Aims/Background Tinnitus is a very common condition, and is a side effect of many medications. The panorama of drug-induced tinnitus has widened in recent decades, and post-marketing data are needed to gain a better insight into adverse drug reactions related to tinnitus. However, there are currently few studies on drug-induced tinnitus. We aimed to explore the details of real-world drug-related tinnitus. Methods We collected data on adverse drug reactions related to tinnitus from the Food and Drug Administration Adverse Event Reporting System (FAERS) database for the fourth quarter of 2012 to the fourth quarter of 2023. The top 25 tinnitus-associated drugs and indications were analyzed, and reporting odds ratios (RORs) were used to assess the association between drugs and adverse events (AEs). Results A total of 29,460 patients were enrolled in our study, with a greater proportion of women (59.1%) than men (31.7%). Among all tinnitus-related drugs, duloxetine (n = 1510, ROR [95% confidence interval (CI)] = 11.99 [11.38-12.63]), ciprofloxacin (n = 938, ROR [95% CI] = 9.96 [9.33-10.63]), and adalimumab (n = 759, ROR [95% CI] = 0.68 [0.64-0.73]) displayed the strongest associations. Among all tinnitus-related indications, depression (n = 1172), rheumatoid arthritis (n = 947), and multiple sclerosis (n = 914) were the most relevant indications. Vertigo (n = 2443, ROR [95% CI] = 7.51 [7.21-7.82]), deafness (n = 1740, ROR [95% CI] = 13.50 [12.86-14.18]), and hypoacusis (n = 1550, ROR [95% CI] = 6.11 [5.81-6.43]) were the most common concomitant ototoxic AEs in patients reporting tinnitus. Conclusion Our study mined and analyzed the AEs signals of drug-induced tinnitus and provided a reference for the safe clinical application of the drugs.
Keywords: Food and Drug Administration (FDA) Adverse Event Reporting System database; adverse events; drug-induced tinnitus; ototoxicity monitoring.