Koskamo

FDA Approvals MCP

An MCP server wrapping openFDA to provide AI agents with tools for searching drug approvals, retrieving approved drug labels, querying recall events, aggregating FAERS adverse-event reports, and searching 510(k) device clearances. It supports pharma research, clinical decision support, and regulatory LLM workflows via HTTP POST JSON-RPC 2.0.

Endpoint and access

No sign-in to connect and list tools. Individual tools may still need a vendor account, credentials, or permissions; check the documented prerequisites.

FDA Approvals MCP logo, by guptaprakhariitrCommunity listingStreamable HTTPNo sign-inEndpoint checked 2026-11-07Published by guptaprakhariitr
You need:Bearer-token auth
MCP endpoint (Streamable HTTP)
https://fda-approvals-mcp.atlasword.workers.dev/mcp
Vendor documentation

What its tools do

4 tools, grouped by the hints the server advertises. Hints are self-declared, not verified behavior.

Not annotated (4)

4 of 4 have a description · 0 of 4 declare behavior hints · 1 of 4 with parameters document them all

Checks and signals

Each line is separate evidence, not a trust score.

  • Passed Endpoint answered the live check ·
  • Availability 1 of 1 checks passed in 30 days

What you can do with it

  • Search FDA drug approvals by sponsor, brand, or date
  • Retrieve FDA-approved drug labels including indications and warnings
  • Query drug, device, or food recall events by classification
  • Aggregate FAERS adverse-event reports with deduplication

Source and maintenance

Community listingRegistry 0.3.1
mcp-registry: io.github.guptaprakhariitr/fda-approvals-mcp@0.3.1Source repositoryProject website
Maintenance checked

Protocol and capabilities

Server
fda-approvals-mcp 0.2.1
MCP protocol negotiated in check
2025-06-18
Tools
4 advertised
Resources
Not advertised
Resource templates
Not advertised
Prompts
Not advertised
Server-advertised capabilities
{
  "tools": {
    "listChanged": false
  }
}

Tools

4 advertised

fda_drug_approval_search
Advertised by the server during the last successful anonymous check.

Search FDA drug approvals from Drugs@FDA. Filter by sponsor, brand name, generic name, or approval date range. Returns the application number, sponsor, brand/generic name, and approval date for each approval (NDA / BLA / supplemental).

fda_drug_approval_search input schema
{
  "type": "object",
  "required": [],
  "properties": {
    "skip": {
      "type": "integer",
      "default": 0
    },
    "brand": {
      "type": "string"
    },
    "limit": {
      "type": "integer",
      "default": 25,
      "maximum": 100,
      "minimum": 1
    },
    "date_to": {
      "type": "string",
      "description": "ISO YYYY-MM-DD."
    },
    "generic": {
      "type": "string",
      "description": "Generic ingredient, e.g. 'semaglutide'."
    },
    "sponsor": {
      "type": "string",
      "description": "Company/sponsor name, e.g. 'Pfizer'."
    },
    "date_from": {
      "type": "string",
      "description": "ISO YYYY-MM-DD."
    }
  }
}
fda_drug_label
Advertised by the server during the last successful anonymous check.

Fetch the FDA-approved drug label for a brand or generic name. Includes indications, dosage, contraindications, warnings, adverse reactions.

fda_drug_label input schema
{
  "type": "object",
  "required": [
    "drug_name"
  ],
  "properties": {
    "drug_name": {
      "type": "string",
      "description": "Brand or generic, e.g. 'Ozempic' or 'semaglutide'."
    }
  }
}
fda_recall_search
Advertised by the server during the last successful anonymous check.

Search drug, device, or food recall events. Filter by classification (Class I = most serious) and date range. Returns recall number, classification, reason, recalling firm, status.

fda_recall_search input schema
{
  "type": "object",
  "required": [],
  "properties": {
    "limit": {
      "type": "integer",
      "default": 25,
      "maximum": 100,
      "minimum": 1
    },
    "domain": {
      "enum": [
        "drug",
        "device",
        "food"
      ],
      "type": "string",
      "default": "drug"
    },
    "date_to": {
      "type": "string"
    },
    "date_from": {
      "type": "string"
    },
    "product_class": {
      "enum": [
        "Class I",
        "Class II",
        "Class III"
      ],
      "type": "string"
    }
  }
}
fda_adverse_events
Advertised by the server during the last successful anonymous check.

