Signal mining of drug-related thyroid abnormalities using the FAERS database

ZHAO Jian-qun; WU Yu-pei; SHI Yan-shuo; YU Zeng-fang; MA Yin-ling

doi:10.20251/j.cnki.1003-3734.2026.07.013

Abstract：Objective:To identify and analyze disproportionality signals of drug-related thyroid adverse reactions,summarize potentially high-risk drugs,and provide references for clinical medication safety.Methods:Reports of thyroid adverse events from the US Food and Drug Administration Adverse Event Reporting System(FAERS)between January 2004 and December 2024 were retrieved.Disproportionality analysis was used to assess drug-thyroid adverse event associations,with further evaluation of demographics,time to onset,and patient outcomes.Results:Among 1 261 drugs,80 exhibited signals of thyroid adverse reactions,including 39 antineoplastic agents(48.75%),7 anti-infectives(8.75%),6 cardiovascular drugs(7.5%),and 9 neurologic agents(11.25%).Amiodarone(2 537 cases),pembrolizumab(1 953 cases),and nivolumab(1 748 cases)were the most frequently reported agents.The strongest thyroid signal intensities(by ROR)were observed for biotin(ROR=164.57),amiodarone(ROR=61.51),bexarotene(ROR=46.85),and benzophenylamine(ROR=35.26).Females showed higher susceptibility(female-to-male ratio:1∶2.33),particularly in individuals aged 18～64 years(18352 cases,59.12%).Thyroid abnormalities associated with antineoplastic drugs had a shorter time to onset.Higher proportions of fatal outcomes were associated with digoxin,sorafenib,pembrolizumab,and nivolumab.Conclusion:Numerous drugs are associated with the risk of thyroid dysfunction,warranting vigilant monitoring.Females,especially those aged 18～64,represent a high-risk population for frug-related thyroid abnormalities.For antineoplastic agents,the first 60 days of treatment constitute a critical monitoring period;long-term medications demand regular surveillance.