openFDA

openFDA is an initiative of the U.S. Food and Drug Administration's Office of Health Informatics that provides APIs and raw download access to high-value FDA datasets, including adverse event reports, drug product labeling, and recall enforcement reports^[1][2].

Launched on June 2, 2014, the platform indexes and documents public-access regulatory data in developer-friendly formats so it can be used directly in applications^[2]. The project is open source, with code published on GitHub, and features a community for sharing examples and ideas^[3].

What It Does

openFDA makes structured FDA data findable and machine-readable through query APIs and downloadable zipped JSON files^[2]. The concept was to index high-value, high-priority, scalable public-access data, format and document it in developer- and consumer-friendly standards, and serve it from a public portal^[2].

Products

Core endpoints cover drug adverse events, medical device reports, and enforcement/recall reports; by September 2014 every mention of a drug in those reports was automatically augmented with full data from related drug datasets, including codes and label information^[2]. Newer datasets listed on the site include the Orange Book (added June 2026), Tobacco Smokefree Research (March 2026), and Covid miRNA and Proteomics Research (August 2026)^[1]. The site also publishes usage statistics for its API endpoints and a gallery of community-built applications^[1].

Delivery And Pricing

All data are delivered free of charge via the open.fda.gov portal, either as JSON returned by REST-style API queries or as bulk downloads^[2]. No paid tiers exist; the service is a government open-data program.

History

openFDA was implemented in support of the 2013 Executive Order "Making Open and Machine Readable the New Default for Government Information", later superseded by the 2019 OPEN Government Data Act. Dr. Taha Kass-Hout started the project in July 2013, obtaining a Presidential Innovation Fellow; the cloud environment was selected in September 2013, and the site launched June 2, 2014^[2]. In May 2015 the FDA announced the first openFDA developer challenge^[2].

Buyers And Use Cases

Since launch, openFDA has been visited by tens of thousands of entities worldwide and is used by several websites^[2]. In quantitative research, its adverse-event and recall datasets support pharmacovigilance signals, drug-safety analytics, and healthcare alternative data signals, complementing other free U.S. government sources such as SEC EDGAR for issuer-level research.

Status And Governance

Wikipedia notes that the provided API has been described as beta and that on March 31, 2025 the openFDA website displayed notice of a temporary suspension of dataset updates^[3]. The project remains open source, with code available through the FDA's GitHub organization^[2][3].