Dataset

FDA drug, device & adverse-event APIs

FDA-regulated products and events exposed as structured JSON: adverse drug-event reports, device recalls and registrations, labels, the NDC directory and food enforcement, used for pharmacovigilance and regulatory-risk screens.

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Dataset card

The FDA drug, device & adverse-event APIs, published by openFDA, provide programmatic access to federal records on pharmaceuticals, medical devices, recalls and safety reports. The product is released under public-domain or open terms, making it freely available for commercial and academic reuse.

What this dataset contains

The openFDA endpoints cover four regulatory domains: human and animal drugs, medical devices, and food. Records reference approvals, labeling, recall classifications, registration details and adverse-event reports submitted to the FDA's MedWatch system. Coverage spans decades of submissions, though exact historical depth and refresh cadence are not stated in the source materials.

Structure and fields

The API returns JSON objects whose exact column list is not documented in the source. Common attributes referenced by analysts include event date, report identifier, product description, manufacturer name, recall classification and adverse-event outcome. Because no schema or sample rows are available, specific field names cannot be confirmed.

How analysts use it

Investment teams monitoring pharmaceutical and medical-device issuers can track recall announcements and adverse-event spikes as potential reputational or litigation signals. The data also supports peer benchmarking of approval pipelines and post-market safety profiles. Concrete use cases beyond those grounded in the documented coverage are not warranted by the available facts.

Documentation & references 2