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, paid plans only (Basic and up)

Live from the data

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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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Query Drug Adverse Events (FAERS) from your AI

Hand any AI your key + the OpenAPI spec and it can pull this dataset directly. Paid plans only (Basic and up): a free key does not include this dataset.

See plans OpenAPI spec → REST docs →

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