# Install globally
npm install -g openfda-mcp-server

# Or use with npx
npx openfda-mcp-server

{
  "mcpServers": {
    "openfda": {
      "command": "npx",
      "args": ["-y", "openfda-mcp-server"],
      "env": {
        "OPENFDA_API_KEY": "your-api-key-optional"
      }
    }
  }
}

Find adverse events for aspirin in the last year that were serious

Retrieve FAERS report with safety report ID 10003641

Find all drugs with boxed warnings related to cardiovascular risks

Get the boxed_warning and contraindications sections for warfarin

Search for Class I drug recalls from Pfizer

Find 510(k) clearances for cardiac pacemakers

Retrieve MDR report number 2649622-2020-08294

Search device adverse events for insulin pumps that resulted in injury

# Start with stdio transport (default)
openfda-mcp-server

# Start with HTTP transport
openfda-mcp-server --transport http --port 3000

# Build and run with docker-compose
docker-compose up -d

# Or build manually
docker build -t openfda-mcp-server .
docker run -p 3000:3000 -e OPENFDA_API_KEY=your-key openfda-mcp-server

services:
  openfda-mcp:
    image: openfda-mcp-server:latest
    ports:
      - "3000:3000"
    environment:
      - OPENFDA_API_KEY=${OPENFDA_API_KEY:-}

docker run -p 3000:3000 \
  -e OPENFDA_API_KEY=your-api-key \
  -e DEBUG=openfda-mcp:* \
  openfda-mcp-server

# Install dependencies
pnpm install

# Run in development mode
pnpm dev

# Test locally
pnpm serve:test

# Run full validation (format, lint, test, build)
pnpm validate

# Build for production
pnpm build

import { createOpenFDAServer, handleSearchDrugAdverseEvents, handleSearchDrugLabels } from "openfda-mcp-server/lib"

// Create a custom server
const server = createOpenFDAServer({
  name: "my-fda-server",
  version: "1.0.0",
})

// Search for adverse events
const adverseEvents = await handleSearchDrugAdverseEvents({
  drugName: "aspirin",
  serious: true,
  limit: 10,
})

// Get a specific adverse event by ID
const specificReport = await handleSearchDrugAdverseEvents({
  safetyReportId: "10003641",
})

// Search for drugs with boxed warnings
const boxedWarningDrugs = await handleSearchDrugLabels({
  hasBoxedWarning: true,
  limit: 10,
})

// Get specific sections of a drug label
const warfarinLabel = await handleSearchDrugLabels({
  setId: "0cbce382-9c88-4f58-ae0f-532a841e8f95",
  sections: ["boxed_warning", "contraindications", "adverse_reactions"],
})