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Drugs
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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
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Additional 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 Adverse Event Reporting System (AERS): Latest Quarterly Data Files
The files listed on this page contain raw data extracted from the AERS database for the indicated time ranges and are not cumulative.
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