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

ABSTRACT: 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. We 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. We assessed the significance of the associatio

SUBMITTER: Song Y 

PROVIDER: S-EPMC11889112 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature