Post-marketing safety of elacestrant in breast cancer: a pharmacovigilance investigation using the FDA adverse event reporting system.

ABSTRACT:

Background

Recently, 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.

Methods

Reports 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.

Results

A total of 3132 reports on elacestrant-related AEs were obtained

SUBMITTER: Fan Z 

PROVIDER: S-EPMC11895172 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature