Other Psychotic Disorder ORAL Zyprexa (Olanzapine) SS Seroquel (Quetiapine Fumarate) SS Concreta (Methylphenidate Hydrochloride) C Date:09/06/05ISR Number: 4766081-0Report Type:Expedited (15-DaCompany Report #2005120764 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zoloft (Sertraline) PS ORAL 25 MG (25 MG, Initial or Prolonged Aggression 1 IN 1 D), Other Agitation ORAL Psychotic Disorder Zyprexa (Olanzapine) SS Unevaluable Event Seroquel (Quetiapine Fumarate) SS Concerta (Methylphenidate Hydrochloride) C Date:09/07/05ISR Number: 4762250-4Report Type:Expedited (15-DaCompany Report #2005UW12154 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Seroquel PS Zeneca Apathy Pharmaceutical ORAL 20 25 MG AND Completed Suicide 20 100 MG Depressed Mood Alcohol SS Hallucination Wellbutrin C Somnolence Zoloft C 4 Other Antidepressants C 22-Feb-2006 08:31 AM Page: 1405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/05ISR Number: 4762455-2Report Type:Expedited (15-DaCompany Report #2005UW09324 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Seroquel PS Zeneca Initial or Prolonged Anal Infection Pharmaceutical ORAL 1639 DAY Disability Asthenia Tegretol C ORAL Bacterial Infection Tegretol C ORAL Blood Pressure Increased Depakote - Slow Coordination Abnormal Release C ORAL Diabetes Mellitus Diabetic Ketoacidosis Dyspnoea Fall Fungal Skin Infection Heart Rate Increased Hypokalaemia Hypophosphataemia Obesity Rash Pustular Tachypnoea Vaginal Candidiasis Weight Increased Date:09/07/05ISR Number: 4762659-9Report Type:Expedited (15-DaCompany Report #2005UW12802 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Seroquel PS Zeneca Initial or Prolonged Aphasia Pharmaceutical ORAL 300 MG AND 25 Disability Confusional State MG PRN Disorientation Seroquel SS Zeneca Serotonin Syndrome Pharmaceutical ORAL 200 MG HS AND Urinary Retention 100 MG PRN Effexor C ORAL Gabapentin C ORAL Date:09/07/05ISR Number: 4762664-2Report Type:Expedited (15-DaCompany Report #2005UW10552 Age:17333 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Auricular Swelling Seroquel PS Zeneca Dry Mouth Pharmaceutical ORAL Ear Pain Seroquel SS Zeneca Local Swelling Pharmaceutical ORAL Neck Pain Zocor C ORAL Shoulder Pain Synthroid C ORAL Tongue Haemorrhage Diovan Hct C ORAL 160/12.5 Norvasc C ORAL Date:09/08/05ISR Number: 4763293-7Report Type:Expedited (15-DaCompany Report #2005UW13002 Age:49 YR Gender:Female I/FU:I Outcome PT Other Affective Disorder Amnesia Aura Bipolar Ii Disorder Confusional State 22-Feb-2006 08:31 AM Page: 1406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Convulsion Fall Fatigue Report Source Product Role Manufacturer Route Dose Duration Loss Of Consciousness Seroquel PS Zeneca Memory Impairment Pharmaceutical ORAL 25MG GRADUAL Nausea INCREASE TO Neck Pain 200MG 17 DAY Paraesthesia Seroquel SS Zeneca Stress Pharmaceutical ORAL Tonic Convulsion Wellbutrin Sr SS ORAL 7 DAY Tremor Wellbutrin Sr SS ORAL Weight Decreased Wellbutrin Sr SS ORAL 200MG AM, 1/2 200MG TABLET AT NIGHT Synthroid C Esterified Estrogens C Doxepin C 310 DAY Zolpidem Tartrate C 526 DAY Lorazepam C 4 MON Zolmitriptan C Date:09/08/05ISR Number: 4763355-4Report Type:Expedited (15-DaCompany Report #2005AC00798 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Seroquel PS Zeneca Pharmaceutical ORAL Date:09/08/05ISR Number: 4763369-4Report Type:Expedited (15-DaCompany Report #2005AP04697 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Seroquel PS Zeneca Ulcerative Keratitis Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Date:09/08/05ISR Number: 4763385-2Report Type:Expedited (15-DaCompany Report #IT-BRISTOL-MYERS SQUIBB COMPANY-13098009 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Trittico PS Apothecon ORAL Hospitalization - Chronic Obstructive Seroquel SS ORAL Initial or Prolonged Pulmonary Disease Sereprile SS ORAL Cardirene C Nimotop C ORAL Date:09/08/05ISR Number: 4763638-8Report Type:Expedited (15-DaCompany Report #2005SE04997 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Quetiapine PS Zeneca Pulmonary Embolism Pharmaceutical ORAL Clonazepam C Clonazepam C Lamotrigin C 25-100 MG Haloperidol C 22-Feb-2006 08:31 AM Page: 1407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paracetamol C Paracetamol C Date:09/08/05ISR Number: 4765923-2Report Type:Direct Company Report #CTU 257864 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Glossodynia Seroquel PS ORAL 300 MG TID PO Sedation Date:09/08/05ISR Number: 4766649-1Report Type:Expedited (15-DaCompany Report #2005110990 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Zoloft (Sertraline) PS Meningitis Professional Seroquel (Quetiapine Paranoia Fumarate) SS Psychotic Disorder Cardizem (Diltiazem Serotonin Syndrome Hydrochloride) C Risperdal (Risperdal) C Date:09/09/05ISR Number: 4764246-5Report Type:Expedited (15-DaCompany Report #DK-RB-1165-2004 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Buprenorphine Other Gingival Bleeding Hydrochloride PS SUBLINGUAL UNKNOWN Pulmonary Haemorrhage Quetiapine Fumarate SS ORAL Splenomegaly Chlorprothixene Hydrochloride SS ORAL Clonazepam SS ORAL Date:09/09/05ISR Number: 4764334-3Report Type:Expedited (15-DaCompany Report #DK-RB-1165-2004 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Buprenorphine Other Gingival Bleeding Hydrochloride PS Reckitt Benckiser SUBLINGUAL UNKNOWN Pulmonary Haemorrhage Quetiapine Fumarate SS ORAL Splenomegaly Chlorprothixene Hydrochloride SS ORAL Clonazepam SS ORAL Date:09/09/05ISR Number: 4764335-5Report Type:Expedited (15-DaCompany Report #2005AC00797 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Seroquel PS Zeneca Hospitalization - Sudden Death Pharmaceutical ORAL Initial or Prolonged 22-Feb-2006 08:31 AM Page: 1408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/05ISR Number: 4764499-3Report Type:Expedited (15-DaCompany Report #2005AC01280 Age:14699 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Seroquel PS Zeneca Initial or Prolonged Intentional Misuse Pharmaceutical ORAL Overdose Seroquel SS Zeneca Sedation Pharmaceutical ORAL Suicide Attempt Date:09/09/05ISR Number: 4764607-4Report Type:Expedited (15-DaCompany Report #2005UW12990 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Seroquel PS Zeneca Initial or Prolonged Hypercalcaemia Pharmaceutical ORAL Malaise Seroquel SS Zeneca Pharmaceutical ORAL Clonidine C Buspar C Remeron C Date:09/09/05ISR Number: 4764609-8Report Type:Expedited (15-DaCompany Report #2005AP04741 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Megaloblastic Seroquel PS Zeneca Pharmaceutical ORAL Date:09/09/05ISR Number: 4764615-3Report Type:Expedited (15-DaCompany Report #2004GB02468 Age:30415 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Seroquel PS Zeneca Initial or Prolonged Fall Pharmaceutical ORAL Fracture Atenolol SS Zeneca Upper Limb Fracture Pharmaceutical ORAL 5 YR Aspirin C ORAL Paracetamol C ORAL Amitriptyline C ORAL Senna C ORAL Atorvastatin C ORAL Date:09/09/05ISR Number: 4764726-2Report Type:Expedited (15-DaCompany Report #2005GB01523 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Quetiapine PS Zeneca Decreased Pharmaceutical ORAL Zaponex SS ORAL 100 AM AND 125 MG PM Diazepam C UNKNOWN 20 MG/DAY /PRN Ibuprofen C UNKNOWN Haloperidol C UNKNOWN Hyoscine C UNKNOWN 22-Feb-2006 08:31 AM Page: 1409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/05ISR Number: 4764879-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050900820 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Risperdal PS Necrosis Ischaemic Seroquel SS Neuroleptic Malignant Syndrome Overdose Renal Failure Acute Rhabdomyolysis Date:09/12/05ISR Number: 4765429-0Report Type:Expedited (15-DaCompany Report #JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BAge:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Liver Disorder Mobic PS B.I. Other Sepsis Pharmaceuticals,Inc. /Ridgefield ORAL Novastatan SS INTRAVENOUS Radicut SS INTRAVENOUS Blopress SS ORAL Seroquel SS ORAL Myslee SS ORAL Loxonin SS ORAL Solita-T No. 3 C INTRAVENOUS Lanirapid C ORAL Itorol C ORAL Aspirin C ORAL Warfarin C ORAL Gaster D C ORAL Lasix C ORAL Dextrose C INTRAVENOUS Date:09/12/05ISR Number: 4765754-3Report Type:Expedited (15-DaCompany Report #2005GB01346 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coordination Abnormal Seroquel PS Zeneca Hospitalization - Decreased Appetite Pharmaceutical ORAL Initial or Prolonged Drug Interaction Seroquel SS Zeneca Drug Prescribing Error Pharmaceutical ORAL 3 DAY Dysarthria Seroquel SS Zeneca Fall Pharmaceutical ORAL 65 DAY Feeling Abnormal Modecate SS UNKNOWN Pneumonia Aspiration Modecate SS UNKNOWN Somnolence Lofepramine SS ORAL Transient Ischaemic Lofepramine SS ORAL Attack Lofepramine SS ORAL INCREASED TO 140MG Tolterodine C Alendronate C Lactose Solution C ORAL Zopiclone C Tramadol Hydrochloride C Ibuprofen C Paracetamol C Tolterodine C Adcal C 22-Feb-2006 08:31 AM Page: 1410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/05ISR Number: 4766362-0Report Type:Expedited (15-DaCompany Report #PHNU2005DE03034 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex / Clozaril Initial or Prolonged Accidental Overdose (Clozapine) PS Novartis Sector: Tachycardia Pharma ORAL 200 mg, ONCE/SINGLE Seroquel SS ORAL 200 mg, ONCE/SINGLE Tavor SS ORAL 2 mg, ONCE/SINGLE Date:09/13/05ISR Number: 4767103-3Report Type:Expedited (15-DaCompany Report #2005UW11563 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Seroquel PS Zeneca Anxiety Pharmaceutical ORAL Depression Bupropion SS ORAL 36 DAY Suicidal Ideation Bupropion SS ORAL 36 DAY Lamictal SS ORAL Effexor SS Cymbalta SS Lithium C Actos C Glipizide C Synthroid C Avapro C Clonazepam C Ambien C Inderal C UNKNOWN Prozac C Climara C Cholestyramine C Elavil C ORAL Date:09/13/05ISR Number: 4767266-XReport Type:Expedited (15-DaCompany Report #2005UW11998 Age:3937 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Quetiapine PS Zeneca Neutropenia Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL 2 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 21 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 21 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY Concerta C ORAL Date:09/13/05ISR Number: 4767331-7Report Type:Expedited (15-DaCompany Report #2005UW09288 Age:16 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Agitation 22-Feb-2006 08:31 AM Page: 1411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bipolar Disorder Drug Ineffective Report Source Product Role Manufacturer Route Dose Duration Quetiapine PS Zeneca Pharmaceutical ORAL 200 MG QAM; 200 MG AFTERNOON; 400 MG HS 106 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 8 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 300 MG QAM; 300 MG 3PM; 200 MG HS Date:09/13/05ISR Number: 4767533-XReport Type:Expedited (15-DaCompany Report #2005PK01656 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Seroquel PS Zeneca Initial or Prolonged Leukopenia Pharmaceutical ORAL No Adverse Drug Effect Date:09/14/05ISR Number: 4768315-5Report Type:Expedited (15-DaCompany Report #2005GB01461 Age:10408 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL 300 MG MANE, 450 MG NOCTE 98 DAY Date:09/14/05ISR Number: 4768317-9Report Type:Expedited (15-DaCompany Report #2005AP04376 Age:14556 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Eruption Seroquel PS Zeneca Hospitalization - Granulocytopenia Pharmaceutical ORAL 48 DAY Initial or Prolonged Limas SS ORAL 48 DAY Hirnamin C ORAL Silece C ORAL Vegatamin A C ORAL Date:09/14/05ISR Number: 4768318-0Report Type:Expedited (15-DaCompany Report #2005AC01292 Age:488 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bulimia Nervosa Seroquel PS Zeneca Pharmaceutical ORAL Depakine C ORAL Maniprex C ORAL Seroxat C ORAL 22-Feb-2006 08:31 AM Page: 1412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/05ISR Number: 4768548-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902585 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Ibuprofen PS ORAL Intentional Misuse Quetiapine SS ORAL Overdose Paroxetine SS ORAL Date:09/14/05ISR Number: 4768610-XReport Type:Expedited (15-DaCompany Report #2003UW13607 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Seroquel PS Zeneca Asthenia Pharmaceutical ORAL Balance Disorder Serzone SS ORAL 4-5 YEARS Brain Damage Serzone SS ORAL Cognitive Disorder Paxil C ORAL Diarrhoea Paxil C ORAL Dysphasia Premarin C Encephalopathy Fatigue Headache Hypersomnia Lethargy Medication Error Memory Impairment Muscle Spasms Muscle Twitching Tremor Wrong Drug Administered Date:09/14/05ISR Number: 4768624-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050901830 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Topiramate PS ORAL Hospitalization - Completed Suicide Acetaminophen/Diphen Initial or Prolonged Electrocardiogram Qt hydramine SS ORAL Corrected Interval Lorazepam SS ORAL Prolonged Quetiapine SS ORAL Intentional Misuse Fluoxetine SS ORAL Respiratory Failure Date:09/14/05ISR Number: 4768646-9Report Type:Expedited (15-DaCompany Report #2005UW13440 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aseptic Necrosis Bone Seroquel PS Zeneca Initial or Prolonged Depression Pharmaceutical ORAL Other Dialysis Seroquel SS Zeneca Neuroleptic Malignant Pharmaceutical ORAL Syndrome Rhabdomyolysis 22-Feb-2006 08:31 AM Page: 1413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/05ISR Number: 4768754-2Report Type:Expedited (15-DaCompany Report #2005018344 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoxia Quilonum Retard PS Glaxosmithkline ORAL 450MG See Initial or Prolonged Intentional Misuse dosage text 1 DAY Sopor Seroquel SS ORAL 100MG See Suicide Attempt dosage text 1 DAY Zopiclon SS ORAL 7.5MG See dosage text 1 DAY Date:09/14/05ISR Number: 4769942-1Report Type:Direct Company Report #CTU 258209 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Ciprofloxacin PS ORAL CIPRO 250 MG Initial or Prolonged BID PO Other Quetiapine SS Date:09/14/05ISR Number: 4771392-9Report Type:Expedited (15-DaCompany Report #HQWYE265006SEP05 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aseptic Necrosis Bone Consumer Effexor Xr PS Initial or Prolonged Depression Seroquel Dialysis (Quetiapine,) SS Hypoaesthesia Intentional Misuse Muscle Disorder Muscle Injury Nerve Injury Neuroleptic Malignant Syndrome Overdose Renal Failure Respiratory Failure Rhabdomyolysis Date:09/14/05ISR Number: 4771617-XReport Type:Direct Company Report #CTU 258175 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Seroquel PS Hospitalization - Phosphokinase Increased Prozac SS Initial or Prolonged Convulsion Required Drug Toxicity Intervention to Medication Error Prevent Permanent Overdose Impairment/Damage Date:09/15/05ISR Number: 4769082-1Report Type:Expedited (15-DaCompany Report #2005UW13274 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Intentional Misuse Pharmaceutical ORAL Overdose Seroquel I Zeneca Suicide Attempt Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone I ORAL Trazodone I ORAL Date:09/15/05ISR Number: 4769083-3Report Type:Expedited (15-DaCompany Report #2005UW11556 Age:10274 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Seroquel PS Zeneca Abdominal Distension Pharmaceutical ORAL 3 DAY Seroquel SS Zeneca Pharmaceutical ORAL INCREASED 26 DAY Prozac C ORAL Date:09/15/05ISR Number: 4769084-5Report Type:Expedited (15-DaCompany Report #2005UW13221 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Seroquel PS Zeneca Initial or Prolonged Balance Disorder Pharmaceutical ORAL Fall Seroquel SS Zeneca Feeling Abnormal Pharmaceutical ORAL Hallucination, Visual Seroquel SS Zeneca Somnolence Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Lithium C Lorazepam C Lisinopril C Date:09/15/05ISR Number: 4769878-6Report Type:Expedited (15-DaCompany Report #2005UW13542 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Seroquel PS Zeneca Initial or Prolonged Renal Failure Pharmaceutical ORAL MULTIPLE STRENGTHS TAKEN Lamictal C Other Medication C Date:09/15/05ISR Number: 4769879-8Report Type:Expedited (15-DaCompany Report #2005PK01554 Age:23545 DYGender:Female I/FU:F Outcome PT Life-Threatening Agitation Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Body Temperature Increased 22-Feb-2006 08:31 AM Page: 1415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Convulsion Disturbance In Attention Fall Report Source Product Role Manufacturer Route Dose Duration Hyponatraemia Seroquel PS Zeneca Inappropriate Pharmaceutical ORAL 59 DAY Antidiuretic Hormone Iscover C Secretion Polydipsia Restlessness Date:09/15/05ISR Number: 4769883-XReport Type:Expedited (15-DaCompany Report #2005AP04380 Age:16318 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Seroquel PS Zeneca Initial or Prolonged Heart Rate Increased Pharmaceutical ORAL 36 TABLETS 2 DAY Other Overdose Myslee SS ORAL 23 TABLETS 2 DAY Pyrexia Suicide Attempt Unresponsive To Verbal Stimuli Date:09/15/05ISR Number: 4769886-5Report Type:Expedited (15-DaCompany Report #2005UW12195 Age:31260 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Seroquel PS Zeneca Initial or Prolonged Hip Fracture Pharmaceutical ORAL Disability Orthostatic Hypotension Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL 15 DAY Date:09/15/05ISR Number: 4770201-1Report Type:Expedited (15-DaCompany Report #RO-JNJFOC-20050900860 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urticaria Quetiapine PS ORAL 28 DAY Seroquel SS ORAL 28 DAY Date:09/15/05ISR Number: 4770600-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050901926 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Acetaminophen/Oxycod one PS ORAL Oxycodone SS ORAL Diazepam SS ORAL Clonazepam SS ORAL Escitalopram SS ORAL Quetiapine SS ORAL Gabapentin SS ORAL 22-Feb-2006 08:31 AM Page: 1416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/05ISR Number: 4770601-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050901955 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Death Risperdal PS Cardiac Arrest Benztropine SS Cardio-Respiratory Arrest Citalopram SS Cerebrovascular Accident Clonazepam SS Electrocardiogram Qt Lorazepam SS Corrected Interval Quetiapine SS Prolonged Ziprasidone SS Hepatocellular Damage Hyperpyrexia Neuroleptic Malignant Syndrome Rhabdomyolysis Supraventricular Tachycardia Torsade De Pointes Ventricular Fibrillation Date:09/16/05ISR Number: 4771766-6Report Type:Expedited (15-DaCompany Report #2005GB01757 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Quetiapine PS Zeneca White Blood Cell Count Pharmaceutical ORAL Decreased Sodium Valproate SS ORAL 750 MG MANE, 1000 MG NOCTE Olanzapine C ORAL 1 MON Semisodium Valproate C Date:09/16/05ISR Number: 4771768-XReport Type:Expedited (15-DaCompany Report #2005UW11740 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Seroquel PS Zeneca Pericardial Effusion Pharmaceutical ORAL Zyprexa C Date:09/16/05ISR Number: 4771883-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902361 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Cyclobenzaprine PS ORAL Hospitalization - Intentional Misuse Acetaminophen/Hydroc Initial or Prolonged odone SS ORAL Acetaminophen/Hydroc odone SS ORAL Quetiapine SS ORAL Propanolol SS ORAL Date:09/16/05ISR Number: 4771884-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902464 Age:33 YR Gender:Female I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:31 AM Page: 1417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Completed Suicide Cyclobenzaprine PS ORAL Drug Screen Positive Sertraline SS ORAL Drug Toxicity Diltiazem SS ORAL Heart Rate Increased Chlorcyclizine SS ORAL Hepatic Necrosis Methamphetamine SS ORAL Hepatomegaly Quetiapine SS ORAL Intentional Misuse Mental Status Changes Metabolic Acidosis Multi-Organ Failure Date:09/16/05ISR Number: 4772469-4Report Type:Direct Company Report #CTU 258354 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Seroquel 300 Mg PS ORAL 300 MG BID PO Initial or Prolonged Diabetic Ketoacidosis Depakote SS 1000 MG Somnolence Date:09/16/05ISR Number: 4773245-9Report Type:Expedited (15-DaCompany Report #KII-2005-0018610 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Morphine Sulfate Initial or Prolonged Alanine Aminotransferase Health (Similar To Nda Other Increased Professional 19-516) (Morphine Aspartate Other Sulfate) PS ORAL ORAL Aminotransferase Quetiapine Increased (Quetiapine) SS ORAL ORAL Aspiration Atenolol (Atenolol) SS ORAL ORAL Blood Pressure Decreased Trazodone Coma (Trazodone) SS ORAL ORAL Confusional State Barbiturates SS Convulsion Benzodiazepine Drug Dependence Derivatives SS Electrocardiogram Qt Ssri SS ORAL ORAL Corrected Interval Meloxicam Prolonged (Meloxicam) SS ORAL ORAL Polysubstance Abuse Felodipine Self-Medication (Felodipine) SS ORAL ORAL Vomiting Tacrolimus (Tacrolimus) SS ORAL ORAL Date:09/19/05ISR Number: 4772142-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902462 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Aspirin PS ORAL Hospitalization - Convulsion Acetaminophen/Bromph Initial or Prolonged Drug Exposure During eniramine/Pseudoephe Pregnancy drine SS Intentional Misuse Quetiapine SS Respiration Abnormal Chlorpheniramine SS ORAL 22-Feb-2006 08:31 AM Page: 1418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/05ISR Number: 4772501-8Report Type:Expedited (15-DaCompany Report #2005UW11544 Age:8725 DY Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Seroquel PS Zeneca Initial or Prolonged Ill-Defined Disorder Pharmaceutical ORAL Other Leukopenia Seroquel SS Zeneca Neutropenia Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Depakote C Date:09/19/05ISR Number: 4772502-XReport Type:Expedited (15-DaCompany Report #2005SE05171 Age:11033 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocardial Infarction Seroquel PS Zeneca Hospitalization - Pharmaceutical ORAL 2 DAY Initial or Prolonged Seroquel SS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 23 DAY Seroquel SS Zeneca Pharmaceutical ORAL 23 DAY Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Trilafon SS ORAL Trilafon SS ORAL Trilafon SS ORAL 8+8+24 MG DAILY 27 DAY Trilafon SS ORAL 8+8+24 MG DAILY 27 DAY Trilafon SS ORAL 8+8+16 MG DAILY 5 DAY Trilafon SS ORAL 8+8+16 MG DAILY 5 DAY Trilafon SS ORAL 8+16 MG DAILY Trilafon SS ORAL 8+16 MG DAILY Trilafon SS Trilafon SS Nozinan C ORAL ACTUAL MEDICAL STATUS THAT DAY, NOT NECESSARILY Nozinan C ORAL 25-50 MG, MAXIMUM X2 Imovane C ORAL ACTUAL MEDICAL STATUS THAT DAY, NOT NECESSARILY Lysantin C ORAL ACTUAL MEDICAL STATUS THAT 22-Feb-2006 08:31 AM Page: 1419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY, NOT NECESSARILY Cipralex C Date:09/19/05ISR Number: 4772644-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902540 Age:41 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Aspirin PS ORAL Intentional Misuse Quetiapine SS ORAL Date:09/19/05ISR Number: 4772722-4Report Type:Expedited (15-DaCompany Report #2005AP04870 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Incoherent Seroquel PS Zeneca Other Intentional Misuse Pharmaceutical ORAL Overdose Seroquel SS Zeneca Suicidal Ideation Pharmaceutical ORAL POSSIBLY TOOK 44 TABLETS AT ONE TIME. Date:09/19/05ISR Number: 4773011-4Report Type:Expedited (15-DaCompany Report #2005AP04475 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Overdose Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Date:09/20/05ISR Number: 4773522-1Report Type:Expedited (15-DaCompany Report #2005UW12218 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Seroquel PS Zeneca Hospitalization - Increased Pharmaceutical ORAL 300 MG TID, Initial or Prolonged Aspartate 1000 MG HS Aminotransferase Seroquel SS Zeneca Increased Pharmaceutical ORAL 300 MG TID, Blood Alkaline 1000 MG HS Phosphatase Increased Seroquel SS Zeneca Cardiac Arrest Pharmaceutical ORAL Hepatic Enzyme Increased Seroquel SS Zeneca Hyperglycaemia Pharmaceutical ORAL Hyperkalaemia Seroquel SS Zeneca Life Support Pharmaceutical ORAL Pancreatitis Seroquel SS Zeneca Renal Failure Pharmaceutical ORAL Ventricular Extrasystoles Seroquel SS Zeneca Pharmaceutical ORAL 300 MG AM, 200 MG PM, 400 MG HS Seroquel SS Zeneca Pharmaceutical ORAL 300 MG AM, 200 MG PM, 400 MG HS Seroquel SS Zeneca 22-Feb-2006 08:31 AM Page: 1420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Fenofibrate SS 12 DAY Fenofibrate SS 12 DAY Topamax C ORAL 25 MG AM, 125 MG HS Topamax C ORAL 25 MG AM, 125 MG HS Chlorpromazine C Chlorpromazine C Clonazepam C Clonazepam C Clonazepam C 2 DAY Clonazepam C 2 DAY Clonazepam C Clonazepam C Clonazepam C 1 MG AM, 2 MG HS Clonazepam C 1 MG AM, 2 MG HS Zopiclone C ORAL Alendronate C ORAL EVERY WEDNESDAY Pantoprazole C ORAL Senokot C ORAL Soflax C ORAL Calcium With Vitamin D C ORAL CALCIUM 500 MG, VIT D 125 UNITS Vitamin D C ORAL Date:09/20/05ISR Number: 4773587-7Report Type:Expedited (15-DaCompany Report #2005UW03421 Age:21699 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 162 DAY Date:09/20/05ISR Number: 4773595-6Report Type:Expedited (15-DaCompany Report #2005GB01779 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dysarthria Seroquel PS Zeneca Fall Pharmaceutical ORAL 1 DAY Somnolence Risperidone C ORAL 127 DAY Aspirin C ORAL Bisoprolol C ORAL Finasteride C UNKNOWN Date:09/20/05ISR Number: 4773905-XReport Type:Periodic Company Report #EE-JNJFOC-20050500043 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Risperidone Consta PS INTRAMUSCULAR No J & J drug Initial or Prolonged given Seroquel SS ORAL Remeron C ORAL 22-Feb-2006 08:31 AM Page: 1421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/05ISR Number: 4773990-5Report Type:Expedited (15-DaCompany Report #2005PK01710 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 56 DAY Leponex SS ORAL 39 DAY Date:09/20/05ISR Number: 4773995-4Report Type:Periodic Company Report #2003AP03447 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Aricept C UNKNOWN Cercine C UNKNOWN Date:09/20/05ISR Number: 4773996-6Report Type:Periodic Company Report #2005UW01764 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erythema Seroquel PS Zeneca Pharmaceutical ORAL Symbyax C Prozac C Date:09/20/05ISR Number: 4774033-XReport Type:Expedited (15-DaCompany Report #2005UW13792 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Seroquel PS Zeneca Other Drug Toxicity Pharmaceutical ORAL AN UNKNOWN Intentional Misuse QUANTITY Loss Of Consciousness CRUSHED AND Murder PUT INTO BEER Overdose Beer SS ORAL DRANK 2 BEERS 1 DAY Date:09/20/05ISR Number: 4775615-1Report Type:Expedited (15-DaCompany Report #S05-USA-04294-01 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Campral (Acamprosate Energy Increased Professional Calcium) PS ORAL 666 MG TID PO Mania Company Seroquel (Quetiapine Personality Change Representative Fumarate SS 200 MG QHS Klonopin (Clonazepam) C Xanax (Alprazolam) C Atenolol C 22-Feb-2006 08:31 AM Page: 1422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/05ISR Number: 4774609-XReport Type:Expedited (15-DaCompany Report #2005AC01378 Age:64 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Intentional Misuse Pharmaceutical ORAL Overdose Clonazepam SS Date:09/21/05ISR Number: 4774610-6Report Type:Expedited (15-DaCompany Report #2005SE05242 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Seroquel PS Zeneca Cardiomyopathy Pharmaceutical ORAL Death Stesolid C Drug Interaction Imovane C Drug Toxicity Leponex I ORAL Intentional Misuse Muscle Spasms Muscle Twitching Overdose Petit Mal Epilepsy Date:09/21/05ISR Number: 4774611-8Report Type:Expedited (15-DaCompany Report #2005SE05251 Age:10790 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Quetiapine PS Zeneca Urticaria Pharmaceutical ORAL 28 DAY Date:09/21/05ISR Number: 4774613-1Report Type:Expedited (15-DaCompany Report #2005UW13774 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Seroquel PS Zeneca Pharmaceutical ORAL 25 MG TITRATED TO 400 MG BID Depakote C Estradiol C Lexapro C Oscal C Naprosyn C Exelon C Prilosec C Tylenol C Trazodone C Cogentin C Dulcolax C Date:09/21/05ISR Number: 4774614-3Report Type:Expedited (15-DaCompany Report #2005SE04997 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Hospitalization - Overdose Pharmaceutical ORAL 1 YR Initial or Prolonged Pulmonary Embolism Quetiapine SS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quetiapine SS Zeneca Pharmaceutical ORAL Clonazepam C Clonazepam C Lamotrigin C 25-100 MG Haloperidol C Paracetamol C Paracetamol C Date:09/21/05ISR Number: 4774617-9Report Type:Expedited (15-DaCompany Report #2005GB01656 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Seroquel PS Zeneca Initial or Prolonged Consciousness Pharmaceutical ORAL 100MG OR Other Dyspnoea 150MG TWICE A Hyperkalaemia DAY Overdose Seroquel SS Zeneca Somnolence Pharmaceutical ORAL 1 DAY Paracetamol SS ORAL 1 DAY Paroxetine SS ORAL 1 DAY Vodka SS ORAL A BOTTLE OF VODKA 1 DAY Date:09/21/05ISR Number: 4774621-0Report Type:Expedited (15-DaCompany Report #2005AC01360 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Incorrect Route Of Drug Quetiapine PS Zeneca Administration Pharmaceutical ORAL TABLETS Sedation CRUSHED AND MADE INTO A SOLUTION, TAKEN Quetiapine SS Zeneca Pharmaceutical ORAL TABLETS CRUSHED AND MADE INTO A SOLUTION, TAKEN Quetiapine SS Zeneca Pharmaceutical ORAL TABLETS CRUSHED AND MADE INTO A SOLUTION, TAKEN Date:09/21/05ISR Number: 4774623-4Report Type:Expedited (15-DaCompany Report #2005AC01382 Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Overdose Pharmaceutical ORAL Oxycodone SS Bupropion SS 22-Feb-2006 08:31 AM Page: 1424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/05ISR Number: 4774624-6Report Type:Expedited (15-DaCompany Report #2005AC01372 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Intentional Misuse Pharmaceutical ORAL Overdose Date:09/21/05ISR Number: 4774626-XReport Type:Expedited (15-DaCompany Report #2005AC01302 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Seroquel PS Zeneca Pharmaceutical ORAL STARTED IN MAY, YEAR NOT SPECIFIED Date:09/21/05ISR Number: 4774728-8Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-A0574943A Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Wellbutrin Sr PS Glaxosmithkline ORAL Pupillary Reflex Impaired Seroquel SS UNKNOWN Tachycardia Clonazepam SS UNKNOWN Citalopram SS UNKNOWN Seroquel SS UNKNOWN Alcohol C Ranitidine C Glaxosmithkline Thyroid C Date:09/21/05ISR Number: 4774793-8Report Type:Expedited (15-DaCompany Report #2005AC01379 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Pharmaceutical ORAL Olanzapine SS Zolpidem SS Date:09/21/05ISR Number: 4775189-5Report Type:Expedited (15-DaCompany Report #US-MERCK-0509USA02202 Age:60 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Zocor PS Merck & Co., Inc ORAL Completed Suicide Quetiapine Fumarate SS ORAL Diclofenac SS ORAL Date:09/21/05ISR Number: 4775287-6Report Type:Direct Company Report #CTU 258568 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Benign Intracranial Seroquel PS 300 MG BID Intervention to Hypertension Zoloft SS 150 MG QD Prevent Permanent Dizziness Impairment/Damage Lumbar Puncture Abnormal Papilloedema Vision Blurred 22-Feb-2006 08:31 AM Page: 1425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/05ISR Number: 4775562-5Report Type:Expedited (15-DaCompany Report #2005UW12217 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Pain Seroquel PS Zeneca Initial or Prolonged Dyskinesia Pharmaceutical ORAL Dyspnoea Seroquel SS Zeneca Menstruation Irregular Pharmaceutical Nasal Congestion Panic Attack Pharyngolaryngeal Pain Thinking Abnormal Throat Tightness Thyroid Function Test Abnormal Vertigo Date:09/22/05ISR Number: 4775568-6Report Type:Expedited (15-DaCompany Report #2005CG01530 Age:13700 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Quetiapine PS Zeneca Initial or Prolonged Depression Pharmaceutical ORAL Persecutory Delusion Quetiapine SS Zeneca Psychotic Disorder Pharmaceutical ORAL 6 DAY Lorazepam C Venlafaxine C ORAL Date:09/22/05ISR Number: 4775569-8Report Type:Expedited (15-DaCompany Report #2005SE05287 Age:11826 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Seroquel PS Zeneca Pupil Fixed Pharmaceutical ORAL 25 DAY Respiratory Arrest Seroquel SS Zeneca Sudden Death Pharmaceutical ORAL 11 DAY Propycil C ORAL 3X1 Date:09/22/05ISR Number: 4775776-4Report Type:Expedited (15-DaCompany Report #2005AC01399 Age:60 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Multiple Drug Overdose Pharmaceutical ORAL Simvastatin SS Diclofenac SS Date:09/22/05ISR Number: 4775777-6Report Type:Expedited (15-DaCompany Report #2005AC01396 Age:62 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Multiple Drug Overdose Pharmaceutical ORAL Clonazepam SS 22-Feb-2006 08:31 AM Page: 1426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/05ISR Number: 4775778-8Report Type:Expedited (15-DaCompany Report #2005AC01395 Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Multiple Drug Overdose Pharmaceutical ORAL Propranolol SS Cyclobenzaprine SS Date:09/22/05ISR Number: 4775779-XReport Type:Expedited (15-DaCompany Report #2005AC01394 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Multiple Drug Overdose Pharmaceutical ORAL Paroxetine SS Ibuprofen SS Date:09/22/05ISR Number: 4775780-6Report Type:Expedited (15-DaCompany Report #2005AC01091 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Microangiopathic Quetiapine PS Zeneca Initial or Prolonged Haemolytic Anaemia Pharmaceutical ORAL Other Plasmapheresis Lithium C Renal Failure Acute Thrombotic Thrombocytopenic Purpura Date:09/22/05ISR Number: 4775781-8Report Type:Expedited (15-DaCompany Report #2005AC01390 Age:41 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Pharmaceutical ORAL Date:09/22/05ISR Number: 4775782-XReport Type:Expedited (15-DaCompany Report #2005AC01400 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Multiple Drug Overdose Pharmaceutical ORAL Valproic Acid SS Sertraline SS Date:09/22/05ISR Number: 4775783-1Report Type:Expedited (15-DaCompany Report #2005AC01391 Age:56 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/05ISR Number: 4775784-3Report Type:Expedited (15-DaCompany Report #2005AC01397 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Multiple Drug Overdose Pharmaceutical ORAL Paroxetine SS Gabapentin SS Date:09/22/05ISR Number: 4775792-2Report Type:Expedited (15-DaCompany Report #2005AC01408 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Multiple Drug Overdose Pharmaceutical Propranolol SS ORAL Acetaminophen Propoxyphene SS Date:09/22/05ISR Number: 4775793-4Report Type:Expedited (15-DaCompany Report #2005AC01393 Age:76 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Multiple Drug Overdose Pharmaceutical ORAL Amlodipine SS Date:09/22/05ISR Number: 4775795-8Report Type:Expedited (15-DaCompany Report #2005AC01409 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Multiple Drug Overdose Pharmaceutical ORAL Lithium SS Thiothixene SS Date:09/22/05ISR Number: 4775796-XReport Type:Expedited (15-DaCompany Report #2005AC01406 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Quetiapine PS Zeneca Pharmaceutical ROUTE: ASPIRATION Escitalopram SS ORAL Clonazepam SS ORAL Date:09/22/05ISR Number: 4775797-1Report Type:Expedited (15-DaCompany Report #2005UW13634 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Seroquel PS Zeneca Initial or Prolonged Phosphokinase Increased Pharmaceutical ORAL Other Hospitalisation Neuroleptic Malignant Syndrome Renal Failure 22-Feb-2006 08:31 AM Page: 1428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/05ISR Number: 4775798-3Report Type:Expedited (15-DaCompany Report #2005AC01403 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Drug Reaction Quetiapine PS Zeneca Pharmaceutical ORAL Ziprasidone SS PARENTERAL Risperidone SS Date:09/22/05ISR Number: 4775800-9Report Type:Expedited (15-DaCompany Report #2005AC01404 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Multiple Drug Overdose Pharmaceutical ORAL Cocaine SS UNKNOWN Morphine SS UNKNOWN Date:09/22/05ISR Number: 4775809-5Report Type:Expedited (15-DaCompany Report #US-MERCK-0509USA02179 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Cogentin PS Merck & Co., Inc ORAL Completed Suicide Venlafaxine Hydrochloride SS ORAL Quetiapine Fumarate SS ORAL Date:09/22/05ISR Number: 4775937-4Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-A0575086A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Wellbutrin Sr PS Glaxosmithkline ORAL 150MG Twice Suicidal Ideation per day Paxil SS Glaxosmithkline ORAL 40MG Unknown Remeron SS UNKNOWN Ativan SS UNKNOWN 2MG Four times per day Seroquel SS UNKNOWN Date:09/22/05ISR Number: 4778911-7Report Type:Expedited (15-DaCompany Report #DSA_70671_2005 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Oramorph Sr PS Feeling Abnormal Professional Paroxetine SS Multiple Drug Overdose Alprazolam SS Accidental Quetiapine SS Date:09/22/05ISR Number: 4778964-6Report Type:Expedited (15-DaCompany Report #2005-131810-NL Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Galactorrhoea Mirtazapine PS 15 MG/30 MG 207 DAY Initial or Prolonged Sinus Tachycardia Risperidone SS 4 WK Tachycardia Quetiapine Fumarate SS 81 DAY Weight Increased Olanzapine SS MG Aripiprazole C 22-Feb-2006 08:31 AM Page: 1429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/05ISR Number: 4776632-8Report Type:Expedited (15-DaCompany Report #2005UW13811 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Seroquel PS Zeneca Pharmaceutical ORAL Date:09/23/05ISR Number: 4776635-3Report Type:Expedited (15-DaCompany Report #2005AC01414 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Pharmaceutical ORAL Methamphetamine SS Date:09/23/05ISR Number: 4776777-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13114582 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Aripiprazole PS Otsuka Initial or Prolonged Intentional Self-Injury Pharmaceutical Company, Ltd. ORAL Aripiprazole SS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel SS Date:09/23/05ISR Number: 4777258-2Report Type:Expedited (15-DaCompany Report #2005GB00851 Age:469 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pitting Oedema Seroquel PS Zeneca Pharmaceutical ORAL Clopixol SS INTRAMUSCULAR CYCLICAL Lithium Carbonate SS ORAL Paroxetine C ORAL Insulin C Pain Killers C Date:09/23/05ISR Number: 4777274-0Report Type:Expedited (15-DaCompany Report #2005SE04997 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Hospitalization - Overdose Pharmaceutical ORAL 1 YR Initial or Prolonged Pulmonary Embolism Quetiapine SS Zeneca Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY Date:09/23/05ISR Number: 4777275-2Report Type:Expedited (15-DaCompany Report #2005AC01323 Age:15416 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL 27 DAY Diazepam C ORAL 22-Feb-2006 08:31 AM Page: 1430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sevredol C ORAL Naproxen C ORAL Pantozol C ORAL Neurontin C ORAL Baclofen C ORAL Haloperidol C ORAL Citalopram C ORAL Rivotril C ORAL Date:09/23/05ISR Number: 4777292-2Report Type:Expedited (15-DaCompany Report #2005AC01320 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Seroquel PS Zeneca Initial or Prolonged Back Pain Pharmaceutical ORAL Porphyria Date:09/26/05ISR Number: 4777868-2Report Type:Expedited (15-DaCompany Report #JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BAge:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Jaundice Mobic PS B.I. Other Liver Disorder Pharmaceuticals,Inc. Sepsis /Ridgefield ORAL Skin Inflammation Novastatan SS INTRAVENOUS Radicut SS INTRAVENOUS Blopress SS ORAL Seroquel SS ORAL Myslee SS ORAL Loxonin SS ORAL Solita-T No. 3 C INTRAVENOUS Lanirapid C ORAL Itorol C ORAL Aspirin C ORAL Warfarin C ORAL Gaster D C ORAL Lasix C ORAL Dextrose C INTRAVENOUS Date:09/26/05ISR Number: 4777890-6Report Type:Expedited (15-DaCompany Report #2005AC01417 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Multiple Drug Overdose Pharmaceutical ORAL Olanzapine SS Date:09/26/05ISR Number: 4778585-5Report Type:Expedited (15-DaCompany Report #2005SE05287 Age:11826 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Seroquel PS Zeneca Hospitalization - Pharmaceutical ORAL 25 DAY Initial or Prolonged Seroquel SS Zeneca Pharmaceutical ORAL 11 DAY Propycil C ORAL 3X1 23 DAY 22-Feb-2006 08:31 AM Page: 1431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/05ISR Number: 4778586-7Report Type:Expedited (15-DaCompany Report #2005SE04772 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Seroquel PS Zeneca Initial or Prolonged Blood Glucose Increased Pharmaceutical ORAL 300+400 MG Blood Prolactin Increased DAILY 81 DAY Galactorrhoea Remeron SS ORAL 207 DAY Glucose Urine Present Risperdal SS ORAL 0.5-1 MG Headache TWICE DAILY 28 DAY Nausea Zyprexa SS ORAL 15-20 MG IN Orthostatic Hypotension THE EVENING Sinus Tachycardia Sleep Disorder Syncope Weight Increased Date:09/26/05ISR Number: 4778597-1Report Type:Expedited (15-DaCompany Report #2005AP04335 Age:24498 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Seroquel PS Zeneca Initial or Prolonged Dehydration Pharmaceutical ORAL Granulocyte Count Seroquel SS Zeneca Decreased Pharmaceutical ORAL 2 DAY Pyrexia Silece SS ORAL Somnolence Silece SS ORAL 2 DAY White Blood Cell Count Pyrethia SS ORAL 2 DAY Increased Limas C ORAL 2 DAY Akineton C ORAL 2 DAY Pursennid C ORAL 2 DAY Date:09/26/05ISR Number: 4778866-5Report Type:Expedited (15-DaCompany Report #2005UW14172 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Seroquel PS Zeneca Asthenia Pharmaceutical ORAL Atherosclerosis Clozaril SS Cardiac Arrest Orap SS Hepatic Steatosis Carbamazepine C Myocardial Ischaemia Clonazepam C Obesity Flurazepam Pulmonary Congestion Hydrochloride C Pulmonary Oedema Gabapentin C Pulmonary Thrombosis Kemadrin C Respiratory Arrest Topamax C Somnolence Date:09/26/05ISR Number: 4778868-9Report Type:Expedited (15-DaCompany Report #2005UW13767 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Seroquel PS Zeneca Neutropenia Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/05ISR Number: 4778870-7Report Type:Expedited (15-DaCompany Report #2005UW13844 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haemoglobin Decreased Seroquel PS Zeneca Mean Cell Volume Pharmaceutical ORAL Decreased Aspirin C Proctalgia Pyrexia Rash Generalised Red Blood Cell Count Increased Vaginal Pain Date:09/26/05ISR Number: 4779031-8Report Type:Expedited (15-DaCompany Report #US-ABBOTT-03P-163-0228662-00 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Depakote PS 1 WK Initial or Prolonged Dermatitis Bullous Risperidone SS Erythema Multiforme Risperidone SS Fall Quetiapine SS Joint Stiffness Quetiapine SS Neuroleptic Malignant Syndrome Date:09/26/05ISR Number: 4780288-8Report Type:Expedited (15-DaCompany Report #2005128538 Age:42 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Alprazolam Completed Suicide Health (Alprazolam) PS Drug Toxicity Professional Methadone Intentional Misuse (Methadone) SS Overdose Quetiapine Respiratory Arrest (Quetiapine) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Date:09/26/05ISR Number: 4780436-XReport Type:Expedited (15-DaCompany Report #2005127472 Age:76 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Amlodipine Completed Suicide Health (Amlodipine) PS ORAL ORAL Drug Toxicity Professional Quetiapine Intentional Misuse (Quetiapine) SS ORAL ORAL Multiple Drug Overdose Date:09/26/05ISR Number: 4780437-1Report Type:Expedited (15-DaCompany Report #2005127620 Age: Gender:Unknown I/FU:I Outcome PT Death Cardio-Respiratory Arrest Completed Suicide 22-Feb-2006 08:31 AM Page: 1433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intentional Misuse Report Source Product Role Manufacturer Route Dose Duration Literature Sertraline Health (Sertraline) PS Professional Quetiapine (Quetiapine) SS Valproic Acid (Valproic Acid) SS Date:09/26/05ISR Number: 4780489-9Report Type:Expedited (15-DaCompany Report #2005128517 Age:45 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Gabapentin Drug Toxicity Health (Gabapentin) PS Intentional Misuse Professional All Other Multiple Drug Overdose Therapeutic Products (All Other Therapeutic Products) SS Quetiapine (Quetiapine) SS Paroxetine (Paroxetine) SS Date:09/26/05ISR Number: 4780500-5Report Type:Expedited (15-DaCompany Report #2005128823 Age:38 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Verapamil Drug Toxicity Health Hydrochloride Tablet Intentional Misuse Professional (Verapamil Overdose Hydrochloride) PS ORAL ORAL Valproic Acid (Valproic Acid) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL Date:09/26/05ISR Number: 4780503-0Report Type:Expedited (15-DaCompany Report #2005128528 Age:48 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Gabapentin Drug Toxicity Health (Gabapentin) PS Intentional Misuse Professional Quetiapine Overdose (Quetiapine) SS Respiratory Arrest Cocaine (Cocaine) SS Date:09/26/05ISR Number: 4781085-XReport Type:Expedited (15-DaCompany Report #8011687 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Alcohol Use Foreign Initial or Prolonged Bipolar Disorder Health Condition Aggravated Professional Hepatic Enzyme Increased Distributor 22-Feb-2006 08:31 AM Page: 1434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Keppra PS ORAL 500 MG 2/D PO Keppra SS ORAL 1000 MG 2/D PO Keppra SS ORAL 1500 MG 2/D PO Seroquel SS ORAL 50 MG 2/D, PO Seroquel SS ORAL 125 MG, PO Lorazepam C Date:09/27/05ISR Number: 4779620-0Report Type:Expedited (15-DaCompany Report #2005UW14048 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Seroquel PS Zeneca Suicide Attempt Pharmaceutical ORAL Citalopram SS ORAL Gabapentin SS ORAL Clozapine SS ORAL Date:09/27/05ISR Number: 4779824-7Report Type:Expedited (15-DaCompany Report #RO-JNJFOC-20050900860 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urticaria Quetiapine PS ORAL 28 DAY Seroquel SS ORAL 28 DAY Date:09/27/05ISR Number: 4779990-3Report Type:Expedited (15-DaCompany Report #2005AC01468 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Quetiapine PS Zeneca Hallucination Pharmaceutical ORAL Painful Erection Quetiapine SS Zeneca Pharmaceutical ORAL Thioridazine C Date:09/27/05ISR Number: 4779993-9Report Type:Expedited (15-DaCompany Report #2005PK01445 Age:9275 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Exposure During Seroquel PS Zeneca Hospitalization - Pregnancy Pharmaceutical ORAL TOOK 60 Initial or Prolonged Intra-Uterine Death TABLETS OF Overdose 200 MG Respiratory Failure Status Epilepticus Date:09/27/05ISR Number: 4780332-8Report Type:Expedited (15-DaCompany Report #2005SE05207 Age: Gender:Male I/FU:I Outcome PT Other Burning Sensation Flushing 22-Feb-2006 08:31 AM Page: 1435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharyngeal Oedema Pruritus Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical Litarex SS Lamictal SS Diclocil C Roxithromycin C Date:09/27/05ISR Number: 4780340-7Report Type:Expedited (15-DaCompany Report #2005SE05356 Age:26566 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Seroquel PS Zeneca Syndrome Pharmaceutical ORAL 1+1+1/4 TABLET/DAY 120 DAY Serenase SS 36 DAY Ebixa C ORAL 12 DAY Temesta C ORAL 1 MG 3 TIMES PER DAY 87 DAY Deprakine C ORAL 87 DAY Date:09/27/05ISR Number: 4780421-8Report Type:Expedited (15-DaCompany Report #2005UW14081 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Other Confusional State Pharmaceutical Depersonalisation Paxil SS ORAL Mania Obsessive-Compulsive Disorder Date:09/27/05ISR Number: 4780466-8Report Type:Expedited (15-DaCompany Report #2005UW14193 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Seroquel PS Zeneca Other Convulsion Pharmaceutical ORAL Respiratory Arrest Clonazepam SS Suicide Attempt Bupropion SS Date:09/27/05ISR Number: 4781710-3Report Type:Expedited (15-DaCompany Report #SUSI-2005-00602 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Study Equetro Therapy Non-Responder Health (Caramazepine Professional Extended Release 200mg) PS ORAL 200 MG, 1X DAY:QD, ORAL Seroquel(Quetiapine Fumarate) SS ORAL 300 MG, 1 XDAY:QHS, ORAL Lantus (Insulin 22-Feb-2006 08:31 AM Page: 1436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glargine) C Date:09/27/05ISR Number: 4781984-9Report Type:Expedited (15-DaCompany Report #2005129248 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Doxepin (Caps) Intentional Misuse Health (Doxepin) PS Multiple Drug Overdose Professional Quetiapine (Quetiapine) SS Date:09/27/05ISR Number: 4782330-7Report Type:Expedited (15-DaCompany Report #2005129268 Age:40 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Doxepin (Caps) Multiple Drug Overdose Health (Doxepin) PS Professional Clonazepam (Clonazepam) SS Quetiapine (Quetiapine) SS Date:09/27/05ISR Number: 4782694-4Report Type:Expedited (15-DaCompany Report #2005129457 Age:47 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lithium (Lithium) PS Multiple Drug Overdose Health Thiothixene Professional (Thiothixene) SS Quetiapine (Quetiapine) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Date:09/27/05ISR Number: 4782853-0Report Type:Expedited (15-DaCompany Report #2005128241 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Therapeutic Agent Literature Ziprasidone (Caps) Toxicity Health (Ziprasidone) PS Professional Quetiapine (Quetiapine) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Risperidone (Risperidone) SS 22-Feb-2006 08:31 AM Page: 1437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/05ISR Number: 4781181-7Report Type:Expedited (15-DaCompany Report #2005UW14275 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Seroquel PS Zeneca Pruritus Pharmaceutical ORAL Rash Erythematous Dexedrine C Somnolence Urticaria Date:09/28/05ISR Number: 4781183-0Report Type:Expedited (15-DaCompany Report #2005UW14245 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Seroquel PS Zeneca Facial Palsy Pharmaceutical ORAL Imovane I ORAL Date:09/28/05ISR Number: 4781184-2Report Type:Expedited (15-DaCompany Report #2005UW14011 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Seroquel PS Zeneca Heart Rate Decreased Pharmaceutical ORAL Date:09/28/05ISR Number: 4781185-4Report Type:Expedited (15-DaCompany Report #2005UW13913 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Seroquel PS Zeneca Initial or Prolonged Palpitations Pharmaceutical ORAL Other Date:09/28/05ISR Number: 4781195-7Report Type:Expedited (15-DaCompany Report #2005SE00348 Age:10394 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Event Seroquel PS Zeneca Initial or Prolonged Akathisia Pharmaceutical ORAL 1 DAY Anxiety Seroquel SS Zeneca Drug Ineffective Pharmaceutical ORAL 1 DAY Hallucination Seroquel SS Zeneca Insomnia Pharmaceutical ORAL 1 DAY Schizoaffective Disorder Seroquel SS Zeneca Pharmaceutical ORAL 3 DAY Seroquel SS Zeneca Pharmaceutical ORAL 3 DAY Seroquel SS Zeneca Pharmaceutical ORAL 44 DAY Biperiden C 20 DAY Zolpidem C 13 DAY Diazepam C 2 DAY Diazepam C 1 DAY 22-Feb-2006 08:31 AM Page: 1438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/05ISR Number: 4781196-9Report Type:Expedited (15-DaCompany Report #2005AC01491 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Drug Toxicity Pharmaceutical Date:09/28/05ISR Number: 4781214-8Report Type:Expedited (15-DaCompany Report #2005UW14156 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Seroquel PS Zeneca Initial or Prolonged Impaired Self-Care Pharmaceutical ORAL Other Lithium C Trileptal C Date:09/28/05ISR Number: 4781305-1Report Type:Expedited (15-DaCompany Report #2005GB01835 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Seroquel PS Zeneca Pharmaceutical ORAL Carbamazepine C Epilim C 500 MG AM & 1000 MG NOCTE Diazepam C Date:09/28/05ISR Number: 4781307-5Report Type:Expedited (15-DaCompany Report #2005AC01494 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Quetiapine PS Zeneca Pharmaceutical Date:09/28/05ISR Number: 4781322-1Report Type:Expedited (15-DaCompany Report #2005UW13910 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abasia Seroquel PS Zeneca Speech Disorder Pharmaceutical ORAL Tardive Dyskinesia Date:09/28/05ISR Number: 4781341-5Report Type:Expedited (15-DaCompany Report #2005GB01803 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL Clozaril C Date:09/28/05ISR Number: 4781518-9Report Type:Expedited (15-DaCompany Report #2005UW13981 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Haemorrhagic Seroquel PS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valproic Acid C Clozapine C Date:09/28/05ISR Number: 4781519-0Report Type:Expedited (15-DaCompany Report #2005UW14092 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Seroquel PS Zeneca Increased Pharmaceutical TRANSPLACENTAL Neonatal Tachypnoea Acetaminophen SS TRANSPLACENTAL Oedema Oedema Neonatal Tachypnoea Date:09/28/05ISR Number: 4781614-6Report Type:Expedited (15-DaCompany Report #2005UW14206 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Seroquel PS Zeneca Apnoea Pharmaceutical ORAL Coma Paroxetine SS Respiratory Depression Suicide Attempt Date:09/28/05ISR Number: 4781616-XReport Type:Expedited (15-DaCompany Report #2005UW14207 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Seroquel PS Zeneca Convulsion Pharmaceutical ORAL Mydriasis Risperdal SS Tachycardia Effexor Xr SS Date:09/28/05ISR Number: 4781618-3Report Type:Expedited (15-DaCompany Report #2005UW14225 Age:53 YR Gender:Male I/FU:I Outcome PT Other Agitation Amnesia Blood Creatine Phosphokinase Increased Disorientation Drug Withdrawal Syndrome Electrocardiogram Qrs Complex Prolonged Electrocardiogram Qt Prolonged Grand Mal Convulsion Hyperhidrosis Hypotension Hypoxia Lethargy Leukocytosis Loss Of Consciousness Metabolic Acidosis Miosis Muscle Contractions 22-Feb-2006 08:31 AM Page: 1440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Involuntary Myoclonus Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Pneumonia Seroquel PS Zeneca Pupillary Reflex Impaired Pharmaceutical ORAL Pyrexia Effexor SS ORAL Respiratory Depression Effexor Xr SS Serotonin Syndrome Ethanol SS ORAL Tachypnoea Date:09/28/05ISR Number: 4782897-9Report Type:Direct Company Report #CTU 259070 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Glycosylated Haemoglobin Seroquel 25 Mg Required Increased Tablets Astrazeneca PS Astrazeneca ORAL 25 MG. 1 TO 4 Intervention to Insulin-Requiring Type Ii FOR ANXIETY Prevent Permanent Diabetes Mellitus PO Impairment/Damage Seroquel 100 Mg Tablets Astrazeneca SS Astrazeneca ORAL 100 MG. 1 AT BEDTIME PO Date:09/28/05ISR Number: 4784397-9Report Type:Expedited (15-DaCompany Report #2005129757 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Consumer Lyrica (Pregabalin) PS ORAL 100 MG (100 Gait Disturbance MG, 1 IN 1 Headache D), ORAL Impaired Driving Ability Elavil Injury Corneal (Amitriptyline Loss Of Consciousness Hydrochloride) SS Overdose Clonazepam Somnolence (Clonazepam) SS Speech Disorder Oxycontin (Oxycodone Hydrochloride) SS Seroquel (Quetiapine Fumarate) SS Date:09/29/05ISR Number: 4782384-8Report Type:Expedited (15-DaCompany Report #2005AC01351 Age:8679 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Facial Palsy Seroquel PS Zeneca Pharmaceutical ORAL Efexor SS ORAL Efexor SS ORAL Date:09/29/05ISR Number: 4782386-1Report Type:Expedited (15-DaCompany Report #2005UW13941 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Seroquel PS Zeneca Liver Function Test Pharmaceutical ORAL Abnormal Seroquel SS Zeneca Pharmaceutical ORAL Perphenazine C ORAL 22-Feb-2006 08:31 AM Page: 1441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Perphenazine C ORAL Date:09/29/05ISR Number: 4782591-4Report Type:Expedited (15-DaCompany Report #2005UW14232 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Seroquel PS Zeneca Phosphokinase Increased Pharmaceutical 1 DAY Body Temperature Haldol SS ENDOTRACHEAL Increased Ativan C Hyperhidrosis Benadryl C Liver Function Test Budesonide C Abnormal Cefotaxime C Muscle Rigidity Chloral Hydrate C Neuroleptic Malignant Enoxaparin C Syndrome Melatonin C Tremor Pantoprazole C Salbutamol C Date:09/29/05ISR Number: 4782993-6Report Type:Expedited (15-DaCompany Report #2005UW14285 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Seroquel PS Zeneca Initial or Prolonged Headache Pharmaceutical ORAL Lexapro C Topamax C Synthroid C Date:09/29/05ISR Number: 4782995-XReport Type:Expedited (15-DaCompany Report #2005GB01861 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Seroquel PS Zeneca Death Pharmaceutical ORAL Dry Mouth Clopixol SS Date:09/29/05ISR Number: 4783193-6Report Type:Expedited (15-DaCompany Report #2005GB01656 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperkalaemia Paracetamol PS Glaxosmithkline ORAL 15G Single Initial or Prolonged Overdose dose 1 DAY Seroquel SS ORAL 3G Single dose 1 DAY Paroxetine SS Glaxosmithkline ORAL 600MG Single dose 1 DAY Alcohol SS ORAL 1 DAY Date:09/29/05ISR Number: 4783221-8Report Type:Expedited (15-DaCompany Report #2005UW14315 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gallbladder Disorder Seroquel PS Zeneca Initial or Prolonged Pancreatitis Pharmaceutical ORAL 1 YR Cardizem C 22-Feb-2006 08:31 AM Page: 1442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lofibra C Wellbutrin Xl C Depakote C Detrol C Propranolol C Date:09/29/05ISR Number: 4783222-XReport Type:Expedited (15-DaCompany Report #2005UW14274 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qrs Seroquel PS Zeneca Complex Prolonged Pharmaceutical ORAL Leukocytosis Overdose Pain Somnolence Tachycardia Date:09/29/05ISR Number: 4783230-9Report Type:Expedited (15-DaCompany Report #2005UW14202 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Seroquel PS Zeneca Depression Pharmaceutical ORAL 1 MON Drug Interaction Loxapine C Pathological Fracture Citalopram I ORAL Psychotic Disorder Neurontin I ORAL Risperdal I ORAL Date:09/29/05ISR Number: 4783231-0Report Type:Expedited (15-DaCompany Report #2005UW14083 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Seroquel PS Zeneca Hypotension Pharmaceutical ORAL Pallor Date:09/29/05ISR Number: 4783393-5Report Type:Expedited (15-DaCompany Report #2005UW14196 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Seroquel PS Zeneca Mobility Decreased Pharmaceutical ORAL Acetaminophen C Avelox C ORAL 14 DAY Laxatives C Metoclopramide C Multivitamins C Olanzapine C Thiamine C 22-Feb-2006 08:31 AM Page: 1443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/05ISR Number: 4784745-XReport Type:Direct Company Report #CTU 259173 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Seroquel PS ORAL 200 MG BID PO 4 DAY Date:09/30/05ISR Number: 4784043-4Report Type:Expedited (15-DaCompany Report #2005UW14090 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Seroquel PS Zeneca Increased Pharmaceutical ORAL Aspartate Acetaminophen SS Aminotransferase Sertraline C Increased Blood Alkaline Phosphatase Increased Drug Exposure During Pregnancy Hyperbilirubinaemia Hypotension Intentional Misuse Overdose Prothrombin Time Prolonged Sedation Tachycardia Date:09/30/05ISR Number: 4784044-6Report Type:Expedited (15-DaCompany Report #2005UW14210 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Casodex PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Adalat Xl C Flomax C Gluconorm C Novolin C SUBCUTANEOUS Periradopril C Plavix C Serax C Tenormin C Date:09/30/05ISR Number: 4784047-1Report Type:Expedited (15-DaCompany Report #2005UW14195 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Atenolol PS Zeneca Bradycardia Pharmaceutical ORAL Intentional Misuse Seroquel SS Zeneca Overdose Pharmaceutical ORAL Nardil SS 22-Feb-2006 08:31 AM Page: 1444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/30/05ISR Number: 4784053-7Report Type:Expedited (15-DaCompany Report #2005UW14478 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Seroquel PS Zeneca Other Dystonia Pharmaceutical ORAL Neuroleptic Malignant Lithium C Syndrome Tegretol C Oculogyration Serotonin Syndrome Date:09/30/05ISR Number: 4784203-2Report Type:Expedited (15-DaCompany Report #2005UW14050 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Disorder Seroquel PS Zeneca Brain Abscess Pharmaceutical ORAL Convulsion Gun Shot Wound Date:09/30/05ISR Number: 4784361-XReport Type:Expedited (15-DaCompany Report #2005UW14203 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Seroquel PS Zeneca Pupillary Reflex Impaired Pharmaceutical ORAL Tachycardia Citalopram SS Clonazepam SS Wellbutrin Sr SS Alcohol C Ranitidine C Thyroid C Date:09/30/05ISR Number: 4784460-2Report Type:Expedited (15-DaCompany Report #2005UW13792 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Seroquel PS Zeneca Other Drug Toxicity Pharmaceutical ORAL AN UNKNOWN Intentional Misuse QUANTITY Loss Of Consciousness CRUSHED AND Overdose PUT INTO BEER Victim Of Crime Beer SS ORAL DRANK 2 BEERS 1 DAY Date:09/30/05ISR Number: 4784463-8Report Type:Expedited (15-DaCompany Report #2005UW14509 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Seroquel PS Zeneca Legal Problem Pharmaceutical ORAL Murder Theft 22-Feb-2006 08:31 AM Page: 1445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/30/05ISR Number: 4784464-XReport Type:Expedited (15-DaCompany Report #2005GB01302 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Seroquel PS Zeneca Liver Function Test Pharmaceutical ORAL Abnormal Anafranil SS ORAL Microcytic Anaemia Normison SS 1 MON White Blood Cell Count Clozaril SS ORAL Decreased Date:09/30/05ISR Number: 4784976-9Report Type:Expedited (15-DaCompany Report #2005UW14097 Age:3 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Seroquel PS Zeneca Initial or Prolonged White Blood Cell Count Pharmaceutical ORAL Other Increased Tylenol C Date:09/30/05ISR Number: 4785023-5Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-05P-167-0310379-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Depakote PS Hypoglycaemia Depakote SS Malaise Haloperidol SS ORAL Haloperidol SS Haloperidol SS Haloperidol SS Quetiapine SS 13 DAY Quetiapine SS 13 DAY Date:09/30/05ISR Number: 4786231-XReport Type:Expedited (15-DaCompany Report #DSA_27164_2005 Age:60 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Diclofenac PS ORAL DF, PO Completed Suicide Health Quetiapine SS ORAL DF, PO Intentional Misuse Professional Simvastatin SS ORAL DF, PO Overdose Respiratory Arrest Date:10/03/05ISR Number: 4785705-5Report Type:Expedited (15-DaCompany Report #2005AC01481 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chorea Quetiapine PS Zeneca Drug Withdrawal Syndrome Pharmaceutical ORAL Dyskinesia Quetiapine SS Zeneca Pharmaceutical ORAL Lithium C PATIENT HAD BEEN RECEIVING LITHIUM FOR SIX MONTHS Divalproex C 500 MG IN MORNING AND 1000 MG AT 22-Feb-2006 08:31 AM Page: 1446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report NIGHT. PATIENT HAD Date:10/03/05ISR Number: 4787332-2Report Type:Expedited (15-DaCompany Report #HQWYE609923SEP05 Age:37 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Inderal (Propranolol Intentional Misuse Hydrochloride) PS ACUTE DOSAGE Multiple Drug Overdose Propoxyphene Hcl And Acetaminophen SS Quetiapine (Quetiapine) SS Date:10/03/05ISR Number: 4787334-6Report Type:Expedited (15-DaCompany Report #HQWYE609823SEP05 Age:46 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Inderal (Propranolol Completed Suicide Hydrochloride) PS Intentional Misuse Cyclobenzaprine Multiple Drug Overdose (Cyclobenzaprine) SS Quetiapine (Quetiapine) SS Date:10/03/05ISR Number: 4787352-8Report Type:Expedited (15-DaCompany Report #HQWYE683927SEP05 Age:24 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Advil (Ibuprofen, Intentional Misuse Tablet, 200 Mg) PS ORAL ORAL Overdose Paroxetine (Paroxetine) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL Date:10/03/05ISR Number: 4787498-4Report Type:Expedited (15-DaCompany Report #DSA_70728_2005 Age:43 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Morphine PS ORAL DF PO Multiple Drug Overdose Health Cocaine SS Professional Quetiapine SS DF Date:10/04/05ISR Number: 4786812-3Report Type:Expedited (15-DaCompany Report #2005UW14301 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anion Gap Abnormal Seroquel PS Zeneca Coma Pharmaceutical ORAL Alcohol C 22-Feb-2006 08:31 AM Page: 1447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/05ISR Number: 4786813-5Report Type:Expedited (15-DaCompany Report #2005UW14085 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Seroquel PS Zeneca Intentional Misuse Pharmaceutical ORAL 1 DAY Multiple Drug Overdose Ativan SS 1 DAY Somnolence Trazodone SS 1 DAY Tachycardia Date:10/04/05ISR Number: 4786816-0Report Type:Expedited (15-DaCompany Report #2005UW14299 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dementia Seroquel PS Zeneca Diabetes Mellitus Pharmaceutical ORAL Epilepsy Asa C Paranoia Epival C Glucophage C Imovane C Insulin C Risperdal C Zyprexa C Date:10/04/05ISR Number: 4786862-7Report Type:Expedited (15-DaCompany Report #2005UW14198 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Seroquel PS Zeneca First Degree Pharmaceutical ORAL Coma Effexor Xr SS Drug Level Increased Lorazepam SS Intentional Misuse Pantoloc SS Overdose Vasotec SS Digoxin SS Date:10/04/05ISR Number: 4786863-9Report Type:Expedited (15-DaCompany Report #2005UW14290 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chromaturia Seroquel PS Zeneca Hepatic Enzyme Increased Pharmaceutical ORAL 14 MON Jaundice Pruritus Date:10/04/05ISR Number: 4786864-0Report Type:Expedited (15-DaCompany Report #2005UW14212 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Seroquel PS Zeneca Personality Disorder Pharmaceutical ORAL 5 DAY Prevacid C Sertraline C 22-Feb-2006 08:31 AM Page: 1448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/05ISR Number: 4786865-2Report Type:Expedited (15-DaCompany Report #2005UW14117 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Seroquel PS Zeneca Increased Pharmaceutical ORAL Oedema Acetaminophen SS ORAL Tachypnoea Date:10/04/05ISR Number: 4786877-9Report Type:Expedited (15-DaCompany Report #2005UW14474 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Seroquel PS Zeneca Mania Pharmaceutical ORAL Campral SS ORAL Klonopin C Xanax C Atenolol C Date:10/04/05ISR Number: 4786879-2Report Type:Expedited (15-DaCompany Report #2005AP04475 Age:16670 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Overdose Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Efexor C Efexor C Oxazepam C Epilim C Avapro C Panadeine Forte C 2 DF TAKEN EVERY 4 HOURS Date:10/04/05ISR Number: 4786880-9Report Type:Expedited (15-DaCompany Report #2005UW14236 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Decreased Seroquel PS Zeneca Hallucination, Visual Pharmaceutical Nozinan SS Date:10/04/05ISR Number: 4786891-3Report Type:Expedited (15-DaCompany Report #2005UW10991 Age:15903 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Seroquel PS Zeneca Initial or Prolonged Suicide Attempt Pharmaceutical ORAL Neurontin SS Oxycodone C Cymbalta C 22-Feb-2006 08:31 AM Page: 1449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/05ISR Number: 4787052-4Report Type:Expedited (15-DaCompany Report #RO-JNJFOC-20050900860 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urticaria Quetiapine PS ORAL 28 DAY Seroquel SS ORAL 28 DAY Date:10/04/05ISR Number: 4787063-9Report Type:Expedited (15-DaCompany Report #2005UW14398 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Autonomic Nervous System Seroquel PS Zeneca Imbalance Pharmaceutical ORAL Confusional State Methadone Hyperhidrosis Maintenance C Hypotension Metabolic Acidosis Pneumonia Renal Failure Acute Date:10/04/05ISR Number: 4787065-2Report Type:Expedited (15-DaCompany Report #2005SE05479 Age:29420 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Seroquel PS Zeneca Pharmaceutical ORAL 25 MG THREE TIMES A DAY 62 DAY Lanoxin C ORAL 0.125 MG DAILY Lasix (Furosemide) C 25 MG Date:10/04/05ISR Number: 4787071-8Report Type:Expedited (15-DaCompany Report #2005AC01292 Age:488 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bulimia Nervosa Seroquel PS Zeneca Pharmaceutical ORAL Depakine C ORAL Maniprex C ORAL Seroxat C ORAL Date:10/04/05ISR Number: 4788231-2Report Type:Direct Company Report #CTU 259464 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Migraine Seroquel 25mg Astra Zeneca PS Astra Zeneca ORAL 25MG ONCE DAILY PO Date:10/04/05ISR Number: 4789051-5Report Type:Expedited (15-DaCompany Report #DSA_27143_2005 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Lorazepam PS ORAL DF UNK PO Health Quetiapine SS ORAL DF UNK PO Professional Acetaminophen Pm SS ORAL DF UNK PO 22-Feb-2006 08:31 AM Page: 1450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/05ISR Number: 4788485-2Report Type:Expedited (15-DaCompany Report #2005GB01848 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Seroquel PS Zeneca Initial or Prolonged Hypotension Pharmaceutical ORAL Date:10/05/05ISR Number: 4788490-6Report Type:Expedited (15-DaCompany Report #2005UW14601 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Seroquel PS Zeneca Dry Skin Pharmaceutical ORAL 3 MON Hyperhidrosis Seroquel SS Zeneca Pharmaceutical ORAL Vasotec C ORAL Glyburide C ORAL Date:10/05/05ISR Number: 4788491-8Report Type:Expedited (15-DaCompany Report #2005PK01781 Age:9443 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis C Seroquel PS Zeneca Initial or Prolonged Transaminases Increased Pharmaceutical ORAL 49 DAY Stangyl C ORAL 100 MG MAXIMAL DOSAGE Tavor C ORAL Tavor C ORAL Fluctin C ORAL Anafranil C ORAL Catapressan C ORAL 6 DAY Ciprobay C ORAL 9 DAY Acc C ORAL 16 DAY Haldol C ORAL Nystatin C ORAL Edronax C ORAL Dominal C ORAL Zodurat C ORAL Chloradurat C ORAL Sedonium C ORAL Atosil C ORAL Atosil C ORAL Taxilan C ORAL Dipiperon C ORAL Dipiperon C ORAL Truxal C ORAL Vomex A C ORAL Dociton C ORAL Benuron C ORAL Hexoralletten C ORAL Akineton Retard C ORAL Date:10/05/05ISR Number: 4788526-2Report Type:Direct Company Report #CTU 259624 Age:50 YR Gender:Female I/FU:I Outcome PT Hospitalization - Contusion Initial or Prolonged Difficulty In Walking 22-Feb-2006 08:31 AM Page: 1451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Feeling Jittery Headache Report Source Product Role Manufacturer Route Dose Duration Syncope Quetiapine 100 Mg PS ORAL 100 MG PO Tremor Lamotrigine C Fluoxetine C Clonazepam C Apap C Date:10/05/05ISR Number: 4790056-9Report Type:Direct Company Report #CTU 259787 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Clearance Decreased Biaxin 500mg PS ORAL 500MG BID PO 14 DAY Intervention to Drug Level Increased Seroquel 100mg SS ORAL 250MG TID PO Prevent Permanent Hypothermia Daily Accuchecks C Impairment/Damage Prevpak -Amox C Biaxin C Prevacid C Doxycycline C Fosamax C Levaquin C Levothyroxine C One-Tab Daily Vitamins C Seroquel C Zoloft C Date:10/05/05ISR Number: 4790135-6Report Type:Direct Company Report #CTU 259695 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Seroquel PS Initial or Prolonged Hypotension Overdose Somnolence Tachycardia Date:10/05/05ISR Number: 4790676-1Report Type:Expedited (15-DaCompany Report #DSA_70812_2005 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Methadone PS ORAL DF PO Multiple Drug Overdose Health Quetiapine SS ORAL DF PO Professional Citalopram SS ORAL DF PO Date:10/05/05ISR Number: 4791975-XReport Type:Expedited (15-DaCompany Report #DSA_70811_2005 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Methadone PS ORAL DF UNK PO Completed Suicide Health Quetiapine SS ORAL DF UNK PO Multiple Drug Overdose Professional Alprazolam SS ORAL DF UNK PO 22-Feb-2006 08:31 AM Page: 1452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/05ISR Number: 4793351-2Report Type:Expedited (15-DaCompany Report #DSA_70816_2005 Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Methadone PS ORAL DF, PO Multiple Drug Overdose Health Zolpidem SS ORAL PO Professional Quetiapine SS ORAL DF PO Date:10/06/05ISR Number: 4789478-1Report Type:Expedited (15-DaCompany Report #2005UW14771 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Seroquel PS Zeneca Initial or Prolonged Suicidal Ideation Pharmaceutical ORAL Date:10/06/05ISR Number: 4789564-6Report Type:Expedited (15-DaCompany Report #2005UW14702 Age:667 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL Date:10/06/05ISR Number: 4789667-6Report Type:Expedited (15-DaCompany Report #2005AP02307 Age:12736 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Self-Injury Quetiapine PS Zeneca Libido Increased Pharmaceutical ORAL 4 MON Quetiapine SS Zeneca Pharmaceutical ORAL Lorazepam C ORAL Moclobemide C ORAL Moclobemide C ORAL Temazepam C ORAL AS REQUIRED AT NIGHT Multivite Six C 2 TABLETS Pamol C 1 - 2 TABLETS Propranolol C ONE TABLET 3-4 TIMES DAILY Date:10/06/05ISR Number: 4789675-5Report Type:Expedited (15-DaCompany Report #2005SE05495 Age:12356 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Quetiapine PS Zeneca Initial or Prolonged Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL Date:10/06/05ISR Number: 4789827-4Report Type:Expedited (15-DaCompany Report #2005018344 Age:45 YR Gender:Female I/FU:F Outcome PT Hospitalization - Alcohol Use Initial or Prolonged Electrocardiogram Qt Prolonged 22-Feb-2006 08:31 AM Page: 1453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypoxia Intentional Misuse Overdose Report Source Product Role Manufacturer Route Dose Duration Sopor Quilonum Retard PS Glaxosmithkline