OpenFDA MCP Server

A Python Model Context Protocol (MCP) server that gives AI assistants access to the U.S. Food and Drug Administration's public datasets through the openFDA API. Query drug adverse events, product labeling, recalls, approvals, shortages, NDC directory data, and medical device regulatory information — all from your AI assistant.

Features

• 10 search tools covering drugs and medical devices
• Async HTTP client built on httpx for fast, concurrent requests
• Pagination and counting — skip/limit and field-level frequency counts out of the box
• Optional API key — works without one (1k req/hr); set FDA_API_KEY for 120k req/hr
• Clean JSON responses with metadata summaries for the LLM

Tools

Drug tools

Tool	Description
search_drug_adverse_events	Search FDA Adverse Event Reporting System (FAERS) data
search_drug_labels	Search drug product labeling (SPL) information
search_drug_ndc	Query the National Drug Code (NDC) directory
search_drug_recalls	Find drug recall enforcement reports
search_drug_approvals	Search the Drugs@FDA database for approved products
search_drug_shortages	Query current drug shortage reports

Device tools

Tool	Description
search_device_510k	Search FDA 510(k) premarket clearance data
search_device_classifications	Search FDA medical device classifications
search_device_adverse_events	Search medical device adverse event (MDR) reports
search_device_recalls	Search medical device recall enforcement reports

Installation

Prerequisites

• pixi (recommended) or Python 3.11+

With pixi

git clone https://github.com/YOUR_USERNAME/openfda-mcp-server.git
cd openfda-mcp-server
pixi install

With pip

pip install -e .

Configuration

All tools work without an API key, but you'll be limited to 1,000 requests per hour. For higher limits:

1. Get a free API key at open.fda.gov/apis/authentication
2. Copy the example env file and add your key:

cp .env.example .env
# edit .env and paste your key

The server loads .env automatically on startup via python-dotenv. Alternatively, set the environment variable directly:

export FDA_API_KEY="your-key-here"

Usage

Running the server

pixi run serve
# or
openfda-mcp-server

The server communicates over stdio, designed for use with MCP-compatible AI assistants.

MCP client configuration

Claude Desktop / Claude Code

{
  "mcpServers": {
    "openfda": {
      "command": "pixi",
      "args": ["run", "serve"],
      "cwd": "/path/to/openfda-mcp-server",
      "env": {
        "FDA_API_KEY": "your-key"
      }
    }
  }
}

Example queries

Once connected, your AI assistant can answer questions like:

• "What adverse events have been reported for Ozempic?"
• "Show me Class I drug recalls from the past year"
• "Look up the NDC codes for metformin"
• "What 510(k) clearances has Medtronic received for cardiac devices?"
• "Are there any current drug shortages for antibiotics?"

openFDA search syntax

All tools accept a search parameter using openFDA query syntax:

# Exact match
patient.drug.openfda.brand_name:"aspirin"

# Date range
receivedate:[20240101+TO+20241231]

# AND / OR
openfda.brand_name:"lipitor"+AND+serious:1

# Count a field (returns frequency data instead of records)
count=patient.reaction.reactionmeddrapt.exact

Development

pixi run test       # run tests
pixi run lint       # lint with ruff
pixi run fmt        # format with ruff
pixi run typecheck  # type check with pyright

Project structure

openfda-mcp-server/
├── pixi.toml                          # environment and task config
├── pyproject.toml                     # package metadata
└── src/openfda_mcp_server/
    ├── client.py                      # async httpx client for openFDA API
    ├── server.py                      # FastMCP server entry point
    └── tools.py                       # MCP tool definitions and handlers

License

MIT