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  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files
  1. Surveillance: Post Drug-Approval Activities

FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files

The FAERS Quarterly Data files listed on this page contain raw data extracted from the AERS database for the indicated time ranges and are not cumulative.

Users of these files need to be familiar with creation of relational databases using applications such as ORACLE®, Microsoft Office Access, MySQL® and IBM DB2 or the use of ASCII files with SAS® analytic tools.

A simple search of FAERS data cannot be performed with these files by persons who are not familiar with creation of relational databases. However, you can get a summary FAERS report for a product by sending a Freedom of Information Act (FOIA) request to FDA. You can also request individual case reports by submitting a FOIA request listing case report numbers. 

The quarterly data files, which are available in ASCII or SGML formats, include: 

  • demographic and administrative information and the initial report image ID number (if available);
  • drug information from the case reports;
  • reaction information from the reports;
  • patient outcome information from the reports;
  • information on the source of the reports;
  • a "README" file containing a description of the files.
How to Make a Freedom of Information Act (FOIA) Request

You can get a summary FAERS report for a product by submitting a Freedom of Information Act (FOIA) request. You can also request individual case reports by submitting a FOIA request. Your request must include the FAERS case numbers.