---
title: Safety Passport
description: >-
  Aggregated drug safety report combining FAERS adverse events, FDA warnings,
  recalls, and organ risk assessment.
tags:
  - passports
  - safety
---

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](/docs/passports-explained) 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.

> The Safety Passport requires the **Flourish plan or higher**.

## 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:

| Organ System | Risk Levels | Determination |
|-------------|-------------|---------------|
| Hepatic | Low / Medium / High | Event count + serious event % |
| Cardiac | Low / Medium / High | Event count + serious event % |
| Renal | Low / Medium / High | Event count + serious event % |
| Immune | Low / Medium / High | Event count + serious event % |

**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)