Safety profile of upadacitinib in inflammatory Bowel disease: a dual-source pharmacovigilance study integrating FAERS signal detection and real-world clinical cohort analysis

BackgroundUpadacitinib, a selective Janus kinase 1 (JAK1) inhibitor, has demonstrated efficacy in inflammatory bowel disease (IBD). However, safety data in real-world Asian populations remain limited. This study aimed to characterize the adverse event (AE) profile of upadacitinib by integrating large-scale pharmacovigilance data with real-world clinical evidence.MethodsWe conducted a dual-source analysis comprising spontaneous reports from the U.S. Food and Drug Administration Adverse Event Repo