Observational studyMedicine2025
Real-world adverse event analysis of Adagrasib: Insights from the FAERS database.
Observational study in Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.