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Study · Observational study · 2026

4 results

Drug-induced gastric motility disorders: A disproportionality analysis from the FAERS and CVARD databases.

Qian Z, Jiang N

PloS one12 Jun 2026

PMID42284324 (opens in a new tab)PMCIDPMC13262828 (opens in a new tab)DOI10.1371/journal.pone.0351731 (opens in a new tab)PepBankPUB-42284324
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Summary

BackgroundDelayed gastric emptying and gastroesophageal reflux represent critical yet frequently underrecognized complications in hospitalized patients, particularly in the context of polypharmacy. While multiple medication classes have been implicated in disrupting gastrointestinal motility, the comprehensive risk spectrum of individual drugs remains poorly characterized. This study aimed to conduct a comprehensive disproportionality analysis to identify drugs associated with delayed gastric emptying and reflux using large-scale pharmacovigilance data.MethodsWe analyzed adverse event reports from the FDA Adverse Event Reporting System (FAERS; 2004-2025; n > 58 million) and validated findings against the Canada Vigilance Adverse Reaction Online Database (CVARD). Disproportionality analysis was performed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN). Weibull time-to-onset analysis was conducted to characterize temporal patterns of adverse event onset.ResultsAmong the top 50 drugs screened, 20 demonstrated positive signals across all three algorithms. Glucagon-like peptide-1 (GLP-1) receptor agonists exhibited the strongest associations with gastric motility disorders, with semaglutide showing the highest ROR for impaired gastric emptying (ROR: 80.27; 95% CI: 76.39-84.34), validated in CVARD (ROR: 54.17). Insulin formulations, particularly insulin degludec (ROR: 18.90), bisphosphonates, angiotensin receptor blockers, and trofinetide also demonstrated significant signals. Weibull analysis revealed divergent temporal patterns, ranging from early-onset (trofinetide: median 6.6 days) to late-onset (immunoglobulin G: median 535.1 days).ConclusionThis study identifies a broad spectrum of drug-associated gastric motility disorders with distinct temporal profiles. These findings provide evidence-based priorities for enhanced pharmacovigilance and inform clinical decision-making to mitigate this preventable cause of morbidity.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanObservational studySafety outcome

    In adverse event reports, semaglutide was linked to impaired gastric emptying with a reporting odds ratio of 80.27 (95% CI 76.39-84.34).

    In plain wordsIn adverse event reports, semaglutide was linked to impaired gastric emptying.

    Peptide
    Semaglutide
    Outcome
    IncreaseImpaired gastric emptying reporting odds in FAERS
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    ROR
    80.27 ratio
    FAERS
    ROR 95% CI
    76.39 to 84.34 ratio
    FAERS

    Source sentences

    Summary
    Glucagon-like peptide-1 (GLP-1) receptor agonists exhibited the strongest associations with gastric motility disorders, with semaglutide showing the highest ROR for impaired gastric emptying (ROR: 80.27; 95% CI: 76.39-84.34), validated in CVARD (ROR: 54.17).
    1 context sentence
    Summary · context
    We analyzed adverse event reports from the FDA Adverse Event Reporting System (FAERS; 2004-2025; n > 58 million) and validated findings against the Canada Vigilance Adverse Reaction Online Database (CVARD). Disproportionality analysis was performed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN).
  2. 02HumanObservational studySafety outcome

    In Canadian adverse event reports, semaglutide was linked to impaired gastric emptying with a reporting odds ratio of 54.17.

    In plain wordsIn Canadian adverse event reports, semaglutide was linked to impaired gastric emptying.

    Peptide
    Semaglutide
    Outcome
    IncreaseImpaired gastric emptying reporting odds in CVARD
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    ROR
    54.17 ratio
    CVARD

    Source sentences

    Summary
    Glucagon-like peptide-1 (GLP-1) receptor agonists exhibited the strongest associations with gastric motility disorders, with semaglutide showing the highest ROR for impaired gastric emptying (ROR: 80.27; 95% CI: 76.39-84.34), validated in CVARD (ROR: 54.17).
    1 context sentence
    Summary · context
    We analyzed adverse event reports from the FDA Adverse Event Reporting System (FAERS; 2004-2025; n > 58 million) and validated findings against the Canada Vigilance Adverse Reaction Online Database (CVARD). Disproportionality analysis was performed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN).
  3. 03HumanObservational studySafety outcome

    In adverse event reports, trofinetide showed a significant signal for gastric motility disorders.

    In plain wordsIn adverse event reports, trofinetide was linked to gastric motility disorders.

    Peptide
    Trofinetide
    Outcome
    IncreaseGastric motility disorder signal
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Insulin formulations, particularly insulin degludec (ROR: 18.90), bisphosphonates, angiotensin receptor blockers, and trofinetide also demonstrated significant signals.
    1 context sentence
    Summary · context
    We analyzed adverse event reports from the FDA Adverse Event Reporting System (FAERS; 2004-2025; n > 58 million) and validated findings against the Canada Vigilance Adverse Reaction Online Database (CVARD). Disproportionality analysis was performed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN).
  4. 04HumanObservational studySafety outcome

    In adverse event reports, trofinetide had a median time to gastric motility adverse event onset of 6.6 days.

    In plain wordsIn adverse event reports, trofinetide had a median time to gastric motility adverse event onset of 6.6 days.

    Peptide
    Trofinetide
    Outcome
    Not applicableTime to adverse event onset
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Median time to onset
    6.6 days
    trofinetide

    Source sentences

    Summary
    Weibull analysis revealed divergent temporal patterns, ranging from early-onset (trofinetide: median 6.6 days) to late-onset (immunoglobulin G: median 535.1 days).
    1 context sentence
    Summary · context
    We analyzed adverse event reports from the FDA Adverse Event Reporting System (FAERS; 2004-2025; n > 58 million) and validated findings against the Canada Vigilance Adverse Reaction Online Database (CVARD). Disproportionality analysis was performed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 3Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 2

    27 Oct 2026, 16:37 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

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