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.

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.

• General Instructions on How to Make a FOIA Request
• Instructions for Requesting Individual Case Reports

 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.

 

FAERS Quarterly Data Files Documentation  

Current thinking about the changes to the FAERS Quarterly Data Extract (QDE) output files and sample ASCII and XML files for users to review and test in their systems.

 

Older Quarterly Data Files Page

 

Latest Data Files

Click on a link below to begin downloading.

July 2012 to August 27, 2012

Note: The files for the 3rd quarter of 2012 contain data only for July 1, 2012 - August 27, 2012.  We expect to post the FAERS data for August 28, 2012 - December 31, 2012 in April 2013.  When we post the first data extract from the FAERS database, we will explain the differences between the AERS and FAERS files.

For more information, please see the latest entry in the 3rd quarter README.DOC file (Section G, Revision History).
 

• AERS_ASCII_2012q3.ZIP (15.3 MB)

• AERS_SGML_2012q3.ZIP (18.6 MB)

April 2012 to June 2012

• AERS_ASCII_2012q2.ZIP (24.7 MB)
• AERS_SGML_2012q2.ZIP (29.5 MB)

January 2012 to March 2012

• AERS_ASCII_2012q1.ZIP (25.4 MB)
• AERS_SGML_2012q1.ZIP (30.1 MB)

October 2011 to December 2011

• AERS_ASCII_2011q4.ZIP (22.5 MB)
• AERS_SGML_2011q4.ZIP (26.8 MB)

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