This table shows all Adverse Drug Reactions reported to the FDA's Adverse Event Reporting System between 2004 and the 2nd Quarter of 2008 where the listed psychiatric drug was identified as the Primary Suspect Drug (FDA's term) deemed responsible for causing or inducing these reactions and where one or more of the Adverse Reactions reported for the Case described a congenital, prenatal or neonatal condition. Where no Age, Date of Event or Indication (the condition being treated) are shown, none were present in the FDA records.
Reported By: CN-Consumer, LW-Lawyer, MD-Physician, OT-Other Healthcare Provider, PH-Pharmacist, Blank-Not Reported in ISR (Individual Safety Report).
The Oxford English Dictionary defines a poison as "a substance that causes death or harm when introduced into or absorbed by a living organism." This psychiatric drug fits that definition.
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 4056351 | 4283401 | 08/30/2003 | 01/29/2004 | Seroquel | MD | Depression | Blood Glucose Abnormal, Caesarean Section, Drug Exposure During Pregnancy, Movement Disorder, Neonatal Disorder | |||||||
| 4056351 | 4292763 | 08/30/2003 | 02/10/2004 | Seroquel | Depression | Agitation Neonatal, Caesarean Section, Chills, Complications of Maternal Exposure To Therapeutic Drugs, Drug Withdrawal Syndrome Neonatal, Dyspnoea, Hyperbilirubinaemia Neonatal, Maternal Drugs Affecting Foetus, Neonatal Disorder, Tremor Neonatal | ||||||||
| F | 4108493 | 4314781 | 03/08/2004 | Seroquel | Drug Dependence, Maternal Drugs Affecting Foetus, Neonatal Disorder, Tremor Neonatal | |||||||||
| M | 4201006 | 4435164 | 05/01/2004 | 08/26/2004 | Seroquel | OT | Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome, Premature Baby | |||||||
| 4201013 | 4435170 | 05/01/2003 | 08/26/2004 | Seroquel | OT | Developmental Delay, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Respiratory Distress Syndrome, Premature Baby | ||||||||
| M | 4208593 | 4444674 | 07/27/2004 | 09/07/2004 | Seroquel | MD | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Disorder, Premature Baby | |||||||
| M | 4208593 | 4467799 | 07/27/2004 | 10/01/2004 | Seroquel | Schizophrenia | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Premature Baby | |||||||
| F | 5651801 | 4476725 | 10/13/2004 | Seroquel | Insomnia | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||||
| F | 5688894 | 4511274 | 09/01/2004 | 11/22/2004 | Seroquel | MD | Drug Exposure During Pregnancy, Ectopic Pregnancy | |||||||
| F | 5688896 | 4511276 | 11/22/2004 | Seroquel | OT | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||||
| 5744610 | 4579756 | 08/29/2004 | 02/10/2005 | Seroquel | Bradycardia Neonatal, Drug Exposure During Pregnancy, Hypothermia Neonatal, Neonatal Apnoeic Attack, Premature Baby | |||||||||
| F | 5790492 | 4648841 | 04/27/2005 | Seroquel | MD | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 5798595 | 4659085 | 05/09/2005 | Seroquel | PH | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||||
| F | 5814983 | 4679250 | 10/01/2003 | 05/31/2005 | Seroquel | CN | Aggression, Cerebrovascular Accident, Drug Exposure During Pregnancy, Hypertension, Myocardial Infarction | |||||||
| M | 5847923 | 4728373 | 02/04/2005 | 07/29/2005 | Quetiapine | OT | Agitation Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Large for Dates Baby, Premature Baby | |||||||
| F | 5854900 | 4737999 | 08/09/2005 | Seroquel | OT | Drug Exposure During Pregnancy, Intra-Uterine Death, Overdose | ||||||||
| M | 5887031 | 4781519 | 09/28/2005 | Seroquel | OT | Alanine Aminotransferase Increased, Neonatal Tachypnoea, Oedema, Oedema Neonatal, Tachypnoea | ||||||||
| M | 5887031 | 4811377 | 10/27/2005 | Seroquel | OT | Alanine Aminotransferase Increased, Intentional Drug Misuse, Oedema, Tachypnoea | ||||||||
| M | 5887031 | 4821628 | 01/01/2004 | 11/07/2005 | Seroquel | OT | Alanine Aminotransferase Increased, Analgesic Drug Level Increased, Drug Exposure During Pregnancy, Intentional Overdose, Neonatal Disorder, Neonatal Tachypnoea, Oedema, Oedema Neonatal, Tachypnoea | |||||||
| M | 5890514 | 4786865 | 10/04/2005 | Seroquel | OT | Alanine Aminotransferase Increased, Oedema, Tachypnoea | ||||||||
| M | 5890514 | 4805630 | 10/21/2005 | Seroquel | OT | Alanine Aminotransferase Increased, Maternal Drugs Affecting Foetus, Oedema, Tachypnoea | ||||||||
| F | 5962221 | 4877385 | 10/01/2003 | 01/09/2006 | Seroquel | CN | Anxiety Disorder, Schizoaffective Disorder | Adverse Drug Reaction, Aggression, Cerebrovascular Accident, Drug Exposure During Pregnancy, Hypertension, Myocardial Infarction, Physical Assault | ||||||
