Safety Assessment of Ritlecitinib Based on the FDA Adverse Event Reporting System (FAERS) Database: A Real-World Pharmacovigilance Study

This study evaluates the safety of ritlecitinib, approved by the FDA for treating severe alopecia areata in individuals aged 12 and older, using data from the FDA Adverse Event Reporting System (FAERS) from early 2023 to late 2024. A total of 12,390 adverse events (AEs) were identified, with 18 positive signal preferred terms (PTs). Common AEs included headache, increased blood creatine phosphokinase, urticaria, acne, infection, and drug hypersensitivity. Additionally, five unexpected significant AEs were discovered, such as diabetes mellitus, hair color changes, thyroid disorder, blood cholesterol abnormality, and increased lipids. The study provides a comprehensive safety overview of ritlecitinib, aiding its clinical application.