mcp-openfda

An MCP (Model Context Protocol) server that gives LLMs direct access to openFDA — search drug adverse events, labels, recalls, and device safety reports.

No API key required. An optional key increases rate limits from 40 to 240 requests/minute.

Quick Start

Add to your MCP client config (Claude Code, Cursor, Windsurf, etc.):

{
  "mcpServers": {
    "openfda": {
      "command": "npx",
      "args": ["-y", "mcp-openfda"]
    }
  }
}

That's it. No configuration needed.

Tools

Drug Safety

| Tool | Description | |------|-------------| | drug_adverse_events | Search FAERS adverse event reports by drug name, reaction, seriousness, indication, and date range | | drug_labels | Search FDA-approved labeling (SPL) — indications, warnings, dosing, adverse reactions, drug interactions | | drug_enforcement | Search drug recalls and enforcement actions by drug, firm, classification, and status |

Device Safety

| Tool | Description | |------|-------------| | device_adverse_events | Search Medical Device Reports (MDR) by device name, event type (Death/Injury/Malfunction), and date range |

Aggregation

| Tool | Description | |------|-------------| | openfda_count | Aggregate top values for any field across any endpoint — e.g. top reactions for a drug, top recalled firms |

Example Prompts

Once connected, you can ask your LLM:

• "What adverse events have been reported for Ozempic?"
• "Show me the warnings section from the Keytruda label"
• "Find Class I drug recalls in the last 6 months"
• "What are the top 10 adverse reactions reported for metformin?"
• "Search for device malfunction reports for insulin pumps"
• "Compare adverse event profiles between Ozempic and Mounjaro"
• "Has there been any recall activity for Novo Nordisk products?"

Typical Workflow

1. drug_adverse_events  → Find safety signals for a drug
2. drug_labels          → Check label warnings and contraindications
3. openfda_count        → Aggregate top reactions or compare drugs
4. drug_enforcement     → Check recall history
5. device_adverse_events → Review device safety for related devices

Environment Variables

| Variable | Default | Description | |----------|---------|-------------| | OPENFDA_API_KEY | (none) | Optional. Get one free at open.fda.gov. Increases rate limit from 40 to 240 req/min. |

Rate Limiting

The server includes a built-in token-bucket rate limiter:

• With API key: 4 requests/second (240/min)
• Without API key: 0.6 requests/second (40/min)
• Automatic retry on 429 (rate limit exceeded) with 2-second backoff

Development

git clone https://github.com/cmanohar/mcp-openfda.git
cd mcp-openfda
npm install
npm run build
node dist/index.js  # runs on stdio

How It Works

This server wraps four openFDA API endpoints:

• Drug Adverse Events (/drug/event.json) — FAERS reports
• Drug Labels (/drug/label.json) — SPL/package inserts
• Drug Enforcement (/drug/enforcement.json) — recalls and enforcement actions
• Device Adverse Events (/device/event.json) — MDR reports

All endpoints support a count parameter for field-level aggregation, exposed via the openfda_count tool.

License

MIT