openFDA website screenshot

openFDA

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.

openFDA publishes 17 APIs on the APIs.io network. Tagged areas include FDA, Food and Drug Administration, Drug Safety, Adverse Events, and Drug Labels.

The openFDA catalog on APIs.io includes 1 JSON-LD context and 1 Spectral governance ruleset.

openFDA’s developer surface includes documentation, engineering blog, authentication, and 9 more developer resources.

🌐 Visit website 📡 Source on GitHub
31.0/100 thin ▼ -5.1 Agent 12/100 agent aware Full breakdown ↓
scored 2026-07-28 · rubric v0.6
AccessFreeOpen⚡ Free to try
17 APIs
FDAFood and Drug AdministrationDrug SafetyAdverse EventsDrug LabelsRecallsMedical DevicesFood SafetyTobaccoPublic HealthOpen DataGovernmentRegulatoryFAERSSPL

Kin Score

Kin Score Kin Score How this is scored →
scored 2026-07-28 · rubric v0.6
Composite quality — 31.0/100 · thin
Contract Quality 4.4 / 25
Developer Ergonomics 4.3 / 20
Commercial Clarity 5.8 / 20
Operational Transparency 2.7 / 13
Governance 6.3 / 12
Discoverability 7.4 / 10
Agent readiness — 12/100 · agent aware
Machine-Readable Contract 0 / 18
Agentic Access Contract 0 / 10
MCP Server 0 / 12
Machine-Readable Auth 10 / 10
Idempotency 0 / 9
Stable Error Semantics 0 / 8
Request/Response Examples 0 / 7
Rate-Limit Signaling 7 / 7
Typed Event Surface 0 / 6
Agent Skills 0 / 5
Well-Known Catalog 0 / 4
Consent & Bot Identity 0 / 3
A2A Agent Card 0 / 8
Dry-Run / Simulate Mode 0 / 4
Improve this rating by publishing the missing artifacts — every area above can be raised, and the full rubric is at apis.io/rating/. This rating is computed from github.com/api-evangelist/open-fda: open an issue to ask a question, or submit a pull request to add artifacts. Want it done for you? Prioritized profiling — $2,500 →

APIs 17

Individual APIs this provider publishes, each with its own machine-readable definition.

Drug Adverse Events API

Access FDA Adverse Event Reporting System (FAERS) data covering adverse event reports for drugs and therapeutic biologic products from 2004 onward, updated quarterly.

Drug Labeling API

Access FDA Structured Product Labeling (SPL) files for prescription and over-the-counter drug products, including indications, adverse reactions, and safety information. Updated...

Drug Recall Enforcement Reports API

Access drug product recall enforcement reports submitted to the FDA.

Medical Device 510(k) Clearances API

Access 510(k) premarket notification data demonstrating that devices are at least as safe and effective as legally marketed predicate devices.

Medical Device Adverse Event Reports API

Access reports of serious injuries, deaths, malfunctions, and other undesirable effects associated with the use of medical devices.

Medical Device Classification API

Access medical device names, product codes, specialty areas, and classification data.

Medical Device Recall Enforcement Reports API

Access medical device product recall enforcement report data.

Medical Device Premarket Approval (PMA) API

Access FDA scientific and regulatory review data for Class III medical devices requiring premarket approval.

Medical Device Recalls API

Access actions taken to address problems with medical devices that violate FDA law.

Medical Device Registrations and Listings API

Access establishment locations and corresponding manufactured device listings.

Unique Device Identifier (UDI) API

Access Global Unique Device Identification Database (GUDID) information for medical devices.

Food Recall Enforcement Reports API

Access food product recall enforcement report data from the FDA.

Food Adverse Event Reports API (CAERS)

Access FDA CFSAN Adverse Event Reporting System (CAERS) data for food, dietary supplement, and cosmetic adverse event reports.

Tobacco Problem Reports API

Access reports about tobacco products that are damaged, defective, contaminated, or cause undesirable health effects.

Tobacco Research Datasets API

Access tobacco prevention advertising and smokefree campaign research datasets examining advertising influence on youth attitudes and public health impact.

Historical FDA Documents API

Access FDA press releases from 1913 to 2014 in searchable format.

Substance Data API

Access molecular-level substance information designed for internal and external applications, including the Unique Ingredient Identifier (UNII) listing.

Scroll for all 17

Pricing Plans 1

Published pricing tiers and plan structures.

Open Fda Plans Pricing

2 plans

PLANS

Rate Limits 1

Documented rate limits and quota policies.

Open Fda Rate Limits

0 limits

RATE LIMITS

FinOps 1

Cost, billing, and metering signals for API financial operations.

Open Fda Finops

FINOPS

Semantic Vocabularies 1

JSON-LD contexts and semantic vocabularies used across these APIs.

Open Fda Context

72 classes · 11 properties

JSON-LD

Spectral Rules 1

Spectral governance rulesets for linting and validating these APIs.

openFDA API Rules

2 rules · 2 warnings

SPECTRAL

JSON Schema 8

Standalone JSON Schema definitions for this provider's data models.

Device 510K Clearance

24 properties

JSON SCHEMA

Device Adverse Event

83 properties

JSON SCHEMA

Drug Adverse Event

27 properties

JSON SCHEMA

Drug Label

179 properties

JSON SCHEMA

Enforcement Recall

26 properties

JSON SCHEMA

Food Adverse Event

7 properties

JSON SCHEMA

Substance Data

21 properties

JSON SCHEMA

Tobacco Problem

9 properties

JSON SCHEMA

Scroll for all 8

Examples 10

Example request and response payloads for these APIs.

Device 510K

2 fields

EXAMPLE

Device Adverse Event

2 fields

EXAMPLE

Device Classification

2 fields

EXAMPLE

Drug Adverse Event

2 fields

EXAMPLE

Drug Enforcement Recall

2 fields

EXAMPLE

Drug Label

2 fields

EXAMPLE

Food Adverse Event

2 fields

EXAMPLE

Food Enforcement Recall

2 fields

EXAMPLE

Substance Data

2 fields

EXAMPLE

Tobacco Problem

2 fields

EXAMPLE

Scroll for all 10

Security Posture 1

Authentication, domain security, vulnerability disclosure, and trust-center signals.

Open Fda Domain Security

TLSv1.3 · HSTS · DNSSEC · DMARC

SECURITY

Resources

Documentation 1

Reference material describing how the API behaves

Documentation
Documentation

Build 2

SDKs, sample code, and the tooling you integrate with

GitHubOrg
GitHubOrg
 GitHubRepository
GitHubRepository

Access & Security 2

Authentication, authorization, and security posture

DomainSecurity
DomainSecurity
 Authentication
Authentication

Operate 2

Status, limits, changes, and where to get help

StatusPage
StatusPage
 RateLimits
RateLimits

Commercial 2

Pricing, plans, and the legal terms of use

Plans
Plans
 FinOps
FinOps

Company 2

The organization behind the API

Website
Website
 Blog
Blog

Other 1

Properties that don't map to a standard resource type

X
X

Source (apis.yml)

apis.yml Raw ↑ 
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
accessModel:
  pricing: free
  onboarding: open
  trial: false
  try_now: true
  public: true
  label: Free · Open access
  confidence: medium
  source:
  - plans
  generated: '2026-07-22'
  method: derived
image: https://kinlane-images.s3.amazonaws.com/shared/apis-json/icons/open-fda.png
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: DomainSecurity
  url: security/open-fda-domain-security.yml
- 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