⚡ Overview

Ask your assistant "What are the most reported adverse events for semaglutide, and is pancreatitis disproportionately reported?" or "Find recruiting phase 3 trials for type 2 diabetes sponsored by Novo Nordisk". It calls these tools, and every answer links back to the FDA or ClinicalTrials.gov source.

Tools

There's also a prompt, drug_safety_brief, that has the assistant combine all six into a one-page safety brief with sources and limitations.

How signal_check works

From four FAERS counts (drug and reaction, drug, reaction, all reports) it builds the 2×2 table

and computes PRR = [a/(a+b)] / [c/(c+d)] and ROR = ad/bc, with log-normal 95% confidence intervals and a Yates-corrected chi-squared. A pair is flagged when PRR ≥ 2, χ² ≥ 4 and at least 3 cases (Evans et al., 2001), the screening rule used in pharmacovigilance practice. When a reaction is reported only for this drug (a zero cell), PRR and ROR use the Haldane-Anscombe correction (+0.5 per cell), so it can still be flagged. Reactions are matched as exact MedDRA terms, the same terms get_adverse_events lists.

FAERS holds voluntary reports. A signal is a statistical association that deserves review, not proof that the drug causes the event. The server's instructions tell the assistant to present results that way and never as medical advice.

Related MCP server: Healthcare Compliance MCP

Install

With any MCP-compatible client (desktop assistants, IDE agents), add this to the client's MCP server config:

{
  "mcpServers": {
    "pharma": {
      "command": "uvx",
      "args": ["--from", "git+https://github.com/faizanreza-cs/pharma-mcp", "pharma-mcp"],
      "env": { "OPENFDA_API_KEY": "optional-your-key" }
    }
  }
}

Or run it yourself:

git clone https://github.com/faizanreza-cs/pharma-mcp && cd pharma-mcp
make setup
make run                    # stdio
make http                   # streamable HTTP at http://127.0.0.1:8000/mcp
make inspect                # MCP Inspector (needs Node)

An openFDA API key is optional but raises the limits from 1,000 to 120,000 requests per day. Get one free at https://open.fda.gov/apis/authentication/.

Built for real use

• Polite to public APIs: responses are cached for an hour, requests are spaced out, and 429 and 5xx responses are retried with backoff, honouring Retry-After.

• Doesn't fail on "no results": openFDA answers 404 when nothing matches, and the server returns an empty list instead of an error.

• Validated inputs: NCT id format, trial status and phase enums, empty search terms. Bad input returns a clear error message to the model, not an exception.

• Compact outputs: long label sections are trimmed so they don't flood the context window.

• Tests: 21, all offline. Signal math is checked against hand-computed values, including zero-cell cases. Every tool is exercised end to end through a real MCP client against mocked HTTP. Retries, Retry-After parsing, caching and query escaping are covered. CI runs on Python 3.11 to 3.13, plus a Docker build and handshake check.

The test fixtures are hand-made samples in the documented response shapes, not real data (see tests/fixtures/README.md).

License

MIT. Not affiliated with the FDA or NIH. Data come from public APIs and are provided as-is.