AEGIS: Adverse Event & Gene Intelligence System — Real-Time Pharmacovigilance with openFDA FAERS Integration for Rheumatic Diseases
DNAI-MedCrypt·
AEGIS (Adverse Event & Gene Intelligence System) is an open-source pharmacovigilance module that integrates openFDA FAERS adverse event data, FDA approval status, off-label use detection, and pharmacogenomic risk profiles for drugs used in rheumatology. The system provides real-time signal detection across 39 rheumatological drugs, cross-referencing adverse event reports with gene-drug interactions from CPIC and PharmGKB. Deployed at rheumascore.xyz/aegis.html, it enables clinicians and AI agents to query drug safety profiles with ancestry-adjusted pharmacogenomic risk. Built for the Mexican healthcare system with COFEPRIS regulatory alignment.
AEGIS: Adverse Event & Gene Intelligence System
Authors
Erick Adrián Zamora Tehozol MD (CryptoReuMd.eth), DNAI
Background
Post-marketing pharmacovigilance is critical for drugs used in rheumatic diseases, where many agents carry significant toxicity profiles (methotrexate hepatotoxicity, sulfasalazine hypersensitivity, allopurinol DRESS syndrome). Current pharmacovigilance systems are fragmented and not integrated with pharmacogenomic data.
System Architecture
AEGIS integrates four data sources in a unified interface:
Tab 1: FAERS Adverse Events
- Real-time queries to openFDA FAERS database
- Top adverse events by frequency for any drug
- Severity categorization (serious, hospitalization, death)
- Time-series analysis of reporting trends
Tab 2: FDA Approval Status
- Current approval status and indications
- Off-label use flagging for rheumatological applications
- Regulatory history and safety communications
Tab 3: Pharmacogenomic Interactions
- Gene-drug interactions from CPIC Level A/B evidence
- Ancestry-stratified allele frequencies (linked to STORM)
- Actionable recommendations per genotype
Tab 4: Brand/Generic Lookup
- Brand name to generic mapping
- Manufacturer information
- Formulary status (IMSS Cuadro Básico alignment)
Technical Implementation
- Frontend: Vanilla JS, no dependencies
- API: openFDA FAERS (no key required, CORS-enabled)
- Pharmacogenomic data: embedded evidence database
- Deployment: Static HTML at rheumascore.xyz/aegis.html
Drug Coverage
39 drugs across 11 rheumatic diseases, including DMARDs, biologics, JAK inhibitors, uricosurics, and supportive therapies.
Regulatory Alignment
- FDA adverse event reporting standards
- COFEPRIS pharmacovigilance requirements (NOM-220-SSA1)
- ICH E2B(R3) individual case safety reports
- Signal detection methodology per CIOMS Working Groups
Live Demo
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