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Exploring Ototoxicity Associated with Capmatinib: Insights from a Real-World Data Analysis of the FDA Adverse Event
Yuhao Lin1, Siqi Xu1, Muling Deng1
1Department of Radiation Oncology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, Fujian, People's Republic of China.
Background:
Capmatinib was approved by the US Food and Drug Administration (FDA) in 2020 for the treatment of non-small cell lung cancer with MET exon 14 mutation (METex14). Real-world studies on the safety of Capmatinib are still lacking. The aim of this study was to explore the significant adverse drug reactions (ADRs) associated with Capmatinib through the FDA Adverse Event Reporting System (FAERS) database.
Methods:
We employed the reported odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and the Empirical Bayes Geometric Mean (EBGM) as primary algorithms for the disproportionality analysis. Adverse events (AEs) were classified as adverse drug reactions (ADRs) solely upon fulfillment of criteria across all four algorithms.
Results:
In our study, there were 1767 cases explicitly attributed to Capmatinib. A total of 38 ADRs in preferred terms (PTs) level in 14 system-organ categories (SOCs) were identified after filtering. Notably, unexpected SOC "Ear and labyrinth disorders" and PTs "hypoacusis" and "deafness" were identified, without being specified in the drug label.
Conclusion:
Our study identified unexpected ADRs associated with Capmatinib, with a focus on ototoxicity-related events, underscoring the need for enhanced clinical monitoring and further investigation into the underlying mechanisms.
Insights
This study identified unexpected adverse drug reactions (ADRs) for Capmatinib, a lung cancer drug, including hearing loss. Further monitoring is recommended for Capmatinib safety in real-world use.
Area of Science:
- Pharmacovigilance
- Oncology
- Drug Safety
Background:
- Capmatinib is FDA-approved for non-small cell lung cancer (NSCLC) with MET exon 14 mutations (METex14).
- Real-world safety data for Capmatinib are limited.
- This study investigates significant adverse drug reactions (ADRs) of Capmatinib using the FDA Adverse Event Reporting System (FAERS).
Purpose of the Study:
- To identify and characterize significant adverse drug reactions (ADRs) associated with Capmatinib.
- To explore potential safety signals not previously documented in the drug label.
- To provide insights for enhanced clinical monitoring of Capmatinib therapy.
Main Methods:
- Utilized disproportionality analysis with four primary algorithms: ROR, PRR, BCPNN, and EBGM.
- Classified adverse events (AEs) as adverse drug reactions (ADRs) based on consensus across all algorithms.
- Analyzed 1767 Capmatinib-associated cases from the FAERS database.
Main Results:
- Identified 38 ADRs at the preferred term (PT) level across 14 system-organ categories (SOCs).
- Detected unexpected "Ear and labyrinth disorders" (SOC), including "hypoacusis" and "deafness" (PTs).
- These ototoxicity-related events were not specified in the current Capmatinib drug label.
Conclusions:
- Capmatinib is associated with unexpected ADRs, particularly ototoxicity.
- The findings highlight the importance of monitoring for hearing-related adverse events.
- Further research is needed to understand the mechanisms of these unexpected ADRs.
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