Pharmacovigilance Signals and Determinants of Adverse Events Linked to Inhaled Asthma Medications: A Retrospective Analysis Using the FAERS Database

PURPOSE: Asthma is a chronic inflammatory respiratory disorder primarily managed with medication. This study evaluated adverse drug events (ADEs) associated with inhaled asthma therapies and related factors using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. METHODS: Data from FAERS spanning Q1 2004 to Q4 2024 were extracted and processed according to FDA guidelines, and ADE reports were classified using Medical Dictionary for Regulatory Activities terms. Analysis included logistic regression with variables such as sex, age, and weight, as well as receiver operating characteristic curve assessment of model predictive performance. ADE onset timing was also examined. FINDINGS: Baseline results indicated that the highest number of ADE reports were associated with budesonide in 2022. Thoracic and respiratory disorders, along with drug ineffectiveness, were the most frequent ADE categories. Univariate regression identified age, weight, and sex as factors linked to reduced ADE risk (odds ratio < 1). Most ADEs occurred within 0-30 days of treatment initiation. IMPLICATIONS: This study offers real-world pharmacovigilance signals regarding the safety of inhaled asthma medications, identifies factors associated with ADEs, characterizes typical ADE onset timing, and highlights directions for future research.