FDA Adverse Event Reporting System (FAERS) Database

FDA Adverse Event Reporting System Database 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.

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

FDA Adverse Event Reporting System (FAERS) Help

• Frequently Asked Questions (FAQs) about FAERS

Additional Information

• Quarterly Data Files from the FDA Adverse Event Reporting System (FAERS)
• Reporting an Adverse Event or Medication Error to FDA