Openfda
liveHealthGovernmentFDA drug data via openFDA: adverse-event reports and safety-signal tools (FAERS search, event counts, disproportionality/ROR-PRR summaries, reaction profiles, trends), drug and novel-drug approvals (Drugs@FDA, by-company application history), drug labeling, drug and food recalls, drug shortages and shortage changes, complete response letters, warning letters, and a postmarket risk-profile compound.
Tools
fda_drug_eventsSearch 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_approvalsFind 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
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fda_applications_by_cikFind 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_approvalsMost recent NOVEL drug approvals, in FDA/CDER's own sense of the word: a new drug or biologic never before approved or marketed in the U.S. (read live from FDA's own published Novel Drug Approvals lis
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fda_drug_labelsGet 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_recallsSearch 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_shortagesSearch 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_changesFDA 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_lettersSearch 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_detailRetrieve 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_recallsSearch 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_countsAggregate 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_lettersSearch 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_summaryCalculate 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_profileSummarize 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_trendAggregate 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_historyRetrieve 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_profileCombine 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.
curl -X POST https://gateway.pipeworx.io/openfda/mcp \
-H "Content-Type: application/json" \
-d '{"jsonrpc":"2.0","id":1,"method":"tools/list"}'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.
import { Pipeworx } from '@pipeworx/sdk';
const px = new Pipeworx();
const result = await px.call("fda_drug_events", {});// Or ask in plain English:
const answer = await px.ask("fda drug data via openfda: adverse-event reports and safety-signal tools (faers search, event counts, disproportionality/ror-prr summaries, reaction profiles, trends), drug and novel-drug approvals (drugs@fda, by-company application history), drug labeling, drug and food recalls, drug shortages and shortage changes, complete response letters, warning letters, and a postmarket risk-profile compound");Related compound tools
These combine Openfda with other data sources in a single call:
Pharma Intel — meta-pack chaining ClinicalTrials.gov, OpenFDA, and RxNorm for drug profiles, pipeline scans, safety reports, and catalyst calendars.
9 tools — pharma_drug_profile, pharma_pipeline_scan, pharma_pipeline_catalysts, pharma_safety_report, pharma_sponsor_diligence, pharma_indication_landscape, pharma_product_sales, pharma_sales_at_risk, pharma_resolve_drug