The label for Tofacitinib (Xeljanz, Xeljanz XR) underwent a significant revision on 2026-06-04, with the addition of a new Boxed Warning. This update highlights critical safety information regarding increased risks of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis for patients.
Background
Tofacitinib is known by its brand names Xeljanz and Xeljanz XR, and is also referred to as tofacitinib citrate. This medication has been subject to ongoing safety evaluations by regulatory bodies.
What this means
The inclusion of a Boxed Warning on the Tofacitinib label, effective 2026-06-04, provides crucial updated safety information for healthcare professionals and patients. This warning explicitly states: "WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS". It further elaborates that "SERIOUS INFECTIONS Patients treated with tofacitinib tablets are at increased risk for developing serious bacterial, fungal, viral, and" other infections. This means prescribers must exercise heightened vigilance when considering Tofacitinib for patients, particularly those with pre-existing risk factors for these conditions. The warning underscores the need for thorough patient evaluation before and during treatment, including monitoring for signs and symptoms of infection, malignancy, cardiovascular events, and thrombosis. Patient counseling should comprehensively cover these serious potential adverse effects, ensuring individuals are fully informed about the risks associated with Tofacitinib therapy.
Source
The information regarding this label revision for Tofacitinib was obtained from the FDA. This update, detailing the addition of a Boxed Warning, became effective on 2026-06-04 and is documented on dailymed.nlm.nih.gov.