Quetiapine - Congenital, Prenatal & Neonatal Adverse Rections


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

This is a list of all Primary Suspect Drugs reported in the Detail Table

Quetiapine (quetiapine), Seroquel (quetiapine)

These are the Adverse Reactions culled from the Individual Safety Reports in the Detail Table

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 Reporting by Consumers

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".