Real-world pharmacovigilance of tobramycin/dexamethasone: A safety signal analysis using the the Food and Drug Administration Adverse Event Reporting System (FAERS)

Abstract Background Tobramycin/dexamethasone is a widely used topical ophthalmic combination of aminoglycoside antibiotic and synthetic glucocorticoid. Its real-world post-marketing safety profile, especially regarding rare adverse events, demographic disparities, and temporal toxicity patterns, remains incompletely characterized. Methods This retrospective pharmacovigilance study analyzed data from the Food and Drug Administration Adverse Event Reporting System (FAERS) (2004 first quarter–2025 second quarter), including reports designating the drug as primary suspect. Disproportionality analyses (Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, Multi-item Gamma Poisson Shrinker), subgroup (gender, age, reporter type) and time-to-onset analyses (Weibull distribution) were conducted. Results A total of 1,085 primary suspect reports (3,338 distinct adverse events) were included. Eye Disorders was the predominant System Organ Class (44.55%, Reporting Odds Ratio = 39.41, 95% confidence interval: 36.79 − 42.21). Core adverse events included Eye Pain (n = 117, Reporting Odds Ratio = 43.46), Intraocular Pressure Increased (n = 62, Reporting Odds Ratio = 90.59), Ocular Hypertension (n = 36, Reporting Odds Ratio = 380.03), and rare severe Corneal Exfoliation (n = 14, Reporting Odds Ratio = 3243.77). Males, pediatric (< 18 years) and elderly (≥ 65 years) patients had higher adverse event risks. Median time-to-onset was 13 days (interquartile range: 2 − 15 days), with 88.08% of adverse events within 1 month and Weibull shape parameter = 0.521. Conclusions This study comprehensively characterizes the drug’s safety profile, confirming known ocular risks and identifying underrecognized severe adverse events. Demographic and temporal patterns support personalized monitoring, providing data-driven evidence to optimize post-marketing risk management.