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

The files listed on this page contain raw data extracted from the AERS database for the indicated time ranges and are not cumulative. When we post the first data extract from the FAERS database, we will provide information about the differences between the AERS and FAERS files.

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 AERS data cannot be performed with these files by persons who are not familiar with creation of relational databases. However, you can get individual case reports from the AERS database by sending a Freedom of Information (FOI) request to FDA.

 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.


Older quarterly data files

Latest Data Files

Click on a link below to begin downloading.

April 2012 to June 2012

January 2012 to March 2012

October 2011 to December 2011

July 2011 to September 2011

For assistance, please email the FDA/CDER Office of Surveillance and Epidemiology, Division of Medication Errors and Technical Support: cderosetracking@fda.hhs.gov.


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