To 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....
Audiologists should be aware that teprotumumab is associated with hearing-related adverse events in post-marketing data; patients on this drug warrant audiological monitoring, though causality and rates require further prospective study.
As teprotumumab use grows in thyroid eye disease management, audiologists may increasingly encounter referred patients with drug-related hearing complications, reinforcing the need for ototoxicity monitoring protocols.
- 01Disproportionality analysis of FDA FAERS data covering 5 years of teprotumumab post-marketing surveillance.
- 02Hearing-related adverse events are flagged as a notable safety signal for teprotumumab.
- 03Teprotumumab is an IGF-1R inhibitor approved for thyroid eye disease, not primarily an audiology drug.
- 04FAERS analysis is hypothesis-generating and cannot establish causation or true incidence rates.
- 05Findings support closer audiological follow-up for patients receiving teprotumumab.
Teprotumumab is associated with disproportionate reporting of hearing-related adverse events in the FDA adverse event reporting system over five years of post-marketing use.
studypartially supported- PMID
- 42089697
- DOI
- 10.1177/11206721261446011.
- Journal
- European Journal of Ophthalmology
- Publication type
- research_article
- Evidence level
- 4
- Population
- Patients with thyroid eye disease reported in FDA FAERS database who received teprotumumab post-approval
- Intervention
- Teprotumumab (IGF-1R inhibitor) for thyroid eye disease
Primary outcomes
Disproportionality of hearing-related adverse event reports in FAERS; Post-marketing safety signal identification over 5 years