A real-world data analysis of Ozanimod in the FDA Adverse Event Reporting System (FAERS) database

Ozanimod was approved in the United States in March 2020 for the treatment of relapsing multiple sclerosis and subsequently in 2021 for moderately to severely active ulcerative colitis. However, there is limited information available on the adverse drug events associated with its use. The main objective of this study was to explore the safety of Ozanimod after its market launch. Data was gathered from the United States Food and Drug Administration Adverse Event Reporting System database. To detect safety signals associated with Ozanimod adverse events, disproportionality analyses were performed using the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker algorithms. We extracted 7,118,789 reports from the FDA Adverse Event Reporting System database, of which 5429 reports identified Ozanimod as the primary suspect drug. Adverse reactions attributed to Ozanimod manifested across 26 organ systems, encompassing a total of 90 preferred terms meeting the criteria of all 4 algorithms simultaneously. In our study, back pain, hypertension, increased blood pressure, elevated hepatic enzymes, abnormal hepatic enzymes, pollakiuria, micturition urgency, and herpes zoster were consistent with the results of clinical trials. Notably, we observed some common adverse drug reaction signals, such as hypesthesia, muscle spasms, balance disorder, and gait disturbance, which were not documented in the official drug label. The majority of adverse events occurred within the initial 30 days following the initiation of Ozanimod treatment. Ozanimod presents the potential for diverse adverse reactions alongside its therapeutic benefits. Hence, in clinical practice, prompt detection of adverse drug reactions and the implementation of timely and effective preventive measures are essential.