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 | ||||
| M | 4207057 | 4445990 | 07/23/2003 | 09/10/2004 | Valium | CN | Drug Use for Unknown Indication | Breech Presentation, Caesarean Section, Cerebral Haemorrhage Neonatal, Congenital Anomaly, Congenital Choroid Plexus Cyst, Congenital Nose Malformation, Drug Exposure During Pregnancy, Ear Malformation, Feeding Problem In Newborn, Foetal Alcohol Syndrome, Foetal Heart Rate Decreased, Growth Retardation, Heart Rate Decreased, Hypoventilation, Lip Disorder, Microgenia, Neonatal Disorder, Premature Baby, Respiratory Rate Decreased, Ultrasound Antenatal Screen Abnormal | ||||||
| F | 5667470 | 4471331 | 10/06/2004 | Diazepam | OT | Musculoskeletal Stiffness | Complication of Delivery, Drug Exposure During Pregnancy, Foetal Distress Syndrome | |||||||
| 5668391 | 4472833 | 09/01/1992 | 10/08/2004 | Diazepam | OT | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Neonatal Asphyxia | |||||||
| 5668394 | 4472836 | 09/01/1992 | 10/08/2004 | Diazepam | OT | Drug Exposure During Pregnancy | Apgar Score Low, Drug Exposure During Pregnancy, Neonatal Asphyxia | |||||||
| 5668396 | 4472838 | 09/01/1992 | 10/08/2004 | Diazepam | OT | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Neonatal Asphyxia | |||||||
| 5668397 | 4472840 | 09/01/1992 | 10/08/2004 | Diazepam | OT | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Neonatal Asphyxia | |||||||
| 5668398 | 4472843 | 09/01/1992 | 10/08/2004 | Diazepam | OT | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Neonatal Asphyxia | |||||||
| 5668399 | 4472845 | 09/01/1992 | 10/08/2004 | Diazepam | OT | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Neonatal Asphyxia | |||||||
| F | 5762505 | 4614012 | 01/24/2005 | 03/21/2005 | Valium | CN | Mania | Apgar Score Low, Caesarean Section, Drug Exposure During Pregnancy, Hypotonia, Neonatal Disorder, Respiratory Failure, Somnolence, Vomiting | ||||||
| 5798951 | 4658672 | 05/09/2005 | Diazepam | Arrhythmia Neonatal, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Hypertonia Neonatal, Irritability, Neonatal Disorder | ||||||||||
| F | 5846537 | 4726318 | 01/08/2005 | 07/27/2005 | Valium | CN | Drug Use for Unknown Indication | Caesarean Section, Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Hypotonia Neonatal | ||||||
| F | 5850320 | 4723789 | 06/28/2005 | 07/22/2005 | Diazepam | Drug Exposure During Pregnancy, Foetal Disorder, Gastroschisis | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 5853781 | 4730334 | 06/28/2005 | 07/29/2005 | Diazepam | OT | Drug Exposure During Pregnancy, Gastroschisis | ||||||||
| F | 5926343 | 4833106 | 11/21/2005 | Diazepam | MD | Convulsion | Condition Aggravated, Congenital Hydrocephalus, Renal Tubular Disorder | |||||||
| M | 5959638 | 4879150 | 02/15/2005 | 01/12/2006 | Valium | CN | Caesarean Section, Drug Exposure During Pregnancy, Polyhydramnios, Premature Labour, Premature Rupture of Membranes | |||||||
| M | 5959638 | 4896629 | 02/15/2005 | 01/31/2006 | Valium | CN | Caesarean Section, Drug Exposure During Pregnancy, Hypoglycaemia, Polyhydramnios, Premature Labour, Premature Rupture of Membranes | |||||||
| M | 6018399 | 4962035 | 04/04/2006 | Valium | CN | Anxiety | Infant, Inguinal Hernia, Maternal Drugs Affecting Foetus | |||||||
| M | 6101161 | 5063688 | 07/24/2006 | Diazepam | MD | Abnormal Behaviour, Aggression, Apgar Score Low, Autism, Bradycardia Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Eye Rolling, Foetal Growth Retardation, Gliosis, Intelligence Test Abnormal, Meconium Increased, Microphthalmos, Neonatal Aspiration, Nystagmus, Periventricular Leukomalacia, Placental Disorder, Psychomotor Skills Impaired, Pupillary Reflex Impaired, Respiratory Disorder Neonatal, Retinal Detachment, Retinopathy of Prematurity, Social Avoidant Behaviour, Stereotypic Movement Disorder, Visual Disturbance | ||||||||
