Evidence map›Paper›PMID 41931341›Full record

ArticleMedicine2026

Evaluation of adverse event profiles for leuprolide and goserelin: Insights from the FDA adverse event reporting system following STROBE guidelines.

Fangyu Zhou, Mengjie Yang, Wenzhong Ji, Jiamin Ma, Ningning Ren, Xiaoyi Ren

Abstract read
In one paragraph

Article in Medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
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0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Fangyu ZhouDepartment of Breast Surgery, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Mengjie Yang
Wenzhong Ji
Jiamin Ma
Xiaoyi Ren

Funding

Henan Provincial Medical Science and Technology Research Program NO.LHGJ20240293
6 · The paper itself

Abstract

Leuprolide and Goserelin, both gonadotropin-releasing hormone (GnRH) agonists, are commonly used for ovarian function suppression and the management of hormone-dependent cancers. However, systematic comparisons of their adverse event (AE) profiles based on real-world pharmacovigilance data remains limited. This study aimed to compare the safety signals associated with Leuprolide and Goserelin using the the U.S. Food and Drug Administration AE Reporting System (FAERS), thereby providing insights into their distinct AE patterns. Food and Drug Administration Adverse Event Reporting System reports from the first quarter of 2004 to the third quarter of 2024 were extracted and standardized. Disproportionality signal detection was performed using the reporting odds ratio, proportional reporting ratio, chi-square (χ2) test, and Bayesian confidence propagation neural network. Significant signals were defined as reporting odds ratio lower 95% CI >1, proportional reporting ratio ≥2 with χ2 ≥4, or Bayesian confidence propagation neural network information component (IC)-2SD >0. Key signals were compared between Leuprolide- and Goserelin-related reports. A total of 12,418,989 AE reports were identified, including 64,324 Leuprolide-related and 4253 Goserelin-related cases. Both drugs showed strong signals for "prostatic specific antigen increased" (Leuprolide: χ2 = 84,009.65, IC-2SD = 5.42; Goserelin: χ2 = 820.31, IC-2SD = 3.38), "blood testosterone increased" (Leuprolide: χ2 = 22,845.52, IC-2SD = 5.56; Goserelin: χ2 = 290.23, IC-2SD = 2.28), and "prostatic specific antigen abnormal" (Leuprolide: χ2 = 51,615.98, IC-2SD = 6.46; Goserelin: χ2 = 422.43, IC-2SD = 2.16). Additional strong signals, such as "prostate cancer metastatic" and "hot flush," were consistently detected in both groups. Notably, the distribution of AEs differed between drugs, suggesting drug-specific safety patterns. Leuprolide demonstrated strong associations with AEs in "Reproductive system and breast disorders," "Neoplastic benign and malignant conditions," and procedure-related categories, whereas Goserelin was more strongly linked to "Endocrine disorders." These findings highlight distinct pharmacovigilance profiles between the 2 drugs and provide clinically relevant evidence to support individualized risk monitoring in hormone-dependent cancer therapies.

Indexed as

Adverse Drug Reaction Reporting SystemsAntineoplastic Agents, HormonalGoserelinLeuprolideFemaleGonadotropin-Releasing HormoneHumansPharmacovigilanceUnited StatesUnited States Food and Drug AdministrationAntineoplastic Agents, HormonalGonadotropin-Releasing HormoneGoserelinLeuprolideadverse event reporting systembreast cancerGoserelinLeuprolideovarian function suppression

Identifiers

PMID41931341
PMCPMC13052953

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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 OpenQuestion graph.