Unofficial FDA API MCP Server

A comprehensive Model Context Protocol (MCP) server that provides access to the U.S. Food and Drug Administration's public datasets through the openFDA API. This server enables querying of drug adverse events, product labeling, recalls, approvals, shortages, NDC directory information, and medical device regulatory data including 510(k) clearances, classifications, and adverse events.

Developed by Augmented Nature

Features

Drug Tools (6 tools implemented)

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

Device Tools (4 tools implemented)

• search_device_510k: Search FDA 510(k) device clearances
• search_device_classifications: Search FDA device classifications
• search_device_adverse_events: Search FDA device adverse events (MDR)
• search_device_recalls: Search FDA device recall enforcement reports

Key Features

• Comprehensive Search: Advanced filtering by drug name, manufacturer, indication, dates, and more
• Rate Limiting: Built-in awareness of FDA API rate limits (1,000 requests/hour without API key)
• Error Handling: Robust error handling with meaningful error messages
• Formatted Results: Clean, structured JSON responses with relevant metadata
• Optional API Key: Supports FDA API key for higher rate limits (120,000 requests/hour)

Installation

1. The server is already built and configured in your MCP settings
2. Optionally set an FDA API key for higher rate limits:

# Set FDA_API_KEY environment variable for higher rate limits
export FDA_API_KEY="your_api_key_here"

To get an FDA API key:

1. Visit https://open.fda.gov/apis/authentication/
2. Sign up for an API key
3. Add it to your MCP settings or environment

Usage Examples

Search Drug Adverse Events

Search for adverse events related to aspirin that occurred in the United States in 2023

Search Drug Labels

Find labeling information for diabetes medications manufactured by Novo Nordisk

Search NDC Directory

Look up NDC information for ibuprofen tablets

Search Drug Recalls

Find all Class I drug recalls from 2023 involving contamination

Search FDA Approved Drugs

Find all FDA-approved drugs sponsored by Pfizer with injection dosage form

Search Drug Shortages

Find current drug shortages for antibiotics

API Response Format

All tools return structured JSON with:

• search_criteria: The parameters used for the search
• total_results: Total number of matching records in FDA database
• results_shown: Number of results returned in this response
• [data_type]: Array of formatted results (e.g., adverse_events, drug_labels)
• api_usage: Information about API key status and rate limits

Rate Limiting

• Without API Key: 1,000 requests per hour
• With API Key: 120,000 requests per hour
• The server automatically handles rate limit errors and provides helpful messages

Architecture

The server is built with a modular architecture:

• /src/index.ts: Main server setup and tool registration
• /src/handlers/drug-handlers.ts: All drug-related tool implementations
• /src/handlers/device-handlers.ts: All device-related tool implementations
• /src/utils/api-client.ts: HTTP client with error handling and rate limiting
• /src/types/fda.ts: TypeScript interfaces for all FDA data structures

Supported Search Parameters

Drug Adverse Events

• drug_name: Name of the drug or medication
• `b

... View full README on GitHub