Pharmacovigilance Analysis of Azelastine-Related Adverse Events: Insights from the FDA FAERS Database (2006-2024)

Azelastine is widely used in the treatment of allergic rhinitis, and it is necessary to gain insight into the true extent of adverse events (AEs) associated with it.

This pharmacovigilance study was based on an analysis of reports from the FDA Adverse Event Reporting System (FAERS) for the period January 1, 2006, to December 31, 2024. AEs of drugs were compared using the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPN), and Multi-item Gamma Poisson Shrinkage (MGPS).

The number of AE occurrences in Respiratory, thoracic, and mediastinal disorders and Product issues was high. There is a significant difference in the proportion of occurrence between men and women. All AEs listed in the drug insert were validated through this analysis. In addition to the improvement of the drug process, the focus should still be on the adverse reactions such as Dysgeusia, Nasal discomfort, and Somnolence.

This study systematically depicts the safety profile of azelastine by analysing large-scale adverse reaction data and provides empirical evidence for the improvement of clinical dosing guidelines and risk communication strategies. Pharmacovigilance departments should maintain vigilance for rare but serious adverse reactions to azelastine to optimize its risk-benefit profile.