FDA Adverse Event Reporting System (FAERS)
Also known as: FAERS, AEMS, Adverse Event Monitoring System, FDA Adverse Event Reporting System
Verified from FDA on 06-02-2026The FDA Adverse Event Reporting System (FAERS) is the federal database used to collect, store, and analyze adverse event reports tied to FDA-regulated products. It serves as a central input into postmarket safety monitoring, signal detection, and regulatory follow-up. The FDA has described a broader effort to consolidate its reporting infrastructure across product categories, summarized in the source quote below.
MedivaScan summary. The authoritative source quote follows below.FDA definition
FDA is implementing the Adverse Event Monitoring System (AEMS) to consolidate multiple disparate reporting systems currently used across all FDA-regulated product categories, including medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary medicines.