OpenFDA MCP 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

``bash


Install globally

npm install -g openfda-mcp-server

Or use with npx

npx openfda-mcp-server
`

Configuration

$3

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

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

$3

| 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

$3

| 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 |

$3

| 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

$3

| 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

$3

| 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 |

$3

| 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

$3

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

$3

`
Retrieve FAERS report with safety report ID 10003641
`

$3

`
Find all drugs with boxed warnings related to cardiovascular risks
`

$3

`
Get the boxed_warning and contraindications sections for warfarin
`

$3

`
Search for Class I drug recalls from Pfizer
`

$3

`
Find 510(k) clearances for cardiac pacemakers
`

$3

`
Retrieve MDR report number 2649622-2020-08294
`

$3

`
Search device adverse events for insulin pumps that resulted in injury
`

CLI Usage

`bash


Start with stdio transport (default)

openfda-mcp-server

Start with HTTP transport

openfda-mcp-server --transport http --port 3000
`

Docker

$3

`bash


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
`

$3

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

$3

Pass environment variables to the container:

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

Development

`bash


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

`typescript
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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