openapi: 3.0.3
info:
  title: openFDA API
  description: >-
    openFDA is an Elasticsearch-based public API serving FDA data on drugs,
    devices, foods, animal/veterinary products, and tobacco. Each noun exposes
    one or more categories (adverse events, recall enforcement reports,
    labeling, classification, registration, etc.).
  version: "1.0"
  contact:
    name: openFDA
    url: https://open.fda.gov/apis
    email: open@fda.hhs.gov
  license:
    name: CC0 1.0 Universal (Public Domain Dedication)
    url: https://creativecommons.org/publicdomain/zero/1.0/
servers:
  - url: https://api.fda.gov
    description: openFDA production API
security:
  - apiKeyQuery: []
  - {}
tags:
  - name: Drug
    description: Drug-related endpoints (adverse events, labeling, recalls, NDC).
  - name: Device
    description: Device-related endpoints (adverse events, classifications, recalls, 510(k), PMA, UDI).
  - name: Food
    description: Food-related endpoints (enforcement reports, adverse events).
  - name: Animal & Veterinary
    description: Adverse events involving animal and veterinary products.
  - name: Tobacco
    description: Tobacco product problem reports.
  - name: Other
    description: Cross-cutting datasets (NSDE, substance, harmonized).
paths:
  /drug/event.json:
    get:
      tags: [Drug]
      summary: Drug adverse events (FAERS)
      description: Query the FDA Adverse Event Reporting System (FAERS) for drug adverse event reports submitted since 2004.
      operationId: searchDrugEvents
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
        '404':
          $ref: '#/components/responses/NotFound'
        '429':
          $ref: '#/components/responses/RateLimited'
  /drug/label.json:
    get:
      tags: [Drug]
      summary: Drug product labeling (SPL)
      description: Query Structured Product Labeling (SPL) records for prescription and over-the-counter drugs.
      operationId: searchDrugLabel
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /drug/enforcement.json:
    get:
      tags: [Drug]
      summary: Drug recall enforcement reports
      description: Query drug recall enforcement reports from the FDA Recall Enterprise System (RES).
      operationId: searchDrugEnforcement
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /drug/ndc.json:
    get:
      tags: [Drug]
      summary: NDC Directory
      description: Query the National Drug Code (NDC) Directory of products in commercial distribution.
      operationId: searchDrugNDC
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /drug/drugsfda.json:
    get:
      tags: [Drug]
      summary: Drugs@FDA
      description: Query Drugs@FDA approval records including applications, submissions, and products.
      operationId: searchDrugsFDA
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /drug/shortages.json:
    get:
      tags: [Drug]
      summary: Drug shortages
      description: Query the FDA drug shortage database.
      operationId: searchDrugShortages
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/event.json:
    get:
      tags: [Device]
      summary: Device adverse events (MAUDE)
      description: Query the Manufacturer and User Facility Device Experience (MAUDE) database for medical device adverse event reports.
      operationId: searchDeviceEvents
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/enforcement.json:
    get:
      tags: [Device]
      summary: Device recall enforcement reports
      operationId: searchDeviceEnforcement
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/recall.json:
    get:
      tags: [Device]
      summary: Device recalls
      operationId: searchDeviceRecalls
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/classification.json:
    get:
      tags: [Device]
      summary: Device product classifications
      operationId: searchDeviceClassification
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/510k.json:
    get:
      tags: [Device]
      summary: 510(k) clearances
      operationId: searchDevice510k
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/pma.json:
    get:
      tags: [Device]
      summary: Premarket Approval (PMA) records
      operationId: searchDevicePMA
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/registrationlisting.json:
    get:
      tags: [Device]
      summary: Device registrations and listings
      operationId: searchDeviceRegistrationListing
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/udi.json:
    get:
      tags: [Device]
      summary: Unique Device Identifier (UDI) database
      operationId: searchDeviceUDI
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/covid19serology.json:
    get:
      tags: [Device]
      summary: COVID-19 serology testing data
      operationId: searchCovid19Serology
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /food/enforcement.json:
    get:
      tags: [Food]
      summary: Food recall enforcement reports
      description: Query food recall enforcement reports from the FDA Recall Enterprise System (RES). Updated weekly, data from 2004 onward.
      operationId: searchFoodEnforcement
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /food/event.json:
    get:
      tags: [Food]
      summary: Food adverse events (CAERS)
      description: Query the CFSAN Adverse Event Reporting System (CAERS) for adverse events associated with foods, dietary supplements, and cosmetics.
      operationId: searchFoodEvents
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /animalandveterinary/event.json:
    get:
      tags: [Animal & Veterinary]
      summary: Animal & veterinary adverse events
      description: Query adverse events involving animal drugs and veterinary products.
      operationId: searchAnimalVetEvents
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /tobacco/problem.json:
    get:
      tags: [Tobacco]
      summary: Tobacco product problem reports
      operationId: searchTobaccoProblems
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /other/nsde.json:
    get:
      tags: [Other]
      summary: National Drug Code SPL Data Elements (NSDE)
      operationId: searchNSDE
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /other/substance.json:
    get:
      tags: [Other]
      summary: Substance data
      operationId: searchSubstance
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /other/historicaldocument.json:
    get:
      tags: [Other]
      summary: Historical FDA documents
      operationId: searchHistoricalDocuments
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
components:
  securitySchemes:
    apiKeyQuery:
      type: apiKey
      in: query
      name: api_key
      description: >-
        Free openFDA API key (obtain at https://open.fda.gov/apis/authentication/).
        Without a key: 240 req/min and 1,000 req/day per IP. With a key: 240
        req/min and 120,000 req/day per key.
  parameters:
    Search:
      name: search
      in: query
      description: Lucene-style search expression scoped to the dataset's fields.
      required: false
      schema:
        type: string
      example: receivedate:[2024-01-01+TO+2024-12-31]
    Sort:
      name: sort
      in: query
      description: Field to sort by, with optional direction (e.g. `receivedate:desc`).
      required: false
      schema:
        type: string
    Count:
      name: count
      in: query
      description: Field to count occurrences against (returns aggregated terms).
      required: false
      schema:
        type: string
    Limit:
      name: limit
      in: query
      description: Maximum number of records to return (max 1000).
      required: false
      schema:
        type: integer
        minimum: 1
        maximum: 1000
        default: 1
    Skip:
      name: skip
      in: query
      description: Number of records to skip for pagination (max 25,000).
      required: false
      schema:
        type: integer
        minimum: 0
        maximum: 25000
        default: 0
  responses:
    SearchResults:
      description: Successful query result.
      content:
        application/json:
          schema:
            $ref: '#/components/schemas/SearchResponse'
    NotFound:
      description: No matching records found.
      content:
        application/json:
          schema:
            $ref: '#/components/schemas/Error'
    RateLimited:
      description: Rate limit exceeded.
      content:
        application/json:
          schema:
            $ref: '#/components/schemas/Error'
  schemas:
    Meta:
      type: object
      properties:
        disclaimer:
          type: string
        terms:
          type: string
          format: uri
        license:
          type: string
          format: uri
        last_updated:
          type: string
          format: date
        results:
          type: object
          properties:
            skip:
              type: integer
            limit:
              type: integer
            total:
              type: integer
    SearchResponse:
      type: object
      properties:
        meta:
          $ref: '#/components/schemas/Meta'
        results:
          type: array
          items:
            type: object
            additionalProperties: true
    Error:
      type: object
      properties:
        error:
          type: object
          properties:
            code:
              type: string
            message:
              type: string