Disproportionality analysis and risk factor assessment of drug-associated thyroid dysfunction adverse events: a study based on the FAERS database.

BACKGROUND

Thyroid dysfunction (TD) is a common adverse event (AE) associated with various pharmacological agents. However, comprehensive real-world evaluations of drug-associated TD AEs remain limited.

METHODS

This study utilized the U.S. FDA Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the fourth quarter of 2024 to perform analysis. The reporting odds ratio method was calculated to detect signals of TD AEs, including hyperthyroidism and hypothyroidism. Chi-square tests, Bonferroni correction, and LASSO regression were employed to select relevant predictors of TD AEs, which were subsequently analyzed using multivariate logistic regression to assess their independent associations.

RESULTS

A total of 46,725 reports with TD AEs were identified, of which 18,057 were hyperthyroidism and 28,668 were hypothyroidism. The results indicated that 21 drugs met the univariate screening criteria for hyperthyroidism, while 36 drugs met the criteria for hypothyroidism. Most of the drugs associated with TD AEs were antineoplastic agents. Multivariate analysis revealed that female patients were more likely to experience drug-associated TD AEs. In addition, 20 drugs were identified as significant factors associated with hyperthyroidism, while 34 drugs were associated with hypothyroidism.

CONCLUSION

This study identified both known and previously unrecognized drug associations with TD AEs, particularly involving antineoplastic agents. The findings underscore the importance of routine thyroid monitoring during high-risk therapies and highlight the value of real-world pharmacovigilance in detecting emerging safety signals.