FDA Adverse Event Reporting System (FAERS)

[Shalini]

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse events and medication error reports submitted to FDA. Compliant with the reporting guidance ICH E2B2 issued by the International Conference on Harmonisation, FDA uses FAERS data to monitor, identify and analyze adverse events and medication errors. The FAERS database, which follows FDA Adverse event reporting regulations, is designed specifically to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. FAERS database adopted an informatic structure based on the guidance issued by ICH E2B or International Conference on Harmonisation. All approved drugs adverse event reports must be submitted by the manufacturer to FAERS electronically using the ICH E2B XML format which replicates Form FDA 3500A.