| 5989707 | 4920415 | 02/23/2006 | Seroquel | MD | Cleft Palate, Drug Exposure During Pregnancy | |||||||||
| M | 5989707 | 4939366 | 02/12/2006 | 03/10/2006 | Seroquel | MD | Schizophrenia | Cleft Palate, Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6039425 | 4994040 | 05/05/2006 | Seroquel | LW | Ill-Defined Disorder, Polytraumatism | ||||||||
| M | 6045353 | 5001696 | 11/04/2005 | 05/15/2006 | Seroquel | MD | Bradycardia Neonatal, Cyanosis Neonatal, Drug Exposure During Pregnancy, Foetal Growth Retardation, Nasal Flaring, Neonatal Disorder, Neonatal Tachypnoea | |||||||
| M | 6045353 | 5045097 | 11/04/2005 | 07/07/2006 | Seroquel | MD | Bradycardia Neonatal, Caesarean Section, Calcinosis, Cyanosis Neonatal, Drug Exposure During Pregnancy, Foetal Growth Retardation, Nasal Flaring, Neonatal Disorder, Neonatal Tachypnoea, Placental Disorder | |||||||
| F | 6056538 | 5015856 | 06/01/2006 | Seroquel | MD | Drug Exposure During Pregnancy, Stillbirth | ||||||||
| F | 6061878 | 5022164 | 06/09/2006 | Seroquel | MD | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Movement Disorder, Neonatal Disorder, Nervous System Disorder, Poor Sucking Reflex, Reflexes Abnormal | ||||||||
| F | 6128721 | 5105599 | 09/15/2006 | Seroquel | LW | Blindness, Diabetes Mellitus | ||||||||
| F | 6128721 | 5404230 | 02/01/2005 | 08/02/2007 | Seroquel | OT | Bipolar Disorder | Abortion Spontaneous, Arrhythmia, Blindness, Cholecystectomy, Convulsion, Diabetes Mellitus, Hernia Repair, Hysterectomy, Myocardial Infarction, Neuropathy Peripheral, Thyroid Disorder, Weight Increased | ||||||
| F | 6128721 | 5429185 | 02/01/2005 | 08/29/2007 | Seroquel | OT | Bipolar Disorder | Abortion Spontaneous, Arrhythmia, Blindness, Cholecystectomy, Convulsion, Diabetes Mellitus, Essential Tremor, Hernia Repair, Hysterectomy, Myocardial Infarction, Neuropathy Peripheral, Thyroid Disorder, Weight Increased | ||||||
| F | 6138953 | 5117331 | 09/29/2006 | Seroquel | MD | Bipolar Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| F | 6138953 | 5120900 | 10/05/2006 | Seroquel | MD | Bipolar Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| 6154978 | 5136208 | 10/27/2006 | Quetiapine | OT | Major Depression | Developmental Delay, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk | ||||||||
| M | 6155145 | 5136357 | 10/27/2006 | Quetiapine | OT | Major Depression | Developmental Delay, Drug Exposure Via Breast Milk, Neurodevelopmental Disorder | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6239431 | 5239669 | 02/16/2007 | Seroquel | OT | Blood Glucose Increased, Limb Deformity, Patent Ductus Arteriosus, Premature Baby | ||||||||
| F | 6239431 | 5280627 | 03/29/2007 | Seroquel | OT | Blood Glucose Increased, Hand Deformity, Patent Ductus Arteriosus, Premature Baby | ||||||||
| 6243361 | 5244397 | 02/22/2007 | Seroquel | MD | Drug Exposure During Pregnancy, Extrapyramidal Disorder | |||||||||
| M | 6243361 | 5263412 | 03/13/2007 | Seroquel | MD | Extrapyramidal Disorder | ||||||||
| F | 6388629 | 5422139 | 09/06/2005 | 08/22/2007 | Seroquel | OT | Drug Exposure During Pregnancy, Neonatal Respiratory Depression | |||||||
| F | 6394300 | 5425837 | 08/05/2000 | 08/24/2007 | Seroquel | CN | Sleep Disorder | Abdominal Strangulated Hernia, Abortion Incomplete, Diarrhoea, Drug Exposure During Pregnancy, Gallbladder Disorder, Malaise, Nausea, Nerve Injury, Neuropathy Peripheral, Stomach Discomfort, Thyroid Disorder, Type 2 Diabetes Mellitus, Weight Increased, Wheelchair User | ||||||
| F | 6417104 | 5456226 | 11/01/2006 | 09/18/2007 | Seroquel | OT | Anxiety | Drug Exposure During Pregnancy, Pancreatitis | ||||||
| F | 6418238 | 5457500 | 09/18/2007 | Seroquel | PH | Drug Exposure During Pregnancy, Drug Screen False Positive | ||||||||
| F | 6418452 | 5457742 | 09/18/2007 | Seroquel | PH | Drug Exposure During Pregnancy, Drug Screen Positive | ||||||||
| F | 6420657 | 5460110 | 09/19/2007 | Seroquel | PH | Drug Exposure During Pregnancy, Drug Screen Positive | ||||||||
| 6446331 | 5492216 | 10/05/2007 | 10/22/2007 | Seroquel | OT | Drug Exposure During Pregnancy, Respiratory Distress | ||||||||
| M | 6457824 | 5505089 | 10/06/2007 | 11/02/2007 | Seroquel | MD | Cardiovascular Disorder | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 6457824 | 5526421 | 10/06/2007 | 11/27/2007 | Seroquel | MD | Cardiac Septal Defect, Drug Exposure During Pregnancy | |||||||
| M | 6460575 | 5503177 | 09/30/2007 | 10/29/2007 | Seroquel | PH | Bipolar Disorder | Agitation Neonatal, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Fever Neonatal, Tremor Neonatal | ||||||
