Tobacco and smoking and Tofacitinib interaction
Tobacco and smoking and Tofacitinib: the Tofacitinib prescribing label flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.
Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.
What the FDA labels say
From the Tofacitinib (XELJANZ XR) label · effective 2026-07-12
Patients who are current or past smokers are at additional increased risk.
Patients who are current or past smokers are at additional increased risk [see Clinical Studies (14.6) ].
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with XELJANZ/XELJANZ XR, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy while on treatment, and patients who are current or past smokers.
The incidence rate of lung cancers per 100 patient-years among current and past smokers was 0.59 for XELJANZ tablets 10 mg twice a day, 0.48 for XELJANZ tablets 5 mg twice a day, and 0.27 for TNF blockers [see Clinical Studies (14.6) ] .
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