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.

Clozapine (clozapine), Clozaril (clozapine), Leponex (clozapine)

Abdominal Distension, Abdominal Pain Upper, Aborted Pregnancy, Abortion, Abortion Missed, Abortion Spontaneous, Accidental Exposure, Agitation, Amniorrhexis, Anaemia, Anal Atresia, Antipsychotic Drug Level Above Therapeutic, Anxiety, Apgar Score Low, Apnoea, Arrested Labour, Arrhythmia, Atrial Septal Defect, Back Pain, Biliary Sepsis, Blood Bilirubin Increased, Blood Glucose Increased, Blood Pressure Increased, Blood Thyroid Stimulating Hormone Increased, Brachycephaly, Breech Presentation, Brief Psychotic Disorder With Postpartum Onset, Burnout Syndrome, Caesarean Section, Cardiac Disorder, Cardiac Murmur, Cerebral Haemorrhage Neonatal, Cervical Incompetence, Chest X-Ray Abnormal, Chills, Chlamydial Infection, Chordee, Chorioamnionitis, Coma Neonatal, Complications of Maternal Exposure To Therapeutic Drugs, Conductive Deafness, Congenital Anomaly, Congenital Central Nervous System Anomaly, Congenital Cystic Lung, Congenital Floppy Infant, Congenital Foot Malformation, Congenital Hand Malformation, Congenital Hydrocephalus, Congenital Hypothyroidism, Congenital Pyelocaliectasis, Convulsion, Convulsion Neonatal, Cryptorchism, Depressed Level of Consciousness, Developmental Coordination Disorder, Developmental Delay, Diabetes Mellitus, Diabetes Mellitus Non-Insulin-dependent, Diarrhoea, Disease Recurrence, Disorder of Orbit, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Intolerance, Drug Withdrawal Syndrome Neonatal, Dysgeusia, Dyskinesia, Dysphemia, Dyspnoea, Emotional Disorder, Encephalopathy Neonatal, Enema Administration, Evacuation of Retained Products of Conception, Eye Pain, Eyelid Disorder, Facial Dysmorphism, Fatigue, Feeding Disorder Neonatal, Foetal Arrhythmia, Foetal Disorder, Foetal Growth Retardation, Foetal Heart Rate Deceleration, Foetal Malposition, Foetal Movements Decreased, Gastric Disorder, Gastrointestinal Tube Insertion, Gastrooesophageal Reflux Disease, General Physical Health Deterioration, Gestational Diabetes, Goitre, Granulocyte Count Increased, Granulocytopenia, Growth Retardation, Haemangioma, Hallucination, Headache, Heart Disease Congenital, Heart Rate Irregular, Heart Sounds Abnormal, Hepatosplenomegaly Neonatal, Hernia Congenital, High Arched Palate, Hospitalisation, Hyperammonaemia, Hyperbilirubinaemia, Hyperglycaemia, Hyperhidrosis, Hypersomnia, Hypothermia, Hypotonia, Hypotonia Neonatal, Hypoxia, Hypoxic Encephalopathy, Induced Labour, Infrequent Bowel Movements, Insomnia, Intestinal Obstruction, Intestinal Stenosis, Intra-Uterine Death, Jaundice, Leukopenia, Life Support, Lip Disorder, Liver Disorder, Mania, Maternal Drugs Affecting Foetus, Meconium Plug Syndrome, Metrorrhagia, Microcephaly, Microgenia, Milk Allergy, Myalgia, Myocarditis, Nasal Disorder, Nasal Septum Deviation, Nasal Septum Disorder, Nasopharyngitis, Nausea, Neck Deformity, Neonatal Apnoeic Attack, Neonatal Asphyxia, Neonatal Disorder, Neonatal Intestinal Obstruction, Neonatal Respiratory Depression, Neonatal Respiratory Distress Syndrome, Neonatal Respiratory Failure, Neonatal Tachypnoea, Neutropenia Neonatal, Neutrophil Count Decreased, Neutrophil Percentage Increased, Oedema Peripheral, Oesophageal Atresia, Oligohydramnios, Opisthotonus, Pallor, Papilloma, Patent Ductus Arteriosus, Pelvic Kidney, Penis Disorder, Pharyngolaryngeal Pain, Physical Testicle Examination Abnormal, Placental Disorder, Poor Sucking Reflex, Pregnancy Induced Hypertension, Premature Baby, Premature Labour, Premature Rupture of Membranes, Premature Separation of Placenta, Psychotic Disorder, Regurgitation, Renal Pain, Road Traffic Accident, Salivary Hypersecretion, Sepsis, Skin Papilloma, Small for Dates Baby, Somnolence, Somnolence Neonatal, Speech Disorder Developmental, Sterilisation, Stillbirth, Stool Analysis, Surgery, Tachycardia Foetal, Talipes, Thyroxine Decreased, Thyroxine Free Decreased, Torticollis, Tremor Neonatal, Tri-Iodothyronine Decreased, Trismus, Trisomy 21, Ultrasound Antenatal Screen Abnormal, Vacterl Syndrome, Vaginal Haemorrhage, Vomiting, Vomiting Neonatal, Weight Decrease Neonatal, Weight Decreased, White Blood Cell Count Decreased, White Blood Cell Count Increased

Clozapine 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.
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.
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.
Cryptorchism	A developmental defect marked by the failure of the testes to descend into the scrotum.
Dysphemia	A speech disorder characterized by stammering or stuttering and usually having an emotional or psychological basis.
Dyspnoea	Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath. Also called air hunger.
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.
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 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.
Hepatosplenomegaly	Enlargement of the liver and the spleen. [Images]
Hypersomnia	Excessive sleepiness.
Metrorrhagia	Bleeding from the uterus that is not associated with menstruation.
Microgenia	Abnormal smallness of the chin. [Images]
Myocarditis	Myocarditis is an inflammatory disease of the heart muscle.
Neonatal Apnoeic Attack	Temporary absence or cessation of breathing in a newborn.
Oligohydramnios	A deficiency in the amount of amniotic fluid.
Opisthotonus	A condition, caused by a tetanic spasm of the back muscles, in which the trunk is arched forward while the head and lower limbs are bent backward. (Tetany is an abnormal condition characterized by periodic painful muscular spasms and tremors.)
Trismus	Lockjaw.
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]

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 Clozapine 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".