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Pharmacovigilance Assessment of Thrombotic Adverse Events Linked to GLP-1 Receptor Agonists: Analysis of FAERS

Eman M Mansory1,2,3, Osman O Radhwi1,2,3

  • 1Department of Hematology, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.

Current Drug Safety
|June 2, 2026
PubMed
Abstract

Insights

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) were not disproportionately linked to thrombotic events in a large FDA safety database analysis. These findings suggest GLP-1 RAs may have a protective profile against thrombotic events.

Area of Science:

  • Pharmacovigilance
  • Cardiovascular Safety
  • Endocrinology

Background:

  • Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are key treatments for diabetes and obesity.
  • Evidence regarding the association between GLP-1 RAs and thrombotic events is conflicting.
  • This study investigated thrombotic adverse event reporting for GLP-1 RAs in the FDA Adverse Event Reporting System (FAERS).

Purpose of the Study:

  • To assess the reporting patterns of thrombotic adverse events associated with GLP-1 receptor agonists (GLP-1 RAs).
  • To compare the risk of thrombotic events with GLP-1 RAs against other weight-loss and diabetes medications.

Main Methods:

  • Retrospective pharmacovigilance analysis of FAERS data.
  • Identification of thrombotic adverse events using Standardized MedDRA Queries.
  • Disproportionality analysis using Reporting Odds Ratios (ROR) and comparison with Orlistat and SGLT2 inhibitors.

Main Results:

  • 1,618 unique thrombotic adverse event reports involving GLP-1 RAs were identified, with arterial events being most common.
  • GLP-1 RAs were not disproportionately associated with overall thrombotic adverse events (ROR = 0.67).
  • GLP-1 RAs showed lower reporting odds for thrombotic events compared to Orlistat and SGLT2 inhibitors.

Conclusions:

  • GLP-1 RAs did not exhibit a disproportionate reporting signal for thrombotic events in the FAERS database.
  • Findings suggest a potentially protective profile for GLP-1 RAs regarding thrombotic events.
  • Continued post-marketing surveillance is recommended to monitor real-world safety data.
Keywords:
FAERSPharmacovigilanceglucagon-like peptide 1liraglutidesemaglutide.thrombosistirzepatidevenous thromboembolism

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