Clonazepam - Congenital, Prenatal & Neonatal Adverse Rections


This table shows all Adverse Drug Reactions reported to the FDA's Adverse Event Reporting System between 2004 and the 2nd Quarter of 2008 where the listed psychiatric drug was identified as the Primary Suspect Drug (FDA's term) deemed responsible for causing or inducing these reactions and where one or more of the Adverse Reactions reported for the Case described a congenital, prenatal or neonatal condition. Where no Age, Date of Event or Indication (the condition being treated) are shown, none were present in the FDA records.

Reported By: CN-Consumer, LW-Lawyer, MD-Physician, OT-Other Healthcare Provider, PH-Pharmacist, Blank-Not Reported in ISR (Individual Safety Report).

The Oxford English Dictionary defines a poison as "a substance that causes death or harm when introduced into or absorbed by a living organism."  This psychiatric drug fits that definition.



Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 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

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

Clonazepam (clonazepam), Clonex (clonazepam), Klonopin (clonazepam), Rivotril (clonazepam)

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

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 (1909–1974), 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 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 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".