The U.S. Food and Drug Administration (FDA) updated the label for tofacitinib (Xeljanz, Xeljanz XR) on 2026-06-09, adding a boxed warning. This significant revision highlights several serious risks associated with the drug, including serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Background
Tofacitinib, marketed as Xeljanz and Xeljanz XR, is a prescription medication. This label revision updates important safety information for healthcare providers and patients regarding its use.
What this means
The addition of a boxed warning to the tofacitinib label on 2026-06-09 is a significant update for healthcare professionals and patients. This warning highlights several critical safety concerns. Patients treated with tofacitinib, including extended-release tablets, are now explicitly noted to be at increased risk for developing serious bacterial, fungal, viral, and other opportunistic infections that may lead to hospitalization or death. Furthermore, the warning emphasizes an increased risk of mortality, various malignancies (including lymphoma and non-melanoma skin cancer), major adverse cardiovascular events (MACE) such as myocardial infarction and stroke, and thrombosis, including deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis. Clinicians prescribing tofacitinib must carefully assess individual patient risk factors for these serious conditions and ensure vigilant monitoring throughout treatment. Patients should receive comprehensive counseling regarding these potential severe adverse events before initiating or continuing therapy.
Source
The information regarding this label revision was sourced from the U.S. Food and Drug Administration (FDA). The updated label for tofacitinib (Xeljanz, Xeljanz XR), including the boxed warning, became effective on 2026-06-09 and is available on dailymed.nlm.nih.gov.