FDA Adverse Event Reports on Drug-Induced Cheilitis with 38 High-Risk Drugs

This dataset underpins a pharmacovigilance study analyzing 5,007 cheilitis reports from the U.S. FDA Adverse Event Reporting System (FAERS) from 2004–2025. The research identified 38 drugs significantly associated with cheilitis, with isotretinoin most reported and crisaborole showing the strongest signal. It integrates disproportionality analysis, network toxicology, and molecular docking results, including binding affinities and molecular dynamics simulations.

Use Cases

• Identify high-risk drugs for cheilitis by analyzing disproportionality signals like Reporting Odds Ratio (ROR) across 38 pharmaceuticals.
• Investigate demographic risk factors by modeling the association between female sex (an independent risk factor) and cheilitis reports using multivariate logistic regression.
• Validate drug-target interactions through molecular docking scores, such as the strong binding affinity for the afatinib-EGFR complex.
• Explore mechanistic pathways by examining enriched signaling pathways like IL-17 and TNF identified through network toxicology.
• Assess drug safety profiles using predicted ADMET properties, such as the high risk of drug-induced liver injury for four compounds.

Strengths

• Analysis is based on 5,007 individual cheilitis adverse event reports from the FAERS database.
• Identifies 38 specific pharmaceuticals with significant associations to cheilitis, providing concrete drug candidates.
• Integrates multiple methodologies: disproportionality analysis, network toxicology, and molecular docking with 500 ns molecular dynamics simulations.
• Provides specific statistical measures like ROR values (e.g., crisaborole ROR=550.48) and molecular binding affinities (e.g., -8.1 to -6.2 kcal/mol).

Limitations

• The underlying raw data (5,007 reports) is not provided; the dataset is a 15.4 KB DOCX file containing study results and analysis.
• Temporal coverage (2004–2025) suggests inclusion of future data, which may indicate projected or incomplete reporting for later years.
• Geographic scope is limited to reports submitted to the U.S. FDA, which may not reflect global adverse event patterns.

Provenance

Source

U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).

Collection Method

Disproportionality analysis, multivariate logistic regression, network toxicology, and molecular docking on extracted reports.

Time Range

2004–2025

Freshness

The study was last updated in March 2026, indicating recent analysis.

Geography

United States