Reporting drug, device problems to the FDA
If you have had a problem taking a medication, or a medical device has caused you harm, tell the FDA about it. The more information the FDA has about so-called adverse reactions the better. This information can be used to make new drugs and devices safer, and to caution other folks about using certain drugs or devices.
MedWatch is a vehicle for reporting serious adverse events arising from the use of an FDA-regulated drug, a biologic product (something made from human cells or tissues, and cellular and tissue-based products), a medical device (pacemaker, etc.), or a special nutritional product or cosmetics. You can submit a MedWatch form online, or call (toll free) 800-332-1088.