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.

Atarax (hydroxyzine), Hydroxyzine (hydroxyzine)

Abortion, Abortion Induced, Abortion Spontaneous, Acidosis, Agitation, Agitation Neonatal, Amniorrhoea, Amniotic Cavity Disorder, Anaemia, Apgar Score Low, Arterial Rupture, Assisted Delivery, Atrial Septal Defect, Blood Glucose Decreased, Bradycardia, Breech Presentation, Bronchitis, Caesarean Section, Cardiac Disorder, Cardiac Murmur, Cardiomyopathy Neonatal, Cervical Incompetence, Cervix Dystocia, Chromosome Abnormality, Circulatory Collapse, Clinodactyly, Coma, Complications of Maternal Exposure To Therapeutic Drugs, Condition Aggravated, Congenital Anomaly, Congenital Atrial Septal Defect, Congenital Cystic Kidney Disease, Congenital Foot Malformation, Congenital Heart Valve Disorder, Congenital Hydronephrosis, Congenital Pyelocaliectasis, Constipation, C-Reactive Protein Increased, Convulsion Neonatal, Cyanosis Neonatal, Death Neonatal, Depressed Level of Consciousness, Disseminated Intravascular Coagulation, Drug Abuser, Drug Administration Error, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Level Below Therapeutic, Drug Withdrawal Convulsions, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Ductus Arteriosus Premature Closure, Dysmorphism, Ecchymosis, Electrocardiogram QT Prolonged, Electroencephalogram Abnormal, Erythroblastosis, Extrapyramidal Disorder, Extrasystoles, Facial Dysmorphism, Fear, Feeding Disorder Neonatal, Feeding Problem In Newborn, Feeling Abnormal, Flatulence, Foetal Disorder, Foetal Distress Syndrome, Fungal Infection, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Gestational Diabetes, Gingival Hypertrophy, Grand Mal Convulsion, Gynaecomastia, Haemorrhage, Headache, High Arched Palate, Hormone Level Abnormal, Hypertension, Hyperthermia Malignant, Hypertonia Neonatal, Hypokinesia Neonatal, Hypospadias, Hypotonia, Hypotonia Neonatal, Hypoxia, Ileus Paralytic, Immune System Disorder, Incorrect Dose Administered, Induced Labour, Inflammation, Injection Site Erythema, Insomnia, Intra-Uterine Death, Irritability, Jaundice Neonatal, Joint Dislocation, Lethargy, Leukocytosis, Listeriosis, Long QT Syndrome Congenital, Loss of Consciousness, Maternal Drugs Affecting Foetus, Meconium Abnormal, Meconium Ileus, Meconium Plug Syndrome, Metrorrhagia, Multiple Congenital Abnormalities, Multiple Sclerosis, Nasopharyngitis, Neonatal Apnoeic Attack, Neonatal Aspiration, Neonatal Disorder, Neonatal Hypoxia, Neonatal Oversedation, Neonatal Respiratory Depression, Neonatal Respiratory Distress Syndrome, Neonatal Tachypnoea, Nipple Disorder, Obstetrical Pulmonary Embolism, Oxygen Saturation Decreased, Parkinson's Disease, Penile Size Reduced, Persistent Foetal Circulation, Placental Disorder, Platelet Count Decreased, Polyhydramnios, Polyuria, Poor Sucking Reflex, Pre-Eclampsia, Pregnancy Induced Hypertension, Premature Baby, Premature Labour, Premature Rupture of Membranes, Psychomotor Hyperactivity, Psychotic Disorder, Pyloric Stenosis, Respiratory Arrest, Respiratory Distress, Retrognathia, Retroplacental Haematoma, Rubella Antibody Positive, Self-Medication, Skin Ulcer, Sleep Disorder, Small for Dates Baby, Somnolence, Somnolence Neonatal, Speech Disorder, Sudden Death, Suicide Attempt, Syndactyly, Systemic Lupus Erythematosus, Tachycardia Foetal, Thinking Abnormal, Threatened Labour, Thrombophlebitis, Toxoplasma Serology Positive, Tremor, Tremor Neonatal, Tricuspid Valve Incompetence, Trisomy 21, Ureteric Dilatation, Uterine Contractions Abnormal, Ventricular Hypertrophy, Ventricular Hypokinesia, Vision Blurred, Vomiting, Weight Decrease Neonatal, Weight Decreased

Hydroxyzine 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.
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)
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.
Cervical Incompetence	A condition in which a pregnant woman's cervix begins to dilate (widen) and efface (thin) before her pregnancy has reached term. Cervical incompetence is a cause of miscarriage and preterm birth in the second and third trimesters.
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.
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]
Extrapyramidal Disorder	Defects in basal ganglia function (the basal ganglia is a group of structures in the base of the brain involved in coordination and movement); characterized by changes in muscle tone, akinesia (loss or impariment of the power of voluntary movement), or dyskinesia (abnormal involuntary movements).
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.
Grand Mal Convusion	A severe form of epilepsy characterized by seizures involving spasms and loss of consciousness.
Hypertonia Neonatal	Extreme tension of the muscles or arteries in a newborn.
Hypotonia	Decrease of normal tonicity (normal firmness or functional readiness in body tissues or organs) or tension. [Images]
Ileus Paralytic	Partial or complete blockage of the small and/or large intestine due to peristalsis stopping (peristalsis is the rhythmic contraction that moves material through the bowel).
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.
Persistent Foetal Circulation	The circulation of blood in the foetus is somewhat different from that of the baby after birth. This transition from foetal to neonatal circulation is one of the major physiologic changes after delivery. Before birth, the lungs are collapsed and the blood pressure in the lungs is quite high. This results in a very low blood flow through the lungs. After delivery, the lungs expand and the blood pressure in the lungs decreases. In some babies, although the lungs expand the blood vessels in the lungs remain constricted resulting in persistently high blood pressure in the lungs. This reduces the amount of blood that the infant can pump through the lungs. This decreased blood flow through the lungs after birth is called persistent foetal circulation because it is a persistence of the pattern of blood flow normally seen prior to birth during the foetal period.
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.
Somnolence	A state of drowsiness; sleepiness.
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).
Tricuspid Valve Incompetence	The tricuspid valve is the three-segmented valve of the heart that keeps blood in the right ventricle from flowing back into the right atrium. Incompetence of this value results in blood flowing from the right atrium back into the right ventricle.
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]

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 Hydroxyzine 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".