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 | 4180128 | 4413076 | 08/02/2004 | Klonopin | OT | Panic Disorder | Apgar Score Low, Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome | |||||||
| F | 4183218 | 4417225 | 09/14/2003 | 08/06/2004 | Rivotril | CN | Drug Use for Unknown Indication | Infection, Maternal Drugs Affecting Foetus, Respiratory Distress | ||||||
| F | 4193967 | 4430077 | 08/20/2004 | Klonopin | CN | Anxiety | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| F | 4221685 | 4465388 | 10/04/2004 | Rivotril | MD | Drug Use for Unknown Indication | Cleft Lip and Palate, Drug Exposure During Pregnancy | |||||||
| F | 4221685 | 4468289 | 04/17/1999 | 10/07/2004 | Rivotril | MD | Epilepsy | Cleft Lip and Palate, Drug Exposure During Pregnancy, Neonatal Asphyxia, Premature Baby, Uterine Leiomyoma | ||||||
| F | 4221685 | 4478302 | 04/17/1999 | 10/19/2004 | Rivotril | MD | Epilepsy | Cleft Lip and Palate, Drug Exposure During Pregnancy, Neonatal Asphyxia, Premature Baby, Small for Dates Baby | ||||||
| F | 4223015 | 4466666 | 06/24/1995 | 10/06/2004 | Rivotril | MD | Epilepsy | Caesarean Section, Drug Exposure During Pregnancy, Neonatal Asphyxia | ||||||
| F | 4223015 | 4482339 | 06/24/1995 | 10/22/2004 | Rivotril | MD | Epilepsy | Caesarean Section, Drug Exposure During Pregnancy, Neonatal Asphyxia, Prolonged Pregnancy | ||||||
| F | 5679359 | 4506744 | 09/23/2004 | 11/22/2004 | Klonopin | MD | Panic Disorder | Apgar Score Low, Drug Exposure During Pregnancy, Feeding Problem In Newborn | ||||||
| F | 5679359 | 4550170 | 09/23/2004 | 01/12/2005 | Klonopin | MD | Panic Disorder | Apgar Score Low, Drug Exposure During Pregnancy, Feeding Problem In Newborn | ||||||
| F | 5679359 | 4627118 | 09/23/2004 | 04/05/2005 | Klonopin | MD | Apgar Score Low, Caesarean Section, Drug Exposure During Pregnancy, Feeding Problem In Newborn, Gestational Diabetes, Pre-Eclampsia | |||||||
| F | 5679359 | 4682447 | 09/23/2004 | 06/06/2005 | Klonopin | MD | Apgar Score Low, Caesarean Section, Developmental Delay, Drug Exposure During Pregnancy, Feeding Problem In Newborn | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 5679359 | 4825718 | 09/23/2004 | 11/11/2005 | Klonopin | MD | Panic Disorder | Apgar Score Low, Caesarean Section, Cleft Palate, Developmental Delay, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Speech Disorder Developmental, Weight Gain Poor | ||||||
| M | 5723924 | 4562588 | 05/10/2004 | 01/27/2005 | Clonazepam | CN | Drug Use for Unknown Indication | Caesarean Section, Drug Exposure During Pregnancy, Hypotonia Neonatal, Premature Baby, Somnolence Neonatal | ||||||
| F | 5729709 | 4570349 | 06/12/2004 | 02/04/2005 | Clonazepam | CN | Drug Use for Unknown Indication | Apnoea, Brain Scan Abnormal, Caesarean Section, Cerebral Disorder, Drug Exposure During Pregnancy, Dyskinesia, Electroencephalogram Abnormal, Hypotonia Neonatal, Oxygen Saturation Decreased | ||||||
| F | 5735762 | 4578683 | 11/18/2002 | 02/11/2005 | Clonazepam | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Hip Dysplasia, Mobility Decreased, Multiple Congenital Abnormalities, Talipes | ||||||
| F | 5739300 | 4582838 | 06/11/2004 | 02/15/2005 | Clonazepam | CN | Drug Use for Unknown Indication | Caesarean Section, Drug Exposure During Pregnancy, Dyskinesia | ||||||
| M | 5751216 | 4598578 | 03/04/2005 | Rivotril | LW | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Foetal Valproate Syndrome, Hypoparathyroidism | |||||||
| M | 5758384 | 4608708 | 03/15/2005 | Rivotril | CN | Epilepsy | Drug Exposure During Pregnancy, Facial Dysmorphism, Limb Malformation, Renal Agenesis, Urinary Tract Malformation | |||||||
