FDA Adverse Event Reporting System Quarterly Data Extract Files

Principal Investigator(s):  View help for Principal Investigator(s) United States Department of Health and Human Services. Food and Drug Administration

Version:  View help for Version V3

Name File Type Size Last Modified
  Data-Files 03/16/2025 09:34:PM
  Supplementary-Information 03/16/2025 07:37:PM

Project Citation: 

United States Department of Health and Human Services. Food and Drug Administration. FDA Adverse Event Reporting System Quarterly Data Extract Files. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2026-03-26. https://doi.org/10.3886/E221501V3

Project Description

Project Title:  View help for Project Title FDA Adverse Event Reporting System Quarterly Data Extract Files
Summary:  View help for Summary Includes data files and supplemental information. Supplemental information includes a reproducible RMarkdown file, an Excel sheet with metadata, and complete webpage files.


From the FAERS Quarterly Data Extract Files Website:

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:
  • 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.
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)

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Microdata: Yes                                                                                    
Level of Analysis: Groups - medications; Individuals - patients  
Variables Present: Unclear Based on the File Type 
File Layout: ascii, sgm                                                                               
Codebook: Yes                                                                       
Weights (with appropriate documentation): n/a                             
Publications: No                                                                              
Aggregate Data: No
Original Distribution URL:  View help for Original Distribution URL https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html

Scope of Project

Subject Terms:  View help for Subject Terms adverse events ; medical errors; product quality complaints
Time Period(s):  View help for Time Period(s) 2004 – 2024
Data Type(s):  View help for Data Type(s) aggregate data


Related Publications

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Published Versions

V3 [2026-03-26]

V2 [2026-03-26]

V1 [2025-03-16]

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This material is distributed exactly as received from the data depositor. ICPSR has not reviewed, checked, or processed this material. For additional information about the study, please contact the investigator(s) directly. If you have questions about the accessibility of materials distributed by ICPSR or require further assistance, please visit ICPSR's Accessibility Center.