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Postmarketing safety monitoring continues to play an important role in evaluating glucagon-like peptide-1 receptor agonists (GLP-1 RAs) used for type 2 diabetes mellitus (T2DM) and obesity. Findings presented at the ADA Scientific Sessions 2026 compared adverse event (AE) reporting patterns for semaglutide and liraglutide using data from the FDA Adverse Event Reporting System (FAERS).

This disproportionality analysis evaluated FAERS reports submitted from 2017 onward that listed semaglutide, liraglutide, metformin, or orlistat as the primary suspect drug. Adverse events were standardized using the Medical Dictionary for Regulatory Activities (MedDRA), and signals were assessed using reporting odds ratio (ROR), proportional reporting ratio, information component, and empirical Bayesian geometric mean analyses.

Findings

  • Among 14,752,169 FAERS reports screened, 53,176 met inclusion criteria for analysis.
  • Semaglutide generated more T2DM than obesity reports (15,515 vs 5,567), while liraglutide showed a similar distribution (3,800 vs 1,284).
  • In T2DM reports, semaglutide showed higher reporting odds for brain fog (ROR, 12.78), optic ischemic neuropathy (ROR, 12.11), impaired gastric emptying (ROR, 9.57), and suicidal ideation (ROR, 4.69) versus liraglutide.
  • In obesity reports, semaglutide showed higher reporting odds for malnutrition (ROR, 10.92), ileus (ROR, 6.98), insomnia (ROR, 2.76), and visual impairment (ROR, 2.38).
  • Similar disproportionality signals were observed when GLP-1 receptor agonists were compared with metformin and orlistat.

This FAERS analysis identified consistent adverse event reporting indications for semaglutide across T2DM and obesity indications. The findings may inform ongoing pharmacovigilance efforts, although spontaneous reporting data cannot determine causality or absolute risk.

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Key highlights
  • Semaglutide showed higher reporting odds for several neurologic, gastrointestinal, and visual adverse events than liraglutide.
  • Similar safety signals were observed across both T2DM and obesity reports.
  • Findings from class comparisons with metformin and orlistat were generally consistent with the primary analysis.
  • FAERS data support signal detection but cannot establish causality or event incidence.
     
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Analysis of 53,176 FAERS reports identified higher reporting odds for neurologic, gastrointestinal, and visual adverse events with semaglutide versus liraglutide.
 

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