| M | 5791401 | 4656159 | 07/30/2004 | 05/09/2005 | Rivotril | CN | Apgar Score Low, Cardiac Arrest, Cardiac Arrest Neonatal, Drug Exposure During Pregnancy, Foetal Arrhythmia, Investigation Abnormal, Neonatal Respiratory Distress Syndrome, Pallor, Pneumothorax, Pulmonary Hypoplasia, Respiratory Disorder, Respiratory Disorder Neonatal, Respiratory Distress, Toe Deformity | |||||||
| M | 5811617 | 4681298 | 06/03/2005 | 01/01/2003 | Clonazepam | CN | Drug Exposure During Pregnancy, Stillbirth | |||||||
| F | 5818849 | 4690231 | 02/21/2005 | 06/15/2005 | Rivotril | CN | Drug Exposure During Pregnancy, Foetal Macrosomia, Somnolence Neonatal | |||||||
| 5864809 | 4749671 | 08/22/2005 | Clonazepam | MD | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Premature Labour | ||||||||
| F | 5889067 | 4784742 | 08/20/2005 | 09/30/2005 | Clonazepam | CN | Epilepsy | Drug Exposure During Pregnancy, Premature Baby, Respiratory Distress, Talipes | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 5926968 | 4834299 | 11/22/2005 | Rivotril | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Hypotonia, Hypotonia Neonatal, Neonatal Respiratory Distress Syndrome, Neonatal Tachypnoea, Respiratory Distress, Tachypnoea | ||||||||
| 5960618 | 4880287 | 06/10/2005 | 01/13/2006 | 06/10/2005 | Klonopin | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Intra-Uterine Death | ||||||
| 5961403 | 4881736 | 01/16/2006 | Rivotril | PH | Drug Use for Unknown Indication | Congenital Hair Disorder, Drug Exposure During Pregnancy | ||||||||
| F | 5974353 | 4898016 | 12/27/2005 | 02/01/2006 | Clonazepam | MD | Complex Partial Seizures | Drug Exposure During Pregnancy, Metabolic Function Test Abnormal, Neonatal Disorder | ||||||
| F | 5987657 | 4916810 | 08/25/2005 | 02/20/2006 | Clonazepam | MD | Schizophrenia | Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Eye Movement Disorder, Fever Neonatal, Hypotonia Neonatal, Irritability, Somnolence Neonatal, Tremor Neonatal | ||||||
| M | 6135335 | 5113878 | 09/25/2006 | Klonopin | CN | Drug Use for Unknown Indication | Autism, Drug Exposure During Pregnancy | |||||||
| F | 6146555 | 5126817 | 10/13/2006 | Rivotril | CN | Drug Exposure During Pregnancy, Retained Placenta or Membranes, Small for Dates Baby, Treatment Noncompliance | ||||||||
| F | 6150668 | 5131543 | 03/30/2005 | 10/20/2006 | 03/30/2005 | Rivotril | CN | Drug Use for Unknown Indication | Apgar Score Low, Caesarean Section, Drug Exposure During Pregnancy, Foetal Growth Retardation, Hypotonia, Poor Weight Gain Neonatal, Premature Baby, Respiratory Depression, Respiratory Distress | |||||
| F | 6150668 | 5159680 | 03/30/2005 | 11/29/2006 | Rivotril | CN | Drug Use for Unknown Indication | Caesarean Section, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Foetal Growth Retardation, Hypotonia, Hypotonia Neonatal, Poor Weight Gain Neonatal, Premature Baby, Respiratory Depression | ||||||
| F | 6159638 | 5141339 | 03/22/2005 | 11/01/2006 | Rivotril | CN | Epilepsy | Atrial Septal Defect, Drug Exposure During Pregnancy, Poor Weight Gain Neonatal, Skull Malformation, Ventricular Septal Defect | ||||||
| F | 6181972 | 5168309 | 06/22/2006 | 12/08/2006 | Rivotril | CN | Panic Disorder | Caesarean Section, Cyanosis Neonatal, Drug Exposure During Pregnancy, Omphalorrhexis, Premature Labour | ||||||
| F | 6181972 | 5168334 | 06/22/2006 | 12/08/2006 | Rivotril | CN | Panic Disorder | Caesarean Section, Cyanosis Neonatal, Drug Exposure During Pregnancy, Immature Respiratory System, Omphalorrhexis, Premature Labour | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6218164 | 5200971 | 02/11/2006 | 01/03/2007 | Clonex | Abortion Induced, Anencephaly, Drug Exposure During Pregnancy | |||||||||
