Disproportionality analysis of ventricular extrasystoles reported with semaglutide in VigiBase and the FDA Adverse Event Monitoring System
- Design
- Pharmacovigilance
- Drugs
- Semaglutide
- Assessment
- Not yet reviewed by a person · added Nov 8, 2026
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Abstract
Semaglutide is widely used to treat type 2 diabetes and obesity and to reduce cardiovascular risk. However, its association with cardiac rhythm-related adverse-event reporting in routine clinical practice remains incompletely characterized. To investigate cardiovascular and rhythm-related adverse-event reporting associated with semaglutide, with a focus on ventricular extrasystoles, we conducted a disproportionality analysis of individual case safety reports from VigiBase and the FDA Adverse Event Monitoring System (AEMS; formerly the FDA Adverse Event Reporting System [FAERS]). Reports were included when semaglutide was recorded as a suspected drug, according to database-specific criteria. Cardiovascular outcomes were identified using Medical Dictionary for Regulatory Activities Preferred Terms. Reporting odds ratios (RORs) and 95% confidence intervals (CIs) were calculated. A cross-database reporting signal was defined as at least three semaglutide-associated reports and a lower 95% CI bound exceeding 1 in each database. After deduplication and application of the predefined inclusion criteria, 1980 semaglutide-associated cardiovascular reports from VigiBase and 1754 from AEMS were included. Among the screened cardiovascular and rhythm-related preferred terms, ventricular extrasystoles was the only term that met the prespecified signal criterion in both databases. Ventricular extrasystoles, clinically corresponding to premature ventricular contractions, showed disproportionate reporting in VigiBase (ROR 1.77, 95% CI 1.31-2.40) and AEMS (ROR 1.37, 95% CI 1.00-1.88; unrounded lower CI bound > 1). Ventricular extrasystoles showed a consistent disproportionality signal across VigiBase and AEMS. Although spontaneous reporting data cannot establish incidence, causality, or prognostic significance, this finding warrants prospective investigation using systematic electrocardiographic assessment and ambulatory rhythm monitoring.