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 | ||||
| F | 3781358 | 5056304 | 01/01/1996 | 07/17/2006 | 09/09/1996 | Xanax | MD | Drug Use for Unknown Indication | Blood Pressure Decreased, Bradycardia Neonatal, Caesarean Section, Congenital Anomaly, Congenital Tricuspid Valve Atresia, Cyanosis, Drug Exposure During Pregnancy, Heart Disease Congenital, Malaise, Maternal Condition Affecting Foetus, Metabolic Acidosis, Oedema Neonatal, Pallor, Premature Baby, Pulmonary Vascular Disorder, Ventricular Fibrillation | |||||
| F | 3781358 | 5076367 | 01/01/1996 | 08/07/2006 | 09/09/1996 | Xanax | MD | Drug Use for Unknown Indication | Anaemia, Apgar Score Low, Blood Culture Positive, Blood Pressure Decreased, Bradycardia Neonatal, Caesarean Section, Cardiac Murmur, Congenital Tricuspid Valve Atresia, Corynebacterium Infection, Cyanosis Neonatal, Death Neonatal, Diabetes Complicating Pregnancy, Drug Exposure During Pregnancy, Glycosylated Haemoglobin Increased, Heart Disease Congenital, Hyperthermia, Malaise, Metabolic Acidosis, Oedema Neonatal, Pallor, Persistent Foetal Circulation, Pre-Eclampsia, Premature Baby, Staphylococcal Infection, Unevaluable Event, Ventricular Fibrillation | |||||
| F | 3781358 | 5080702 | 08/09/2006 | 09/09/1996 | Xanax | OT | Drug Use for Unknown Indication | Apgar Score Low, Bradycardia Neonatal, Caesarean Section, Congenital Anomaly, Congenital Tricuspid Valve Atresia, Cyanosis Neonatal, Death Neonatal, Drug Exposure During Pregnancy, Heart Disease Congenital, Malaise, Maternal Condition Affecting Foetus, Metabolic Acidosis, Neonatal Disorder, Neonatal Hypotension, Oedema Neonatal, Oxygen Saturation Decreased, Pallor, Patent Ductus Arteriosus, Premature Baby, Small for Dates Baby, Ventricular Fibrillation | ||||||
| 3970335 | 4780376 | 04/01/2002 | 09/26/2005 | Xanax | MD | Borderline Personality Disorder | Congenital Hand Malformation, Drug Exposure During Pregnancy, Neonatal Disorder, Syndactyly | |||||||
| F | 4019871 | 4395915 | 09/02/2003 | 07/07/2004 | Xanax | MD | Apert's Syndrome, Congenital Anomaly, Congenital Hand Malformation, Congenital Musculoskeletal Anomaly, Drug Exposure During Pregnancy, Echography Abnormal | |||||||
| F | 4089983 | 4288541 | 11/30/2003 | 02/05/2004 | Xanax | MD | Abortion Induced, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Urinary Tract Malformation | |||||||
| F | 4089983 | 4293037 | 11/30/2003 | 02/10/2004 | Xanax | MD | Chromosome Abnormality, Congenital Bladder Anomaly, Maternal Drugs Affecting Foetus, Urinary Tract Malformation | |||||||
| F | 4127795 | 4338138 | 06/25/2003 | 04/07/2004 | Xanax | MD | Depression | Drug Exposure During Pregnancy, Polyhydramnios | ||||||
| F | 4129408 | 4340418 | 09/19/2003 | 04/14/2004 | Xanax | OT | Bradycardia Neonatal, Drug Exposure During Pregnancy | |||||||
| F | 4132797 | 4345401 | 03/01/2004 | 04/21/2004 | Frontal | CN | Anxiety | Complications of Maternal Exposure To Therapeutic Drugs, Genital Discharge, Intra-Uterine Death | ||||||
| 4132856 | 4345438 | 04/21/2004 | Frontal | CN | Anxiety | Drug Exposure During Pregnancy, Intra-Uterine Death, Multiple Congenital Abnormalities | ||||||||
| M | 5723785 | 4556994 | 01/18/2005 | Xanax | MD | Ill-Defined Disorder | Apgar Score Low, Deformity Thorax, Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Foetal Growth Retardation, Growth Retardation, Hypertonia Neonatal, Hypotonia Neonatal, Irritability, Small for Dates Baby, Tricuspid Valve Incompetence | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 5723785 | 4562658 | 01/24/2005 | Xanax | MD | Ill-Defined Disorder | Apgar Score Low, Caesarean Section, Cardiac Disorder, Cardiac Failure, Drug Exposure During Pregnancy, Foetal Disorder, Foetal Growth Retardation, Hypertonia Neonatal, Hypotonia Neonatal, Irritability, Neonatal Apnoeic Attack, Neonatal Disorder, Oligohydramnios, Patent Ductus Arteriosus, Placental Disorder, Premature Baby, Tricuspid Valve Incompetence, Ultrasound Antenatal Screen Abnormal | |||||||
| 5728570 | 4562674 | 01/24/2005 | Alprazolam | PH | Ill-Defined Disorder | Drug Exposure During Pregnancy, Rhabdomyolysis | ||||||||
