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.

Risperdal (risperidone), Risperidone (risperidone), Rispolept (risperidone)

Abortion, Abortion Incomplete, Abortion Induced, Abortion Spontaneous, Abortion Threatened, Acidosis, Acute Psychosis, Affect Lability, Aggression, Agitation, Amenorrhoea, Amnesia, Amniocentesis Abnormal, Amniotic Cavity Infection, Anaemia, Anxiety, Apgar Score Low, Apnoeic Attack, Arrhythmia, Arrhythmia Neonatal, Atrial Septal Defect, Atrioventricular Block Second Degree, Bladder Disorder, Blighted Ovum, Blood Glucose Fluctuation, Blood Glucose Increased, Blood PH Decreased, Blood Pressure Increased, Blood Prolactin Increased, Bradyarrhythmia, Bradycardia Neonatal, Brain Malformation, Breast Cancer, Breast Enlargement, Breast Tenderness, Bronchitis, Caesarean Section, Cardiac Disorder, Cardiac Murmur, Central Pontine Myelinolysis, Cerebral Atrophy, Cerebrovascular Accident, Cleft Lip, Cleft Lip and Palate, Cleft Palate, Clonic Convulsion, Cold Sweat, Complications of Maternal Exposure To Therapeutic Drugs, Condition Aggravated, Congenital Anomaly, Congenital Arterial Malformation, Congenital Atrial Septal Defect, Congenital Foot Malformation, Congenital Heart Valve Disorder, Congenital Teratoma, Convulsion, Convulsion Neonatal, Crying, Cryptorchism, Cystitis Interstitial, Death, Delusion, Depressed Level of Consciousness, Depression, Developmental Coordination Disorder, Developmental Delay, Diabetes Mellitus, Diabetes Mellitus Non-Insulin-dependent, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Drug Interaction, Drug Level Decreased, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Dyskinesia, Dyskinesia Neonatal, Dysplasia, Dystonia, Ear Disorder, Ear Malformation, Ectopic Pregnancy, Electroencephalogram Abnormal, Embolism, Emotional Disorder, Escherichia Sepsis, Euphoric Mood, Extrapyramidal Disorder, Eye Movement Disorder, Facial Dysmorphism, Failure To Thrive, Fallot's Tetralogy, Feeding Disorder Neonatal, Feeling Jittery, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate Abnormal, Foetal Heart Rate Deceleration, Foetal Heart Rate Decreased, Foetal Movements Decreased, Forceps Delivery, Galactorrhoea, Gastrointestinal Disorder, Gastroschisis, Gestational Diabetes, Grimacing, Growth Retardation, Haemangioma, Hallucination, Head Banging, Heart Disease Congenital, Heart Rate Decreased, Heart Rate Increased, Hormone Level Abnormal, Hospitalisation, Humerus Fracture, Hyperhidrosis, Hyperprolactinaemia, Hypertonia, Hypertonia Neonatal, Hyperventilation, Hypoaesthesia, Hypoglycaemia, Hypoglycaemia Neonatal, Hyponatraemia, Hypotension, Hypothermia, Hypotonia, Hypotonia Neonatal, Hypoventilation, Hypoxia, Increased Appetite, Incubator Therapy, Infection, Insomnia, Intentional Overdose, Intentional Self-Injury, Intra-Uterine Death, Irritability, Ischaemic Stroke, Jaundice Neonatal, Labour Pain, Laryngomalacia, Leukopenia, Lip Disorder, Liver Function Test Abnormal, Long QT Syndrome, Macrosomia, Malnutrition, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Menstruation Irregular, Mental Retardation Severity Unspecified, Metrorrhagia, Monoplegia, Multiple Congenital Abnormalities, Muscle Cramp, Muscle Spasms, Muscle Twitching, Muscular Weakness, Myoclonus, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Neuroleptic Malignant Syndrome, Oesophageal Atresia, Oligohydramnios, Opisthotonus, Overdose, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Penile Size Reduced, Peritonitis, Persecutory Delusion, Plagiocephaly, Platelet Count Decreased, Pneumonia, Pneumothorax, Polyhydramnios, Poor Sucking Reflex, Post Abortion Haemorrhage, Pre-Eclampsia, Premature Baby, Premature Labour, Premature Rupture of Membranes, Premature Separation of Placenta, Procedural Hypotension, Psychiatric Symptom, Psychomotor Hyperactivity, Psychotic Disorder, Pulmonary Artery Stenosis Congenital, Pulmonary Embolism, Pyelectasia, Pyrexia, Radius Fracture, Red Blood Cell Count Decreased, Refusal of Treatment By Patient, Respiratory Disorder, Respiratory Disorder Neonatal, Respiratory Distress, Respiratory Failure, Restlessness, Resuscitation, Rhinitis, Salivary Hypersecretion, Schizophrenia, Sepsis, Small for Dates Baby, Somatoform Disorder Pregnancy, Somnolence, Somnolence Neonatal, Stress, Suicidal Ideation, Suicide Attempt, Suppressed Lactation, Tachycardia, Tachycardia Foetal, Tachypnoea, Tearfulness, Temperature Regulation Disorder, Thinking Abnormal, Thoracic Vertebra Injury, Thrombosis, Transient Tachypnoea of the Newborn, Traumatic Brain Injury, Tremor, Tremor Neonatal, Trisomy 13, Ultrasound Antenatal Screen Abnormal, Umbilical Cord Abnormality, Umbilical Cord Around Neck, Unevaluable Event, Urinary Bladder Haemorrhage, Urinary Tract Infection, Urine Output Decreased, Uterine Contractions Abnormal, Uterine Contractions During Pregnancy, Vasodilatation, Ventricular Hypoplasia, Visual Tracking Test Abnormal, Vomiting, Vomiting In Pregnancy, Weight Increased, Withdrawal Syndrome

Risperidone 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 (e.g. Drug Withdrawal Syndrome, Foetal Distress Syndrome).
Drug Withdrawal Syndrome	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.
Dystonia	Abnormal tonicity of muscle, characterized by prolonged, repetitive muscle contractions that may cause twisting or jerking movements of the body or a body part. [Images]
Facial Dysmorphism	An anatomical malformation of the face. [Images]
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]
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.
Hypertonia	Extreme tension of the muscles or arteries.
Laryngomalacia	A birth defect that causes the tissues around the larynx to partially collapse and narrow the air passageway, causing noisy breathing.
Leukopenia	An abnormally low number of white blood cells in the circulating blood.
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.
Opisthotonus	A condition, caused by a tetanic (muscle) spasm of the back muscles, in which the trunk is arched forward while the head and lower limbs are bent backward.
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.
Trisomy	A condition in which an extra copy of a chromosome is present in the cell nuclei, causing developmental abnormalities.
Trisomy 13	Patau syndrome, also called Trisomy 13, is a congenital disorder associated with the presence of an extra copy of chromosome 13 which causes numerous physical and mental abnormalities, especially heart defects. [Images]
Ventricular Hypertrophy	Blood travels through the right ventricle to the lungs. If conditions occur which decrease pulmonary circulation, meaning blood does not flow well from the heart to the lungs, extra stress can be placed on the right ventricle. This can lead to right ventricular hypertrophy (enlargement of the ventrical walls - normal heart shown on left, ventricular hypertrophy shown on right).

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 Risperidone 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".