ORIGINAL RESEARCH article
Front. Endocrinol.
Sec. Reproduction
This article is part of the Research TopicInnovative Approaches in Pharmacovigilance: Enhancing Detection and Analysis of Adverse Drug Reactions in Clinical and Real-World SettingsView all articles
Drug-induced Polycystic Ovary Syndrome: A Real-World Pharmacovigilance Study Based on the FAERS Database
Provisionally accepted
- 1Department of Obstetrics and Gynecology, Northwest University First Hospital, Northwest University, Xi'an, China
- 2Department of Obstetrics and Gynecology, Air Force Medical University Tangdu Hospital, Xi'an, China
- 3The Department of Obstetrics and Gynecology, Yan'an University Affiliated Hospital, Yan'an, China
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Objective: Previous studies have shown an association between polycystic ovary syndrome (PCOS) and the use of various medications. However, there is still a lack of systematic research exploring this relationship in depth. This study aims to identify and evaluate drugs that may influence the risk of PCOS using the US FDA Adverse Event Reporting System (FAERS) database. Methods: Adverse events (AEs) related to drug-induced PCOS were retrieved from the FAERS database (Q1 2014 to Q4 2024). Four statistical methods (ROR, PRR, BCPNN, and MGPS) were used for imbalance analysis to identify drugs significantly associated with PCOS risk. Additionally, a latency (TTO) analysis was conducted to assess the timing of onset and the risk characteristics of PCOS-related adverse reactions. Results: This study identified 18 drugs significantly associated with PCOS-related AEs from a total of 1,516 cases through imbalance analysis. These drugs span various categories, including respiratory, antipsychotic, and anticonvulsant medications. Among them, Mecasermin (ROR=67.54) and Ciclesonide (ROR=62.10) presented the highest risk, followed by Valproic acid (ROR=20.78) and Olanzapine (ROR=10.27). Adverse events were most commonly observed either after 360 days of medication use or within 30 days. The median time to onset for the top three drugs with the highest signal frequency was as follows: Olanzapine (155.5 days), Quetiapine (335 days), and Valproic acid (905 days). Conclusion: This study is the first large-scale, systematic exploration of drug signals related to PCOS using the FAERS database. The drugs identified are primarily associated with the nervous system, followed by respiratory system medications and other types of drugs. These findings provide new warning evidence and references for clinical drug safety, suggesting that enhanced monitoring of female patients should be implemented when prescribing such drugs.
Keywords: polycystic, Ovary, syndrome, FAERS, adverse, events, Disproportionality analysis, Pharmacovigilance
Received: 23 Jul 2025; Accepted: 11 Nov 2025.
Copyright: © 2025 Zhang, Di, Wang, Ma, Gou and Zhou. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Zhuo Zhou, 550677140@qq.com
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.