ArticleHeliyon2024
A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for alpelisib.
Article in Heliyon, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
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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.
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Who cites it
13 citing papers in PubMed.
- A real-world pharmacovigilance study of dacomitinib based on FDA adverse event reporting system (FAERS) database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- A Novel Patient-Derived Xenograft Model of Inflammatory Breast Cancer.Research square · 2026Article
- Real-world disproportionality analysis of trabectedin using the United States food and drug administration adverse event reporting system.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- SGLT2 Inhibitor Dapagliflozin Attenuates Cardiomyocyte Injury and Inflammation Induced by PI3Kα-Selective Inhibitor Alpelisib and Fulvestrant Under Hyperglycemia.International journal of molecular sciences · 2026Article
- A real-world pharmacovigilance study of romidepsin based on FDA adverse event reporting system database.Frontiers in oncology · 2026Article
- The real-world safety profile and potential mechanism of isatuximab: Integration of pharmacovigilance and transcriptomic analysis.Medicine · 2025Article
- Review
- Continuing Cyclin-Dependent Kinase 4/6 Inhibitors Beyond Progression in Advanced Breast Cancer: A Meta-Analysis.Cancers · 2025Review
- Rotigotine safety in real-world settings: a pharmacovigilance study using FAERS data.BMC pharmacology & toxicology · 2025Article
- Cyclobenzaprine-related adverse events: a comprehensive pharmacovigilance analysis using the FDA Adverse Event Reporting System.Frontiers in medicine · 2025Article
- Real-world safety of carboplatin in non-small cell lung cancer: a retrospective signal detection and subgroup analysis based on the FAERS database.Frontiers in medicine · 2025Article
- Disproportionality analysis of adverse events associated with pacritinib: a real-world study based on FDA Adverse Event Reporting System (FAERS) database.Frontiers in oncology · 2025Article
- Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In this study, we delved into the safety profile of alpelisib, an FDA-approved treatment for hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, and PIK3CA-Related Overgrowth Spectrum (PROS). Despite its approval, real-world, long-term safety data is lacking. Our research scrutinizes the FDA database to assess alpelisib 's safety. We retrospectively analyzed data from April 2019 to June 2023 using four algorithms. Among 7,609,450 reports, 6692 implicated alpelisib as the primary suspected drug, uncovering adverse events (AEs) across 26 organ systems. Notably, we identified 21 previously unlisted AEs. Furthermore, differences in AEs emerged between patients with PIK3CA-mutated breast cancer and those with PROS. This study provides vital insights for healthcare professionals to navigate AEs in clinical practice and informs future research for enhancing alpelisib 's safety profile.
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Registered trials
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