| M | 6114727 | 5082612 | 08/14/2006 | Diastat | MD | Bone Disorder, Congenital Anomaly, Drug Exposure During Pregnancy, Encephalocele, Skin Atrophy, Skull Malformation | ||||||||
| 6217911 | 5201945 | 01/04/2007 | Diazepam | OT | Limb Hypoplasia Congenital, Limb Reduction Defect | |||||||||
| 6221488 | 5201631 | 01/04/2007 | Diazepam | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Limb Hypoplasia Congenital, Limb Reduction Defect | |||||||||
| M | 6269294 | 5274209 | 03/23/2007 | Diazepam | Autism Spectrum Disorder, Bradycardia, Dyspnoea, Foetal Growth Retardation, Neonatal Aspiration, Periventricular Leukomalacia, Retinopathy of Prematurity | |||||||||
| F | 6341685 | 5369198 | 06/25/2007 | Valium | OT | Neck Pain | Aortic Stenosis, Ventricular Septal Defect | |||||||
| F | 6343259 | 5363466 | 06/18/2007 | Diazepam | MD | Pain | Abdominal Pain, Abdominal Pain Upper, Accident, Amnesia, Arthralgia, Cauda Equina Syndrome, Chest Pain, Complex Regional Pain Syndrome, Constipation, Drug Abuser, Drug Dependence, Drug Exposure During Pregnancy, Drug Toxicity, Drug Withdrawal Syndrome, Factitious Disorder, Gallbladder Perforation, Heart Disease Congenital, Hepatitis Toxic, Hyperventilation, Iatrogenic Injury, Incorrect Dose Administered, Lethargy, Loss of Consciousness, Lymphadenopathy, Moaning, Peritonitis, Procedural Pain, Substance Abuse, Toothache, Urinary Retention, Vomiting | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6344917 | 5361764 | 06/15/2007 | Diazepam | MD | Drug Exposure During Pregnancy | Activities of Daily Living Impaired, Benign Lymph Node Neoplasm, Cauda Equina Syndrome, Constipation, Dependence, Disorientation, Drug Abuser, Drug Dependence, Drug Detoxification, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Factitious Disorder, Hepatitis Toxic, Hypersomnia, Legal Problem, Lethargy, Loss of Consciousness, Pain, Urinary Retention, Wrong Drug Administered | ||||||||
| 6352347 | 5381831 | 07/09/2007 | Diazepam | MD | Drug Use for Unknown Indication | Developmental Delay, Drug Exposure During Pregnancy, Nystagmus, Visual Acuity Reduced | ||||||||
| 6352349 | 5381838 | 07/09/2007 | Diazepam | MD | Drug Use for Unknown Indication | Developmental Delay, Drug Withdrawal Syndrome Neonatal, Nystagmus | ||||||||
| 6352350 | 5381840 | 07/09/2007 | Diazepam | MD | Drug Use for Unknown Indication | Developmental Delay, Drug Exposure During Pregnancy, Nystagmus, Posture Abnormal, Strabismus, Visual Acuity Reduced | ||||||||
| 6352352 | 5381842 | 07/09/2007 | Diazepam | MD | Drug Use for Unknown Indication | Developmental Delay, Drug Withdrawal Syndrome Neonatal, Microcephaly, Nystagmus | ||||||||
| 6352353 | 5381843 | 07/09/2007 | Diazepam | MD | Drug Use for Unknown Indication | Developmental Delay, Drug Withdrawal Syndrome Neonatal, Nystagmus | ||||||||
| 6352355 | 5381845 | 07/09/2007 | Diazepam | MD | Drug Use for Unknown Indication | Attention Deficit/Hyperactivity Disorder, Developmental Delay, Drug Withdrawal Syndrome Neonatal, Nystagmus | ||||||||
| 6352357 | 5381847 | 07/09/2007 | Diazepam | MD | Drug Use for Unknown Indication | Drug Withdrawal Syndrome Neonatal, Microcephaly, Nystagmus | ||||||||
| 6352363 | 5381858 | 07/09/2007 | Diazepam | MD | Drug Use for Unknown Indication | Developmental Delay, Foetal Alcohol Syndrome, Microcephaly, Nystagmus | ||||||||
| 6360952 | 5390646 | 07/18/2007 | Diazepam | Congenital Nystagmus, Developmental Delay, Posture Abnormal, Strabismus | ||||||||||
| 6360954 | 5390648 | 07/18/2007 | Diazepam | Congenital Nystagmus, Developmental Delay, Learning Disorder, Posture Abnormal | ||||||||||
