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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)

U.S. regulatory cards also contain a separate FDA orphan-designation block. That block preserves designation date, designation status, approval status, marketing approval, exclusivity end, sponsor, indication, and the validated FDA record link as separate facts. An orphan designation does not imply FDA approval.

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 a denominator-specific report share,
  • percentage_context in JSON whenever reaction percentage rows are present.

Ordinary search calculates each reaction's share of returned reports from the returned page, which is only a sample of all matching reports. The drug helper calculates each reaction's share of matching reports from OpenFDA's aggregate count response and the total matching report count. The structured context names the denominator as returned_reports or all_matching_reports, records the exact divisor in denominator_count, and marks both is_incidence and establishes_causality false. It is omitted when there are no reaction percentage rows and remains additive to all existing summary keys.

FAERS contains spontaneous reports, not a denominator of treated or exposed patients. These percentages are not incidence estimates and do not establish causality.

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.