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

The dataset underpins a pharmacovigilance study analyzing 5,007 cheilitis reports from the U.S. FDA Adverse Event Reporting System (FAERS) from 2004–2025. It identifies 38 pharmaceuticals significantly associated with the adverse reaction, with disproportionality analysis and molecular docking results. The study was authored by Xuefeng Wang.

Use Cases

• Identify high-risk pharmaceuticals for cheilitis using reported odds ratios (ROR) like those for isotretinoin (ROR=42.61) and crisaborole (ROR=550.48).
• Analyze demographic risk factors such as female sex (OR=0.771) and protective effects of age and weight from multivariate logistic regression.
• Validate binding affinities (e.g., -8.1 to -6.2 kcal/mol) between drugs like afatinib and molecular targets such as EGFR via molecular docking data.
• Examine enriched signaling pathways (IL-17, TNF, PI3K-Akt) and core targets (IL6, TNF, AKT1, VEGFA, STAT3) identified through network toxicology.
• Assess drug safety profiles using ADMET predictions, such as the high liver injury risk for four compounds versus lamotrigine's favorable profile.

Strengths

• Based on 5,007 individual adverse event reports from the authoritative U.S. FDA FAERS database.
• Integrates multiple analytical methods: disproportionality analysis, network toxicology, and molecular docking with 500 ns simulations.
• Identifies 38 specific pharmaceuticals with significant associations to cheilitis, providing concrete drug candidates for study.

Limitations

• The primary data file is a 70.9 KB DOCX document, indicating the underlying tabular data or analysis results are not provided in a structured, machine-readable format.
• Sample data and column definitions are unavailable, limiting direct computational analysis without significant manual extraction.
• The dataset scope is limited to the specific integrative study; it is not a raw, continuously updated feed of FAERS data.

Provenance

Source

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

Collection Method

Analysis of FAERS reports using disproportionality analysis, multivariate logistic regression, network toxicology, and molecular docking.

Time Range

2004–2025

Freshness

Last updated March 20, 2026, covering FAERS data up to 2025.

Geography

United States (data source is U.S. FDA).