Haloperidol - 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 3008284 5215788 04/03/1995 01/23/2007 Haldol OT Drug Use for Unknown Indication Arrhythmia, Premature Baby, Sepsis Neonatal, Small for Dates Baby
F 5745788 4591180 03/18/2004 02/25/2005 Haldol MD Drug Use for Unknown Indication Clavicle Fracture, Drug Exposure During Pregnancy, Small for Dates Baby
M 5753861 4602779 01/02/2005 03/09/2005 Haldol OT Drug Use for Unknown Indication Atrial Septal Defect, Drug Exposure During Pregnancy, Facial Dysmorphism, Ventricular Septal Defect
M 5794183 4660482 05/12/2005 Haloperidol OT Congenital Anomaly, Drug Exposure During Pregnancy, Gastroschisis
5826231 4700257 04/05/2005 06/27/2005 Haldol MD Foetal Growth Retardation, Foot Deformity, Jaundice, Premature Baby
F 5826231 4714959 04/05/2005 07/15/2005 Haldol MD Foetal Growth Retardation, Foot Deformity, Jaundice, Premature Baby
F 5849918 4730316 08/01/2005 Haloperidol PH Diarrhoea, Dyskinesia, Irritability, Metabolic Acidosis
F 5849918 4766481 09/26/2001 09/12/2005 Haloperidol PH Agitation Neonatal, Diarrhoea, Diarrhoea Neonatal, Drug Exposure During Pregnancy, Dyskinesia, Grand Mal Convulsion, Irritability, Late Metabolic Acidosis of Newborn, Metabolic Acidosis
F 5876864 4767496 09/13/2005 Haldol CN Drug Use for Unknown Indication Abortion Spontaneous, Drug Exposure During Pregnancy
5876865 4767497 09/13/2005 Haldol CN Drug Use for Unknown Indication Abortion Spontaneous
5953181 4869262 12/30/2005 Haldol OT Nausea Congenital Anomaly
M 5957039 4869535 10/25/2005 12/27/2005 Haldol OT Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding 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
M 6027009 4975012 03/21/1993 04/18/2006 Haldol OT Agitation, Crying, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeding Disorder Neonatal, Forceps Delivery, Hypertonia Neonatal, Hypotonia Neonatal, Moaning, Threatened Labour
M 6029976 4979662 06/23/1999 04/21/2006 Serenace OT Apgar Score Low, Attention Deficit Hyperactivity Disorder, Complications of Maternal Exposure To Therapeutic Drugs, Cyst, Decreased Activity, Excitability, Hypotonia Neonatal, Irritability, Opisthotonus, Premature Baby, Thrombocythaemia, Tremor Neonatal
F 6213341 5205973 04/18/2006 01/11/2007 Haldol MD Drug Use for Unknown Indication Abortion Spontaneous, Drug Exposure During Pregnancy
F 6220302 5215490 07/12/1994 01/23/2007 Haldol OT Drug Exposure During Pregnancy Developmental Coordination Disorder, Small for Dates Baby, Strabismus
F 6220685 5215787 02/08/1997 01/23/2007 Haloperidol OT Drug Exposure During Pregnancy Premature Baby, Small for Dates Baby
M 6220686 5215789 04/03/1995 01/23/2007 Haldol OT Drug Exposure During Pregnancy Arrhythmia Neonatal, Bacterial Sepsis, Drug Exposure During Pregnancy, Foetal Growth Retardation, Premature Baby, Sepsis Neonatal, Small for Dates Baby
F 6280504 5287945 07/16/2005 04/05/2007 Haldol OT Tension Drug Exposure During Pregnancy, Premature Labour, Suicidal Ideation
M 6294933 5305498 12/17/2006 04/24/2007 Haldol OT Drug Exposure During Pregnancy Agitation, Syndactyly, Talipes, Tremor Neonatal
M 6344714 5373354 12/02/2006 06/28/2007 Haldol OT Psychotic Disorder Bradycardia, Drug Exposure During Pregnancy, Pierre Robin Syndrome
F 6365312 5395006 07/24/2007 Haldol MD Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Dwarfism, Foetal Growth Retardation, Growth Retardation
F 6365312 5402888 08/01/2007 Haldol MD Drug Exposure During Pregnancy Dwarfism
F 6373645 5403895 07/01/2007 08/02/2007 Haldol OT Psychotic Disorder Acute Psychosis, Physical Assault
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6373645 5494497 07/30/2007 10/24/2007 Haldol MD Psychotic Disorder Disturbance In Social Behaviour, Drug Exposure During Pregnancy, Physical Assault, Psychotic Disorder
F 6373645 5508818 07/30/2007 11/07/2007 Haldol MD Psychotic Disorder Disturbance In Social Behaviour, Drug Exposure During Pregnancy, Psychotic Disorder
