Tofacitinib FDA label update (2026-07-27)

What To Know

This is the FDA (DailyMed) updated prescription drug label (regulatory record) for tofacitinib extended‑release (XELJANZ) reflecting indications, boxed warnings, and safety-limited dosing.

The label lists approved indications including moderately to severely active ulcerative colitis in adults, and repeats boxed warnings about serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

It also states dosing limitations and recommends against combining tofacitinib with biologic therapies or potent immunosuppressants (e.g., azathioprine, cyclosporine) for UC. The update is a regulatory/drug‑label document, not a research paper or clinical trial report.

It documents known safety concerns (infections, increased mortality in a specific RA postmarketing study versus TNF blockers, malignancy risks, and thrombotic events) and contains usage limitations and monitoring guidance. Follow-up sections of the label describe baseline screening (e.g., latent TB testing) and monitoring during treatment.

If you take tofacitinib or are considering it for ulcerative colitis, discuss the label changes with your prescribing clinician. They can explain how the boxed warnings and dosing limitations apply to your personal risks (age, smoking, cardiovascular risk factors, concurrent immunosuppression) and whether alternative therapies are preferred.