MedWatch Form 3500 is for reporting adverse reactions to?

MedWatch Form 3500 is specifically designed for healthcare professionals and consumers to report adverse events, including serious side effects and medication errors associated with drug products. By allowing the reporting of these adverse reactions, the form helps the Food and Drug Administration (FDA) monitor the safety and efficacy of medications on the market. This reporting system is crucial because it collects important real-world information that can lead to better risk management and ensures that medications remain safe for public use.

While vaccines are reported through a different system (the Vaccine Adverse Event Reporting System or VAERS), and veterinary products or agricultural products have their own channels for adverse event reporting, Form 3500 is focused solely on human drug products, making it the proper choice for reporting adverse reactions to drugs.