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, U.S. approval context, and the optional diagnostic
regulatory overlay. 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> regulatory --region us|all |
U.S. regulatory context | Also includes a separately labeled, exact-alias overlay from FDA Orphan Drug Designations and Approvals; designation is not approval |
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 |
get diagnostic <id> regulatory |
FDA device 510(k)/PMA status overlay | Exact-name-first live lookup over device regulatory records |
Example commands¶
Returns an adverse-event summary with report totals and a compact result table.
The ordinary search summary reports reaction shares within the returned page;
biomcp drug adverse-events <name> reports aggregate shares across all
matching FAERS reports. Both label the denominator in Markdown and in JSON
percentage_context when percentage rows exist.
FAERS is a spontaneous-reporting system. Its reports are affected by incomplete reporting and reporting behavior, and they do not provide the number of treated or exposed patients. BioMCP therefore labels these report shares as not incidence and as not establishing causality. A report may also list multiple products and reactions without linking a particular reaction to one product.
Returns a recall results table with recall number, classification, and product fields.
Returns a device-event table for MAUDE-backed reports.
Returns an FDA label section with public labeling text.
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, device records, and related public regulatory data.