| M | 6471276 | 5521155 | 02/09/2007 | 11/19/2007 | Seroquel | OT | Hypoglycaemia Neonatal | |||||||
| F | 6483310 | 5537490 | 12/07/2007 | Seroquel | MD | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||||
| F | 6483310 | 5595920 | 01/18/2008 | Seroquel | MD | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||||
| F | 6487539 | 5542057 | 06/01/2003 | 12/10/2007 | Seroquel | MD | Abortion Spontaneous, Skin Disorder, Type 1 Diabetes Mellitus | |||||||
| 0 | Days | F | 5978146 | 4902709 | 08/25/2005 | 02/07/2006 | Seroquel | MD | Schizophrenia | Apgar Score Low, Drug Withdrawal Syndrome Neonatal, Hypotonia Neonatal, Irritability, Somnolence Neonatal, Syncope | ||||
| 0 | Days | F | 5978146 | 4916657 | 08/25/2005 | 02/20/2006 | Seroquel | OT | Schizophrenia | Aspiration, Blood Creatine Phosphokinase Increased, Blood Lactate Dehydrogenase Increased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Vacuum Extractor Delivery | ||||
| M | 6638108 | 5735115 | 05/12/2008 | Quetiapine | OT | Congenital Oculomotor Apraxia, Congestive Cardiomyopathy, Dilatation Ventricular, Ejection Fraction Decreased, Hypotonia, Nuclear Magnetic Resonance Imaging Brain Abnormal | ||||||||
| 6649741 | 5749966 | 05/27/2008 | Seroquel | MD | Bipolar Disorder | Cleft Palate, Drug Exposure During Pregnancy, Fallot's Tetralogy | ||||||||
| 2 | Hours | F | 6141339 | 5120451 | 09/18/2006 | 10/04/2006 | Seroquel | PH | Agitation Neonatal, Convulsion Neonatal, Drug Exposure During Pregnancy | |||||
| 2 | Hours | F | 6141339 | 5134679 | 09/18/2006 | 10/25/2006 | Seroquel | PH | Agitation Neonatal, Convulsion Neonatal, Drug Exposure During Pregnancy, Nervousness | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 2 | Hours | M | 6289870 | 5299165 | 01/01/2007 | 04/17/2007 | Seroquel | OT | Schizophrenia, Paranoid Type | Convulsion Neonatal, Feeling Jittery, Hypocalcaemia | ||||
| 2 | Hours | M | 6289870 | 5389973 | 01/01/2007 | 07/18/2007 | Seroquel | OT | Schizophrenia, Paranoid Type | Convulsion Neonatal, Feeling Jittery, Hypocalcaemia | ||||
| 1 | Day | M | 5852043 | 4734602 | 04/01/2005 | 08/04/2005 | Seroquel | MD | Cyanosis Neonatal, Drug Exposure During Pregnancy, Premature Baby | |||||
| 1 | Day | M | 5852043 | 4735782 | 04/01/2005 | 08/05/2005 | Seroquel | MD | Cyanosis Neonatal, Drug Exposure During Pregnancy, Premature Baby | |||||
| 1 | Day | M | 6446331 | 5504747 | 10/04/2007 | 11/02/2007 | Seroquel | OT | Neonatal Respiratory Depression | |||||
| 1 | Day | M | 6446331 | 5516895 | 10/04/2007 | 11/14/2007 | Seroquel | OT | Neonatal Respiratory Depression | |||||
| 2 | Weeks | F | 6464105 | 5512705 | 09/23/2007 | 11/12/2007 | 09/23/2007 | Quetiapine | OT | Schizophrenia | Drug Exposure Via Breast Milk, Sudden Infant Death Syndrome | |||
| 1 | Year | M | 6638108 | 5739066 | 05/15/2008 | Quetiapine | OT | Areflexia, Congenital Oculomotor Apraxia, Congestive Cardiomyopathy, Developmental Delay, Failure To Thrive, Growth Retardation, Hypotonia, Muscle Spasticity, Nuclear Magnetic Resonance Imaging Brain Abnormal, Reflexes Abnormal | ||||||
| 18 | Years | F | 6416932 | 5456034 | 01/01/2004 | 09/18/2007 | Seroquel | OT | Depression | Diabetes Mellitus, Drug Exposure During Pregnancy | ||||
| 19 | Years | F | 6541586 | 5611261 | 12/01/2007 | 02/01/2008 | Seroquel | OT | Bipolar Disorder | Drug Exposure During Pregnancy | ||||
| 19 | Years | F | 4128350 | 4338324 | 04/09/2004 | Seroquel | MD | Schizophrenia (Residual Type) | Brief Psychotic Disorder With Postpartum Onset, Condition Aggravated | |||||
| 19 | Years | F | 6045355 | 5001698 | 05/15/2006 | Seroquel | MD | Albuminuria, Drug Exposure During Pregnancy, Foetal Growth Retardation | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 19 | Years | F | 6045355 | 5045099 | 07/07/2006 | Seroquel | MD | Albuminuria, Caesarean Section, Calcinosis, Drug Exposure During Pregnancy, Foetal Growth Retardation, Placental Disorder, Vaginal Haemorrhage | ||||||
| 19 | Years | F | 6418391 | 5457681 | 09/18/2007 | Seroquel | MD | Drug Exposure During Pregnancy, Weight Increased | ||||||
| 20 | Years | F | 5774845 | 4629242 | 03/16/2005 | 04/04/2005 | Seroquel | MD | Drug Exposure During Pregnancy, Polyhydramnios, Premature Separation of Placenta | |||||
| 20 | Years | F | 6278635 | 5285110 | 03/24/2007 | 04/03/2007 | Seroquel | CN | Insomnia | Confusional State, Drug Exposure During Pregnancy, Hyperhidrosis, Pallor, Pyrexia, Thirst, Tremor | ||||
| 20 | Years | F | 6557953 | 5633152 | 12/13/2001 | 02/21/2008 | Seroquel | MD | Schizophrenia | Abdominal Pain, Back Pain, Chest Pain, Convulsion, Dehydration, Diabetes Mellitus Inadequate Control, Dyspnoea, Dysuria, Eye Irritation, Hypoglycaemia, Mental Status Changes, Nausea, Oedema Peripheral, Pain, Pain In Extremity, Pelvic Pain, Polycystic Ovaries, Premature Labour, Pyrexia, Sleep Disorder, Type 2 Diabetes Mellitus, Vaginal Haemorrhage, Vomiting | ||||
