@pipeworx/openfda

Connect: https://gateway.pipeworx.io/openfda/mcp · Install: one-click buttons

Tools: 5

The U.S. Food and Drug Administration’s open data platform. Adverse event reports (FAERS), drug approvals, drug labels, recalls, device reports, food recalls, tobacco enforcement. The official source for what’s been reported to or by the FDA. Free, no auth required (rate-limited).

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” → fda_drug_events({query: "ozempic"}) → individual safety reports + counts.
• Bucket reactions. “Top reactions reported for Ozempic” → fda_event_counts({query: "ozempic", count_field: "patient.reaction.reactionmeddrapt.exact"}) → MedDRA-coded counts.
• Approval history. “When was Ozempic approved and for what?” → fda_drug_approvals({query: "ozempic"}).
• Recalls. “Any Ozempic recalls?” → fda_drug_recalls({query: "ozempic"}).
• Label content. “What does the FDA label say about contraindications?” → fda_drug_labels({query: "ozempic"}).

Used by the pharma_drug_profile and pharma_safety_report compounds.

Auth

Public, no key required. Anonymous IP-based limit: ~240 requests/min, 1,000/day. With a free key from https://open.fda.gov/apis/authentication/, the daily limit lifts to 120,000. Pass via _apiKey.

Datasets

Common pitfalls

• Reports are not unique patients. A single hospitalization can produce multiple FAERS reports. The total field is reports, not adverse-event-suffering-individuals.
• Causality not implied. A FAERS report links a drug to an event temporally; it does not prove the drug CAUSED the event. Use language carefully.
• Brand vs generic naming. Searching “ozempic” finds Ozempic-tagged reports. Searching “semaglutide” finds reports for any semaglutide product. They can differ — the user’s intent determines which to search.
• Query syntax is FDA’s, not ours. OpenFDA uses Lucene-style search with field-specific queries. Pipeworx tool descriptions show the syntax. Quotation marks matter.
• Lag from event to report. FAERS reports lag the event by months — sometimes years. The “last 30 days” view is misleading; recent counts will keep growing as reports flow in.

Tools

• fda_drug_events — Search adverse event reports for drugs by name, reaction type, or date range. Returns event counts, reaction types, seriousness levels, and dates.
• fda_drug_approvals — Find FDA-approved drugs by brand name, generic name, or application number (e.g., “ANDA123456”). Returns approval status, sponsor, and application details.
• fda_drug_labels — Get drug safety information from FDA labels by drug name. Returns indications, warnings, dosage, contraindications, and adverse reactions.
• fda_drug_recalls — Search FDA drug recalls and enforcement actions by drug name or reason. Returns recall classification, date, and enforcement status.
• fda_event_counts — Aggregate adverse events by reaction type, patient age, or outcome. Returns top reactions for a drug and event trends over time.