A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for etrasimod.

ABSTRACT:

Objective

To characterize the post-marketing safety profile of etrasimod using the latest data from the FDA Adverse Event Reporting System (FAERS), and to provide a comparative analysis versus other sphingosine-1-phosphate (S1P) receptor modulators.

Methods

AE reports associated with etrasimod were retrieved from FAERS (Q1 2004 - Q2 2025). Disproportionality analyses were conducted using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) methods. A comparative analysis against fingolimod and ozanimod was performed to contextualize findings.

Results

We identified 2,104 AE reports from 967 patients-a larger cohort than previously described. The most freq

SUBMITTER: Wu Y 

PROVIDER: S-EPMC12644091 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature