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FDA Adverse Event Monitoring System (AEMS)

FDA's current adverse-event monitoring system, formerly known as FAERS, with public dashboards, data files and electronic submission resources.

Resource family Safety & Signal Databases
Resource type Regulatory Adverse Event Reporting And Monitoring System
Maintained by US Food and Drug Administration
Jurisdiction United States
Status Official FDA safety monitoring system
Access Public information; reporting/submission access depends on user role
Official link verified 2026-09-04
Official source Visit official resource ↗

The FDA Adverse Event Monitoring System (AEMS) is FDA's current platform for adverse-event monitoring and related safety workflows. FDA now labels AEMS as the successor terminology to the FDA Adverse Event Reporting System (FAERS).

Why a pharmacovigilance professional uses it

FDA provides AEMS resources for electronic ICSR submissions, public data exploration, quarterly data files and publication of potential safety signals or new safety information.

Search note

Because many historical procedures, internal documents and publications still use the term FAERS, QPPV.com indexes both names. Searching either “AEMS” or “FAERS” will therefore return this resource.