| 6360962 | 5390656 | 07/18/2007 | Diazepam | Congenital Nystagmus, Drug Withdrawal Syndrome Neonatal, Microcephaly, Visual Acuity Reduced | ||||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6361052 | 5387369 | 07/11/2007 | Diazepam | MD | Congenital Nystagmus, Drug Exposure During Pregnancy, Microcephaly | |||||||||
| 6378094 | 5404757 | 08/01/2007 | Diazepam | OT | Drug Exposure During Pregnancy | Developmental Delay, Drug Exposure During Pregnancy, Foetal Alcohol Syndrome, Microcephaly, Nystagmus | ||||||||
| 6442677 | 5480180 | 10/03/2007 | Diazepam | MD | Drug Exposure During Pregnancy | Astigmatism, Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypermetropia, Microcephaly, Myopia, Nystagmus, Optic Nerve Hypoplasia, Strabismus, Vision Abnormal Neonatal | ||||||||
| 6443571 | 5483176 | 10/05/2007 | Diazepam | Drug Exposure During Pregnancy | Astigmatism, Drug Exposure During Pregnancy, Hypermetropia, Microcephaly, Myopia, Nystagmus, Strabismus | |||||||||
| 6443589 | 5483178 | 10/05/2007 | Diazepam | Drug Exposure During Pregnancy | Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypermetropia, Microcephaly, Myopia, Nystagmus, Optic Nerve Hypoplasia, Strabismus | |||||||||
| M | 6550073 | 5622248 | 11/09/2006 | 02/11/2008 | Valium | MD | Apnoea, Bradycardia, Decreased Activity, Hypotonia, Neonatal Respiratory Distress Syndrome | |||||||
| 6558438 | 5622097 | 02/01/2008 | Diazepam | MD | Anal Atresia, Congenital Anomaly, Drug Exposure During Pregnancy, Hypospadias | |||||||||
| 0 | Days | F | 6452888 | 5499624 | 10/26/2007 | Cercine | MD | Sedation | Neonatal Asphyxia | |||||
| F | 6617100 | 5708241 | 02/01/2007 | 04/17/2008 | Valium | OT | Coarctation of the Aorta, Ventricular Septal Defect | |||||||
| F | 6647792 | 5747710 | 12/18/1979 | 05/23/2008 | Valium | CN | Nervousness | Congenital Anomaly, Cyanosis, Premature Baby | ||||||
| M | 6649664 | 5749875 | 04/08/2008 | 05/27/2008 | Valium | MD | Epilepsy | Bradycardia, Premature Baby | ||||||
| 1 | Hours | M | 4101662 | 4312455 | 02/01/2004 | 03/05/2004 | Valium | CN | Apnoea, Feeding Problem In Newborn, Maternal Drugs Affecting Foetus, Neonatal Apnoeic Attack | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 1 | Hours | 6087989 | 5058088 | 06/12/2006 | 07/21/2006 | Valium | CN | Drug Use for Unknown Indication | Anaemia Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Hypotonia, Neonatal Disorder, Pallor, Respiratory Distress | |||||
| 1 | Hours | 6087989 | 5281788 | 06/12/2006 | 03/30/2007 | Valium | CN | Drug Use for Unknown Indication | Hypotonia, Respiratory Distress | |||||
| 12 | Hours | M | 4193369 | 4429502 | 08/19/2004 | Valium | CN | Drug Exposure During Pregnancy, Foetal Growth Retardation, Neonatal Diabetes Mellitus | ||||||
| 1 | Day | F | 6144103 | 5123768 | 06/15/2006 | 10/10/2006 | Valium | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Hypotonia, Hypotonia Neonatal, Malaise, Somnolence, Somnolence Neonatal | ||||
| 1 | Day | M | 6144103 | 5283737 | 06/15/2006 | 04/02/2007 | Valium | CN | Drug Use for Unknown Indication | Feeding Disorder Neonatal, Hypotonia, Malaise, Somnolence | ||||
| 1 | Day | F | 6217030 | 5196974 | 12/27/2006 | Diazepam | Depression | Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Feeling Jittery, Hypotonia Neonatal, Neonatal Tachypnoea, Poor Sucking Reflex | ||||||
| 1 | Day | F | 6218264 | 5201803 | 01/04/2007 | Diazepam | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Dysphagia, Feeding Disorder Neonatal, Feeling Jittery, Hypotonia Neonatal, Neonatal Disorder, Neonatal Tachypnoea, Poor Sucking Reflex | ||||||
| 6 | Months | 6376940 | 5404078 | 07/31/2007 | Diazepam | Drug Exposure During Pregnancy | Congenital Nystagmus, Developmental Delay, Drug Exposure During Pregnancy, Microcephaly, Visual Disturbance | |||||||
| 6 | Months | 6384615 | 5412617 | 08/09/2007 | Diazepam | Developmental Delay, Drug Exposure During Pregnancy, Nystagmus, Visual Disturbance | ||||||||
