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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (FDA) is warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body. A new warning has been added to the Geodon drug label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Patients who have a fever with a rash and/or swollen lymph glands should seek urgent medical care. Health care professionals should immediately stop treatment with ziprasidone if DRESS is suspected.
Ziprasidone is an antipsychotic drug used to treat the serious mental health disorders schizophrenia and bipolar I disorder. Ziprasidone helps restore certain natural substances in the brain and can decrease hallucinations, delusions, other psychotic symptoms, and mania. To work properly, ziprasidone should be taken every day as prescribed. Patients should not stop taking their medicine or change their dose without first talking to their health care professional.
DRESS may start as a rash that can spread to all parts of the body. It can include fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas. DRESS also causes a higher-than-normal number of a particular type of white blood cell called eosinophils in the blood. DRESS can lead to death.
For more information please visit: Ziprasidone
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