ArticlePloS one2025
Adverse event profile differences among long-acting gonadotropin-releasing hormone analogs: A real-world, pharmacovigilance study.
Article in PloS one, 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Investigation of Adverse Events Associated with Predicted GnRHR Agonists Using the FAERS Database.International journal of molecular sciences · 2026Article
- Comparative effectiveness and integrated safety of goserelin sustained-release microspheres versus implants in prostate cancer: a patient-based real-world study and systematic review with meta-analysis.Frontiers in oncology · 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
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLong-acting Gonadotropin-releasing hormone analogs(GnRHa), including leuprolide, goserelin, histrelin, buserelin, triptorelin, have been widely used for a variety of diseases including prostate cancer, breast cancer, endometriosis, uterine leiomyomas, and central precocious puberty (CPP). However, their real-world safety profile differences have not been adequately compared.
objectiveWe aimed to investigate the adverse event (AE) profile differences of long-acting GnRHa reported by the US Food and Drug Administration Adverse Event Reporting System (FAERS).
methodsAll indications were searched long-acting GnRHa, as primary suspect drugs, from FAERS data (January 2004 to September 2023). We performed disproportionality analyses by reporting odds ratios (ROR) and conducted univariate and multivariate logistical regression analyses to determine the odds ratio (OR) of serious AEs associated with long-acting GnRHa under different exposure factors.
resultsReproductive system and breast disorders accounted for the greatest proportion of adverse events among the five long-acting GnRHa formulations analyzed. Both buserelin and histrelin showed distinct adverse effect profiles, with buserelin demonstrating a higher incidence of gastrointestinal disorders and histrelin showing a greater propensity for psychiatric disorders. Logistic regression analysis revealed these five medications carried an elevated risk of significant medical events, and this risk was notably lower in pediatric patients (<18 years) compared to adult populations (≥18 years).
conclusionsSignificant disparities exist between the adverse event profiles of long-acting GnRHa. The identification of high-risk factors and the enhancement of AEs monitoring are crucial during clinical application.
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Registered trials
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