| M | 5728570 | 4634366 | 01/10/2005 | 04/11/2005 | Alprazolam | MD | Congenital Anomaly, Dehydration, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Problem In Newborn, Infection, Muscle Disorder, Rhabdomyolysis, Somnolence | |||||||
| M | 5728570 | 4708765 | 07/05/2005 | Alprazolam | MD | Anxiety | Congenital Anomaly, Decreased Activity, Dehydration, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Muscular Dystrophy, Neonatal Disorder, Neonatal Infection, Rhabdomyolysis, Somnolence Neonatal, Stress, Weight Decrease Neonatal | |||||||
| 5739182 | 4574752 | 02/04/2005 | Xanax | MD | Anxiety | Drug Exposure During Pregnancy, Heart Disease Congenital | ||||||||
| 5758776 | 4600379 | 03/04/2005 | Alprazolam | MD | Depression | Developmental Delay, Drug Exposure During Pregnancy | ||||||||
| 5758776 | 4616406 | 03/21/2005 | Xanax | MD | Anxiety, Depression | Developmental Delay, Drug Exposure During Pregnancy | ||||||||
| F | 5759340 | 4603333 | 01/01/2004 | 03/08/2005 | Alprazolam | PH | Ill-Defined Disorder | Drug Exposure During Pregnancy, Intestinal Atresia | ||||||
| 5791304 | 4650321 | 04/28/2005 | Xanax | OT | Drug Exposure During Pregnancy, Premature Baby, Small for Dates Baby | |||||||||
| 5829193 | 4698248 | 06/21/2005 | Xanax | PH | Drug Exposure During Pregnancy, Foetal Movements Decreased | |||||||||
| 5830741 | 4699380 | 06/22/2005 | Alprazolam | Drug Exposure During Pregnancy, Ventricular Septal Defect | ||||||||||
| 5837618 | 4709210 | 07/05/2005 | Xanax | Ill-Defined Disorder | Congenital Neurological Disorder, 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 | ||||
| M | 5837690 | 4709168 | 07/05/2005 | Xanax | CN | Ill-Defined Disorder | Attention Deficit Hyperactivity Disorder, Drug Exposure During Pregnancy | |||||||
| 5838273 | 4709253 | 07/05/2005 | Xanax | Ill-Defined Disorder | Atypical Attention Deficit Syndrome, Congenital Neurological Disorder, Drug Exposure During Pregnancy | |||||||||
| 5838277 | 4709256 | 07/05/2005 | Xanax | Ill-Defined Disorder | Atypical Attention Deficit Syndrome, Drug Exposure During Pregnancy | |||||||||
| M | 5840599 | 4713507 | 01/01/2003 | 07/11/2005 | Xanax | MD | Depression | Abnormal Behaviour, Bone Development Abnormal, Cerebral Atrophy Congenital, Congenital Anomaly, Congenital Hair Disorder, Congenital Nail Disorder, Drug Exposure During Pregnancy, Epilepsy Congenital, Facial Dysmorphism, Flat Feet, Karyotype Analysis Abnormal, Late Developer, Psychomotor Retardation, Skin Hypoplasia, Skin Malformation | ||||||
| M | 5840599 | 4733622 | 01/01/2003 | 07/29/2005 | Xanax | MD | Depression | Abnormal Behaviour, Atrophy, Bone Development Abnormal, Congenital Central Nervous System Anomaly, Congenital Hair Disorder, Congenital Nail Disorder, Developmental Coordination Disorder, Developmental Delay, Drug Exposure During Pregnancy, Epilepsy, Facial Dysmorphism, Flat Feet, Growth Retardation, Karyotype Analysis Abnormal, Multiple Congenital Abnormalities, Phalangeal Hypoplasia, Skin Malformation, Toe Deformity | ||||||
| 5930613 | 4699380 | 06/22/2005 | Alprazolam | Drug Exposure During Pregnancy, Ventricular Septal Defect | ||||||||||
| 5953451 | 4865831 | 01/01/2005 | 12/20/2005 | Alprazolam | MD | Ill-Defined Disorder | Caesarean Section, Drug Exposure During Pregnancy, Neonatal Asphyxia, Neonatal Respiratory Depression | |||||||
| M | 5953451 | 4868782 | 01/01/2005 | 12/23/2005 | Alprazolam | MD | Ill-Defined Disorder | Apgar Score Low, Caesarean Section, Drug Exposure During Pregnancy, Neonatal Asphyxia, Neonatal Respiratory Depression | ||||||
| M | 5953451 | 4911046 | 01/01/2005 | 02/09/2006 | Alprazolam | MD | Ill-Defined Disorder | Apgar Score Low, Caesarean Section, Drug Exposure During Pregnancy, Neonatal Asphyxia, Neonatal Respiratory Depression | ||||||
| F | 5972809 | 4887482 | 01/18/2006 | Xanax | MD | Ill-Defined Disorder | Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Dysphagia, Feeding Disorder Neonatal, Neonatal Disorder, Tremor Neonatal | |||||||
| F | 6073887 | 5030524 | 06/15/2006 | Alprazolam | Ill-Defined Disorder | Deafness Unilateral, Drug Exposure During Pregnancy, Fluid Retention, Hypersensitivity, Myocardial Infarction | ||||||||