| F | 6225256 | 5221895 | 11/26/2006 | 01/29/2007 | Rivotril | CN | Epilepsy | Agitation, Agitation Neonatal, Detoxification, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia, Hypertonia Neonatal, Screaming, Small for Dates Baby, Tremor Neonatal | ||||||
| F | 6225256 | 5260868 | 11/26/2006 | 03/09/2007 | Rivotril | CN | Epilepsy | Agitation, Drug Withdrawal Syndrome, Hypertonia, Screaming, Tremor Neonatal | ||||||
| M | 6301922 | 5314032 | 07/15/2006 | 05/01/2007 | Rivotril | OT | Drug Use for Unknown Indication | Abortion, Arnold-Chiari Malformation, Congenital Central Nervous System Anomaly, Congenital Foot Malformation, Drug Exposure During Pregnancy, Meningomyelocele, Skull Malformation, Transmission of Drug Via Semen | ||||||
| F | 6303930 | 5316042 | 05/03/2007 | Klonopin | CN | Abortion Spontaneous | ||||||||
| F | 6361722 | 5391425 | 07/19/2007 | Rivotril | CN | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| F | 6361722 | 5409785 | 08/09/2007 | Clonazepam | CN | Drug Use for Unknown Indication | Abortion Spontaneous | |||||||
| M | 6462588 | 5511248 | 11/09/2007 | Rivotril | MD | Epilepsy | Psychomotor Skills Impaired | |||||||
| F | 6483161 | 5537320 | 01/29/2006 | 12/07/2007 | 08/10/2006 | Rivotril | MD | Drug Use for Unknown Indication | Death Neonatal, Drug Exposure During Pregnancy, Premature Baby, Premature Rupture of Membranes, Sepsis Neonatal | |||||
| F | 6531376 | 5597537 | 01/21/2008 | Clonazepam | CN | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| F | 6531376 | 5655530 | 03/07/2008 | Rivotril | MD | Drug Use for Unknown Indication | Abortion Spontaneous | |||||||
| M | 6462588 | 5695026 | 07/04/2005 | 04/04/2008 | Rivotril | MD | Epilepsy | Drug Exposure During Pregnancy, Psychomotor Skills Impaired | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 6644564 | 5744426 | 05/20/2008 | Clonazepam | OT | Drug Use for Unknown Indication | Convulsion, Drug Exposure During Pregnancy, Premature Baby, Pulmonary Hypertension, Therapeutic Agent Toxicity | |||||||
| M | 6644564 | 5774219 | 06/16/2008 | Clonazepam | OT | Drug Use for Unknown Indication | Convulsion, Drug Exposure During Pregnancy, Epilepsy, Nuclear Magnetic Resonance Imaging Brain Abnormal, Premature Baby, Pulmonary Hypertension, Therapeutic Agent Toxicity | |||||||
| M | 6644572 | 5744438 | 05/20/2008 | Clonazepam | OT | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Premature Baby, Therapeutic Agent Toxicity | |||||||
| 1 | Hours | 6059270 | 5019314 | 02/10/2006 | 06/06/2006 | 03/15/2006 | Rivotril | CN | Anxiety | Aortic Disorder, Cardiac Murmur, Drug Exposure During Pregnancy, Multi-Organ Failure | ||||
| 1 | Hours | F | 6155009 | 5136244 | 10/17/2006 | 10/27/2006 | Rivotril | MD | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Neonatal Respiratory Arrest, Trisomy 21 | ||||
| 1 | Hours | F | 6155009 | 5140155 | 10/17/2006 | 10/31/2006 | Rivotril | MD | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Neonatal Respiratory Arrest | ||||
| 1 | Hours | F | 6155009 | 5144215 | 10/17/2006 | 11/06/2006 | Rivotril | MD | Borderline Personality Disorder | Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Trisomy 21 | ||||
| 1 | Hours | M | 6349733 | 5378608 | 01/31/2007 | 07/05/2007 | Rivotril | OT | Cleft Lip, Micrognathia | |||||
| 24 | Hours | M | 5972729 | 4895563 | 01/30/2006 | Rivotril | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Poor Sucking Reflex, Somnolence | |||||
| 1 | Day | M | 6550898 | 5623260 | 02/22/2007 | 02/12/2008 | Rivotril | MD | Drug Use for Unknown Indication | Agitation, Cleft Palate, Dysmorphism, Foetal Growth Retardation, Hypotonia Neonatal | ||||
