FDA Adverse Event Reporting System (FAERS) Quarterly Data Extract 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 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:

Additional fields will appear in the 2014 Q3 date files below.
For more details: Summary of Changes for the 2014 Q3 Quarterly Date Extract (PDF -71 KB)

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.


Click on a year and then choose ASCII or XML for the desired quarter to download FAERS data files.

October - December 2017

ASCII
(ZIP - 41MB)
XML
(ZIP - 76MB)

July - September 2017

ASCII
(ZIP - 48MB)
XML
(ZIP - 91MB)

April - June 2017

ASCII
(ZIP - 46MB)
XML
(ZIP - 86MB)

January - March 2017

ASCII
(ZIP - 48MB)
XML
(ZIP - 91MB)

October - December 2016

ASCII
(ZIP - 44MB)
XML
(ZIP - 82MB)

July - September 2016

ASCII
(ZIP - 46MB)
XML
(ZIP - 87MB)

April - June 2016

ASCII
(ZIP - 44MB)
XML
(ZIP - 81MB)

January - March 2016

ASCII
(ZIP - 46MB)
XML
(ZIP - 84MB)

October - December 2015

ASCII
(ZIP - 42MB)
XML
(ZIP - 77MB)

July - September 2015

ASCII
(ZIP - 47MB)
XML
(ZIP - 88MB)

April - June 2015

ASCII
(ZIP - 38MB)
XML
(ZIP - 70MB)

January - March 2015

ASCII
(ZIP - 39MB)
XML
(ZIP - 72MB)

October - December 2014

ASCII
(ZIP - 28MB)
XML
(ZIP - 53MB)

July - September 2014

ASCII
(ZIP - 28MB)
XML
(ZIP - 54MB)

April - June 2014

ASCII
(ZIP - 25MB)
XML
(ZIP - 44MB)

January - March 2014

ASCII
(ZIP - 30MB)
XML
(ZIP - 52MB)

October - December 2013

ASCII
(ZIP - 26MB)
XML
(ZIP - 46MB)

July - September 2013

ASCII
(ZIP - 22MB)
XML
(ZIP - 40MB)

April - June 2013

ASCII
(ZIP - 21MB)
XML
(ZIP - 38MB)

January - March 2013

ASCII
(ZIP - 25MB)
XML
(ZIP - 44MB)

October - December 2012

ASCII
(ZIP - 28MB)
XML
(ZIP - 50MB)

October - December 2011

ASCII
(ZIP - 23MB)
XML
(ZIP - 29MB)

July - September 2011

ASCII
(ZIP - 23MB)
XML
(ZIP - 29MB)

April - June 2011

ASCII
(ZIP - 23MB)
XML
(ZIP - 29MB)

January - March 2011

ASCII
(ZIP - 21MB)
XML
(ZIP - 26MB)

October - December 2010

ASCII
(ZIP - 20MB)
XML
(ZIP - 25MB)

July - September 2010

ASCII
(ZIP - 22MB)
XML
(ZIP - 28MB)

April - June 2010

ASCII
(ZIP - 17MB)
XML
(ZIP - 22MB)

January - March 2010

ASCII
(ZIP - 16MB)
XML
(ZIP - 20MB)

October - December 2009

ASCII
(ZIP - 16MB)
XML
(ZIP - 20MB)

July - September 2009

ASCII
(ZIP - 16MB)
XML
(ZIP - 19MB)

April - June 2009

ASCII
(ZIP - 14MB)
XML
(ZIP - 18MB)

January - March 2009

ASCII
(ZIP - 13MB)
XML
(ZIP - 16MB)

October - December 2008

ASCII
(ZIP - 13MB)
XML
(ZIP - 16MB)

July - September 2008

ASCII
(ZIP - 13MB)
XML
(ZIP - 16MB)

April - June 2008

ASCII
(ZIP - 12MB)
XML
(ZIP - 16MB)

January - March 2008

ASCII
(ZIP - 12MB)
XML
(ZIP - 15MB)

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