Drug Information

Adverse Event Reporting System
(AERS)

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 drug and therapeutic biologic products. The ultimate goal of AERS is to improve the public health by providing the best available tools for storing and analyzing safety reports.

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 an Oracle™ database. The structure of this database is in compliance with the international safety reporting guidance (ICH E2B) issued by the International Conference on Harmonisation. The guidance describes the content and format for the electronic submission of reports from manufacturers. All reported adverse event terms are coded 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; and various output reports. Reports from AERS are used by FDA staff 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.

• How to order CD-ROMs containing AERS data through National Technical Information Service (NTIS)
  • Main NTIS Site
• MedWatch: The FDA   Safety  Information and Adverse Event Reporting Program
• Information about Postmarketing Safety Reporting
  The Web page http://www.fda.gov/medwatch/report/mfg.htm contains information about the following:
• Mandatory Reporting Form and Instructions (FDA 3500A)
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• Regulations Related to Postmarketing Safety Reporting
• Guidance for Industry
• Guidance for FDA Field Staff
• MedWatch to Manufacturer Program (MMP)
• Electronic Submission Postmarketing Safety Reports - Pilot Program
• Federal Register Publications Related to Postmarketing Reporting

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FDA/Center for Drug Evaluation and Research
Last Updated: August 7, 2002
Originator: OTCOM/DLIS
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