ORAL 450MG See Suicide Attempt dosage text 1 DAY Seroquel SS ORAL 100MG See dosage text 1 DAY Zopiclon SS ORAL 7.5MG See dosage text 1 DAY Alcohol SS ORAL 1 DAY Date:10/06/05ISR Number: 4789931-0Report Type:Expedited (15-DaCompany Report #2005SE05251 Age:10790 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Quetiapine PS Zeneca Urticaria Pharmaceutical ORAL 28 DAY Date:10/06/05ISR Number: 4792000-7Report Type:Expedited (15-DaCompany Report #PAR_0267_2005 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Doxepin PS ORAL DF UNK PO Overdose Health Quetiapine SS ORAL DF UNK PO Professional Date:10/06/05ISR Number: 4792001-9Report Type:Expedited (15-DaCompany Report #PAR_0268_2005 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Doxepin PS ORAL DF UNK PO Overdose Health Quetiapine SS ORAL DF UNK PO Professional Clonazepam SS ORAL DF UNK PO Date:10/06/05ISR Number: 4792010-XReport Type:Expedited (15-DaCompany Report #PAR_0212_2005 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Benztropine PS ORAL DF UNK PO Overdose Health Venlafaxine SS ORAL DF UNK PO Professional Quetiapine SS ORAL DF UNK PO Date:10/06/05ISR Number: 4792016-0Report Type:Expedited (15-DaCompany Report #PAR_0313_2005 Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Propanolol PS ORAL DF, PO Completed Suicide Health Quetiapine SS ORAL DF, PO Overdose Professional Cyclobenzaprine SS ORAL DF, PO 22-Feb-2006 08:31 AM Page: 1454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/05ISR Number: 4792026-3Report Type:Expedited (15-DaCompany Report #PAR_0219_2005 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Citalopram PS ORAL DF UNK PO Multiple Drug Overdose Health Methadone SS ORAL DF UNK PO Professional Quetiapine SS ORAL DF UNK PO Date:10/06/05ISR Number: 4792029-9Report Type:Expedited (15-DaCompany Report #PAR_0311_2005 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Propranolol PS ORAL DF UNK PO Intentional Misuse Health Acetaminophen Multiple Drug Overdose Professional W/Propoxyphene SS ORAL DF UNK PO Quetiapine SS ORAL DF UNK PO Date:10/06/05ISR Number: 4792036-6Report Type:Expedited (15-DaCompany Report #PAR_0223_2005 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Citalopram PS ORAL DF UNK PO Health Phenobarbital SS ORAL DF UNK PO Professional Quetiapine SS ORAL DFUNK PO Date:10/06/05ISR Number: 4793451-7Report Type:Expedited (15-DaCompany Report #AND_0188_2005 Age:73 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Acetaminophen Multiple Drug Overdose Health W/Propoxyphene PS DF Professional Quetiapine SS DF Unknown Chemical SS DF Date:10/06/05ISR Number: 4793522-5Report Type:Expedited (15-DaCompany Report #PAR_0270_2005 Age:22 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Fluoxetine PS ORAL DF PO Multiple Drug Overdose Health Quetiapine SS ORAL DF PO Professional Methanol SS ORAL DF PO Date:10/06/05ISR Number: 4793543-2Report Type:Expedited (15-DaCompany Report #AND_0080_2005 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Acetaminophen Multiple Drug Overdose Health W/Propoxyphene PS DF Professional Propranolol SS DF Quetiapine SS DF 22-Feb-2006 08:31 AM Page: 1455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/05ISR Number: 4793889-8Report Type:Expedited (15-DaCompany Report #PAR_0331_2005 Age:19 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Valproic Acid PS ORAL DF PO Completed Suicide Health Quetiapine SS ORAL DF PO Multiple Drug Overdose Professional Sertraline SS ORAL DF PO Respiratory Arrest Date:10/06/05ISR Number: 4795059-6Report Type:Expedited (15-DaCompany Report #PAR_0294_2005 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ibuprofen PS ORAL DF, PO Intentional Misuse Health Quetiapine SS ORAL DF, PO Overdose Professional Paroxetine SS ORAL DF, PO Date:10/06/05ISR Number: 4795188-7Report Type:Expedited (15-DaCompany Report #PAR_0342_2005 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Verapamil PS ORAL DF PO Multiple Drug Overdose Health Quetiapine SS ORAL DF PO Professional Valproic Acid SS ORAL DF PO Date:10/06/05ISR Number: 4798066-2Report Type:Direct Company Report #CTU 260053 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Oxycodone PS Initial or Prolonged Intentional Misuse Seroquel SS Multiple Drug Overdose Lexapro SS Self Injurious Behaviour Ativan SS Topamax SS Tylenol SS Date:10/06/05ISR Number: 4799714-3Report Type:Direct Company Report #CTU 259885 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Apap PS Initial or Prolonged Increased Seroquel SS Aspartate Aminotransferase Increased Blood Pressure Systolic Decreased Heart Rate Increased Incontinence Laboratory Test Abnormal Loss Of Consciousness Respiratory Depression Respiratory Rate Decreased Vomiting 22-Feb-2006 08:31 AM Page: 1456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/05ISR Number: 4791023-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050905834 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Reminyl PS ORAL Apathy Dipiperon I ORAL Drug Interaction Seroquel I ORAL Renal Failure Aurorix I ORAL Bromazepam I UNKNOWN Date:10/07/05ISR Number: 4791041-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902585 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Ibuprofen PS ORAL Hospitalization - Intentional Misuse Acetaminophen SS ORAL Initial or Prolonged Neuroleptic Malignant Acetaminophen SS ORAL Syndrome Quetiapine SS ORAL Overdose Paroxetine SS ORAL Therapy Non-Responder Ventricular Arrhythmia Date:10/07/05ISR Number: 4791172-8Report Type:Expedited (15-DaCompany Report #2005UW12322 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Seroquel PS Zeneca Blood Urea Increased Pharmaceutical ORAL Dehydration Baby Aspirin C Infection Musculoskeletal Stiffness Weight Increased White Blood Cell Count Decreased Date:10/07/05ISR Number: 4791283-7Report Type:Expedited (15-DaCompany Report #2005UW14820 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Seroquel PS Zeneca Hepatitis C Pharmaceutical ORAL Date:10/07/05ISR Number: 4791286-2Report Type:Expedited (15-DaCompany Report #2005UW14777 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Creatinine Renal Seroquel PS Zeneca Clearance Decreased Pharmaceutical ORAL Dystonia Liver Function Test Abnormal 22-Feb-2006 08:31 AM Page: 1457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/05ISR Number: 4791658-6Report Type:Expedited (15-DaCompany Report #2005PK01803 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Dizziness Pharmaceutical ORAL Injury Asphyxiation Seroquel SS Zeneca Pharmaceutical ORAL Date:10/07/05ISR Number: 4791708-7Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-B0395868A Age:27 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Lamotrigine PS Glaxosmithkline ORAL Completed Suicide Quetiapine SS ORAL Date:10/07/05ISR Number: 4791709-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-B0395869A Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Lamotrigine PS Glaxosmithkline ORAL Quetiapine SS ORAL Oxcarbazepine SS ORAL Unspecified Drugs SS Date:10/07/05ISR Number: 4791710-5Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-B0395870A Age:49 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Lamotrigine PS Glaxosmithkline ORAL Venlafaxine Hydrochloride SS ORAL Quetiapine SS ORAL Unspecified Drugs SS UNKNOWN Date:10/07/05ISR Number: 4791723-3Report Type:Expedited (15-DaCompany Report #US-KINGPHARMUSA00001-K200501293 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Morphine Sulfate PS King Pharmaceuticals, Inc. Quetiapine SS ORAL Cocaine SS Date:10/07/05ISR Number: 4794211-3Report Type:Direct Company Report #CTU 260147 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Serquel PS Depressed Level Of Consciousness Somnolence 22-Feb-2006 08:31 AM Page: 1458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/05ISR Number: 4792398-XReport Type:Expedited (15-DaCompany Report #2005SE05356 Age:26566 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Femur Fracture Seroquel PS Zeneca Neuroleptic Malignant Pharmaceutical ORAL 1+1+1/4 Syndrome TABLET/DAY 120 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1+1+1/4 TABLET/DAY 120 DAY Serenase SS ORAL 2.5+2.5 TABLETS/DAY 36 DAY Ebixa C ORAL 12 DAY Ebixa C ORAL 12 DAY Temesta C ORAL 1 MG 3 TIMES PER DAY 87 DAY Deprakine C ORAL 87 DAY Date:10/10/05ISR Number: 4792893-3Report Type:Expedited (15-DaCompany Report #2005UW14963 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Seroquel PS Zeneca Pharmaceutical ORAL Geodon SS Date:10/10/05ISR Number: 4792928-8Report Type:Expedited (15-DaCompany Report #2005UW14824 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Seroquel PS Zeneca Initial or Prolonged Retrograde Amnesia Pharmaceutical ORAL Other Lamictal C Date:10/11/05ISR Number: 4793872-2Report Type:Expedited (15-DaCompany Report #2005PK01805 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombosis Seroquel PS Zeneca Venous Thrombosis Pharmaceutical Date:10/11/05ISR Number: 4794435-5Report Type:Expedited (15-DaCompany Report #CA-ROCHE-419604 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Naproxen PS Roche UNKNOWN Overdose Seroquel SS UNKNOWN Tecnal SS UNKNOWN Topamax SS UNKNOWN Date:10/11/05ISR Number: 4794514-2Report Type:Expedited (15-DaCompany Report #2005UW14616 Age:16 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Urea Decreased Initial or Prolonged Depression Hypertension 22-Feb-2006 08:31 AM Page: 1459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypokalaemia Suicidal Ideation Syncope Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Provigil C Lamictal C Lexapro C Date:10/11/05ISR Number: 4794517-8Report Type:Expedited (15-DaCompany Report #2005UW14878 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Seroquel PS Zeneca Initial or Prolonged Dehydration Pharmaceutical ORAL Drug Toxicity Seroquel SS Zeneca Hypernatraemia Pharmaceutical ORAL Mental Status Changes Nolvadex C ORAL Pneumonia Aldactone C Colace C Dulcolax C Lexapro C Prevacid C Lipitor C Bumex C Date:10/11/05ISR Number: 4794518-XReport Type:Expedited (15-DaCompany Report #2005GB01835 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Seroquel PS Zeneca Pharmaceutical ORAL 6 DAY Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Tegretol C ORAL STARTED MANY YEARS AGO Epilim C ORAL 500 MG AM & 1000 MG NOCTE Diazepam C ORAL Date:10/11/05ISR Number: 4794523-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13114582 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Aripiprazole PS Otsuka Initial or Prolonged Intentional Self-Injury Pharmaceutical Company, Ltd. ORAL Aripiprazole SS Otsuka Pharmaceutical Company, Ltd. ORAL Seroquel SS 22-Feb-2006 08:31 AM Page: 1460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/05ISR Number: 4795377-1Report Type:Expedited (15-DaCompany Report #2005PK01720 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrophie Blanche Seroquel PS Zeneca Initial or Prolonged Finger Amputation Pharmaceutical ORAL Other Citalopram C ORAL Zopiclon C ORAL Date:10/12/05ISR Number: 4795379-5Report Type:Expedited (15-DaCompany Report #2005SE05614 Age:11769 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Quetiapine PS Zeneca Initial or Prolonged Pharmaceutical ORAL 113 DAY Date:10/12/05ISR Number: 4795382-5Report Type:Expedited (15-DaCompany Report #2005PK01818 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Seroquel PS Zeneca Hospitalization - Suicidal Ideation Pharmaceutical ORAL Initial or Prolonged Date:10/12/05ISR Number: 4795385-0Report Type:Expedited (15-DaCompany Report #2005PK01819 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Seroquel PS Zeneca Hospitalization - Suicidal Ideation Pharmaceutical ORAL Initial or Prolonged Date:10/12/05ISR Number: 4795386-2Report Type:Expedited (15-DaCompany Report #2005PK01816 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Seroquel PS Zeneca Hospitalization - Suicidal Ideation Pharmaceutical ORAL Initial or Prolonged Date:10/12/05ISR Number: 4795387-4Report Type:Expedited (15-DaCompany Report #2005GB01302 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Seroquel PS Zeneca Liver Function Test Pharmaceutical ORAL Abnormal Seroquel SS Zeneca Microcytic Anaemia Pharmaceutical ORAL White Blood Cell Count Anafranil SS ORAL Decreased Anafranil SS ORAL Normison SS 1 MON Clozaril SS ORAL 22-Feb-2006 08:31 AM Page: 1461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/05ISR Number: 4795481-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051001244 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Risperdal PS ORAL Initial or Prolonged Fall Risperdal SS ORAL Inadequate Diet Risperdal SS ORAL Neuroleptic Malignant Quetiapine Fumarate SS ORAL Syndrome Quetiapine Fumarate SS ORAL Open Wound Risperdal SS ORAL Etizolam C ORAL Flunitrazepam C ORAL Triazolam C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Date:10/12/05ISR Number: 4795746-XReport Type:Expedited (15-DaCompany Report #2005UW15158 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Self-Medication Pharmaceutical ORAL Date:10/12/05ISR Number: 4795749-5Report Type:Expedited (15-DaCompany Report #2005UW14886 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Seroquel PS Zeneca Initial or Prolonged Hyperthermia Pharmaceutical ORAL Cogentin SS Date:10/12/05ISR Number: 4799811-2Report Type:Expedited (15-DaCompany Report #HQWYE935010OCT05 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Efexor (Venlafaxine Initial or Prolonged Hepatic Enzyme Increased Professional Hydrochloride, Other Leukocytosis Other Tablet) PS ORAL 75MG , ORAL Neutrophilia Clozaril (Clozapine, Psychotic Disorder ) SS ORAL SEE IMAGE Tardive Dyskinesia Quetiapine Treatment Noncompliance (Quetiapine) SS ORAL 100 MG, ORAL Vomiting Valium (Diazepam, ) SS . C . C . C Date:10/12/05ISR Number: 4799978-6Report Type:Direct Company Report #CTU 260489 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphagia Seroquel Initial or Prolonged Drug Abuser -Quetiapine- Insomnia Astrazeneca PS Astrazeneca ORAL 300MG BID PO Oligodipsia Treatment Noncompliance 22-Feb-2006 08:31 AM Page: 1462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/05ISR Number: 4799980-4Report Type:Direct Company Report #CTU 260490 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blepharospasm Seroquel Initial or Prolonged Cerebrovascular Accident -Quetiapine- Facial Palsy Astrazeneca PS Astrazeneca ORAL 100MG BID Hypoaesthesia Oral PO Overdose Suicide Attempt Treatment Noncompliance Date:10/12/05ISR Number: 4800344-5Report Type:Expedited (15-DaCompany Report #2005-BP-12458RO Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ammonia Increased Health Methadone Hcl Blood Bilirubin Increased Professional Tablets Usp, 10 Mg Mental Status Changes (Methadone Hydrochloride) PS ORAL 5 MG BID (5 MG), PO 1 TO 2 WEEKS Seroquel (Quetiapine Fumarate) SS ORAL 125 MG QHS PO 1 TO 2 WEEKS Lexapro (Escitalopram Oxalate) SS ORAL 10 MG/DAY PO 1 TO 2 WEEKS Xeloda (Capecitabine) C Date:10/12/05ISR Number: 4801236-8Report Type:Expedited (15-DaCompany Report #2005138035 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Foreign Nardil (Phenelzine Bradycardia Health Sulfate) PS ORAL 800 MG, ORAL Intentional Misuse Professional Atenolol (Atenolol) SS ORAL ORAL Overdose Seroquel (Quetiapine Fumarate) SS ORAL 75 MG, ORAL Date:10/13/05ISR Number: 4796877-0Report Type:Expedited (15-DaCompany Report #2005SE04172 Age:8874 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Quetiapine PS Zeneca Initial or Prolonged Pharmaceutical ORAL 178 DAY Date:10/13/05ISR Number: 4797325-7Report Type:Expedited (15-DaCompany Report #2005UW14478 Age:64 YR Gender:Male I/FU:F Outcome PT Life-Threatening Dystonia Other Neuroleptic Malignant Syndrome Oculogyration 22-Feb-2006 08:31 AM Page: 1463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Serotonin Syndrome Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL Lithium C ORAL Tegretol C Date:10/13/05ISR Number: 4797338-5Report Type:Expedited (15-DaCompany Report #2005PK01828 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatocellular Damage Seroquel PS Zeneca Initial or Prolonged Injury Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Valproat SS ORAL Valproat SS ORAL Lamotrigin SS ORAL Lamotrigin SS ORAL Date:10/13/05ISR Number: 4797339-7Report Type:Expedited (15-DaCompany Report #2005AC01360 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Quetiapine PS Zeneca Incorrect Route Of Drug Pharmaceutical ORAL TABLETS Administration CRUSHED AND Intentional Misuse MADE INTO A Sedation SOLUTION, TAKEN Quetiapine SS Zeneca Pharmaceutical ORAL TABLETS CRUSHED AND MADE INTO A SOLUTION, TAKEN Quetiapine SS Zeneca Pharmaceutical ORAL TABLETS CRUSHED AND MADE INTO A SOLUTION, TAKEN Date:10/13/05ISR Number: 4797385-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902540 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Aspirin PS ORAL Other Completed Suicide Seroquel SS ORAL Hyperventilation Intentional Misuse Metabolic Acidosis Paralysis 22-Feb-2006 08:31 AM Page: 1464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/05ISR Number: 4799896-3Report Type:Expedited (15-DaCompany Report #HQWYE944110OCT05 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Effexor (Venlafaxine Completed Suicide Health Hydrochloride, Delirium Professional Tablet) PS ORAL SEE IMAGE Fall Other Alcohol (Ethanol,) SS ORAL "A BOTTLE OF Hallucination, Auditory VODKA" ORAL Intentional Misuse Seroquel Overdose (Quetiapine,) SS ORAL ORAL Date:10/13/05ISR Number: 4800621-8Report Type:Direct Company Report #CTU 260550 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Seroquel 300 Mg White Blood Cell Count Astrazeneca PS Astrazeneca ORAL 600 MG DAILY Decreased PO Colace C Fibercon C Lactulose C Synthroid C Lithium Carbonate C Ativan C Seroquel C Date:10/13/05ISR Number: 4803533-9Report Type:Expedited (15-DaCompany Report #IMP_0904_2005 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Oxycodone PS Drug Abuser Professional Quetiapine SS ORAL DF UNK PO Multiple Drug Overdose Respiratory Arrest Date:10/13/05ISR Number: 4803599-6Report Type:Expedited (15-DaCompany Report #IMP_0935_2005 Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Bupropion (Long Completed Suicide Health Acting) PS ORAL DF, PO Multiple Drug Overdose Professional Quetiapine SS DF Respiratory Arrest Oxycodone SS DF Date:10/14/05ISR Number: 4798200-4Report Type:Expedited (15-DaCompany Report #2005PK01217 Age:3151 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Other Seroquel SS Zeneca Pharmaceutical ORAL 57 DAY Dipiperon C ORAL Dipiperon C ORAL 61 DAY 22-Feb-2006 08:31 AM Page: 1465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/14/05ISR Number: 4798202-8Report Type:Expedited (15-DaCompany Report #2005GB01914 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Pharmaceutical ORAL Lamotrigine C Valproate C Date:10/14/05ISR Number: 4798279-XReport Type:Expedited (15-DaCompany Report #2005UW15197 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Seroquel PS Zeneca Pharmaceutical ORAL 1 MON Lithium SS 1 MON Unspecified Prescription Drugs SS Date:10/14/05ISR Number: 4798299-5Report Type:Expedited (15-DaCompany Report #2005SE05730 Age:27093 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Seroquel PS Zeneca Ventricular Fibrillation Pharmaceutical ORAL Serenase SS ORAL Elopram SS ORAL Date:10/14/05ISR Number: 4798304-6Report Type:Expedited (15-DaCompany Report #2005SE05767 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Disorder Seroquel PS Zeneca Prescribed Overdose Pharmaceutical ORAL Date:10/14/05ISR Number: 4798321-6Report Type:Expedited (15-DaCompany Report #2005UW13792 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Seroquel PS Zeneca Other Drug Toxicity Pharmaceutical ORAL AN UNKNOWN Loss Of Consciousness QUANTITY Overdose CRUSHED AND Victim Of Crime PUT INTO BEER Beer SS ORAL DRANK 2 BEERS 1 DAY Date:10/14/05ISR Number: 4798856-6Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0578084A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Bupropion PS Glaxosmithkline Drug Exposure During Flonase SS Glaxosmithkline Pregnancy Avandia SS Glaxosmithkline Foetal Heart Rate Nabumetone SS Glaxosmithkline Abnormal Nitroquick SS Glaxosmithkline Prenatal Vitamins SS Insulin SS 22-Feb-2006 08:31 AM Page: 1466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS Amaryl SS Hydrochlorothiazide SS Hydroxyzine Hcl SS Nexium SS Singulair SS Buspar SS Hydrocodone SS Metformin SS Carisoprodol SS Tramadol SS Benazepril SS Zocor SS Date:10/14/05ISR Number: 4798923-7Report Type:Expedited (15-DaCompany Report #2005SE05479 Age:29669 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Seroquel PS Zeneca Pharmaceutical ORAL 25 MG THREE TIMES A DAY 143 DAY Lanoxin C ORAL 0.125 MG DAILY Lasix (Furosemide) C 25 MG Date:10/14/05ISR Number: 4798927-4Report Type:Expedited (15-DaCompany Report #2005UW15258 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Date:10/14/05ISR Number: 4803631-XReport Type:Expedited (15-DaCompany Report #8011687 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Foreign Keppra PS ORAL 500 MG 2/D PO Initial or Prolonged Blood Alkaline Health Keppra SS ORAL 1000 MG 2/D Phosphatase Increased Professional PO Distributor Keppra SS ORAL 1500 MG 2/D Other PO Keppra SS ORAL 500 MG 3/D PO Keppra SS ORAL 2500 MG PO Seroquel /01270901/ SS ORAL 50 MG 2/D PO Seroquel /01270901/ SS ORAL 125 MG PO Lorazepam C Date:10/14/05ISR Number: 4826182-5Report Type:Periodic Company Report #2005SP001931 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disorientation Consumer Lunesta (3 Mg) PS ORAL 1.5 MG;HS; Hallucination ORAL Somnolence Seroquel (175 Mg) SS ORAL 175 MG ; HS ; ORAL Klonopin C 22-Feb-2006 08:31 AM Page: 1467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/05ISR Number: 4800071-4Report Type:Expedited (15-DaCompany Report #2005AP03876 Age:26933 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Seroquel PS Zeneca Hospitalization - C-Reactive Protein Pharmaceutical ORAL Initial or Prolonged Increased Seroquel SS Zeneca Hypercreatininaemia Pharmaceutical ORAL Pyrexia Seroquel SS Zeneca White Blood Cell Count Pharmaceutical ORAL RESUMED AT A Increased DECREASED DOSAGE 21 DAY Seroquel SS Zeneca Pharmaceutical ORAL RESUMED AT A DECREASED DOSAGE 21 DAY Serenace SS ORAL 36 DAY Serenace SS ORAL 26 DAY Tetramide SS ORAL 40 DAY Tetramide SS ORAL 85 DAY Gramalil SS ORAL 90 DAY Tecipul C ORAL 5 MON Amoxan C ORAL Reslin C ORAL Halcion C ORAL 65 DAY Atarax-P C ORAL 68 DAY Pursennid C ORAL 76 DAY Antidepressant (Unspecified) C Date:10/17/05ISR Number: 4801119-3Report Type:Expedited (15-DaCompany Report #2005AC01608 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Affective Disorder Quetiapine PS Zeneca Hospitalization - Asthma Pharmaceutical ORAL Initial or Prolonged Convulsion Albuterol C Other Drug Dependence Escitalopram C Liver Function Test Abnormal Long Qt Syndrome Suicidal Ideation Torsade De Pointes Ventricular Fibrillation Date:10/17/05ISR Number: 4801121-1Report Type:Expedited (15-DaCompany Report #2005UW15039 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Seroquel PS Zeneca Convulsions Pharmaceutical ORAL 400 MG - 600 MG Date:10/17/05ISR Number: 4801128-4Report Type:Expedited (15-DaCompany Report #2005AC01566 Age:60 YR Gender:Female I/FU:I Outcome PT Other Neuroleptic Malignant Syndrome 22-Feb-2006 08:31 AM Page: 1468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Serotonin Syndrome Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL Lithium C Date:10/17/05ISR Number: 4802231-5Report Type:Direct Company Report #CTU 260715 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Etanercept PS SUBCUTANEOUS 25 MG SQ Initial or Prolonged Diabetes Mellitus TWICE WEEKLY Quetiapine SS ORAL 200MG PO QHS Temazepam C Etercept C Oxybutynin C Divalproex Sodium C Calcipotriene Ointment C Clobetasol Proinate Cream C Fluocinolone Topical Solution C Hydrocortisone C Ketoconazole Shampoo C Folic Acid C Simvastatin C Terazosin C Hydroxyzine Pamoate C Quitapine Fumarate C Clorprenaline Maleate C Methotrexate C Sildenalfil Citrate C Desonide 0.5 Topical Cream C Date:10/17/05ISR Number: 4802919-6Report Type:Direct Company Report #CTU 260745 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Quetiapine PS ORAL 200MG PO TID Initial or Prolonged Prolonged Omeprazole C Promethazine Hcl C Fluoxetine Hcl C Prazosin Hcl C Quetiapine Fumarate C Trazodone C Ibuprofen C Felodipine C Metoclopramide Hcl C Multivitamin C Flunisolide Nasal Spray C Potassium Chl C Loperamide Hcl C 22-Feb-2006 08:31 AM Page: 1469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/05ISR Number: 4804277-XReport Type:Expedited (15-DaCompany Report #B0395913A Age:47 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lithium Salt PS UNKNOWN UNKNOWN Drug Level Above Health Quetiapine Therapeutic Professional (Formulation Unknown) (Quetiapine) SS ORAL UNK/ORAL Thiothixene (Formulation Unknown) (Thiothixene) SS UNKNOWN UNKNOWN Date:10/17/05ISR Number: 4804285-9Report Type:Expedited (15-DaCompany Report #B0395870A Age:49 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lamotrigine Multiple Drug Overdose Health (Lamotrigine) PS ORAL ORAL Professional Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL Date:10/17/05ISR Number: 4804299-9Report Type:Expedited (15-DaCompany Report #B0395846A Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Paxil (Paroxetine Health Hydrochloride) PS Professional Quetiapine (Quetiapine) SS ORAL ORAL Gabapentin (Gabapentin) SS . C Date:10/17/05ISR Number: 4804300-2Report Type:Expedited (15-DaCompany Report #B0395847A Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Paxil (Paroxetine Health Hydrochloride) PS Professional Quetiapine (Quetiapine) SS ORAL ORAL Ibuprofen (Ibuprofen) SS . C Date:10/17/05ISR Number: 4804306-3Report Type:Expedited (15-DaCompany Report #B0395868A Age:27 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Lamotrigine Completed Suicide Health (Lamotrigine) PS ORAL ORAL Professional Quetiapine 22-Feb-2006 08:31 AM Page: 1470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Quetiapine) SS ORAL ORAL Date:10/17/05ISR Number: 4804307-5Report Type:Expedited (15-DaCompany Report #B0395869A Age:30 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lamotrigine Health (Lamotrigine) PS ORAL ORAL Professional Quetiapine (Quetiapine) SS ORAL ORAL Oxcarbazepine (Oxcarbazepine) SS ORAL ORAL Unknown (Formulation Unknown) (Unknown) SS Date:10/17/05ISR Number: 4804901-1Report Type:Expedited (15-DaCompany Report #S05-GER-03775-01 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Missed Foreign Cipralex Drug Exposure During Health (Escitalopram) PS ORAL 15 MG QD PO Pregnancy Professional Cipralex Intra-Uterine Death Other (Escitalopram) SS ORAL 10 MG QD PO Cipralex (Escitalopram) SS ORAL 5 MG QD PO Seroquel (Quetiapine Fumarate) SS 50 MG QD Seroquel (Quetiapine Fumarate) SS 100 MG QD Seroquel (Quetiapine Fumarate) SS 250 MG QD Seroquel (Quetiapine Fumarate) SS 400 MG QD Date:10/17/05ISR Number: 4805112-6Report Type:Expedited (15-DaCompany Report #CAR_0051_2005 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Fluoxetine PS ORAL DF PO Intentional Misuse Health Quetiapine SS ORAL DF PO Multiple Drug Overdose Professional Methanol SS ORAL DF PO Date:10/17/05ISR Number: 4805122-9Report Type:Expedited (15-DaCompany Report #CAR_0049_2005 Age:26 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Fluoxetine PS ORAL DF PO Medication Error Health Quetiapine SS ORAL DF PO Multiple Drug Overdose Professional Methanol SS ORAL DF PO Respiratory Arrest Date:10/17/05ISR Number: 4805147-3Report Type:Expedited (15-DaCompany Report #CAR_0042_2005 Age:22 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Death Completed Suicide Literature Multiple Drug Overdose Health 22-Feb-2006 08:31 AM Page: 1471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Fluoxetine PS ORAL DF PO Quetiapine SS ORAL DF PO Methanol SS ORAL DF PO Date:10/17/05ISR Number: 4805184-9Report Type:Expedited (15-DaCompany Report #CAR_0041_2005 Age:60 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Diclofenac PS ORAL DF PO Completed Suicide Health Quetiapine SS ORAL DF PO Intentional Misuse Professional Simvastatin SS ORAL DF PO Multiple Drug Overdose Respiratory Arrest Date:10/17/05ISR Number: 4805191-6Report Type:Expedited (15-DaCompany Report #12617 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Morphine PS Other Multiple Drug Overdose Health Quetiapine SS Professional Cocaine SS Date:10/18/05ISR Number: 4805523-9Report Type:Expedited (15-DaCompany Report #S05-USA-04578-01 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Consumer Lexapro Initial or Prolonged Blood Sodium Decreased (Escitalopram) PS ORAL 20 MG QD PO Drug Interaction Lexapro (Escitalorpam) SS ORAL 10 MG QD PO Seroquel (Quetiapine Fumarate) SS 25 MG QD Date:10/18/05ISR Number: 4805786-XReport Type:Direct Company Report #CTU 260829 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Quetiapine Fumarate Prolonged 200mg PS ORAL 100MG HS PO Tachycardia Date:10/19/05ISR Number: 4802832-4Report Type:Expedited (15-DaCompany Report #2005UW15355 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Seroquel PS Zeneca Coma Pharmaceutical ORAL Unresponsive To Verbal Seroquel SS Zeneca Stimuli Pharmaceutical ORAL Risperdal C Valproic Acid C Flomax C Cogentin C 22-Feb-2006 08:31 AM Page: 1472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/05ISR Number: 4803384-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051001244 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Risperdal PS ORAL Initial or Prolonged Dehydration Risperdal SS ORAL Fall Risperdal SS ORAL Inadequate Diet Quetiapine Fumarate SS ORAL Neuroleptic Malignant Quetiapine Fumarate SS ORAL Syndrome Risperdal SS ORAL Open Wound Etizolam C ORAL Pneumonia Flunitrazepam C ORAL Triazolam C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Date:10/19/05ISR Number: 4803406-1Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20051001955 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ventricular Fibrillation Serenase PS ORAL 588 DAY Seroquel SS ORAL 320 DAY Citalopram SS ORAL 588 DAY Date:10/19/05ISR Number: 4803472-3Report Type:Expedited (15-DaCompany Report #2005AC01091 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Microangiopathic Quetiapine PS Zeneca Initial or Prolonged Haemolytic Anaemia Pharmaceutical ORAL Other Renal Failure Acute Lithium C Thrombotic Thrombocytopenic Purpura Date:10/19/05ISR Number: 4803475-9Report Type:Expedited (15-DaCompany Report #2005PK01888 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Seroquel PS Zeneca Pharmaceutical Anafranil SS Date:10/19/05ISR Number: 4803478-4Report Type:Expedited (15-DaCompany Report #2005UW15509 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Seroquel PS Zeneca Pharmaceutical Mao Inhibitors C 22-Feb-2006 08:31 AM Page: 1473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/05ISR Number: 4803480-2Report Type:Expedited (15-DaCompany Report #2005AC01612 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Seroquel PS Zeneca Neuroleptic Malignant Pharmaceutical ORAL 19 DAY Syndrome Seroquel I Zeneca Serotonin Syndrome Pharmaceutical ORAL 19 DAY Lithium I ORAL 8 DAY Trazolan I 25 DAY Notrilen I ORAL Date:10/19/05ISR Number: 4805966-3Report Type:Direct Company Report #CTU 260926 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Seroquel PS 25 MG TWO Q HS Date:10/20/05ISR Number: 4804390-7Report Type:Expedited (15-DaCompany Report #2005PK01777 Age:7471 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Seroquel PS Zeneca Drug Toxicity Pharmaceutical ORAL Overdose Seroquel SS Zeneca Status Epilepticus Pharmaceutical ORAL Date:10/20/05ISR Number: 4804596-7Report Type:Expedited (15-DaCompany Report #2005UW15537 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucinations, Mixed Seroquel PS Zeneca Initial or Prolonged Incorrect Dose Pharmaceutical ORAL Administered Vitamin E C ORAL Irritability Levoxyl C ORAL Orthostatic Hypotension Vitamin C C ORAL Psychotic Disorder Mvi C ORAL Urinary Incontinence Date:10/20/05ISR Number: 4804647-XReport Type:Expedited (15-DaCompany Report #2005SE05656 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Granulocytopenia Seroquel PS Zeneca Leukopenia Pharmaceutical ORAL Date:10/20/05ISR Number: 4804865-0Report Type:Expedited (15-DaCompany Report #2005UW13774 Age:87 YR Gender:Female I/FU:F Outcome PT Death Cardio-Respiratory Arrest Other Hypotension Oxygen Saturation Decreased Respiratory Failure Stupor 22-Feb-2006 08:31 AM Page: 1474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL 25 MG TITRATED TO 400 MG TID Depakote C Estradiol C Lexapro C 10 ONE HALF DAILY Oscal Plus D C Naprosyn C Exelon C Prilosec Otc C Tylenol C Trazodone C Cogentin C Dulcolax C Atarax C Cipro C Probiotica C Diflucan C Lisinopril C Multivitamins C ORAL Lotrel C Risperdal C Ativan C Date:10/20/05ISR Number: 4804868-6Report Type:Expedited (15-DaCompany Report #2005UW15102 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Seroquel PS Zeneca Complication Of Pregnancy Pharmaceutical OTHER Infertility Transmission Of Drug Via Semen Date:10/20/05ISR Number: 4805173-4Report Type:Expedited (15-DaCompany Report #US-ABBOTT-05P-163-0314056-00 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Valproic Acid PS Not reported Completed Suicide Quetiapine SS Not reported Sertraline SS Not reported Date:10/20/05ISR Number: 4807449-3Report Type:Direct Company Report #CTU 261068 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Seroquel 100 Mg And Dyspnoea 300 Mg Tablets PS Astra Zeneca Muscle Spasms Pharmaceuticals Lp TABLETS Sleep Disorder Speech Disorder Tremor 22-Feb-2006 08:31 AM Page: 1475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/05ISR Number: 4807870-3Report Type:Expedited (15-DaCompany Report #HQWYE947710OCT05 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Efexor (Venlafaxine Initial or Prolonged Neuroleptic Malignant Professional Hydrochloride) PS SEE IMAGE Other Syndrome Other Quetiapine Rhabdomyolysis (Quetiapine, ) SS ORAL 150 MG 1X PER 1 DAY, ORAL Stilonox (Zopidem, ) SS ORAL ORAL Promethazine Hydrochloride (Promethazine Hydrochloride) SS Valproate Sodium (Valproate Sodium) SS ORAL SEE IMAGE Panadol (Paracetamol) C Sandomigran (Pizotifen Maleate0 C Mersyndol (Codeine Phosphate/Doxylamine Succinate/Paracetamo l) C Salbutamol (Salbutamol) C Diazepam (Diazepam) C Date:10/21/05ISR Number: 4805630-0Report Type:Expedited (15-DaCompany Report #2005UW14117 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Seroquel PS Zeneca Increased Pharmaceutical ORAL Maternal Drugs Affecting Acetaminophen SS ORAL Foetus Oedema Tachypnoea Date:10/21/05ISR Number: 4805631-2Report Type:Expedited (15-DaCompany Report #2005UW14172 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Seroquel PS Zeneca Asthenia Pharmaceutical ORAL Atherosclerosis Clozaril SS Cardiac Arrest Orap SS Hepatic Steatosis Carbamazepine C Myocardial Ischaemia Clonazepam C Obesity Flurazepam Pulmonary Congestion Hydrochloride C Pulmonary Oedema Gabapentin C Pulmonary Thrombosis Kemadrin C Respiratory Arrest Topamax C Somnolence 22-Feb-2006 08:31 AM Page: 1476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/05ISR Number: 4805638-5Report Type:Expedited (15-DaCompany Report #2003UW13607 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Seroquel PS Zeneca Asthenia Pharmaceutical ORAL Balance Disorder Serzone SS ORAL 4-5 YEARS Brain Damage Serzone SS ORAL Breast Cancer Female Paxil C ORAL Cognitive Disorder Paxil C ORAL Condition Aggravated Premarin C Crying Multivitamin C Depression Calcium C Diarrhoea Metamucil C 6AM AND 6PM Dysphasia Encephalopathy Fatigue Headache Hypersomnia Lethargy Medication Error Memory Impairment Muscle Spasms Muscle Twitching Social Avoidant Behaviour Somnolence Tremor Date:10/21/05ISR Number: 4805952-3Report Type:Expedited (15-DaCompany Report #2005GB01861 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Seroquel PS Zeneca Constipation Pharmaceutical ORAL Dry Mouth Clopixol C INTRAMUSCULAR Sudden Death Date:10/21/05ISR Number: 4806263-2Report Type:Expedited (15-DaCompany Report #2005GB01521 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bloody Discharge Seroquel PS Zeneca Chest Pain Pharmaceutical ORAL Drug Toxicity Hyperhidrosis Lung Infection Malaise Nausea Rectal Discharge Vertigo Date:10/21/05ISR Number: 4806401-1Report Type:Expedited (15-DaCompany Report #2005SE05743 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Seroquel PS Zeneca Neutropenia Pharmaceutical ORAL Tolvon SS ORAL 22-Feb-2006 08:31 AM Page: 1477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/05ISR Number: 4806421-7Report Type:Expedited (15-DaCompany Report #2005UW15698 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Seroquel PS Zeneca Pharmaceutical ORAL Date:10/21/05ISR Number: 4806463-1Report Type:Expedited (15-DaCompany Report #2005UW15687 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Disability Injury Pharmaceutical ORAL 22 MON Abilify SS 22 MON Risperdal SS 22 MON Date:10/21/05ISR Number: 4806480-1Report Type:Expedited (15-DaCompany Report #2005UW15677 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperthermia Seroquel PS Zeneca Other Medication Error Pharmaceutical ORAL Movement Disorder Date:10/21/05ISR Number: 4806482-5Report Type:Expedited (15-DaCompany Report #2005UW15699 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Seroquel PS Zeneca Hospitalization - Diabetic Ketoacidosis Pharmaceutical ORAL Initial or Prolonged Lipids Increased Olanzapine C Respiratory Disorder Date:10/24/05ISR Number: 4807135-XReport Type:Expedited (15-DaCompany Report #2005AC01292 Age:488 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bulimia Nervosa Seroquel PS Zeneca Pharmaceutical ORAL Depakine C ORAL Maniprex C ORAL Seroxat C ORAL Date:10/24/05ISR Number: 4807141-5Report Type:Expedited (15-DaCompany Report #2005GB01558 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Apnoea Syndrome Quetiapine PS Zeneca Pharmaceutical ORAL 50MG NOCTE FOR 5 NIGHTS THEN 100MG NOCTE 10 DAY Depakote C ORAL 1000MG MANE + 500MG NOCTE 22-Feb-2006 08:31 AM Page: 1478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/05ISR Number: 4807176-2Report Type:Expedited (15-DaCompany Report #2005SE05767 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Seroquel PS Zeneca Aorta Hypoplasia Pharmaceutical ORAL 8 MON Cardiac Arrest Seroquel SS Zeneca Drug Abuser Pharmaceutical ORAL 4 MON Prescribed Overdose Seroquel SS Zeneca Pharmaceutical ORAL Tranquirit C 12 MON Largactil C Nozinan C Entumin C 7 MON Rivotril C Date:10/24/05ISR Number: 4807177-4Report Type:Expedited (15-DaCompany Report #2005PK01901 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Seroquel PS Zeneca Prothrombin Time Pharmaceutical ORAL Prolonged Sintrom I 17 DAY Sintrom I 17 DAY Date:10/25/05ISR Number: 4808331-8Report Type:Expedited (15-DaCompany Report #2005UW12475 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypoaesthesia Oral Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Verapamil C Diovan C Date:10/25/05ISR Number: 4808338-0Report Type:Expedited (15-DaCompany Report #2005UW15420 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adenoma Benign Seroquel PS Zeneca Pharmaceutical ORAL 6 MON Date:10/25/05ISR Number: 4808652-9Report Type:Expedited (15-DaCompany Report #2005PK01777 Age:7471 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Seroquel PS Zeneca Hospitalization - Drug Toxicity Pharmaceutical ORAL Initial or Prolonged Overdose Seroquel SS Zeneca Status Epilepticus Pharmaceutical ORAL Suicide Attempt 22-Feb-2006 08:31 AM Page: 1479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/05ISR Number: 4808657-8Report Type:Expedited (15-DaCompany Report #2005AP05443 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Seroquel PS Zeneca Increased Pharmaceutical ORAL 2 DAY Aspartate Seroquel SS Zeneca Aminotransferase Pharmaceutical ORAL 1 DAY Increased Dantrium SS ORAL 7 DAY Blood Alkaline Magmitt C Phosphatase Increased Silece C Gamma-Glutamyltransferase Risperdal C 2 DAY Increased Risperdal C 4 DAY Hepatic Function Abnormal Jaundice Date:10/25/05ISR Number: 4809172-8Report Type:Expedited (15-DaCompany Report #2005UW15421 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Seroquel PS Zeneca Initial or Prolonged Insomnia Pharmaceutical ORAL Lethargy Seroquel SS Zeneca Overdose Pharmaceutical ORAL Suicidal Ideation Ambien SS ORAL 1 DAY Lithium Carbonate C Famotidine C Inderal C Albuterol Inhaler C RESPIRATORY (INHALATION) 2 PUFFS Q 4 HRS PRN Fish Oil C Date:10/25/05ISR Number: 4810548-3Report Type:Direct Company Report #CTU 261436 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Arrest Quetiapine PS 25 PO BID Electrocardiogram Qt Captopril C Prolonged Clonidine C Ventricular Fibrillation Clonidine Patch C Ventricular Tachycardia Heparin C Isosorbide Dinitrate C Metoprolol C Nicotine Patch C Ranitidine C Date:10/25/05ISR Number: 4811695-2Report Type:Expedited (15-DaCompany Report #S05-ITA-03865-01 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ventricular Fibrillation Foreign Elopram (Citalopram) Health (Citalopram) PS ORAL 20 MG QD PO Professional Quetiapine Fumarate SS ORAL 125 MG QD PO Other Haloperidol SS ORAL 1.5 MG QD PO 22-Feb-2006 08:31 AM Page: 1480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/05ISR Number: 4809814-7Report Type:Expedited (15-DaCompany Report #2005UW15926 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Detachment Seroquel PS Zeneca Pharmaceutical ORAL 1 YR Date:10/26/05ISR Number: 4810069-8Report Type:Expedited (15-DaCompany Report #2005AC01637 Age:8386 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL 25 DAY Date:10/26/05ISR Number: 4810086-8Report Type:Expedited (15-DaCompany Report #2005SE05937 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Seroquel PS Zeneca Pharmaceutical ORAL Date:10/26/05ISR Number: 4810090-XReport Type:Expedited (15-DaCompany Report #2005AC01493 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Seroquel PS Zeneca Initial or Prolonged Drug Withdrawal Syndrome Pharmaceutical ORAL 3 MON Dyskinesia Seroquel SS Zeneca Dystonia Pharmaceutical ORAL DURING THIS PERIOD, DRUG WAS REDUCED FROM 900 MG TO 0 MG 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL Abilify C Date:10/27/05ISR Number: 4810908-0Report Type:Expedited (15-DaCompany Report #2005UW15686 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Seroquel PS Zeneca Injury Pharmaceutical ORAL 52 MON Pancreatitis Chronic Risperdal SS 52 MON Zyprexa SS 52 MON Date:10/27/05ISR Number: 4810939-0Report Type:Expedited (15-DaCompany Report #2005PK01941 Age:27397 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Seroquel PS Zeneca Hospitalization - Phosphokinase Increased Pharmaceutical ORAL 5 MON Initial or Prolonged General Physical Health Seroquel SS Zeneca Deterioration Pharmaceutical ORAL 26 DAY Pyrexia Stalevo C ORAL 26 DAY 22-Feb-2006 08:31 AM Page: 1481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/05ISR Number: 4811157-2Report Type:Expedited (15-DaCompany Report #2005GB02003 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Circulatory Collapse Seroquel PS Zeneca Delirium Pharmaceutical ORAL Loss Of Consciousness Seroquel SS Zeneca Overdose Pharmaceutical ORAL Date:10/27/05ISR Number: 4811158-4Report Type:Expedited (15-DaCompany Report #2005AC01671 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Multiple Drug Overdose Pharmaceutical Poisoning Salicylic Acid SS Vomiting Carbamazepine SS Trazodone SS Trihexyphenidyl SS Ibuprofen SS Date:10/27/05ISR Number: 4811377-7Report Type:Expedited (15-DaCompany Report #2005UW14092 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Seroquel PS Zeneca Increased Pharmaceutical TRANSPLACENTAL Intentional Misuse Acetaminophen SS TRANSPLACENTAL Oedema Tachypnoea Date:10/27/05ISR Number: 4815370-XReport Type:Expedited (15-DaCompany Report #2005RL000145 Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Innopran Xl PS Completed Suicide Health Quetiapine SS Professional Cyclobenzaprine SS Date:10/27/05ISR Number: 4815371-1Report Type:Expedited (15-DaCompany Report #2005RL000143 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Innopran Xl PS Health Acetaminophen SS Professional Propoxyphene SS Quetiapine SS Date:10/28/05ISR Number: 4812078-1Report Type:Expedited (15-DaCompany Report #2005UW15717 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Sulindac C Artane C 22-Feb-2006 08:31 AM Page: 1482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/05ISR Number: 4812185-3Report Type:Expedited (15-DaCompany Report #2005UW15532 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Seroquel PS Zeneca Initial or Prolonged Peripheral Circulatory Pharmaceutical ORAL Failure Date:10/28/05ISR Number: 4813113-7Report Type:Expedited (15-DaCompany Report #2005GB02019 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thyroid Function Test Seroquel PS Zeneca Abnormal Pharmaceutical ORAL Weight Increased Epilim Chrono C ORAL Diazepam C ORAL DOSE VARIED 2 MON Carbamazepine C ORAL 15 DAY Date:10/28/05ISR Number: 4813116-2Report Type:Expedited (15-DaCompany Report #2005AP05420 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL Date:10/28/05ISR Number: 4813121-6Report Type:Expedited (15-DaCompany Report #2005AP04741 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Megaloblastic Seroquel PS Zeneca Pharmaceutical ORAL Date:10/28/05ISR Number: 4813125-3Report Type:Expedited (15-DaCompany Report #2005UW15690 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Small Intestinal Seroquel PS Zeneca Initial or Prolonged Obstruction Pharmaceutical ORAL Urinary Retention Inderal SS Clonopin SS Date:10/28/05ISR Number: 4814054-1Report Type:Expedited (15-DaCompany Report #2005UW16110 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Interaction Seroquel PS Zeneca Completed Suicide Pharmaceutical ORAL 3 DAY Intentional Misuse Seroquel I Zeneca Overdose Pharmaceutical ORAL Wine I ORAL 22-Feb-2006 08:31 AM Page: 1483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/05ISR Number: 4814070-XReport Type:Expedited (15-DaCompany Report #2005SE05207 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Burning Sensation Seroquel PS Zeneca Flushing Pharmaceutical Pharyngeal Oedema Litarex SS Pruritus Lamictal SS Diclocil C 4 DAY Roxithromycin C Antabus C Nitracepam C Paracetamol C Date:10/28/05ISR Number: 4814193-5Report Type:Expedited (15-DaCompany Report #2005GB02029 Age:13310 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Seroquel PS Zeneca Headache Pharmaceutical ORAL Somnolence Seroquel SS Zeneca Vision Blurred Pharmaceutical ORAL Lithium C Date:10/28/05ISR Number: 4814970-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051001244 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Risperdal PS ORAL Initial or Prolonged Dehydration Risperdal SS ORAL Fall Risperdal SS ORAL Inadequate Diet Quetiapine Fumarate SS ORAL Neuroleptic Malignant Quetiapine Fumarate SS ORAL Syndrome Risperdal SS ORAL Open Wound Etizolam C ORAL Pneumonia Flunitrazepam C ORAL Triazolam C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Date:10/28/05ISR Number: 4815519-9Report Type:Direct Company Report #CTU 261729 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Quetiapine-Astrazene Initial or Prolonged Dizziness ca PS Astrazeneca ORAL 300 MG PO HS Feeling Abnormal Furosemide C Hypoaesthesia Aspirin C Hypotension Oxycodone/Acetaminop Nausea hen C Paraesthesia Simvastatin/Ezetimib e C Losartan C Maloxicam C Clopidogrel C Nitroglycerin C 22-Feb-2006 08:31 AM Page: 1484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/05ISR Number: 4816421-9Report Type:Expedited (15-DaCompany Report #GBWYE775427JUN05 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Neonatal Foreign Efexor Xl PS TRANSPLACENTAL 225 MG, Caesarean Section Health FREQUENCY NOT Drug Exposure During Professional STATED, Pregnancy Other TRANSPLACENTA Feeding Disorder Neonatal L Large For Dates Baby Amitripytline (Amitriptyline) SS TRANSPLACENTAL Olanzapine (Olanzapine, , 0) SS TRANSPLACENTAL Quetiapine (Quetiapine, , O) SS TRANSPLACENTAL 600 MG 1X PER 1 DAY, TRANSPLACENTA L Date:10/28/05ISR Number: 4816433-5Report Type:Expedited (15-DaCompany Report #GBWYE936829JUL04 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Efexor Xl PS ORAL 225 MG , ORAL Caesarean Section Health Amitriptyline Drug Exposure During Professional Pregnancy Other (Amitriptyline, , 0) SS AT TIME OF Gestational Diabetes GIVING BIRTH Pregnancy Olanzapine (Olanzapine) SS AT TIME OF GIVING BIRTH Quetiapine (Quetiapine) SS ORAL 600 MG, ORAL Date:10/31/05ISR Number: 4815831-3Report Type:Expedited (15-DaCompany Report #2005PK01964 Age:706 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL DAILY DOSE INCREASED TO 600 MG 3 WK Seroquel SS Zeneca Pharmaceutical ORAL 5 MON Seroquel SS Zeneca Pharmaceutical ORAL Insulin C SUBCUTANEOUS Date:10/31/05ISR Number: 4816567-5Report Type:Direct Company Report #CTU 261765 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Quetiapine 25mg Required Phosphokinase Increased Astra Zeneca PS Astra Zeneca ORAL 50 MG QAM PO Intervention to Cogwheel Rigidity ; 100MG QHS Prevent Permanent Musculoskeletal Stiffness PO Impairment/Damage 22-Feb-2006 08:31 AM Page: 1485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/05ISR Number: 4817876-6Report Type:Direct Company Report #CTU 261847 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Tramadol PS 100 MG QID Initial or Prolonged Blood Pressure Sertraline SS 50 MG QD Fluctuation Quetiapine SS ORAL 200 MG PO Q Dizziness HS Drug Interaction Dyskinesia Muscle Spasms Nausea Paraesthesia Serotonin Syndrome Date:10/31/05ISR Number: 4818308-4Report Type:Direct Company Report #CTU 261896 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Quetiapine PS ORAL 100 MG PO QHS Initial or Prolonged Corrected Interval Other Prolonged Myocardial Infarction Date:11/01/05ISR Number: 4816838-2Report Type:Expedited (15-DaCompany Report #2005UW16226 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Seroquel PS Zeneca Respiratory Failure Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Fentanyl Patch C TRANSDERMAL Paxil C Date:11/01/05ISR Number: 4816971-5Report Type:Expedited (15-DaCompany Report #2005UW15898 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Seroquel PS Zeneca Initial or Prolonged Drug Administration Error Pharmaceutical ORAL Psychotic Disorder Depakote C Xanax C Date:11/01/05ISR Number: 4817208-3Report Type:Expedited (15-DaCompany Report #2005UW15968 Age:68 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Cerebellar Haemorrhage Muscle Rigidity Neuroleptic Malignant Syndrome 22-Feb-2006 08:31 AM Page: 1486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Porphyria Posture Abnormal Pyrexia Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL 2 WK Seroquel SS Zeneca Pharmaceutical ORAL Plavix C Date:11/01/05ISR Number: 4817213-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051005927 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Risperdal PS Other Neuroleptic Malignant Seroquel SS Syndrome Zyprexa SS Date:11/01/05ISR Number: 4817671-8Report Type:Direct Company Report #CTU 261999 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Seroquel 200 Mg Intervention to (Astra-Zeneca) PS Astra-Zeneca 200 MG Prevent Permanent Impairment/Damage Date:11/01/05ISR Number: 4843477-XReport Type:Periodic Company Report #DSA_26188_2005 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Ativan PS ORAL 1 MG BID PO Required Professional Prozac SS 100 MG Q DAY Intervention to Remeron SS ORAL 7.5 MG Q DAY Prevent Permanent PO Impairment/Damage Seroquel SS ORAL 150 MG Q DAY PO Wellbutrin SS ORAL 450 MG Q DAY PO Zofran SS ORAL 8 MG PRN PO Date:11/02/05ISR Number: 4817931-0Report Type:Expedited (15-DaCompany Report #2005UW14886 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Seroquel PS Zeneca Initial or Prolonged Hyperthermia Malignant Pharmaceutical ORAL Pneumonia Aspiration Seroquel SS Zeneca Pulmonary Oedema Pharmaceutical ORAL Skin Laceration Mirapex C Urinary Retention Cogentin C 22-Feb-2006 08:31 AM Page: 1487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/05ISR Number: 4818016-XReport Type:Expedited (15-DaCompany Report #2005AP05572 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Leukopenia Pharmaceutical ORAL 100 - 200 MG BID 26 DAY Captopril C ORAL Cedocard C ORAL Cefoperazone C Date:11/02/05ISR Number: 4818343-6Report Type:Expedited (15-DaCompany Report #2005UW16106 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neoplasm Malignant Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Haldol C Norvasc C Atenolol C Divalproic Acid C Date:11/02/05ISR Number: 4818384-9Report Type:Expedited (15-DaCompany Report #2005SE05730 Age:27093 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apathy Seroquel PS Zeneca Cardiac Arrest Pharmaceutical ORAL Catheter Related Serenase SS ORAL Infection Elopram SS ORAL Death Of Relative Electrocardiogram T Wave Amplitude Decreased Extrapyramidal Disorder Genitourinary Tract Infection Orchitis Sepsis Sinus Tachycardia Stress Supraventricular Extrasystoles Urinary Tract Infection Ventricular Extrasystoles Ventricular Fibrillation Date:11/03/05ISR Number: 4819088-9Report Type:Expedited (15-DaCompany Report #2005SE06206 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/05ISR Number: 4819093-2Report Type:Expedited (15-DaCompany Report #2005GB02039 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Idiopathic Seroquel PS Zeneca Thrombocytopenic Purpura Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Simvastatin C HAS BEEN TAKING FOR A LONG TIME WITH NO PROBLEMS Spironolactone C HAS BEEN TAKING FOR A LONG TIME WITH NO PROBLEMS Lorazepam C HAS BEEN TAKING FOR A LONG TIME WITH NO PROBLEMS Frusemide C HAS BEEN TAKING FOR A LONG TIME WITH NO PROBLEMS Date:11/03/05ISR Number: 4819120-2Report Type:Expedited (15-DaCompany Report #2005UW14963 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Seroquel PS Zeneca Drug Toxicity Pharmaceutical ORAL 190 DAY Hepatomegaly Geodon SS ORAL Obesity Overdose Date:11/03/05ISR Number: 4819121-4Report Type:Expedited (15-DaCompany Report #2005UW16044 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Seroquel PS Zeneca Initial or Prolonged Blood Sodium Decreased Pharmaceutical ORAL Drug Interaction Lexapro I ORAL 7 DAY Lexapro I ORAL 7 DAY Lexapro I ORAL Lexapro I ORAL Date:11/03/05ISR Number: 4819122-6Report Type:Expedited (15-DaCompany Report #2005UW16011 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Seroquel PS Zeneca Pharmaceutical ORAL Lamictal C 22-Feb-2006 08:31 AM Page: 1489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paxil C Wellbutrin C Date:11/03/05ISR Number: 4819521-2Report Type:Expedited (15-DaCompany Report #2005SE03558 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Seroquel PS Zeneca Initial or Prolonged Anxiety Pharmaceutical ORAL START DOSE 50 Other Chills MG, INCREASED Dizziness IN INTERVALS Dyspnoea OF 50 MG TO Hyperhidrosis MAX 450 MG Hypertension Seroquel SS Zeneca Hypotension Pharmaceutical ORAL 150 MG + 300 Nausea MG Pallor Seroquel SS Zeneca Paraesthesia Mucosal Pharmaceutical ORAL 150 MG + 100 Psychotic Disorder MG 1 DAY Tachycardia Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Zyprexa SS ORAL Zyprexa SS ORAL Zyprexa SS ORAL 2.5 MG + 5 MG 1 DAY Zyprexa SS ORAL 1 DAY Vallergan C ORAL Date:11/03/05ISR Number: 4820817-9Report Type:Expedited (15-DaCompany Report #L05-USA-03935-58 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Propranolol PS Multiple Drug Overdose Health Acetaminophen/Propox Intentional Professional yphene SS Quetiapine SS Date:11/03/05ISR Number: 4820867-2Report Type:Expedited (15-DaCompany Report #L05-USA-03935-60 Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Propranolol PS Completed Suicide Health Quetiapine SS Multiple Drug Overdose Professional Cyclobenzaprine SS Intentional Respiratory Arrest Date:11/03/05ISR Number: 4821168-9Report Type:Expedited (15-DaCompany Report #L05-USA-03935-50 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Literature Escitalopram PS Cardiac Arrest Health Quetiapine SS Multiple Drug Overdose Professional Clonazepam SS Respiratory Arrest 22-Feb-2006 08:31 AM Page: 1490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/05ISR Number: 4822280-0Report Type:Expedited (15-DaCompany Report #L05-USA-03935-03 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Citalopram PS Multiple Drug Overdose Health Methadone SS Intentional Professional Quetiapine SS Date:11/04/05ISR Number: 4820391-7Report Type:Expedited (15-DaCompany Report #2004GB01160 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Quetiapine PS Zeneca Dementia Pharmaceutical ORAL Sudden Death Quetiapine SS Zeneca Pharmaceutical ORAL Risperidone C ORAL 500 MCG TO 1 MG 21 MON Aspirin C ORAL Lactulose C UNKNOWN Zopiclone C UNKNOWN Date:11/04/05ISR Number: 4820569-2Report Type:Expedited (15-DaCompany Report #2005GB02063 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Quetiapine PS Zeneca Initial or Prolonged Drug Interaction Pharmaceutical ORAL Disability Facial Paresis Bendrofluazide C UNKNOWN Gastroenteritis Omeprazole C UNKNOWN Hemiparesis Tamsulosin C UNKNOWN Therapeutic Agent Flomax Mr C UNKNOWN Toxicity Lorazepam C UNKNOWN Prostap C UNKNOWN Priadel I ORAL 22 DAY Date:11/04/05ISR Number: 4820571-0Report Type:Expedited (15-DaCompany Report #2005GB01532 Age:40 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Quetiapine PS Zeneca Disability Mobility Decreased Pharmaceutical ORAL Other Obesity Warfarin C UNKNOWN PER INR Weight Increased Warfarin C UNKNOWN PER INR Co-Amilofruse C ORAL Diazepam C ORAL Diazepam C ORAL Frusemide C ORAL Procyclidine C ORAL Date:11/04/05ISR Number: 4820572-2Report Type:Expedited (15-DaCompany Report #2005GB02060 Age:35 YR Gender: I/FU:I Outcome PT Other Agitation Chills Confusional State Headache 22-Feb-2006 08:31 AM Page: 1491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Myoclonus Serotonin Syndrome Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL 6 DAY Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Tegretol C ORAL Epilim C ORAL 500 MG EVERY MORNING AND 1000 MG EVERY EVENING Diazepam C ORAL Date:11/04/05ISR Number: 4822470-7Report Type:Direct Company Report #USP 57504 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Dispensing Error Seroquel PS Astra Zeneca TABLETS Medication Error Serzone SS Teva TABLETS Somnolence Date:11/07/05ISR Number: 4821216-6Report Type:Expedited (15-DaCompany Report #2005UW16445 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL Date:11/07/05ISR Number: 4821222-1Report Type:Expedited (15-DaCompany Report #2005UW14090 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Seroquel PS Zeneca Initial or Prolonged Increased Pharmaceutical ORAL 10-30 TABLETS Other Aspartate Acetaminophen SS 128 TABLETS Aminotransferase Sertraline C Increased Blood Alkaline Phosphatase Increased Drug Exposure During Pregnancy Hyperbilirubinaemia Hypotension Intentional Overdose Multiple Drug Overdose Intentional Prothrombin Time Prolonged Sedation Tachycardia 22-Feb-2006 08:31 AM Page: 1492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/05ISR Number: 4821234-8Report Type:Expedited (15-DaCompany Report #2005UW15677 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cognitive Deterioration Seroquel PS Zeneca Other Cognitive Disorder Pharmaceutical ORAL Cold Sweat Hypothermia Medication Error Memory Impairment Movement Disorder Narcolepsy Skin Discolouration Somnolence Victim Of Crime Date:11/07/05ISR Number: 4821278-6Report Type:Expedited (15-DaCompany Report #2005UW16299 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haemoglobin Decreased Seroquel PS Zeneca White Blood Cell Count Pharmaceutical ORAL Decreased Date:11/07/05ISR Number: 4821627-9Report Type:Expedited (15-DaCompany Report #2005UW16506 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Seroquel PS Zeneca Laryngospasm Pharmaceutical ORAL Psychiatric Symptom Fentanyl C TOPICAL Methadone C Hydromorphone Contin C Gabapentin C Lithium C Date:11/07/05ISR Number: 4821628-0Report Type:Expedited (15-DaCompany Report #2005UW14092 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Seroquel PS Zeneca Initial or Prolonged Increased Pharmaceutical TRANSPLACENTAL Analgesic Drug Level Acetaminophen SS TRANSPLACENTAL Increased Drug Exposure During Pregnancy Intentional Overdose Neonatal Disorder Neonatal Tachypnoea Oedema Oedema Neonatal Tachypnoea 22-Feb-2006 08:31 AM Page: 1493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/05ISR Number: 4821646-2Report Type:Expedited (15-DaCompany Report #2005UW16485 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL Risperidone C Cipralex C Date:11/07/05ISR Number: 4821648-6Report Type:Expedited (15-DaCompany Report #2005UW16622 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Seroquel PS Zeneca Pulmonary Embolism Pharmaceutical ORAL Date:11/07/05ISR Number: 4821649-8Report Type:Expedited (15-DaCompany Report #2005AC01737 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Quetiapine PS Zeneca Anticholinergic Syndrome Pharmaceutical ORAL Delirium Clonazepam SS Overdose Date:11/07/05ISR Number: 4821653-XReport Type:Expedited (15-DaCompany Report #2005AC01682 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Quetiapine PS Zeneca Initial or Prolonged Electrocardiogram Qt Pharmaceutical ORAL DOSE BEFORE Corrected Interval OVERDOSE. Prolonged TITRATED UP Overdose T0 300 MG Sedation TWICE DAILY Sinus Tachycardia Quetiapine SS Zeneca Somnolence Pharmaceutical ORAL Suicide Attempt Quetiapine SS Zeneca Pharmaceutical ORAL TAKEN AS OVERDOSE Quetiapine SS Zeneca Pharmaceutical RE-STARTED ONE WEEK AFTER OVERDOSE. TITRATED UP Alcohol SS PATIENT TOOK APPROX 4 CL OF GIN Lorazepam C Date:11/07/05ISR Number: 4821984-3Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-13015938 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Abilify PS Otsuka Initial or Prolonged Prescribed Overdose Pharmaceutical Company, Ltd. ORAL Increased to 22-Feb-2006 08:31 AM Page: 1494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 45 mg/d on 31-Dec-04 and continuing. Seroquel SS ORAL Initiated at 400mg on 08-Oct-04/350 mg(13-18-Oct) /300mg(19-09- Date:11/08/05ISR Number: 4822596-8Report Type:Expedited (15-DaCompany Report #2005AP05443 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Alanine Aminotransferase Seroquel PS Zeneca Increased Pharmaceutical ORAL 2 DAY Aspartate Seroquel SS Zeneca Aminotransferase Pharmaceutical ORAL 1 DAY Increased Dantrium SS ORAL 7 DAY Blood Alkaline Magmitt C ORAL 21 DAY Phosphatase Increased Silece C ORAL 24 DAY Gamma-Glutamyltransferase Risperdal C 2 DAY Increased Risperdal C 4 DAY Hepatic Function Abnormal Jaundice Liver Disorder Date:11/08/05ISR Number: 4822972-3Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20051001955 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apathy Serenase PS ORAL 20 drops Hospitalization - Bradykinesia Serenase SS ORAL 15 drops Initial or Prolonged Catheter Related Seroquel SS ORAL 320 DAY Other Infection Seroquel SS ORAL 320 DAY Electrocardiogram Qt Citalopram SS ORAL 588 DAY Prolonged Electrocardiogram Repolarisation Abnormality Extrapyramidal Disorder Hypertonia Muscle Rigidity Sepsis Sinus Tachycardia Tremor Urinary Tract Infection Ventricular Fibrillation Date:11/08/05ISR Number: 4824450-4Report Type:Expedited (15-DaCompany Report #S05-USA-04294-01 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Campral (Acamprosate Mania Professional Calcium) PS ORAL 666 MG TID PO Company Seroquel (Quetiapine Representative Fumarate) SS 200 MG QHS Klonopin (Clonazepam) C Xanax (Alprazolam) C 22-Feb-2006 08:31 AM Page: 1495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atenolol C Zyprexa (Olanzapine) C Date:11/08/05ISR Number: 4824547-9Report Type:Expedited (15-DaCompany Report #S05-ITA-03865-01 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Elopram (Citalopram) Apathy Health (Citalopram) PS ORAL 20 MG QD PO Bradykinesia Professional Seroquel (Quetiapine Cerebral Parenchymal Other Fumarate) SS ORAL 125 MG QD PO Calcification Seroquel (Quetiapine Cerebral Ventricle Fumarate) SS ORAL 100 MG QHS Dilatation PO Condition Aggravated Seroquel (Quetiapine Electrocardiogram Fumarate) SS ORAL 125 MG QD PO Repolarisation Serenase Abnormality (Haloperiodol) SS ORAL 15 DROPS QD Electrocardiogram T Wave PO Amplitude Decreased Serenase Extrapyramidal Disorder (Haloperiodol) SS ORAL 10 DROPS QD Fall PO Genitourinary Tract Serenase Infection (Haloperiodol) SS 15 DROPS QD Hypertonia PO Insomnia Serenase Muscle Rigidity (Haloperiodol) SS ORAL 5 DROPS QD PO Sinus Tachycardia Serenase Supraventricular (Haloperiodol) SS ORAL 20 DROPS QD Extrasystoles PO Tremor Serenase Ventricular Extrasystoles (Haloperiodol) SS ORAL 10 DROPS QD Ventricular Fibrillation PO Serenase (Haloperiodol) SS ORAL 1.5 MG QD PO Lorazepam C Zyprexa (Olanzapine) C Date:11/09/05ISR Number: 4823345-XReport Type:Expedited (15-DaCompany Report #2005UW16558 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperkalaemia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Depakote C Dilantin C Paxil C Doxepin C Prilosec C Chlorzoxazone C Date:11/09/05ISR Number: 4823496-XReport Type:Expedited (15-DaCompany Report #2005UW16779 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cognitive Disorder Seroquel PS Zeneca Death Pharmaceutical ORAL Delirium Zyprexa C 22-Feb-2006 08:31 AM Page: 1496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/05ISR Number: 4823687-8Report Type:Expedited (15-DaCompany Report #2005UW16779 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cognitive Disorder Seroquel PS Zeneca Death Pharmaceutical ORAL Delirium Zyprexa C Date:11/09/05ISR Number: 4823701-XReport Type:Expedited (15-DaCompany Report #2005AP05753 Age:19622 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Seroquel PS Zeneca Initial or Prolonged Amenorrhoea Pharmaceutical ORAL Blood Cholesterol Efexor-Xr SS ORAL Increased Prozac C Bruxism Cortisone C Candidiasis Neurontin C Dermatitis Exfoliative Valium C Flushing Xanax C Mania Pariet C Memory Impairment Renitec C Poor Peripheral Di-Gesic C Circulation Pethidine Psoriasis Hydrochloride C Skin Discolouration Vitamins C Suicidal Ideation Tongue Biting Date:11/09/05ISR Number: 4823702-1Report Type:Expedited (15-DaCompany Report #2005AP05739 Age:12783 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Joint Stiffness Seroquel PS Zeneca Initial or Prolonged Musculoskeletal Stiffness Pharmaceutical ORAL Trismus Clozapine SS ORAL 5 DAY Date:11/09/05ISR Number: 4823840-3Report Type:Expedited (15-DaCompany Report #2005AP05572 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Leukopenia Pharmaceutical ORAL 100 - 200 MG BID 26 DAY Captopril C ORAL Cedocard C ORAL Cefoperazone C Date:11/09/05ISR Number: 4824011-7Report Type:Expedited (15-DaCompany Report #2005UW16485 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL Risperidone C Cipralex C 22-Feb-2006 08:31 AM Page: 1497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/05ISR Number: 4824035-XReport Type:Expedited (15-DaCompany Report #2005UW16799 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Hospitalization - Dehydration Pharmaceutical Initial or Prolonged Pain Date:11/09/05ISR Number: 4825041-1Report Type:Direct Company Report #CTU 262785 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Oestrogen Abnormal Haldol-1mg PS MORNING/NIGHT 30 MON Required Blood Prolactin Increased Seroquel-200mg SS MORNING/NIGHT 30 MON Intervention to Blood Testosterone Arctane C Prevent Permanent Abnormal Haldol C Impairment/Damage Gynaecomastia Trazadone With Seroquel C Date:11/10/05ISR Number: 4824516-9Report Type:Expedited (15-DaCompany Report #2005SE05937 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Seroquel Granulocyte Count Enterotablets PS Zeneca Decreased Pharmaceutical ORAL 130 DAY Platelet Count Decreased Oxazepam C White Blood Cell Count Decreased Date:11/10/05ISR Number: 4824627-8Report Type:Expedited (15-DaCompany Report #2005AP05740 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Toxic Epidermal Seroquel PS Zeneca Necrolysis Pharmaceutical ORAL Lamictal SS ORAL Chlorpromazine Hydrochloride SS Lithium Carbonate SS ORAL Sodium Valproate SS ORAL Biperiden Hydrochloride SS ORAL Date:11/10/05ISR Number: 4824699-0Report Type:Expedited (15-DaCompany Report #2005GB02047 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cold Sweat Seroquel PS Zeneca Disorientation Pharmaceutical ORAL 1 DAY Dizziness Seroquel SS Zeneca Gait Disturbance Pharmaceutical ORAL 1 DAY Hyperhidrosis Seroquel SS Zeneca Nausea Pharmaceutical ORAL 1 DAY Pallor Vomiting 22-Feb-2006 08:31 AM Page: 1498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/05ISR Number: 4824700-4Report Type:Expedited (15-DaCompany Report #2005UW13002 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Affective Disorder Seroquel PS Zeneca Amnesia Pharmaceutical ORAL 25MG GRADUAL Aura INCREASE TO Bipolar Ii Disorder 200MG 17 DAY Confusional State Seroquel SS Zeneca Convulsion Pharmaceutical ORAL Fall Wellbutrin Sr SS ORAL 7 DAY Fatigue Wellbutrin Sr SS ORAL Loss Of Consciousness Wellbutrin Sr SS ORAL 200MG AM, 1/2 Memory Impairment 200MG TABLET Nausea AT NIGHT Neck Pain Synthroid C ORAL Paraesthesia Doxepin C ORAL 310 DAY Tonic Convulsion Doxepin C ORAL 310 DAY Tremor Zolpidem Tartrate C ORAL 526 DAY Lorazepam C ORAL 4 MON Menest C ORAL Zomig C ORAL 1-2 TABL Q6-8 HRS PRN Date:11/10/05ISR Number: 4824993-3Report Type:Expedited (15-DaCompany Report #2005AC01739 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Quetiapine PS Zeneca Anticholinergic Syndrome Pharmaceutical ORAL Delirium Overdose Date:11/10/05ISR Number: 4828478-XReport Type:Expedited (15-DaCompany Report #S05-ITA-03865-01 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Elopram (Citalopram) Calcinosis Health (Citalopram) PS ORAL 20 MG QD PO Condition Aggravated Professional Seroquel (Quetiapine Electrocardiogram T Wave Other Fumarate) SS ORAL 125 MG QD PO Amplitude Decreased Seroquel (Quetiapine Extrapyramidal Disorder Fumarate) SS ORAL 100 MG QHS PO Fall Seroquel (Quetiapine Genitourinary Tract Fumarate) SS ORAL 125 MG QD PO Infection Serenase Insomnia (Haloperidol) SS ORAL 15 DROPS QD Muscle Rigidity PO Pyrexia Serenase Ventricular Extrasystoles (Haloperidol) SS ORAL 10 DROPS QD Ventricular Fibrillation PO Serenase (Haloperidol) SS ORAL 15 DROPS QD PO Serenase(Haloperidol ) SS 105 MG QD PO Serenase (Haloperidol) SS ORAL 5 DROPS QD PO Serenase (Haloperidol) SS ORAL 20 DROPS QD 22-Feb-2006 08:31 AM Page: 1499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Serenase (Haloperidol) SS ORAL 10 DROPS QD PO Lorazepam C Zyprexa (Olanzapine) C Date:11/11/05ISR Number: 4825636-5Report Type:Expedited (15-DaCompany Report #2005UW16106 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Seroquel PS Zeneca Pharmaceutical ORAL Haldol C Norvasc C Atenolol C Divalproic Acid C Date:11/11/05ISR Number: 4825639-0Report Type:Expedited (15-DaCompany Report #2005UW16963 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Seroquel PS Zeneca Pharmaceutical ORAL Date:11/11/05ISR Number: 4825715-2Report Type:Expedited (15-DaCompany Report #2005UW16784 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL Depakote C Benzotropine C Remeron C Date:11/11/05ISR Number: 4826023-6Report Type:Expedited (15-DaCompany Report #2005PK01828 Age:16186 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Seroquel PS Zeneca Initial or Prolonged Increased Pharmaceutical ORAL Other Aspartate Seroquel SS Zeneca Aminotransferase Pharmaceutical ORAL Increased Seroquel SS Zeneca Extrapyramidal Disorder Pharmaceutical ORAL Gamma-Glutamyltransferase Seroquel SS Zeneca Increased Pharmaceutical ORAL SLOWLY Leukopenia DECREASED Transaminases Increased UNTIL WITHDRAWAL 21 DAY Seroquel SS Zeneca Pharmaceutical ORAL SLOWLY DECREASED UNTIL WITHDRAWAL 21 DAY Seroquel SS Zeneca Pharmaceutical ORAL SLOWLY DECREASED 22-Feb-2006 08:31 AM Page: 1500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report UNTIL WITHDRAWAL 21 DAY Ergenyl SS ORAL Ergenyl SS ORAL Ergenyl SS ORAL Ergenyl SS ORAL Ergenyl SS ORAL Ergenyl SS ORAL Ergenyl SS ORAL Ergenyl SS ORAL Ergenyl SS ORAL Lamictal SS ORAL Lamictal SS ORAL SLOWLY WITHDRAWN FROM 400 MG PER DAY 17 DAY Date:11/11/05ISR Number: 4826209-0Report Type:Expedited (15-DaCompany Report #2005UW12322 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Seroquel PS Zeneca Blood Urea Increased Pharmaceutical ORAL Dehydration Baby Aspirin C Fluid Retention Infection Musculoskeletal Stiffness Weight Increased White Blood Cell Count Decreased Date:11/11/05ISR Number: 4826311-3Report Type:Expedited (15-DaCompany Report #2005PK02065 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Tavor C Date:11/11/05ISR Number: 4826745-7Report Type:Direct Company Report #CTU 262889 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Quetiapine Initial or Prolonged Hypokalaemia -Seroquel- Unk Hypotension Astrazeneca Loss Of Consciousness Pharmaceutical PS Astrazeneca Renal Failure Acute Pharmaceutical ORAL PO Rhabdomyolysis Sertraline C Valsartan C Levothyroxine C Chlordiazepoxide C 22-Feb-2006 08:31 AM Page: 1501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/05ISR Number: 4827267-XReport Type:Expedited (15-DaCompany Report #2005AC01745 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Seroquel PS Zeneca Initial or Prolonged Depressed Level Of Pharmaceutical ORAL DRUG GIVEN IN Other Consciousness ERROR Hypotension Oseltamivir SS DRUG USUALLY Loss Of Consciousness PRESCRIBED. Tachycardia Hydrocodone Cough Wrong Drug Administered Syrup C Date:11/14/05ISR Number: 4827556-9Report Type:Expedited (15-DaCompany Report #2005UW15509 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Seroquel PS Zeneca Road Traffic Accident Pharmaceutical Mao Inhibitors C Methadone I Date:11/14/05ISR Number: 4827585-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051102786 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Event Risperdal PS 22 MON Death Abilify SS 22 MON Seroquel SS 22 MON Date:11/14/05ISR Number: 4827586-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051102788 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS 27 MON Zyprexa SS 27 MON Seroquel SS 27 MON Date:11/14/05ISR Number: 4827852-5Report Type:Direct Company Report #CTU 262965 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Quetiapine 75 Mg PS ORAL 75 MG BID Inadequate Control PO 6 MON Drug Effect Decreased Acetaminophen C Glycosylated Haemoglobin Claforan C Increased Albuterol C Cleocin C Amlodipine C Levaquin C Budesonide C Zosyn C Enalapril C Epoetin C Ipratropium C Lansoprazole C Heparin C 22-Feb-2006 08:31 AM Page: 1502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/05ISR Number: 4827923-3Report Type:Direct Company Report #USP 57416 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Dispensing Error Sinequan PS Pfizer CAPSULE Medication Error Seroquel SS Astrazeneca TABLET Somnolence Wrong Drug Administered Date:11/14/05ISR Number: 4830002-2Report Type:Expedited (15-DaCompany Report #2005AL004225 Age:43 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Citalopram Multiple Drug Overdose Health Hydrobromide Intentional Professional Tablets, 40 Mg (Purepac) PS ORAL PO Methadone SS ORAL PO Quetiapine SS ORAL PO Date:11/14/05ISR Number: 4830004-6Report Type:Expedited (15-DaCompany Report #2005AL004224 Age:42 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Alprazolam Tablets Completed Suicide Health Usp, 2 Mg (Purepac) PS ORAL PO Multiple Drug Overdose Professional Methadone SS ORAL PO Intentional Quetiapine SS ORAL PO Respiratory Arrest Date:11/14/05ISR Number: 4830011-3Report Type:Expedited (15-DaCompany Report #2005AL004069 Age:73 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chemical Abuser Literature Propoxyphene Completed Suicide Health Napsylate And Multiple Drug Overdose Professional Acetaminophen Intentional Tablets Usp, 100 Mg/650 Mg (Purepac) PS Quetiapine SS Unknown Chemical SS Date:11/14/05ISR Number: 4830359-2Report Type:Expedited (15-DaCompany Report #2005AL004110 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Verapamil Multiple Drug Overdose Health Hydrochloride Professional Tablets, 120 Mg (Purepac) PS ORAL PO Valproic Acid SS ORAL PO Quetiapine SS ORAL PO 22-Feb-2006 08:31 AM Page: 1503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/05ISR Number: 4833500-0Report Type:Expedited (15-DaCompany Report #2005AL004185 Age:48 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Gabapentin Tablets, Drug Abuser Health 800 Mg (Purepac) PS Purepac Multiple Drug Overdose Professional Gabapentin Capsules, Intentional 400 Mg (Purepac) SS Purepac Respiratory Arrest Cocaine SS Quetiapine SS Date:11/14/05ISR Number: 4833536-XReport Type:Expedited (15-DaCompany Report #2005AL004171 Age:64 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Clonazepam Tablets Multiple Drug Overdose Usp, 2 Mg (Purepac) PS ORAL PO Quetiapine SS ORAL PO Date:11/14/05ISR Number: 4833538-3Report Type:Expedited (15-DaCompany Report #2005AL004170 Age:62 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Clonazepam Tablets Multiple Drug Overdose Health Usp, 2 Mg (Purepac) PS ORAL PO Professional Quetiapine SS ORAL PO Date:11/14/05ISR Number: 4833539-5Report Type:Expedited (15-DaCompany Report #2005AL004173 Age:45 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Gabapentin Tablets, Multiple Drug Overdose Health 800 Mg (Purepac) PS Purepac Professional Gabapentin Capsules, 400 Mg (Purepac) SS Purepac Quetiapine SS Paroxetine SS Date:11/14/05ISR Number: 4833541-3Report Type:Expedited (15-DaCompany Report #2005AL004172 Age:40 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Literature Clonazepam Tablets Cardiac Arrest Health Usp, 2 Mg (Purepac) PS Purepac Multiple Drug Overdose Professional Quetiapine SS Respiratory Arrest Escitalopram SS Unevaluable Event Date:11/14/05ISR Number: 4834922-4Report Type:Expedited (15-DaCompany Report #2005AL004029 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Clonazepam Tablets Multiple Drug Overdose Health Usp, 2 Mg (Purepac) PS ORAL PO Intentional Professional Amitriptyline SS ORAL PO Quetiapine SS ORAL PO 22-Feb-2006 08:31 AM Page: 1504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/05ISR Number: 4834923-6Report Type:Expedited (15-DaCompany Report #2005AL004000 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Clonazepam Tablets Drug Abuser Health Usp, 2 Mg (Purepac) PS Multiple Drug Overdose Professional Oxycodone (Long Intentional Acting) SS Respiratory Arrest Quetiapine SS Date:11/14/05ISR Number: 4835015-2Report Type:Expedited (15-DaCompany Report #2005AL003930 Age:32 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lorazepam Tablets Multiple Drug Overdose Health Usp, 2 Mg (Purepac) PS ORAL UNKNOWN; UNK; Intentional Professional PO Acetaminophen/Diphen hydramine SS ORAL UNKNOWN; UNK; PO Quetiapine SS ORAL UNKNOWN; UNK; PO Date:11/14/05ISR Number: 4835035-8Report Type:Expedited (15-DaCompany Report #2005AL004101 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Propoxyphene Multiple Drug Overdose Health Napsylate And Intentional Professional Acetaminophen Tablets Usp, 100 Mg/650 Mg (Purepac) PS ORAL PO Propranolol SS ORAL PO Quetiapine SS ORAL PO Date:11/14/05ISR Number: 4835110-8Report Type:Expedited (15-DaCompany Report #2005AL003911 Age:22 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Fluoxetine Oral Multiple Drug Overdose Health Solution Usp, Intentional Professional 20mg/5ml (Alpharma) PS ORAL PO Methanol SS ORAL PO Quetiapine SS ORAL PO Date:11/14/05ISR Number: 4835113-3Report Type:Expedited (15-DaCompany Report #2005AL004040 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Clonazepam Tablets Multiple Drug Overdose Health Usp, 2 Mg (Purepac) PS Purepac ORAL PO Professional Doxepin SS ORAL PO Quetiapine SS ORAL PO 22-Feb-2006 08:31 AM Page: 1505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/05ISR Number: 4835117-0Report Type:Expedited (15-DaCompany Report #2005AL004039 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Citalopram Health Hydrobromide Professional Tablets, 40 Mg (Purepac) PS Purepac ORAL PO Phenobarbital SS ORAL PO Quetiapine SS ORAL PO Date:11/14/05ISR Number: 4835138-8Report Type:Expedited (15-DaCompany Report #2005AL004174 Age:24 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ibuprofen Oral Multiple Drug Overdose Health Suspension Usp, 100 Intentional Professional Mg/5 Ml (Rx) (Alpharma) PS ORAL PO Quetiapine SS ORAL PO Paroxetine SS ORAL PO Date:11/15/05ISR Number: 4827927-0Report Type:Expedited (15-DaCompany Report #2005UW17163 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Pharmaceutical ORAL Date:11/15/05ISR Number: 4829326-4Report Type:Direct Company Report #CTU 263184 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Trazodone PS ORAL 300MG DAILY AT BEDTIME PO (DURATION: GREATER THAN 1 YR Seroquel Unknown Unknown SS ORAL VARIABLE VARIABLE PO (DURATION: GREATER THAN ONE YEAR) 1 YR Date:11/15/05ISR Number: 4834790-0Report Type:Expedited (15-DaCompany Report #KII-2005-0019472 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Areflexia Study Hydromorphone Hcl Initial or Prolonged Back Pain Health (Similar To Nda Other Coma Professional 21-044) Respiratory Rate Other (Hydromorphone Decreased Hydrochloride) PS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL 22-Feb-2006 08:31 AM Page: 1506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/05ISR Number: 4829186-1Report Type:Expedited (15-DaCompany Report #2005UW16816 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Seroquel PS Zeneca Initial or Prolonged Feeling Abnormal Pharmaceutical ORAL 4 DAY Intentional Self-Injury Abliify C Nightmare Geodon C Restlessness Zoloft C Self Injurious Behaviour Sleep Terror Treatment Noncompliance Date:11/16/05ISR Number: 4829188-5Report Type:Expedited (15-DaCompany Report #2005UW17232 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Seroquel PS Zeneca Pharmaceutical ORAL Date:11/16/05ISR Number: 4829225-8Report Type:Expedited (15-DaCompany Report #2005UW16982 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Seroquel PS Zeneca Infection Pharmaceutical ORAL TITRATED UP Injury Lamictal C Localised Infection Effexor C Orthostatic Hypotension Haldol C Skin Laceration Date:11/16/05ISR Number: 4829227-1Report Type:Expedited (15-DaCompany Report #2005UW17182 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Brain Damage Seroquel PS Zeneca Other Heart Rate Irregular Pharmaceutical ORAL Date:11/16/05ISR Number: 4829229-5Report Type:Expedited (15-DaCompany Report #2005UW17184 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Pharmaceutical ORAL Date:11/16/05ISR Number: 4829340-9Report Type:Expedited (15-DaCompany Report #2005SE06496 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Insomnia Seroquel PS Zeneca Other Suicide Attempt Pharmaceutical ORAL 100+25+25+25+ Treatment Noncompliance 25 MG /DAY 22-Feb-2006 08:31 AM Page: 1507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/05ISR Number: 4829343-4Report Type:Expedited (15-DaCompany Report #2005UW16226 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Seroquel PS Zeneca Respiratory Arrest Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Fentanyl Patch C TRANSDERMAL 9 DAY Paxil C ORAL 14 DAY Date:11/16/05ISR Number: 4829345-8Report Type:Expedited (15-DaCompany Report #2005PK02107 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Seroquel PS Zeneca Drug Abuser Pharmaceutical ORAL Drug Screen Positive Seroquel SS Zeneca Neutrophil Count Pharmaceutical ORAL 4 MON Decreased Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL 3 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 5 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 35 DAY Solian SS Ergenyl C ORAL Taxilan C ORAL 5 DAY Taxilan C ORAL 3 DAY Taxilan C ORAL 15 DAY Date:11/16/05ISR Number: 4829529-9Report Type:Expedited (15-DaCompany Report #2005SE06206 Age:50 YR Gender:Female I/FU:F Outcome PT Death Acute Myocardial Infarction Pulmonary Embolism 22-Feb-2006 08:31 AM Page: 1508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sudden Death Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL 100+200 MG DAILY Citalopram C Lamitrogen C Oxazepam C Date:11/16/05ISR Number: 4829532-9Report Type:Expedited (15-DaCompany Report #2005PK01009 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Seroquel PS Zeneca Initial or Prolonged Condition Aggravated Pharmaceutical ORAL 327 DAY Other Delusion Seroquel SS Zeneca Drug Effect Increased Pharmaceutical ORAL 1 DAY Excitability Seroquel SS Zeneca Psychotic Disorder Pharmaceutical ORAL 1 DAY Refusal Of Treatment By Seroquel SS Zeneca Patient Pharmaceutical ORAL 21 DAY Serotonin Syndrome Seroquel SS Zeneca Stress Pharmaceutical ORAL 13 DAY Seroquel SS Zeneca Pharmaceutical ORAL 13 DAY Seroquel SS Zeneca Pharmaceutical ORAL Zoloft SS ORAL 8 DAY Zoloft SS ORAL 9 DAY Zoloft SS ORAL 26 DAY Temesta C ORAL 1 DAY Temesta C ORAL 4 DAY Temesta C ORAL 2 DAY Temesta C ORAL 1 DAY Temesta C ORAL 5 DAY Temesta C ORAL 1 DAY Temesta C ORAL 4 DAY Temesta C ORAL 2 DAY Temesta C ORAL 4 DAY Tenoretic C Eltroxin C ORAL Date:11/16/05ISR Number: 4829536-6Report Type:Expedited (15-DaCompany Report #2005UW16890 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Seroquel PS Zeneca Initial or Prolonged Amnesia Pharmaceutical ORAL Disability Brain Damage Other Constipation Dehydration Dizziness Headache Pain Sleep Disorder 22-Feb-2006 08:31 AM Page: 1509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/05ISR Number: 4829538-XReport Type:Expedited (15-DaCompany Report #2005UW13123 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Failure Seroquel PS Zeneca Initial or Prolonged Cardiac Disorder Pharmaceutical ORAL 7 DAY Cardiomegaly Seroquel SS Zeneca Cor Pulmonale Pharmaceutical ORAL 7 DAY Disorientation Seroquel SS Zeneca Eye Swelling Pharmaceutical ORAL Hypertension Seroquel SS Zeneca Movement Disorder Pharmaceutical ORAL Oedema Peripheral Wellbutrin SS ORAL 12 DAY Pickwickian Syndrome Depakote SS ORAL 12 DAY Pulmonary Oedema Respiratory Acidosis Respiratory Failure Sleep Apnoea Syndrome Somnolence Troponin Increased Date:11/16/05ISR Number: 4832288-7Report Type:Direct Company Report #CTU 263261 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tinnitus Seroquel PS ORAL 400 MG PO Q HS Date:11/17/05ISR Number: 4829863-2Report Type:Expedited (15-DaCompany Report #2005UW16894 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Seroquel PS Zeneca Initial or Prolonged Somnolence Pharmaceutical ORAL 2800-3800 MG Date:11/17/05ISR Number: 4830104-0Report Type:Expedited (15-DaCompany Report #2005AP04475 Age:16670 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Overdose Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Efexor C Efexor C Oxazepam C Epilim C Avapro C Panadeine Forte C 2 DF TAKEN EVERY 4 HOURS Date:11/17/05ISR Number: 4832676-9Report Type:Expedited (15-DaCompany Report #HQWYE465009NOV05 Age:24 YR Gender:Male I/FU:I Outcome PT Death Accidental Exposure Hospitalization - Body Temperature Initial or Prolonged Increased 22-Feb-2006 08:31 AM Page: 1510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report General Physical Health Deterioration Hyperhidrosis Report Source Product Role Manufacturer Route Dose Duration Respiratory Arrest Health Effexor Xr Tachycardia Professional (Venlafaxine Tremor Company Hydrochloride, Wrong Drug Administered Representative Capsule, Extended Release) PS ORAL 225 MG 1X PER 1 DAY, ORAL Buspar (Buspirone Hydrochloride, ) SS 1 DOSAGE FORM 2X PER 1 DAY Risperdal (Risperidone, ) SS 0.5 MG 2X PER 1 DAY Seroquel (Quetiapine, ) SS 300 MG 2X PER 1 DAY Tegretol (Carbamazepine) C Haldol (Haloperidol) C Benadryl (Diphenhydramine Hydrochloride) C Ativan (Lorazepam) C Loxitane (Loxapine) C Geodon (Ziprasidone) C Date:11/18/05ISR Number: 4831199-0Report Type:Expedited (15-DaCompany Report #2005UW17164 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Seroquel PS Zeneca Consciousness Pharmaceutical ORAL Drug Interaction Clonazepam I Somnolence Bupropion I Date:11/18/05ISR Number: 4831203-XReport Type:Expedited (15-DaCompany Report #2005AP05443 Age:23490 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Seroquel PS Zeneca Initial or Prolonged Increased Pharmaceutical ORAL 2 DAY Aspartate Seroquel SS Zeneca Aminotransferase Pharmaceutical ORAL 1 DAY Increased Dantrium SS ORAL 7 DAY Blood Alkaline Magmitt C ORAL 21 DAY Phosphatase Increased Silece C ORAL 24 DAY Gamma-Glutamyltransferase Risperdal C 2 DAY Increased Risperdal C 5 DAY Hepatic Function Abnormal Jaundice Liver Disorder 22-Feb-2006 08:31 AM Page: 1511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/05ISR Number: 4831344-7Report Type:Expedited (15-DaCompany Report #2005PK02140 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Seroquel PS Zeneca Initial or Prolonged Dizziness Pharmaceutical ORAL 63 DAY Dizziness Postural Seropram C ORAL Drug Interaction Amisulpride C Orthostatic Hypotension Klacid I ORAL 12 DAY Date:11/18/05ISR Number: 4831347-2Report Type:Expedited (15-DaCompany Report #2005AP05902 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Seroquel PS Zeneca Other Death Pharmaceutical ORAL Hypotension Date:11/18/05ISR Number: 4831921-3Report Type:Expedited (15-DaCompany Report #AU-ROCHE-423869 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Diazepam PS Roche UNKNOWN Hospitalization - Atrioventricular Block Doxepin SS Roche UNKNOWN Initial or Prolonged First Degree Clonazepam SS Roche UNKNOWN Bradycardia Temazepam SS Roche UNKNOWN Cardiac Arrest Verapamil Sr SS UNKNOWN Depression Quetiapine SS UNKNOWN Drug Ineffective Electrocardiogram St Segment Depression Haemodialysis Hypotension Metabolic Acidosis Multiple Drug Overdose Overdose Subendocardial Ischaemia Date:11/18/05ISR Number: 4833793-XReport Type:Expedited (15-DaCompany Report #2005-BP-19469RO Age:42 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Methadone Completed Suicide Health (Methadone) PS Multiple Drug Overdose Professional Alprazolam Intensol Intentional [Oral Solution Respiratory Arrest (Concentrate)] 1 Mg/Ml (Alprazolam) SS Quetiapine (Quetiapine) SS Date:11/18/05ISR Number: 4833811-9Report Type:Expedited (15-DaCompany Report #2005-BP-19395RO Age:48 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Cocaine (Cocaine) PS Polysubstance Abuse Health Quetiapine Respiratory Arrest Professional (Quetiapine) SS 22-Feb-2006 08:31 AM Page: 1512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gabapentin (Gabapentin) SS Date:11/18/05ISR Number: 4833824-7Report Type:Expedited (15-DaCompany Report #2005-BP-19470RO Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Methadone Health (Methadone) PS Professional Citalopram (Citalopram) SS Quetiapine (Quetiapine) SS Date:11/18/05ISR Number: 4833833-8Report Type:Expedited (15-DaCompany Report #2005-BP-19474RO Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Methadone Respiratory Arrest Health (Methadone) PS Professional Zolpidem (Zolpidem) SS Quetiapine (Quetiapine) SS Date:11/18/05ISR Number: 4833917-4Report Type:Expedited (15-DaCompany Report #2005-BP-19734RO Age:60 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Diclofenac Multiple Drug Overdose Health (Diclofenac) PS Intentional Professional Quetiapine (Quetiapine) SS Simvastatin (Simvastatin) SS Date:11/18/05ISR Number: 4833940-XReport Type:Direct Company Report #CTU 263437 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Risperdal PS Hospitalization - Aggression Seroquel SS (?UNSURE) Initial or Prolonged Bipolar Disorder 300MG DAILY Difficulty In Walking Benadryl C Drooling Depakote C Increased Appetite Viracept C Intelligence Test Epivir C Abnormal Zerit C Mental Retardation Severity Unspecified Paralysis Staring Swelling Face Tongue Disorder Tremor Weight Increased 22-Feb-2006 08:31 AM Page: 1513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/05ISR Number: 4833956-3Report Type:Expedited (15-DaCompany Report #2005-BP-19646RO Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Citalopram Health (Citalopram) PS Professional Phenobarbital (Phenobarbital) SS Quetiapine (Quetiapine) SS Date:11/21/05ISR Number: 4832404-7Report Type:Expedited (15-DaCompany Report #2005AP05855 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Quetiapine Fumarate PS Zeneca Initial or Prolonged Dehydration Pharmaceutical ORAL 2 DAY Fall Quetiapine Fumarate SS Zeneca Inadequate Diet Pharmaceutical ORAL 2 DAY Insomnia Risperdal SS ORAL Neuroleptic Malignant Risperdal SS ORAL 2 DAY Syndrome Risperdal SS ORAL Open Wound Risperdal SS ORAL 2 DAY Pneumonia Etizolam C ORAL 13 DAY Flunitrazepam C ORAL Triazolam C ORAL Biperiden Hydrochloride C ORAL 2 DAY Biperiden Hydrochloride C ORAL 2 DAY Date:11/21/05ISR Number: 4832565-XReport Type:Expedited (15-DaCompany Report #2005PK02145 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Seroquel PS Zeneca Initial or Prolonged Phosphokinase Increased Pharmaceutical ORAL Drug Interaction Medicinalproduct Not Myopathy Specified By Sender C Seroquel I Zeneca Pharmaceutical ORAL Zyprexa I UP TO 15 MG Zyprexa I Zyprexa I Zyprexa I BETWEEN 10 AND 20 MG 4 DAY Zyprexa I 3 DAY Zyprexa I 4 DAY Zyprexa I Date:11/21/05ISR Number: 4832724-6Report Type:Expedited (15-DaCompany Report #2005SE06618 Age:13727 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Quetiapine PS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca 22-Feb-2006 08:31 AM Page: 1514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 23 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 14 DAY Quetiapine SS Zeneca Pharmaceutical ORAL Biperideni C ORAL 14 DAY Biperideni C ORAL 14 DAY Biperideni C ORAL 3 DAY Date:11/21/05ISR Number: 4832871-9Report Type:Expedited (15-DaCompany Report #BR-GLAXOSMITHKLINE-A0582800A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Lamictal PS Glaxosmithkline ORAL 300MG Single Somnolence dose Suicide Attempt Clonazepam SS ORAL Fenoterol SS ORAL Carbamazepine SS ORAL 6TAB Single dose Seroquel SS ORAL Date:11/21/05ISR Number: 4833290-1Report Type:Expedited (15-DaCompany Report #CH-ABBOTT-05P-151-0317080-00 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Klacid PS ORAL 11 DAY Initial or Prolonged Malaise Quetiapine SS ORAL 62 DAY Orthostatic Hypotension Citalopram Hydrobromide C ORAL Citalopram Hydrobromide C Date:11/21/05ISR Number: 4835511-8Report Type:Expedited (15-DaCompany Report #2005107341 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Neurontin Other Drug Ineffective (Gabapentin) PS Overdose Seroquel (Quetiapine Fumarate) SS Date:11/21/05ISR Number: 4836784-8Report Type:Expedited (15-DaCompany Report #2005156610 Age:5 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Insufficiency Foreign Zyrtec Initial or Prolonged Arnold-Chiari Health (Tablets)(Cetirizine Congenital Anomaly Malformation Professional ) PS Other Drug Exposure During Dilantin Suspension Pregnancy (Phenytoin Sodium) SS Premature Baby Keppra (Levetiracetam) SS 200 MG 22-Feb-2006 08:31 AM Page: 1515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (DAILY) Paxil Cr (Paroxetine Hydrochloride) SS 200 MG (DAILY) Seroquel SS Methylcellulose (Methylcellulose) C Folic Acid (Folic Acid) C Date:11/22/05ISR Number: 4833876-4Report Type:Expedited (15-DaCompany Report #2005UW17184 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Seroquel PS Zeneca Syndrome Pharmaceutical ORAL Date:11/22/05ISR Number: 4833877-6Report Type:Expedited (15-DaCompany Report #2005UW17177 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Seroquel PS Zeneca Initial or Prolonged Cellulitis Pharmaceutical ORAL Leukopenia Seroquel SS Zeneca Mouth Ulceration Pharmaceutical ORAL Neutropenia Vicodin C Pharyngolaryngeal Pain Amoxicillin C Ibuprofen C Date:11/22/05ISR Number: 4833878-8Report Type:Expedited (15-DaCompany Report #2005UW16799 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Seroquel PS Zeneca Hospitalization - Neuroleptic Malignant Pharmaceutical ORAL Initial or Prolonged Syndrome Pain Date:11/22/05ISR Number: 4834182-4Report Type:Expedited (15-DaCompany Report #2005AP05977 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bile Duct Stenosis Seroquel PS Zeneca Bile Duct Stone Pharmaceutical ORAL 280 DAY Magnesium Oxide C ORAL 280 DAY Date:11/22/05ISR Number: 4834183-6Report Type:Expedited (15-DaCompany Report #2005UW17252 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Seroquel PS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/05ISR Number: 4834187-3Report Type:Expedited (15-DaCompany Report #2005UW17227 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Seroquel PS Zeneca Right Ventricular Failure Pharmaceutical ORAL Klonopin C Zoloft C Date:11/22/05ISR Number: 4834206-4Report Type:Expedited (15-DaCompany Report #2005UW17400 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Seroquel PS Zeneca Initial or Prolonged Anxiety Pharmaceutical ORAL 200 TO 800 MG 1 YR Insomnia Lithium C Mental Disorder Date:11/22/05ISR Number: 4834208-8Report Type:Expedited (15-DaCompany Report #2005UW17387 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Seroquel PS Zeneca Pharmaceutical ORAL Date:11/22/05ISR Number: 4834209-XReport Type:Expedited (15-DaCompany Report #2005UW17536 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Completed Suicide Seroquel PS Zeneca Pain Pharmaceutical Suicide Attempt Date:11/22/05ISR Number: 4834416-6Report Type:Expedited (15-DaCompany Report #2005SE06496 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Seroquel PS Zeneca Initial or Prolonged Suicide Attempt Pharmaceutical ORAL 100+25+25+25+ Treatment Noncompliance 25 MG /DAY Date:11/22/05ISR Number: 4834636-0Report Type:Expedited (15-DaCompany Report #2005-04-2098 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Wellbutrin PS Glaxosmithkline ORAL Initial or Prolonged Amnesia Seroquel SS ORAL Bipolar Disorder Peg-Intron SS SUBCUTANEOUS 150MCG Weekly 34 DAY Depression Rebetol SS ORAL 1200MG Per Overdose day 34 DAY Suicidal Ideation Alcohol SS ORAL Tearfulness Depakote C ORAL 750MG Per day 22-Feb-2006 08:31 AM Page: 1517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/05ISR Number: 4834699-2Report Type:Expedited (15-DaCompany Report #RRS-04-013 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Lamictal PS Glaxosmithkline ORAL 12.5MG per Initial or Prolonged Hepatic Enzyme Increased day Seroquel SS ORAL 55 DAY Mirtazapine SS ORAL Cymbalta SS ORAL Zopiclone C ORAL 7.5MG Unknown 33 DAY Mestinon C ORAL 270MG per day MON Digimerck C ORAL .07MG per day YR Atacand C ORAL 16MG per day YR Prednisolon C Glaxosmithkline ORAL 4MG per day WK Ideos C ORAL 3500MG per day MON Date:11/23/05ISR Number: 4835657-4Report Type:Expedited (15-DaCompany Report #2005UW17122 Age:13054 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Seroquel PS Zeneca Leukopenia Pharmaceutical ORAL Thrombocytopenia Pantoloc SS ORAL Dilantin C ORAL Effexor- Xr C ORAL Ferrous Sulfate C ORAL Folic Acid C Date:11/23/05ISR Number: 4835658-6Report Type:Expedited (15-DaCompany Report #2005UW16784 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Seroquel PS Zeneca White Blood Cell Count Pharmaceutical ORAL Decreased Depakote C Benzotropine C Remeron C Date:11/23/05ISR Number: 4835820-2Report Type:Expedited (15-DaCompany Report #2005AC01566 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Seroquel PS Zeneca Syndrome Pharmaceutical ORAL Serotonin Syndrome Lithium C Date:11/23/05ISR Number: 4835821-4Report Type:Expedited (15-DaCompany Report #2005AP05894 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombosis Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Tegretol C ORAL Aleviatin C Mystan C ORAL Excegran C ORAL Ravonal C 22-Feb-2006 08:31 AM Page: 1518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/05ISR Number: 4835967-0Report Type:Expedited (15-DaCompany Report #2005UW15420 Age:8695 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Benign Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL 25 TO 100 MG DAILY Prozac C ORAL 20-40 MG Klonopin C ORAL 0.5 - 2 MG Date:11/23/05ISR Number: 4836019-6Report Type:Expedited (15-DaCompany Report #2005UW17773 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Pharmaceutical ORAL Zoloft C Ativan C Buspar C Effexor C Date:11/23/05ISR Number: 4836020-2Report Type:Expedited (15-DaCompany Report #2005UW17599 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Impaired Healing Seroquel PS Zeneca Open Wound Pharmaceutical ORAL Rash Cemopril C Atarax C Benadryl C Date:11/23/05ISR Number: 4838399-4Report Type:Expedited (15-DaCompany Report #2005156819 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Geodon (Ziprasidone) PS 80 UNK (2 IN Initial or Prolonged Professional 1 D) Company Seroquel (Quetiapine Representative Fumarate) SS Benzodiazepine Derivatives (Benzodiazepine Derivatives) SS Date:11/23/05ISR Number: 4838405-7Report Type:Expedited (15-DaCompany Report #8013248 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Insufficiency Health Keppra PS VIA 35 WK Initial or Prolonged Arnold-Chiari Professional Zyrtec SS VIA Congenital Anomaly Malformation Dilantin SS VIA Drug Exposure During Paxil SS VIA Pregnancy Seroquel SS VIA Premature Baby Citrucel C Folic Acid C 22-Feb-2006 08:31 AM Page: 1519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/05ISR Number: 4850424-3Report Type:Periodic Company Report #TPA2005A01153 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Rozerem (Ramelteon) Drug Interaction Professional (8 Milligram, Tablets) PS ORAL 8 MG, PER ORAL Seroquel (Quetiapine Fumarate) SS Date:11/25/05ISR Number: 4841738-1Report Type:Expedited (15-DaCompany Report #2005-DE-04895GD Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Morphine (Morphine) PS Multiple Drug Overdose Cocaine (Cocaine) SS Intentional Quetiapine (Quetiapine) SS Date:11/25/05ISR Number: 4841835-0Report Type:Expedited (15-DaCompany Report #2005-BP-19667RO Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lorazepam Multiple Drug Overdose Health (Lorazepam) PS Intentional Professional Acetaminophen W/Diphenydramine (Tylenol Pm) SS Quetiapine (Quetiapine) SS Date:11/25/05ISR Number: 4841850-7Report Type:Expedited (15-DaCompany Report #2005-BP-19723RO Age:46 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Propranolol Suicide Attempt Health (Propranolol) PS NR Professional Quetiapine (Quetiapine) SS NR Cyclobenzaprine (Cyclobenzaprine) SS NR Date:11/25/05ISR Number: 4841852-0Report Type:Expedited (15-DaCompany Report #2005-BP-19721RO Age:37 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Propranolol Suicide Attempt Health (Propranolol) PS NR Professional Acetaminophen W/ Propoxyphene (Doxyphene) SS NR Quetiapine (Quetiapine) SS NR 22-Feb-2006 08:31 AM Page: 1520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/05ISR Number: 4837627-9Report Type:Expedited (15-DaCompany Report #2005PK02195 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Drug Level Increased Pharmaceutical ORAL Dry Mouth Phenytoin SS ORAL 26 DAY Malaise Lyrica C ORAL Urinary Incontinence Vertigo Date:11/28/05ISR Number: 4837628-0Report Type:Expedited (15-DaCompany Report #2005PK02177 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Hepatic Enzyme Increased Pharmaceutical ORAL 31 DAY Seroquel SS Zeneca Pharmaceutical ORAL 9 DAY Seroquel SS Zeneca Pharmaceutical ORAL 5 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL 3 DAY Mirtazapin SS ORAL 26 DAY Mirtazapin SS ORAL Cymbalta SS ORAL 13 DAY Cymbalta SS ORAL Lamictal SS ORAL DOSAGE INCREASED Zop C ORAL 26 DAY Zop C ORAL 7 DAY Mestinon C ORAL FOR WEEKS Digimerck C ORAL FOR YEARS Atacand C ORAL FOR YEARS Prednisolon C ORAL FOR WEEKS Ideos C ORAL FOR MONTHS Date:11/28/05ISR Number: 4837894-1Report Type:Expedited (15-DaCompany Report #2005GB01521 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bloody Discharge Seroquel PS Zeneca Chest Pain Pharmaceutical ORAL Drug Toxicity Hyperhidrosis Lung Infection Malaise Nausea Rectal Discharge Vertigo Date:11/28/05ISR Number: 4838119-3Report Type:Expedited (15-DaCompany Report #2005SE05937 Age:20 YR Gender:Male I/FU:F Outcome PT Other Bone Marrow Depression Granulocyte Count 22-Feb-2006 08:31 AM Page: 1521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Leukopenia Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Seroquel Enterotablets PS Zeneca Pharmaceutical ORAL 200 + 700 MG 130 DAY Oxapax C UNKNOWN Oxapax C UNKNOWN Truxal C UNKNOWN Truxal C UNKNOWN Date:11/28/05ISR Number: 4838121-1Report Type:Expedited (15-DaCompany Report #2005AP05976 Age:30184 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Aspiration Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Gramalil SS ORAL Risperdal SS ORAL Myslee C ORAL Date:11/28/05ISR Number: 4838124-7Report Type:Expedited (15-DaCompany Report #2005PK02157 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Seroquel PS Zeneca Leukopenia Pharmaceutical ORAL Akineton Retard C Tavor C 2 DAY Tavor C 6 DAY Tavor C Leponex C Tavor C Tavor C Tavor C 4 DAY Seroquel I Zeneca Pharmaceutical ORAL 4 DAY Seroquel I Zeneca Pharmaceutical ORAL 2 DAY Seroquel I Zeneca Pharmaceutical ORAL 4 DAY Seroquel I Zeneca Pharmaceutical ORAL Seroquel I Zeneca Pharmaceutical ORAL Seroquel I Zeneca Pharmaceutical ORAL Seroquel I Zeneca Pharmaceutical ORAL Haldol I ORAL Haldol Decanoat I INTRAMUSCULAR 22-Feb-2006 08:31 AM Page: 1522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/05ISR Number: 4838961-9Report Type:Expedited (15-DaCompany Report #2005PK02203 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical Date:11/29/05ISR Number: 4838964-4Report Type:Expedited (15-DaCompany Report #2005AP05420 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL Date:11/29/05ISR Number: 4839100-0Report Type:Expedited (15-DaCompany Report #2005SE05207 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Lamictal PS Glaxosmithkline Flushing Seroquel SS 300MG Per day Pharyngeal Oedema Litarex SS Pruritus Diclocil C Glaxosmithkline Roxithromycin C Glaxosmithkline Antabus C UNKNOWN Paracetamol C Glaxosmithkline UNKNOWN Nitrazepam C UNKNOWN Date:11/30/05ISR Number: 4840622-7Report Type:Expedited (15-DaCompany Report #2005UW17697 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Seroquel PS Zeneca Initial or Prolonged Overdose Pharmaceutical ORAL Self-Medication Date:11/30/05ISR Number: 4840624-0Report Type:Expedited (15-DaCompany Report #2005UW17696 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Seroquel PS Zeneca Initial or Prolonged Intentional Misuse Pharmaceutical ORAL Overdose Date:11/30/05ISR Number: 4840702-6Report Type:Expedited (15-DaCompany Report #2005SE06618 Age:13727 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Quetiapine PS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY 22-Feb-2006 08:31 AM Page: 1523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quetiapine SS Zeneca Pharmaceutical ORAL 23 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 14 DAY Quetiapine SS Zeneca Pharmaceutical ORAL Biperideni C ORAL 14 DAY Biperideni C ORAL 14 DAY Biperideni C ORAL 3 DAY Date:11/30/05ISR Number: 4841156-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13146394 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceuticals Europe Limited Risperidone SS Seroquel SS Date:11/30/05ISR Number: 4841191-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13158316 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Abilify PS Otsuka Urticaria Pharmaceuticals Europe Limited Seroquel SS Date:11/30/05ISR Number: 4841629-6Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0573892A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Wellbutrin PS Glaxosmithkline UNKNOWN Drug Interaction Seroquel SS UNKNOWN Date:11/30/05ISR Number: 4842025-8Report Type:Expedited (15-DaCompany Report #2005SE04735 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Seroquel PS Zeneca Gamma-Glutamyltransferase Pharmaceutical ORAL 2 MON Increased Seroquel SS Zeneca Hepatic Enzyme Increased Pharmaceutical ORAL Lipids Increased Seroquel SS Zeneca Weight Increased Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Date:11/30/05ISR Number: 4843000-XReport Type:Expedited (15-DaCompany Report #200510210BCA Age:79 YR Gender:Female I/FU:F Outcome PT Hospitalization - Arthralgia Initial or Prolonged Confusional State Other Deep Vein Thrombosis 22-Feb-2006 08:31 AM Page: 1524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Delirium Hallucination, Visual Joint Effusion Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Foreign Avelox (Moxifloxacin Viral Infection Health Hydrochloride) PS ORAL 400 MG, TOTAL Professional DAILY, ORAL Other Quetiapine SS ORAL 18.75 MG, TOTAL DAILY, ORAL Laxatives C Metoclopramide C Multivitamins C Olanzapine C Seroquel C Thiamine C Acetaminophen C Date:11/30/05ISR Number: 4844543-5Report Type:Direct Company Report #CTU 264087 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertension Quetiapine PS ADMITTED ON Tachycardia 150MG PER DAY ON 07/06/05-TAPE RED UP Date:11/30/05ISR Number: 4844559-9Report Type:Direct Company Report #CTU 264069 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alcohol Use Lithobid 300mg PS 1AM 3PM Intervention to Apathy Seroquel Fumarate SS Prevent Permanent Depression . C Impairment/Damage Hypersomnia Impaired Self-Care Insomnia Memory Impairment Self-Medication Social Avoidant Behaviour Thinking Abnormal Weight Increased Date:11/30/05ISR Number: 4846025-3Report Type:Expedited (15-DaCompany Report #8013431 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Health Keppra PS VIA Drug Exposure During Professional Lexapro SS VIA Pregnancy Seroquel Placenta Praevia Premature Baby /01270901/ SS VIA Baby Aspirin SS VIA Prenatal Vitamins SS VIA 22-Feb-2006 08:31 AM Page: 1525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4846026-5Report Type:Expedited (15-DaCompany Report #8010447 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Health Keppra PS ORAL 1000 MG /D PO Complications Of Maternal Professional Keppra SS ORAL 1500 