openFDA

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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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-images.s3.amazonaws.com/shared/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