Safety Passport

The Safety Passport answers "what are the known safety liabilities of this drug?" by compiling FAERS adverse events, FDA label warnings, recall history, and computed organ-system risk into one profile. You give it a single drug name — generic or brand — and generate it when you want the assembled safety picture rather than one database at a time. Pulling FAERS, FDA labels, and recalls yourself returns the same records, but the passport aggregates them from that fixed source set and adds the organ-risk determination on top. See what a passport is for the model behind these.

Safety Passport

The Safety Passport compiles FDA adverse event reports, label warnings, recall history, and computed organ risk into a comprehensive drug safety profile.

Input

• Format: Drug name (generic or brand, case-insensitive)
• Duration: 5–15 seconds
• Access: Flourish plan or higher

Data Sources Aggregated

FAERS Adverse Events

FDA Adverse Event Reporting System data:

• Total reports, serious event count, fatal event count
• Top 25 reactions with seriousness percentage
• Demographic breakdown (age, sex, reporter type)
• Drug-drug interaction signals from concomitant medication data

FDA Label Warnings

Structured label data:

• Boxed warnings (black box) — most serious safety concerns
• Contraindications — when the drug should not be used
• Major warnings — important safety information
• Precautions — monitoring and usage guidance
• Pregnancy category — reproductive safety classification

Drug Recalls

Enforcement action history:

• Class I — most serious (reasonable probability of adverse health consequences or death)
• Class II — may cause temporary or reversible adverse health consequences
• Class III — not likely to cause adverse health consequences
• Recall reason, status, and affected products

Risk Assessment

Computed organ-system risks:

Risk scoring:

• High: >1,000 events or >50% serious
• Medium: >100 events or >25% serious
• Low: >0 events, below medium thresholds
• Overall score: 0–1 average of organ risks + 0.3 boost if boxed warning present

Sections Displayed

1. Adverse Events — FAERS summary with top reactions and demographic breakdown
2. Drug Interactions — concomitant drug signals from FAERS co-reporting
3. Label Warnings — boxed warnings, contraindications, and precautions
4. Recalls — enforcement action history with classification
5. Risk Assessment — organ-specific risk levels with visual indicators

Canvas Visualization

• Card size: 300×250px
• Border color: Brown (#795548)
• Tier 2 metrics: FAERS adverse event count, FDA warning count, risk assessment level

Chat Usage

Example Prompts

• "Run a safety passport on metformin"
• "What's the safety profile of atorvastatin?"
• "Generate a safety report for Humira"

Workflow Chaining

• Accepts from: Any drug name (typed or extracted from literature via BioBERT)
• Feeds into: Therapeutic Area Passport (contributes to safety landscape section)