MG /D PO Exposure To Therapeutic Company Lexapro SS ORAL 20 MG /D PO Drugs Representative Seroquel SS ORAL 100 MG /D PO Placenta Praevia Baby Aspirin SS ORAL PO Pregnancy Prenatal Vitamins SS ORAL PO Date:11/30/05ISR Number: 4846276-8Report Type:Expedited (15-DaCompany Report #US016177 Age:24 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Gabitril PS Completed Suicide Literature Diazepam SS Drug Toxicity Health Sertraline SS Multiple Drug Overdose Professional Olanzapine SS Intentional Quetiapine SS Respiratory Arrest Date:12/01/05ISR Number: 4842717-0Report Type:Expedited (15-DaCompany Report #2005AC01320 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Seroquel PS Zeneca Initial or Prolonged Back Pain Pharmaceutical ORAL Porphyria Date:12/01/05ISR Number: 4842760-1Report Type:Expedited (15-DaCompany Report #2005PK02240 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Seroquel PS Zeneca Hospitalization - Disturbance In Attention Pharmaceutical ORAL Initial or Prolonged Date:12/01/05ISR Number: 4842763-7Report Type:Expedited (15-DaCompany Report #2005PK01816 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Seroquel PS Zeneca Hospitalization - Overdose Pharmaceutical ORAL 787 DAY Initial or Prolonged Suicide Attempt Seroquel SS Zeneca Pharmaceutical ORAL 787 DAY Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Date:12/01/05ISR Number: 4844723-9Report Type:Direct Company Report #CTU 264216 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased 22-Feb-2006 08:31 AM Page: 1526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Hyperglycaemia Hyperglycaemic Report Source Product Role Manufacturer Route Dose Duration Hyperosmolar Nonketotic Quetiapine 200mg Syndrome Astrazeneca PS Astrazeneca ORAL 200MG AT Mental Status Changes BEDTIME PO Date:12/01/05ISR Number: 4844889-0Report Type:Direct Company Report #CTU 264207 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Quetiapine 25 Mg Initial or Prolonged Disorientation Astrazeneca PS Astrazeneca ORAL 75 MG AT Drug Abuser BEDTIME PO Hallucination Norvasc C Klonopin C Paxil C Hydrochlorothiazide C Isoniazid C Pyridoxine C Protonix C Septra Ds C Megace C Date:12/01/05ISR Number: 4844891-9Report Type:Direct Company Report #CTU 264208 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Quetiapine 25 Mg Initial or Prolonged Aggression Astrazeneca PS Astrazeneca ORAL 75 MG AT Fall BEDTIME PO Psychotic Disorder Tiagabine C Selegiline C Hydrocodone/Acetamin ophen C Date:12/01/05ISR Number: 4844893-2Report Type:Direct Company Report #CTU 264209 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Quetiapine 100 Mg Initial or Prolonged Intentional Overdose Astrazeneca PS Astrazeneca ORAL 150 MG AT Intentional Self-Injury BEDTIME PO Stress Quetiapine 25 Mg Suicide Attempt Astrazeneca SS Astrazeneca Lamotrigine C Sertraline C Venlafaxine C Date:12/01/05ISR Number: 4844896-8Report Type:Direct Company Report #CTU 264210 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Alcohol Use Initial or Prolonged Asthenia Balance Disorder Body Temperature 22-Feb-2006 08:31 AM Page: 1527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Cough Difficulty In Walking Fall Report Source Product Role Manufacturer Route Dose Duration Head Injury Quetiapine Overdose Astrazeneca PS Astrazeneca ORAL PO Pleuritic Pain Quaifenesin C Upper Respiratory Tract Valproic Acid C Infection Fluoxetine C Diphenhydramine C Date:12/01/05ISR Number: 4844901-9Report Type:Direct Company Report #CTU 264211 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Quetiapine 300 Mg Initial or Prolonged Phosphokinase Increased Astrazeneca PS Astrazeneca Mental Status Changes Diazepam C Risperidone C Trazodone C Date:12/02/05ISR Number: 4843641-XReport Type:Expedited (15-DaCompany Report #2005UW17934 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Pharmaceutical ORAL Prednisone C ORAL Unspecified Medications C Date:12/02/05ISR Number: 4843668-8Report Type:Expedited (15-DaCompany Report #2005UW17687 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Problem Seroquel PS Zeneca Initial or Prolonged Alcoholism Pharmaceutical ORAL Other Amnesia Seroquel SS Zeneca Bipolar Disorder Pharmaceutical ORAL Condition Aggravated Wellbutrin SS ORAL Depression Wellbutrin SS ORAL Intentional Overdose Peg-Intron SS SUBCUTANEOUS 34 DAY Suicidal Ideation Rebetol SS ORAL 34 DAY Tearfulness Depakote C ORAL Date:12/02/05ISR Number: 4843669-XReport Type:Expedited (15-DaCompany Report #2005UW17497 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical 22-Feb-2006 08:31 AM Page: 1528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/05ISR Number: 4843670-6Report Type:Expedited (15-DaCompany Report #2005UW15926 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Retinal Detachment Seroquel PS Zeneca Pharmaceutical ORAL 400 MG DAILY + 50 MG HS 3 MON Seroquel SS Zeneca Pharmaceutical ORAL 400 MG DAILY + 50 MG HS 3 MON Seroquel SS Zeneca Pharmaceutical ORAL 400 MG DAILY + 50 MG HS 3 MON Paxil C Clomipramine C Imovane C Date:12/02/05ISR Number: 4844060-2Report Type:Expedited (15-DaCompany Report #2005AC01886 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bacteraemia Quetiapine PS Zeneca Hospitalization - Overdose Pharmaceutical ORAL Initial or Prolonged Respiratory Failure Quetiapine SS Zeneca Suicide Attempt Pharmaceutical ORAL Date:12/02/05ISR Number: 4846540-2Report Type:Expedited (15-DaCompany Report #8013248 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Insufficiency Health Keppra PS VIA 35 WK Initial or Prolonged Neonatal Professional Zyrtec /00884302/ SS VIA Congenital Anomaly Arnold-Chiari Dilantin /00017401/ SS VIA Malformation Paxil SS VIA Developmental Delay Seroquel /01270901/ SS VIA Drug Exposure During Citrucel C Pregnancy Folic Acid C Premature Baby Date:12/02/05ISR Number: 4847437-4Report Type:Expedited (15-DaCompany Report #2005156610 Age:4 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Insufficiency Foreign Zyrtec (Tablets) Initial or Prolonged Arnold-Chiari Health (Cetirizine) PS UNKNOWN UNKNOWN Congenital Anomaly Malformation Professional Dilantin Suspension Other Childhood Disintegrative (Phenytoin Sodium) SS UNKNOWN UNKNOWN Disorder Keppra Drug Exposure During (Levetiracetam) SS UNKNOWN 2000 MG Pregnancy (DAILY), Premature Baby UNKNOWN Paxil Cr (Paroxetine Hydrochloride) SS UNKNOWN UNKNOWN Seroquel (Quetiapine Fumarate) SS UNKNOWN UNKNOWN Methylcellulose (Methylcellulose) C Folic Acid (Folic Acid) C 22-Feb-2006 08:31 AM Page: 1529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/05ISR Number: 4845029-4Report Type:Expedited (15-DaCompany Report #2005AP05855 Age:9917 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Quetiapine Fumarate PS Zeneca Hospitalization - Dehydration Pharmaceutical ORAL 2 DAY Initial or Prolonged Encephalitis Quetiapine Fumarate SS Zeneca Fall Pharmaceutical ORAL 2 DAY Inadequate Diet Risperdal SS ORAL Neuroleptic Malignant Risperdal SS ORAL 2 DAY Syndrome Risperdal SS ORAL Open Wound Risperdal SS ORAL 2 DAY Pneumonia Etizolam C ORAL 12 DAY Treatment Noncompliance Flunitrazepam C ORAL Triazolam C ORAL Biperiden Hydrochloride C ORAL 2 DAY Biperiden Hydrochloride C ORAL 2 DAY Date:12/05/05ISR Number: 4845103-2Report Type:Expedited (15-DaCompany Report #2005UW16816 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Seroquel PS Zeneca Initial or Prolonged Contusion Pharmaceutical ORAL 4 DAY Feeling Abnormal Abliify C Intentional Self-Injury Geodon C Nightmare Zoloft C Restlessness Sleep Terror Treatment Noncompliance Date:12/06/05ISR Number: 4845855-1Report Type:Expedited (15-DaCompany Report #2005023706 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Seroxat PS Glaxosmithkline ORAL 240MG Single Intentional Overdose dose Suicide Attempt Biperiden Retard SS ORAL 6TAB Single dose Lorazepam SS ORAL 1TAB Single dose Perazin SS ORAL 1800MG Single dose Seroquel SS ORAL 1800MG Single dose Date:12/06/05ISR Number: 4846039-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050905834 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Reminyl PS ORAL Apathy Dipiperon I ORAL Drug Interaction Seroquel I ORAL Renal Failure Aurorix I ORAL Bromazepam I UNKNOWN 22-Feb-2006 08:31 AM Page: 1530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/05ISR Number: 4846295-1Report Type:Expedited (15-DaCompany Report #CA-ROCHE-426524 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Arrest Clonazepam PS Roche UNKNOWN Convulsion Seroquel SS UNKNOWN Overdose Bupropion SS UNKNOWN Respiratory Arrest Suicide Attempt Date:12/06/05ISR Number: 4847898-0Report Type:Direct Company Report #CTU 264459 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Seroquel 25 Mg PS ORAL 25 MG ONCE Corrected Interval DAILY PO Prolonged Coreg C Gastroenteritis Viral Lipitor C Digoxin C Amiodarone C Colace C Aranesp C Imdur C Lactulose C Lasix C Combivent C Date:12/07/05ISR Number: 4846870-4Report Type:Expedited (15-DaCompany Report #2005UW17164 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Seroquel PS Zeneca Loss Of Consciousness Pharmaceutical ORAL Sinusitis Neurontin C ORAL Unresponsive To Verbal Possible Unspecified Stimuli Pain Or Sinus Medications C Seroquel I Zeneca Pharmaceutical ORAL ACUTE EXACERBATION Klonopin I ORAL Date:12/07/05ISR Number: 4847008-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051102497 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS ORAL Initial or Prolonged Neuroleptic Malignant Risperdal SS ORAL Disability Syndrome Haloperidol I INTRAMUSCULAR Biperiden Hydrochloride I ORAL Biperiden Hydrochloride I ORAL Fluphenazine Decanoate I INTRAMUSCULAR Chlorpromazine Hydrochloride/Promet hazine Hydrochloride/Phenob 22-Feb-2006 08:31 AM Page: 1531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report arbital I ORAL Levomepromazine Maleate I ORAL Olanzapine I ORAL Quetiapine Fumarate I ORAL Date:12/07/05ISR Number: 4847326-5Report Type:Expedited (15-DaCompany Report #2005GB01914 Age:20582 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Injury Asphyxiation Pharmaceutical ORAL GRADUALLY INCREASED UP TO 700MG IN TWO DIVIDED DOSES Seroquel SS Zeneca Pharmaceutical ORAL GRADUALLY INCREASED UP TO 700MG IN TWO DIVIDED DOSES Seroquel SS Zeneca Pharmaceutical ORAL 200 AM AND 700 NOC INCREASED UP TO 900MG TWO WEEKS PRIOR Seroquel SS Zeneca Pharmaceutical ORAL 200 AM AND 700 NOC INCREASED UP TO 900MG TWO WEEKS PRIOR Cipramil SS Sodium Valproate SS ORAL 1G IN 2 DIVIDED DOSES Lamotrigine SS ORAL Lisinopril C ORAL Date:12/07/05ISR Number: 4847346-0Report Type:Expedited (15-DaCompany Report #AU-ROCHE-426695 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Diazepam PS Roche ORAL Initial or Prolonged Consciousness Levlen C Drug Interaction Ferro-Gradumet C Mylanta C Nicabate C Midazolam Hydrochloride I Roche INTRAMUSCULAR Seroquel I UNKNOWN Droperidol I INTRAMUSCULAR Abilify I ORAL 10 DAY Lamictal I ORAL Epilim I ORAL 22-Feb-2006 08:31 AM Page: 1532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/05ISR Number: 4847395-2Report Type:Expedited (15-DaCompany Report #2005SE06927 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Seroquel PS Zeneca Multiple Sclerosis Pharmaceutical ORAL APPROX. 400 MG Date:12/07/05ISR Number: 4847398-8Report Type:Expedited (15-DaCompany Report #2005SE06926 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Seroquel PS Zeneca Multiple Sclerosis Pharmaceutical ORAL APPROX. 400 MG Date:12/07/05ISR Number: 4850445-0Report Type:Direct Company Report #CTU 264609 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Quetiapine PS ORAL 100MG PO ONE Initial or Prolonged Blood Creatine TIME Required Phosphokinase Increased Ziprasidone SS INTRAMUSCULAR 20MG IM ONE Intervention to Blood Creatinine TIME Prevent Permanent Increased Impairment/Damage Hyperpyrexia Neuroleptic Malignant Syndrome Posturing Urinary Incontinence Date:12/08/05ISR Number: 4848252-8Report Type:Expedited (15-DaCompany Report #2005AP06252 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anticholinergic Syndrome Seroquel PS Zeneca Hospitalization - Death Pharmaceutical ORAL Initial or Prolonged Dry Mouth Risperdal C ORAL Hyperglycaemia Contomin C ORAL Artane C ORAL Flivas C ORAL Bup-4 C ORAL Date:12/08/05ISR Number: 4848316-9Report Type:Expedited (15-DaCompany Report #2005SE06938 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Seroquel PS Zeneca Ocular Hyperaemia Pharmaceutical ORAL 3 DAY Periorbital Oedema Cipramil C ORAL Rivotril C ORAL Noritren C ORAL 22-Feb-2006 08:31 AM Page: 1533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/05ISR Number: 4848355-8Report Type:Expedited (15-DaCompany Report #2005AC01745 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Seroquel PS Zeneca Initial or Prolonged Depressed Level Of Pharmaceutical ORAL DRUG GIVEN IN Other Consciousness ERROR. DOSE = Hypotension 19.4 MG/KG. Lethargy Oseltamivir SS DRUG USUALLY Pallor PRESCRIBED. Tachycardia Hydrocodone Cough Wrong Drug Administered Syrup C Date:12/08/05ISR Number: 4848424-2Report Type:Expedited (15-DaCompany Report #8013248 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Insufficiency Paxil Cr PS Glaxosmithkline Initial or Prolonged Arnold-Chiari Zyrtec SS Glaxosmithkline Congenital Anomaly Malformation Keppra SS 2000MG per Drug Exposure During day 35 WK Pregnancy Dilantin SS Premature Baby Seroquel SS Methylcellulose C Glaxosmithkline Folic Acid C Date:12/09/05ISR Number: 4849075-6Report Type:Expedited (15-DaCompany Report #2005AP05976 Age:30183 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Seroquel PS Zeneca Dysphagia Pharmaceutical ORAL 32 DAY Pneumonia Aspiration Seroquel SS Zeneca Pharmaceutical ORAL Gramalil SS ORAL 52 DAY Gramalil SS ORAL Risperdal SS ORAL 52 DAY Risperdal SS ORAL Myslee C ORAL 53 DAY Myslee C ORAL Date:12/09/05ISR Number: 4849090-2Report Type:Expedited (15-DaCompany Report #2005SE05171 Age:11033 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Seroquel PS Zeneca Hospitalization - Cardiac Disorder Pharmaceutical ORAL 2 DAY Initial or Prolonged Myocarditis Seroquel SS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 23 DAY Seroquel SS Zeneca Pharmaceutical ORAL 23 DAY Seroquel SS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Trilafon SS ORAL Trilafon SS ORAL Trilafon SS ORAL 8+8+24 MG DAILY 27 DAY Trilafon SS ORAL 8+8+24 MG DAILY 27 DAY Trilafon SS ORAL 8+8+16 MG DAILY 5 DAY Trilafon SS ORAL 8+8+16 MG DAILY 5 DAY Trilafon SS ORAL 8+16 MG DAILY 2 DAY Trilafon SS ORAL 8+16 MG DAILY 2 DAY Trilafon SS ORAL 15 DAY Trilafon SS ORAL 15 DAY Trilafon SS Trilafon SS Nozinan C ORAL ACTUAL MEDICAL STATUS THAT DAY, NOT NECESSARILY Nozinan C ORAL 25-50 MG, MAXIMUM X2 Imovane C ORAL ACTUAL MEDICAL STATUS THAT DAY, NOT NECESSARILY Lysantin C ORAL ACTUAL MEDICAL STATUS THAT DAY, NOT NECESSARILY Cipralex C ORAL ACTUAL MEDICAL STATUS THAT DAY, NOT NECESSARILY Nicotinell C TRANSDERMAL Date:12/09/05ISR Number: 4849091-4Report Type:Expedited (15-DaCompany Report #2005UW13981 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancreatitis Haemorrhagic Seroquel PS Zeneca Hospitalization - Pharmaceutical ORAL 0 YR Initial or Prolonged Seroquel SS Zeneca Other Pharmaceutical ORAL Valproic Acid C ORAL 4 YR Clozapine C 1 YR 22-Feb-2006 08:31 AM Page: 1535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/05ISR Number: 4849093-8Report Type:Expedited (15-DaCompany Report #2005AP03278 Age:28760 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Seroquel PS Zeneca Consciousness Pharmaceutical ORAL 1 DAY Pam C INTRAVENOUS DRIP 1 DAY Atropine Sulfate C INTRAVENOUS 2 DAY Propofol C INTRAVENOUS DRIP 2 DAY Date:12/09/05ISR Number: 4849094-XReport Type:Expedited (15-DaCompany Report #2005AP03335 Age:5181 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 8 DAY Depakene R SS ORAL Haloperidol C ORAL Tremin C ORAL Rohypnol C ORAL Eurodin C ORAL 8 DAY Date:12/09/05ISR Number: 4849098-7Report Type:Expedited (15-DaCompany Report #2005PK02332 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Life-Threatening Electroencephalogram Pharmaceutical ORAL 2 DAY Other Abnormal Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 14 DAY Remeron SS ORAL 2 DAY Remeron SS 27 DAY Orfiril SS ORAL 1 DAY Orfiril SS ORAL 4 DAY Lioresal SS ORAL 6 DAY Mephanol SS ORAL Selipran SS ORAL Xatral SS ORAL 22-Feb-2006 08:31 AM Page: 1536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/05ISR Number: 4849135-XReport Type:Expedited (15-DaCompany Report #2005UW18088 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Seroquel PS Zeneca Urinary Retention Pharmaceutical ORAL 12.5 MG QAM / Urinary Tract Infection 25 MG QHS 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 12.5 MG QAM / 50 MG QHS 3 DAY Seroquel SS Zeneca Pharmaceutical ORAL Prozac C Cardizem C Date:12/09/05ISR Number: 4849275-5Report Type:Expedited (15-DaCompany Report #2005UW18059 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Seroquel PS Zeneca Increased Pharmaceutical ORAL Diabetes Mellitus Date:12/09/05ISR Number: 4852004-2Report Type:Expedited (15-DaCompany Report #8013248 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arnold-Chiari Health Keppra PS VIA 35 WK Initial or Prolonged Malformation Professional Zyrtec SS VIA Congenital Anomaly Congenital Anomaly Of Dilantin Adrenal Gland /00017401/ SS VIA Drug Exposure During Paxil SS VIA Pregnancy Seroquel Premature Baby /01270901/ SS VIA Citrucel SS VIA Folic Acid SS VIA Date:12/09/05ISR Number: 4852129-1Report Type:Expedited (15-DaCompany Report #2005156610 Age:4 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Insufficiency Health Zyrtec (Tablets) Initial or Prolonged Arnold-Chiari Professional (Cetirizine) PS Congenital Anomaly Malformation Dilantin Suspension Other Developmental Delay (Phenytoin Sodium) SS Drug Exposure During Keppra Pregnancy (Levetiracetam) SS 2000 MG Premature Baby (DAILY) Paxil Cr (Paroxetine Hydrochloride) SS Seroquel (Quetiapine Fumarate) SS Citrucel (Methylcellulose) SS Folic Acid (Folic Acid) C 22-Feb-2006 08:31 AM Page: 1537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/05ISR Number: 4879472-4Report Type:Periodic Company Report #USA-2005-0021384 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Health Oxycodone Accidental Professional Hydrochloride (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS UNKNOWN Diphenhydramine (Diphenhydramine) SS UNKNOWN Citalopram (Citalopram) SS UNKNOWN Promethazine (Promethazine) SS UNKNOWN Quetiapine (Quetiapine) SS UNKNOWN Date:12/09/05ISR Number: 4881588-3Report Type:Periodic Company Report #USA-2005-0021049 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Dependence Consumer Oxycontin Tablets Multiple Drug Overdose Health (Oxycodone Intentional Professional Hydrochloride) PS Polysubstance Abuse Other Morphine Sulfate (Similar To Nda 19-516) (Morphine Sulfate) SS Fentanyl (Fentanyl) SS Cocaine (Cocaine) SS Oxymorphone (Oxymorphone) SS Xanax (Alprazolam) SS Percocet (Paracetamol, Oxycodone Hydrochloride) SS Seroquel (Quetiapine) SS Date:12/12/05ISR Number: 4852219-3Report Type:Direct Company Report #CTU 264862 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Seroquel 25 Mg PS 25 MG 1 X DAY Non-Insulin-Dependent Date:12/13/05ISR Number: 4851813-3Report Type:Expedited (15-DaCompany Report #2005UW18357 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Seroquel PS Zeneca Feeling Drunk Pharmaceutical ORAL STARTER PACK Lower Limb Fracture 22-Feb-2006 08:31 AM Page: 1538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/05ISR Number: 4852144-8Report Type:Expedited (15-DaCompany Report #2005PK01819 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Seroquel PS Zeneca Hospitalization - Suicidal Ideation Pharmaceutical ORAL Initial or Prolonged Date:12/13/05ISR Number: 4852146-1Report Type:Expedited (15-DaCompany Report #2005PK01818 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Seroquel PS Zeneca Hospitalization - Suicidal Ideation Pharmaceutical ORAL Initial or Prolonged Date:12/13/05ISR Number: 4854193-2Report Type:Expedited (15-DaCompany Report #2005163379 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Nardil (Phenelzine Bipolar Disorder Professional Sulfate) PS ORAL 60 MG (15 MG, Diarrhoea 1 IN 1 D), Drug Interaction ORAL Dysgeusia Geodon (Ziprasidone) SS ORAL 40 MG (20 MG, Hallucination, Visual 2 IN 1 D), Hyperhidrosis ORAL Insomnia Seroquel (Quetiapine Mania Fumarate) SS (AS Psychotic Disorder NECESSARY), Sedation Valium (Diazepam) C Serotonin Syndrome Ibuprofen Tremor (Ibuprofen) C Lortab (Hydrocodone Bitartrate, Paracetamol) C Soma (Carisoprodol) C Pulmicort (Budesonide) C Date:12/13/05ISR Number: 4854247-0Report Type:Direct Company Report #CTU 264948 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Amnesia Seroquel Carboard Hospitalization - Burning Sensation Starter/Blister Pack Initial or Prolonged Chest Pain Astra Zeneca? PS Astra Zeneca SUBDERMAL 1 DOSE Other Coordination Abnormal Required Disturbance In Attention Intervention to Dizziness Prevent Permanent Dyspnoea Impairment/Damage Jaw Disorder Nausea Panic Attack Paranoia Sensory Disturbance Sinus Disorder Tinnitus Visual Acuity Reduced 22-Feb-2006 08:31 AM Page: 1539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/05ISR Number: 4853074-8Report Type:Expedited (15-DaCompany Report #2005UW17825 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Increased Pharmaceutical ORAL Date:12/14/05ISR Number: 4853309-1Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-B0395834A Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Bupropion PS Glaxosmithkline UNKNOWN Completed Suicide Quetiapine SS ORAL Oxycodone SS UNKNOWN Date:12/14/05ISR Number: 4853625-3Report Type:Expedited (15-DaCompany Report #2005UW17142 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Communication Disorder Seroquel PS Zeneca Difficulty In Walking Pharmaceutical ORAL STARTER PACK 1 DAY Dizziness Seroquel SS Zeneca Dyspnoea Pharmaceutical ORAL STARTER PACK 1 DAY Feeling Drunk Seroquel SS Zeneca Incoherent Pharmaceutical ORAL STARTER PACK 1 DAY Mental Impairment Seroquel SS Zeneca Somnolence Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Valium C Ms Contin C Morphine C Compazine C Date:12/14/05ISR Number: 4853629-0Report Type:Expedited (15-DaCompany Report #2005GB02396 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Ketoacidosis Quetiapine PS Zeneca Hospitalization - Drug Interaction Pharmaceutical ORAL 150 MG MANE Initial or Prolonged 450 MG NOCTE Folic Acid C ORAL Olanzapine I ORAL Date:12/14/05ISR Number: 4853640-XReport Type:Expedited (15-DaCompany Report #2005AC01915 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Seroquel PS Zeneca Cardiogenic Shock Pharmaceutical ORAL Haemorrhage Remergon C Temesta C Amoxiciline C 22-Feb-2006 08:31 AM Page: 1540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/05ISR Number: 4854438-9Report Type:Direct Company Report #CTU 265066 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemic Quetiapine 25 Mg PS ORAL 75 MG DAILY Hyperosmolar Nonketotic PO Syndrome Date:12/15/05ISR Number: 4854419-5Report Type:Expedited (15-DaCompany Report #2005UW18617 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Seroquel PS Zeneca Medication Error Pharmaceutical ORAL Wrong Drug Administered Lamictal C Date:12/15/05ISR Number: 4854568-1Report Type:Expedited (15-DaCompany Report #2005AP06341 Age:26625 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Seroquel PS Zeneca Shock Pharmaceutical ORAL 3 DAY Goodmin C ORAL 3 DAY Aricept C ORAL Blopress C ORAL Amisalin C ORAL Ferromia C ORAL Zyrtec C ORAL Gasmotin C ORAL Diamox C ORAL Date:12/16/05ISR Number: 4855554-8Report Type:Expedited (15-DaCompany Report #2005UW18703 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Seroquel PS Zeneca Respiratory Failure Pharmaceutical ORAL Fentanyl Patch I TRANSDERMAL Date:12/16/05ISR Number: 4855637-2Report Type:Expedited (15-DaCompany Report #2005GB02391 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Ejaculation Disorder Quetiapine PS Zeneca Pelvic Discomfort Pharmaceutical ORAL ABOVE 200 MG Epilim C UNKNOWN 1 - 2 DOSES Date:12/16/05ISR Number: 4855643-8Report Type:Expedited (15-DaCompany Report #2005PK02396 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angle Closure Glaucoma Seroquel PS Zeneca Pharmaceutical 22-Feb-2006 08:31 AM Page: 1541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/05ISR Number: 4855871-1Report Type:Expedited (15-DaCompany Report #2005GB02374 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL Date:12/16/05ISR Number: 4855878-4Report Type:Expedited (15-DaCompany Report #2005PK02401 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Seroquel PS Zeneca Apathy Pharmaceutical ORAL Drug Interaction Reminyl I Red Blood Cell Dipiperon I ORAL Sedimentation Rate Aurorix I ORAL Increased Bromazepam I Renal Failure Date:12/16/05ISR Number: 4855879-6Report Type:Expedited (15-DaCompany Report #2005PK02410 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Valproat SS Date:12/16/05ISR Number: 4855910-8Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0360740A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Paroxetine Anger Hydrochloride PS Glaxosmithkline UNKNOWN YR Drug Ineffective Quetiapine SS UNKNOWN Drug Withdrawal Syndrome Celecoxib SS UNKNOWN Overdose Paranoia Stress Date:12/19/05ISR Number: 4859937-1Report Type:Expedited (15-DaCompany Report #2005PK02454 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Antipsychotic Drug Level Seroquel PS Zeneca Hospitalization - Above Therapeutic Pharmaceutical ORAL Initial or Prolonged Ileus Megacolon Psychotic Disorder Date:12/19/05ISR Number: 4860020-XReport Type:Expedited (15-DaCompany Report #2005SE05495 Age:12356 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Quetiapine PS Zeneca Initial or Prolonged Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quetiapine SS Zeneca Pharmaceutical ORAL Date:12/19/05ISR Number: 4863194-XReport Type:Expedited (15-DaCompany Report #MK200512-0192-1 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Morphine Sulfate Er Multiple Drug Overdose Health Tablet PS ORAL PO Intentional Professional Quetiapine SS Cocaine SS Unspecified Substances SS Date:12/19/05ISR Number: 4863314-7Report Type:Direct Company Report #CTU 265324 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Dispensing Error Seroquel 100 Mg PS ORAL ONE TAB PO Medication Error QID Seroquel 200 Mg SS ORAL ONE TAB PO QID Date:12/19/05ISR Number: 4863944-2Report Type:Direct Company Report #CTU 265323 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Seroquel 300mg Intervention to Hepatic Steatosis Astra Zeneca PS Astra Zeneca ORAL 300MG ONCE A Prevent Permanent DAY PO Impairment/Damage Geodon 40mg Pfizer SS Pfizer ORAL 20MG TWICE PER DAY PO Date:12/19/05ISR Number: 4864047-3Report Type:Direct Company Report #CTU 265354 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Quetiapine PS 200 MG BID Prolonged Aspirin C Benztropine C Clonazepam C Divalproex C Fosinopril C Haloperidol C Nifedipine C Quetiapine C Ranitidine C Date:12/20/05ISR Number: 4860734-1Report Type:Expedited (15-DaCompany Report #AU-SOLVAY-00205004209 Age:11692 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Coversyl PS ORAL Daily dose: 4 Initial or Prolonged milligram(s) 2 DAY Cipramil SS ORAL Daily dose: 20 22-Feb-2006 08:31 AM Page: 1543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report milligram(s) 15 DAY Seroquel SS ORAL Daily dose: 100 milligram(s) 16 DAY Date:12/20/05ISR Number: 4860773-0Report Type:Expedited (15-DaCompany Report #2005PK02428 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Seroquel PS Zeneca Leukopenia Pharmaceutical ORAL Orthostatic Hypotension Seroquel SS Zeneca Restless Legs Syndrome Pharmaceutical ORAL Date:12/20/05ISR Number: 4861051-6Report Type:Expedited (15-DaCompany Report #2005AP06376 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Seroquel PS Zeneca White Blood Cell Count Pharmaceutical ORAL Decreased Date:12/20/05ISR Number: 4861082-6Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0360740A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Paroxetine Anger Hydrochloride PS Glaxosmithkline UNKNOWN YR Drug Ineffective Quetiapine SS UNKNOWN Drug Withdrawal Syndrome Celecoxib SS UNKNOWN Mental Status Changes Paracetamol SS Glaxosmithkline UNKNOWN Overdose Ranitidine C Glaxosmithkline UNKNOWN Painkiller C UNKNOWN Procyclidine C Glaxosmithkline UNKNOWN Diazepam C UNKNOWN Amisulpride C UNKNOWN Date:12/20/05ISR Number: 4861114-5Report Type:Expedited (15-DaCompany Report #2005AC01915 Age:18687 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiogenic Shock Seroquel PS Zeneca Haemorrhage Pharmaceutical ORAL Myocardial Infarction Remergon 30 C ORAL Temesta C Amoxiciline C Serenase C ORAL Date:12/20/05ISR Number: 4861117-0Report Type:Expedited (15-DaCompany Report #2005UW18847 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mouth Ulceration Seroquel PS Zeneca Initial or Prolonged Oral Pain Pharmaceutical ORAL Other Tardive Dyskinesia Effexor C Tic 22-Feb-2006 08:31 AM Page: 1544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/05ISR Number: 4861161-3Report Type:Expedited (15-DaCompany Report #2005AP05976 Age:30183 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Seroquel PS Zeneca Pneumonia Aspiration Pharmaceutical ORAL 32 DAY Seroquel SS Zeneca Pharmaceutical ORAL Gramalil SS ORAL 52 DAY Gramalil SS ORAL Risperdal SS ORAL 52 DAY Risperdal SS ORAL Myslee C ORAL 53 DAY Myslee C ORAL Date:12/20/05ISR Number: 4861444-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051202220 Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Miosis Risperdal SS ORAL Mianserin Hydrochloride SS ORAL Quetiapine Fumarate SS ORAL Hydroxyzine Pamoate C ORAL Date:12/20/05ISR Number: 4861531-3Report Type:Expedited (15-DaCompany Report #2005UW18842 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Pharmaceutical ORAL Date:12/20/05ISR Number: 4866250-5Report Type:Expedited (15-DaCompany Report #8011687 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Keppra PS ORAL 500 MG 2/D PO Initial or Prolonged Bipolar Disorder Health Keppra SS ORAL 1000 MG 2/D Blood Alkaline Professional PO Phosphatase Increased Distributor Keppra SS ORAL 1500 MG 2/D Delusion Of Grandeur Other PO Disinhibition Keppra SS ORAL 500MG 3/D PO Hepatic Enzyme Increased Keppra SS ORAL 2500 MG PO Keppra SS ORAL 500 MG 3/D PO Keppra SS ORAL 2500 MG/D PO Keppra SS ORAL 500 MG 2/D PO Keppra SS ORAL 250 MG 2/D PO Seroquel /01270901/ SS ORAL 50 MG 2/D PO Seroquel /01270901/ SS ORAL 125 MG PO Seroquel /01270901/ SS ORAL 100 MG/D PO Lorazepam C 22-Feb-2006 08:31 AM Page: 1545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/05ISR Number: 4862175-XReport Type:Expedited (15-DaCompany Report #2005UW18685 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Seroquel PS Zeneca Diarrhoea Pharmaceutical 3 YR Dysphagia Clozapine C 5 YR Flatulence Diane 25 C 5 YR Hyperhidrosis Lymphadenopathy Memory Impairment Nausea Pharyngolaryngeal Pain Pyrexia Red Blood Cell Count Decreased Red Blood Cell Sedimentation Rate Increased Renal Cyst Schizophrenia Tachycardia Paroxysmal Date:12/21/05ISR Number: 4862490-XReport Type:Expedited (15-DaCompany Report #2005PK02475 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Seroquel PS Zeneca Pharmaceutical ORAL Date:12/21/05ISR Number: 4864390-8Report Type:Direct Company Report #CTU 265495 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Quetiapine PS ORAL 800MG DAILY PO Date:12/21/05ISR Number: 4864412-4Report Type:Direct Company Report #CTU 265497 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fall Quetiapine PS ORAL 500MG DAILY Gait Disturbance PO Muscular Weakness Propranolol C Posture Abnormal Divalproex C Trazodone C Tiagabine C Date:12/21/05ISR Number: 4864416-1Report Type:Direct Company Report #CTU 265493 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gaze Palsy Quetiapine PS ORAL PO 22-Feb-2006 08:31 AM Page: 1546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/05ISR Number: 4866050-6Report Type:Expedited (15-DaCompany Report #KII-2005-0020252 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Morphine Sulfate Initial or Prolonged Ammonia Abnormal Health (Similar To Nda Asterixis Professional 19-516) (Morphine Blood Bicarbonate Other Sulfate) PS Abnormal Sumatriptan Blood Bilirubin Abnormal (Sumatriptan) SS Blood Calcium Abnormal Topiramate Blood Glucose Abnormal (Topiramate) SS Blood Ketone Body Niacin (Nicotinic Increased Acid) SS Blood Pressure Systolic Quetiazepine () SS Increased Levothyroxine Confusional State (Levothyroxine) SS Diarrhoea Valproic Acid Haematocrit Abnormal (Valproic Acid) SS Haematocrit Decreased Metformin Haemoglobin Abnormal (Metformin) SS Heart Rate Increased Acetaminophen Ketonuria W/Oxycodone Ketosis (Paracetamol, Metabolic Acidosis Oxycodone Nausea Hydrochloride) SS Occult Blood Positive Lisinopril Oliguria (Lisinopril) SS Perseveration Furosemide Renal Failure Acute (Furosemide) SS Vomiting Serumlipidreducing Agents () SS Acetylsalicylic Acid (Acetylsalicylic Acid) SS Amfetamine (Amfetamine) SS Date:12/21/05ISR Number: 4866360-2Report Type:Expedited (15-DaCompany Report #TPA2005A01628 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Rozerem (Ramelteon) Required Electrocardiogram Qt Professional (8 Milligram, Intervention to Prolonged Tablets) PS ORAL 8 MG, QHS, Prevent Permanent PER ORAL Impairment/Damage Seroquel (Quetiapine Fumarate) SS ORAL 100 MG BID & 200 MG QHS, PER ORAL Lexapro (Escitalopram Oxalate) (10 Milligram) SS ORAL 10 MG, 1 IN 1 D, PER ORAL Diflucan (Fluconazole) C Clonidine (Clonidine) C Flexeril (Cyclobenaaprine 22-Feb-2006 08:31 AM Page: 1547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:12/21/05ISR Number: 4887322-5Report Type:Periodic Company Report #US-YAMANOUCHI-YPA20050442 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Consumer Vesicare PS ORAL 5 MG QD PO MON Fluid Retention Seroquel SS ORAL 600 MG DAILY Stomach Discomfort PO Abilify C Klonopin C Effexor C Cogentin C Protonix C Date:12/22/05ISR Number: 4863345-7Report Type:Expedited (15-DaCompany Report #2005GB01636 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Quetiapine PS Zeneca Other Coronary Artery Stenosis Pharmaceutical ORAL Drug Interaction Quetiapine I Zeneca Haematoma Pharmaceutical ORAL Myocardial Infarction Fluoxetine I ORAL Date:12/22/05ISR Number: 4864243-5Report Type:Expedited (15-DaCompany Report #2005PK02433 Age:521 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Seroquel PS Zeneca Initial or Prolonged Chest Discomfort Pharmaceutical ORAL Dizziness Seroquel SS Zeneca Dyspnoea Pharmaceutical ORAL Hot Flush Cipramil C ORAL Nausea Cipramil C ORAL Paraesthesia Oral Broncho Retard C FOR MANY Tachycardia YEARS Tremor Spiriva C FOR MANY Vomiting YEARS Date:12/22/05ISR Number: 4864248-4Report Type:Expedited (15-DaCompany Report #2005GB02417 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Flutter Seroquel PS Zeneca Electrocardiogram Pharmaceutical ORAL 13 MON Abnormal Hot Flush Tachycardia Date:12/22/05ISR Number: 4864251-4Report Type:Expedited (15-DaCompany Report #2005SE07298 Age:70 YR Gender:Female I/FU:I Outcome PT Disability Apathy Incontinence Neuroleptic Malignant 22-Feb-2006 08:31 AM Page: 1548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL Date:12/22/05ISR Number: 4864253-8Report Type:Expedited (15-DaCompany Report #2005AP06377 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Seroquel PS Zeneca Breast Cancer Female Pharmaceutical ORAL 800-900 MG DAILY Date:12/22/05ISR Number: 4864260-5Report Type:Expedited (15-DaCompany Report #2005AC01981 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Seroquel PS Zeneca Initial or Prolonged Increased Pharmaceutical ORAL DOSE STARTED Blood Glucose Increased MORE THAN ONE Blood Triglycerides YEAR AGO Increased Diabetes Mellitus Dyslipidaemia Date:12/22/05ISR Number: 4864264-2Report Type:Expedited (15-DaCompany Report #2005AC01963 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Seroquel PS Zeneca Initial or Prolonged Increased Pharmaceutical ORAL Blood Triglycerides Haldoldec SS INTRAMUSCULAR Increased Dyslipidaemia Date:12/22/05ISR Number: 4864265-4Report Type:Expedited (15-DaCompany Report #2005AC01962 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Seroquel PS Zeneca Initial or Prolonged Increased Pharmaceutical ORAL DOSE STARTED Blood Triglycerides MORE THAN ONE Increased YEAR AGO Dyslipidaemia Date:12/22/05ISR Number: 4864266-6Report Type:Expedited (15-DaCompany Report #2005AC01971 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Seroquel PS Zeneca Initial or Prolonged Increased Pharmaceutical ORAL Blood Triglycerides Increased Dyslipidaemia 22-Feb-2006 08:31 AM Page: 