| 22 | Years | F | 4158579 | 4379114 | 05/28/2004 | 06/10/2004 | Seroquel | OT | Schizoaffective Disorder | Drug Exposure During Pregnancy, Premature Baby | ||||
| 22 | Years | F | 4158579 | 4435997 | 05/28/2004 | 08/26/2004 | Seroquel | OT | Hallucination, Paranoia, Schizoaffective Disorder | Drug Exposure During Pregnancy, Premature Labour | ||||
| 23 | Years | F | 6419373 | 5458718 | 10/01/2006 | 09/19/2007 | Seroquel | CN | Bipolar Disorder | Depression, Disturbance In Attention, Drug Exposure During Pregnancy | ||||
| 23 | Years | F | 6420647 | 5460098 | 10/01/2006 | 09/19/2007 | Seroquel | CN | Bipolar Disorder | Drug Exposure During Pregnancy, Weight Increased | ||||
| 24 | Years | F | 6420883 | 5460357 | 09/19/2007 | Seroquel | MD | Anxiety | Delusion, Drug Exposure During Pregnancy, Mania | |||||
| 25 | Years | F | 6282331 | 5277698 | 06/01/2004 | 12/13/2006 | Seroquel | Insomnia | Drug Exposure During Pregnancy, Overdose | |||||
| 25 | Years | F | 4104615 | 4310811 | 04/26/2003 | 03/02/2004 | Seroquel | MD | Panic Attack, Schizophrenia | Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 25 | Years | F | 4104615 | 4311970 | 04/26/2003 | 03/03/2004 | Seroquel | MD | Panic Attack, Schizophrenia | Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy | ||||
| 25 | Years | F | 5854900 | 4761574 | 07/28/2005 | 09/06/2005 | Seroquel | OT | Schizophrenia | Convulsion, Drug Exposure During Pregnancy, Intra-Uterine Death, Overdose, Respiratory Failure, Status Epilepticus | ||||
| 25 | Years | F | 5854900 | 4779993 | 07/28/2005 | 09/27/2005 | Seroquel | OT | Schizophrenia | Drug Exposure During Pregnancy, Intra-Uterine Death, Overdose, Respiratory Failure, Status Epilepticus | ||||
| 26 | Years | F | 6039425 | 5262228 | 01/01/1999 | 03/12/2007 | Seroquel | MD | Hallucination (Visual) | Asthma, Blood Cholesterol Increased, Diabetes Mellitus Non-Insulin-dependent, Drug Exposure During Pregnancy, Fibromyalgia, Gestational Diabetes, Hyperlipidaemia, Hypothyroidism | ||||
| 26 | Years | F | 6419131 | 5458428 | 09/19/2007 | Seroquel | Sleep Disorder Therapy | Cardiac Disorder, Drug Abuse, Drug Exposure During Pregnancy, Gastrointestinal Motility Disorder, Heart Rate Increased, Therapeutic Response Decreased | ||||||
| 26 | Years | F | 5888581 | 4784043 | 09/30/2005 | Seroquel | OT | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Drug Exposure During Pregnancy, Hyperbilirubinaemia, Hypotension, Intentional Misuse, Overdose, Prothrombin Time Prolonged, Sedation, Tachycardia | ||||||
| 26 | Years | F | 5888581 | 4821222 | 01/01/2004 | 11/07/2005 | Seroquel | OT | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Drug Exposure During Pregnancy, Hyperbilirubinaemia, Hypotension, Intentional Overdose, Multiple Drug Overdose Intentional, Prothrombin Time Prolonged, Sedation, Tachycardia | |||||
| 26 | Years | F | 5952442 | 4868117 | 11/01/2004 | 12/29/2005 | Seroquel | MD | Schizophrenia | Drug Exposure During Pregnancy, Leukopenia | ||||
| 28 | Years | F | 6174631 | 5158772 | 11/28/2006 | Seroquel | OT | Psychotic Disorder | Drug Exposure During Pregnancy, Palpitations | |||||
| 28 | Years | F | 6415403 | 5454318 | 09/17/2007 | Seroquel | MD | Schizophrenia | Drug Exposure During Pregnancy, Hepatic Enzyme Increased | |||||
| 29 | Years | F | 6415479 | 5454396 | 09/17/2007 | Seroquel | CN | Bipolar Disorder | Drug Exposure During Pregnancy, Insomnia, Vomiting | |||||
| 29 | Years | F | 3967716 | 4355250 | 04/02/2003 | 05/05/2004 | Seroquel | OT | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 29 | Years | F | 5718104 | 4550063 | 09/04/2004 | 01/07/2005 | Seroquel | Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 30 | Years | F | 6071740 | 5033988 | 06/26/2006 | Seroquel | CN | Bipolar Disorder | Abnormal Dreams, Aggression, Blood Glucose Fluctuation, Blood Glucose Increased, Bone Pain, Dependence, Diarrhoea, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Eating Disorder, Euphoric Mood, Hallucination (Auditory), Hallucination (Visual), Influenza Like Illness, Insomnia, Muscle Spasms, Myalgia, Nausea, Oral Intake Reduced, Pain, Palpitations, Paranoia, Self Mutilation, Sleep Walking, Vomiting | |||||
| 30 | Years | F | 6172265 | 5156196 | 09/30/2005 | 11/22/2006 | 09/30/2005 | Seroquel | OT | Bipolar I Disorder | Drug Exposure During Pregnancy, Intra-Uterine Death | |||