| 9 | Months | 6442770 | 5480948 | 10/04/2007 | Diazepam | OT | Developmental Delay, Drug Exposure During Pregnancy, Microcephaly, Nystagmus, Visual Acuity Reduced | |||||||
| 1 | Year | 6378090 | 5404758 | 08/01/2007 | Diazepam | OT | Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Nystagmus, Strabismus | |||||||
| 1 | Year | 6442771 | 5480942 | 10/04/2007 | Diazepam | OT | Drug Exposure During Pregnancy, Nystagmus | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 1 | Year | 6422728 | 5449742 | 09/10/2007 | Diazepam | Drug Exposure During Pregnancy | Developmental Delay, Drug Exposure During Pregnancy, Nystagmus, Posture Abnormal, Strabismus, Visual Acuity Reduced | |||||||
| 1 | Year | 6444062 | 5484428 | 10/10/2007 | Diazepam | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Nystagmus | |||||||
| 3 | Years | 6443601 | 5483180 | 10/05/2007 | Diazepam | OT | Congenital Nystagmus, Drug Exposure During Pregnancy, Nystagmus | |||||||
| 3 | Years | 6624843 | 5705469 | 04/10/2008 | Diazepam | Drug Use for Unknown Indication | Developmental Delay, Drug Exposure During Pregnancy, Drug Interaction, Nystagmus, Posture Abnormal, Refraction Disorder, Strabismus, Visual Acuity Reduced, Visual Disturbance | |||||||
| 3 | Years | 6625369 | 5705474 | 04/11/2008 | Diazepam | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Microcephaly, Nystagmus, Refraction Disorder, Visual Acuity Reduced, Visual Disturbance | |||||||
| 4 | Years | 6361305 | 5387376 | 07/11/2007 | Diazepam | MD | Developmental Delay, Drug Exposure During Pregnancy, Nystagmus | |||||||
| 4 | Years | 6376146 | 5402771 | 07/30/2007 | Diazepam | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Microcephaly, Nystagmus | |||||||
| 4 | Years | 6442759 | 5480943 | 10/04/2007 | Diazepam | OT | Drug Exposure During Pregnancy, Nystagmus | |||||||
| 4 | Years | 6444070 | 5484432 | 10/10/2007 | Diazepam | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Nystagmus | |||||||
| 4 | Years | 6376942 | 5404080 | 07/31/2007 | Diazepam | Drug Exposure During Pregnancy | Congenital Nystagmus, Developmental Delay, Drug Exposure During Pregnancy, Strabismus, Visual Acuity Reduced | |||||||
| 4 | Years | 6376943 | 5404083 | 07/31/2007 | Diazepam | Drug Exposure During Pregnancy | Congenital Nystagmus, Developmental Delay, Drug Exposure During Pregnancy, Posture Abnormal, Strabismus, Visual Acuity Reduced | |||||||
| 4 | Years | 6380513 | 5406948 | 08/02/2007 | Diazepam | Developmental Delay, Drug Exposure During Pregnancy, Nystagmus | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 4 | Years | 6391126 | 5410414 | 08/08/2007 | Diazepam | OT | Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Nystagmus, Strabismus | |||||||
| 8 | Years | 6375645 | 5402833 | 07/30/2007 | Diazepam | Drug Exposure During Pregnancy | Attention Deficit/Hyperactivity Disorder, Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Nystagmus, Posture Abnormal, Visual Acuity Reduced | |||||||
| 8 | Years | 6380515 | 5406950 | 08/02/2007 | Diazepam | Attention Deficit/Hyperactivity Disorder, Developmental Delay, Drug Exposure During Pregnancy, Nystagmus, Visual Acuity Reduced | ||||||||
| 8 | Years | 6443604 | 5483184 | 10/05/2007 | Diazepam | OT | Drug Exposure During Pregnancy, Nystagmus | |||||||
| 9 | Years | 6621101 | 5704234 | 04/09/2008 | Diazem | Drug Use for Unknown Indication | Abnormal Behaviour, Developmental Delay, Drug Exposure During Pregnancy, Drug Interaction, Learning Disorder, Nystagmus, Posture Abnormal, Refraction Disorder, Visual Acuity Reduced | |||||||
| 9 | Years | 6361070 | 5387377 | 07/11/2007 | Diazepam | MD | Abnormal Behaviour, Developmental Delay, Drug Exposure During Pregnancy, Learning Disability, Nystagmus, Visual Disturbance | |||||||
