The label for Tofacitinib (Xeljanz) was updated on 2026-05-31 to include a new boxed warning. This warning highlights significant risks, including serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, for patients treated with the drug.
Background
Tofacitinib (Xeljanz, Xeljanz XR) is an oral medication. The new boxed warning, effective 2026-05-31, explicitly states that patients treated with tofacitinib oral solution are at increased risk for developing serious bacterial, fungal, and viral infections. Beyond infections, the warning also highlights risks of increased mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis, including deep vein thrombosis (DVT) and pulmonary embolism (PE). This comprehensive warning aims to inform prescribers and patients about the significant safety considerations associated with the drug.
What this means
The addition of a boxed warning to the Tofacitinib label on 2026-05-31 signifies an elevated level of concern regarding specific safety risks associated with the drug. Clinicians prescribing Tofacitinib must now counsel patients more thoroughly on the potential for serious infections, increased mortality, malignancy, major adverse cardiovascular events, and thrombosis. This label change underscores the importance of careful patient selection, ongoing monitoring for adverse events, and a thorough risk-benefit assessment before and during treatment with Tofacitinib.
Source
This information regarding the label revision for Tofacitinib was obtained from the U.S. Food and Drug Administration (FDA) through its DailyMed database. The label update, effective 2026-05-31, is accessible via dailymed.nlm.nih.gov.