| 30 | Years | F | 6417983 | 5457232 | 06/30/2006 | 09/18/2007 | Seroquel | OT | Bipolar Disorder | Drug Exposure During Pregnancy, Gestational Diabetes | ||||
| 31 | Years | F | 4199718 | 4431895 | 08/19/2004 | Seroquel | OT | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||
| 31 | Years | F | 6071490 | 5033743 | 06/23/2006 | Seroquel | Schizoaffective Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy, Psychotic Disorder | ||||||
| 31 | Years | F | 6082467 | 5051314 | 04/25/2006 | 07/14/2006 | Seroquel | MD | Insomnia | Drug Exposure During Pregnancy, Gestational Diabetes | ||||
| 31 | Years | F | 6082467 | 5058067 | 04/25/2006 | 07/21/2006 | Seroquel | MD | Insomnia | Drug Exposure During Pregnancy, Gestational Diabetes | ||||
| 31 | Years | F | 6082467 | 5488136 | 10/17/2007 | Seroquel | OT | Insomnia | Diabetes Mellitus, Drug Exposure During Pregnancy | |||||
| 31 | Years | F | 6327530 | 5347405 | 06/06/2007 | Seroquel | MD | Depression | Drug Exposure During Pregnancy, Psychotic Disorder | |||||
| 31 | Years | F | 6327530 | 5362412 | 06/19/2007 | Seroquel | MD | Depression | Drug Exposure During Pregnancy, Psychotic Disorder | |||||
| 31 | Years | F | 6327530 | 5375194 | 06/29/2007 | Seroquel | MD | Depression | Premature Baby, Psychotic Disorder | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 31 | Years | F | 6415871 | 5454827 | 06/01/2006 | 09/17/2007 | Seroquel | MD | Bipolar Disorder | Condition Aggravated, Drug Exposure During Pregnancy | ||||
| 31 | Years | F | 6418085 | 5457342 | 02/09/2007 | 09/18/2007 | Seroquel | CN | Schizophrenia | Drug Exposure During Pregnancy, Vomiting | ||||
| 32 | Years | F | 5688894 | 4529391 | 06/01/2004 | 12/14/2004 | Seroquel | OT | Bipolar Disorder | Drug Exposure During Pregnancy, Ectopic Pregnancy | ||||
| 32 | Years | F | 5867417 | 4753549 | 05/01/2002 | 08/26/2005 | Seroquel | CN | Bipolar Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy, Ovarian Cyst, Premature Separation of Placenta, Progesterone Decreased, Pyrexia | ||||
| 32 | Years | F | 6181146 | 5167073 | 12/07/2006 | Seroquel | OT | Bipolar Disorder | Foetal Growth Retardation | |||||
| 32 | Years | F | 6181146 | 5179207 | 12/19/2006 | Seroquel | OT | Bipolar Disorder | Drug Exposure During Pregnancy, Foetal Growth Retardation | |||||
| 32 | Years | F | 6181146 | 5239668 | 02/16/2007 | Seroquel | OT | Bipolar Disorder | Foetal Growth Retardation | |||||
| 32 | Years | F | 6181146 | 5280609 | 03/29/2007 | Seroquel | OT | Bipolar Disorder | Foetal Growth Retardation | |||||
| 32 | Years | F | 6302831 | 5315035 | 05/02/2007 | Seroquel | OT | Drug Exposure During Pregnancy, Loss of Consciousness, Multiple Drug Overdose | ||||||
| 32 | Years | F | 6418098 | 5457355 | 09/18/2007 | Seroquel | Bipolar Disorder | Drug Exposure During Pregnancy, Drug Ineffective, Weight Increased | ||||||
| 32 | Years | F | 6429683 | 5470694 | 01/01/2007 | 09/28/2007 | Seroquel | CN | Insomnia | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 32 | Years | F | 6269230 | 5274148 | 02/24/2007 | 03/23/2007 | Seroquel | MD | Major Depression | Drug Exposure During Pregnancy, Intentional Overdose | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 32 | Years | F | 6605365 | 5693685 | 02/10/2008 | 04/03/2008 | Seroquel | OT | Drug Interaction | |||||
| 32 | Years | F | 6605365 | 5715936 | 02/10/2008 | 04/24/2008 | Seroquel | OT | Abortion Spontaneous, Drug Interaction | |||||
| 32 | Years | F | 6605365 | 5737515 | 02/10/2008 | 05/14/2008 | Seroquel | OT | Anxiety | Abortion Spontaneous, Alopecia, Drug Exposure During Pregnancy, Drug Interaction, Dry Mouth, Nausea, Visual Disturbance | ||||
| 33 | Years | F | 4128350 | 4365871 | 11/27/2003 | 05/21/2004 | Seroquel | MD | Schizophrenia (Residual Type) | Aggression, Brief Psychotic Disorder With Postpartum Onset, Drug Ineffective, Hypomania | ||||
| 33 | Years | F | 5710554 | 4541739 | 12/27/2004 | Seroquel | PH | Psychotic Disorder | Drug Exposure During Pregnancy, Gestational Diabetes | |||||
| 33 | Years | F | 5710554 | 4621030 | 12/31/2004 | 03/25/2005 | Seroquel | PH | Psychotic Disorder | Drug Exposure During Pregnancy, Gestational Diabetes, Induced Labour, Pregnancy Induced Hypertension, Premature Baby | ||||
| 33 | Years | F | 5849715 | 4729962 | 07/01/2004 | 08/01/2005 | Quetiapine | OT | Schizophrenia | Blood Pressure Increased, Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes, Premature Baby | ||||
| 33 | Years | F | 5905409 | 4804868 | 10/20/2005 | Seroquel | CN | Abortion Spontaneous, Complication of Pregnancy, Infertility, Transmission of Drug Via Semen | ||||||