| 9 | Years | 6376938 | 5404075 | 07/31/2007 | Diazepam | Condition Aggravated, Congenital Nystagmus, Developmental Delay, Drug Exposure During Pregnancy, Nystagmus, Visual Acuity Reduced | ||||||||
| 9 | Years | 6443610 | 5483185 | 10/05/2007 | Diazepam | Drug Exposure During Pregnancy | Astigmatism, Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypermetropia, Microcephaly, Myopia, Nystagmus, Optic Nerve Hypoplasia, Posture Abnormal, Strabismus, Visual Acuity Reduced | |||||||
| 27 | Years | F | 6470611 | 5513556 | 08/16/2007 | 11/08/2007 | Diazepam | Drug Exposure During Pregnancy, Drug Interaction, Intra-Uterine Death | ||||||
| 31 | Years | F | 6530406 | 5596058 | 01/18/2008 | Valium | MD | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Intra-Uterine Death | |||||
| 31 | Years | F | 6530406 | 5597617 | 01/21/2008 | Valium | MD | Drug Use for Unknown Indication | Intra-Uterine Death | |||||
| 31 | Years | F | 6586672 | 5656235 | 10/15/2007 | 03/05/2008 | Diazepam | Intervertebral Disc Protrusion | Abortion Spontaneous, Drug Exposure Before Pregnancy | |||||
| 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 | 5839878 | 4717018 | 07/19/2005 | Diazepam | MD | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 31 | Years | F | 6004346 | 4943307 | 03/01/2006 | 03/14/2006 | Valium | MD | Coma, Drug Exposure During Pregnancy, Multiple Drug Overdose Intentional, Suicide Attempt | |||||
| 37 | Years | 6375622 | 5402824 | 07/30/2007 | Diazepam | Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Microcephaly, Nystagmus, Optic Nerve Hypoplasia, Posture Abnormal, Visual Acuity Reduced | ||||||||
| 39 | Years | F | 4152524 | 4375525 | 06/10/2004 | Valium | CN | Epilepsy | Abortion Induced, Maternal Drugs Affecting Foetus, Microcephaly, Talipes | |||||
| 39 | Years | F | 4152524 | 4390263 | 07/06/2004 | Valium | CN | Epilepsy | Abortion Induced, Drug Exposure During Pregnancy, Microcephaly | |||||
| 41 | Years | F | 6428801 | 5458076 | 09/17/2007 | Diazepam | MD | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 41 | Years | F | 6428801 | 5483179 | 10/05/2007 | Diazepam | MD | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 10 Males | 20 Females | 85 Cases (Gender was not reported for 55 Cases) | 91 Individual Safety Reports | |||||||||||
Cercine (diazepam), Diastat (diazepam), Diazem (diazepam), Diazepam (diazepam), Valium (diazepam)
Abdominal Pain, Abdominal Pain Upper, Abnormal Behaviour, Abortion Induced, Abortion Spontaneous, Accident, Activities of Daily Living Impaired, Aggression, Amnesia, Anaemia Neonatal, Anal Atresia, Aortic Stenosis, Apgar Score Low, Apnoea, Arrhythmia Neonatal, Arthralgia, Astigmatism, Attention Deficit/Hyperactivity Disorder, Autism, Autism Spectrum Disorder, Benign Lymph Node Neoplasm, Bone Disorder, Bradycardia, Bradycardia Neonatal, Breech Presentation, Caesarean Section, Cauda Equina Syndrome, Cerebral Haemorrhage Neonatal, Chest Pain, Coarctation of the Aorta, Coma, Complex Regional Pain Syndrome, Complication of Delivery, Complications of Maternal Exposure To Therapeutic Drugs, Condition Aggravated, Congenital Anomaly, Congenital Choroid Plexus Cyst, Congenital Hydrocephalus, Congenital Nose Malformation, Congenital Nystagmus, Constipation, Cyanosis, Decreased Activity, Dependence, Developmental Delay, Disorientation, Drug Abuser, Drug Dependence, Drug Detoxification, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Interaction, Drug Toxicity, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Dysphagia, Dyspnoea, Ear Malformation, Encephalocele, Eye Rolling, Factitious Disorder, Feeding Disorder Neonatal, Feeding Problem In Newborn, Feeling Jittery, Foetal Alcohol Syndrome, Foetal Cardiac Disorder, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate Decreased, Gallbladder Perforation, Gastroschisis, Gliosis, Growth Retardation, Heart Disease Congenital, Heart Rate