A real-world pharmacovigilance study of omalizumab using disproportionality analysis in the FDA adverse drug events reporting system database

Nature : published 7 March 2025

Omalizumab is a biologic agent used in the management of allergic conditions, including asthma and urticaria. Although the efficacy of omalizumab has been well established, its safety profile is primarily derived from clinical trials with limited sample sizes. To conduct a comprehensive evaluation of its safety in larger populations, this study conducted an extensive analysis of data sourced from the America Food and Drug Administration’s Adverse Event Reporting System (FAERS), with the aim of elucidating adverse drug events associated with omalizumab in real-world settings. The study extracted reports of adverse events associated with omalizumab from the FAERS database covering the period from the first quarter of 2004 to the second quarter of 2024.

The results of the analysis indicated that omalizumab-related adverse events displayed significant gender and age disparities. The median time to onset for all documented adverse events was approximately 145 days, with a substantial proportion occurring after one year of treatment. This study not only offers a significant reference for optimizing the utilization of omalizumab, enhancing its efficacy while minimizing potential side effects, but also facilitates the safe application and broader implementation of omalizumab in clinical practice.

Link to full article : https://www.nature.com/articles/s41598-025-91463-5