| 33 | Years | F | 6007102 | 4947233 | 06/27/2005 | 03/17/2006 | Seroquel | CN | Bipolar Disorder | Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Stillbirth | ||||
| 34 | Years | F | 6415888 | 5454844 | 09/17/2007 | Seroquel | OT | Dizziness, Drug Exposure During Pregnancy | ||||||
| 34 | Years | F | 6415972 | 5454926 | 09/17/2007 | Seroquel | MD | Drug Exposure During Pregnancy | ||||||
| 34 | Years | F | 5761475 | 4606105 | 12/01/2004 | 03/09/2005 | Seroquel | Bipolar Disorder | Abortion Spontaneous, Agitation, Drug Exposure During Pregnancy, Insomnia | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 34 | Years | F | 6144432 | 5124198 | 10/10/2006 | Seroquel | MD | Schizophrenia | Abortion Induced, Cardiac Malposition, Drug Exposure During Pregnancy, Gastrointestinal Malformation, Intra-Uterine Death, Kidney Malformation, Mediastinal Disorder, Multiple Congenital Abnormalities | |||||
| 34 | Years | F | 6002035 | 4940080 | 05/01/2005 | 03/10/2006 | Seroquel | OT | Bipolar Disorder | Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Gestational Diabetes | ||||
| 37 | Years | F | 6128721 | 5518495 | 01/01/2003 | 11/15/2007 | Seroquel | OT | Bipolar Disorder | Abortion Spontaneous, Arrhythmia, Blindness, Blood Disorder, Cardiac Disorder, Cholecystectomy, Convulsion, Diabetes Mellitus, Essential Tremor, Hernia Repair, Hysterectomy, Myocardial Infarction, Neuropathy Peripheral, Thyroid Disorder, Weight Increased | ||||
| 38 | Years | F | 6415148 | 5453961 | 09/17/2007 | Seroquel | Sleep Disorder | Drug Exposure During Pregnancy, Hypercholesterolaemia, Hypothyroidism | ||||||
| 38 | Years | F | 6512536 | 5571092 | 07/17/2007 | 12/21/2007 | Seroquel | MD | Delivery, Drug Exposure During Pregnancy, Gestational Diabetes | |||||
| 38 | Years | F | 6128721 | 5384060 | 02/01/2005 | 07/11/2007 | Seroquel | OT | Bipolar Disorder | Abortion Spontaneous, Blindness, Cholecystectomy, Convulsion, Diabetes Mellitus, Hernia Repair, Myocardial Infarction | ||||
| 38 | Years | F | 5849936 | 4730378 | 08/01/2005 | Seroquel | MD | Drug Exposure During Pregnancy, Intra-Uterine Death | ||||||
| 38 | Years | F | 5849936 | 4760423 | 06/01/2005 | 09/02/2005 | Seroquel | MD | Mania | Abortion Incomplete, Abortion Missed, Drug Exposure During Pregnancy | ||||
| 40 | Years | F | 6058987 | 5018939 | 07/18/2005 | 06/06/2006 | Quetiapine | OT | Depression | Abortion Induced, Chorioamnionitis, Drug Exposure During Pregnancy, Foetal Growth Retardation, Oligohydramnios | ||||
| 41 | Years | F | 6232039 | 5231248 | 01/01/2006 | 02/06/2007 | Seroquel | MD | Schizophrenia | Abortion, Drug Exposure During Pregnancy | ||||
| 41 | Years | F | 6420937 | 5460415 | 09/19/2007 | Seroquel | OT | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 42 | Years | F | 6242874 | 5243631 | 02/22/2007 | Seroquel | OT | Blood Glucose Increased, Drug Exposure During Pregnancy | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 42 | Years | F | 6242874 | 5243695 | 02/22/2007 | Seroquel | OT | Blood Glucose Increased, Drug Exposure During Pregnancy | ||||||
| 42 | Years | F | 6470256 | 5519937 | 05/29/2006 | 11/16/2007 | Seroquel | OT | Drug Exposure During Pregnancy, Gestational Diabetes | |||||
| 44 | Years | F | 6419158 | 5458463 | 03/01/2007 | 09/19/2007 | Seroquel | Depression | Crying, Depressed Mood, Drug Exposure During Pregnancy, Emotional Disorder | |||||
| 13 Males | 82 Females | 103 Cases (Gender was not reported for 8 Cases) | 147 Individual Safety Reports | |||||||||||
Quetiapine (quetiapine), Seroquel (quetiapine)
Abdominal Pain, Abdominal Strangulated Hernia, Abnormal Dreams, Abortion, Abortion Incomplete, Abortion Induced, Abortion Missed, Abortion Spontaneous, Adverse Drug Reaction, Aggression, Agitation, Agitation Neonatal, Alanine Aminotransferase Increased, Albuminuria, Alopecia, Analgesic Drug Level Increased, Apgar Score Low, Areflexia, Arrhythmia, Aspartate Aminotransferase Increased, Aspiration, Asthma, Back Pain, Blindness, Blood Alkaline Phosphatase Increased, Blood Cholesterol Increased, Blood Creatine Phosphokinase Increased, Blood Disorder, Blood Glucose Abnormal, Blood Glucose Fluctuation, Blood Glucose Increased, Blood Lactate Dehydrogenase Increased, Blood Pressure Increased, Bone Pain, Bradycardia Neonatal, Brief Psychotic Disorder With Postpartum Onset, Caesarean Section, Calcinosis, Cardiac Disorder, Cardiac Malposition, Cardiac Septal Defect, Cardiovascular Disorder, Cerebrovascular Accident, Chest Pain, Chills, Cholecystectomy, Chorioamnionitis, Cleft Palate, Complication of Pregnancy, Complications of Maternal Exposure To Therapeutic Drugs, Condition Aggravated, Confusional State, Congenital Oculomotor Apraxia, Congestive