Data pharmacovigilance analysis of medroxyprogesterone-related adverse events in the FDA adverse event reporting system

Xiaomeng Wang, Jimei Wang, Fang Liu, Kexin Zhang, Min Zhao, Lin Xu
Expert opinion on drug safety · 2026 · vol. 25(3) , pp. 515–522 · doi:10.1080/14740338.2024.2446414 · PMID:39888632
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This study analyzed real-world adverse event reports for medroxyprogesterone acetate (MPA) using a retrospective pharmacovigilance approach based on the US FDA Adverse Event Reporting System (FAERS) from 2003–2023. Using reporting advantage ratio, proportional report ratio, BCPNN, and EBGM, the authors identified 26,437 MPA-related adverse events, mostly in females, and detected 116 disproportionate ADR signals across 19 system organ classes, including expected events such as female breast cancer and ovarian cancer, as well as unexpected events like acquired diaphragmatic eventration. The authors explicitly note that additional research is needed to confirm these associations and address newly identified safety concerns, reflecting a limitation of FAERS signal detection rather than causal inference. MPA is widely used for endometriosis and menstrual disorders, and this paper is centrally about endometriosis—specifically, it analyzes MPA-related adverse event signals in a drug used to treat endometriosis.

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Abstract

OBJECTIVES: Medroxyprogesterone 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. METHODS: This 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). RESULTS: In 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. CONCLUSION: Our 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.
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Abstract

Objectives Medroxyprogesterone 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.

Methods

This 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).

Results

In 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.

Conclusion

Our 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. Declaration of interest The 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. Data availability statement All data for this study can be accessed at the following website: https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html. Reviewer disclosures Peer reviewers on this manuscript have no relevant financial or other relationships to disclose. Author contributions X 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. Ethical approval Ethical approval was not needed because FAERS is a public anonymized database.

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Condition tags

endometriosis

MeSH descriptors

Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems Adverse Drug Reaction Reporting Systems

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europepmc
last seen: 2026-06-13T06:22:48.782012+00:00
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