ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacoepidemiology
A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for Etrasimod
Provisionally accepted
- 1Eighth Clinical Medical College, Guangzhou University of Chinese Medicine, Foshan, China
- 2Foshan Hospital of Traditional Chinese Medicine, Foshan, China
- 3First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
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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 frequent AEs were drug ineffectiveness, condition aggravated, headache, and dizziness. Signals were concentrated in gastrointestinal, general, and nervous system disorders. Strong signals included ulcerative proctitis, increased faecal calprotectin, and macular oedema. Critically, our comparative analysis suggested a potentially distinct safety profile for etrasimod, such as a more favorable signal for lymphocyte count decreased compared to other S1P modulators. Conclusions: This large-scale, updated analysis confirms the established safety profile of etrasimod while providing novel, comparative insights. Our findings, derived from the most recent and extensive FAERS dataset to date, underscore that etrasimod's real-world safety is characterized by class-related AEs and disease exacerbations. The lack of unexpected signals remains reassuring. The frequent reporting of lack of efficacy highlights the need for close monitoring, and the comparative data offer valuable context for clinicians selecting S1P receptor modulator therapy.
Keywords: Etrasimod, FDA Adverse Event Reporting System, disproportionality analyses, Pharmacovigilance, Adverse event
Received: 26 Aug 2025; Accepted: 30 Oct 2025.
Copyright: © 2025 Wu, Ke and Li. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Yingxiu Wu, wyx20201206@163.com
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.