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.

Cymbalta (duloxetine), Duloxetine (duloxetine), Yentreve (duloxetine)

Abdominal Distension, Abdominal Pain, Abnormal Behaviour, Abortion, Abortion Induced, Abortion Missed, Abortion Spontaneous, Activities of Daily Living Impaired, Affect Lability, Amniotic Fluid Volume Decreased, Anencephaly, Angioedema, Anxiety, Apnoea, Arrested Labour, Arrhythmia, Asthenia, Blood Glucose Increased, Bradycardia Neonatal, Bronchiolitis, Cardiac Murmur, Cerebral Haemorrhage Neonatal, Cervix Disorder, Choking, Chorioamnionitis, Condition Aggravated, Congenital Anomaly, Congenital Hand Malformation, Congenital Hydronephrosis, Congenital Pulmonary Valve Atresia, Constipation, Convulsion, Convulsion Neonatal, Cyanosis Neonatal, Decreased Appetite, Depression, Diarrhoea, Discomfort, Disturbance In Attention, Dizziness, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Drug Interaction, Drug Screen Positive, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Ear Infection, Ectopic Pregnancy, Fatigue, Feeding Disorder Neonatal, Feeding Problem In Newborn, Feeling Abnormal, Fluid Retention, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Malformation, Gestational Diabetes, Haemorrhage, Hangover, Headache, Hepatic Enzyme Increased, Hydrocephalus, Hydronephrosis, Hyperacusis, Hyperemesis Gravidarum, Hypoaesthesia, Hypospadias, Hypotonia Neonatal, Impaired Driving Ability, Impaired Self-Care, Increased Appetite, Induced Labour, Infantile Apnoeic Attack, Infection, Insomnia, Intestinal Functional Disorder, Irritability, Limb Malformation, Limb Reduction Defect, Liver Function Test Abnormal, Major Depression, Malaise, Memory Impairment, Menstruation Irregular, Mental Disorder, Movement Disorder, Nausea, Neonatal Asphyxia, Neonatal Aspiration, Neonatal Disorder, Neonatal Hypoxia, Neonatal Respiratory Distress Syndrome, Nervousness, Noonan Syndrome, Oligohydramnios, Oxygen Saturation Decreased, Pain, Paraesthesia, Patent Ductus Arteriosus, Pelvi-Ureteric Obstruction, Placental Disorder, Polydactyly, Postpartum Depression, Pre-Eclampsia, Premature Baby, Premature Labour, Premature Rupture of Membranes, Premenstrual Syndrome, Pruritus, Pulmonary Valve Stenosis, Rash, Respiratory Tract Infection, Restlessness, Retained Placenta or Membranes, Small for Dates Baby, Somnolence, Stillbirth, Stomach Discomfort, Syncope, Tinnitus, Transient Tachypnoea of the Newborn, Treatment Noncompliance, Umbilical Cord Around Neck, Uterine Leiomyoma, Vaginal Haemorrhage, Viral Infection, Vomiting, Weight Decreased, Weight Increased

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.
Anencephaly	Congenital absence of most of the brain and spinal cord.
Apnea	Temporary absence or cessation of breathing.
Bradycardia	Slowness of heart rate.
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.
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.
Hyperemesis Gravidarum	In pregnant women, nausea and vomiting (morning sickness) are common, affecting up to 80% of pregnancies. Hyperemesis, or extreme nausea and excessive vomiting, occur in about 1% of pregnancies. This condition causes uncontrollable vomiting, severe dehydration, and weight loss for the mother.
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.

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 Duloxetine 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".