How to report an Adverse Drug Reaction If you think you or someone in your family has experienced a serious reaction to a FDA-regulated medical product, report it to the FDA immediately. Contact the FDA's MedWatch program by phone, mail or via the internet www.fda.gov. MedWatch is the FDA's program for reporting serious reactions and problems with medical products, such as drugs and medical devices. The toll-free number is 888-463-6332, or call the FDA Office of Emergency Operations at 301-443-1240.