Substance-Level Disproportionate Reporting of Impaired Gastric Emptying for Five Glucagon-Like Peptide-1 Receptor Agonists: A Reproducible Signal-Detection Analysis of the FDA Adverse Event Reporting System
Semaglutide has the highest reported association with impaired gastric emptying among GLP-1 receptor agonists, but this study does not claim causation.
Where it sits
this study against the rest of the semaglutide corpusSummary and findings
This study analyzed the reporting of impaired gastric emptying associated with five glucagon-like peptide-1 receptor agonists (GLP-1 RAs) using the FDA Adverse Event Reporting System. Semaglutide exhibited the highest proportional reporting ratio (PRR) of 88.7 based on 3,052 reports. The study does not assert causation but highlights the reporting trends for these substances.
Abstract
Abstract Background. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) delay gastric emptying as an on-target effect. Independent FAERS analyses have reported that GLP-1 RAs account for a large share of impaired-gastric-emptying (IGE) reports (Huang et al., 2025; Tu et al., 2026). We sought to reproduce this signal at the active-substance level using a transparent, fully reproducible pipeline, without asserting causation. Methods. Using the public openFDA interface to the FDA Adverse Event Reporting System (FAERS), we identified reports for five GLP-1 RA substances via the generic-name field. The outcome was the MedDRA Preferred Term "Impaired gastric emptying" (10021518). For each substance we computed the proportional reporting ratio (PRR), reporting odds ratio (ROR), 95% confidence intervals, and the Yates-corrected chi-square. Counts reflect the full database snapshot at the extraction date; all figures are reproducible from the public openFDA source using the analysis script. Results. All five substances met conventional signal criteria. Semaglutide showed the strongest disproportionality (PRR 88.7, 95% CI 85.1–92.4; 3,052 of 82,911 reports), followed by dulaglutide (37.7; 1,593/86,770), liraglutide (20.9; 563/50,219), tirzepatide (20.2; 1,409/140,435), and exenatide (4.7; 136/52,308). Conclusions. These results reproduce, with a transparent and fully reproducible method, the substance-level IGE disproportionate-reporting signal described by independent groups. Disproportionality quantifies reporting, not incidence or risk, and cannot establish causality. The analysis is descriptive and hypothesis-generating and makes no claim about clinical risk.
Background
The study appears to address the safety profile of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), focusing on the adverse event of impaired gastric emptying. This is relevant as GLP-1 RAs are widely used in diabetes management, and understanding their side effects is crucial for patient safety.
Methods
Not reported in abstract.
Results
Not reported in abstract.
Interpretation
Without specific data, it is difficult to assess how this study's findings compare to existing literature or their clinical significance. The lack of detailed information limits the ability to draw conclusions about the implications for practice.
Key findings
- Not reported in abstract.
Limitations
- Not reported in abstract.