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Comprehensive analysis of etrasimod-related adverse events based on the FDA Adverse Event Reporting System database
Zi-Ru Zhou1, Wen-Jia Zhang, Xiao-Yi Zhao
1Department of Gastroenterology, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi, Jiangsu, China.
Indian Journal of Pharmacology
|August 12, 2026
Summary
Etrasimod, a new ulcerative colitis treatment, shows safety risks including gastrointestinal issues and unexpected diabetes-related adverse events. Early monitoring for conditions like diabetic retinopathy is crucial for patient safety.
Area of Science:
- Pharmacovigilance
- Gastroenterology
- Endocrinology
Background:
- Etrasimod is a novel selective sphingosine-1-phosphate receptor modulator for ulcerative colitis treatment.
- Real-world safety data are essential for understanding Etrasimod's adverse event profile.
Purpose of the Study:
- To analyze real-world adverse events (AEs) of Etrasimod using the FDA Adverse Event Reporting System (FAERS) database.
- To identify key AE signals and provide a comprehensive safety assessment for Etrasimod.
Main Methods:
- Analysis of Etrasimod-related AE data from FAERS (Q4 2023 - Q1 2025) using frequency and Bayesian methods.
- Utilized reporting odds ratio (ROR), proportional reporting ratio, and Bayesian confidence propagation neural network for signal detection.
- Data accessed on July 7, 2025; de-identified case reports were analyzed.
Main Results:
- 1284 AE reports collected; 871 were Etrasimod-related, predominantly from the U.S. in patients aged 18-65.
- Common AEs included gastrointestinal disorders and general disorders, with "Drug Ineffective" and "Condition Aggravated" as prominent signals.
- Significant signals for eye disorders (diabetic eye disease, diabetic retinopathy) and new potential metabolic AEs (Type 2 diabetes mellitus) were identified.
Conclusions:
- Etrasimod safety concerns encompass gastrointestinal, metabolic, and eye diseases, plus administration site reactions.
- Diabetes-related AEs (Type 2 diabetes, diabetic retinopathy) emerged as a significant, unexpected safety signal requiring prioritized monitoring.
- Close monitoring of high-risk populations, especially early in treatment, is recommended; further research is needed.
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