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KATEGORIE: SAFETY SURVEILLANCE
FAERS (FDA Adverse Event Reporting System)
Die FDA-Datenbank für spontane Meldungen unerwünschter Ereignisse bei Arzneimitteln und Biologika.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
FAERS (FDA Adverse Event Reporting System) is FDA’s database for drug and therapeutic biologic adverse events. Device professionals use it when combination products, drug-device interactions, or medication-related device failures appear in the signal landscape—distinct from MAUDE for devices.
PROCESS / STEPS
- Do not confuse FAERS (drugs/biologics) with MAUDE/MDR (devices).
- For combination products, evaluate which reporting system and lead center apply.
- Use openFDA FAERS endpoints for research alongside device vigilance sources.
- Document signal hypotheses separately by product type.
EXAMPLES
- A prefilled syringe signal may require both drug safety (FAERS) and device component evaluation (MAUDE/MDR).
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to FAERS (FDA Adverse Event Reporting System) across 27 authorities in real time.
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