ArticleScientific reports2025
Safety evaluation of etrasimod for ulcerative colitis based on the FAERS database.
Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- Review
- Multi-target-directed drugs: new additions in 2025 and post-marketing safety surveillance of drugs marketed in 2022-2024.Pharmacological reports : PR · 2026Review
- Article
- A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for etrasimod.Frontiers in pharmacology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
Etrasimod is a sphingosine 1-phosphate (S1P) receptor modulator that selectively activates S1P receptor subtypes 1, 4, and 5, but exhibits no detectable activity on S1P2 and S1P3. It is primarily used for the treatment of ulcerative colitis (UC). There has been limited research on the adverse events (AEs) associated with etrasimod during its use in treating UC, necessitating a comprehensive and real-world evaluation of its clinical safety. This study aims to assess the AEs of etrasimod in UC patients using data from the FDA Adverse Event Reporting System (FAERS) database. By analyzing all AEs in the FAERS database since 2004, the safety of etrasimod in clinical applications was evaluated. Based on the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinkage (MGPS), we employed disproportionality analysis to identify all AEs associated with etrasimod in clinical application. In this study, positive signals of etrasimod-related AEs spanned multiple system organ classes (SOCs), including general disorders and administration site conditions (ROR = 1.59, 95% CI: 1.41-1.80), gastrointestinal disorders (ROR = 2.36, 95% CI: 2.06-2.71), eye disorders(ROR = 5.18, 95% CI: 4.34-6.19), metabolic and nutritional disorders(ROR = 3.49, 95% CI: 2.85-4.28), and immune system disorders(ROR = 1.56, 95% CI: 1.04-2.33). And we identified previously unreported AEs not currently listed on drug label, including headache, dizziness, fatigue, diarrhea, blurred vision, etc. Our research provides real-world evidence on the safety profile of etrasimod, which is crucial for clinicians to safeguard patient health.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.