Decreased, Hepatitis Toxic, Hypermetropia, Hypersomnia, Hypertonia Neonatal, Hyperventilation, Hypoglycaemia, Hypospadias, Hypotonia, Hypotonia Neonatal, Hypoventilation, Iatrogenic Injury, Incorrect Dose Administered, Infant, Inguinal Hernia, Intelligence Test Abnormal, Intra-Uterine Death, Irritability, Learning Disability, Learning Disorder, Legal Problem, Lethargy, Limb Hypoplasia Congenital, Limb Reduction Defect, Lip Disorder, Loss of Consciousness, Lymphadenopathy, Malaise, Maternal Drugs Affecting Foetus, Meconium Increased, Microcephaly, Microgenia, Microphthalmos, Moaning, Multiple Drug Overdose Intentional, Myopia, Neonatal Apnoeic Attack, Neonatal Asphyxia, Neonatal Aspiration, Neonatal Diabetes Mellitus, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Neonatal Tachypnoea, Nystagmus, Optic Nerve Hypoplasia, Pain, Pallor, Peritonitis, Periventricular Leukomalacia, Placental Disorder, Polyhydramnios, Poor Sucking Reflex, Posture Abnormal, Premature Baby, Premature Labour, Premature Rupture of Membranes, Procedural Pain, Psychomotor Skills Impaired, Pupillary Reflex Impaired, Refraction Disorder, Renal Tubular Disorder, Respiratory Disorder Neonatal, Respiratory Distress, Respiratory Failure, Respiratory Rate Decreased, Retinal Detachment, Retinopathy of Prematurity, Skin Atrophy, Skull Malformation, Social Avoidant Behaviour, Somnolence, Somnolence Neonatal, Stereotypic Movement Disorder, Strabismus, Substance Abuse, Suicide Attempt, Talipes, Toothache, Ultrasound Antenatal Screen Abnormal, Urinary Retention, Ventricular Septal Defect, Vision Abnormal Neonatal, Visual Acuity Reduced, Visual Disturbance, Vomiting, Wrong Drug Administered
| Diazepam Adverse Reaction 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. |
| Apgar Score Low | A system of assessing the general physical condition of a newborn infant based on a rating of 0, 1, or 2 for five criteria: heart rate, respiration, muscle tone, skin color, and response to stimuli. The five scores are added together, with a perfect score being 10. The persistence of low Apgar scores at 20 minutes of age is predictive of high rates of morbidity (disease) and mortality (death). (Virginia Apgar (19091974), American physician) |
| Arrhythmia | An arrhythmia is an abnormality in the heart's rhythm, or heartbeat pattern. The heartbeat can be too slow, too fast, have extra beats, skip a beat, or otherwise beat irregularly. |
| Cauda Equina Syndrome | A serious neurologic condition in which there is acute loss of function of the neurologic elements (nerve roots) of the spinal canal below the termination of the spinal cord. |
| Coarctation of the Aorta | A defect that develops in the fetus in which there is a narrowing of the aortic arch, the main blood artery that delivers blood from the left ventricle of the heart to the rest of the body. |
| Congenital | A physical abnormality that is present at birth. |
| Congenital Anomaly | Medical term for a birth defect which is a physical abnormality that is present at birth; they are also called congenital abnormalities. When multiple birth defects occur together and have a similar cause, they are called syndromes (e.g. Cauda Equina Syndrome, Drug Withdrawal Syndrome Neonatal). |
| Congenital Nystagmus | Rhythmic, oscillating motions of the eyes are called nystagmus. The to-and-fro motion is generally involuntary. Vertical nystagmus occurs much less frequently than horizontal nystagmus and is often, but not necessarily, a sign of serious brain damage. Nystagmus can be a normal physiological response or a result of a pathologic problem. |
| 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] |
| Dysphagia | Difficulty in swallowing. |
| Dyspnoea | Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath. Also called air hunger. |
