# Openfda [Health: Active]

**Category:** 🧬 Biology & Bioinformatics  
**Repository:** https://github.com/pipeworx-io/mcp-openfda  
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**Directory Page:** https://allmcps.com/mcp/openfda

## Description
OpenFDA MCP — wraps the openFDA API (free, no auth required)

## Tools
Capabilities this server exposes over MCP:

- **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_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 — never add application_type:"ANDA" (it returns 0 results). To limit to generics, search by active ingredient and read the ANDA/NDA prefix on application_number in the results. This endpoint has NO indication/disease field — for "drugs approved to treat <condition>" use fda_drug_labels (which searches indications_and_usage); an indication phrase passed here is silently ignored and matches by drug name only. The response `total` can exceed the 100-row cap on a single page — use `skip` to page past it, and `sort` to get genuinely-newest-first ordering ("most recently approved" is not the default order).
- **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 variant containing it in one call — returning the combined application list plus a `sponsor_name_forms` breakdown showing exactly which spellings were found. Use this INSTEAD of guessing sponsor_name strings for fda_drug_approvals when you have (or can resolve) the company's CIK/ticker. For a subsidiary or operating name that isn't itself SEC-listed, resolve to the parent first with edgar's sponsor_to_filer, then pass that CIK here.
- **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 biologics this month/year". Returns original NDA/BLA approvals (generics excluded by default) sorted newest-first, with approval date, brand name, active ingredients, sponsor, and application number. Not for label text (fda_drug_labels) or searching a specific known drug (fda_drug_approvals).
- **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 may not have a label yet.
- **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_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 imply availability at any specific pharmacy or hospital. Most rows in any window are "Reverified" (FDA re-checking a status it already had) — pass update_type to filter to the change kinds that actually matter, e.g. New/Discontinued/To Be Discontinued/Resolved, and exclude Reverified.
- **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_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_event_counts** — Aggregate adverse events by reaction type, patient age, or outcome. Returns top reactions for a drug and event trends over time.
- **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 letter", "recent FDA warning letters about supplements/devices". By default `search` matches the RECIPIENT company the letter was issued to, so the answer is about that firm's own enforcement history; set match:"fulltext" to search the whole letter record instead, which also finds letters that merely mention a firm. Every row reports matched_field so a caller can tell "issued to" from "mentions". Covers the 3,680 letters fda.gov publishes from 2021 onward — recipient company, posted and issued dates, issuing FDA office, subject and a link to the full letter text — and, for a firm with nothing in that window, falls back to the FDA compliance-actions archive of older letters back to 2010, which gives the firm, place, product type and issue date but no document. Every row says which of the two it came from. Live, no caller credential needed.
- **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_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_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_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_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 substitute for FDA communications and clinical review.

## Claude Desktop Quick Installation
Install path detected from listing signals. Uses `npx` (confidence: high):

```json
"mcpServers": {
  "openfda": {
    "command": "npx",
    "args": ["-y","@pipeworx/mcp-openfda"]
  }
}
```

## Documentation

## What Openfda MCP server does

The Openfda MCP server connects AI clients to openFDA data through the Pipeworx MCP gateway. Its coverage centers on FDA drug information, including FAERS adverse-event reports, safety-signal analysis, Drugs@FDA approvals, current labels, recalls, shortages, shortage changes, complete response letters, and warning letters. It also exposes tools for company application history and a cross-source postmarket risk profile.

The available data spans several time ranges. Drug adverse-event data begins in 1968, approvals extend back to 1939, and warning-letter results include a published rolling window beginning in 2021, with older compliance-action records available through an FDA archive in some cases. Device and food recall or adverse-event datasets are described as separate tool areas.

## How it works

Clients connect to `https://gateway.pipeworx.io/openfda/mcp` and discover the tools through MCP. The endpoint includes the pack's FDA tools plus shared Pipeworx gateway tools, so the result of `tools/list` is broader than the Openfda-specific capability list. The connection's initialization response is the authoritative source for the tools available at that time.

Searches use openFDA's Lucene-style, field-specific query syntax. Available workflows include searching drug reports, counting reactions with MedDRA fields, reviewing approval history, retrieving label content, checking recalls, and examining warning letters. Company application searches should use a CIK or ticker when possible because `sponsor_name` is an exact string match and does not provide a stable company identifier.

## Setup and configuration

The Openfda MCP server requires no API key for basic use. Add the remote URL to an MCP client configuration, for example:

```json
{
  "mcpServers": {
    "openfda": {
      "url": "https://gateway.pipeworx.io/openfda/mcp"
    }
  }
}
```

Anonymous access is limited to approximately 240 requests per minute and 1,000 requests per day per IP address. An `api.data.gov` key can authenticate requests to the FDA API and raise the daily limit to 120,000. Pipeworx can supply a platform key, while callers can provide their own through the `_apiKey` request option. If a supplied key is rejected, the pack retries anonymously.

## Tools and capabilities

The Openfda MCP server supports capabilities including:

- Searching FAERS reports and counting adverse-event fields.
- Calculating disproportionality measures such as ROR and PRR.
- Building reaction profiles and report trends.
- Querying drug approvals, labels, recalls, shortages, and shortage changes.
- Finding complete response letters and FDA warning letters.
- Aggregating company applications with `fda_applications_by_cik`.
- Combining sources into a postmarket drug risk profile.

## Limitations and notes

FAERS totals represent reports, not unique patients, and a report does not establish that a drug caused an event. Drug-name choice also matters: a brand search and an ingredient search can return different populations of reports.

Reaction filters match one complete MedDRA preferred term rather than arbitrary substrings. If a term cannot be resolved, the response identifies that condition; it should not be interpreted as evidence that no reports exist. Warning-letter searches distinguish addressed companies from full-text mentions, and older archive rows may lack the original letter subject and URL. Broad recipient searches may be incomplete when more than 600 candidates require scanning.

FDA reporting can lag the underlying event by months or years, so recent-period counts are not final. The Openfda MCP server is therefore best used for FDA-reported evidence and structured review, not as a substitute for causal assessment or a complete real-time record.

_Full upstream README: https://allmcps.com/mcp/openfda/readme_