Openfda MCP

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.

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 "

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" matc

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

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, dos

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

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 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 actua

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.

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.

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).

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

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

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 n

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.

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 not

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.

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.