FDA Adverse Event Reporting System

The United States Food and Drug Administration (US FDA) has established a drug safety database known as the Adverse Event Reporting System (AERS).

The basic information stored in the AERS is taken from the Individual Safety Report (ISR), which contains all of the information contained on the MedWatch form (FDA Form 3500 or FDA Form 3500A). ISRs can be submitted to the FDA by consumers, health care providers, and drug manufacturers. A real limitation to the database, however, is under-reporting. One study found that only 1% of serious adverse events are reported to the FDA.