FAERS - FDA Adverse Event Reporting System

Description

The FDA Adverse Event Reporting System (FAERS) Database supports the FDA's post-marketing safety surveillance program for all marketed drug and therapeutic biologic products. It contains quarterly adverse event reports FDA has received from manufacturers as required by regulation along with reports received directly from consumers and healthcare professionals.

The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonisation (ICH E2B). Adverse events and medication errors are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.

FAERS is being consolidated into the FDA’s new FDA Adverse Event Monitoring System (AEMS), which is refreshed daily.