Five year of post-marketing safety of teprotumumab: A disproportionality analysis of the FDA adverse event reporting system.

PurposeTo evaluate adverse events (AEs) associated with teprotumumab in the reatment of thyroid eye disease (TED).MethodsReports involving teprotumumab were extracted from the U.S.FDA Adverse Event Reporting System (FAERS) from the first quarter of 2020 to the first quarter of 2025. After data standardization, disproportionality analyses were performed using multiple signal detection algorithms, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM).ResultsA total of 1,357 reports were identified. Detected signals at the system organ class (SOC) level included ear and labyrinth disorders, eye disorders, social circumstances and reproductive system and breast disorders. A total of 143 Preferred Terms (PTs) met the criteria of four algorithms. Among these, signals within the "Ear and labyrinth disorders" SOC were predominant (n = 598). Tinnitus was the most frequently reported PT (n = 146). The highest disproportionality signals, based on ROR values, were observed for permanent deafness (ROR 10,021.8; 95% CI 5,544.31-18,115.24), autophony (ROR 3,282.12; 95% CI 1,333.19-8,080.12), and patulous eustachian tube (ROR 1,401.68;95% CI 499.54-3,932.99).ConclusionThese findings provide important real-world safety evidence and may support safer clinical use of teprotumumab.