Adverse Event Reporting System (AERS)

The Adverse Event Reporting System (AERS) is a database maintained by the FDA that collects information about adverse events—such as side effects or health problems—that occur after a patient uses a medication or medical device. Healthcare providers, consumers, and manufacturers report these events to monitor safety. The data helps regulators identify potential risks, take appropriate actions, and ensure that medications and devices remain safe for public use. AERS plays a crucial role in ongoing safety surveillance and improving risk management in healthcare.