On 2026-08-04, the FDA label for tofacitinib carried a boxed warning for serious infections. The warning states that patients treated with tofacitinib tablets are at increased risk for serious bacterial, fungal, viral, and opportunistic infections, including tuberculosis, that may lead to hospitalization or death.
Background
Tofacitinib is marketed as Xeljanz, Xeljanz XR, and tofacitinib citrate. The label revision was posted by the FDA in DailyMed and applies to the product label identified by setid 7d4f5cfa-35a8-1458-a609-f6b417946abb.
What this means
This label action reinforces infection risk as a major safety issue for clinicians prescribing tofacitinib. The boxed warning highlights the need to weigh benefit against the risk of serious infection, including tuberculosis, when using the drug.
Source
This information is based on an FDA label revision dated 2026-08-04 in DailyMed. The record is available at dailymed.nlm.nih.gov.