| 5 | Weeks | F | 6087985 | 5058084 | 05/30/2006 | 07/21/2006 | Rivotril | CN | Drug Use for Unknown Indication | Apnoea, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Gastrooesophageal Reflux Disease | ||||
| 2 | Months | M | 6462588 | 5676120 | 07/04/2005 | 03/21/2008 | Rivotril | MD | Epilepsy | Psychomotor Skills Impaired | ||||
| 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 | F | 6052858 | 5011933 | 05/26/2006 | 12/01/2005 | Rivotril | CN | Depression | Cardiac Disorder, Congenital Anomaly, Transmission of Drug Via Semen, Trisomy 21 | ||||
| 4 | Years | F | 6052858 | 5567093 | 12/19/2007 | 12/01/2005 | Rivotril | CN | Depression | Cardiac Disorder, Trisomy 21 | ||||
| 24 | Years | F | 5846533 | 4726312 | 07/27/2005 | Clonazepam | MD | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||
| 24 | Years | F | 6560902 | 5637375 | 02/25/2008 | Rivotril | MD | Drug Use for Unknown Indication | Caudal Regression Syndrome, Congenital Bladder Anomaly | |||||
| 25 | Years | F | 5698442 | 4531775 | 12/20/2004 | Clonazepam | CN | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 27 | Years | F | 6524525 | 5588103 | 01/11/2008 | Klonopin | MD | Anxiety | Abortion Spontaneous | |||||
| 28 | Years | F | 4168174 | 4397166 | 07/14/2004 | Klonopin | MD | Panic Disorder | Drug Exposure During Pregnancy, Pre-Eclampsia | |||||
| 28 | Years | F | 4168174 | 4505506 | 11/19/2004 | Klonopin | MD | Panic Disorder | Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes, Pre-Eclampsia | |||||
| 28 | Years | F | 4168174 | 4550151 | 01/12/2005 | Klonopin | MD | Panic Disorder | Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes, Pre-Eclampsia | |||||
| 28 | Years | F | 4168174 | 4626247 | 04/04/2005 | Klonopin | MD | Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes, Paranoia, Pre-Eclampsia, Refusal of Treatment By Patient | ||||||
| 28 | Years | F | 4168174 | 4681211 | 06/03/2005 | Klonopin | MD | Drug Exposure During Pregnancy, Gestational Diabetes, Paranoia, Pre-Eclampsia | ||||||
| 28 | Years | F | 4168174 | 4819298 | 11/03/2005 | Klonopin | MD | Panic Disorder | Blood Glucose Increased, Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes, Paranoia, Pre-Eclampsia | |||||
| 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 | 5743098 | 4588232 | 12/21/2004 | 02/21/2005 | Rivotril | CN | Epilepsy | Drug Exposure During Pregnancy, Drug Resistance, Facial Dysmorphism, Petit Mal Epilepsy, Status Epilepticus | ||||
| 31 | Years | F | 5743098 | 4608700 | 12/21/2004 | 03/15/2005 | Rivotril | CN | Epilepsy | Facial Dysmorphism, Maternal Drugs Affecting Foetus | ||||
| 31 | Years | F | 5744415 | 4589676 | 02/23/2005 | Rivotril | CN | Epilepsy | Drug Exposure During Pregnancy, Grand Mal Convulsion, Petit Mal Epilepsy | |||||
| 31 | Years | F | 5744415 | 4608704 | 03/15/2005 | Rivotril | CN | Epilepsy | Agitation, Constipation, Drug Exposure During Pregnancy, Electroencephalogram Abnormal, Grand Mal Convulsion, Hypoxia, Laryngeal Obstruction, Petit Mal Epilepsy, Quadriparesis | |||||
| 31 | Years | F | 5981705 | 4908058 | 02/10/2006 | Clonazepam | CN | Epilepsy | Drug Exposure During Pregnancy, Hemivertebra | |||||
| 32 | Years | F | 4158124 | 4383417 | 06/23/2004 | Rivotril | MD | Insomnia | Abortion Spontaneous, Blighted Ovum, Drug Exposure During Pregnancy | |||||
| 32 | Years | F | 6050423 | 5008612 | 05/23/2006 | Rivotril | CN | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 32 | Years | F | 6265438 | 5269722 | 12/01/2005 | 03/20/2007 | Clonazepam | CN | Drug Use for Unknown Indication | Abortion Induced, Dysmorphism, Foot Deformity, Syndactyly | ||||
