On 2026-07-21, the label for Tofacitinib (Xeljanz, Xeljanz XR) received a new boxed warning from the FDA. This significant safety update highlights increased risks of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis for patients treated with the medication.
Background
Tofacitinib, also known by its brand names Xeljanz and Xeljanz XR, is a medication used to treat various inflammatory conditions. A boxed warning, also known as a Black Box Warning, is the strongest safety warning that the U.S. Food and Drug Administration (FDA) requires to be placed on the labeling of prescription medications. It is intended to call attention to serious or life-threatening risks associated with the drug.
What this means
The addition of a boxed warning to the tofacitinib label signals critical safety information for healthcare providers and patients. Clinicians prescribing tofacitinib extended-release tablets must now be acutely aware of the heightened risks. The warning specifically details increased risks for serious bacterial and fungal infections, an elevated risk of mortality, the potential for malignancy, the occurrence of major adverse cardiovascular events, and the risk of thrombosis. This necessitates careful patient selection, thorough risk assessment before and during treatment, and close monitoring for signs and symptoms of these adverse events. Patients should be counseled on these serious risks and advised to seek immediate medical attention if they experience any concerning symptoms. This label change underscores the importance of weighing the benefits of tofacitinib against its serious potential risks in each individual patient.
Source
This information is based on an FDA label revision for Tofacitinib Citrate, effective 2026-07-21. The details of the boxed warning are available on dailymed.nlm.nih.gov.