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.

Abilify (aripiprazole), Aripiprazole (aripiprazole)

Abdominal Pain, Abortion, Abortion Induced, Abortion Missed, Abortion Spontaneous, Abortion Threatened, Acute Psychosis, Acute Respiratory Distress Syndrome, Agitation, Agitation Neonatal, Alanine Aminotransferase Increased, Alpha 1 Foetoprotein Amniotic Fluid Increased, Amniorrhexis, Anal Atresia, Anorexia, Antepartum Haemorrhage, Aortic Valve Stenosis, Arnold-Chiari Malformation, Aspartate Aminotransferase Increased, Aspiration, Asthenia, Atrial Septal Defect, Blighted Ovum, Blood Disorder, Blood Human Chorionic Gonadotropin Decreased, Breech Presentation, Caesarean Section, Cardiac Arrest Neonatal, Cardiac Murmur, Cardiac Valve Disease, Cholecystectomy, Coloboma, Complications of Maternal Exposure To Therapeutic Drugs, Congenital Anomaly, Congenital Aortic Valve Stenosis, Congenital Cardiovascular Anomaly, Congenital Central Nervous System Anomaly, Congenital Cystic Kidney Disease, Congenital Ectopic Bladder, Congenital Multiplex Arthrogryposis, Death Neonatal, Dehydration, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Drug Withdrawal Syndrome Neonatal, Dyskinesia, Dysmorphism, Dyspnoea, Ectopic Pregnancy, Electrocardiogram Abnormal, Electroencephalogram Abnormal, Epstein-Barr Virus Infection, Eye Rolling, Failure To Thrive, Fatigue, Feeding Disorder Neonatal, Foetal Alcohol Syndrome, Foetal Growth Retardation, Foetal Movements Decreased, Hallucination, Hallucination (Auditory), Hallucination (Visual), Heart Disease Congenital, High-Pitched Crying, Hypertelorism of Orbit, Hypertension, Infantile Apnoeic Attack, Intra-Uterine Death, Kidney Malformation, Limb Malformation, Live Birth, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Meningitis Bacterial, Meningomyelocele, Mental Disorder, Microcephaly, Microphthalmos, Multiple Congenital Abnormalities, Neonatal Disorder, Neonatal Oversedation, Neonatal Respiratory Distress Syndrome, Neuroleptic Malignant Syndrome, Persecutory Delusion, Poor Personal Hygiene, Pre-Eclampsia, Premature Baby, Premature Labour, Premature Rupture of Membranes, Procedural Complication, Respiratory Depth Decreased, Respiratory Disorder, Sedation, Self Injurious Behaviour, Sepsis, Skull Malformation, Small for Dates Baby, Spina Bifida, Stillbirth, Stress, Suppressed Lactation, Syndactyly, Synostosis, Systemic Lupus Erythematosus, Tethered Cord Syndrome, Threatened Labour, Transmission of Drug Via Semen, Trisomy 21, Umbilical Cord Abnormality, Univentricular Heart, Vaginal Candidiasis, Ventricular Septal Defect, Vesicoureteric Reflux, Vomiting, Weight Decreased

Aripiprazole 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.
Anal Atresia	The anus is either not present or it is in the wrong place.
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.
Congenital	A physical abnormality that is present at birth.
Congenital Anomaly	Medical wording for "Birth Defect".
Dysmorphism	An anatomical malformation.
Dyspnoea	Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath. Also called air hunger.
Ectopic Pregnancy	In an ectopic pregnancy, the fertilized egg implants in a location outside the uterus and tries to develop there. The word ectopic means "in an abnormal place or position." The most common site is the fallopian tube, the tube that normally carries eggs from the ovary to the uterus. However, ectopic pregnancy can also occur in the ovary, the abdomen, and the cervical canal (the opening from the uterus to the vaginal canal). The phrases tubal pregnancy, ovarian pregnancy, cervical pregnancy, and abdominal pregnancy refer to the specific area of an ectopic pregnancy.
Meningomyelocele	Protrusion of the spinal membranes and spinal cord through a defect in the vertebral column. [Images]
Microcephaly	Abnormal smallness of the head. [Images]
Microphthalmos	Abnormal smallness of one or both eyes.
Spina Bifida	A serious birth abnormality in which the spinal cord is malformed and lacks its usual protective skeletal and soft tissue coverings.
	Spina bifida may appear in the body midline anywhere from the neck to the buttocks. In its most severe form, termed spinal rachischisis, the entire spinal canal is open, exposing the spinal cord and nerves. More commonly, the abnormality appears as a localized mass on the back that is covered by skin or by the meninges, the three-layered membrane that envelopes the spinal cord. Spina bifida is usually readily apparent at birth because of the malformation of the back and paralysis below the level of the abnormality. [Images]
Syndactyl	A congenital anomaly in humans characterized by two or more fused fingers or toes. [Images]
Trisomy	A condition in which an extra copy of a chromosome is present in the cell nuclei, causing developmental abnormalities.
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]
Univentricular Heart	The fetal heart begins its development as a long tube. During the first trimester, the lower part of this tube normally divides into two pumping chambers: the left ventricle and the right ventricle. However, there are rare cases in which this normal separation does not occur, and the baby is born with one functional ventricle instead of two. As a result of this defect, oxygen-rich blood and oxygen-poor blood mix together in the single ventricle instead of remaining separate. Some oxygen-rich blood needlessly travels back to the lungs, and some oxygen-poor blood uselessly travels to the rest of the oxygen-demanding body. Unless corrected surgically, single ventricle usually results in heart failure and death.
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 Aripiprazole 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".