Comprehensive analysis of etrasimod-related adverse events based on the FDA Adverse Event Reporting System database

Abstract: OBJECTIVE: Etrasimod, a selective sphingosine-1-phosphate receptor modulator, is a new treatment for ulcerative colitis. This study aims to analyze the real-world distribution of adverse events (AEs) related to Etrasimod using the FDA Adverse Event Reporting System (FAERS) database, identify key AE signals, and provide a comprehensive safety assessment. MATERIALS AND METHODS: AE data related to Etrasimod from the FAERS database between Q4 2023 and Q1 2025 were analyzed using frequency-based and Bayesian methods, including reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and Empirical Bayesian Geometric Mean. Data from the FAERS were accessed on July 7, 2025. The authors did not have access to information that could identify individual participants during or after data collection, as FAERS provides only de-identified case reports. RESULTS: A total of 1284 AE reports were collected, of which 871 were Etrasimod related. Most reports (94.9%) came from the U.S. and primarily involved patients aged 18–65 (66.9%). The most common AEs were related to gastrointestinal disorders and general disorders, with “Drug Ineffective” and “Condition Aggravated” being prominent signals. Eye disorders, including diabetic eye disease and diabetic retinopathy (DR), were identified with high signal strength. New potential AEs such as Type 2 diabetes mellitus and diabetic eye disease were also identified. Severe events such as macular edema and blood cholesterol abnormal, although rare, showed high signal strength. CONCLUSION: Etrasimod’s safety risks primarily involve gastrointestinal issues, metabolic disorders, eye diseases, and reactions at the administration site. Most notably and unexpectedly, diabetes-related AEs constituted a prominent new safety signal, including type 2 diabetes, DR, and diabetic eye disease, and should be prioritized in early safety monitoring. Clinicians should monitor high-risk populations closely, especially in the early stages of treatment. Further research is needed to validate these findings and optimize safe use of Etrasimod.