MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human drug products marketed without an approved application.
https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program