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Tools

Seven tools for querying FDA data across drugs, food, devices, and recalls:

Tool	Description
openfda_search_adverse_events	Search adverse event reports across drugs, food, and devices
openfda_search_recalls	Search enforcement reports and recall actions across drugs, food, and devices
openfda_count	Aggregate and tally unique values for any field across any openFDA endpoint
openfda_get_drug_label	Look up FDA drug labeling (package inserts / SPL documents)
openfda_search_drug_approvals	Search the Drugs@FDA database for NDA/ANDA application approvals
openfda_search_device_clearances	Search FDA device premarket notifications — 510(k) clearances and PMA approvals
openfda_lookup_ndc	Look up drugs in the NDC (National Drug Code) Directory

openfda_search_adverse_events

Search adverse event reports across drugs, food, and devices. Use to investigate safety signals, find reports for a specific product, or explore reactions by demographics.

• Category selection: drug, food, or device — each returns different field schemas
• Elasticsearch query syntax for filtering by product, reaction, seriousness, date range
• Pagination via limit (up to 1000) and skip (up to 25000)
• Formatted output includes report ID, seriousness, patient demographics, reactions, drugs with characterization/indication/route, and all remaining fields

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openfda_count

Aggregate and tally unique values for any field across any openFDA endpoint. Returns ranked term-count pairs sorted by count descending.

• Works across all 19 openFDA endpoints (drugs, food, devices, animal/veterinary, other)
• Use .exact suffix on field names for whole-phrase counting
• Optional search filter to scope the aggregation
• Returns up to 1000 terms per query

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openfda_search_recalls

Search enforcement reports and recall actions across drugs, food, and devices.

• Supports enforcement (all categories) and recall (devices only) endpoints
• Filter by classification (Class I/II/III), recalling firm, reason, status
• Formatted output includes recall number, classification, product description, reason, distribution pattern

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openfda_search_device_clearances

Search FDA device premarket notifications — 510(k) clearances and PMA approvals.

• Two pathways: 510k (174K+ records, most common) and pma (higher-risk devices)
• Filter by applicant, product code, advisory committee, device name
• Formatted output adapts to pathway: 510(k) shows K-number/clearance type, PMA shows supplement info

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openfda_get_drug_label

Look up FDA drug labeling (package inserts / SPL documents). Check indications, warnings, dosage, contraindications, active ingredients, or any structured label section.

• Search by brand name, generic name, manufacturer, or set ID
• Formatted output dynamically renders all label sections and openfda metadata present in the record
• Large sections are automatically truncated to keep output readable
• Default limit of 5 — labels are large documents

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openfda_search_drug_approvals

Search the Drugs@FDA database for drug application approvals (NDAs and ANDAs). Returns application details, sponsor info, and full submission history.

• Filter by brand name, sponsor, submission type, review priority
• Formatted output includes products with active ingredients, dosage forms, routes, and marketing status
• Full submission history with type, status, date, and review priority
• Pagination via limit (up to 1000) and skip (up to 25000)

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openfda_lookup_ndc

Look up drugs in the NDC (National Drug Code) Directory. Identify drug products by NDC code, find active ingredients, packaging details, or manufacturer info.

• Search by product NDC, brand name, generic name, manufacturer, or active ingredient
• Returns product details, active ingredients with strengths, and packaging information
• Sortable by listing expiration date or other fields

Features

Built on @cyanheads/mcp-ts-core:

• Declarative tool definitions — single file per tool, framework handles registration and validation
• Unified error handling across all tools
• Pluggable auth (none, jwt, oauth)
• Swappable storage backends: in-memory, filesystem, Supabase, Cloudflare KV/R2/D1
• Structured logging with optional OpenTelemetry tracing
• Runs locally (stdio/HTTP) or on Cloudflare Workers from the same codebase

openFDA-specific:

• Generic API client for all openFDA endpoints with retry (exponential backoff) and rate-limit awareness
• Automatic error normalization — 404 returns empty results, 429/5xx retries, 400 provides actionable messages
• Optional API key support — works without a key (1K requests/day), increases to 120K/day with a free key

