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June 25, 2026Indian Journal of Pharmacology

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

Zi-Ru Zhou Wen-Jia Zhang Xiao-Yi Zhao Yue Shen Q Zhan Jing Sun

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Key Points

This study aims to analyze adverse events related to Etrasimod and identify key safety signals using the FAERS database.
Analyzed AE data from FAERS database between Q4 2023 and Q1 2025.
Employed frequency-based and Bayesian methods including reporting odds ratio (ROR) and Bayesian neural network.
Collected a total of 1284 AE reports, with 871 linked to Etrasimod.
94.9% of AE reports were from the U.S., primarily involving patients aged 18-65 (66.9%).
Common AEs included gastrointestinal disorders, with 'Drug Ineffective' and 'Condition Aggravated' as prominent signals.
New potential AEs identified included Type 2 diabetes, with high signal strength for eye disorders like diabetic retinopathy.

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Implication

Analyzes adverse events of Etrasimod in ulcerative colitis, highlighting key safety signals.

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Cite This Study

Zhou et al. (2026) studied this question.

synapsesocial.com/papers/6a3f6972aea7db3c195403d4 https://doi.org/10.4103/ijp.ijp_1209_25

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5Beyond the Colon: Acute Hemolysis Associated With Etrasimod TherapyOriginal Research · 2026