ArticleBMC pharmacology & toxicology2025
Post-marketing safety of elacestrant in breast cancer: a pharmacovigilance investigation using the FDA adverse event reporting system.
Article in BMC pharmacology & toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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.
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Who cites it
2 citing papers in PubMed.
- Article
- Profiles of neuropsychiatric toxicity associated with different endocrine therapies for breast cancer: a global pharmacovigilance study based on FAERS and VigiAccess.Frontiers in pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRecently, the US Food and Drug Administration approved a new oral selective estrogen receptor downregulator for breast cancer, namely, elacestrant (Orserdu). This study aimed to analyze the signals of adverse events (AEs) within the introduction of elacestrant to the market using the FDA Adverse Event Reporting System (FAERS) database.
methodsReports on the AEs of elacestrant after its marketing were obtained from the FAERS database. Disproportionality was analyzed using the reporting odds ratio to calculate the magnitude of the risk of the target drug and the AE combination, and the proportional reporting ratio to quantify the strength of the association between the drug and the AEs.
resultsA total of 3132 reports on elacestrant-related AEs were obtained, with disease progression, drug ineffectiveness, product dose omission, arthralgia, asthenia, increased tumor marker levels, and bone pain (Number of reported cases (a) ≥ 3 and lower limit of 95% confidence interval >1) being the high-frequency events not mentioned on the drug label. The top three total frequencies at the system organ class level comprised general disorders and administration site conditions, gastrointestinal disorders, and musculoskeletal and connective tissue disorders.
conclusionsFAERS data analyses were conducted to evaluate the safety of post-marketing clinical use of elacestrant and to ensure that physicians identify the risk factors for the AEs of this drug.
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