| F | 6145915 | 5126031 | 05/03/2006 | 10/12/2006 | Xanax | OT | Bipolar Disorder | Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Oxygen Saturation Decreased, Placenta Praevia, Premature Baby, Respiratory Distress | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 6204544 | 5177383 | 01/01/2005 | 12/07/2006 | Xanax | OT | Anorectal Disorder, Apgar Score Low, Drug Exposure During Pregnancy, Gastrointestinal Malformation | |||||||
| F | 6268108 | 5273148 | 01/01/2006 | 03/22/2007 | Xanax | OT | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia, Tremor Neonatal | |||||||
| F | 6268108 | 5307526 | 01/01/2006 | 04/25/2007 | Xanax | OT | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia, Tremor Neonatal | |||||||
| M | 6274972 | 5280840 | 03/29/2007 | Alprazolam | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Muscular Dystrophy, Rhabdomyolysis | |||||||||
| F | 6276568 | 5282257 | 01/01/2005 | 03/30/2007 | Frontal | OT | Anxiety | Breast Cyst, Chromosome Abnormality, Pain | ||||||
| F | 6276568 | 5285229 | 01/01/2004 | 04/03/2007 | Frontal | OT | Anxiety | Chromosome Abnormality, Pain, Weight Increased | ||||||
| M | 6282013 | 5289524 | 01/01/2004 | 04/06/2007 | Solanax | Congenital Anomaly, Decreased Activity, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeding Disorder, Muscular Dystrophy, Rhabdomyolysis, Somnolence, Stress, Weight Decreased | ||||||||
| M | 6282013 | 5473613 | 01/01/2004 | 10/01/2007 | Alprazolam | Congenital Anomaly, Decreased Activity, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeding Disorder, Muscular Dystrophy, Rhabdomyolysis, Somnolence, Stress, Weight Decreased | ||||||||
| M | 6320882 | 5335603 | 01/01/2005 | 05/26/2007 | Xanax | MD | Depression | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | ||||||
| M | 6324779 | 5342718 | 06/01/2007 | Alprazolam | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | |||||||||
| M | 6324779 | 5411579 | 08/10/2007 | Alprazolam | Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia, Hypertonia Neonatal, Irritability, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Sepsis Neonatal, Streptococcal Infection | |||||||||
| M | 6331260 | 5341409 | 05/30/2007 | Alprazolam | Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Irritability, Neonatal Respiratory Distress Syndrome, Sepsis Neonatal, Streptococcal Infection | |||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 6341997 | 5369581 | 06/25/2007 | Alprazolam | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Irritability, Neonatal Respiratory Distress Syndrome, Sepsis Neonatal | |||||||||
| M | 6367015 | 5397006 | 07/25/2007 | Alprazolam | Anxiety | Drug Withdrawal Syndrome Neonatal, Hypertonia, Irritability, Respiratory Distress, Sepsis Neonatal | ||||||||
| 6367355 | 5387134 | 07/11/2007 | Alprazolam | MD | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Respiratory Distress Syndrome, Sepsis Neonatal, Vertical Infection Transmission | |||||||||
| M | 6375219 | 5403481 | 07/30/2007 | Alprazolam | Abnormal Labour Affecting Foetus, Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Irritability, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Sepsis Neonatal, Streptococcal Sepsis, Vertical Infection Transmission | |||||||||
| M | 6381554 | 5409059 | 08/06/2007 | Alprazolam | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | ||||||||
| M | 6385331 | 5415477 | 08/08/2007 | Alprazolam | Drug Exposure During Pregnancy | Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Group B Streptococcus Neonatal Sepsis, Hypertonia Neonatal, Irritability, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Premature Rupture of Membranes, Sepsis Neonatal | ||||||||
| F | 6407699 | 5445179 | 01/01/2007 | 09/06/2007 | Alprazolam | MD | Abortion | |||||||
| F | 6407699 | 5454353 | 01/01/2007 | 09/17/2007 | Alprazolam | MD | Abortion | |||||||
| F | 6426338 | 5466282 | 09/24/2007 | Xanax | MD | Anxiety | Abortion Spontaneous, Rash Pruritic | |||||||
| 6430783 | 5472027 | 09/28/2007 | Alprazolam | PH | Drug Exposure During Pregnancy, Hypotonia Neonatal, Respiratory Disorder Neonatal | |||||||||
