A comprehensive study on drug-related dysphonia: a 20-year disproportionality analysis of the FAERS database.

OBJECTIVE: Utilizing the FDA Adverse Event Reporting System (FAERS) database, this study conducts signal detection for drugs associated with dysphonia, aiming to optimize clinical decision-making and ensure safer drug usage. METHODS: Four disproportionality analysis methods—the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM)—were applied to data extracted from the FAERS database to identify adverse events (AEs) associated with dysphonia. RESULTS: From the first quarter of 2004 to the fourth quarter of 2024, a total of 52654 drug-related dysphonia reports were recorded. A total of 4250 drugs were identified as having potential risk signals. The highest incidence of populations related to dysphonia AEs was 30.77% in the 41–65 age group. Based on the sheer number of reported cases, among the top 5 drugs with the highest number of reported drug-induced dysphonia events, etanercept (1378 cases) ranked first. Adalimumab (1349 cases) and fluticasone/salmeterol (1134 cases) were the second and third most reported medications, respectively. In contrast, the top 5 drugs associated with the risk of dysphonia under the ROR algorithm were fluticasone/salmeterol (ROR = 27.5), aclidinium bromide (ROR = 23.14), cabozantinib (ROR = 18.66), ipratropium bromide (ROR = 16.8), and irbesartan (ROR = 15.21). Additionally, the timing analysis of dysphonia-related AEs revealed that the highest incidence (41.22%) occurred within the first seven days. CONCLUSION: This study, based on large-scale real-world data, reveals the potential associations between drugs and dysphonia. The findings provide valuable insights for drug safety monitoring and have significant public health implications. By uncovering previously unrecognized potential risks, this research lays the groundwork for further advancements in pharmacovigilance.