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

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.

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Publication Details

Journal
Frontiers in Pharmacology
Published
2025-11-11
DOI
https://doi.org/10.3389/fphar.2025.1693090
Citations
4
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
Type
article
Field-Weighted Citation Impact
5.23

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article

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

Wei Ke, Yingxiu Wu, Huibiao Li
4 citations
Frontiers in Pharmacology
Pharmacovigilance and Adverse Drug Reactions
5.23
article

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

Wei Ke, Yingxiu Wu, Huibiao Li
article en
4 citations

Abstract

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.

Frontiers in PharmacologyVol. 16
Guangzhou University of Chinese Medicine (CN), Foshan Hospital of TCM (CN), First Affiliated Hospital of Guangzhou University of Chinese Medicine (CN)
National Natural Science Foundation of China
Openalex Percentile: Top 4%
Pharmacovigilance and Adverse Drug Reactions
5.23
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