Openfda MCP server

OpenFDA — FDA Drug, Device, and Food Data

The U.S. Food and Drug Administration's open data platform. This pack covers the drug side: adverse-event reports and safety-signal tools (FAERS search, event counts, disproportionality/ROR-PRR, reaction profiles, trends), drug and novel-drug approvals (Drugs@FDA, by-company application history), drug labels, drug and food recalls, drug shortages and shortage changes, complete response letters, warning letters, and a cross-source postmarket risk-profile compound. The official source for what's been reported to or by the FDA. Free, no auth required (rate-limited).

Part of Pipeworx — an MCP gateway connecting AI agents to 1679+ live data sources.

Why this matters for AI agents

Drug-safety questions resolve here. Adverse event volumes, label changes, approval timelines, recall posture — all structured. For the full drug picture, pair with RxNorm (canonical IDs) and ClinicalTrials.gov (trials).

Common flows:

• Adverse events for a drug. "Reports for Ozempic" → fdadrugevents({query: "ozempic"}) → individual safety reports + counts.
• Bucket reactions. "Top reactions reported for Ozempic" → fdaeventcounts({query: "ozempic", count_field: "patient.reaction.reactionmeddrapt.exact"}) → MedDRA-coded counts.
• Approval history. "When was Ozempic approved and for what?" → fdadrugapprovals({query: "ozempic"}).
• Recalls. "Any Ozempic recalls?" → fdadrugrecalls({query: "ozempic"}).
• Label content. "What does the FDA label say about contraindications?" → fdadruglabels({query: "ozempic"}).
• All applications for a company. "Every Drugs@FDA application Eli Lilly has filed" → fdaapplicationsbycik({cikorticker: "LLY"}). Resolves the company via SEC and aggregates across every sponsorname spelling it filed under — see the pitfall below before reaching for fdadrugapprovals with a guessed sponsor name.

Used by the pharmadrugprofile and pharmasafetyreport compounds.

Auth

Public, no key required. Anonymous limit is ~240 requests/min and 1,000/day, counted per IP — so every caller sharing an egress address shares one 1,000/day budget, not one each.

api.fda.gov runs on api-umbrella, the same stack as api.data.gov, so an api.data.gov key authenticates it and lifts the daily limit to 120,000. Pipeworx injects a platform key (PLATFORMDATAGOVKEY); bring your own with _apiKey and your calls draw on your quota instead. Register free at https://open.fda.gov/apis/authentication/.

A key that is rejected or revoked does not fail the call — the pack retries once anonymously, since openFDA is fully usable without one.

Datasets

Common pitfalls

Shortened. The full README is on GitHub.