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U.S. Department of Health and Human Services


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Adverse Event Reporting System (AERS)

The Adverse Event Reporting System supports the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. It contains adverse drug reaction reports FDA has received from manufacturers as required by regulation. We provide downloadable files only; you cannot search the database online.


Dates of Coverage: January 2004-present
Update Frequency: Quarterly


Additional Information