Tofacitinib’s label carried a boxed warning effective 2026-08-07. The warning highlighted risks of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Background
Tofacitinib is marketed as Xeljanz, Xeljanz XR, and tofacitinib citrate. The FDA label revision applies to the product record available on DailyMed.
What this means
The boxed warning places these safety risks prominently on the prescribing information and is intended to guide clinician risk assessment when considering tofacitinib. For patient-facing use, the warning underscores the need to weigh benefits against serious infectious, cardiovascular, thrombotic, and malignancy-related risks described on the label.
Source
This information is based on an FDA label revision dated 2026-08-07. The record is available on dailymed.nlm.nih.gov at the provided label URL.