| F | 6463094 | 5511900 | 11/09/2007 | Alprazolam | CN | Abasia, Amnesia, Cardiac Arrest, Cardiac Disorder, Depression, Drug Exposure During Pregnancy, Malaise, Muscle Disorder, Nervous System Disorder, Physical Disability, Reproductive Tract Disorder | ||||||||
| 6463096 | 5511902 | 11/09/2007 | Alprazolam | CN | Death, 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 | 6473624 | 5524250 | 07/30/2007 | 11/21/2007 | Xanax | OT | Anxiety | Drug Exposure During Pregnancy, Ductus Arteriosus Premature Closure | ||||||
| M | 6473721 | 5524340 | 11/01/2007 | 11/21/2007 | Solanax | MD | Drug Exposure During Pregnancy, Feeding Disorder Neonatal | |||||||
| F | 6473721 | 5577792 | 10/30/2007 | 12/31/2007 | Solanax | MD | Postpartum Depression | Aspartate Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Decreased Activity, Drug Exposure During Pregnancy, Feeding Disorder, Foetal Distress Syndrome, Hypertonia, Irritability, Leukocytosis, Meconium Stain, Neonatal Disorder, Pyrexia, Thrombocythaemia, Tremor | ||||||
| M | 6476534 | 5528327 | 05/29/2006 | 11/28/2007 | Xanax | MD | Drug Exposure During Pregnancy, Hypoglycaemia Neonatal | |||||||
| F | 6478867 | 5531143 | 01/01/2007 | 11/30/2007 | Xanax | CN | Anxiety | Abdominal Pain, Abortion Spontaneous, Anxiety, Drug Withdrawal Syndrome, Eructation, Irritable Bowel Syndrome, Muscle Spasms, Muscle Tightness, Paraesthesia | ||||||
| 6562411 | 5639334 | 01/18/2006 | 02/26/2008 | Xanax | MD | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Tremor | ||||||||
| F | 6562428 | 5639363 | 03/01/2006 | 02/26/2008 | Xanax | MD | Drug Dependence | Drug Exposure During Pregnancy, Foetal Growth Retardation | ||||||
| F | 6565304 | 5643662 | 01/01/2007 | 02/28/2008 | Xanax | MD | Anxiety Disorder | Drug Exposure During Pregnancy, Foetal Growth Retardation | ||||||
| M | 6590926 | 5676359 | 01/07/2007 | 03/21/2008 | Xanax | MD | Depression | Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Premature Baby | ||||||
| M | 6626854 | 5707867 | 04/14/2008 | Alprazolam | Drug Exposure During Pregnancy | Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hypertonia Neonatal, Irritability, Neonatal Disorder, Neonatal Infection, Neonatal Respiratory Distress Syndrome, Premature Rupture of Membranes, Respiratory Distress, Sepsis, Streptococcal Infection | ||||||||
| M | 6631709 | 5726849 | 01/01/2006 | 05/02/2008 | Xanax | OT | Drug Exposure During Pregnancy, Dysmorphism, Microcephaly | |||||||
| M | 6631783 | 5726920 | 02/04/2008 | 05/02/2008 | Xanax | OT | Abdominal Distension, Abdominal Pain, Agitation, Anxiety, Drug Exposure During Pregnancy, Hypoglycaemia, Tremor | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 6631783 | 5733855 | 02/04/2008 | 05/09/2008 | Xanax | OT | Abdominal Distension, Abdominal Pain, Agitation, Anxiety, Drug Exposure During Pregnancy, Hypertonia, Hypoglycaemia, Tremor | |||||||
| 6637447 | 5734042 | 04/01/2008 | 05/09/2008 | Solanax | PH | Drug Exposure During Pregnancy, Gastrointestinal Haemorrhage | ||||||||
| F | 6637447 | 5756228 | 04/01/2008 | 06/02/2008 | Solanax | MD | Borderline Personality Disorder | Drug Exposure During Pregnancy, Melaena Neonatal, Weight Gain Poor | ||||||
| M | 6640253 | 5738127 | 02/14/2008 | 05/14/2008 | Xanax | OT | Cyanosis, Drug Exposure During Pregnancy, Hypertonia, Hypotonia Neonatal, Nystagmus, Poor Sucking Reflex, Skull Malformation | |||||||
| M | 6640253 | 5741008 | 01/01/2007 | 05/16/2008 | Xanax | OT | Atrial Septal Defect, Cyanosis, Drug Exposure During Pregnancy, Hypertonia, Hypotonia Neonatal, Nystagmus, Poor Sucking Reflex, Skull Malformation | |||||||
| F | 6661649 | 5793916 | 04/25/2008 | 06/27/2008 | Xanax | MD | Anxiety | Abortion Missed | ||||||
| 1 | Day | F | 4005815 | 4344330 | 08/19/2003 | 04/19/2004 | Xanax | OT | Cardio-Respiratory Arrest Neonatal, Drug Exposure During Pregnancy, Foetal Arrhythmia, Forceps Delivery, Regurgitation of Food, Somnolence Neonatal | |||||
| 1 | Day | M | 4064368 | 4264642 | 12/06/2003 | 01/02/2004 | Alprazolam | Panic Disorder | Apgar Score Abnormal, Cyanosis Central, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypersensitivity, Hypopnoea, Hypotonia, Irritability, Muscle Twitching, Neonatal Apnoeic Attack, Therapeutic Agent Toxicity | |||||
