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.

FDA Adverse Event Reporting System (FAERS) is a useful tool for FDA to monitor various activities. FDA Adverse event reporting requirements include –

• Looking out for new safety concerns that might be related to a marketed product
• Evaluating a manufacturer’s compliance to reporting regulations
• Responding to outside requests for information

An adverse event can be defined as any side effect or unexpected experience witnessed by humans with the use of a drug or other therapeutic biologic, irrespective of its relation to the use of the product. An adverse event could occur:

• with use in professional practice
• due to lack of expected effectiveness
• from accidental or intentional overdose
• from drug or prod"
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