OpenFDA Safety Data MCP Server

MCP (Model Context Protocol) server providing AI agents with direct access to FDA safety data — 20M+ drug adverse events (FAERS), drug and food recalls, and 23M+ medical device incidents (MAUDE).

Connect any MCP-compatible client (Claude Desktop, Cursor, Cline, etc.) to search FDA safety databases.

Tools

Tool	Description
search_drug_events	Search drug adverse event reports (FAERS) by drug name, date, severity
search_drug_recalls	Search FDA drug recall enforcement reports
search_food_recalls	Search FDA food recall enforcement reports
search_device_events	Search medical device adverse event reports (MAUDE)

Connect via MCP

Claude Desktop / Cursor

{
  "mcpServers": {
    "openfda": {
      "url": "https://aligned-kettledrum--openfda-mcp-server.apify.actor/mcp",
      "headers": {
        "Authorization": "Bearer YOUR_APIFY_TOKEN"
      }
    }
  }
}

Using mcp-remote (npx)

npx mcp-remote https://aligned-kettledrum--openfda-mcp-server.apify.actor/mcp \
  --header "Authorization: Bearer YOUR_APIFY_TOKEN"

Example Queries

Once connected, ask your AI assistant:

• "What are the most common adverse reactions reported for Ozempic?"
• "Show me recent Class I drug recalls"
• "Find food recalls involving salmonella in 2024"
• "Search for adverse events involving insulin pumps"

Data Sources

Database	Records	Coverage
Drug Adverse Events (FAERS)	20M+	1960s–present
Drug Recalls	28K+	2004–present
Food Recalls	24K+	2004–present
Device Events (MAUDE)	23M+	1991–present

All data comes from the official OpenFDA API maintained by the U.S. Food and Drug Administration. Free, no API key required.

FAQ

Q: Do I need an FDA API key? A: No. The OpenFDA API is free and open. The server handles rate limiting (240 req/min) automatically.

Q: How current is the data? A: FDA data is updated quarterly with a 3-6 month reporting lag. Device events and recalls may appear faster.

Q: Can I search by generic drug name? A: Yes. The drug_name parameter searches both brand and generic names via OpenFDA's drug terminology.

Q: What does "serious" mean for adverse events? A: FDA classifies events as "serious" if they resulted in death, hospitalization, disability, life-threatening condition, or congenital anomaly.

Q: Can I use custom OpenFDA query syntax? A: Yes. Each tool has a search parameter that accepts raw OpenFDA query syntax for advanced filtering.

Batch Processing

For large-scale data extraction (thousands of records), use the OpenFDA Safety Data Actor which supports bulk downloads with pagination.