| 32 | Years | F | 6265438 | 5273863 | 12/01/2005 | 03/23/2007 | Rivotril | CN | Drug Use for Unknown Indication | Abortion Induced, Dysmorphism, Limb Malformation, Syndactyly | ||||
| 33 | Years | F | 6358314 | 5388054 | 07/16/2007 | Rivotril | CN | Panic Attack | Abortion Spontaneous | |||||
| 33 | Years | F | 5774009 | 4632950 | 04/12/2005 | Rivotril | CN | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||
| 34 | Years | F | 4187999 | 4414497 | 07/02/2004 | Klonopin | OT | Panic Disorder | Drug Withdrawal Syndrome, Night Sweats, Panic Attack, Suicidal Ideation | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 34 | Years | F | 4187999 | 4714228 | 06/30/2005 | Klonopin | OT | Depression, Drug Withdrawal Syndrome, Night Sweats, Panic Attack, Postpartum Depression, Suicidal Ideation | ||||||
| 35 | Years | F | 5816534 | 4688080 | 06/10/2005 | Rivotril | CN | Abortion Induced, Drug Exposure During Pregnancy, Facial Dysmorphism, Multiple Congenital Abnormalities, Oesophageal Atresia | ||||||
| 35 | Years | F | 6359202 | 5389113 | 07/17/2007 | Rivotril | CN | Anxiety Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 35 | Years | F | 6359207 | 5389115 | 07/17/2007 | Rivotril | CN | Anxiety Disorder | Abortion Spontaneous | |||||
| 37 | Years | F | 6335577 | 5360728 | 06/18/2007 | Klonopin | CN | Epilepsy | Abortion Spontaneous | |||||
| 37 | Years | F | 6336500 | 5362170 | 06/19/2007 | Klonopin | CN | Epilepsy | Abortion Spontaneous | |||||
| 38 | Years | F | 6005227 | 4944598 | 03/15/2006 | Clonazepam | CN | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 39 | Years | F | 5968974 | 4884487 | 01/01/2005 | 01/17/2006 | Clonazepam | OT | Abortion Spontaneous, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Foetal Heart Rate Abnormal | |||||
| 39 | Years | F | 5968974 | 4892217 | 01/24/2006 | Clonazepam | OT | Abortion Spontaneous, Drug Exposure During Pregnancy, Foetal Heart Rate Abnormal | ||||||
| 40 | Years | F | 4101651 | 4312438 | 03/05/2004 | Rivotril | MD | Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Maternal Drugs Affecting Foetus | ||||||
| 40 | Years | F | 5996192 | 4929023 | 03/01/2006 | Clonazepam | CN | Bipolar Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 40 | Years | F | 6512559 | 5571132 | 12/21/2007 | Rivotril | MD | Neuralgia | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 40 | Years | F | 6512559 | 5584048 | 01/08/2008 | Rivotril | MD | Neuralgia | Abortion Spontaneous | |||||
| 45 | Years | F | 5780386 | 4642448 | 04/22/2005 | Klonopin | MD | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||
| 54 | Years | F | 6440320 | 5474173 | 09/28/2007 | Clonazepam | Anxiety, Panic Attack | Asthenia, Dizziness, Drug Exposure During Pregnancy, Drug Ineffective, Gait Disturbance, Heart Rate Decreased | ||||||
| 14 Males | 50 Females | 70 Cases (Gender was not reported for 6 Cases) | 99 Individual Safety Reports | |||||||||||
Clonazepam (clonazepam), Clonex (clonazepam), Klonopin (clonazepam), Rivotril (clonazepam)
Abortion, Abortion Induced, Abortion Spontaneous, Agitation, Agitation Neonatal, Anencephaly, Aortic Disorder, Apgar Score Low, Apnoea, Arnold-Chiari Malformation, Asthenia, Atrial Septal Defect, Autism, Blighted Ovum, Blood Glucose Increased, Brain Scan Abnormal, Caesarean Section, Cardiac Arrest, Cardiac Arrest Neonatal, Cardiac Disorder, Cardiac Murmur, Caudal Regression Syndrome, Cerebral Disorder, Cleft Lip, Cleft Lip and Palate, Cleft Palate, Complications of Maternal Exposure To Therapeutic Drugs, Congenital Anomaly, Congenital Bladder Anomaly, Congenital Central Nervous System Anomaly, Congenital Foot Malformation, Congenital Hair Disorder, Constipation, Convulsion, Cyanosis Neonatal, Death Neonatal, Depression, Detoxification, Developmental