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

Functioning as derived from 5,007 cheilitis reports from the U.S. FDA Adverse Event Reporting System (2004–2025). It identifies 38 pharmaceuticals significantly associated with cheilitis, with disproportionality analysis results like ROR values, and includes network toxicology and molecular docking findings on core targets and binding affinities.

Use Cases

• Identify high-risk pharmaceuticals for cheilitis by analyzing disproportionality signals like ROR values from 5,007 adverse event reports.
• Investigate demographic risk factors for drug-induced cheilitis using multivariate logistic regression results on variables like female sex, age, and weight.
• Validate binding interactions between high-risk drugs (e.g., afatinib, capecitabine) and core molecular targets (e.g., EGFR, IL6) using molecular docking affinity scores.
• Explore enriched biological pathways (e.g., IL-17, TNF, PI3K-Akt) associated with drug-induced cheilitis through network toxicology analysis of protein-protein interactions.

Strengths

• Based on 5,007 cheilitis reports from the authoritative U.S. FDA Adverse Event Reporting System.
• Identifies 38 pharmaceuticals with significant associations to cheilitis, providing specific risk metrics like ROR values.
• Integrates multiple analytical methods: pharmacovigilance, network toxicology, and molecular docking with binding affinity scores.

Limitations

• The dataset is very small at 13.6 KB, indicating it contains summary results rather than the raw 5,007 report-level data.
• The underlying FAERS data may have reporting biases inherent to spontaneous adverse event systems.
• Molecular docking and dynamics results are computational predictions requiring experimental validation.

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

Covers reports from 2004 to 2025; last updated in March 2026.

Geography

United States