Aggregate FDA adverse-event reports (FAERS) for a drug. Deduplicates by safetyreportid (bug fixed in 0.2.1). Returns total reports, unique reaction count, and top 20 reactions by frequency in the requested window.

fda_adverse_events input schema
{
  "type": "object",
  "required": [
    "drug"
  ],
  "properties": {
    "drug": {
      "type": "string",
      "description": "Generic drug name."
    },
    "limit": {
      "type": "integer",
      "default": 100,
      "maximum": 1000,
      "minimum": 1
    },
    "date_to": {
      "type": "string"
    },
    "date_from": {
      "type": "string"
    }
  }
}

Prompts

Not advertised

No prompt definitions available.

Resources

Not advertised

No resource definitions available.

30-day availability

Aggregated from read-only remote checks; this is not a tool-execution or security guarantee.

Successful checks
1 of 1 (100%)
Average latency
1460 ms
95th percentile latency
1460 ms

Maintenance history

Public check and source-refresh events. Editorial and ownership records remain private.

  • · probe · passed · 1460 ms · metadata changed · 4 tool(s)

Connect from your client

Each snippet registers the same endpoint; pick the client you use.

This server is operated by the named third party. Listing and endpoint checks are not an endorsement or a security audit. Review the operator's permissions, terms, and data handling before connecting. How listings are checked and corrected.

Claude Code

Run this once in a terminal. It registers the remote server. Use --scope project to write .mcp.json for the repo.
Claude Code configuration
claude mcp add --transport http fda-approvals-mcp https://fda-approvals-mcp.atlasword.workers.dev/mcp

Codex

Run this once. Codex stores MCP servers in ~/.codex/config.toml (or .codex/config.toml in a trusted project).
Codex configuration
codex mcp add fda-approvals-mcp --url https://fda-approvals-mcp.atlasword.workers.dev/mcp

Cursor

Merge this server into .cursor/mcp.json in your project, then enable fda-approvals-mcp in your MCP settings.
Cursor configuration
{
  "mcpServers": {
    "fda-approvals-mcp": {
      "url": "https://fda-approvals-mcp.atlasword.workers.dev/mcp"
    }
  }
}

Cline

Merge this into cline_mcp_settings.json (Cline → MCP Servers → Configure).
Cline configuration
{
  "mcpServers": {
    "fda-approvals-mcp": {
      "type": "streamableHttp",
      "url": "https://fda-approvals-mcp.atlasword.workers.dev/mcp",
      "disabled": false
    }
  }
}

VS Code

Merge this server into .vscode/mcp.json. Use MCP: List Servers to start fda-approvals-mcp and inspect its tools.
VS Code configuration
{
  "servers": {
    "fda-approvals-mcp": {
      "type": "http",
      "url": "https://fda-approvals-mcp.atlasword.workers.dev/mcp"
    }
  }
}

Gemini CLI

Run this once. It writes .gemini/settings.json in the current project; pass --scope user for ~/.gemini/settings.json.
Gemini CLI configuration
gemini mcp add --transport http fda-approvals-mcp https://fda-approvals-mcp.atlasword.workers.dev/mcp

Claude Desktop

Open Claude Settings > Connectors > Add custom connector, enter this server URL and enable it for the conversation. This is a manual remote-connector handoff, not a desktop JSON configuration.
Claude Desktop configuration
https://fda-approvals-mcp.atlasword.workers.dev/mcp

Windsurf

Merge this into ~/.codeium/windsurf/mcp_config.json, then refresh MCP in Cascade. Windsurf remote servers use serverUrl, not url.
Windsurf configuration
{
  "mcpServers": {
    "fda-approvals-mcp": {
      "serverUrl": "https://fda-approvals-mcp.atlasword.workers.dev/mcp"
    }
  }
}

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