Delay, Dizziness, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Drug Resistance, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Dyskinesia, Dysmorphism, Electroencephalogram Abnormal, Epilepsy, Eye Movement Disorder, Facial Dysmorphism, Feeding Disorder Neonatal, Feeding Problem In Newborn, Fever Neonatal, Foetal Arrhythmia, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate Abnormal, Foetal Macrosomia, Foetal Valproate Syndrome, Foot Deformity, Gait Disturbance, Gastrooesophageal Reflux Disease, Gestational Diabetes, Grand Mal Convulsion, Heart Rate Decreased, Hemivertebra, Hip Dysplasia, Hypertonia, Hypertonia Neonatal, Hypoparathyroidism, Hypotonia, Hypotonia Neonatal, Hypoxia, Immature Respiratory System, Infantile Apnoeic Attack, Infection, Intra-Uterine Death, Investigation Abnormal, Irritability, Laryngeal Obstruction, Limb Malformation, Maternal Drugs Affecting Foetus, Meningomyelocele, Metabolic Function Test Abnormal, Micrognathia, Mobility Decreased, Multi-Organ Failure, Multiple Congenital Abnormalities, Neonatal Asphyxia, Neonatal Disorder, Neonatal Respiratory Arrest, Neonatal Respiratory Distress Syndrome, Neonatal Tachypnoea, Night Sweats, Nuclear Magnetic Resonance Imaging Brain Abnormal, Oesophageal Atresia, Omphalorrhexis, Oxygen Saturation Decreased, Pallor, Panic Attack, Paranoia, Petit Mal Epilepsy, Pneumothorax, Poor Sucking Reflex, Poor Weight Gain Neonatal, Postpartum Depression, Pre-Eclampsia, Premature Baby, Premature Labour, Premature Rupture of Membranes, Prolonged Pregnancy, Psychomotor Skills Impaired, Pulmonary Hypertension, Pulmonary Hypoplasia, Quadriparesis, Refusal of Treatment By Patient, Renal Agenesis, Respiratory Depression, Respiratory Disorder, Respiratory Disorder Neonatal, Respiratory Distress, Retained Placenta or Membranes, Screaming, Sepsis Neonatal, Skull Malformation, Small for Dates Baby, Somnolence, Somnolence Neonatal, Speech Disorder Developmental, Status Epilepticus, Stillbirth, Suicidal Ideation, Syndactyly, Tachypnoea, Talipes, Therapeutic Agent Toxicity, Toe Deformity, Transmission of Drug Via Semen, Treatment Noncompliance, Tremor Neonatal, Trisomy 21, Urinary Tract Malformation, Uterine Leiomyoma, Ventricular Septal Defect, Weight Gain Poor
| Clonazepam 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. |
| Anencephaly | Congenital absence of most of the brain and spinal cord. [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) |
| Arnold-Chiari Malformation | Arnold-Chiari malformation is a rare genetic disorder in which parts of the brain are formed abnormally. Malformations may occur in the lower portion of the brain (cerebellum) or in the brain stem. [Images] |
| 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. |
| Blighted Ovum | A blighted ovum (also know as "anembryonic pregnancy") happens when a fertilized egg attaches itself to the uterine wall, but the embryo does not develop [an - without + embryonic - embryo]. It is usually the result of chromosomal problems. A woman's body recognizes abnormal chromosomes in a fetus and naturally does not try to continue the pregnancy because the fetus will not develop into a normal, healthy baby. [link] |
| 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. Drug Withdrawal Syndrome Neonatal, Foetal Distress Syndrome). |
| 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] |
| Dyskinesia | An impairment in the ability to control movements, characterized by spasmodic or repetitive motions or lack of coordination. |
| Dysmorphism | An anatomical malformation. [Images] |
| Foetal 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. |
