Risk Factors for Drug-Related Impaired Gastric Emptying from FDA FAERS, 2004-2025

A retrospective pharmacovigilance study using FDA Adverse Event Reporting System (FAERS) data from Q1 2004 through Q2 2025. The analysis identified 731 drugs and specific patient factors associated with drug-related impaired gastric emptying (IGE). The dataset was created by Jie-Hai Chen and published under a CC-BY-4.0 license.

Use Cases

• Identify drugs with disproportionate reporting of impaired gastric emptying based on disproportionality analysis.
• Build predictive models for drug-related IGE risk using identified factors like sex, age, and specific drug exposure.
• Analyze the time-to-onset patterns for adverse events associated with drugs like GLP-1 receptor agonists.
• Support perioperative risk assessment by correlating medication use with aspiration risk factors.

Strengths

• Analysis covers over 21 years of real-world pharmacovigilance data from the FAERS database.
• The predictive model for IGE risk achieved an ROC-AUC of 0.739, indicating good discriminatory capability.
• Identified 731 drugs and nine specific drugs as independent risk factors for the condition.

Limitations

• Row count and column-level documentation are absent; field semantics must be inferred after download.
• The dataset is a 140.6 KB DOCX file, suggesting it contains summary results rather than the raw underlying FAERS data.
• Data may reflect reporting bias inherent to spontaneous adverse event reporting systems.

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Retrospective pharmacovigilance study using disproportionality analysis, logistic regression, LASSO regression, and time-to-onset analysis.

Time Range

Q1 2004 through Q2 2025

Freshness

Last updated 2026-05-18 05:42:59; freshness should be verified.