Safety evaluation of etrasimod for ulcerative colitis based on the FAERS database

Etrasimod is a sphingosine 1-phosphate (S1P) receptor modulator that selectively activates S1P receptor subtypes 1, 4, and 5, but exhibits no detectable activity on S1P2 and S1P3. It is primarily used for the treatment of ulcerative colitis (UC). There has been limited research on the adverse events (AEs) associated with etrasimod during its use in treating UC, necessitating a comprehensive and real-world evaluation of its clinical safety. This study aims to assess the AEs of etrasimod in UC patients using data from the FDA Adverse Event Reporting System (FAERS) database. By analyzing all AEs in the FAERS database since 2004, the safety of etrasimod in clinical applications was evaluated. Based on the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinkage (MGPS), we employed disproportionality analysis to identify all AEs associated with etrasimod in clinical application. In this study, positive signals of etrasimod-related AEs spanned multiple system organ classes (SOCs), including general disorders and administration site conditions (ROR = 1.59, 95% CI: 1.41-1.80), gastrointestinal disorders (ROR = 2.36, 95% CI: 2.06-2.71), eye disorders(ROR = 5.18, 95% CI: 4.34-6.19), metabolic and nutritional disorders(ROR = 3.49, 95% CI: 2.85-4.28), and immune system disorders(ROR = 1.56, 95% CI: 1.04-2.33). And we identified previously unreported AEs not currently listed on drug label, including headache, dizziness, fatigue, diarrhea, blurred vision, etc. Our research provides real-world evidence on the safety profile of etrasimod, which is crucial for clinicians to safeguard patient health.