Causality assessment · Expected pharmacological effect

Semaglutide and Impaired gastric emptying: is the FAERS signal real?

n=3,558 co-reports · PRR 111.3 · ROR 117.0

A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.

Expected pharmacological effect

Semaglutide ↔ Impaired gastric emptying

n=3,558 co-reports · PRR 111.3 · ROR 117.0

Semaglutide is a GLP-1 receptor agonist; by slowing gastric emptying it can cause nausea, vomiting, and, in some patients, gastroparesis-like symptoms severe enough to risk aspiration during anaesthesia (impaired gastric emptying 3,558 co-reports, PRR 111.3). The label advises caution, and anaesthesia societies recommend holding GLP-1 agonists before surgery.

Regulatory basis: semaglutide (Ozempic/Wegovy) prescribing information — nausea/vomiting and delayed gastric emptying; anaesthesia guidance.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Slowed emptying with therapy
Strength	met	PRR 111.3, an extreme signal
Consistency	met	Consistent across GLP-1 agonists
Specificity	partial	Shared across the class
Biological gradient	met	Dose-related
Plausibility	met	GLP-1-mediated delay in gastric emptying
Coherence	met	Fits the mechanism
Experiment	met	Trials measured gastric emptying
Analogy	met	Analogous to liraglutide effects

This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.

✓ Trial evidence found — A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (NCT03914326)

Adverse event	Oral Semaglutide (n=4825) · Placebo (n=4825)
Impaired gastric emptying	3/4825	0/4825

Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →