Assessment of Drug Induced Thyroid Dysfunction Risk Using the United States Food and Drug Administration Adverse Event Reporting System
Authors' conclusion
This study identified multiple drugs significantly associated with TD and highlighted sex, age, and specific medications as independent risk factors. These findings support improved pharmacovigilance and clinical awareness of drug-induced TD.
Study context
- Population
- Reports of thyroid dysfunction (TD) in the FDA Adverse Event Reporting System, Q1 2004 to Q1 2025reports
- Participants
- 44,317 reports
- Outcome
- Drugs associated with TD
Methodological detailsdisproportionality analysis of FDA Adverse Event Reporting System, disproportionality analysis (reporting OR; Bayesian confidence propagation neural network), least absolute shrinkage and selection operator (LASSO) regression, multivariate logistic regression, time-to-onset analysis
- Disproportionality analysis of FDA Adverse Event Reporting System
- Disproportionality analysis (reporting OR; Bayesian confidence propagation neural network)
- LASSO regression
- Multivariate logistic regression
- Time-to-onset analysis
Main finding
As reported in the abstract
Suspect drugs significantly associated with TD (signal detection)
172
Drugs associated with TD (LASSO)
43
Further findings
Time to onset of drug-induced TD
- Median time-to-onset
- 34 days (IQR: 7-105 days)
- Cases within first 100 days of drug initiation
- ≈75%
Report characteristics
- Female patients
- 60.3%
- Median patient age
- 59 years (IQR: 45-69 years)
Original publication
Assessment of Drug Induced Thyroid Dysfunction Risk Using the United States Food and Drug Administration Adverse Event Reporting System. Endocr Pract. Published 29 December 2025. doi:10.
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