OpenFDA Server

An MCP (Model Context Protocol) server that provides access to U.S. FDA public datasets including drugs, medical devices, adverse events, recalls, and more.

Features

• 10 FDA Tools: Query drug and device databases through a standardized MCP interface
• Drug Tools: Adverse events (FAERS), labels, NDC directory, recalls, Drugs@FDA, shortages
• Device Tools: 510(k) clearances, classifications, adverse events (MDR), recalls
• Individual Record Lookup: Retrieve specific reports by ID (safety report ID, set ID, MDR report number)
• Advanced Filtering: Filter drug labels by boxed warnings, request specific label sections
• Rate Limit Aware: Supports authenticated requests for higher rate limits (120k/hour vs 1k/hour)
• TypeScript: Fully typed with Zod schema validation

Installation

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

# Or use with npx
npx openfda-mcp-server

Configuration

Claude Desktop

Add to your Claude Desktop configuration (~/Library/Application Support/Claude/claude_desktop_config.json on macOS):

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

Environment Variables

Variable	Description	Default
OPENFDA_API_KEY	FDA API key for higher rate limits	None (uses public limits)

Get a free API key at: https://open.fda.gov/apis/authentication/

Available Tools

Drug Tools

Tool	Description
search_drug_adverse_events	Search FAERS for drug safety reports. Retrieve specific report by safetyReportId.
search_drug_labels	Search drug labeling/prescribing info. Get by setId, filter by hasBoxedWarning, select sections.
search_drug_ndc	Search the National Drug Code directory
search_drug_recalls	Search drug recall enforcement reports
search_drugs_at_fda	Search approved drug applications
search_drug_shortages	Search current and resolved drug shortages

Device Tools

Tool	Description
search_device_510k	Search 510(k) premarket notifications
search_device_classifications	Search device classification database
search_device_adverse_events	Search MDR adverse event reports. Retrieve specific report by reportNumber.
search_device_recalls	Search device recall enforcement reports

Tool Parameters

search_drug_labels

Parameter	Type	Description
setId	string	Retrieve a specific label by its unique set_id
drugName	string	Drug brand or generic name
indication	string	Medical indication or use case
activeIngredient	string	Active ingredient/substance name
route	string	Route of administration (e.g., 'oral', 'intravenous')
hasBoxedWarning	boolean	Filter for drugs with boxed warnings (most serious warnings)
sections	string[]	Specific label sections to return (see below)
limit	number	Maximum results (1-100)
skip	number	Number of results to skip for pagination

Available sections: indications_and_usage, dosage_and_administration, contraindications, warnings, warnings_and_cautions, adverse_reactions, drug_interactions, clinical_pharmacology, mechanism_of_action, pharmacokinetics, overdosage, description, how_supplied, storage_and_handling, boxed_warning

search_drug_adverse_events

Parameter	Type	Description
safetyReportId	string	Retrieve a specific FAERS report by its 8-digit ID
drugName	string	Drug or product name to search
reaction	string	Adverse reaction (e.g., 'headache', 'nausea')
manufacturer	string	Drug manufacturer name
serious	boolean	Filter for serious adverse events only
dateFrom	string	Start date (YYYY-MM-DD)
dateTo	string	End date (YYYY-MM-DD)
limit	number	Maximum results (1-100)
skip	number	Number of results to skip for pagination

search_device_adverse_events

Parameter	Type	Description
reportNumber	string	Retrieve a specific MDR report by report number
deviceName	string	Device generic name
brandName	string	Device brand name
manufacturerName	string	Device manufacturer name
eventType	string	Type: 'Injury', 'Malfunction', 'Death', 'Other'
dateFrom	string	Start date (YYYY-MM-DD)
dateTo	string	End date (YYYY-MM-DD)
limit	number	Maximum results (1-100)
skip	number	Number of results to skip for pagination

Usage Examples

Search for drug adverse events

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

Get a specific adverse event report

Retrieve FAERS report with safety report ID 10003641

Search for drugs with boxed warnings

Find all drugs with boxed warnings related to cardiovascular risks

Get specific label sections

Get the boxed_warning and contraindications sections for warfarin

Search for drug recalls

Search for Class I drug recalls from Pfizer

Search for device clearances

Find 510(k) clearances for cardiac pacemakers

Get a specific device adverse event report

Retrieve MDR report number 2649622-2020-08294

Search for device adverse events

Search device adverse events for insulin pumps that resulted in injury

CLI Usage

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

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

Docker

Quick Start

# 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

Docker Compose

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

Environment Variables

Pass environment variables to the container:

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

Development

# 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

Programmatic Usage

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"],
})

API Rate Limits

Authentication	Per Minute	Per Hour
Without API Key	40	1,000
With API Key	240	120,000

License

MIT

Acknowledgments

• OpenFDA - FDA open data API

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