| Encephalocele | Hernia (bulge or protrusion) of the brain through a congenital or traumatic opening in the cranium. |
| Gastroschisis | A congenital fissure (split or crack) in the abdominal wall usually accompanied by protrusion of the viscera (intestines). Also called celoschisis. |
| Hypermetropia | An abnormal condition of the eye in which vision is better for distant objects than for near objects. It results from the eyeball being too short from front to back, causing images to be focused behind the retina. |
| Hypoplasia | The incomplete or arrested development of an organ or part (Limb Hypoplasia, Optic Nerve Hypoplasia). |
| Hypospadias | In males, a congenital anomaly in which the urethra (the canal through which urine is discharged from the bladder) opens on the ventral (lower) surface of the penis or in the perineum (area between scrotum and anus), or in females, the urethra opens into the vagina. |
| Hypotonia | Decease of normal tonicity (normal firmness or functional readiness in body tissues or organs) or tension. |
| Microcephaly | Abnormal smallness of the head. |
| Myopia | A visual defect in which distant objects appear blurred because their images are focused in front of the retina rather than on it; nearsightedness. Also called short sight. |
| Neonatal Asphyxia | A condition in which an extreme decrease in the concentration of oxygen in the body accompanied by an increase in the concentration of carbon dioxide leads to loss of consciousness or death. |
| Nystagmus | Rhythmic, oscillating motions of the eyes are called nystagmus. The to-and-fro motion is generally involuntary. Vertical nystagmus occurs much less frequently than horizontal nystagmus and is often, but not necessarily, a sign of serious brain damage. Nystagmus can be a normal physiological response or a result of a pathologic problem. |
| Periventricular Leukomalacia | A brain condition affecting fetuses and newborns in which there is softening, dysfunction, and death of the white matter of the brain. |
| Premature Baby | Birth less than 37 weeks after conception. Infants born as early as 23 – 24 weeks may survive but many face lifelong disabilities (e.g., cerebral palsy, blindness, deafness). Premature infants account for 8 9% of live births but two-thirds of infant deaths. |
| Optic Nerve Hypoplasia | During the second month of pregnancy, a structure called the optic stalk develops into a pair of optic nerve bundles. These bundles, which are designed to send signals from the eyes to the occipital lobe of the brain, naturally undergo pruning as the fetus develops. In some individuals, however, either this pruning process is too complete, or the nerves simply fail to develop fully. Such an occurrence causes a congenital condition called optic nerve hypoplasia (ONH). |
| Strabismus | Strabismus is a condition in which the eyes do not point in the same direction. It can also be referred to as a tropia or squint. |
| Talipes | Clubfoot is a condition in which one or both feet are twisted into an abnormal position at birth. The condition is also known as talipes. |
| Ventricular Septal Defect | A ventricular septal defect is a hole in the wall of the heart (septum) that separates the left lower chamber (left ventricle) from the right lower chamber (right ventricle). The hole allows blood to flow from the left ventricle to the right ventricle instead of entering the aorta for distribution throughout the body. This blood recycles through the lungs before returning to the left ventricle. This results in less oxygenated blood reaching the body. If the hole is sufficiently large, the lack of oxygen being delivered to the body can cause severe problems, including heart failure and breathlessness. |
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 Diazepam 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".