| 1 | Day | M | 4064368 | 4288543 | 12/06/2003 | 02/05/2004 | Alprazolam | Panic Disorder | Apgar Score Low, Cyanosis Central, Drug Toxicity, Drug Withdrawal Syndrome, Heart Rate Increased, Hypersensitivity, Hypopnoea, Hypotonia, Hypotonia Neonatal, Irritability, Maternal Drugs Affecting Foetus, Muscle Twitching, Neonatal Apnoeic Attack | |||||
| 1 | Day | F | 4127847 | 4338323 | 10/14/2003 | 04/07/2004 | Xanax | MD | Depression | Agitation, Anorectal Disorder, Caesarean Section, Developmental Delay, Drug Exposure During Pregnancy, Feeding Problem In Newborn, Gastric Disorder, High Arched Palate, Hypertonia, Hypotonia, Irritability, Laryngomalacia, Leukopenia, Microcephaly, Monocytosis, Neonatal Disorder, Nervous System Disorder, Oesophagitis, Polyhydramnios, Poor Sucking Reflex, Sedation, Stridor, Tachypnoea, Viral Infection | ||||
| 1 | Day | F | 4131734 | 4344334 | 06/17/2003 | 04/19/2004 | Xanax | OT | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Growth Retardation, Hypertonia Neonatal, Neonatal Disorder, Tremor Neonatal | |||||
| 1 | Day | F | 4213873 | 4450269 | 09/01/2004 | 09/14/2004 | Alprazolam | PH | Panic Disorder | Drug Exposure During Pregnancy, Respiratory Disorder Neonatal | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 1 | Day | F | 4213873 | 4466153 | 09/01/2004 | 09/30/2004 | Alprazolam | PH | Panic Disorder | Anaesthetic Complication, Caesarean Section, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Disorder, Neonatal Respiratory Acidosis, Neonatal Respiratory Arrest, Oliguria, Respiratory Disorder Neonatal | ||||
| 1 | Day | 5728570 | 4567784 | 01/13/2005 | 01/27/2005 | Alprazolam | PH | Ill-Defined Disorder | Drug Exposure During Pregnancy, Neonatal Disorder, Rhabdomyolysis | |||||
| 1 | Day | M | 5728570 | 4585441 | 01/10/2005 | 02/14/2005 | Alprazolam | PH | Ill-Defined Disorder | Congenital Anomaly, Dehydration, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Problem In Newborn, Neonatal Disorder, Neonatal Infection, Rhabdomyolysis, Somnolence Neonatal | ||||
| 1 | Day | M | 5728570 | 4594850 | 01/12/2005 | 02/23/2005 | Alprazolam | PH | Anxiety | Anxiety, Drug Exposure During Pregnancy, No Reaction On Previous Exposure To Drug | ||||
| 1 | Day | M | 5881374 | 4767761 | 08/25/2005 | 09/12/2005 | Alprazolam | MD | Ill-Defined Disorder | Convulsion Neonatal, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Hypertonia Neonatal, Stridor | ||||
| 1 | Day | M | 5881374 | 4781471 | 09/27/2005 | Alprazolam | MD | Ill-Defined Disorder | Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Gaze Palsy, Hypertonia Neonatal, Joint Hyperextension, Opisthotonus, Stridor, Tremor | |||||
| 1 | Day | M | 6062646 | 5018185 | 02/04/2006 | 05/30/2006 | Xanax | MD | Anxiety | Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease | ||||
| 1 | Day | M | 6150276 | 5127346 | 05/04/2005 | 10/10/2006 | Xanax | OT | Coagulopathy, Congenital Mitral Valve Incompetence, Heart Disease Congenital | |||||
| 1 | Day | F | 6180528 | 5158841 | 08/07/2006 | 11/17/2006 | Xanax | OT | Bipolar Disorder | Agitation Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Respiratory Distress Syndrome, Premature Baby | ||||
| 1 | Day | M | 6205298 | 5179779 | 06/15/2006 | 12/12/2006 | Xanax | OT | Agitation Neonatal, Amniocentesis Abnormal, Cleft Palate, Congenital Hearing Disorder, Congenital Jaw Malformation, Drug Effect Decreased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Micrognathia, Neonatal Respiratory Distress Syndrome, Paresis, Pierre Robin Syndrome, Pilonidal Cyst Congenital, Retrognathia | |||||
| 1 | Month | M | 5864017 | 4743874 | 01/01/2004 | 08/09/2005 | Xanax | MD | Ill-Defined Disorder | Convulsion Neonatal, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Hyperbilirubinaemia Neonatal, Hypertonia Neonatal, Hypotonia Neonatal, Neonatal Disorder, Pain, Sleep Disorder, Tension, Vomiting Neonatal, Weight Decrease Neonatal | ||||
| 1 | Year | M | 5798570 | 4659600 | 05/10/2005 | Xanax | MD | Cleft Uvula, Drug Exposure During Pregnancy, Epiphyseal Disorder, Glossoptosis, Multiple Congenital Abnormalities, Pierre Robin Syndrome, Talipes, Ventricular Septal Defect | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 22 | Years | F | 5716435 | 4547142 | 01/01/2004 | 01/05/2005 | Xanax | MD | Anxiety | Convulsion, Drug Exposure During Pregnancy, Pelvic Inflammatory Disease, Tooth Abscess | ||||
