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Posted on • Originally published at thenextgennexus.com

New: FDA Adverse Events — FAERS & MAUDE Records API — signal-scored pharmacovigilance feed

What it does

FDA Adverse Events pulls adverse-event reports from openFDA's FAERS database (drugs) and MAUDE database (devices) into a single signal-scored feed. Each report carries seriousness flags, MedDRA Preferred Terms, and — the differentiator — a PRR disproportionality signal per drug-event pair, so you can spot statistically over-reported reactions instead of reading raw case counts.

Who it's for

Pharmacovigilance teams running signal detection; mass-tort plaintiff firms qualifying intake against real-world adverse-event patterns; device-compliance teams monitoring MAUDE reports for their product codes; and medical journalists investigating drug and device safety.

Sample fields / output

Each report is clean JSON with 21 fields, including:

  • source
  • report_id
  • report_type
  • received_date
  • occur_country
  • reporter_country
  • serious
  • seriousness_flags
  • patient_age
  • patient_age_unit

Example use cases

  • Signal detection: rank drug-event pairs by PRR disproportionality to surface emerging safety signals early.
  • Mass-tort intake: check whether a claimed reaction is actually over-represented in FAERS before accepting cases.
  • Device surveillance: monitor MAUDE reports for your product codes with seriousness flags for compliance triage.

Try FDA Adverse Events on Apify →

Related actors

FAQ

What is a PRR signal?

The Proportional Reporting Ratio compares how often an event is reported for one drug versus all drugs — a standard pharmacovigilance disproportionality measure included per drug-event pair.

How is it priced?

Pay-per-event at $0.100 per report — about 10 signal-scored reports per $1.

Is this medical advice?

No — FAERS and MAUDE are public regulatory datasets of voluntarily submitted reports; reports don't prove causation and this is not medical advice.

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