Analyze drug safety signals from FDA adverse event reports, label warnings, and pharmacogenomic data. Calculates disproportionality measures (PRR, ROR), identifies serious adverse events, assesses pharmacogenomic risk variants. Use when asked about drug safety, adverse events, post-market surveillance, or risk-benefit assessment.
Systematic drug safety analysis using FAERS adverse event data, FDA labeling, PharmGKB pharmacogenomics, and clinical trial safety signals.
KEY PRINCIPLES:
Apply when user asks:
[DRUG]_safety_report.md FIRST with all section headers and [Researching...] placeholders[DRUG]_adverse_events.csv and [DRUG]_pharmacogenomics.csvEvery safety signal MUST include source tool, data period, PRR, case counts, and serious/fatal breakdown.
| Tool | WRONG Parameter | CORRECT Parameter |
|---|---|---|
FAERS_count_reactions_by_drug_event | drug | drug_name |
DailyMed_search_spls | name | drug_name |
PharmGKB_search_drug | drug | query |
OpenFDA_get_drug_events | drug_name | search |
Phase 1: Drug Disambiguation
-> Resolve drug name, get identifiers (ChEMBL, DrugBank)
Phase 2: Adverse Event Profiling (FAERS)
-> Query FAERS, calculate PRR, stratify by seriousness
Phase 3: Label Warning Extraction
-> DailyMed boxed warnings, contraindications, precautions
Phase 4: Pharmacogenomic Risk
-> PharmGKB clinical annotations, high-risk genotypes
Phase 5: Clinical Trial Safety
-> ClinicalTrials.gov Phase 3/4 safety data
Phase 5.5: Pathway & Mechanism Context
-> KEGG drug metabolism, target pathway analysis
Phase 5.6: Literature Intelligence
-> PubMed, BioRxiv/MedRxiv, OpenAlex citation analysis
Phase 6: Signal Prioritization
-> Rank by PRR x severity x frequency
Phase 7: Report Synthesis
DailyMed_search_spls(drug_name=...) for NDC, SPL setid, generic nameChEMBL_search_drugs(query=...) for molecule ID, max phaseFAERS_count_reactions_by_drug_event(drug_name=..., limit=50) for top events(A/B) / (C/D) where A=drug+event, B=drug+any, C=event+any_other, D=total_otherSeverity classification:
See SIGNAL_DETECTION.md for detailed disproportionality formulas and example output tables.
DailyMed_get_spl_by_set_id(setid=...)PharmGKB_search_drug(query=...) for clinical annotationsPGx Evidence Levels:
| Level | Description | Action |
|---|---|---|
| 1A | CPIC/DPWG guideline, implementable | Follow guideline |
| 1B | CPIC/DPWG guideline, annotation | Consider testing |
| 2A | VIP annotation, moderate evidence | May inform |
| 2B | VIP annotation, weaker evidence | Research |
| 3 | Low-level annotation | Not actionable |
search_clinical_trials(intervention=..., phase="Phase 3", status="Completed")PubMed_search_articles(query='"[drug]" AND (safety OR adverse OR toxicity)')Signal Score = PRR x Severity_Weight x log10(Case_Count + 1)
Severity weights: Fatal=10, Life-threatening=8, Hospitalization=5, Disability=5, Other serious=3, Non-serious=1
Categorize signals:
Save as [DRUG]_safety_report.md. See REPORT_TEMPLATES.md for the full report structure and example outputs.
| Tier | Criteria | Example |
|---|---|---|
| T1 | PRR >10, fatal outcomes, boxed warning | Lactic acidosis |
| T2 | PRR 3-10, serious outcomes | Hepatotoxicity |
| T3 | PRR 2-3, moderate concern | Hypoglycemia |
| T4 | PRR <2, known/expected | GI side effects |
| Primary Tool | Fallback 1 | Fallback 2 |
|---|---|---|
FAERS_count_reactions_by_drug_event | OpenFDA_get_drug_events | Literature search |
DailyMed_get_spl_by_set_id | FDA_drug_label_search | DailyMed website |
PharmGKB_search_drug | CPIC_get_guidelines | Literature search |
search_clinical_trials | ClinicalTrials.gov API | PubMed for trial results |
See CHECKLIST.md for the full phase-by-phase verification checklist.