To identify and analyze disproportionality signals of drug-related thyroid adverse reactions, summarize potentially high-risk drugs, and provide references for clinical medication safety.
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.
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 (18 352 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.
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.
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |