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Comprehensive Analysis of Ozanimod-Related Adverse Events Based on the FAERS Database
Zi Ru Zhou1,2, Qun Yan Zhou1,2, Yue Shen1
1Department of Gastroenterology, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi, Jiangsu, China.
World Journal of Oncology
|July 23, 2026
Summary
This study analyzed 15,910 adverse event reports for ozanimod, identifying known safety concerns and potential new signals like depression and thyroid cancer. Continued monitoring and further validation are recommended for this ulcerative colitis and multiple sclerosis drug.
Area of Science:
- Pharmacovigilance and Drug Safety
- Clinical Pharmacology
- Immunology
Background:
- Ozanimod is approved for ulcerative colitis (UC) and multiple sclerosis (MS).
- Postmarketing adverse event (AE) data for ozanimod requires further characterization.
- Sphingosine-1-phosphate receptor modulation is the mechanism of action.
Purpose of the Study:
- To characterize the postmarketing adverse event (AE) profile of ozanimod.
- To identify pharmacovigilance reporting signals using FAERS data.
- To evaluate both labeled and unlabeled safety signals associated with ozanimod.
Main Methods:
- Utilized FDA Adverse Event Reporting System (FAERS) database for AE reports from Q2 2020 to Q1 2025.
- Applied frequency-based and Bayesian disproportionality methods (ROR, PRR, BCPNN, EBGM).
- Analyzed 15,910 AE reports, with 7,305 suspecting ozanimod as the primary drug.
Main Results:
- Common AEs included fatigue, headache, dizziness, and back pain.
- Confirmed labeled safety events: decreased lymphocyte count, bradycardia, hypertension, macular edema, liver abnormalities.
- Identified potential unlabeled signals: depression, despair, decreased interest, penile swelling, papillary thyroid cancer.
- Disease-related terms (MS relapse, UC) were frequent but may reflect disease activity.
Conclusions:
- The study provides a postmarketing safety profile for ozanimod.
- Supports ongoing monitoring of known safety issues and careful interpretation of disease-related reports.
- Recommends further validation of unlabeled signals in prospective studies or real-world data.
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