On August 13, 2026, a boxed warning was present on the FDA-listed label for tofacitinib, also known as Xeljanz and Xeljanz XR. The warning states that patients treated with tofacitinib tablets face an increased risk of serious infections, including bacterial, fungal, viral, and opportunistic infections and tuberculosis, which may lead to hospitalization or death.
Background
Tofacitinib is the drug identified in the labeling record. The available data describe the label warning and its safety concern but do not provide additional information about the drug’s class, mechanism, approved indications, dosing, or the prevalence of any related condition.
What the label says
The boxed warning identifies serious infections as a major risk for patients receiving tofacitinib tablets. The listed infection categories include bacterial, fungal, viral, and opportunistic infections. Tuberculosis is specifically included among the risks. The warning states that these infections may result in hospitalization or death.
What this means
The label language places serious infection risk at the highest-warning level used in the prescribing information. Clinicians and patients reviewing tofacitinib treatment should consult the current product labeling for the full warning, including the information referenced by the label. This record alone does not provide infection rates, comparative findings, treatment recommendations, or details about the circumstances under which the risks occurred.
Source
This article is based on an FDA-listed drug-label document available through DailyMed, with the label event effective on August 13, 2026. The source document is the DailyMed prescribing-information record for tofacitinib, available at dailymed.nlm.nih.gov.