FDA Adverse Drug Event Signal Monitor

Run daily or weekly. Pay only for newly seen adverse drug event reports that match your drugs or MedDRA reaction terms.

buyer wedge

Built for pharmacovigilance teams, pharma compliance groups, and healthcare product safety officers who need a narrow adverse-event feed—not another bulk FDA dump.

why it is different

• signal, not retrieval: unmatched adverse event reports are omitted and free.
• MedDRA term filtering: phrase match against reaction terms in the report.
• correction-aware: a materially changed source record emits SOURCE_CORRECTION once.
• replay-safe: stable event IDs and provider idempotency keys suppress duplicate charges.
• bounded spend: maxEvents and maxTotalChargeUsd cap each run before charging.
• audit evidence: every row includes the official openFDA query, source fingerprint, timestamp, and disclaimer.

price example: five new adverse event reports plus one material source correction cost $0.55; unmatched and unchanged reports cost $0.00.

source and scope

The Actor queries the official openFDA adverse drug event API. No API key, browser, proxy, personal data, or AI inference is required. FDA states that adverse event data is generally updated daily and is not maintained as an authoritative safety-signal tracker. Accordingly, this Actor is an internal screening aid and emits new or corrected reports; it does not issue public alerts, provide medical advice, or claim a safety signal was confirmed or escalated.

matching

At least one watch term is required:

• drugs: phrase match against drug names in the report
• medDraTerms: phrase match against MedDRA reaction terms in the report

baselineMode=emit_matches returns matching reports in the initial lookback window. Use silent to establish state without emitting or charging initial matches. Reuse the same watchlistId, settings, and stateStoreName for scheduled monitoring.

output

Paid dataset rows are either:

• NEW_REPORT — $0.10
• SOURCE_CORRECTION — $0.05

Unmatched reports, unchanged replays, silent baselines, malformed input, and failed source fetches are not paid events. A deterministic run report is stored as REPORT with source window, counts, receipts, state size, and claim scope.

operational note

If openFDA returns an error or an unexpected response shape, the run fails before state is advanced or events are charged. Event settlement is fail-closed: an ambiguous prior settlement refuses another provider charge.

quick start

Start with a silent baseline so historical reports do not create paid events, then schedule the identical input daily or weekly.

{
  "watchlistId": "drug-safety-watch",
  "drugs": ["atorvastatin", "lisinopril"],
  "medDraTerms": ["rash", "hypotension"],
  "lookbackDays": 14,
  "baselineMode": "silent",
  "maxEvents": 20,
  "maxTotalChargeUsd": 5,
  "stateStoreName": "drug-safety-watch-state"
}

After the baseline, keep watchlistId, watch terms, and stateStoreName stable. Route returned NEW_REPORT rows to a pharmacovigilance review queue. Confirm every action against the linked openFDA source; this feed is deliberately not an emergency notification or safety-signal-confirmation system.

Other focused monitors: FDA food recall matches, regulatory rule changes, and weather business impact alerts.