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Study · Observational study · 2025

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Adverse event profile differences among long-acting gonadotropin-releasing hormone analogs: A real-world, pharmacovigilance study.

Chen Y, Lu W, Liao R, Zhang X, Chen W, Wang J, Feng H

PloS one11 Jul 2025

PMID40644420 (opens in a new tab)PMCIDPMC12250665 (opens in a new tab)DOI10.1371/journal.pone.0327842 (opens in a new tab)PepBankPUB-40644420
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Summary

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.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study1

1 result from studies that gave the peptide. 1 result from people.

  1. 01HumanObservational studySafety outcome

    In FAERS reports, histrelin showed a greater propensity for psychiatric disorders than the other long-acting GnRH analogs analyzed.

    In plain wordsIn FDA adverse event reports, histrelin was linked to a greater tendency for psychiatric disorders than other long-acting GnRH drugs.

    Peptide
    Histrelin
    Outcome
    IncreasePsychiatric adverse event profile
    Study

    n: not reported in source

    Comparator
    Other long-acting GnRH analogs in the FAERS analysis
    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    Dose not stated

    Source sentences

    Summary
    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.
    2 context sentences
    Summary · context
    We 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).
    Summary · context
    All indications were searched long-acting GnRHa, as primary suspect drugs, from FAERS data (January 2004 to September 2023).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 5Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Versions 2 to 4

    27 Oct 2026, 16:37 UTC

    The same notice was added 3 times, first on 27 Oct 2026, 16:35 UTC. The status did not change between them.

    Study data updated · source update from Europe PMC

  3. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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