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.

Mirtazapine (mirtazapine), Remeron (mirtazapine)

Abnormal Behaviour, Abortion Missed, Abortion Spontaneous, Agitation Neonatal, Back Pain, Blood Glucose Increased, Blood Pressure Systolic Increased, Breast Pain, Caesarean Section, Cerebral Haemorrhage Neonatal, Cleft Palate, Colostomy, Complications of Maternal Exposure To Therapeutic Drugs, Congenital Anomaly, Congenital Diaphragmatic Hernia, Congenital Ectopic Bladder, Congenital Renal Cyst, Congenital Spinal Cord Anomaly, Cystic Lymphangioma, Death Neonatal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome Neonatal, Ectopic Pregnancy, Failed Forceps Delivery, Fallot's Tetralogy, Feeding Disorder Neonatal, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Malformation, Gastrointestinal Disorder Congenital, Gastrooesophageal Reflux Disease, Glycosylated Haemoglobin Increased, Head Deformity, Heart Disease Congenital, Heart Rate Increased, Hydrocephalus, Hygroma Colli, Hypertelorism of Orbit, Hyponatraemia, Hysterosalpingogram Abnormal, Intentional Misuse, Jaundice Neonatal, Limb Hypoplasia Congenital, Limb Reduction Defect, Liver Disorder, Loss of Consciousness, Lung Infection, Maternal Drugs Affecting Foetus, Meningocele, Meningomyelocele, Metabolic Disorder, Microcephaly, Myocardial Infarction, Neonatal Disorder, Neonatal Hyponatraemia, Neonatal Respiratory Distress Syndrome, Neonatal Tachycardia, Neonatal Tachypnoea, Nervous System Disorder, Placental Disorder, Pneumothorax, Postmature Baby, Pre-Eclampsia, Pregnancy Test Positive, Premature Baby, Premature Labour, Premature Rupture of Membranes, Psychomotor Retardation, Psychomotor Skills Impaired, Pyrexia, Reflux Oesophagitis, Renal Impairment Neonatal, Sedation, Sepsis Neonatal, Small for Dates Baby, Somnolence, Stress, Suicide Attempt, Syndactyly, Synovial Cyst, Talipes, Tremor Neonatal, Underweight, Weight Increased

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 Mirtazapine 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".