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 findings from network toxicology and molecular docking studies.

Use Cases

• Analyze disproportionality signals (e.g., ROR=550.48 for crisaborole) across the 38 identified pharmaceuticals to prioritize drug safety monitoring.
• Investigate demographic risk factors like female sex (OR=0.771) and protective effects of age and weight within the 5,007 adverse event reports.
• Validate molecular docking predictions of binding affinities (e.g., -8.1 kcal/mol for afatinib-EGFR) using the provided network toxicology targets like IL6 and TNF.
• Profile ADMET predictions, such as high liver injury risk for four compounds, against the pharmacovigilance signals for the identified drugs.

Strengths

• Based on 5,007 adverse event reports from the authoritative U.S. FDA Adverse Event Reporting System.
• Identifies 38 specific pharmaceuticals with significant associations to cheilitis, including concrete disproportionality metrics (e.g., ROR values).
• Integrates multiple analytical methods: pharmacovigilance, network toxicology identifying core targets (e.g., IL6, TNF), and molecular docking with binding affinity scores.

Limitations

• The dataset is very small at 15.5 KB, indicating it is likely a summary or processed results table, not the raw 5,007 reports.
• Temporal coverage extends to 2025, which is a future date, suggesting potential projection or error in the date range.
• Limited scope focused solely on cheilitis, which is a specific adverse event, reducing generalizability to other drug reactions.

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 2026-03-20, indicating recent maintenance.

Geography

United States