Openfda

What Openfda MCP server does

The Openfda MCP server connects AI clients to openFDA data through the Pipeworx MCP gateway. Its coverage centers on FDA drug information, including FAERS adverse-event reports, safety-signal analysis, Drugs@FDA approvals, current labels, recalls, shortages, shortage changes, complete response letters, and warning letters. It also exposes tools for company application history and a cross-source postmarket risk profile.

The available data spans several time ranges. Drug adverse-event data begins in 1968, approvals extend back to 1939, and warning-letter results include a published rolling window beginning in 2021, with older compliance-action records available through an FDA archive in some cases. Device and food recall or adverse-event datasets are described as separate tool areas.

How it works

Clients connect to https://gateway.pipeworx.io/openfda/mcp and discover the tools through MCP. The endpoint includes the pack's FDA tools plus shared Pipeworx gateway tools, so the result of tools/list is broader than the Openfda-specific capability list. The connection's initialization response is the authoritative source for the tools available at that time.

Searches use openFDA's Lucene-style, field-specific query syntax. Available workflows include searching drug reports, counting reactions with MedDRA fields, reviewing approval history, retrieving label content, checking recalls, and examining warning letters. Company application searches should use a CIK or ticker when possible because sponsor_name is an exact string match and does not provide a stable company identifier.

Setup and configuration

The Openfda MCP server requires no API key for basic use. Add the remote URL to an MCP client configuration, for example:

{
  "mcpServers": {
    "openfda": {
      "url": "https://gateway.pipeworx.io/openfda/mcp"
    }
  }
}

Anonymous access is limited to approximately 240 requests per minute and 1,000 requests per day per IP address. An api.data.gov key can authenticate requests to the FDA API and raise the daily limit to 120,000. Pipeworx can supply a platform key, while callers can provide their own through the _apiKey request option. If a supplied key is rejected, the pack retries anonymously.

Tools and capabilities

The Openfda MCP server supports capabilities including:

• Searching FAERS reports and counting adverse-event fields.
• Calculating disproportionality measures such as ROR and PRR.
• Building reaction profiles and report trends.
• Querying drug approvals, labels, recalls, shortages, and shortage changes.
• Finding complete response letters and FDA warning letters.
• Aggregating company applications with fda_applications_by_cik.
• Combining sources into a postmarket drug risk profile.

Limitations and notes

FAERS totals represent reports, not unique patients, and a report does not establish that a drug caused an event. Drug-name choice also matters: a brand search and an ingredient search can return different populations of reports.

Reaction filters match one complete MedDRA preferred term rather than arbitrary substrings. If a term cannot be resolved, the response identifies that condition; it should not be interpreted as evidence that no reports exist. Warning-letter searches distinguish addressed companies from full-text mentions, and older archive rows may lack the original letter subject and URL. Broad recipient searches may be incomplete when more than 600 candidates require scanning.

FDA reporting can lag the underlying event by months or years, so recent-period counts are not final. The Openfda MCP server is therefore best used for FDA-reported evidence and structured review, not as a substitute for causal assessment or a complete real-time record.