1549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/05ISR Number: 4864487-2Report Type:Expedited (15-DaCompany Report #2005AC01970 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyslipidaemia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Solian SS ORAL Date:12/22/05ISR Number: 4867574-8Report Type:Expedited (15-DaCompany Report #MK200512-0306-1 Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Oxycodone Hcl Completed Suicide Health Tablets PS ORAL PO Multiple Drug Overdose Professional Quetiapine SS Intentional Bupropion SS Respiratory Arrest Date:12/22/05ISR Number: 4867579-7Report Type:Expedited (15-DaCompany Report #MK200512-0299-1 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Oxycodone Hcl Drug Abuser Health Tablets PS ORAL PO Multiple Drug Overdose Professional Quetiapine SS Respiratory Arrest Clonazepam SS Date:12/22/05ISR Number: 4867609-2Report Type:Expedited (15-DaCompany Report #MK200512-0263-1 Age:73 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Propoxyphene Exposure To Chemical Health Napsylate Apap Tabs Pollution Professional (Strength Unk) PS ORAL PO Multiple Drug Overdose Quetiapine SS Intentional Date:12/22/05ISR Number: 4867651-1Report Type:Expedited (15-DaCompany Report #MK200512-0305-1 Age:37 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Propoxyphene Multiple Drug Overdose Health Napsylate Apap Tabs PS ORAL PO Intentional Professional Propranolol SS Quetiapine SS Date:12/22/05ISR Number: 4867652-3Report Type:Direct Company Report #CTU 265592 Age:59 YR Gender:Male I/FU:I Outcome PT Cellulitis Hypoventilation Lethargy Moaning Oxygen Saturation Decreased Somnolence 22-Feb-2006 08:31 AM Page: 1550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unresponsive To Verbal Stimuli Report Source Product Role Manufacturer Route Dose Duration Quetiapine 100mg PS 3 DAY Tylenol C Aspirin C Buspirone C Folic Acid C Gabapentin C Haloperidol C Insulin C Omeprazole C Propranolol C Simethicone C Spironolactone C Thiamine C Tramadol C Vancomycin C Date:12/23/05ISR Number: 4865307-2Report Type:Expedited (15-DaCompany Report #2005PK02521 Age:12937 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Treatment Noncompliance Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL 103 DAY Stilnox C Date:12/23/05ISR Number: 4865310-2Report Type:Expedited (15-DaCompany Report #2005UW19111 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Seroquel PS Zeneca Initial or Prolonged Hunger Pharmaceutical ORAL Psychotic Disorder Date:12/23/05ISR Number: 4865311-4Report Type:Expedited (15-DaCompany Report #2005GB02456 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Quetiapine PS Zeneca Initial or Prolonged Psychotic Disorder Pharmaceutical ORAL 401 DAY Disability Levothyroxine C ORAL Carbamazepine C ORAL 22 DAY Lorazepam C ORAL VARIABLE 22-Feb-2006 08:31 AM Page: 1551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4865320-5Report Type:Expedited (15-DaCompany Report #2005GB02293 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscular Weakness Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL DOSE REDUCED TO 150 AM AND 175MG PM Date:12/23/05ISR Number: 4865321-7Report Type:Expedited (15-DaCompany Report #2005AC01976 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Seroquel PS Zeneca Initial or Prolonged Increased Pharmaceutical ORAL Blood Triglycerides Abnormal Dyslipidaemia Date:12/23/05ISR Number: 4865337-0Report Type:Expedited (15-DaCompany Report #2005SE07235 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL 200+400 MG DAILY Date:12/23/05ISR Number: 4865382-5Report Type:Expedited (15-DaCompany Report #2005AC01949 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glucose Tolerance Seroquel PS Zeneca Initial or Prolonged Impaired Pharmaceutical ORAL Other Lithium SS ORAL Depakine SS ORAL Date:12/23/05ISR Number: 4892991-XReport Type:Periodic Company Report #PHEH2005US05143 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Health Clozaril (Clozapine) Confusional State Professional Unknown PS ORAL 800MG, QD, Coordination Abnormal ORAL Delusion Trileptal Disorientation (Oxcarbazepine) Drug Interaction Unknown SS ORAL 600 MG, BID, Sedation ORAL Gabitril (Tiagabine Hydrochloride) SS ORAL 2 MG, QHS FOR 7 DAYS, ORAL; 4 MG, QHS, ORAL Lithium (Lithium) SS ORAL 600 MG, BID, ORAL Klonopin (Clonazepam) SS ORAL 0.5 MG, TID, 22-Feb-2006 08:31 AM Page: 1552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Seroquel (Quetiapine Fumarate) SS 600 MG, TID, ORAL Date:12/27/05ISR Number: 4866447-4Report Type:Expedited (15-DaCompany Report #2005SE07298 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Apathy Seroquel PS Zeneca Catatonia Pharmaceutical ORAL 4 WK Incontinence Anafranil C Lamictal C 150 MG + 200 MG DAILY DOSAGE Imovane C Cisordinol C Cisordinol C Date:12/28/05ISR Number: 4867464-0Report Type:Expedited (15-DaCompany Report #2005UW19199 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Seroquel PS Zeneca Initial or Prolonged Pharmaceutical Seroquel SS Zeneca Pharmaceutical Seroquel SS Zeneca Pharmaceutical Lithium C Erythromycin C TOPICAL Colace C Date:12/28/05ISR Number: 4869143-2Report Type:Direct Company Report #CTU 265810 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Quetiapine 25 Mg Corrected Interval Tablets Astra Zeneca PS Astra Zeneca ORAL 50 MG =2 TABS Prolonged PO QHS Metoprolol C Aspirin, Ec C Phenytoin C Acetaminophen C Hydrochlorothiazide C Cyanocobalamin C Clopidogrel Bisulfate C Date:12/28/05ISR Number: 4870138-3Report Type:Expedited (15-DaCompany Report #J081-002-002113 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Hot Foreign Aricept (Donepezil Initial or Prolonged Haemorrhage Health Hydrochloride) PS ORAL 3 MG, 1 IN 1 Pemphigoid Professional D, ORAL; 1 IN D, ORAL Aricept D (Donepezil 22-Feb-2006 08:31 AM Page: 1553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS ORAL 5 MG, 1 IN 1 D, ORAL Seroquel (Quetiapine Fumarate) SS ORAL 12.5 MG, 1 IN 1 D, ORAL; 25 MG, 1 IN 1 D, ORAL Selbex (Teprenone) SS ORAL 150 MG, 3 IN 1 D, ORAL Blostar M (Famotidine) C Magnesium Oxide (Magnesium Oxide) C Calfina (Alfacalcidol) C Celtect (Oxatomide) C Banan (Cefpodoxime Proxetil) C Zopicool (Zopiclone) C Ozex (Tosufloxacin Tosilate) C Date:12/29/05ISR Number: 4868094-7Report Type:Expedited (15-DaCompany Report #PHBS2005US18990 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Methylphenidate Mania Hydrochloride PS Novartis Sector: Muscle Spasms Pharma 60 mg, QD Sedation Quetiapine SS 200 mg Q4PM Somnolence Quetiapine SS 600 mg, QHS Torticollis Quetiapine SS 200 mg, BID Quetiapine SS 300 mg, QHS Quetiapine SS 200 mg, QD Buspirone C 15 mg, BID Aripiprazole C 10 mg, QD Aripiprazole C 5 mg, QD Atomoxetine C 60 mg, BID Date:12/29/05ISR Number: 4868117-5Report Type:Expedited (15-DaCompany Report #2005PK02550 Age:327 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Exposure During Seroquel PS Zeneca Pregnancy Pharmaceutical ORAL Leukopenia Seroquel SS Zeneca Normal Newborn Pharmaceutical ORAL Pregnancy Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL 2 MON Seroquel SS Zeneca Pharmaceutical ORAL POSTPARTAL UP TO 800 MG/DAY Chlorprothixen C ORAL Levomepromazin C ORAL 22-Feb-2006 08:31 AM Page: 1554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/05ISR Number: 4868119-9Report Type:Expedited (15-DaCompany Report #2005AP06341 Age:26625 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Seroquel PS Zeneca Blood Pressure Systolic Pharmaceutical ORAL 3 DAY Increased Diamox SS ORAL Shock Goodmin C ORAL 3 DAY Aricept C ORAL Blopress C ORAL Amisalin C ORAL Ferromia C ORAL Zyrtec C ORAL Gasmotin C ORAL Date:12/29/05ISR Number: 4868121-7Report Type:Expedited (15-DaCompany Report #2005PK02536 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Fibrillation Seroquel PS Zeneca Ventricular Fibrillation Pharmaceutical ORAL 11 MON Ventricular Flutter Seroquel SS Zeneca Pharmaceutical ORAL 11 MON Marcoumar C Date:12/29/05ISR Number: 4868125-4Report Type:Expedited (15-DaCompany Report #2005PK01527 Age:14476 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Seroquel PS Zeneca Initial or Prolonged Complete Pharmaceutical ORAL UPTITRATED Electrocardiogram Qt WITHIN 12 Prolonged DAYS FROM 150 Ventricular Tachycardia MG TO 600 MG 53 DAY Date:12/29/05ISR Number: 4871313-4Report Type:Expedited (15-DaCompany Report #MK200512-0489-1 Age:42 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Methadose Methadone Completed Suicide Health Hy Oral Con Usp PS Usp ORAL PO Multiple Drug Overdose Professional Quetiapine SS Intentional Alprazolam SS Respiratory Arrest Date:12/29/05ISR Number: 4871317-1Report Type:Expedited (15-DaCompany Report #MK200512-0492-1 Age:43 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Methadose Methadone Multiple Drug Overdose Health Hy Oral Con Usp PS Usp ORAL PO Intentional Professional Quetiapine SS Citalopram SS 22-Feb-2006 08:31 AM Page: 1555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/05ISR Number: 4871445-0Report Type:Expedited (15-DaCompany Report #MK200512-0499-1 Age:46 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Methadose@ Methadone Multiple Drug Overdose Health Hy Oral Con Usp PS ORAL PO Respiratory Arrest Professional Zolpidem SS Quetiapine SS Date:12/30/05ISR Number: 4869164-XReport Type:Expedited (15-DaCompany Report #2005UW19391 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Seroquel PS Zeneca Initial or Prolonged Convulsion Pharmaceutical ORAL Prolixin C Date:12/30/05ISR Number: 4869165-1Report Type:Expedited (15-DaCompany Report #2005UW19251 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Unilateral Seroquel PS Zeneca Pharmaceutical ORAL Lithium C Date:12/30/05ISR Number: 4869353-4Report Type:Expedited (15-DaCompany Report #2005UW19309 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Haemorrhage Seroquel PS Zeneca Pharmaceutical Date:12/30/05ISR Number: 4869374-1Report Type:Expedited (15-DaCompany Report #2005UW19454 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Seroquel PS Zeneca Death Pharmaceutical ORAL Incontinence Seroquel SS Zeneca Sleep Walking Pharmaceutical ORAL Staring Effexor C Wellbutrin C Date:01/02/06ISR Number: 4870244-3Report Type:Expedited (15-DaCompany Report #2005PK02107 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Seroquel PS Zeneca Drug Screen Positive Pharmaceutical ORAL 1 MON Neutrophil Count Seroquel SS Zeneca Decreased Pharmaceutical ORAL 4 MON Seroquel SS Zeneca Pharmaceutical ORAL 6 MON Seroquel SS Zeneca Pharmaceutical ORAL 3 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY 22-Feb-2006 08:31 AM Page: 1556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 5 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 35 DAY Solian SS Ergenyl C ORAL 31 DAY Ergenyl C ORAL 15 DAY Taxilan C ORAL 5 DAY Taxilan C ORAL 3 DAY Taxilan C ORAL 15 DAY Date:01/02/06ISR Number: 4870252-2Report Type:Expedited (15-DaCompany Report #2005AP05894 Age:12188 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aphonia Seroquel PS Zeneca Confusional State Pharmaceutical ORAL 3 YR Deep Vein Thrombosis Seroquel SS Zeneca Oedema Peripheral Pharmaceutical ORAL 32 DAY Pneumonia Seroquel SS Zeneca Respiratory Disorder Pharmaceutical ORAL >300MG DAILY 7 DAY Status Epilepticus Tegretol C ORAL 0.8-2.6G DIVIDED IN 2 OR 3 DOSES 20 DAY Aleviatin C INTRAVENOUS 2 DAY Aleviatin C INTRAVENOUS 2 DAY Aleviatin C ORAL 1-2G THREE TIMES DAILY Aleviatin C ORAL 1-2G THREE TIMES DAILY Mystan C ORAL Excegran C ORAL Ravonal C INTRAVENOUS DRIP 1-10G 3 DAY Dalacin C INTRAVENOUS 8 DAY Pentcillin C INTRAVENOUS 10 DAY Gaster D C DIVIDED INTO 3 DOSES Laxoberon C 10-30 DROPS/DAY Dormicum C INTRAVENOUS DRIP 2 DAY Cercine C 10-15 MG DAILY IN 1-5 DOSES 2 DAY Phenobal C INTRAMUSCULAR 1 DAY 22-Feb-2006 08:31 AM Page: 1557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/06ISR Number: 4870512-5Report Type:Expedited (15-DaCompany Report #2005PK02107 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Seroquel PS Zeneca Drug Abuser Pharmaceutical ORAL 1 MON Drug Screen Positive Seroquel SS Zeneca Pharmaceutical ORAL 4 MON Seroquel SS Zeneca Pharmaceutical ORAL 6 MON Seroquel SS Zeneca Pharmaceutical ORAL 3 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 5 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 7 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 35 DAY Solian SS Ergenyl C ORAL 31 DAY Ergenyl C ORAL 15 DAY Taxilan C ORAL 5 DAY Taxilan C ORAL 3 DAY Taxilan C ORAL 15 DAY Date:01/03/06ISR Number: 4870738-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051102497 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS ORAL Initial or Prolonged Neuroleptic Malignant Risperdal SS ORAL Disability Syndrome Haloperidol I INTRAMUSCULAR Biperiden Hydrochloride I ORAL Biperiden Hydrochloride I ORAL Fluphenazine Decanoate I INTRAMUSCULAR Chlorpromazine Hydrochloride/Promet hazine Hydrochloride/Phenob arbital I ORAL Levomepromazine Maleate I ORAL Olanzapine I ORAL Quetiapine Fumarate I ORAL 22-Feb-2006 08:31 AM Page: 1558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/06ISR Number: 4873942-0Report Type:Direct Company Report #CTU 266053 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Seroquel 200mg Hospitalization - Astrazeneca PS ORAL 900MG QD PO 1 MON Initial or Prolonged Date:01/04/06ISR Number: 4871648-5Report Type:Expedited (15-DaCompany Report #JP-SOLVAY-00305004308 Age:0 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Drug Exposure During Luvox 25 PS TRANSPLACENTAL Daily dose: Pregnancy 50 Drug Withdrawal Syndrome milligram(s) Neonatal Artane SS TRANSPLACENTAL Daily dose: 4 Eye Movement Disorder milligram(s) Hypotonia Rivotril SS TRANSPLACENTAL Daily dose: 1 Irritability milligram(s) Pyrexia Seroquel SS TRANSPLACENTAL Daily dose: Somnolence 75 Tremor milligram(s) Hiberna SS TRANSPLACENTAL Daily dose: 75 milligram(s) Silece SS TRANSPLACENTAL Daily dose: 4 milligram(s) Risperdal SS TRANSPLACENTAL Daily dose: 4 milligram(s) Date:01/04/06ISR Number: 4871713-2Report Type:Expedited (15-DaCompany Report #2005SE04641 Age:10260 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Quetiapine PS Zeneca Initial or Prolonged Schizoaffective Disorder Pharmaceutical ORAL 154 DAY Valproicum C ORAL 560 DAY Valproicum C ORAL 51 DAY Valproicum C ORAL Date:01/04/06ISR Number: 4871904-0Report Type:Expedited (15-DaCompany Report #2006PK00005 Age:22640 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Seroquel PS Zeneca Initial or Prolonged Delirium Pharmaceutical ORAL 1 DAY Date:01/04/06ISR Number: 4874203-6Report Type:Direct Company Report #CTU 266149 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Seroquel PS 58 TABS X 1 22-Feb-2006 08:31 AM Page: 1559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/06ISR Number: 4874224-3Report Type:Direct Company Report #CTU 266155 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Multiple Drug Overdose Seroquel PS Hospitalization - Pneumonia Aspiration Wellbutrin SS Initial or Prolonged Respiratory Failure Xanax C Lipitor C Date:01/04/06ISR Number: 4874506-5Report Type:Direct Company Report #CTU 266207 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Seroquel PS ORAL 25 MG PO AM AND 50 MG PO HS Date:01/04/06ISR Number: 4874521-1Report Type:Direct Company Report #CTU 266211 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Quetiapine 25 Mg Corrected Interval Tablets Astra Zeneca PS Astra Zeneca ORAL 50 MG = 2 Prolonged TABS QHS PO Metoprolol C Aspirin Ec C Phenytoin C Acetaminophen C Hydrochlorothiazide C Cyanocobalamin C Clopidogrel Bisulfate C Felodipine C Date:01/04/06ISR Number: 4874871-9Report Type:Expedited (15-DaCompany Report #2005172525 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Foreign Sogilen Initial or Prolonged Extrapyramidal Disorder Health (Cabergoline) PS ORAL 6 MG (ORAL) Hallucination Professional Quetiapine Psychomotor Hyperactivity Company (Quetiapine) SS ORAL ORAL Representative Levodopa (Levodopa) C Alprazolam (Alprazolam) C Date:01/04/06ISR Number: 4875050-1Report Type:Expedited (15-DaCompany Report #2005172607 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Zeldox Drug Exposure Before Consumer Pregnancy Other (Ziprasidone) PS ORAL 40 MG (20 MG, Hormone Level Abnormal 2 IN 1 D), ORAL Trevilor (Venlafaxine 22-Feb-2006 08:31 AM Page: 1560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS ORAL 75 MG, ORAL Seroquel SS ORAL 25 MG, ORAL Date:01/06/06ISR Number: 4873733-0Report Type:Expedited (15-DaCompany Report #2005CG01530 Age:13700 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Quetiapine PS Zeneca Initial or Prolonged Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL 6 DAY Lorazepam C Venlafaxine C ORAL Date:01/06/06ISR Number: 4873735-4Report Type:Expedited (15-DaCompany Report #2006PK00061 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Quetiapine Fumarate PS Zeneca Intentional Overdose Pharmaceutical ORAL Somnolence Dipiperon SS ORAL Speech Disorder Mirtazapine SS Suicide Attempt Tachycardia Date:01/06/06ISR Number: 4873990-0Report Type:Expedited (15-DaCompany Report #2005SE05937 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Seroquel Coagulation Factor Vii Enterotablets PS Zeneca Level Decreased Pharmaceutical ORAL 200 + 700 MG 130 DAY Coagulation Factor X Oxapax C UNKNOWN 3 X 15 MG PRN Level Decreased Truxal C UNKNOWN Granulocyte Count Truxal C UNKNOWN Decreased Leukopenia Prothrombin Level Decreased Thrombocytopenia Date:01/06/06ISR Number: 4874204-8Report Type:Expedited (15-DaCompany Report #2006AC00007 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Pharmaceutical ORAL Date:01/06/06ISR Number: 4874249-8Report Type:Expedited (15-DaCompany Report #US-MERCK-0510USA04433 Age:63 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Anaemia Other Anhedonia Asthenia Atrial Fibrillation 22-Feb-2006 08:31 AM Page: 1561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chest Pain Cough Cyst Report Source Product Role Manufacturer Route Dose Duration Deafness Vioxx PS Merck & Co., Inc ORAL Dementia Seroquel SS UNKNOWN Depression Diverticulum Intestinal Dizziness Dyspnoea Fatigue Gastrooesophageal Reflux Disease Goitre Haemorrhoids Hiatus Hernia Hyperhidrosis Hyperreflexia Lung Disorder Memory Impairment Meningioma Nasal Sinus Drainage Nocturia Oesophageal Disorder Pain In Extremity Palpitations Pollakiuria Polyp Somnolence Tinnitus Transient Ischaemic Attack Weight Decreased Date:01/06/06ISR Number: 4876108-3Report Type:Direct Company Report #CTU 266293 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Quetiapine PS 200MG QHS Initial or Prolonged Diarrhoea Ziprasidone SS 60 MG QPM Date:01/06/06ISR Number: 4876235-0Report Type:Expedited (15-DaCompany Report #J081-002-002113 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Hot Foreign Aricept (Donepezil Initial or Prolonged Haemorrhage Health Hydrochloride) PS ORAL 3 MG, 1 IN 1 Pemphigoid Professional D, ORAL Pruritus Aricept D (Donepezil Skin Exfoliation Hydrochloride) SS ORAL 5 MG, 1 IN 1 D, ORAL Seroquel (Quetiapine Fumarate) SS ORAL 12.5 MG, 1 IN 1 D, ORAL Selbex (Teprenone) SS ORAL 150 MG, 3 IN 1 D, ORAL Blostar M (Famotidine) C Magnesium Oxide (Magnesium Oxide) C 22-Feb-2006 08:31 AM Page: 1562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Calfina (Alfacalcidol) C Celtect (Oxatomide) C Banan (Cefpodoxime Proxetil) C Zopicool (Zopiclone) C Ozex (Tosufloxacin Tosilate) C Date:01/09/06ISR Number: 4874808-2Report Type:Expedited (15-DaCompany Report #2006UW00108 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Seroquel PS Zeneca Blindness Transient Pharmaceutical ORAL Depakote SS Date:01/09/06ISR Number: 4874880-XReport Type:Expedited (15-DaCompany Report #2006UW00130 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Date:01/09/06ISR Number: 4874882-3Report Type:Expedited (15-DaCompany Report #2006UW00101 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Increased Seroquel PS Zeneca Initial or Prolonged Schizophrenia, Paranoid Pharmaceutical ORAL Type Tongue Black Hairy Weight Increased White Blood Cell Count Increased Date:01/09/06ISR Number: 4874883-5Report Type:Expedited (15-DaCompany Report #2005UW17007 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polymyositis Seroquel PS Zeneca Pharmaceutical ORAL Geodon C ORAL Lamictal C ORAL Date:01/09/06ISR Number: 4875110-5Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-B0405569A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Paroxetine PS Glaxosmithkline UNKNOWN Phosphokinase Increased Quetiapine SS UNKNOWN Myoglobinaemia Neuroleptic Malignant Syndrome 22-Feb-2006 08:31 AM Page: 1563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/06ISR Number: 4877255-2Report Type:Direct Company Report #CTU 266438 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Strangulated Seroquel PS 25 MG 1 ADAY Initial or Prolonged Hernia Diarrhoea Rectal Haemorrhage Urinary Retention Date:01/09/06ISR Number: 4877385-5Report Type:Direct Company Report #CTU 266450 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Drug Reaction Seroquel PS 800 MG DAILY Initial or Prolonged Aggression Disability Cerebrovascular Accident Drug Exposure During Pregnancy Hypertension Myocardial Infarction Physical Assault Pregnancy Date:01/09/06ISR Number: 4877518-0Report Type:Expedited (15-DaCompany Report #KII-2005-0020492 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Study Oxycontin Tablets Initial or Prolonged Electrocardiogram Qt Health (Oxycodone Corrected Interval Professional Hydrochloride)Cr Prolonged Other Tablet PS ORAL ORAL Electrocardiogram Qt Quetiapine Prolonged (Quetiapine) SS ORAL ORAL Lethargy Ssri ( ) SS ORAL ORAL Overdose Ethanol (Ethanol) SS ORAL ORAL Date:01/10/06ISR Number: 4876181-2Report Type:Expedited (15-DaCompany Report #2006UW00196 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Seroquel PS Zeneca Diarrhoea Pharmaceutical ORAL Erythema Seroquel SS Zeneca Haematemesis Pharmaceutical ORAL Hepatocellular Damage Depakote C ORAL Vomiting Ativan C ORAL Date:01/10/06ISR Number: 4876190-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060101251 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal Consta PS "2 lots of 25 Prolonged mg and 1 lot 37.5 mg" Risperdal SS ORAL Depixol SS Quetiapine SS 22-Feb-2006 08:31 AM Page: 1564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diuretics C Beta Blockers C Date:01/10/06ISR Number: 4878026-3Report Type:Expedited (15-DaCompany Report #2006000098 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antipsychotic Drug Level Consumer Lithium (Lithium) PS ORAL ORAL Initial or Prolonged Above Therapeutic Geodon (Ziprasidone) SS ORAL 160 MG (80 Other Delusion MG, 1 IN 1 Extrapyramidal Disorder D), ORAL Incorrect Dose Benadryl Administered (Diphenhydramine) SS ORAL ORAL Intentional Misuse Alcohol (Ethanol) SS ORAL ORAL Mania Seroquel (Quetiapine Muscle Tightness Fumarate) SS ORAL ORAL Palpitations Klonopin Psychotic Disorder (Clonazepam) SS ORAL ORAL Restlessness Somnolence Weight Increased Date:01/10/06ISR Number: 4878101-3Report Type:Expedited (15-DaCompany Report #2006-136580-NL Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypotension Foreign Mirtazapine PS ORAL DF ORAL Multiple Drug Overdose Health Pipamperone SS ORAL 400 MG ORAL Intentional Professional Quetiapine Fumarate SS ORAL 150 MG ORAL Somnolence Speech Disorder Suicide Attempt Tachycardia Date:01/11/06ISR Number: 4877263-1Report Type:Expedited (15-DaCompany Report #US-SOLVAY-00306000120 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Fluvoxamine PS UNKNOWN Daily dose: Drug Toxicity unknown Quetiapine SS UNKNOWN Daily dose: unknown Acetaminophen SS UNKNOWN Daily dose: unknown Diphenhydramine SS UNKNOWN Daily dose: unknown Date:01/11/06ISR Number: 4878018-4Report Type:Expedited (15-DaCompany Report #2006AP00061 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Quetiapine Fumarate PS Zeneca Other Miosis Pharmaceutical ORAL Risperdal SS ORAL Risperdal SS ORAL Mianserin Hydrochloride SS ORAL 22-Feb-2006 08:31 AM Page: 1565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydroxyzine Pamoate C ORAL Date:01/11/06ISR Number: 4878025-1Report Type:Expedited (15-DaCompany Report #2006AC00007 Age:10661 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Carbon Monoxide Poisoning Seroquel PS Zeneca Completed Suicide Pharmaceutical ORAL Fluanxol C ORAL Sipralexa C ORAL 7 DAY Trazolam C ORAL 7 DAY Trazolam C ORAL 7 DAY Staurodorm C ORAL 14 DAY Date:01/12/06ISR Number: 4878572-2Report Type:Expedited (15-DaCompany Report #2006SE00092 Age:9589 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Seroquel PS Zeneca Phosphokinase Increased Pharmaceutical ORAL INCREASED TO Dizziness 400 MG IN Hallucination FOUR DAYS 13 DAY Nausea Date:01/12/06ISR Number: 4878886-6Report Type:Expedited (15-DaCompany Report #2006PK00097 Age:19897 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Seroquel PS Zeneca Neutropenia Pharmaceutical ORAL 24 DAY Date:01/13/06ISR Number: 4879562-6Report Type:Expedited (15-DaCompany Report #2006UW00336 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choking Seroquel PS Zeneca Initial or Prolonged Retching Pharmaceutical ORAL LOWER DOSE Scratch Seroquel SS Zeneca Screaming Pharmaceutical ORAL LOWER DOSE Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Tegretol C Remeron C Prozac C Date:01/13/06ISR Number: 4879618-8Report Type:Expedited (15-DaCompany Report #2006UW00575 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Seroquel PS Zeneca Treatment Noncompliance Pharmaceutical ORAL Biaxin SS Alcohol SS 22-Feb-2006 08:31 AM Page: 1566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/06ISR Number: 4879838-2Report Type:Expedited (15-DaCompany Report #2006UW00455 Age:17 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Contusion Seroquel PS Zeneca Epistaxis Pharmaceutical ORAL Thrombocytopenia Date:01/13/06ISR Number: 4879839-4Report Type:Expedited (15-DaCompany Report #2006PK00089 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Factor Ii Mutation Seroquel PS Zeneca Initial or Prolonged Pulmonary Embolism Pharmaceutical ORAL Zyprexa SS ORAL Date:01/13/06ISR Number: 4879843-6Report Type:Expedited (15-DaCompany Report #2005PK02454 Age:19422 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ileus Seroquel PS Zeneca Hospitalization - Megacolon Pharmaceutical ORAL 18 DAY Initial or Prolonged Psychotic Disorder Diazepam C ORAL 23 DAY Date:01/16/06ISR Number: 4881535-4Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-B0405569A Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Paroxetine PS Glaxosmithkline UNKNOWN 30MG per day 5 DAY Aminotransferase Quetiapine SS UNKNOWN 5 DAY Increased Olanzapine C Blood Creatine Loxapine C Phosphokinase Increased Blood Pressure Increased Heart Rate Increased Myoglobinaemia Neuroleptic Malignant Syndrome Pyrexia Tachycardia Date:01/17/06ISR Number: 4884488-8Report Type:Expedited (15-DaCompany Report #KII-2006-0020597 Age:56 YR Gender:Male I/FU:I Outcome PT Hospitalization - Activated Partial Initial or Prolonged Thromboplastin Time Other Prolonged Agitation Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Asthenia Blood Bicarbonate Decreased Blood Calcium Decreased 22-Feb-2006 08:31 AM Page: 1567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Ph Decreased Body Temperature Increased Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Study Morphine Sulfate Consciousness Health (Similar To Nda Dyspnoea Professional 19-516) (Morphine Gastrointestinal Other Sulfate) Cr Tablet PS ORAL ORAL Haemorrhage Olanzapine Heart Rate Increased (Olanzapine) SS ORAL ORAL Hyperkalaemia Quetiapine Hypotension (Quetiapine) SS ORAL ORAL Hypoxia Loratadine Ileus (Loratadine) SS ORAL ORAL Intentional Misuse Lisinopril International Normalised (Lisinopril) SS ORAL ORAL Ratio Increased Carisoprodol Intracardiac Thrombus (Carisoprodol) SS ORAL 5600 MG, 5600 Irritability MG, SEE TEXT, Prothrombin Time ORAL Prolonged Benzatropine Pupillary Reflex Impaired (Benzatropine) SS ORAL 4 MG, SEE Pupils Unequal TEXT, ORAL Rales Acetylsalicylic Acid Renal Failure (Acetylsalicylic White Blood Cell Count Acid) SS ORAL SEE TEXT, Increased ORAL Venlafaxine (Venlafaxine) SS ORAL 1200 MG, SEE TEXT, ORAL Metoprolol (Metoprolol) SS ORAL 200 MG, SEE TEXT, ORAL Coumadine (Warfarin Sodium) SS ORAL 10 MG, SEE TEXT, ORAL Raniditine (Ranitidine) SS ORAL 1200 MG, SEE TEXT, ORAL Niaspan (Nicotinic Acid) SS ORAL 8000 MG, SEE TEXT, ORAL Acetaminophen (Paracetamol) SS ORAL ORAL M.V.I. (Nicotinamide, Dexpanthenol, Riboflavin, Thiamine Hydrochloride, SS ORAL SEE TEXT, ORAL Benzodiazepine Derivatives SS Date:01/17/06ISR Number: 4885118-1Report Type:Expedited (15-DaCompany Report #2005127617 Age:24 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Sertraline Completed Suicide Consumer (Sertraline) PS Drug Toxicity Diazepam (Diazepam) SS Tiagabine 22-Feb-2006 08:31 AM Page: 1568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Tiagabine) SS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS Date:01/18/06ISR Number: 4883191-8Report Type:Expedited (15-DaCompany Report #2005AC01886 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Quetiapine PS Zeneca Hospitalization - Distress Syndrome Pharmaceutical ORAL Initial or Prolonged Bacteraemia Quetiapine SS Zeneca Other Electrocardiogram Qt Pharmaceutical ORAL Corrected Interval Quetiapine SS Zeneca Prolonged Pharmaceutical ORAL Myoclonus Quetiapine SS Zeneca Overdose Pharmaceutical ORAL Somnolence Quetiapine SS Zeneca Suicide Attempt Pharmaceutical ORAL Quetiapine SS Zeneca Pharmaceutical ORAL Valproic Acid C Gabapentin C Desipramine C Paroxetine C Date:01/18/06ISR Number: 4883205-5Report Type:Expedited (15-DaCompany Report #2006UW00434 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Seroquel PS Zeneca Diabetic Complication Pharmaceutical ORAL Date:01/18/06ISR Number: 4883368-1Report Type:Expedited (15-DaCompany Report #2006SE00159 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Seroquel PS Zeneca Pancytopenia Pharmaceutical ORAL Seroxat I ORAL Date:01/18/06ISR Number: 4883370-XReport Type:Expedited (15-DaCompany Report #2006UW00339 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL Tenex C Date:01/18/06ISR Number: 4883614-4Report Type:Expedited (15-DaCompany Report #2005PK02433 Age:521 MON Gender:Female I/FU:F Outcome PT Hospitalization - Asthenia Initial or Prolonged Chest Discomfort Dizziness 22-Feb-2006 08:31 AM Page: 1569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Hot Flush Nausea Report Source Product Role Manufacturer Route Dose Duration Paraesthesia Oral Seroquel PS Zeneca Tachycardia Pharmaceutical ORAL Tremor Seroquel SS Zeneca Vomiting Pharmaceutical ORAL Cipramil C ORAL Cipramil C ORAL Broncho Retard C FOR MANY YEARS Spiriva C FOR MANY YEARS Date:01/19/06ISR Number: 4884897-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13233432 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Tubular Necrosis Didanosine PS Bristol-Myers Squibb Initial or Prolonged Company ORAL Abacavir SS ORAL Tenofovir SS ORAL 6 WK Sertraline SS ORAL Seroquel SS ORAL Trazodone Hcl SS Apothecon ORAL Atenolol SS Sandoz Inc. (Geneva Pharm Tech) ORAL Dapsone SS ORAL Gabapentin C ORAL Methadone C ORAL Date:01/19/06ISR Number: 4884931-4Report Type:Expedited (15-DaCompany Report #2006UW00727 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glioma Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Risperdal C Lithium C Celexa C Date:01/19/06ISR Number: 4884973-9Report Type:Expedited (15-DaCompany Report #PHEH2006US00946 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Comtan PS Orion Sf Pancytopenia Sinemet SS Amantadine SS Remeron SS Paxil SS Seroquel SS Prednisone SS 22-Feb-2006 08:31 AM Page: 1570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/06ISR Number: 4885067-9Report Type:Expedited (15-DaCompany Report #US-MERCK-0511USA00567 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Vytorin PS Merck & Co., Inc OPHTHALMIC 40 DAY Increased Lopid SS UNKNOWN Aspartate Tylenol SS UNKNOWN Aminotransferase Seroquel SS UNKNOWN Increased Lexapro SS UNKNOWN Blood Alkaline Vytorin SS Merck & Co., Inc OPHTHALMIC 40 DAY Phosphatase Increased Coreg C UNKNOWN Headache Ecotrin C UNKNOWN Hepatic Steatosis Toprol Xl Tablets C UNKNOWN Hepatotoxicity Furosemide C UNKNOWN Hypertensive Crisis K-Dur C UNKNOWN Hypoaesthesia Clonidine C UNKNOWN Oedema Peripheral Date:01/19/06ISR Number: 4885322-2Report Type:Expedited (15-DaCompany Report #2006UW00775 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Seroquel PS Zeneca Other Convulsion Pharmaceutical ORAL 3 WK Death Seroquel SS Zeneca Dyspnoea Pharmaceutical ORAL Musculoskeletal Stiffness Unspecified Neuroleptic Malignant Medications C Syndrome Respiratory Arrest Date:01/19/06ISR Number: 4885331-3Report Type:Expedited (15-DaCompany Report #2006UW00791 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Seroquel PS Zeneca Diabetic Complication Pharmaceutical ORAL 7 MON Ill-Defined Disorder Zyprexa SS 13 MON Date:01/19/06ISR Number: 4885332-5Report Type:Expedited (15-DaCompany Report #2006UW00336 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choking Seroquel PS Zeneca Initial or Prolonged Retching Pharmaceutical ORAL LOWER DOSE Scratch Seroquel SS Zeneca Screaming Pharmaceutical ORAL LOWER DOSE Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Tegretol C Remeron C Prozac C 22-Feb-2006 08:31 AM Page: 1571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/06ISR Number: 4885365-9Report Type:Expedited (15-DaCompany Report #2006AP00120 Age:23567 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eating Disorder Quetiapine PS Zeneca Initial or Prolonged Pharmaceutical ORAL TITRATED Disability DAILY 4 DAY Quetiapine SS Zeneca Pharmaceutical ORAL TITRATED DAILY Study Procedure SS Lamictal C ORAL Solian C ORAL Riivotril C > 3 MONTHS PRIOR TO STUDY START Riivotril C > 3 MONTHS PRIOR TO STUDY START Date:01/19/06ISR Number: 4885672-XReport Type:Expedited (15-DaCompany Report #AU-ABBOTT-06P-008-0321752-00 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Toxic Epidermal Akineton PS ORAL Necrolysis Sodium Valproate SS ORAL Lamotrigine SS ORAL Quetiapine SS ORAL Chlorpromazine Hydrochloride SS Lithium Carbonate SS ORAL Date:01/19/06ISR Number: 4887579-0Report Type:Direct Company Report #CTU 267302 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Topiramate PS ORAL 250 MG PO BID Initial or Prolonged Hyperthermia Quetiapine SS 300 MG QHS Serotonin Syndrome Mirtazapine 7.5 Mg Q Hs X 7. Then 15 Mg Po Qhs SS Date:01/20/06ISR Number: 4889215-6Report Type:Direct Company Report #CTU 267489 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Seroquel PS 1 GM/DAY (BUT Hospitalization - Dialysis RECENT Initial or Prolonged Diarrhoea INCREASE IN Disability Gastrointestinal Necrosis DOSE) 5 YR Required Hypotension Haldol C Intervention to Hypothyroidism Synthroid C Prevent Permanent Mesenteric Vascular Impairment/Damage Insufficiency Myocardial Ischaemia Pulmonary Oedema Renal Failure Acute Renal Failure Chronic Septic Shock 22-Feb-2006 08:31 AM Page: 1572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/06ISR Number: 4887490-5Report Type:Expedited (15-DaCompany Report #2006PK00161 Age:14273 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Other Seroquel SS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Beloc Zok Mite C ORAL FOR MONTHS Theophyllin C ORAL FOR MONTHS Date:01/23/06ISR Number: 4891159-0Report Type:Expedited (15-DaCompany Report #HQWYE310412JAN06 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Efexor (Venlafaxine Initial or Prolonged Anger Other Hydrochloride, Unspec) PS Seroquel 9quetiapine, ) SS ORAL 800 MG 1X PER 1 DAY; ORAL Clonazepam C Valproate Sodium C Chlorpromazine Hydrochloride C Lamotrigine C Date:01/24/06ISR Number: 4889264-8Report Type:Expedited (15-DaCompany Report #2006SE00092 Age:9589 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Seroquel PS Zeneca Phosphokinase Increased Pharmaceutical ORAL Delusion Seroquel SS Zeneca Dizziness Pharmaceutical ORAL 1 DAY Hallucination Seroquel SS Zeneca Nausea Pharmaceutical ORAL 100 MG IN THE MORNIG AND 300 MG IN THE EVENING 7 DAY Olanzapine C Diazepam C THERAPEUTIC DOSE Temazepam C THERAPEUTIC DOSE Date:01/24/06ISR Number: 4889409-XReport Type:Expedited (15-DaCompany Report #2006UW00563 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coagulopathy Seroquel PS Zeneca Restless Legs Syndrome Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/06ISR Number: 4889537-9Report Type:Expedited (15-DaCompany Report #2006GB00070 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Decreased Pharmaceutical ORAL Date:01/24/06ISR Number: 4889538-0Report Type:Expedited (15-DaCompany Report #2006UW00106 