{"paper_id":"46110979-9460-4b9c-86fe-ec198c320df2","body_text":"ABSTRACT\nObjectives\nMedroxyprogesterone acetate (MPA), a steroid progesterone, is widely used to treat endometriosis, menstrual disorders, and uterine bleeding in clinical practice. However, the safety profile of MPA requires comprehensive evaluation.\nMethods\nThis study performed a retrospective analysis using real-world data extracted from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Case reports from 2003 to 2023 were analyzed using methods like reporting advantage ratio (ROR), proportional report ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and empirical Bayes geometric mean (EBGM).\nResults\nIn the case reports spanning from 2003 to 2023, showed 26,437 adverse events (AEs) related to MPA, mostly in females (25,639). Disproportionality analysis identified 116 ADRs across 19 system organ class (SOC) levels, including expected AEs like ‘female breast cancer’(n = 8717) and ‘ovarian cancer’ (n = 459). Unexpected AEs, such as ‘acquired diaphragmatic eventration’(n = 3), were also noted.\nConclusion\nOur study identifies potential new and unexpected ADR signals linked to MPA, which align with clinical observations. Additional research is necessary to confirm these associations and address previously unrecognized safety concerns. This research provides a novel and distinctive approach to exploring drug-related AEs.\nDeclaration of interest\nThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.\nData availability statement\nAll data for this study can be accessed at the following website: https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.\nReviewer disclosures\nPeer reviewers on this manuscript have no relevant financial or other relationships to disclose.\nAuthor contributions\nX Wang and L Xu designed the study. X Wang and J Wang coordinated the project. X Wang, J Wang, F Liu, K Zhang and M Zhao performed data analysis. X Wang and L Xu prepared the manuscript. All authors approved the final manuscript.\nEthical approval\nEthical approval was not needed because FAERS is a public anonymized database.","source_license":"public-domain-us","license_restricted":false}