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.

Nefazodone (nefazodone), Serzone (nefazodone)

Amnesia, Auditory, Blood Cholesterol Increased, Cardiac Failure, Cardiomegaly, Chest Discomfort, Coma, Congenital Atrial Septal Defect, Crying, Dizziness, Drug Exposure During Pregnancy, Dyspnoea, Exaggerated Startle Response, Hallucination, Hepatoblastoma, Hyperadrenalism, Immature Respiratory System, Impaired Work Ability, Insomnia, Liver Function Test Abnormal, Malaise, Middle Insomnia, Migraine, Mood Altered, Nausea, Oedema Peripheral, Palpitations, Premature Baby, Premature Labour, Sleep Talking, Sleep Walking, Visual Disturbance, Vomiting

Definitions
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.
Cardiomegaly	Enlargement of the heart.
Congenital	A physical abnormality that is present at birth.
Dyspnoea	Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath. Also called air hunger.
Malaise	A vague feeling of bodily discomfort, as at the beginning of an illness. A general sense of depression or unease.
Middle Insomnia	Difficulty returning to sleep after awakening in the middle of the night.

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 Nefazadone 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".