The FDA revised the boxed warning on the tofacitinib label effective August 24, 2026. The warning addresses serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, including increased risk of serious bacterial infections with tofacitinib extended-release tablets.
What changed
The event was a boxed-warning revision to the tofacitinib label. The supplied FDA summary identifies the warning categories as serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Key safety information
The label warning states that patients treated with tofacitinib extended-release tablets are at increased risk of developing serious bacterial infections. The supplied data do not provide incidence figures, comparative risks, patient-selection criteria, or additional details about the revised warning language.
What this means
The revision highlights serious infectious, cardiovascular, thrombotic, malignancy, and mortality risks associated with tofacitinib labeling. Clinicians, patients, and researchers should consult the revised FDA labeling for the complete warning text and applicable prescribing information. The supplied record does not identify a new indication, dosing change, contraindication, or clinical-trial result.
Source
Source: FDA, DailyMed drug-label document, effective August 24, 2026. The authoritative document is hosted at dailymed.nlm.nih.gov.