ArticleFrontiers in pharmacology2024
A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for sunitinib.
Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed.
- The safety of rituximab in pediatric nephrotic syndrome patients: a pharmacovigilance study of the FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Risk signals and clinical characteristics of serious adverse events of neutropenia associated with pembrolizumab: a FAERS database study.BMC cancer · 2026Article
- Current Status of Molecularly Targeted Therapeutics in Blood Cancers.International journal of molecular sciences · 2025Review
- Roles of PDGF/PDGFR signaling in various organs.The Korean journal of physiology & pharmacology : official journal of the Korean Physiological Society and the Korean Society of Pharmacology · 2025Review
- A real-world disproportionality analysis of ripretinib data mining of the public version of FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- Adverse reactions of four multi-targeted tyrosine kinase inhibitors: a descriptive analysis of the WHO-VigiAccess database.Frontiers in pharmacology · 2025Article
- Drug-induced coagulopathies: a real-world pharmacovigilance study using the FDA adverse event reporting system.Frontiers in pharmacology · 2024Article
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Authors and funding
6 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Background: Sunitinib is approved for the treatment of metastatic renal cell carcinoma (mRCC), imatinib-resistant gastrointestinal stromal tumors (GIST), and advanced pancreatic neuroendocrine tumors (PNET). This study aims to investigate the safety profiles of sunitinib through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: The individual case safety reports (ICSRs) on sunitinib from 2006 Q1 to 2024 Q1 were collected from the ASCII data packages in the Food and Drug Administration Adverse Event Reporting System (FAERS). After standardizing the data, a variety of disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) were employed to identify the potential safety signals of sunitinib-associated AEs. Results: A total of 35,923 ICSRs of sunitinib as the "primary suspected" drug were identified within the reporting period. The search detected 276 disproportionate preferred terms (PTs). The most common AEs, including diarrhea, asthenia, decreased appetite, hypertension, and dysgeusia, were consistent with the drug label and clinical trials. Unexpected significant AEs, such as uveal melanocytic proliferation, salivary gland fistula, yellow skin, eyelash discoloration, scrotal inflammation, were detected. The median onset time of sunitinib-related AEs was 57 days (interquartile range [IQR]16-170 days), with most of the ICSRs developing within the first month (n = 4,582, 39.73%) after sunitinib therapy as initiated. Conclusion: The results of our study were consistent with routine clinical observations, and some unexpected AEs signals were also identified for sunitinib, providing valuable evidence for the safe use of sunitinib in the real-world and contributing to the clinical monitoring and risk identification of sunitinib.
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