Post-Marketing Safety Signals of Four JAK Inhibitors for Alopecia Areata: An Indication-Restricted FAERS Pharmacovigilance Study
March 2026
in “
Journal of Dermatological Treatment
”
JAK inhibitors tofacitinib baricitinib ruxolitinib ritlecitinib alopecia areata FDA Adverse Event Reporting System neuropsychiatric events autoimmune events thrombocytosis deep vein thrombosis breast cancer pyrexia elevated blood cholesterol gastrointestinal events creatine phosphokinase elevation infections FDA
TLDR JAK inhibitors for alopecia areata have different safety risks, requiring specific monitoring for each drug.
This study analyzed the post-marketing safety profiles of four JAK inhibitors— tofacitinib, baricitinib, ruxolitinib, and ritlecitinib—used for alopecia areata by examining data from the FDA Adverse Event Reporting System from 2015 to 2025. The results showed that each JAK inhibitor had distinct safety signals: tofacitinib was linked to neuropsychiatric and autoimmune events, baricitinib to thrombocytosis, deep vein thrombosis, and breast cancer, ruxolitinib to pyrexia and elevated blood cholesterol, and ritlecitinib to gastrointestinal events and creatine phosphokinase elevation. The time-to-onset of adverse events varied, with tofacitinib and ruxolitinib showing earlier onset, ritlecitinib clustering within the first month, and baricitinib having a delayed onset. Serious adverse events were mostly related to infections, but varied by agent. The study concludes that JAK inhibitors for alopecia areata have diverse safety profiles, suggesting the need for agent-specific monitoring and personalized risk assessment in clinical settings.
