Regulatory & compliance

Drug Adverse Events (FAERS)

FDA's Adverse Event Reporting System: every adverse-event and medication-error report submitted to FDA — ~20M reports, 2004-present, growing ~2M/yr. Served as a LIVE passthrough to openFDA: total_count is FDA's authoritative number for your filtered query, and count_by returns top reactions / drugs / manufacturers instead of records. FDA's own caveat applies: reports are unverified and establish neither causation nor incidence.

EndpointGET /v1/drug-adverse-events

SourceopenFDA FAERS (live passthrough)

Authx-api-key — a free key works

What it returns

Records are openFDA's fields verbatim — deeply nested (patient.drug[] with openFDA annotations, patient.reaction[]); count_by mode returns [{term, count}] facet rows. See the live example below for the full field set.

Filters

drug	Drug name phrase — brand ('ozempic'), generic ('semaglutide'), or reported product name.
manufacturer	Manufacturer name phrase (openFDA annotation, e.g. 'novo nordisk').
reaction	MedDRA reaction term phrase (e.g., 'pancreatitis', 'myocardial infarction').
serious	true = serious reports only (death, hospitalization, disability, …); false = non-serious only.
outcome	One specific seriousness outcome flag.
country	Country where the event occurred (ISO-2, e.g. 'US').
since	FDA receive-date lower bound (YYYY-MM-DD inclusive).
until	FDA receive-date upper bound (YYYY-MM-DD inclusive).
count_by	Facet mode: return top terms + counts instead of records (reaction \| drug \| brand \| manufacturer \| country).
limit	Records per page (default 10, max 100 — records are heavy). In count_by mode: facet rows (default 25, max 1000).
skip	Pagination offset (openFDA hard cap 25,000). Not used in count_by mode.

Example request

curl "https://api.keyvex.com/v1/drug-adverse-events?limit=1" \
  -H "x-api-key: YOUR_KEY"

Response

{
  "results": [
    {
      "term": "NAUSEA",
      "count": 9389
    }
  ],
  "count": 1,
  "has_more": false
}

Example questions you can answer

The most-reported reactions for a specific drug.
Death or hospitalization report counts for a product over time.
A manufacturer's adverse-event footprint.
Pair a safety-signal trend with recalls, approvals, or insider selling.

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