Diazepam - 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
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

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

Cercine (diazepam), Diastat (diazepam), Diazem (diazepam), Diazepam (diazepam), Valium (diazepam)

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

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 (1909–1974), 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 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 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".