Openfda

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Search adverse event reports for drugs by name, reaction type, or date range.

18 tools
0ms auth
free tier 50 calls/day

Tools

fda_drug_events

Search FAERS adverse event reports by drug name, MedDRA reaction term, or date range. Returns report counts, reaction types, seriousness levels, and dates. Natural multi-word reaction phrasing is retr

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fda_drug_approvals

Find FDA-approved drugs by brand name, active ingredient, or application number. To find generic versions of a drug, search by active ingredient using products.active_ingredients.name (NOT openfda.gen

No parameters required.

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fda_applications_by_cik

Find ALL Drugs@FDA applications for a company by SEC CIK, ticker, or company name — without needing to know its FDA sponsor_name spelling. Drugs@FDA has no company-ID field: sponsor_name is free text,

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fda_novel_approvals

Most recent novel drug approvals — the newest drugs approved by the FDA. Use for "what is the most recent novel drug the FDA approved", "latest FDA drug approvals", "recently approved new drugs or bio

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fda_drug_labels

Get FDA drug labeling (SPL) by drug name OR by INDICATION. This is the tool for "what drugs are approved to treat <condition>" — it searches the indications_and_usage text, which the drugsfda approval

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fda_drug_recalls

Search FDA drug recalls and enforcement actions by drug name or reason — returns recall classification, date, reason and enforcement status. A multi-word search is tried as ALL terms first and falls b

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fda_drug_shortages

Search the FDA Drug Shortages database by generic or brand name, manufacturer, status, or an advanced openFDA query. Returns national supply records and available FDA dates; reason and other details a

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fda_shortage_changes

FDA drug-shortage records ordered by update_date, newest first, then restricted to the requested look-back window. Use for recently updated, discontinued, or resolved national shortages; this does not

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fda_complete_response_letters

Search FDA-disclosed Complete Response Letters for drug and biologic applications. Defaults to letter_type "COMPLETE RESPONSE"; optionally include other letter types in the same dataset. Returns the a

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fda_crl_detail

Retrieve one FDA Complete Response Letter by application number and optionally letter date. Returns the FDA-disclosed letter text and document URL. Confidential commercial and trade-secret material ma

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fda_food_recalls

Search FDA FOOD recall / enforcement reports (openFDA /food/enforcement) — product recalls, reasons, classification, recalling firm, distribution, and status. Use for food-safety / recall-history ques

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fda_event_counts

Aggregate adverse events by reaction type, patient age, or outcome. Returns top reactions for a drug and event trends over time.

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fda_warning_letters

Search FDA WARNING LETTERS — official enforcement letters FDA sends firms for violations (CGMP, adulterated/misbranded products, unapproved claims). Answers "has <company> received an FDA warning lett

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fda_faers_signal_summary

Calculate report-level FAERS disproportionality routing metrics for one drug/reaction pair using a 2×2 reporting table. The reaction argument matches one whole MedDRA preferred term, so a broad word l

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fda_faers_reaction_profile

Summarize the most frequently co-reported FAERS reactions plus serious/non-serious report counts for a drug. Counts are spontaneous reports with duplicates, co-medications, and reporting bias—not even

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fda_faers_trend

Aggregate daily FAERS report counts into calendar months for a drug and optional reaction over a bounded date window. The reaction argument matches one whole MedDRA preferred term, so a broad word lik

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fda_application_history

Retrieve one Drugs@FDA NDA, ANDA, or BLA application and return its products and chronological submission-action history. Submission codes require regulatory interpretation and do not by themselves es

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fda_postmarket_risk_profile

Combine a drug’s FAERS reporting profile, label warning fields, and FDA recall records for review routing. This is not a validated safety comparison, causal assessment, incidence estimate, or substitu

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Test with curl

The gateway speaks JSON-RPC 2.0 over HTTP POST. You can test any pack directly from the terminal.

List available tools
bash
curl -X POST https://gateway.pipeworx.io/openfda/mcp \
  -H "Content-Type: application/json" \
  -d '{"jsonrpc":"2.0","id":1,"method":"tools/list"}'
Call a tool
bash
curl -X POST https://gateway.pipeworx.io/openfda/mcp \
  -H "Content-Type: application/json" \
  -d '{"jsonrpc":"2.0","id":2,"method":"tools/call","params":{"name":"fda_drug_events","arguments":{}}}'

Use with the SDK

Install @pipeworx/sdk to call tools from any TypeScript/Node project.

TypeScript
import { Pipeworx } from '@pipeworx/sdk';
const px = new Pipeworx();
const result = await px.call("fda_drug_events", {});
ask_pipeworx
// Or ask in plain English:
const answer = await px.ask("search adverse event reports for drugs by name, reaction type, or date range");

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