aid: open-fda
name: openFDA
description: openFDA is the FDA's open data platform providing REST APIs for public access to FDA regulatory datasets. It covers drug adverse events (FAERS), drug labeling (SPL), drug recall enforcement reports, medical device 510(k) clearances, device adverse event reports, device recalls and classifications, food recall enforcement actions, food adverse events (CAERS), tobacco problem reports, tobacco research datasets, historical FDA documents, and substance data. All data is returned as JSON and is available free of charge with or without an API key.
type: Index
image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
url: https://raw.githubusercontent.com/api-evangelist/open-fda/refs/heads/main/apis.yml
created: '2026-06-13'
modified: '2026-06-13'
specificationVersion: '0.19'
tags:
  - FDA
  - Food and Drug Administration
  - Drug Safety
  - Adverse Events
  - Drug Labels
  - Recalls
  - Medical Devices
  - Food Safety
  - Tobacco
  - Public Health
  - Open Data
  - Government
  - Regulatory
  - FAERS
  - SPL
apis:
  - aid: open-fda:drug-adverse-events
    name: Drug Adverse Events API
    description: Access FDA Adverse Event Reporting System (FAERS) data covering adverse event reports for drugs and therapeutic biologic products from 2004 onward, updated quarterly.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/drug/event/
    baseURL: https://api.fda.gov
    tags:
      - Drug Safety
      - Adverse Events
      - FAERS
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/drug/event/
  - aid: open-fda:drug-labeling
    name: Drug Labeling API
    description: Access FDA Structured Product Labeling (SPL) files for prescription and over-the-counter drug products, including indications, adverse reactions, and safety information. Updated weekly.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/drug/label/
    baseURL: https://api.fda.gov
    tags:
      - Drug Labels
      - SPL
      - Prescriptions
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/drug/label/
  - aid: open-fda:drug-recall-enforcement
    name: Drug Recall Enforcement Reports API
    description: Access drug product recall enforcement reports submitted to the FDA.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/drug/enforcement/
    baseURL: https://api.fda.gov
    tags:
      - Drug Recalls
      - Enforcement
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/drug/enforcement/
  - aid: open-fda:device-510k
    name: Medical Device 510(k) Clearances API
    description: Access 510(k) premarket notification data demonstrating that devices are at least as safe and effective as legally marketed predicate devices.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/device/510k/
    baseURL: https://api.fda.gov
    tags:
      - Medical Devices
      - 510k
      - Clearances
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/device/510k/
  - aid: open-fda:device-adverse-events
    name: Medical Device Adverse Event Reports API
    description: Access reports of serious injuries, deaths, malfunctions, and other undesirable effects associated with the use of medical devices.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/device/event/
    baseURL: https://api.fda.gov
    tags:
      - Medical Devices
      - Adverse Events
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/device/event/
  - aid: open-fda:device-classification
    name: Medical Device Classification API
    description: Access medical device names, product codes, specialty areas, and classification data.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/device/classification/
    baseURL: https://api.fda.gov
    tags:
      - Medical Devices
      - Classification
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/device/classification/
  - aid: open-fda:device-recall-enforcement
    name: Medical Device Recall Enforcement Reports API
    description: Access medical device product recall enforcement report data.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/device/enforcement/
    baseURL: https://api.fda.gov
    tags:
      - Medical Devices
      - Recalls
      - Enforcement
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/device/enforcement/
  - aid: open-fda:device-pma
    name: Medical Device Premarket Approval (PMA) API
    description: Access FDA scientific and regulatory review data for Class III medical devices requiring premarket approval.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/device/pma/
    baseURL: https://api.fda.gov
    tags:
      - Medical Devices
      - PMA
      - Premarket Approval
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/device/pma/
  - aid: open-fda:device-recalls
    name: Medical Device Recalls API
    description: Access actions taken to address problems with medical devices that violate FDA law.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/device/recall/
    baseURL: https://api.fda.gov
    tags:
      - Medical Devices
      - Recalls
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/device/recall/
  - aid: open-fda:device-registrations-listings
    name: Medical Device Registrations and Listings API
    description: Access establishment locations and corresponding manufactured device listings.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/device/registrationlisting/
    baseURL: https://api.fda.gov
    tags:
      - Medical Devices
      - Registrations
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/device/registrationlisting/
  - aid: open-fda:device-udi
    name: Unique Device Identifier (UDI) API
    description: Access Global Unique Device Identification Database (GUDID) information for medical devices.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/device/udi/
    baseURL: https://api.fda.gov
    tags:
      - Medical Devices
      - UDI
      - GUDID
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/device/udi/
  - aid: open-fda:food-recall-enforcement
    name: Food Recall Enforcement Reports API
    description: Access food product recall enforcement report data from the FDA.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/food/enforcement/
    baseURL: https://api.fda.gov
    tags:
      - Food Safety
      - Recalls
      - Enforcement
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/food/enforcement/
  - aid: open-fda:food-adverse-events
    name: Food Adverse Event Reports API (CAERS)
    description: Access FDA CFSAN Adverse Event Reporting System (CAERS) data for food, dietary supplement, and cosmetic adverse event reports.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/food/event/
    baseURL: https://api.fda.gov
    tags:
      - Food Safety
      - Adverse Events
      - CAERS
      - Dietary Supplements
      - Cosmetics
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/food/event/
  - aid: open-fda:tobacco-problem-reports
    name: Tobacco Problem Reports API
    description: Access reports about tobacco products that are damaged, defective, contaminated, or cause undesirable health effects.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/tobacco/problem/
    baseURL: https://api.fda.gov
    tags:
      - Tobacco
      - Problem Reports
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/tobacco/problem/
  - aid: open-fda:tobacco-research
    name: Tobacco Research Datasets API
    description: Access tobacco prevention advertising and smokefree campaign research datasets examining advertising influence on youth attitudes and public health impact.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/tobacco/
    baseURL: https://api.fda.gov
    tags:
      - Tobacco
      - Research
      - Public Health
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/tobacco/
  - aid: open-fda:other-historical-documents
    name: Historical FDA Documents API
    description: Access FDA press releases from 1913 to 2014 in searchable format.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/other/historicaldocument/
    baseURL: https://api.fda.gov
    tags:
      - Historical Documents
      - Press Releases
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/other/historicaldocument/
  - aid: open-fda:other-substance-data
    name: Substance Data API
    description: Access molecular-level substance information designed for internal and external applications, including the Unique Ingredient Identifier (UNII) listing.
    image: https://kinlane-productions.s3.amazonaws.com/apis-json/apis-json-logo.jpg
    humanURL: https://open.fda.gov/apis/other/substance/
    baseURL: https://api.fda.gov
    tags:
      - Substances
      - UNII
      - Molecular Data
    properties:
      - type: Documentation
        url: https://open.fda.gov/apis/other/substance/
common:
  - type: Website
    url: https://open.fda.gov/
  - type: Documentation
    url: https://open.fda.gov/apis/
  - type: GitHubOrg
    url: https://github.com/FDA
  - type: GitHubRepository
    url: https://github.com/FDA/openfda
  - type: Blog
    url: https://open.fda.gov/about/updates/
  - type: StatusPage
    url: https://open.fda.gov/about/status/
  - type: X
    url: https://x.com/openFDA
  - type: Authentication
    url: https://open.fda.gov/apis/authentication/
  - type: Plans
    url: plans/open-fda-plans-pricing.yml
  - type: RateLimits
    url: rate-limits/open-fda-rate-limits.yml
  - type: FinOps
    url: finops/open-fda-finops.yml
maintainers:
  - FN: Kin Lane
    email: kin@apievangelist.com