FDA Adverse Event Reporting System

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The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might occur with these products. It is a system that measures occasional harms from medications to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular drug and to identify correctable and preventable problems in health care delivery (such as need for retraining to prevent prescribing errors). The system interacts with several related systems including MedWatch and the Vaccine Adverse Event Reporting System. FAERS replaced legacy AERS system in Sep 2012.