FDA Quarterly Data Extract from the Adverse Event Reporting System (AERS)
(Raw Data File on CD-ROM)

Food and Drug Administration, Washington, DC.


Subscription order number: SUB-5460
SGML and ASCII delimited data on CD-ROM, Issued quarterly
Price $450; outside of U.S., Canada, and Mexico $900

Single issue available: Price $115; outside of U.S., Canada, and Mexico $230


The Adverse Event Reporting System (AERS) of the Center for Drug Evaluation and Research is a computerized data base of drug adverse reactions reported by health professionals and others.

The system contains only adverse reactions detected and reported after marketing of the drug during the quarter. The information is not cumulative. The primary purpose for the AERS data base is to serve as an early warning or signaling system for adverse drug reactions not detected during premarket testing.

The files included on the CD-ROM are:

  • Information on demographic and administrative information and the initial report image ID number (if the image is available)
  • Drug information on the case reports
  • Reaction information on the reports
  • Patient outcome information on the reports
  • Information on the source of the reports


Historical Data may be ordered through the NTIS Sales Desk at 1-800-553-6847.