Openfda

Install

Works with Claude Code, VS Code, Cursor, Windsurf. Read the repository before you give any tool access to your data.

npx agentmarket install connector/pipeworx-io-openfda

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Permissions

What this server can do and what it asks for, from its tool list and install config. Checked Oct 25, 2026.

Tools

13 read · 1 write · 0 delete · 4 not yet classified

Secrets

None asked for

Install scripts

Nothing to install (hosted)

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Hosted (remote endpoint)

Tools (18)

Read from the source code; the running server may differ. Descriptions are the server’s own words; hidden characters are shown as [U+…].

• 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 establish approval scope, exclusivity, or current marketing.

• 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, and one company routinely files under several forms (e.g. Eli Lilly appears as "LILLY", "ELI LILLY AND CO", "ELI LILLY CO", "LILLY RES LABS" — its own SEC-registered name "ELI LILLY AND COMPANY" matches ZERO of them in fda_drug_approvals). This resolves the company via SEC (same identity as the edgar pack), derives its most distinctive name token, and searches Drugs@FDA for every sponsor_name var…

• 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 application’s current approval_status, letter metadata, an excerpt, and the official document URL.

• 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 may be redacted by FDA.

• 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.generic_name — that field only works in the label endpoint). IMPORTANT: drug names in the FDA database are stored in UPPERCASE — always pass ingredient and brand names in uppercase (e.g. "APIXABAN" not "apixaban") or you will get 0 results. Returns approval status, sponsor, application number (ANDA = generic, NDA = brand), and application details. There is NO queryable "application_type" field — neve…

• 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 retried against MedDRA preferred-term word order before an empty result is reported. FAERS reports do not establish incidence or causality.

• 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 approvals endpoint does NOT carry. Query by brand/generic name (openfda.brand_name:"HUMIRA"), or by indicated use (indications_and_usage:"rheumatoid arthritis"). Returns indications, boxed/other warnings, dosage, contraindications, and adverse reactions (each text field capped, set_id preserved for out-of-band full-label fetch). Note: FDA label publication trails approval by weeks, so a just-approved drug…

• 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 back to ANY term when nothing matches all of them; the response says which happened in match_mode, so a loose match is never mistaken for a precise one. Recall reasons are free narrative text and often name the contaminant rather than the harm ("NDMA impurity", not "cancer"), so search the substance when a symptom finds nothing.

• 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 are sparse in the upstream data. This is not local pharmacy inventory or medical advice.

• fda_event_counts

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

• 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 event rates or proof of causation.

• 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 like "neuropathy" counts only reports filed under that exact term and not the specific terms containing it. Natural multi-word phrasing is resolved to MedDRA word order and disclosed; a term matching nothing is reported as unresolved rather than as zero reports. ROR/PRR are screening statistics—not incidence, causality, comparative drug safety, or an FDA safety conclusion.

• 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 like "neuropathy" counts only reports filed under that exact term and not the specific terms containing it. Natural multi-word phrasing is resolved to MedDRA word order and disclosed; a term matching nothing is reported as unresolved rather than as zero reports. Trends reflect reporting activity, publicity, utilization, duplicates, and database updates—not incidence or changing clinical risk.

• 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 questions (distinct from fda_drug_recalls which covers drugs).

• fda_novel_approvals

  Most 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 list). Use for "what is the most recent novel drug the FDA approved", "how many novel drugs has CDER approved this year", "latest FDA drug approvals". Excludes generics, reformulations of an already-approved ingredient, and biosimilars — these are NOT on FDA's novel list even though they are "original" NDA/BLA submissions. Returns approval date, drug name, active ingredient, and approved use, sorted …

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Last commit

Oct 16, 2026 (13 days ago)

Last release

Oct 16, 2026 (13 days ago)

From GitHub (fetched Oct 24, 2026).

Details

Registry name

io.github.pipeworx-io/openfda

Version

0.1.5

Auth

Auth not stated

License

MIT

Repository

github.com/pipeworx-io/mcp-openfda

Website

pipeworx.io/packs/openfda

First seen

Oct 24, 2026

Last checked

Oct 24, 2026

Source

Official MCP Registrygithub-graphql