| 22 | Years | F | 5716435 | 4568081 | 01/01/2003 | 01/28/2005 | Xanax | MD | Anxiety | Drug Exposure During Pregnancy, Drug Withdrawal Convulsions, Pelvic Inflammatory Disease, Tooth Abscess | ||||
| 22 | Years | F | 5716435 | 4616409 | 01/01/2003 | 03/21/2005 | Xanax | MD | Anxiety | Convulsion, Drug Exposure During Pregnancy, Infection, Pelvic Inflammatory Disease, Tooth Abscess | ||||
| 27 | Years | F | 6586173 | 5669817 | 01/02/2007 | 03/17/2008 | Xanax | MD | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 30 | Years | M | 4072602 | 4274024 | 10/03/2003 | 01/15/2004 | Xanax | OT | Agitation Neonatal, Anxiety, Caesarean Section, Carbohydrate Metabolism Disorder, Facial Dysmorphism, Feeding Problem In Newborn, Foetal Cardiac Disorder, Irritability, Maternal Drugs Affecting Foetus, Neonatal Disorder, Premature Baby, Sleep Disorder, Tremor Neonatal | |||||
| 30 | Years | F | 5779171 | 4640995 | 04/21/2005 | Alprazolam | Drug Exposure During Pregnancy, Premature Labour | |||||||
| 30 | Years | F | 5787438 | 4642994 | 04/21/2005 | Alprazolam | Drug Exposure During Pregnancy, Premature Labour | |||||||
| 31 | Years | F | 5779169 | 4640992 | 04/21/2005 | Alprazolam | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| 31 | Years | F | 5787454 | 4642996 | 04/21/2005 | Alprazolam | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| 31 | Years | F | 6132173 | 5103123 | 06/01/2005 | 09/08/2006 | Xanax | MD | Anxiety, Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 32 | Years | F | 5663696 | 4493175 | 10/29/2004 | Xanax | OT | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||
| 33 | Years | F | 5953402 | 4865768 | 10/12/2005 | 12/20/2005 | Alprazolam | MD | Dysthymic Disorder | Caesarean Section, 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 | ||||
| 33 | Years | F | 5953402 | 4868751 | 10/12/2005 | 12/23/2005 | Alprazolam | MD | Dysthymic Disorder | Apgar Score Low, Caesarean Section, Drug Exposure During Pregnancy, Neonatal Asphyxia, Neonatal Respiratory Depression | ||||
| 33 | Years | F | 5953402 | 4909986 | 10/12/2005 | 02/08/2006 | Alprazolam | MD | Dysthymic Disorder | Caesarean Section, Drug Exposure During Pregnancy | ||||
| 35 | Years | F | 5723811 | 4556581 | 04/01/2003 | 01/18/2005 | Alprazolam | OT | Tremor | Abdominal Pain Upper, Cholecystectomy, Drug Exposure During Pregnancy, Vomiting | ||||
| 35 | Years | F | 5723811 | 4640005 | 04/01/2003 | 04/18/2005 | Xanax | OT | Abdominal Pain Upper, Cholecystectomy, Drug Exposure During Pregnancy, Premature Baby, Small for Dates Baby, Vomiting, Weight Increased | |||||
| 35 | Years | F | 6661649 | 5764468 | 04/25/2008 | 06/10/2008 | Xanax | MD | Anxiety | Abortion Missed | ||||
| 36 | Years | F | 5852986 | 4728142 | 05/01/2005 | 07/27/2005 | Alprazolam | MD | Anxiety, Suicide Attempt | Drug Exposure During Pregnancy, Overdose | ||||
| 37 | Years | F | 6331139 | 5341411 | 05/30/2007 | Alprazolam | Anxiety | Caesarean Section, Drug Exposure During Pregnancy, Premature Rupture of Membranes | ||||||
| 37 | Years | F | 5758285 | 4600507 | 11/01/2004 | 03/04/2005 | Xanax | MD | Insomnia | Abortion Induced, Drug Exposure During Pregnancy, Drug Tolerance Increased, Drug Withdrawal Syndrome | ||||
| 29 Males | 38 Females | 85 Cases (Gender was not reported for 18 Cases) | 116 Individual Safety Reports | |||||||||||
Alprazolam (alprazolam), Frontal (alprazolam), Solanax (alprazolam), Xanax (alprazolam)
