ArticleCureus2026
Comparative Gynecological Safety of the Dual GIP/GLP-1 Receptor Agonist Tirzepatide vs. the GLP-1 Receptor Agonist Semaglutide: A Real-World Pharmacovigilance Analysis (2022-2025).
Article in Cureus, 2026. 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.
- Postmenopausal bleeding associated with semaglutide: a diagnostic challenge.JCEM case reports · 2026Article
- Multi-target-directed drugs: new additions in 2025 and post-marketing safety surveillance of drugs marketed in 2022-2024.Pharmacological reports : PR · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background The rapid adoption of incretin-based therapies for obesity has raised questions regarding their comparative safety profiles. While the gynecological safety of glucagon-like peptide-1 (GLP-1) receptor agonists is documented, the potential risks associated with dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 agonism remain less characterized. This study aimed to evaluate the reporting patterns of gynecological hemorrhagic events associated with tirzepatide compared to semaglutide using real-world pharmacovigilance data. Methods A retrospective disproportionality analysis was conducted of the FDA Adverse Event Reporting System (FAERS) database from Q1 2022 to Q3 2025. Cases of gynecological hemorrhage were identified using standardized MedDRA queries. Reporting odds ratios (RORs) with 95% confidence intervals (CIs) were calculated to compare the reporting frequency of hemorrhagic events between tirzepatide and semaglutide. Results A total of 103,607 female-specific reports were analyzed (tirzepatide: n = 70,768; semaglutide: n = 32,839). Gynecological hemorrhagic events were reported in 0.60% of tirzepatide cases and 0.62% of semaglutide cases. The ROR for tirzepatide versus semaglutide was 0.97 (95% CI = 0.82-1.14), indicating no statistically significant difference in reporting odds. A significant disparity in reporter sources was observed, with 94.6% of tirzepatide reports originating from consumers compared to 53.4% for semaglutide. Conclusions This analysis of post-marketing surveillance data did not detect a disproportionate reporting signal suggesting an increased risk of gynecological hemorrhagic events with tirzepatide compared to semaglutide. While these findings suggest a comparable safety profile, the high proportion of consumer-driven reporting for tirzepatide warrants cautious interpretation. Future prospective studies are needed to confirm these findings in controlled clinical settings.
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