Skip to content

Drug Approvals and Adverse-Event Summary

This reference covers the Drugs@FDA approvals section plus the adverse-event search summary contract for OpenFDA FAERS and vaccine-capable CDC WONDER VAERS searches.

Drug approvals (Drugs@FDA)

Use the approvals section on drug entities:

biomcp get drug dabrafenib approvals

The section includes:

  • application number (NDA/BLA),
  • sponsor,
  • key product rows (brand/dosage form/route/status),
  • submission timeline rows (type/number/status/date).

Base drug cards and JSON also expose compact approval fields derived from the existing normalized approval date:

  • approval_date_raw keeps the stable ISO form,
  • approval_date_display provides a human-friendly month-name rendering,
  • approval_summary provides a one-line "FDA approved on <date>" summary.

Adverse-event summary statistics

OpenFDA FAERS search responses include summary metadata above the report table:

biomcp search adverse-event -d pembrolizumab --limit 10

OpenFDA FAERS summary fields:

  • total reports from OpenFDA FAERS metadata,
  • returned report count,
  • top reactions with count and percentage.

The same summary appears in:

biomcp drug adverse-events pembrolizumab --limit 10

For vaccine queries, search adverse-event also supports CDC WONDER VAERS:

biomcp search adverse-event "COVID-19 vaccine" --source all --limit 10
biomcp search adverse-event "MMR vaccine" --source vaers --limit 10

--source all preserves the FAERS table and adds a CDC VAERS aggregate summary when the query resolves to a vaccine and the active filters are VAERS-compatible. --source vaers is aggregate-only and surfaces matched vaccine identity, CDC WONDER code, CVX code(s) when available, serious vs non-serious counts, age distribution, and top reactions.