Cardiomyopathy, Convulsion, Convulsion Neonatal, Crying, Cyanosis Neonatal, Dehydration, Delivery, Delusion, Dependence, Depressed Mood, Depression, Developmental Delay, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Non-Insulin-dependent, Diarrhoea, Dilatation Ventricular, Disturbance In Attention, Dizziness, Drug Abuse, Drug Dependence, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Drug Interaction, Drug Screen False Positive, Drug Screen Positive, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Dry Mouth, Dyspnoea, Dysuria, Eating Disorder, Ectopic Pregnancy, Ejection Fraction Decreased, Emotional Disorder, Essential Tremor, Euphoric Mood, Extrapyramidal Disorder, Eye Irritation, Failure To Thrive, Fallot's Tetralogy, Feeding Disorder Neonatal, Feeling Jittery, Fever Neonatal, Fibromyalgia, Foetal Growth Retardation, Gallbladder Disorder, Gastrointestinal Malformation, Gastrointestinal Motility Disorder, Gestational Diabetes, Growth Retardation, Hallucination (Auditory), Hallucination (Visual), Hand Deformity, Heart Rate Increased, Hepatic Enzyme Increased, Hernia Repair, Hyperbilirubinaemia, Hyperbilirubinaemia Neonatal, Hypercholesterolaemia, Hyperhidrosis, Hyperlipidaemia, Hypertension, Hypertonia Neonatal, Hypocalcaemia, Hypoglycaemia, Hypoglycaemia Neonatal, Hypomania, Hypotension, Hypothermia Neonatal, Hypothyroidism, Hypotonia, Hypotonia Neonatal, Hysterectomy, Ill-Defined Disorder, Induced Labour, Infertility, Influenza Like Illness, Insomnia, Intentional Drug Misuse, Intentional Misuse, Intentional Overdose, Intra-Uterine Death, Irritability, Kidney Malformation, Large for Dates Baby, Leukopenia, Limb Deformity, Loss of Consciousness, Malaise, Mania, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Mediastinal Disorder, Mental Status Changes, Movement Disorder, Multiple Congenital Abnormalities, Multiple Drug Overdose, Multiple Drug Overdose Intentional, Muscle Spasms, Muscle Spasticity, Myalgia, Myocardial Infarction, Nasal Flaring, Nausea, Neonatal Apnoeic Attack, Neonatal Disorder, Neonatal Respiratory Depression, Neonatal Respiratory Distress Syndrome, Neonatal Tachypnoea, Nerve Injury, Nervous System Disorder, Nervousness, Neurodevelopmental Disorder, Neuropathy Peripheral, Nuclear Magnetic Resonance Imaging Brain Abnormal, Oedema, Oedema Neonatal, Oedema Peripheral, Oligohydramnios, Oral Intake Reduced, Ovarian Cyst, Overdose, Pain, Pain In Extremity, Pallor, Palpitations, Pancreatitis, Paranoia, Patent Ductus Arteriosus, Pelvic Pain, Physical Assault, Placental Disorder, Polycystic Ovaries, Polyhydramnios, Polytraumatism, Poor Sucking Reflex, Pregnancy Induced Hypertension, Premature Baby, Premature Labour, Premature Separation of Placenta, Progesterone Decreased, Prothrombin Time Prolonged, Psychotic Disorder, Pyrexia, Reflexes Abnormal, Respiratory Distress, Respiratory Failure, Sedation, Self Mutilation, Skin Disorder, Sleep Disorder, Sleep Walking, Somnolence Neonatal, Status Epilepticus, Stillbirth, Stomach Discomfort, Sudden Infant Death Syndrome, Syncope, Tachycardia, Tachypnoea, Therapeutic Response Decreased, Thirst, Thyroid Disorder, Transmission of Drug Via Semen, Tremor, Tremor Neonatal, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Vacuum Extractor Delivery, Vaginal Haemorrhage, Visual Disturbance, Vomiting, Weight Increased, Wheelchair User
| Definitions | |
| Abortion Spontaneous | Miscarriage means loss of an embryo or fetus before the 20th week of pregnancy. Most miscarriages occur during the first 14 weeks of pregnancy. The medical term for miscarriage is spontaneous abortion. |
| Alanine Aminotransferase Increased | Alanine Aminotransferase (ALT) is an enzyme. Significant elevation of the serum levels of ALT is a specific indicator of liver damage. |
| Albuminuria | The presence of albumin in the urine, sometimes indicating kidney disease. |
| Bradycardia | Slowness of heart rate. |
| Calcinosis | An abnormal condition in which calcium salts are deposited in a part or tissue of the body. |
| Diabetes Mellitus | Diabetes mellitus is a condition in which the pancreas no longer produces enough insulin or when cells stop responding to the insulin that is produced, so that glucose in the blood cannot be absorbed into the cells of the body. |
| Drug Withdrawal Syndrome Neonatal | Refers to the characteristic signs and symptoms that appear when a drug that causes physical dependence is regularly used for a long time and then suddenly discontinued or decreased in dosage. Also known as abstinence syndrome. A group of unpleasant symptoms produced by the abrupt termination of drug taking. These symptoms, commonly called withdrawal symptoms, include anxiety, muscle weakness, nausea, vomiting, tremor, and a rapid heart beat. [Image] |
