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# Hypersensitivity Precaution Added to Olumiant
- URL: https://www.fdaweb.com/hypersensitivity-precaution-added-to-olumiant/
- Published: 2020-07-13T12:00:00.000Z
- Updated: 2026-09-14T16:20:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147180

FDA has [posted](https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?utm%5Fcampaign=SLC%2007%2F10%2F2020&utm%5Fmedium=email&utm%5Fsource=Eloqua&event=searchdetail.page&DrugNameID=2084&elqTrackId=e77714359bc64d20946a417a2b666e49&elq=5e776849ae7d4dd68b97fee) a drug safety-related labeling change for Eli Lilly and Incyte’s NDA for Olumiant (baricitinib 2mg), a once-daily oral drug for treating adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies. A new hypersensitivity precaution warns about reactions such as angioedema, urticaria, and rash that have been observed in patients taking Olumiant, including serious reactions. It advises that patients should discontinue therapy if a serious hypersensitivity reaction occurs.