Alprazolam - 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
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

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

Alprazolam (alprazolam), Frontal (alprazolam), Solanax (alprazolam), Xanax (alprazolam)

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

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 (1909–1974), 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 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 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".