On 2026-08-10, the FDA revised the label for tofacitinib to include a boxed warning. The warning on the updated labeling highlights serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Background
Tofacitinib, also marketed as Xeljanz, Xeljanz XR, and tofacitinib citrate, is an FDA-labeled medicine with an updated safety warning in this revision. The change is reflected on the DailyMed label record for the product.
What this means
For clinicians and pharmacists, the label revision reinforces that serious infections and other major safety risks remain central to prescribing and monitoring decisions for tofacitinib. Because this event is a label update rather than a new efficacy readout, the key takeaway is the strengthened boxed warning language on the product label.
Source
This information is based on the FDA label record for tofacitinib, dated 2026-08-10, available on dailymed.nlm.nih.gov at the linked product label page.