Getting Started

Public Hosted Instance

A public instance is available at https://openfda.caseyjhand.com/mcp — no installation required. Point any MCP client at it via Streamable HTTP:

{
  "mcpServers": {
    "openfda": {
      "type": "streamable-http",
      "url": "https://openfda.caseyjhand.com/mcp"
    }
  }
}

Via bunx (no install)

Add to your MCP client config:

{
  "mcpServers": {
    "openfda": {
      "type": "stdio",
      "command": "bunx",
      "args": ["@cyanheads/openfda-mcp-server@latest"],
      "env": {
        "MCP_TRANSPORT_TYPE": "stdio",
        "MCP_LOG_LEVEL": "info",
        "OPENFDA_API_KEY": "your-key-here"
      }
    }
  }
}

Or with npx (no Bun required):

{
  "mcpServers": {
    "openfda": {
      "type": "stdio",
      "command": "npx",
      "args": ["-y", "@cyanheads/openfda-mcp-server@latest"],
      "env": {
        "MCP_TRANSPORT_TYPE": "stdio",
        "MCP_LOG_LEVEL": "info",
        "OPENFDA_API_KEY": "your-key-here"
      }
    }
  }
}

Or with Docker:

{
  "mcpServers": {
    "openfda": {
      "type": "stdio",
      "command": "docker",
      "args": ["run", "-i", "--rm", "-e", "MCP_TRANSPORT_TYPE=stdio", "ghcr.io/cyanheads/openfda-mcp-server:latest"]
    }
  }
}

For Streamable HTTP, set the transport and start the server:

MCP_TRANSPORT_TYPE=http MCP_HTTP_PORT=3010 bun run start:http
# Server listens at http://localhost:3010/mcp

Prerequisites

• Bun v1.3.0 or higher.
• Optional: openFDA API key for higher rate limits (120K requests/day vs 1K/day).

Installation

1. Clone the repository:

git clone https://github.com/cyanheads/openfda-mcp-server.git

2. Navigate into the directory:

cd openfda-mcp-server

3. Install dependencies:

bun install

Configuration

All configuration is validated at startup via Zod schemas in src/config/server-config.ts. Key environment variables:

Variable	Description	Default
MCP_TRANSPORT_TYPE	Transport: stdio or http	stdio
MCP_HTTP_PORT	HTTP server port	3010
MCP_AUTH_MODE	Authentication: none, jwt, or oauth	none
MCP_LOG_LEVEL	Log level (debug, info, warning, error, etc.)	info
LOGS_DIR	Directory for log files (Node.js only).	<project-root>/logs
STORAGE_PROVIDER_TYPE	Storage backend: in-memory, filesystem, supabase, cloudflare-kv/r2/d1	in-memory
OPENFDA_API_KEY	Free API key from open.fda.gov. Increases daily limit from 1K to 120K requests.	none
OPENFDA_BASE_URL	Base URL override for testing against a proxy or mock.	https://api.fda.gov
OTEL_ENABLED	Enable OpenTelemetry	false

Running the Server

Local Development

• Build and run the production version:

  # One-time build
  bun run rebuild
  
  # Run the built server
  bun run start:http
  # or
  bun run start:stdio
  

• Run checks and tests:

  bun run devcheck  # Lints, formats, type-checks, and more
  bun run test      # Runs the test suite
  

Project Structure

Directory	Purpose
src/index.ts	Entry point — createApp() with tool registration and service setup.
src/config/	Server-specific env var parsing and validation with Zod.
src/services/openfda/	openFDA API client with retry, rate-limit handling, and error normalization.
src/mcp-server/tools/definitions/	Tool definitions (*.tool.ts). Seven openFDA tools.

Development Guide

See CLAUDE.md for development guidelines and architectural rules. The short version:

• Handlers throw, framework catches — no try/catch in tool logic
• Use ctx.log for request-scoped logging
• Register new tools in src/mcp-server/tools/definitions/index.ts

Contributing

Issues and pull requests are welcome. Run checks and tests before submitting:

bun run devcheck
bun run test

License

This project is licensed under the Apache 2.0 License. See the LICENSE file for details.