FDA 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
- FDA Adverse Event Reporting System (FAERS)
Background information and details about FAERS.
- Quarterly Data Files from the FDA Adverse Event Reporting System (FAERS)
Raw data extracted from the AERS and FAERS databases.
- Reporting an Adverse Event or Medication Error to FDA
MedWatch: The FDA Safety Information and Adverse Event Reporting Program