Drug Safety MCP Server

MCP server for FDA Adverse Event Reporting System (FAERS) data via the OpenFDA API. A complete pharmacovigilance toolkit for drug safety analysis.

Features

• Search adverse event reports by drug, reaction, date range
• Get aggregated event counts grouped by reaction, outcome, demographics
• Compare safety profiles across multiple drugs
• Analyze serious events (deaths, hospitalizations, etc.)
• View reporting trends over time
• Find drugs associated with specific reactions
• Identify commonly co-reported drugs
• Get FDA drug label information (warnings, contraindications, boxed warnings)
• Search FDA drug recalls and enforcement actions
• Search by indication to compare drugs in the same therapeutic class
• Search by drug class (e.g., all TNF inhibitors, GLP-1 agonists)
• Compare label to FAERS reports - identify emerging safety signals
• Pediatric safety analysis with adult comparison
• Geriatric safety analysis with younger adult comparison
• Executive safety summary - quick due diligence
• Pregnancy & lactation info - critical for protocol exclusion criteria

Installation

npm install drug-safety-mcp

Or clone and build from source:

git clone https://github.com/sine-ai/drug-safety-mcp.git
cd drug-safety-mcp
npm install
npm run build

Configuration

Claude Desktop / Claude.ai

Add to your Claude configuration file:

macOS: ~/Library/Application Support/Claude/claude_desktop_config.json Windows: %APPDATA%\Claude\claude_desktop_config.json

{
  "mcpServers": {
    "drug-safety": {
      "command": "node",
      "args": ["/path/to/drug-safety-mcp/dist/index.js"],
      "env": {
        "OPENFDA_API_KEY": "your_api_key_here"
      }
    }
  }
}

Cursor IDE

Add to your Cursor MCP settings:

{
  "mcpServers": {
    "drug-safety": {
      "command": "node",
      "args": ["/path/to/drug-safety-mcp/dist/index.js"],
      "env": {
        "OPENFDA_API_KEY": "your_api_key_here"
      }
    }
  }
}

Remote Mode (Streamable HTTP)

For remote/cloud deployments, the server supports Streamable HTTP transport:

# Start in remote mode
MCP_MODE=remote PORT=3000 npm start

# Or use the script
npm run start:remote

Connect to the remote server:

{
  "mcpServers": {
    "drug-safety": {
      "url": "https://your-server.com/mcp"
    }
  }
}

Endpoints:

• GET /health - Health check
• POST /mcp - MCP Streamable HTTP endpoint

OAuth 2.0 Authentication (via MCP Gateway)

Remote mode uses MCP Gateway for OAuth 2.0 authentication. Users sign in with their Microsoft account:

• ✅ Microsoft work/school accounts (Azure AD / Microsoft 365)
• ✅ Microsoft personal accounts (Outlook, Hotmail, Xbox, Skype)

How It Works

User → drug-safety-mcp → MCP Gateway → Azure AD → User signs in
                              ↓
                    Token returned to client

1. MCP client discovers OAuth endpoints via /.well-known/oauth-authorization-server
2. Client redirects user to MCP Gateway's authorization endpoint
3. User signs in with Microsoft account via Gateway
4. Gateway returns access token
5. Client uses token for MCP requests

Configuration

OAUTH_ENABLED=true
MCP_GATEWAY_URL=https://your-mcp-gateway.example.com
BASE_URL=https://your-server.com

Security Notes:

• Always use HTTPS in production
• Set CORS_ORIGIN to specific origins in production
• MCP Gateway handles Azure AD integration and token management

Docker Deployment

Build and run with Docker:

# Build the image
docker build -t drug-safety-mcp .

# Run the container
docker run -p 3000:3000 -e OPENFDA_API_KEY=your_key drug-safety-mcp

Or with Docker Compose:

version: '3.8'
services:
  drug-safety-mcp:
    build: .
    ports:
      - "3000:3000"
    environment:
      - MCP_MODE=remote
      - PORT=3000
      - OPENFDA_API_KEY=${OPENFDA_API_KEY:-}
    healthcheck:
      test: ["CMD", "wget", "--spider", "-q", "http://localhost:3000/health"]
      interval: 30s
      timeout: 10s
      retries: 3

Deploy to cloud platforms:

• Azure Container Apps: az containerapp up --source .
• Google Cloud Run: gcloud run deploy --source .
• AWS App Runner: Connect your GitHub repo

OpenFDA API Key (Optional)

The OpenFDA API works without an API key, but with limits:

• Without key (free mode): 240 requests/min, 1,000 requests/day per IP
• With key: 240 requests/min, 120,000 requests/day per key

To get a free API key:

1. Go to https://open.fda.gov/apis/authentication/
2. Enter your email address
3. Check your email for the API key

Example Prompts

Here are working examples that demonstrate core functionality:

1. Basic Drug Safety Search

What are the most common adverse events reported for Ozempic?

This uses get_event_counts to show top reactions grouped by frequency.

2. Safety Profile Comparison

Compare the safety profiles of Humira, Enbrel, and Remicade for rheumatoid arthritis treatment.

This uses compare_safety_profiles to show side-by-side adverse event data for TNF inhibitors.

3. Executive Safety Summary

Give me a quick safety summary for metformin including any recalls or boxed warnings.

This uses get_safety_summary to provide a comprehensive overview with total reports, top reactions, trends, recalls, and label warnings.

4. Pediatric Safety Analysis

What adverse events are reported for Adderall in children aged 6-12?

This uses get_pediatric_safety with age group filtering to show pediatric-specific safety data.

