FDA Adverse Event Reporting System supports the FDA's post-marketing safety surveillance program for all marketed drug and therapeutic biologic products. It contains adverse event reports FDA has received from manufacturers as required by regulation along with reports received directly from consumers and healthcare professionals. We provide downloadable files only; you cannot search the database online.
Dates of Coverage: January 2004 - present
Update Frequency: Quarterly
FDA Adverse Event Reporting System (FAERS) Help
- Frequently Asked Questions (FAQs) about FAERS
- FAERS Online: Tutorial
- Sample Event Tally Report from FDA AERS Online (PDF)
- Sample Detailed Report from FDA AERS Online (PDF)