The FDA revised the boxed warning on tofacitinib labeling, effective 2026-07-31. The updated warning highlights risks of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Background
Tofacitinib is marketed as Xeljanz, Xeljanz XR, and tofacitinib citrate. The label revision applies to the FDA-labeled product information hosted on DailyMed.
What this means
For clinicians, the revised boxed warning reinforces that patients treated with tofacitinib tablets are at increased risk for serious bacterial, fungal, viral, and other infections. The warning also directs attention to the broader safety concerns now listed prominently on the label, including cancer, cardiovascular events, and thrombosis.
Source
This information is based on the FDA label revision for tofacitinib with an effective date of 2026-07-31. The record is available at dailymed.nlm.nih.gov.