The U.S. Food and Drug Administration (FDA) revised the boxed warning on the label for tofacitinib (Xeljanz, Xeljanz XR) on 2026-07-06. This revision emphasizes increased risks of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis for patients treated with the drug.
Background
Tofacitinib is an oral Janus kinase (JAK) inhibitor approved for various inflammatory conditions. Boxed warnings, also known as black box warnings, are the strongest warnings the FDA requires for prescription drugs. They are used to call attention to serious or life-threatening risks associated with the drug.
Key Changes
The updated boxed warning for tofacitinib now explicitly highlights several critical safety concerns. These include an increased risk for developing serious bacterial, fungal, and viral infections. The warning also addresses increased risks of mortality, malignancy, major adverse cardiovascular events, and thrombosis. The revision specifically notes that patients treated with tofacitinib tablets are at increased risk for these serious adverse events.
What this means
This label revision serves to reinforce the importance of careful patient selection and monitoring for individuals receiving tofacitinib. Clinicians should be aware of the heightened risks of serious infections, cardiovascular events, malignancies, and thrombosis, and counsel patients accordingly. The update underscores the need for ongoing vigilance in assessing the benefit-risk profile for each patient prescribed tofacitinib.
Source
This FDA label revision was effective on 2026-07-06. The updated labeling information for tofacitinib is available on the DailyMed website, hosted by the National Library of Medicine (NLM).