The label for Tofacitinib (Xeljanz, Xeljanz XR) was updated on 2026-06-24 by the FDA to include a prominent boxed warning. This critical revision alerts healthcare professionals and patients to increased risks of serious infections, higher mortality, potential for malignancy, occurrence of major adverse cardiovascular events (MACE), and heightened risk of thrombosis.
Background
Tofacitinib, marketed as Xeljanz and Xeljanz XR, is a prescription medication. The recent label revision by the FDA on 2026-06-24 specifically added a boxed warning to highlight significant safety concerns associated with its use.
What this means
The addition of a comprehensive boxed warning to the Tofacitinib label provides crucial safety information for clinicians and patients. The warning explicitly states that patients treated with tofacitinib extended-release tablets are at increased risk for developing serious bacterial and fungal infections, among others. Furthermore, the warning underscores elevated risks for mortality, various forms of malignancy, significant major adverse cardiovascular events, and the potential for thrombosis. Healthcare providers are advised to carefully weigh these risks against the potential benefits when prescribing Tofacitinib and to monitor patients closely for any signs or symptoms related to these serious adverse events. This update emphasizes the need for informed decision-making and patient counseling regarding the safety profile of Tofacitinib.
Source
The information regarding the boxed warning on the Tofacitinib label was made effective on 2026-06-24 by the FDA. The details of this label revision are available on dailymed.nlm.nih.gov.