F 6413631 5452680 05/27/2006 09/14/2007 Haldol OT Psychotic Disorder Caesarean Section, Drug Exposure During Pregnancy, Premature Rupture of Membranes
F 6413853 5452828 12/02/2006 09/14/2007 Haldol OT Drug Use for Unknown Indication Bradycardia Neonatal, Caesarean Section, Colonic Stenosis, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Foetal Heart Rate Deceleration, Hypoglycaemia Neonatal, Hypotonia Neonatal, Hypoventilation Neonatal, Necrotising Colitis, Neonatal Disorder, Patent Ductus Arteriosus, Premature Baby, Premature Rupture of Membranes, Shock
6441926 5485108 10/15/2007 Haldol MD Drug Exposure During Pregnancy Microcephaly
M 6517944 5579353 09/26/2007 01/02/2008 Haldol OT Drug Exposure During Pregnancy Cardiac Murmur, Cardiomegaly, Coloboma, Congenital Multiplex Arthrogryposis, Drug Exposure During Pregnancy, Kidney Malformation, Macroglossia, Neck Deformity, Pulmonary Hypertension, Respiratory Distress
F 6519723 5581985 01/29/2007 01/04/2008 Haldol MD Drug Exposure During Pregnancy Cri Du Chat Syndrome, Drug Exposure During Pregnancy, Micrognathia
F 6519723 5588903 01/07/2007 01/11/2008 Haldol MD Drug Exposure During Pregnancy Cri Du Chat Syndrome, Drug Exposure During Pregnancy, Micrognathia
F 6537087 5605556 01/29/2008 Haldol MD Drug Use for Unknown Indication Abortion Spontaneous, Accidental Exposure, Drug Exposure During Pregnancy
F 6537087 5633318 02/21/2008 Haldol MD Drug Use for Unknown Indication Abortion Spontaneous, Accidental Exposure, Drug Exposure During Pregnancy
F 6373645 5700174 07/30/2007 04/09/2008 Haldol MD Schizophrenia Disturbance In Social Behaviour, Drug Exposure During Pregnancy, Psychotic Disorder
M 6624237 5717505 03/12/2008 04/25/2008 Haldol OT Drug Exposure During Pregnancy Apgar Score Low, Caesarean Section, Drug Exposure During Pregnancy, Hypotonia, Neonatal Disorder, Somnolence
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6646217 5746053 05/15/2008 05/22/2008 Haldol CN Confusional State Crying, Drug Dependence, Drug Exposure During Pregnancy, Dyspnoea, Heart Rate Increased, Morbid Thoughts, Sedation
8 Days F 4160927 4382949 11/01/2003 06/17/2004 Haloperidol PH Drug Exposure During Pregnancy Dyskinesia Neonatal, Maternal Drugs Affecting Foetus
3 Months M 6034570 4986128 04/28/2006 Haloperidol MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Silver-Russell Syndrome
4 Months F 3007837 5210389 07/12/1994 01/17/2007 Haldol OT Drug Use for Unknown Indication Psychomotor Skills Impaired, Small for Dates Baby, Strabismus
22 Years F 6290893 5288648 03/30/2007 Haloperidol MD Agitation Catatonia, Drug Exposure During Pregnancy, Neuroleptic Malignant Syndrome, No Therapeutic Response, Renal Failure Acute, Schizophreniform Disorder
24 Years F 6670953 5776960 06/08/2008 06/18/2008 Haldol OT Drug Use for Unknown Indication Drug Exposure During Pregnancy, Intentional Overdose, Somnolence, Suicide Attempt
28 Years F 5700770 4535351 01/01/2004 12/22/2004 Haldol MD Delusion Albuminuria, Drug Exposure During Pregnancy, Gestational Diabetes
31 Years F 6183412 5164314 11/21/2006 11/27/2006 Haldol MD Bipolar Disorder Apgar Score Low, Caesarean Section, Drug Exposure During Pregnancy, Eclampsia, Premature Baby, Premature Separation of Placenta
35 Years F 6537086 5605555 01/29/2008 Haldol MD Drug Use for Unknown Indication Abortion Spontaneous, Accidental Exposure, Drug Exposure During Pregnancy
35 Years F 6537086 5632733 02/21/2008 Haldol MD Drug Use for Unknown Indication Abortion Spontaneous, Accidental Exposure, Drug Exposure During Pregnancy
35 Years F 6154956 5136178 10/27/2006 Haldol CN Mania Confusional State, Constipation, Depression, Drug Exposure During Pregnancy, Suicide Attempt, Urinary Retention
40 Years F 4108696 4315915 12/01/2003 03/10/2004 Haldol OT Delusion Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Maternal Drugs Affecting Foetus
12 Males 23 Females 39 Cases (Gender was not reported for 4 Cases) 48 Individual Safety Reports