Abasia, Abdominal Distension, Abdominal Pain, Abdominal Pain Upper, Abnormal Behaviour, Abnormal Labour Affecting Foetus, Abortion, Abortion Induced, Abortion Missed, Abortion Spontaneous, Agitation, Agitation Neonatal, Amnesia, Amniocentesis Abnormal, Anaemia, Anaesthetic Complication, Anorectal Disorder, Anxiety, Apert's Syndrome, Apgar Score Abnormal, Apgar Score Low, Aspartate Aminotransferase Increased, Atrial Septal Defect, Atrophy, Attention Deficit Hyperactivity Disorder, Atypical Attention Deficit Syndrome, Blood Culture Positive, Blood Lactate Dehydrogenase Increased, Blood Pressure Decreased, Bone Development Abnormal, Bradycardia Neonatal, Breast Cyst, Caesarean Section, Carbohydrate Metabolism Disorder, Cardiac Arrest, Cardiac Disorder, Cardiac Failure, Cardiac Murmur, Cardio-Respiratory Arrest Neonatal, Cerebral Atrophy Congenital, Cholecystectomy, Chromosome Abnormality, Cleft Palate, Cleft Uvula, Coagulopathy, Complications of Maternal Exposure To Therapeutic Drugs, Congenital Anomaly, Congenital Bladder Anomaly, Congenital Central Nervous System Anomaly, Congenital Hair Disorder, Congenital Hand Malformation, Congenital Hearing Disorder, Congenital Jaw Malformation, Congenital Mitral Valve Incompetence, Congenital Musculoskeletal Anomaly, Congenital Nail Disorder, Congenital Neurological Disorder, Congenital Tricuspid Valve Atresia, Convulsion, Convulsion Neonatal, Corynebacterium Infection, Cyanosis, Cyanosis Central, Cyanosis Neonatal, Deafness Unilateral, Death, Death Neonatal, Decreased Activity, Deformity Thorax, Dehydration, Depression, Developmental Coordination Disorder, Developmental Delay, Diabetes Complicating Pregnancy, Drug Effect Decreased, Drug Exposure During Pregnancy, Drug Tolerance Increased, Drug Toxicity, Drug Withdrawal Convulsions, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Ductus Arteriosus Premature Closure, Dysmorphism, Dysphagia, Echography Abnormal, Epilepsy, Epilepsy Congenital, Epiphyseal Disorder, Eructation, Facial Dysmorphism, Feeding Disorder, Feeding Disorder Neonatal, Feeding Problem In Newborn, Flat Feet, Fluid Retention, Foetal Arrhythmia, Foetal Cardiac Disorder, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Movements Decreased, Forceps Delivery, Gastric Disorder, Gastrointestinal Haemorrhage, Gastrointestinal Malformation, Gastrooesophageal Reflux Disease, Gaze Palsy, Genital Discharge, Glossoptosis, Glycosylated Haemoglobin Increased, Group B Streptococcus Neonatal Sepsis, Growth Retardation, Heart Disease Congenital, Heart Rate Increased, High Arched Palate, Hyperbilirubinaemia Neonatal, Hypersensitivity, Hyperthermia, Hypertonia, Hypertonia Neonatal, Hypoglycaemia, Hypoglycaemia Neonatal, Hypopnoea, Hypotonia, Hypotonia Neonatal, Infantile Apnoeic Attack, Infection, Intestinal Atresia, Intra-Uterine Death, Irritability, Irritable Bowel Syndrome, Joint Hyperextension, Karyotype Analysis Abnormal, Laryngomalacia, Late Developer, Leukocytosis, Leukopenia, Malaise, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Meconium Stain, Melaena Neonatal, Metabolic Acidosis, Microcephaly, Micrognathia, Monocytosis, Multiple Congenital Abnormalities, Muscle Disorder, Muscle Spasms, Muscle Tightness, Muscle Twitching, Muscular Dystrophy, Myocardial Infarction, Neonatal Apnoeic Attack, Neonatal Asphyxia, Neonatal Disorder, Neonatal Hypotension, Neonatal Infection, Neonatal Respiratory Acidosis, Neonatal Respiratory Arrest, Neonatal Respiratory Depression, Neonatal Respiratory Distress Syndrome, Nervous System Disorder, No Reaction On Previous Exposure To Drug, Nystagmus, Oedema Neonatal, Oesophagitis, Oligohydramnios, Oliguria, Opisthotonus, Overdose, Oxygen Saturation Decreased, Pain, Pallor, Paraesthesia, Paresis, Patent Ductus Arteriosus, Pelvic Inflammatory Disease, Persistent Foetal Circulation, Phalangeal Hypoplasia, Physical Disability, Pierre Robin Syndrome, Pilonidal Cyst Congenital, Placenta Praevia, Placental Disorder, Polyhydramnios, Poor Sucking Reflex, Pre-Eclampsia, Premature Baby, Premature Labour, Premature Rupture of Membranes, Psychomotor Retardation, Pulmonary Vascular Disorder, Pyrexia, Rash Pruritic, Regurgitation of Food, Reproductive Tract Disorder, Respiratory Disorder Neonatal, Respiratory Distress, Retrognathia, Rhabdomyolysis, Sedation, Sepsis, Sepsis Neonatal, Skin Hypoplasia, Skin Malformation, Skull Malformation, Sleep Disorder, Small for Dates Baby, Somnolence, Somnolence Neonatal, Staphylococcal Infection, Streptococcal Infection, Streptococcal Sepsis, Stress, Stridor, Syndactyly, Tachypnoea, Talipes, Tension, Therapeutic Agent Toxicity, Thrombocythaemia, Toe Deformity, Tooth Abscess, Tremor, Tremor Neonatal, Tricuspid Valve Incompetence, Ultrasound Antenatal Screen Abnormal, Unevaluable Event, Urinary Tract Malformation, Ventricular Fibrillation, Ventricular Septal Defect, Vertical Infection Transmission, Viral Infection, Vomiting, Vomiting Neonatal, Weight Decrease Neonatal, Weight Decreased, Weight Gain Poor, Weight Increased
