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