Go to FDA website
Go to HHS websiteU.S. Department of Health and Human ServicesFood and Drug Administration
Skip navigation, go to start of content
Go to openFDA homepage
Home
About
What is openFDA?UpdatesAPI statusAPI usage statistics
APIs
API basicsAnimal and Veterinary EndpointsDrug EndpointsDevice EndpointsFood EndpointsOther Endpoints
Community
Source code (GitHub)Q&A (StackExchange)@openFDA (Twitter)openFDA Apps
Downloads

Datasets

api.fda.gov/data/faers/

FAERS

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA.

See the FAERS web site for download information.

api.fda.gov/data/maude/

MAUDE

FDA dataset that contains medical device adverse event reports submitted by mandatory reporters—manufacturers, importers and device user facilities—and voluntary reporters such as health care professionals, patients, and consumers.

See the MAUDE web site for download information.

api.fda.gov/data/res/

RES

The Recall Enterprise System (RES) is an electronic data system used by FDA recall personnel to submit, update, classify, and terminate recalls.

See the RES web site for download information.

api.fda.gov/data/spl/

SPL

Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.

See the SPL web site for download information.

api.fda.gov/data/nsde/

NSDE

Comprehensive NDC SPL Data Elements.

See the NDC web page for download information.

  • Go to FDA website
  • U.S. Food and Drug Administration
  • 10903 New Hampshire Avenue
  • Silver Spring, MD 20993
  • 1-888-INFO-FDA (1-888-463-6332)
  • Contact FDA
  • FDA Home
  • Accessibility
  • Careers
  • FDA Basics
  • FOIA
  • No Fear Act
  • Site Map
  • Transparency
  • Website
  • openFDA Terms of Service
  • License
  • Email the openFDA team

Some links on this website may direct you to non-FDA locations. FDA does not endorse or guarantee the integrity of information on these external sites.