| Alprazolam 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. |
| Anomaly | Something that deviates from what is standard, normal or expected (Congenital Anomaly, Congenital Bladder Anomaly, Congenital Central Nervous System Anomaly, Congenital Musculoskeletal Anomaly). |
| Apert's Syndrome | Acrocephalosyndactyly (a congenital syndrome characterized by a peaked head due to premature closure of the skull sutures and associated with fusion or webbing of the fingers or toes) with the second through fifth digits fused into one mass with a common nail. Also called Apert's Syndrome. [Images] |
| 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) |
| Atrial Septal Defect | An atrial septal defect (ASD), a congenital defect, occurs when there is an opening in the atrial septum, or dividing wall between the two upper chambers of the heart, known as the right and left atria.Normally, oxygen-poor (blue) blood returns to the right atrium from the body, travels to the right ventricle, then is pumped into the lungs where it receives oxygen. Oxygen-rich (red) blood returns to the left atrium from the lungs, passes into the left ventricle, then is pumped out to the body through the aorta. An atrial septal defect allows oxygen-rich (red) blood to pass from the left atrium through the opening in the septum, and then mix with oxygen-poor (blue) blood in the right atrium. This heart defect can cause lung problems if not repaired. When blood passes through the ASD from the left atrium to the right atrium, a larger volume of blood than normal must be handled by the right side of the heart, causing the right side to become overworked and enlarged. Extra blood then passes through the pulmonary artery into the lungs, causing higher pressure than normal in the blood vessels in the lungs, a condition known as pulmonary hypertension. |
| Bradycardia | Slowness of heart rate. |
| 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. Apert's Syndrome, Drug Withdrawal Syndrome Neonatal). |
| 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] |
| Dysmorphism | An anatomical malformation. |
| Hypertonia | Extreme tension of the muscles or arteries. |
| Hypotonia | Decease of normal tonicity (normal firmness or functional readiness in body tissues or organs) or tension. |
| Neonatal Respiratory Distress Syndrome | Respiratory distress syndrome (RDS) of the newborn, also known as infant RDS, is an acute lung disease present at birth, which usually affects premature babies. Layers of tissue called hyaline membranes keep the oxygen that is breathed in from passing into the blood. The lungs are said to be "airless." Without treatment, the infant will die within a few days after birth. |
| Pierre Robin Syndrome | Pierre Robin Syndrome (PRS) is a congenital condition of facial abnormalities in humans. As PRS is not caused by a single defect gene, it is not a genetic syndrome, but rather a chain of certain developmental malformations, one entailing the next. [Images] |
| 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. |
| 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. |
| Rhabdomyolysis | An acute, fulminant (occurring suddently, rapily and with great severity or intensity), potentially fatal disease that destroys skeletal muscle and is often accompanied by the excretion of myoglobin (a protein found in muscle fibers) in the urine. |
| Somnolence | A state of drowsiness; sleepiness. |
| Syndactyly | A congenital anomaly in humans characterized by two or more fused fingers or toes. |
| Tremor | Tremor is an unintentional (involuntary), rhythmical alternating movement that may affect the muscles of any part of the body. Tremor is caused by the rapid alternating contraction and relaxation of muscles and is a common symptom of diseases of the nervous system (neurologic disease). |
| 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 Alprazolam 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".