Postmarketing Safety Signals and Medication‐Use Risks of GLP ‐1‐Based Therapies in Diabetes and Obesity: A Multi‐Source Pharmacovigilance and Regulatory Evidence‐Mapping Study
Pharmacovigilance study reveals gastrointestinal and administration-related risks for GLP-1 therapies in diabetes and obesity, highlighting key targets for patient education.
Key Points
To characterise postmarketing adverse event signals and medication-use risks linked to GLP-1 receptor agonists and the dual GIP/GLP-1 co-agonist tirzepatide in diabetes and obesity treatment.
Extracted FDA Adverse Event Reporting System (FAERS) data from 2021Q1 through 2026Q1 across 8,995,547 background reports, applying deduplication and retaining latest versions of primary-suspect records for semaglutide, tirzepatide, dulaglutide, liraglutide, exenatide, and lixisenatide.
Calculated disproportionality statistics including reporting odds ratios, proportional reporting ratios, and an approximate Information Component, integrating findings with Canada Vigilance records, Medicaid utilization, and FDA regulatory communications.
Identified 243,114 GLP-1 primary-suspect case-product records, with tirzepatide accounting for 133,100 reports, semaglutide for 55,619 reports, and dulaglutide for 38,406 reports.
The most frequently reported terms included incorrect dose administered, nausea, injection-site pain, diarrhoea, vomiting, off-label use, and extra dose administered.
Prioritised safety domains involved gastrointestinal intolerance, medication-use and device errors, impaired gastric emptying, pancreatobiliary events, renal/dehydration events, and hypoglycaemia.