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