What problem does it solve? Manually compiling a drug safety profile requires querying FAERS adverse event data, FDA labeling, PharmGKB pharmacogenomics, and clinical trial results separately, then calculating disproportionality statistics by hand. This Skill automates that multi-source pharmacovigilance workflow into a single structured safety report. ## Core Features & Use Cases - Disproportionality Signal Detection: Queries FAERS adverse event counts and calculates PRR with 95% confidence intervals, applying WHO-UMC signal thresholds and tiering signals T1-T4 by severity. - Multi-Source Triangulation: Combines DailyMed boxed warnings and contraindications, PharmGKB pharmacogenomic variants with evidence levels, ClinicalTrials.gov Phase 3/4 safety data, KEGG pathway context, and PubMed/preprint literature. - Structured Report Generation: Produces a progressive [DRUG]_safety_report.md with 10 sections plus CSV exports of adverse events and pharmacogenomic variants, with mandatory source citations. - Use Case: Ask whether metformin is safe for a patient with mild renal impairment and receive a report covering the lactic acidosis boxed warning, FAERS PRR analysis, renal dosing thresholds, and monitoring recommendations. ## Quick Start Generate a pharmacovigilance safety report for metformin including FAERS adverse event signals, FDA label warnings, and pharmacogenomic risk factors.
