openFDA API

openFDA API

openFDA is the FDA's JSON API for adverse-event reports, product recalls, drug labels and device data, drawn from FDA's own public datasets. The license page says: "unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication." The terms of service add: "Works where CC0 do not apply will be clearly marked by a warning in the relevant documentation."

Coverage

US FDA-regulated products: drug, device and food adverse-event reports, recall enforcement reports, drug labels/NDC and device clearances. For food enforcement, the overview page says: "Currently, this data covers publicly releasable records from 2004-present. The data is updated weekly." Other endpoints' history and update cadence vary and are not stated as one figure here.

Verdict

A JSON API for FDA adverse-event reports, product recalls, drug labels and device data. The auth docs say: "With no API key: 240 requests per minute, per IP address. 1,000 requests per day, per IP address." and "With an API key: 240 requests per minute, per key. 120,000 requests per day, per key." WARNING: device records that reproduce GMDN terminology are separately licensed — the license page says any extraction of that content for commercial re-use "must first obtain an appropriate license from The GMDN Agency." Do not imply FDA endorsement when using or citing the work. Signal Lab links only.