Tofacitinib boxed warning revised on FDA label

FDA revised the boxed warning on tofacitinib labeling effective 2026-07-30. The update highlights serious safety risks on the label for this drug, which is also marketed as Xeljanz and Xeljanz XR.

Background

Tofacitinib, also listed as tofacitinib citrate, is a prescription drug with an updated FDA label on DailyMed. The revision concerns the boxed warning language for the product.

What this means

The label now emphasizes risks of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. For clinicians and patients, the revised boxed warning underscores the need to weigh these safety concerns when using tofacitinib.

Source

This information is based on an FDA label revision dated 2026-07-30. The label is available on dailymed.nlm.nih.gov at https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=21a89264-8047-40ac-8b10-fa6461072509.