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

Haldol (haloperidol), Haloperidol (haloperidol), Serenace (haloperidol)

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

Abortion Spontaneous, Accidental Exposure, Acute Psychosis, Agitation, Agitation Neonatal, Albuminuria, Apgar Score Low, Arrhythmia, Arrhythmia Neonatal, Atrial Septal Defect, Attention Deficit Hyperactivity Disorder, Bacterial Sepsis, Bradycardia, Bradycardia Neonatal, Caesarean Section, Cardiac Murmur, Cardiomegaly, Catatonia, Clavicle Fracture, Coloboma, Colonic Stenosis, Complications of Maternal Exposure To Therapeutic Drugs, Confusional State, Congenital Anomaly, Congenital Multiplex Arthrogryposis, Constipation, Cri Du Chat Syndrome, Crying, Cyst, Decreased Activity, Depression, Developmental Coordination Disorder, Diarrhoea, Diarrhoea Neonatal, Disturbance In Social Behaviour, Drug Dependence, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Dwarfism, Dyskinesia, Dyskinesia Neonatal, Dyspnoea, Eclampsia, Excitability, Facial Dysmorphism, Feeding Disorder Neonatal, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate Deceleration, Foot Deformity, Forceps Delivery, Gastroschisis, Gestational Diabetes, Grand Mal Convulsion, Growth Retardation, Heart Rate Increased, Hypertonia Neonatal, Hypoglycaemia Neonatal, Hypotonia, Hypotonia Neonatal, Hypoventilation Neonatal, Intentional Overdose, Irritability, Jaundice, Kidney Malformation, Late Metabolic Acidosis of Newborn, Macroglossia, Maternal Drugs Affecting Foetus, Metabolic Acidosis, Microcephaly, Micrognathia, Moaning, Morbid Thoughts, Neck Deformity, Necrotising Colitis, Neonatal Disorder, Neuroleptic Malignant Syndrome, No Therapeutic Response, Opisthotonus, Patent Ductus Arteriosus, Physical Assault, Pierre Robin Syndrome, Premature Baby, Premature Labour, Premature Rupture of Membranes, Premature Separation of Placenta, Psychomotor Skills Impaired, Psychotic Disorder, Pulmonary Hypertension, Renal Failure Acute, Respiratory Distress, Schizophreniform Disorder, Sedation, Sepsis Neonatal, Shock, Silver-Russell Syndrome, Small for Dates Baby, Somnolence, Strabismus, Suicidal Ideation, Suicide Attempt, Syndactyly, Talipes, Threatened Labour, Thrombocythaemia, Tremor Neonatal, Urinary Retention, Ventricular Septal Defect


Haloperidol 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.
  
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.
  
Athrogryposis Multiplex The permanent fixation of joints in a contracted position. [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.
  
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. 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.
  
Dyskinesia An impairment in the ability to control movements, characterized by spasmodic or repetitive motions or lack of coordination.
  
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.
  
Gastroschisis A congenital fissure (split or crack) in the abdominal wall usually accompanied by protrusion of the viscera (intestines). [Images]
  
Grand Mal Convusion A severe form of epilepsy characterized by seizures involving spasms and loss of consciousness.
  
Hypotonia Decease of normal tonicity (normal firmness or functional readiness in body tissues or organs) or tension.
  
  
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.
  
  
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]
  
Strabismus Strabismus is a condition in which the eyes do not point in the same direction. It can also be referred to as a tropia or squint. [Images]
  
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 (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 Haloperidol 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".