Skip to content

OpenFDA

OpenFDA is where drug-safety work turns from abstract concern into concrete public records. It matters because FAERS, MAUDE, recalls, and label documents are the source material behind many real-world surveillance, safety-review, and regulatory triage workflows.

In BioMCP, OpenFDA covers adverse events, recalls, device-event reporting, labels, shortages, and U.S. approval context. Approval views are Drugs@FDA-derived inside BioMCP, not a separate direct client, so the OpenFDA page is the right mental model for those U.S. safety and approval workflows.

What BioMCP exposes

Command What BioMCP gets from this source Integration note
search adverse-event --drug <name> FAERS report search by drug OpenFDA adverse-event path
search adverse-event --type recall --drug <name> Drug recall search results OpenFDA recall path
search adverse-event --type device --device <name> MAUDE device-event search results OpenFDA device-event path
get adverse-event <report_id> Source-aware adverse-event detail card Resolves the report against the relevant OpenFDA-backed dataset
get drug <name> label FDA public label text and sections OpenFDA label path
get drug <name> shortage Current U.S. shortage status and availability context Default shortage path is OpenFDA-backed
get drug <name> approvals U.S. approval and application details Drugs@FDA-derived approval context surfaced through BioMCP
get drug <name> interactions Public interaction text when labels expose it Uses label-backed interaction content or a truthful fallback
get drug <name> safety --region us U.S. safety summary and recall context OpenFDA-backed U.S. safety workflow

Example commands

biomcp search adverse-event --drug pembrolizumab --limit 3

Returns an adverse-event summary with report totals and a compact result table.

biomcp search adverse-event --type recall --drug metformin --limit 3

Returns a recall results table with recall number, classification, and product fields.

biomcp search adverse-event --type device --device "insulin pump" --limit 3

Returns a device-event table for MAUDE-backed reports.

biomcp get drug vemurafenib label

Returns an FDA label section with public labeling text.

biomcp get drug dabrafenib approvals

Returns U.S. approval and application details from the Drugs@FDA-derived path.

API access

Optional OPENFDA_API_KEY for higher quota headroom. Configure it with the API Keys guide and request one from the OpenFDA authentication page.

Official source

OpenFDA is the official FDA developer surface for adverse events, recalls, labels, and related public regulatory data.