Real-world adverse event analysis of Adagrasib: Insights from the FAERS database

Adagrasib is a potent and orally available small-molecule inhibitor that irreversibly targets the KRAS G12C mutant isoform. This innovative therapeutic agent represents a significant advancement in the field of oncology, offering a targeted approach to treating cancers driven by this specific mutation. The precision and potency of Adagrasib make it a promising candidate for improving patient outcomes in KRAS G12C-mutated cancers. However, alongside its therapeutic potential, it is crucial to thoroughly understand and evaluate the safety profile of Adagrasib. The safety assessment includes a detailed examination of the adverse events (AEs) associated with its use. Comprehensive evaluation of these AEs is essential to ensure that the benefits of the drug outweigh any potential risks to patients. This retrospective pharmacovigilance study evaluated AEs associated with Adagrasib using data from the FDA adverse event reporting system database. We collected adverse drug reaction data for Adagrasib from the fourth quarter of 2022 to the first quarter of 2025. After standardizing the data, we applied several signal quantification methods, including the reporting odds ratio, proportional reporting ratio, Bayesian confidence propensity for neural networks, and Multi-item Gamma Poisson Shrinker (MGPS), for analysis. In this analysis of 556 adverse drug event reports where Adagrasib was identified as the primary suspect, we discovered 38 preferred terms across 20 system organ classifications. The 3 most prevalent system organ classifications were general disorders and administration site conditions, gastrointestinal disorders, and nervous system disorders. Notably, this study uncovered several new, previously unlabeled adverse reactions, including skin hyperpigmentation and seizures. These findings highlight the importance of ongoing pharmacovigilance to ensure comprehensive understanding of a drug's safety profile. These findings highlight the need for continued monitoring and understanding of Adagrasib potential risks. Further research is necessary to confirm these associations and address any previously unrecognized safety concerns.