Evidence mapPaperPMID 40890214Full record

ArticleScientific reports2025

Triptorelin associated adverse events evaluated using FAERS pharmacovigilance data.

Wei Jia, Tiezhou Wang

Abstract read
In one paragraph

Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Wei JiaDepartment of Pharmacy, Tonglu branch Hospital, Hangzhou First People's Hospital, No.899 Meilin Road, Tonglu, Hangzhou, 330000, Zhejiang Province, China. weij8341@163.com.
Tiezhou WangDepartment of Orthopaedics, Tonglu branch Hospital, Hangzhou First People's Hospital, No.899 Meilin Road, Tonglu, Hangzhou, 330000, Zhejiang Province, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Triptorelin, a gonadotropin-releasing hormone(GnRH) agonist, is approved by the US Food and Drug Administration(FDA) for treating advanced prostate cancer, endometriosis, and central precocious puberty(CPP) in children aged ≥ 2 years. This study aimed to characterize the real-world adverse event(AE) profile associated with triptorelin using data from the FDA Adverse Event Reporting System(FAERS). We conducted a retrospective pharmacovigilance study utilizing FAERS reports from the first quarter of 2004 to the third quarter of 2024 (2004Q1-2024Q3). Disproportionality analysis employing four distinct algorithms (Reporting Odds Ratio [ROR], Proportional Reporting Ratio [PRR], Bayesian Confidence Propagation Neural Network [BCPNN], and Multi-item Gamma Poisson Shrinker [MGPS]) was performed to identify potential statistical signals of triptorelin-associated AEs. Among 18,541,994 eligible FAERS reports, 4018 primary suspect reports involving triptorelin were identified. Disproportionality analysis revealed 102 statistically significant Preferred Terms(PTs). Unexpected statistical signals warranting further investigation included defiant behavior and Alzheimer's dementia. The median time-to-onset (TTO) of AEs was 132 days (interquartile range[IQR] 36-361 days). AE reporting exhibited a bimodal distribution, with the highest proportions occurring within the first month (22.59%) and after more than one year (25.07%) following administration. Distinct statistical signal profiles were observed between genders. Analysis of FAERS data elicited statistical signals for both expected and unexpected AEs associated with triptorelin. These findings highlight potential safety signals, particularly defiant behavior and Alzheimer's dementia, which meet the European Medicines Agency (EMA) 2024 criteria for safety signals requiring further investigation. Continuous pharmacovigilance monitoring is recommended. It is crucial to emphasize that these findings represent statistical associations identified through disproportionality analysis; they require clinical validation and do not establish causality.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsPharmacovigilanceTriptorelin PamoateAdolescentAdultAgedBayes TheoremChildChild, PreschoolFemaleHumansMaleMiddle AgedRetrospective StudiesUnited StatesTriptorelin PamoateAdverse eventsFAERSPharmacovigilanceTriptorelin

Identifiers

PMID40890214
PMCPMC12402341

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.