| Dyspnoea | Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath. Also called air hunger. |
| Gestational Diabetes | Gestational diabetes is a condition that occurs during pregnancy. Like other forms of diabetes, gestational diabetes involves a defect in the way the body processes and uses sugars (glucose) in the diet. |
| In diabetes, blood levels of glucose remain abnormally high. In many forms of diabetes, this is because the pancreas does not produce enough insulin. | |
| In gestational diabetes, the pancreas is not at fault. Instead, the problem is in the placenta. During pregnancy, the placenta provides the baby with nourishment. It also produces a number of hormones that interfere with the body's usual response to insulin. This condition is referred to as "insulin resistance." Most pregnant women do not suffer from gestational diabetes, because the pancreas works to produce extra quantities of insulin in order to compensate for insulin resistance. However, when a woman's pancreas cannot produce enough extra insulin, blood levels of glucose stay abnormally high, and the woman is considered to have gestational diabetes. | |
| Hyperbilirubinaemia Neonatal | Jaundice is a condition in which a person's skin and the whites of the eyes are discolored yellow due to an increased level of bile pigments in the blood resulting from liver disease. |
| Hypocalcaemia | Abnormally low level of calcium in the blood; associated with hypoparathyroidism or kidney malfunction or vitamin D deficiency. |
| Hypotonia | Decease of normal tonicity (normal firmness or functional readiness in body tissues or organs) or tension. |
| Myocardial Infarction | Sudden interruption or insufficiency of the supply of blood to the heart, typically resulting from occlusion or obstruction of a coronary artery and often characterized by severe chest pain (heart attack). |
| Oedema | Edema is a condition of abnormally large fluid volume in the circulatory system or in tissues between the body's cells (interstitial spaces). |
| Patent Ductus Arteriosus | Patent ductus arteriosus (PDA) is a heart defect that occurs when the ductus arteriosus (the temporary fetal blood vessel that connects the aorta and the pulmonary artery) does not close at birth.Because the placenta does the work of exchanging oxygen and carbon dioxide through the mother's circulation, the fetal lungs are not used for breathing. Instead of blood flowing to the lungs to pick up oxygen and then flowing to the rest of the body, the fetal circulation shunts (bypasses) most of the blood away from the lungs. In the fetus, blood is shunted from the pulmonary artery to the aorta through the ductus arteriosus. However, with the first breaths of air the baby takes at birth, the fetal circulation changes. A larger amount of blood is sent to the lungs to pick up oxygen. Because the ductus arteriosus is no longer needed, it normally begins to wither and close off. In some infants, the ductus arteriosus remains open (or patent) and the resulting heart defect is known as patent ductus arteriosus. The shunting causes too much blood to flow to the lungs and not enough to the other parts of the body. There may be changes in the blood pressure, and the heart may enlarge as it tries to make up for the abnormal blood flow. Babies with PDA may be at risk for infection or inflammation of the arteries. Severe PDA can cause slow growth, and may result in heart failure. |
| Pyrexia | Fever. |
| Status Epilepticus | Occurrence of prolonged, generalized epileptic seizures in rapid succession with brief intervals of coma. |
MedWatch is the Food and Drug Administration's program for reporting any undesirable experience associated with the use of a medical product. If you think you or someone in your family has experienced an adverse reaction from taking Quetiapine and it has not been reported to the FDA, see this page for instructions on reporting the adverse event through your doctor or directly to the FDA using an online form.
A May 2006 USA Today article states that "drug companies are required to file any reports they have to the FDA, but consumers and doctors report such events on a voluntary basis. Studies suggest the FDA's Adverse Events Reporting System database captures only 1% to 10% of drug-induced side effects and deaths, "maybe even less than 1%," says clinical pharmacologist Alastair J.J. Wood, an associate dean at Vanderbilt Medical School in Nashville. So the real number of cases is almost certainly much higher".