Adverse Event Reporting System (AERS)

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Last updated on July 28, 2025

The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drugs.

The FDA receives adverse drug reaction reports from manufacturers as required by regulation. Health care professionals and consumers send reports voluntarily through the MedWatch program. These reports become part of a database. The structure of this database is in compliance with the international safety reporting guidance (ICH E2B ) issued by the International Conference on Harmonization. The guidance describes the content and format for the electronic submission of reports from manufacturers. FDA codes all reported adverse events using a standardized international terminology, MedDRA (the Medical Dictionary for Regulatory Activities). Among AERS system features are:

The on-screen review of reports;
Searching tools;
Various output reports.

FDA staff use reports from AERS in conducting postmarketing drug surveillance and compliance activities and in responding to outside requests for information.

The reports in AERS are evaluated by clinical reviewers in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to detect safety signals and to monitor drug safety. They form the basis for further epidemiological studies when appropriate. As a result, the FDA may take regulatory actions to improve product safety and protect the public health, such as updating a product’s labeling information, sending out a "Dear Health Care Professional" letter, or re-evaluating an approval decision.

* Information on this page is from the USFDA website.

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Adverse Event Reporting System (AERS)

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