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Seroquel PS Zeneca Initial or Prolonged Diabetic Hyperosmolar Pharmaceutical ORAL Coma Seroquel SS Zeneca Hyperglycaemia Pharmaceutical ORAL Hypokalaemia Wellbutrin C Iron Deficiency Anaemia Ambien C ORAL Polydipsia Polyuria Renal Failure Date:01/24/06ISR Number: 4889541-0Report Type:Expedited (15-DaCompany Report #2006UW00883 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Seroquel PS Zeneca Pharmaceutical ORAL Date:01/24/06ISR Number: 4889550-1Report Type:Expedited (15-DaCompany Report #2006UW00985 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Seroquel PS Zeneca Other Neuroleptic Malignant Pharmaceutical ORAL Syndrome Risperdal SS Zyprexa SS Date:01/24/06ISR Number: 4889551-3Report Type:Expedited (15-DaCompany Report #2005UW18685 Age:42 YR Gender:Female I/FU:F Outcome PT Other Constipation Diarrhoea Dysphagia Flatulence Follicle Centre Lymphoma, Follicular Grade I, Ii, Iii Hyperhidrosis Memory Impairment Nausea Pharyngolaryngeal Pain Pyrexia Red Blood Cell Count Decreased Red Blood Cell Sedimentation Rate Increased 22-Feb-2006 08:31 AM Page: 1574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Cyst Schizophrenia Tachycardia Paroxysmal Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical 3 YR Clozapine C 5 YR Diane 25 C 5 YR Date:01/24/06ISR Number: 4889553-7Report Type:Expedited (15-DaCompany Report #2005UW15699 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Seroquel PS Zeneca Hospitalization - Diabetic Ketoacidosis Pharmaceutical ORAL Initial or Prolonged Lipids Increased Olanzapine C Respiratory Disorder Date:01/24/06ISR Number: 4893291-4Report Type:Expedited (15-DaCompany Report #2005149433 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cataract Operation Foreign Lyrica (Pregabalin) PS ORAL 150 MG (75 Hospitalization - Coma Health MG, 2 IN 1 Initial or Prolonged Dehydration Professional D), ORAL Other Depressed Level Of Company Edronax (Reboxetine) SS ORAL 8 MG (4 MG, 2 Consciousness Representative IN 1 D), ORAL Hypopituitarism Quetiapine Sepsis (Quetiapine) SS Somnolence Ditropan Unevaluable Event (Oxybutynin) SS 15 MG (5 MG, 3 IN 1 D) Diamox (Acetazolamide) SS 250 MG (250 MG, 1 IN 1 D) Codeine (Codeine) C Diaformin (Metformin Hydrochloride) C Mixtard (Insulin, Insulin Injection, Isophane) C Omeprazole (Omeprazole) C Glimepiride (Glimepiride) C Coloxyl With Senna (Docusate Sodium, Sennoside A+B) C Ferrous Sulfate/Folic Acid (Ferrous Sulfate, Folic Acid) C Hiprex (Methenamine Hippurate) C Irbesartan (Irbesartan) C Frusemide (Furosemide) C Domperidone (Domperidone) C 22-Feb-2006 08:31 AM Page: 1575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ostelin (Ergocalciferol) C Paracetamol (Paracetamol) C Centrum (Minerals Nos, Vitamins Nos) C Chloramphenicol (Chloramphenicol) C Dexamethasone (Dexamethasone) C Diclofenac (Diclofenac Sodium) C Date:01/25/06ISR Number: 4890832-8Report Type:Expedited (15-DaCompany Report #2005PK02475 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Seroquel PS Zeneca Pharmaceutical ORAL Date:01/25/06ISR Number: 4890848-1Report Type:Expedited (15-DaCompany Report #2005UW19111 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Seroquel PS Zeneca Initial or Prolonged Anxiety Pharmaceutical ORAL 500 MG - 600 Bipolar I Disorder MG Drug Ineffective Strattera C ORAL Dysphagia Depakote Er C ORAL Headache Effexor Xr C ORAL Hunger Effexor Xr C ORAL Hypomania Equetro C ORAL Increased Appetite Psychotic Disorder Sleep Disorder Date:01/25/06ISR Number: 4891029-8Report Type:Expedited (15-DaCompany Report #2006AP00360 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Seroquel PS Zeneca Pharmaceutical ORAL 650-800MG DOSE DAILY Date:01/26/06ISR Number: 4891845-2Report Type:Expedited (15-DaCompany Report #2006UW01105 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Seroquel PS Zeneca Initial or Prolonged Phosphokinase Increased Pharmaceutical ORAL Dyskinesia Seroquel SS Zeneca Pharyngolaryngeal Pain Pharmaceutical ORAL Pyrexia Ritalin C Ritalin C 22-Feb-2006 08:31 AM Page: 1576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/06ISR Number: 4892074-9Report Type:Expedited (15-DaCompany Report #2006AP00320 Age:23543 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Seroquel PS Zeneca Initial or Prolonged Confusional State Pharmaceutical ORAL 3 DAY Convulsion Sodium Valproate C Fall Irbesartan C Hypotension Glucosamine Nos C Tachycardia Seretide 250/25 Mdi C Thiamine C Date:01/26/06ISR Number: 4892273-6Report Type:Expedited (15-DaCompany Report #2005PK02475 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Seroquel PS Zeneca Pharmaceutical ORAL Date:01/26/06ISR Number: 4892448-6Report Type:Expedited (15-DaCompany Report #2006GB00097 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Seroquel PS Zeneca Pharmaceutical ORAL 7 DAY Epilim C Venlafaxine C Date:01/26/06ISR Number: 4894795-0Report Type:Direct Company Report #CTU 267881 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Methylprednisolone PS INTRAVENOUS 125MG IV Initial or Prolonged Q8H Quetiapine SS ORAL 150MG PO QHS Albuterol C Albuterol So4 C Amoxicillin / Clav K C Azithromycin C Citalopram Hydrobromide C Cyclobenzaprine Hcl C Doxycycline Hyclate C Enalapril Maleate C Fluconazole C Fluticas / Salmeterol C Gatifloxacin C Guaifenesin C Ibuprofen C Montelukast Na C Nicotine Polacrilex C Omeprazole C Oxycodone & Acetamin. C Oyst Cal D C Prednisone C 22-Feb-2006 08:31 AM Page: 1577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/06ISR Number: 4893535-9Report Type:Expedited (15-DaCompany Report #2006UW00971 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Seroquel PS Zeneca Hepatic Congestion Pharmaceutical ORAL Date:01/27/06ISR Number: 4893540-2Report Type:Expedited (15-DaCompany Report #2005UW08185 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL Study Procedure SS Seroquel C ORAL Date:01/27/06ISR Number: 4893788-7Report Type:Expedited (15-DaCompany Report #2006SE00357 Age:12460 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Quetiapine PS Zeneca Initial or Prolonged Drug Toxicity Pharmaceutical ORAL Other Quetiapine SS Zeneca Pharmaceutical ORAL Date:01/27/06ISR Number: 4894011-XReport Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0555817A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Wellbutrin PS Glaxosmithkline ORAL 300MG Per day Hangover Bupropion Muscle Twitching Hydrochloride SS Glaxosmithkline ORAL 300MG Per day 21 DAY Restless Legs Syndrome Paxil Cr SS Glaxosmithkline ORAL 25MG Twice Tic per day 5 YR Seroquel SS ORAL 25MG Variable dose Date:01/27/06ISR Number: 4894381-2Report Type:Expedited (15-DaCompany Report #2006AP00322 Age:6528 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Seroquel PS Zeneca Initial or Prolonged Phosphokinase Increased Pharmaceutical ORAL 11 DAY Headache Ativan C ORAL Hypertension Ativan C ORAL 4 DAY Tachycardia Aropax C ORAL Zyprexa C ORAL 4 DAY Paxam C ORAL Date:01/27/06ISR Number: 4898173-XReport Type:Expedited (15-DaCompany Report #TPA2005A01628 Age:28 YR Gender:Female I/FU:F Outcome Other Required Intervention to Prevent Permanent 22-Feb-2006 08:31 AM Page: 1578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Arrhythmia Health Rozerem (Ramelteon) Electrocardiogram Qt Professional (8 Milligram, Prolonged Tablets) PS ORAL 8 MG, QHS, Heart Rate Irregular PER ORAL Palpitations Seroquel (Quetiapine Sinus Tachycardia Fumarate) (50 Supraventricular Milligram) SS ORAL 50 MG, EVERY Extrasystoles 8 HRS AND 100 Vertigo MG AT HS, PER ORAL) Lexapro (Escitalopram Oxalate) (10 Milligram) SS ORAL 10 MG, 1 IN 1 D, PER ORAL Flexeril (Cyclobenzaprine Hydrochloride) (10 Milligram) SS 10 MG, QAM & QHS Diflucan (Fluconazole) C Clonidine (Clonidine) C Valium (Diazepam) C Tigan (Trimethobenzamide Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Trazadone (Trazodone) C Ibuprofen (Ibuprofen) C Toradol (Ketorolac Tromethamine) C Keflex (Cefalexin) I Date:01/30/06ISR Number: 4894772-XReport Type:Expedited (15-DaCompany Report #2006UW01152 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Seroquel PS Zeneca Initial or Prolonged Treatment Noncompliance Pharmaceutical ORAL 80 DAY Date:01/30/06ISR Number: 4895227-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0589415A Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Lamictal PS Glaxosmithkline ORAL 200MG Twice Aphasia per day Confusional State Seroquel SS UNKNOWN Mental Disorder Clonazepam C Benztropine C Risperdal C 22-Feb-2006 08:31 AM Page: 1579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/06ISR Number: 4895513-2Report Type:Expedited (15-DaCompany Report #2006UW01396 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Convulsion Pharmaceutical ORAL 200 MG IN Fall AM/600 MG HS Intentional Overdose Overdose Date:01/30/06ISR Number: 4895592-2Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13253638 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Self-Injury Abilify PS Otsuka Psychotic Disorder Pharmaceuticals Europe Limited Quetiapine SS Date:01/30/06ISR Number: 4897467-1Report Type:Direct Company Report #CTU 268112 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Quetiapine Initial or Prolonged Chest Pain (Seroquel) Required Dyspnoea Astra-Zeneca PS Astra-Zeneca ORAL BID PO; 600 Intervention to Hepatitis MG/DAY Prevent Permanent Muscle Rigidity Fluoxetine C Impairment/Damage Neuroleptic Malignant Syndrome Rhabdomyolysis Tremor Date:01/31/06ISR Number: 4896619-4Report Type:Expedited (15-DaCompany Report #JP-SOLVAY-00305004308 Age:0 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Drug Withdrawal Syndrome Luvox 25 PS TRANSPLACENTAL Daily dose: Neonatal 50 Eye Movement Disorder milligram(s) 5 MON Hypotonia Artane SS TRANSPLACENTAL Daily dose: 4 Irritability milligram(s) 5 MON Pyrexia Rivotril SS TRANSPLACENTAL Daily dose: 1 Somnolence milligram(s) 5 MON Tremor Seroquel SS TRANSPLACENTAL Daily dose: 75 milligram(s) 5 MON Hiberna SS TRANSPLACENTAL Daily dose: 75 milligram(s) 5 MON Silece SS TRANSPLACENTAL Daily dose: 4 milligram(s) 5 MON Risperdal SS TRANSPLACENTAL Daily dose: 4 milligram(s) 24 MON 22-Feb-2006 08:31 AM Page: 1580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/06ISR Number: 4899497-2Report Type:Expedited (15-DaCompany Report #J081-002-002113 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Hot Foreign Aricept (Donepezil Initial or Prolonged Haemorrhage Health Hydrochloride) PS ORAL 3 MG, 1 IN 1 Pemphigoid Professional D, ORAL Aricept D (Donepezil Hydrochloride) SS ORAL 5 MG, 1 IN 1 D, ORAL Seroquel (Quetiapine Fumarate) SS ORAL 12.5 MG, 1 IN 1 D, ORAL Selbex (Teprenone) SS ORAL 150 MG, 3 IN 1 D, ORAL Blostar M (Famotidine) C Magnesium Oxide (Magnesium Oxide) C Calfina (Alfacalcidol) C Celtect (Oxatomide) C Banan (Cefpodoxime Proxetil) C Zpicool (Zopiclone) C Ozex (Tosufloxacin Tosilate) C Date:02/01/06ISR Number: 4897446-4Report Type:Expedited (15-DaCompany Report #2006UW01594 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Seroquel PS Zeneca Increased Pharmaceutical ORAL Lexapro C Date:02/01/06ISR Number: 4897621-9Report Type:Expedited (15-DaCompany Report #2006UW01306 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Flutter Seroquel PS Zeneca Pharmaceutical ORAL 200 MG QAM AND 600 MG HS Restoril C Date:02/01/06ISR Number: 4897623-2Report Type:Expedited (15-DaCompany Report #2006UW01511 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Pharmaceutical ORAL Date:02/01/06ISR Number: 4897624-4Report Type:Expedited (15-DaCompany Report #2006UW01262 Age:37 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Abdominal Pain 22-Feb-2006 08:31 AM Page: 1581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Drug Dependence Pancreatic Cyst Report Source Product Role Manufacturer Route Dose Duration Pancreatitis Seroquel PS Zeneca Staphylococcal Infection Pharmaceutical ORAL 3 YR Zoloft C Diazepam C Date:02/01/06ISR Number: 4897729-8Report Type:Expedited (15-DaCompany Report #2006UW01391 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dysgraphia Seroquel PS Zeneca Other Pharmaceutical ORAL 5 YR Date:02/01/06ISR Number: 4897730-4Report Type:Expedited (15-DaCompany Report #2006UW01416 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Seroquel PS Zeneca Hyperprolactinaemia Pharmaceutical ORAL 7 MON Pituitary Tumour Benign Seroquel SS Zeneca Visual Field Defect Pharmaceutical ORAL 1 MON Weight Increased Depakote C Date:02/01/06ISR Number: 4897732-8Report Type:Expedited (15-DaCompany Report #2006PK00238 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Seroquel PS Zeneca Initial or Prolonged Hyperhidrosis Pharmaceutical ORAL 1 DAY Palpitations Seroquel SS Zeneca Suicidal Ideation Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 4 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Solian C ORAL 2 YR Solian C ORAL 2 DAY Solian C ORAL 1 DAY Solian C ORAL 1 DAY Lithiofor C ORAL 2 YR Lithiofor C ORAL Date:02/01/06ISR Number: 4897760-2Report Type:Expedited (15-DaCompany Report #2006GB00084 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Quetiapine PS Zeneca Pharmaceutical ORAL Zaponex SS ORAL 5 DAY Olanzapine SS ORAL Citalopram C UNKNOWN 22-Feb-2006 08:31 AM Page: 1582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zopiclone C UNKNOWN Date:02/01/06ISR Number: 4897996-0Report Type:Expedited (15-DaCompany Report #2006UW01198 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stereotypic Movement Seroquel PS Zeneca Disorder Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Date:02/01/06ISR Number: 4901428-3Report Type:Direct Company Report #CTU 268423 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Quetiapine 100 Mg PS ORAL 100 MG TID PO Initial or Prolonged Fluctuation Quetiapine SS ORAL 500 MG HS PO Hyperthermia Lethargy Leukocytosis Mental Status Changes Myalgia Neuroleptic Malignant Syndrome Somnolence Stupor Date:02/02/06ISR Number: 4898648-3Report Type:Expedited (15-DaCompany Report #2006GB00113 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL Epilim Chrono C Date:02/02/06ISR Number: 4903712-6Report Type:Expedited (15-DaCompany Report #8011687 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Keppra PS ORAL 500 MG 2/D/PO Initial or Prolonged Alcohol Use Health Keppra SS ORAL 1000 MG 2/D Bipolar Disorder Professional PO Blood Alkaline Distributor Keppra SS ORAL 1500 MG 2/D Phosphatase Increased Other PO Condition Aggravated Keppra SS ORAL 500 MG 3/D PO Delusion Of Grandeur Keppra SS ORAL 2500 MG PO Disinhibition Keppra SS ORAL 500 MG 3/D PO Hepatic Enzyme Increased Keppra SS ORAL 2500 MG /D PO Treatment Noncompliance Keppra SS ORAL 500 MG 2/D PO Keppra SS ORAL 250 MG 2/D PO Seroquel SS ORAL 50 MG 2/D PO Seroquel SS ORAL 125 MG PO Seroquel SS ORAL 100 MG /D PO Lorazepam C Clozapine C 22-Feb-2006 08:31 AM Page: 1583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/06ISR Number: 4900028-9Report Type:Expedited (15-DaCompany Report #2003UW13607 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Seroquel PS Zeneca Anxiety Pharmaceutical ORAL Asthenia Serzone SS ORAL 4-5 YEARS Balance Disorder Serzone SS ORAL Brain Damage Paxil C ORAL Brain Neoplasm Paxil C ORAL Breast Cancer In Situ Premarin C ORAL Cognitive Disorder Multivitamin C Confusional State Calcium C Crying Metamucil C 6AM AND 6PM Depression Estradiol C ORAL Diarrhoea Clonazepam C ORAL Dyslexia Piroxicam C ORAL Dysphasia Vicoprofen C ORAL 7.5MG/200MG Dysstasia Q4HR PRN Encephalopathy Celebrex C ORAL Fatigue Amoxicillin-Clavamox C Gait Disturbance Meclizine C PRN Headache Darvocet-N C ORAL Q4HR 1-2 Hypersomnia TABLETS Impaired Work Ability Evista C ORAL Lethargy Wellbutrin C ORAL Medication Error Memory Impairment Mental Impairment Muscle Spasms Muscle Twitching Post-Traumatic Stress Disorder Premenstrual Syndrome Restlessness Social Avoidant Behaviour Tremor Wrong Drug Administered Date:02/03/06ISR Number: 4900062-9Report Type:Expedited (15-DaCompany Report #2006UW01313 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amblyopia Seroquel PS Zeneca Hallucination Pharmaceutical ORAL 1 YR Neutropenia Date:02/03/06ISR Number: 4900359-2Report Type:Expedited (15-DaCompany Report #2006SE00159 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Seroquel PS Zeneca Initial or Prolonged Increased Pharmaceutical ORAL 1 DAY Drug Interaction Seroquel I Zeneca Pancytopenia Pharmaceutical ORAL 2 DAY Seroquel I Zeneca Pharmaceutical ORAL Seroquel I Zeneca Pharmaceutical ORAL Seroxat I ORAL 2 MON 22-Feb-2006 08:31 AM Page: 1584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/06ISR Number: 4900412-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060105708 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Risperidone PS ORAL 2x2mg Dipiperon SS ORAL 2x40mg Doxepin SS ORAL 2x50mg Seroquel SS ORAL 1x100mg Date:02/03/06ISR Number: 4900452-4Report Type:Expedited (15-DaCompany Report #2005PK02475 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Date:02/03/06ISR Number: 4900549-9Report Type:Expedited (15-DaCompany Report #2006PK00261 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Seroquel PS Zeneca Initial or Prolonged Confusional State Pharmaceutical ORAL 4 DAY Drug Interaction Aulin C Overdose Nexium C ORAL Sopor Neurontin I ORAL Lioresal I ORAL Tofranil I ORAL Temesta I ORAL Date:02/03/06ISR Number: 4900614-6Report Type:Expedited (15-DaCompany Report #2006UW00775 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Seroquel PS Zeneca Other Neuroleptic Malignant Pharmaceutical ORAL 3 WK Syndrome Seroquel SS Zeneca Respiratory Failure Pharmaceutical ORAL Unspecified Medications C Date:02/03/06ISR Number: 4900616-XReport Type:Expedited (15-DaCompany Report #2006SE00161 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Thrombocytopenia Pharmaceutical ORAL 1 MON Seroxate I ORAL Date:02/06/06ISR Number: 4901356-3Report Type:Expedited (15-DaCompany Report #2006UW01671 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Seroquel PS Zeneca Weight Increased Pharmaceutical ORAL Seroquel SS Zeneca 22-Feb-2006 08:31 AM Page: 1585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical ORAL Date:02/06/06ISR Number: 4901950-XReport Type:Expedited (15-DaCompany Report #2006AP00417 Age:9326 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Seroquel PS Zeneca Pharmaceutical ORAL DAILY DOSE 150 MG TO 300 MG 120 DAY Depakene C ORAL 500 MG - 1000 MG Akineton C ORAL 4MG TO 6MG DAILY Eurodin C ORAL Sennoside C ORAL Date:02/06/06ISR Number: 4902174-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060105647 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Risperdal PS ORAL Initial or Prolonged Risperdal SS ORAL Other Seroquel SS taken for several months Date:02/06/06ISR Number: 4903506-1Report Type:Direct Company Report #CTU 268710 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Quetiapine PS 300MG QAM; Initial or Prolonged 400MG QPM Lasix C Lisinopril C Date:02/07/06ISR Number: 4902306-6Report Type:Expedited (15-DaCompany Report #PHBS2006CH01472 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Lioresal PS Novartis Sector: Initial or Prolonged Confusional State Pharma UNKNOWN 50 mg/day Sopor Lioresal SS Novartis Sector: Pharma UNKNOWN 5760 MIN Tofranil SS UNKNOWN 75 mg/day Tofranil SS UNKNOWN 5760 MIN Neurontin SS UNKNOWN 1300 mg/day Neurontin SS UNKNOWN 5760 MIN Seroquel SS UNKNOWN 25 mg/day Seroquel SS UNKNOWN 5760 MIN Temesta SS UNKNOWN Aulin C UNKNOWN Nexium C UNKNOWN 20 mg/day 22-Feb-2006 08:31 AM Page: 1586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/06ISR Number: 4902709-XReport Type:Expedited (15-DaCompany Report #2006AP00409 Age:0 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Seroquel PS Zeneca Initial or Prolonged Drug Withdrawal Syndrome Pharmaceutical TRANSPLACENTAL 5 MON Congenital Anomaly Neonatal Luvox SS TRANSPLACENTAL 5 MON Hypotonia Neonatal Artane SS TRANSPLACENTAL 5 MON Irritability Rivotril SS TRANSPLACENTAL 5 MON Somnolence Neonatal Hiberna SS TRANSPLACENTAL 5 MON Syncope Silece SS TRANSPLACENTAL 5 MON Risperdal SS TRANSPLACENTAL 24 MON Date:02/07/06ISR Number: 4902842-2Report Type:Expedited (15-DaCompany Report #2006AP00120 Age:23567 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Quetiapine PS Zeneca Initial or Prolonged Diet Refusal Pharmaceutical ORAL TITRATED Disability Eating Disorder DAILY 4 DAY Quetiapine SS Zeneca Pharmaceutical ORAL TITRATED DAILY Study Procedure SS Lamictal C ORAL Solian C ORAL Riivotril C > 3 MONTHS PRIOR TO STUDY START Riivotril C > 3 MONTHS PRIOR TO STUDY START Date:02/07/06ISR Number: 4905289-8Report Type:Direct Company Report #CTU 268805 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Lexapro 10 Mg PS ORAL 10 MG DAILY Infarction PO Cardio-Respiratory Arrest Seroquel 200 Mg SS ORAL 800 MG DAILY Dyspnoea PO Nausea Sudden Death Date:02/07/06ISR Number: 4905338-7Report Type:Direct Company Report #CTU 268792 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Quetiapine 25 Mg PS ORAL 25-50 MG Initial or Prolonged Nightmare BEDTIME PO Post-Traumatic Stress Disorder Screaming 22-Feb-2006 08:31 AM Page: 1587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/06ISR Number: 4906072-XReport Type:Direct Company Report #CTU 268914 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Quetiapine PS 25 MG QHS Initial or Prolonged Galantamine Hydrobromide C Quetiapine Flumarate C Date:02/08/06ISR Number: 4903672-8Report Type:Expedited (15-DaCompany Report #2006UW01672 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colectomy Seroquel PS Zeneca Constipation Pharmaceutical ORAL Intestinal Functional Disorder Date:02/08/06ISR Number: 4903673-XReport Type:Expedited (15-DaCompany Report #2006UW01879 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholelithiasis Seroquel PS Zeneca Pharmaceutical ORAL Date:02/08/06ISR Number: 4905258-8Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0584802A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Paxil PS Glaxosmithkline UNKNOWN Zoloft SS UNKNOWN Seroquel SS UNKNOWN Date:02/08/06ISR Number: 4905339-9Report Type:Expedited (15-DaCompany Report #2006PK00281 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Seroquel PS Zeneca Initial or Prolonged Drug Interaction Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 20 DAY Seroquel SS Zeneca Pharmaceutical ORAL 9 DAY Temesta SS ORAL 6 DAY Temesta SS ORAL 5 DAY Akineton Retard SS ORAL 4 DAY Akineton Retard SS ORAL 4 DAY Akineton Retard SS ORAL 3 DAY Temesta SS ORAL 3 DAY Temesta SS ORAL 3 DAY Dominal Forte C 4 DAY Forlax C 4 DAY Sortis C 4 DAY Nexium C 69 DAY Forlax C 7 DAY Delpral I 7 DAY 22-Feb-2006 08:31 AM Page: 1588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Delpral I Date:02/08/06ISR Number: 4905487-3Report Type:Expedited (15-DaCompany Report #2006PK00279 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Seroquel PS Zeneca Initial or Prolonged Hypoglycaemia Pharmaceutical ORAL Hypotension Loss Of Consciousness Date:02/09/06ISR Number: 4906115-3Report Type:Expedited (15-DaCompany Report #2006UW01878 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholelithiasis Seroquel PS Zeneca Gallbladder Operation Pharmaceutical ORAL Date:02/09/06ISR Number: 4906116-5Report Type:Expedited (15-DaCompany Report #2006UW02045 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Hospitalisation Pharmaceutical ORAL Date:02/09/06ISR Number: 4906373-5Report Type:Expedited (15-DaCompany Report #2005UW18685 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Seroquel PS Zeneca Diarrhoea Pharmaceutical 3 YR Dysphagia Clozapine C 5 YR Flatulence Diane 25 C 5 YR Follicle Centre Lymphoma, Follicular Grade I, Ii, Iii Hallucination, Auditory Hyperhidrosis Memory Impairment Nausea Pharyngolaryngeal Pain Pyrexia Red Blood Cell Count Decreased Red Blood Cell Sedimentation Rate Increased Renal Cyst Schizophrenia Tachycardia Paroxysmal 22-Feb-2006 08:31 AM Page: 1589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/06ISR Number: 4906463-7Report Type:Expedited (15-DaCompany Report #2006UW01859 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Seroquel PS Zeneca Pharmaceutical ORAL Date:02/09/06ISR Number: 4906675-2Report Type:Expedited (15-DaCompany Report #2005UW16485 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Risperidone C Cipralex C Date:02/10/06ISR Number: 4907781-9Report Type:Expedited (15-DaCompany Report #2006SE00357 Age:12460 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Quetiapine PS Zeneca Initial or Prolonged Drug Toxicity Pharmaceutical ORAL Other Quetiapine SS Zeneca Pharmaceutical ORAL Date:02/10/06ISR Number: 4907867-9Report Type:Expedited (15-DaCompany Report #JP-SOLVAY-00306000418 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glaucoma Luvox 25 PS ORAL Daily dose: Initial or Prolonged 50 milligram(s) 3 DAY Luvox 25 SS ORAL Daily dose: 100 milligram(s) Lexotan SS ORAL Daily dose: 10 milligram(s) 12 DAY Amoban SS ORAL Daily dose: 7.5 milligram(s) Seroquel SS ORAL Daily dose: 25 milligram(s) 4 DAY Lendormin SS ORAL Daily dose: .25 milligram(s) Seroquel SS ORAL Daily dose: 12.5 milligram(s) 12 DAY Magnesium Oxide C ORAL Daily dose: unknown Juvela Nicotinate C ORAL Daily dose: unknown Gaster C UNKNOWN Daily dose: unknown 22-Feb-2006 08:31 AM Page: 1590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/06ISR Number: 4908127-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060200881 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Risperdal PS Initial or Prolonged Neonatal Luvox SS Eye Movement Disorder Artane SS Hypotonia Rivotril SS Irritability Seroquel SS Liver Function Test Hiberna SS Abnormal Silece SS Pyrexia Somnolence Tremor Date:02/10/06ISR Number: 4908852-3Report Type:Periodic Company Report #8013248 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complex Partial Seizures Paxil Cr PS Glaxosmithkline Premature Labour Zyrtec SS Glaxosmithkline Simple Partial Seizures Keppra SS 2000MG per day Dilantin SS Seroquel SS Methylcellulose C Glaxosmithkline Folic Acid C Date:02/13/06ISR Number: 4909025-0Report Type:Expedited (15-DaCompany Report #JP-SOLVAY-00305004308 Age:0 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Luvox 25 PS TRANSPLACENTAL Daily dose: Neonatal 50 Eye Movement Disorder milligram(s) 5 MON Fever Neonatal Artane SS TRANSPLACENTAL Daily dose: 4 Hypotonia Neonatal milligram(s) 5 MON Irritability Rivotril SS TRANSPLACENTAL Daily dose: 1 Somnolence Neonatal milligram(s) 5 MON Tremor Neonatal Seroquel SS TRANSPLACENTAL Daily dose: 75 milligram(s) 5 MON Hiberna SS TRANSPLACENTAL Daily dose: 75 milligram(s) 5 MON Silece SS TRANSPLACENTAL Daily dose: 4 milligram(s) 5 MON Risperdal SS TRANSPLACENTAL Daily dose: 4 milligram(s) 24 MON Date:02/13/06ISR Number: 4909264-9Report Type:Expedited (15-DaCompany Report #PHBS2006IL01944 Age:32 YR Gender:Male I/FU:I Outcome PT Other Delusion Of Grandeur Depression Euphoric Mood Mania Mood Altered 22-Feb-2006 08:31 AM Page: 1591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Carbamazepine PS Novartis Sector: Pharma UNKNOWN 750 mg/day Lamotrigine SS UNKNOWN 25 mg/day Lamotrigine SS UNKNOWN 200 mg/day Lamotrigine SS UNKNOWN 50 mg/day Quetiapine SS UNKNOWN 600 mg/day Quetiapine SS UNKNOWN 800 mg/day Date:02/13/06ISR Number: 4909903-2Report Type:Expedited (15-DaCompany Report #2006AP00351 Age:7984 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alcohol Use Seroquel PS Zeneca Hospitalization - Apnoea Pharmaceutical ORAL 11 DAY Initial or Prolonged Blood Creatine Seroquel SS Zeneca Other Phosphokinase Increased Pharmaceutical ORAL OVERDOSE: Delirium POSSIBLY Family Stress 25-30 TABLETS Intentional Overdose TAKEN 1 DAY Loss Of Consciousness Suicide Attempt Tachycardia Vomiting White Blood Cell Count Increased Date:02/13/06ISR Number: 4909913-5Report Type:Expedited (15-DaCompany Report #2006AP00120 Age:23567 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disability Quetiapine PS Zeneca Initial or Prolonged Eating Disorder Pharmaceutical ORAL TITRATED Disability DAILY 4 DAY Quetiapine SS Zeneca Pharmaceutical ORAL TITRATED DAILY Study Procedure SS Lamictal C ORAL Solian C ORAL Riivotril C > 3 MONTHS PRIOR TO STUDY START Riivotril C > 3 MONTHS PRIOR TO STUDY START Date:02/13/06ISR Number: 4909991-3Report Type:Expedited (15-DaCompany Report #2006UW01152 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 82 DAY Seroquel SS Zeneca Pharmaceutical ORAL 22-Feb-2006 08:31 AM Page: 1592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/06ISR Number: 4910594-5Report Type:Expedited (15-DaCompany Report #2006AC00007 Age:10661 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Carbon Monoxide Poisoning Seroquel PS Zeneca Completed Suicide Pharmaceutical ORAL Fluanxol C ORAL Sipralexa C ORAL 7 DAY Trazolam C ORAL 7 DAY Trazolam C ORAL 7 DAY Staurodorm C ORAL 14 DAY Date:02/14/06ISR Number: 4910756-7Report Type:Expedited (15-DaCompany Report #2006PK00317 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL Lithium C LONG TERM MEDICATION Pipamperone C LONG TERM MEDICATION Date:02/14/06ISR Number: 4910759-2Report Type:Expedited (15-DaCompany Report #2006PK00320 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL Date:02/14/06ISR Number: 4910895-0Report Type:Expedited (15-DaCompany Report #2006AC00252 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Quetiapine PS Zeneca Drug Toxicity Pharmaceutical ORAL Fluvoxamine SS Acetaminophen SS Diphenhydramine SS Date:02/14/06ISR Number: 4910901-3Report Type:Expedited (15-DaCompany Report #2006PK00279 Age:336 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Seroquel PS Zeneca Hospitalization - Hypoglycaemia Pharmaceutical ORAL 2 DAY Initial or Prolonged Hypotension Seroquel SS Zeneca Syncope Pharmaceutical ORAL 2 DAY Seroquel SS Zeneca Pharmaceutical ORAL 2 DAY Quilonum Retard C ORAL Haldol C ORAL Akineton Retard C ORAL 22-Feb-2006 08:31 AM Page: 1593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/06ISR Number: 4910906-2Report Type:Expedited (15-DaCompany Report #2006PK00321 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Seroquel SS Zeneca Pharmaceutical ORAL 6 DAY Zoloft SS ORAL 23 DAY Lexotanil SS ORAL 23 DAY Date:02/14/06ISR Number: 4910938-4Report Type:Expedited (15-DaCompany Report #2006SE00159 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Seroquel PS Zeneca Initial or Prolonged Body Temperature Pharmaceutical ORAL 1 DAY Increased Seroquel I Zeneca Cardiac Disorder Pharmaceutical ORAL 2 DAY Drug Interaction Seroquel I Zeneca Dysuria Pharmaceutical ORAL Haematochezia Seroquel I Zeneca Haemolytic Anaemia Pharmaceutical ORAL Inflammation Seroxat I ORAL 2 MON Lung Disorder Pancytopenia Weight Decreased Yellow Skin Date:02/15/06ISR Number: 4911825-8Report Type:Expedited (15-DaCompany Report #2006UW02166 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Unilateral Seroquel PS Zeneca Visual Disturbance Pharmaceutical ORAL Toprol Xl C Prozac C Norvasc C Aciphex C Altace C Date:02/15/06ISR Number: 4911826-XReport Type:Expedited (15-DaCompany Report #2005UW17961 Age:11420 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Seroquel PS Zeneca Initial or Prolonged Loss Of Consciousness Pharmaceutical ORAL 99 DAY Overdose Lexapro C ORAL Suicide Attempt Lamictal C ORAL Tachycardia 22-Feb-2006 08:31 AM Page: 1594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/15/06ISR Number: 4912742-XReport Type:Expedited (15-DaCompany Report #2006AP00656 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Seroquel PS Zeneca Phosphokinase Increased Pharmaceutical ORAL Collapse Of Lung Venlafaxine Hcl C Neuroleptic Malignant Syndrome Date:02/15/06ISR Number: 4912743-1Report Type:Expedited (15-DaCompany Report #2006SE00159 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Seroquel PS Zeneca Initial or Prolonged Haemolytic Anaemia Pharmaceutical ORAL 1 DAY Pancytopenia Seroquel I Zeneca Pharmaceutical ORAL 2 DAY Seroquel I Zeneca Pharmaceutical ORAL Seroquel I Zeneca Pharmaceutical ORAL Seroxat I ORAL 2 MON Date:02/15/06ISR Number: 4912862-XReport Type:Expedited (15-DaCompany Report #2006UW01511 Age:95 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Effect Seroquel PS Zeneca Pharmaceutical ORAL Date:02/16/06ISR Number: 4913540-3Report Type:Expedited (15-DaCompany Report #2006UW02168 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Ill-Defined Disorder Seroquel PS Zeneca Polytraumatism Pharmaceutical ORAL Risperdal SS Zyprexa SS Date:02/16/06ISR Number: 4913565-8Report Type:Expedited (15-DaCompany Report #2006AP00682 Age:13360 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinsonism Seroquel PS Zeneca White Blood Cell Count Pharmaceutical ORAL 114 DAY Decreased Primperan C ORAL 173 DAY Primperan C ORAL 173 DAY Goodmin C ORAL 191 DAY Pariet C ORAL Toughmac E C ORAL Toughmac E C ORAL 22-Feb-2006 08:31 AM Page: 1595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/06ISR Number: 4914847-6Report Type:Expedited (15-DaCompany Report #PHEH2006US02015 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Lamisil PS Novartis Sector: Initial or Prolonged Drug Interaction Pharma ORAL 250 mg, QD 82 DAY Disability Electroconvulsive Therapy Duloxetine Other Suicidal Ideation Hydrochloride SS ORAL 60 mg, QD Quetiapine SS ORAL 200 mg, QD Mirtazapine SS ORAL 15 mg, QD Venlafaxine SS ORAL 300 mg, QD Temazepam C ORAL 30 mg, QD Date:02/17/06ISR Number: 4914907-XReport Type:Expedited (15-DaCompany Report #2006GB00271 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Seroquel PS Zeneca Overdose Pharmaceutical ORAL Date:02/17/06ISR Number: 4914909-3Report Type:Expedited (15-DaCompany Report #2006UW02205 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Seroquel PS Zeneca Initial or Prolonged Confusional State Pharmaceutical ORAL Drug Toxicity Seroquel SS Zeneca Dyspnoea Pharmaceutical ORAL Hypertension Effexor SS Hypoaesthesia Multiple Drugs SS Loss Of Consciousness Miosis Overdose Pupil Fixed Pyrexia Tachycardia Date:02/17/06ISR Number: 4915240-2Report Type:Expedited (15-DaCompany Report #2005PK02473 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Seroquel PS Zeneca No Adverse Drug Effect Pharmaceutical ORAL Date:02/17/06ISR Number: 4915243-8Report Type:Expedited (15-DaCompany Report #2006PK00331 Age:25556 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Seroquel PS Zeneca Thrombocytopenia Pharmaceutical ORAL 40 DAY Haldol SS ORAL 1 MG TO 2 MG 20 DAY 22-Feb-2006 08:31 AM Page: 1596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/06ISR Number: 4916462-7Report Type:Expedited (15-DaCompany Report #2006AP00417 Age:9326 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Seroquel PS Zeneca Pancytopenia Pharmaceutical ORAL 50 MG Sedation TITRATED TO 75 MG, TITRATED TO 100 MG Seroquel SS Zeneca Pharmaceutical ORAL 32 DAY Seroquel SS Zeneca Pharmaceutical ORAL 37 DAY Seroquel SS Zeneca Pharmaceutical ORAL 18 DAY Seroquel SS Zeneca Pharmaceutical ORAL TITRATED DOWN DUE TO DAYTIME SEDATION AND DIZZINESS 10 DAY Seroquel SS Zeneca Pharmaceutical ORAL TITRATED DOWN DUE TO SEDATION 4 DAY Seroquel SS Zeneca Pharmaceutical ORAL 13 DAY Depakene C ORAL 400MG DAILY INCREASED TO 1000 MG EVERY DAY 1199 DAY Depakene C ORAL 181 DAY Depakene C ORAL 4 DAY Depakene C ORAL 2 DAY Depakene C ORAL 10 DAY Depakene C ORAL Akineton C ORAL 4MG TO 6MG DAILY Eurodin C ORAL Sennoside C ORAL Date:02/20/06ISR Number: 4916463-9Report Type:Expedited (15-DaCompany Report #2005SE06618 Age:13727 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Quetiapine PS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 1 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 23 DAY Quetiapine SS Zeneca Pharmaceutical ORAL 14 DAY Quetiapine SS Zeneca 22-Feb-2006 08:31 AM Page: 1597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical ORAL Biperideni C ORAL 14 DAY Biperideni C ORAL 14 DAY Biperideni C ORAL 3 DAY Date:02/20/06ISR Number: 4916464-0Report Type:Expedited (15-DaCompany Report #2006UW02448 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Seroquel PS Zeneca Increased Pharmaceutical ORAL Lexapro SS ORAL Lexapro SS ORAL Date:02/21/06ISR Number: 4916984-9Report Type:Expedited (15-DaCompany Report #PHBS2006CH02498 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Leponex PS Novartis Sector: Initial or Prolonged Neuroleptic Malignant Pharma 75 mg/day Syndrome Leponex SS Novartis Sector: Pharma 125 mg/day Leponex SS Novartis Sector: Pharma 400 mg/day Seroquel SS 200 mg/day Haldol SS 10 mg/day Quilonorm /Sch/ SS ORAL 1-2 tablets/day 22-Feb-2006 08:31 AM Page: 1598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Summary report for FOI selections: Selection by inexact search of active ingredient: QUETIAPINE% Selection by inexact search of Tradename/Verbatim: SEROQUEL% Total number of reports: 6,955 From: 01-NOV-1997 To: Present 22-Feb-2006 08:31 AM Page: 1599