The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.
The FDA receives some adverse event and medication error reports directly from health care professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others).
Adverse events in FAERS are coded to terms in the Medical Dictionary for Regulatory Activities terminology (MedDRA)3.
FAERS is a useful tool for the FDA, which uses it for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance to reporting regulations and responding to outside requests for information.
A more reliable medical injury database is kept up-to-date by the Health Resources and Services Administration (HRSA), as claims must first undergo a thorough vetting process before being awarded compensation.