| Foetal Distress Syndrome | An abnormal condition of a fetus during gestation or at the time of delivery, marked by altered heart rate or rhythm and leading to compromised blood flow or changes in blood chemistry. |
| Foetal Macrosomia | Large for gestational age (LGA) babies are those whose birth weight lies above the 90th percentile for that gestational age. Macrosomia, also known as big baby syndrome, is sometimes used synonymously with LGA, or is otherwise defined as a fetus that weighs above 4000 grams (8 lb 13 oz) or 4500 grams (9 lb 15 oz) regardless of gestational age. |
| Foetal Valproate Syndrome | Typified by a wide-bridged nose, wide forehead, mental retardation and difficulties with movement. [Images] |
| Gestational Diabetes | Gestational diabetes is a condition that occurs during pregnancy. Like other forms of diabetes, gestational diabetes involves a defect in the way the body processes and uses sugars (glucose) in the diet. In diabetes, blood levels of glucose remain abnormally high. In many forms of diabetes, this is because the pancreas does not produce enough insulin. In gestational diabetes, the pancreas is not at fault. Instead, the problem is in the placenta. During pregnancy, the placenta provides the baby with nourishment. It also produces a number of hormones that interfere with the body's usual response to insulin. This condition is referred to as "insulin resistance." Most pregnant women do not suffer from gestational diabetes, because the pancreas works to produce extra quantities of insulin in order to compensate for insulin resistance. However, when a woman's pancreas cannot produce enough extra insulin, blood levels of glucose stay abnormally high, and the woman is considered to have gestational diabetes. |
| Hypotonia | Decease of normal tonicity (normal firmness or functional readiness in body tissues or organs) or tension. |
| Meningomyelocele | Protrusion of the spinal membranes and spinal cord through a defect in the vertebral column. [Images] |
| Micrognathia | A condition of abnormal smallness of the jaws, particularly the mandible (the lower jaw). [Images] |
| 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. |
| 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. |
| Omphalorrhexis | Rupture of the umbilical cord during childbirth. |
| Pre-Eclampsia | Abnormal state of pregnancy characterized by hypertension and fluid retention and albuminuria (the presence of albumin in the urine, sometimes indicating kidney disease); if untreated, can lead to eclampsia (coma and convulsions before, during, or shortly after childbirth, characterized by edema, hypertension, and proteinuria). |
| 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. |
| Pulmonary Hypoplasia | Incomplete or defective development of the lungs. |
| Renal Agenesis | Failure of the fetal kidneys (renal) to form. |
| Somnolence | A state of drowsiness; sleepiness. |
| Status Epilepticus | Occurrence of prolonged, generalized epileptic seizures in rapid succession with brief intervals of coma. |
| Syndactyly | A congenital anomaly in humans characterized by two or more fused fingers or toes. [Images] |
| 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. [Images] |
| 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. |
| Trisomy 21 | Down syndrome is the most common cause of mental retardation and malformation in a newborn. It occurs because of the presence of an extra chromosome. The extra chromosome in Down syndrome is labeled number 21. For this reason, the existence of three such chromosomes is sometimes referred to as Trisomy 21. [Images] |
| 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 Clonazepam 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".