Tofacitinib’s FDA label revision took effect on 2026-08-06, and the updated labeling includes a boxed warning. The warning highlights risks of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Background
Tofacitinib is sold as Xeljanz and Xeljanz XR, and the label revision applies to tofacitinib citrate. The FDA-linked DailyMed record identifies the change as a label update for this product.
What this means
For clinicians and patients, the boxed warning is a prominent safety signal that should be reviewed when considering or continuing therapy with tofacitinib. The label language emphasizes that patients treated with tofacitinib tablets are at increased risk for serious bacterial, fungal, viral, and other infections.
Source
This information is based on an FDA label record for Tofacitinib dated 2026-08-06. The record is available at dailymed.nlm.nih.gov.