Post-marketing safety of Adagrasib: a disproportionality analysis based on the FAERS database.

Abstract

Background: Adagrasib is a novel KRAS G12C inhibitor. While its clinical efficacy has been demonstrated, comprehensive post-marketing safety data remain limited. This study aimed to analyze adverse reactions involving Adagrasib from the FAERS database to identify potential safety signals.

Research design and methods: A retrospective pharmacovigilance analysis was performed using FAERS data during Q4 2022 through Q2 2024. After deduplication. disproportionality analysis was performed using four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM).

Results: A total of 598 cases involving Adagrasib were identified, encompassing 1717 adverse events (AEs). The most common AEs were diarrhea, nausea, vomiting, asthenia, and decreased appetite. New strong significant AE signals were detected, including dissociation, status epilepticus, cerebral disorder, and photosensitivity reaction. The median time to AE onset was 34 days, and most AEs happened within the initial month of treatment.

Conclusions: Our study highlights some new AE signals associated with Adagrasib, emphasizing the importance of continued pharmacovigilance. While the findings contribute to understanding Adagrasib's safety profile, further validation through large-scale prospective studies is needed.