The 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 AERS/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.

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

 

Posted on the FDA website on 4 June 2014