Adverse Event Reporting System (AERS)

QualityTool

Adverse Event Reporting System (AERS)

Description

The Adverse Event Reporting System (AERS) is a computerized information database designed to support the U.S. Food and Drug Administration (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products.

Reporting of adverse events from the point of care is voluntary in the United States. Health care professionals and consumers may report adverse events using MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

This site provides the following information:

  • How to report adverse events using MedWatch
  • AERS data files and summary statistics
  • Postmarket drug safety information for patients and providers
  • Guidance, compliance, and regulatory information

Developer:

Food and Drug Administration (U.S.)

Funding Sources:

Food and Drug Administration (U.S.)

History

Release Date: 2009
Original Summary: June 2010
Last Updated: 06/23/10

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