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# FDA Adds Warning to Olanzapine Products Over Rash
- URL: https://www.fdaweb.com/fda-adds-warning-to-olanzapine-products-over-rash/
- Published: 2016-05-10T12:00:00.000Z
- Updated: 2026-09-14T21:01:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135619

> FDA is warning that the antipsychotic medicine olanzapine (Eli Lilly’s Zyprexa, Symbyax, and generic equivalents) can cause a rare and serious skin reaction that can progress to affect other parts of the body. The agency has ordered a new warning to the drug labels for all olanzapine-containing products that describes this severe condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).  
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> FDA found 23 cases of DRESS worldwide in its adverse event database since 1996, when the first olanzapine-containing product was approved. “One patient taking olanzapine experienced DRESS and died; however, this patient was taking multiple medicines that could also have contributed to death,” a [drug safety alert](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbXNpZD0mYXVpZD0mbWFpbGluZ2lkPTIwMTYwNTEwLjU4ODI2NjgxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDUxMC41ODgyNjY4MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3Njk2MTQxJmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ0YXJnZXRpZD0mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&100&&&http://www.fda.gov/Drugs/DrugSafety/ucm499441.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says.  
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> DRESS may start as a rash that can spread to all parts of the body, the agency says, and it can include fever and swollen lymph nodes and a swollen face. It causes a higher-than-normal number of infection-fighting white blood cells called eosinophils that can cause inflammation, or swelling. DRESS can also result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death.  
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> Olanzapine is an antipsychotic medicine used to treat mental health disorders schizophrenia and bipolar disorder. It can decrease hallucinations, in which people hear or see things that do not exist, and other psychotic symptoms such as disorganized thinking.