Reference · built on requestCommons signalPublic health

openFDA

FDA public data on drug adverse events (FAERS), medical device reports, structured labels, and daily drug shortages.

Request accessPricing ↗

About

openFDA is the principal developer API and open data platform operated by the United States Food and Drug Administration (FDA). Providing programmatic REST access to regulatory data, openFDA serves post-market drug adverse event reports (FAERS), medical device adverse events (MAUDE), structured product labeling (SPL), daily-updated national drug shortages, and FDA recall enforcement reports.

Through Fibric, an operator references daily pharmaceutical shortage updates, product recall notices, and medication adverse event signals, proposing clinical supply replenishment alternatives, pharmacy procurement adjustments, and immediate patient safety alerts across healthcare operations.

This is a reference listing. It documents what Fibric would read from openFDA and what it could propose, based on the publisher's published interfaces. Fibric builds it under a managed deployment when you request it; selecting it here installs nothing.

Inputs

  • Post-market human drug adverse event reports from the FDA Adverse Event Reporting System (FAERS)
  • Daily-updated commercial drug shortages including shortage status, therapeutic categories, and manufacturer availability notes
  • FDA product recall enforcement reports covering pharmaceutical drugs, medical devices, and regulated food items
  • Structured Product Labeling (SPL) containing package inserts, indications, boxed warnings, and active ingredient tables
  • Medical device adverse event reports and 510(k) premarket clearances from the MAUDE database

Proposed actions

Read-only. This feed informs operators; it changes nothing.

Proposed actions are target capabilities. Every action runs propose-first and needs a validated deployment and the appropriate permissions.

What you can build

  • Detect pharmaceutical shortages to adjust pharmacy replenishment

    Poll openFDA daily drug shortage records for critical therapeutics, proposing alternative formulations or secondary suppliers before stockouts impact patient care.

    With Stockout Forecast, Reorder Point

  • Cross-reference medical device inventory with recall notices

    Query openFDA device recall reports against internal asset registers, proposing equipment maintenance holds and safety inspections for impacted biomedical devices.

    With Predictive Maintenance, Quality Hold

Requirements

  • HTTP client capable of constructing Lucene-style search queries across openFDA endpoint fields
  • Optional FDA API key passed as query parameter (api_key) for higher concurrency usage
  • Mapping logic linking National Drug Codes (NDC) and RxNorm identifiers to internal inventory catalog items
Authentication
None. openFDA endpoints are openly accessible without authentication at 40 requests per minute; a free registered API key raises the limit to 240 requests per minute.

Limits

  • Unauthenticated client requests are rate-limited to 40 requests per minute and 1,000 requests per day
  • Adverse event reports represent voluntary and mandatory spontaneous submissions and do not establish clinical causality
  • Search query result windows return a maximum of 25,000 matched records using pagination skip parameters

Access and pricing

Reference listing. Public feed access is separate from Fibric integration. If you request this feed, your quote covers the build, usage, and support.

Request openFDA ↗

Questions and answers

What datasets are accessible through openFDA?
openFDA provides API endpoints for drug adverse events, drug shortages, structured product labels, medical device reports, and recall enforcement reports.
Is an API key required to use openFDA?
No. openFDA allows unauthenticated queries up to 40 requests per minute. Registering a free API key increases the limit to 240 requests per minute.
What license applies to openFDA data?
openFDA data is in the public domain and published under Creative Commons Zero (CC0 1.0 Universal) terms.
Ask about openFDA

Ask about the capabilities and requirements in this listing.

For project-specific requirements, contact Fibric.

This Commons signal listing is developed, published, and supported by Fibric. It reads public data published by U.S. Food and Drug Administration (FDA / open.fda.gov). Upstream agencies and projects are the property of their respective owners, who are not affiliated with Fibric and do not sponsor or endorse this listing. Trademark policy