FAERS review of 43,754 semaglutide reports flags gastric emptying, optic neuropathy

The wire

1. 01Researchers screened FDA Adverse Event Reporting System records from 2004 Q1 to 2025 Q3 where semaglutide was the primary suspect drug, finding 43,754 reports led by nausea (5,637), vomiting (4,097) and diarrhoea (3,276).
2. 02Impaired gastric emptying appeared in 5.03% of reports with a markedly elevated signal, and high disproportionality was seen for poor weight loss and optic ischaemic neuropathy, relevant to prescriber monitoring.
3. 03Spontaneous reporting cannot establish causation or incidence, and the authors call for continued pharmacovigilance rather than label change; signal strength was consistent across ROR, PRR, RRR and EBGM.

From the source

Characterizing the Adverse Event Profile of Semaglutide: A Comprehensive U.S. Food and Drug Administration Adverse Event Reporting System-Based Pharmacovigilance Study

Clinical nutrition ESPEN · 2026 Oct 12 · Thawkar SA, Singare SR, Sakle NS et al.