Capmatinib and Hearing Loss
Yes, capmatinib can cause hearing loss, and this represents a newly identified adverse effect not currently listed in the FDA drug label. Recent real-world pharmacovigilance data from the FDA Adverse Event Reporting System has identified ototoxicity as an unexpected adverse drug reaction associated with capmatinib, specifically including hypoacusis (reduced hearing) and deafness 1.
Evidence for Ototoxicity
A 2025 pharmacovigilance analysis of 1,767 capmatinib cases identified "Ear and labyrinth disorders" as a significant adverse drug reaction category, with specific events of "hypoacusis" and "deafness" meeting all four disproportionality analysis criteria (ROR, PRR, BCPNN, and EBGM) 1.
These ototoxicity-related events were not specified in the original drug label, making this an unexpected safety signal that warrants clinical attention 1.
The Phase 1 clinical trial data did not specifically highlight hearing loss as a prominent adverse event, though the study focused primarily on dose-limiting toxicities at various dose levels 2.
Clinical Implications and Monitoring
Patients receiving capmatinib should be counseled about the potential risk of hearing loss and instructed to report any auditory symptoms immediately, including:
- Decreased hearing acuity 1
- Tinnitus (ringing in the ears) 1
- Difficulty understanding speech 1
- Any subjective changes in hearing 1
Baseline audiometry should be considered before initiating capmatinib therapy, with periodic monitoring during treatment, particularly in patients with:
- Pre-existing hearing impairment 1
- Concurrent use of other ototoxic medications 3, 4
- Advanced age 3
- Renal impairment (which may affect drug clearance) 3
Important Caveats
The mechanism of capmatinib-induced ototoxicity remains unclear and requires further investigation 1.
The incidence and severity of hearing loss with capmatinib are not yet well-characterized, as this adverse effect was identified through post-marketing surveillance rather than controlled clinical trials 1.
If hearing loss develops during capmatinib therapy, immediate consultation with an audiologist is recommended, and consideration should be given to dose modification or discontinuation depending on the severity and the patient's cancer treatment needs 1.
Unlike aminoglycoside-induced hearing loss, which is well-documented as often irreversible 5, the reversibility of capmatinib-associated hearing loss is currently unknown 1.