FDA Adverse Event Reporting System

The FDA produces FDA Adverse Event Reporting System (FAERS) quarterly data. The FAERS include the following:

• 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;
• drug therapy start dates and end dates from the reports;
• all "Medical Dictionary for Regulatory Activities" (MedDRA) terms from the reports;
• a "README" file containing a description of the files.

The FDA provides a lot of additional information about the FAERS.

FDA Adverse Event Reporting System (FAERS) began 2012Q4.

Legacy Adverse Event Reporting System (AERS) are available 2004Q1-2012Q3. I have used FAERS variable names in the AERS files in cases where the variables are the same.

The FDA Adverse Event Reporting System (FAERS) data is offered here in SAS, Stata, and CSV formats to make the database a bit easier to use.

Updates and changes.

Contact data@nber.org with questions, comments, or suggestions.

Contact data@nber.org with questions, comments, or suggestions.