5. Signal Detection

Are there any adverse events being reported for Keytruda that aren't on the FDA label?

This uses compare_label_to_reports to identify potential emerging safety signals.

6. Drug Class Analysis

What are the common side effects across all GLP-1 receptor agonists?

This uses search_by_drug_class to analyze the entire drug class.

7. Pregnancy Safety

What is the pregnancy and lactation safety information for methotrexate?

This uses get_pregnancy_lactation_info to retrieve FDA label guidance for reproductive safety.

8. Serious Events Only

Show me only the fatal adverse events reported for warfarin.

This uses get_serious_events with outcome_type="death" to filter to the most serious outcomes.

Available Tools (17 Total)

Core Adverse Event Tools

| Tool | Description | |------|-------------| | search_adverse_events | Search AE reports by drug, reaction, date | | get_event_counts | Aggregated counts by reaction, outcome, demographics | | compare_safety_profiles | Compare AE profiles across 2-5 drugs | | get_serious_events | Filter to serious outcomes only | | get_reporting_trends | AE volume over time by year/quarter/month | | search_by_reaction | Find drugs associated with a reaction | | get_concomitant_drugs | Find commonly co-reported drugs |

Drug Class & Indication Tools

| Tool | Description | |------|-------------| | search_by_indication | Find AEs for drugs used for a specific condition | | search_by_drug_class | Search AEs across entire drug class (TNF inhibitors, SSRIs, etc.) |

Signal Detection Tools

| Tool | Description | |------|-------------| | compare_label_to_reports | Compare FDA label to FAERS - identify emerging signals | | get_pediatric_safety | Pediatric-specific safety with adult comparison | | get_geriatric_safety | Geriatric-specific safety (65+) with younger adult comparison |

Executive & Protocol Tools

| Tool | Description | |------|-------------| | get_safety_summary | Executive summary: counts, top reactions, trends, recalls, warnings | | get_pregnancy_lactation_info | Pregnancy/lactation info for protocol exclusion criteria |

Drug Information Tools

| Tool | Description | |------|-------------| | get_drug_label_info | FDA drug label (warnings, contraindications, boxed warnings) | | get_recall_info | FDA drug recalls and enforcement actions | | get_data_info | Database info and limitations |

User Personas

| User | Primary Tools | |------|---------------| | Medical Monitor | search_adverse_events, compare_safety_profiles, get_pediatric_safety, get_geriatric_safety | | Protocol Writer | search_by_drug_class, get_drug_label_info, get_pregnancy_lactation_info, get_pediatric_safety | | Pharmacovigilance | compare_label_to_reports, get_reporting_trends, get_serious_events, get_safety_summary | | Regulatory Affairs | compare_label_to_reports, get_drug_label_info, get_recall_info, get_pregnancy_lactation_info | | BD / Competitive Intel | compare_safety_profiles, search_by_drug_class, get_recall_info, get_safety_summary | | Medical Affairs | get_event_counts, get_drug_label_info, search_by_reaction, get_safety_summary |

Data Limitations

IMPORTANT: FAERS data has significant limitations:

• A report does NOT prove the drug caused the event
• Voluntary reporting means many events go unreported
• Cannot calculate incidence rates (no denominator)
• Reporting influenced by publicity and time on market
• Duplicate and incomplete reports exist

This data should be used for signal detection and hypothesis generation, not as the sole basis for clinical decisions.

Development

# Install dependencies
npm install

# Build
npm run build

# Run in development mode
npm run dev

# Run tests
npm test

# Type check
npm run typecheck

# Lint
npm run lint

Environment Variables

| Variable | Default | Description | |----------|---------|-------------| | MCP_MODE | local | local (stdio) or remote (Streamable HTTP) | | PORT | 3000 | HTTP port for remote mode | | BASE_URL | - | Server's public URL (required for remote mode) | | OPENFDA_API_KEY | - | OpenFDA API key (optional, uses free tier if not set) | | LOG_LEVEL | info | debug, info, warn, error | | OAUTH_ENABLED | false | Enable OAuth 2.0 authentication for remote mode | | MCP_GATEWAY_URL | - | MCP Gateway URL for OAuth (handles Azure AD) | | CORS_ORIGIN | * | Allowed CORS origin (set specific origin in production) |

Privacy & Data

This MCP server:

• Does not collect any user data or conversation history
• Only queries public FDA databases via the OpenFDA API
• Does not store any data locally beyond runtime caching
• Does not transmit data to any third parties other than OpenFDA

All tools are read-only and query publicly available FDA safety data.

For details on how OpenFDA handles data, see: https://open.fda.gov/apis/

Security

For security vulnerabilities, please see SECURITY.md.

Support & Contact

Developer: SineAI

For issues, questions, or security concerns:

• GitHub Issues: https://github.com/sine-ai/drug-safety-mcp/issues
• Security Issues: [email protected]
• General Inquiries: [email protected]

Troubleshooting

Common Issues

"No results found" errors

• Check drug name spelling
• Try brand name instead of generic (or vice versa)
• Use simpler search terms

Rate limit errors

• Set OPENFDA_API_KEY environment variable for higher limits
• Get a free key at https://open.fda.gov/apis/authentication/

Connection errors in remote mode

• Verify PORT is not in use
• Check firewall settings
• Ensure the server is accessible from the client

License

MIT License - see LICENSE file.

Author

SineAI
https://sineai.co

This software is not affiliated with, endorsed by, or sponsored by Anthropic, PBC or the U.S. Food and Drug Administration. "Claude" and "Anthropic" are trademarks of Anthropic, PBC.