Chemistry and drugs · Database
openFDA
An open-access platform providing indexed US Food and Drug Administration datasets and APIs for researchers.
What openFDA is
openFDA is an initiative that indexes, formats, and publishes public data from the United States Food and Drug Administration (FDA). Built to make regulatory data accessible to the public, the platform aims to support public education and assist efforts to save lives.
The repository covers diverse regulatory information, including adverse drug event reports, product labels, recalls, and medical device records. It also incorporates dedicated scientific and regulatory datasets such as the Orange Book, Covid miRNA and Proteomics Research, and Tobacco Smokefree Research.
How it is organised
The platform processes and structures FDA records into standardized datasets accessible through application programming interfaces (APIs). Data can be queried programmatically via these endpoints or downloaded directly in bulk as zipped JSON archives.
Key facts
- Data formats
- Zipped JSON
- Record types
- Adverse events, product labels, recalls, device records
- Access mechanisms
- Web APIs and bulk download
- API status
- Beta
What you can use it for
- Adverse event surveillance
- Researchers can query structured drug adverse event reports to analyse post-market safety trends and reported complications.
- Product label and recall analysis
- Clinicians and data scientists can examine official product labels and track regulatory recalls across pharmaceuticals and devices.
- Specialised biomedical data extraction
- Computational biologists can retrieve focused public datasets, such as Covid miRNA and Proteomics Research, for secondary research.
Query it here
The research agent queries openFDA directly — no account, no API key — and every answer links back to the record it came from. Ask in plain language and it writes the query.
Strengths and limits
Good at
- Makes disparate FDA public records easily accessible through structured API endpoints and bulk data downloads.
- Data is offered in standard zipped JSON format for computational workflows.
- Supported by an open-source codebase on GitHub and an open community for sharing tools and examples.
Watch out for
- The data access API is provided under a beta version.
- Dataset updates have previously experienced temporary suspensions.
Questions
Can I search openFDA without writing code?
Yes. The research agent queries openFDA directly, with no account or API key, and cites the record behind every answer. Ask in plain language — for a gene, a protein, a compound or a study — and it builds the query for you.
Can I reuse data from openFDA?
CC0 1.0. FDA: do not rely on openFDA for medical decisions; adverse-event reports are unverified and do not establish causation. Terms: https://open.fda.gov/license/
What formats are available for bulk data access?
Data from the endpoints can be downloaded in zipped JSON format.
What core clinical and regulatory records does the database contain?
It contains FDA drug adverse event reports, product labels, medical device records, and recall notices.
Is the codebase for openFDA publicly available?
Yes, openFDA is an open-source project with code available on GitHub.
Written from openFDA's own website and reference material. Statements citing a figure that does not appear there are removed before publication. Licence and running details come from our registry.