Adverse Event Database (FDA AERS Database)

The FDA Adverse Event Reporting System (FAERS) (Formerly known as the 'FDA AERS' database) is a cumulative, centralized database containing every adverse event or report from every single approved drug. The FDA AERS Database includes adverse event reports collected by drug manufacturers from every manufacturer adverse event data on every FDA approved drug. The FDA AERS database is comprised of MedWatch reports, as well as drug company accumulated reports.

The database has existed in one form or another since 1967. The adverse event database was developed to support the FDA's post-marketing safety surveillance program for drugs. The presentation of the FAERS/FDA AERS database adheres to the international safety reporting guidance issued by the ICH. FDA AERS/FAERS reports are available to the public via a FOIA request, but the ICHE2B format of the data makes them impossible to review or search. An FDA AERS expert at Georgetown University would be necessary to present the FDA AERS database into a usable format.

Reporting of adverse events may come from healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report adverse events and/or medication errors to the products' manufacturers. If a manufacturer receives an adverse event report, they are required to send the report to FDA as dictated by the FDA Code of Federal Regulations. The reports received directly and the reports from manufacturers are entered into FAERS/FDA AERS Database.

If you are a consumer and wish to report an adverse event associated with a medication, you may click here to be forwarded to the FDA's MedWatch homepage. Alternatively, you may call the FDA's Medwatch at: 1-800-332-1088

If you need FDA AERS database search results, contact an FDA AERS expert to search the AERS Database at The Georgetown School of Medicine, contact Dr. David Gortler by Clicking HERE.