MedWatch Online Voluntary Reporting Form

Information You Should Report to MedWatch

• Unexpected side effects or adverse events can include everything from skin rashes to more serious complications.
• Product quality problems such as information if a product isn't working properly or if it has a defect.
• Product Use/Medication Errors that can be prevented. These can be caused by various issues, including choosing the wrong product because of labels or packaging that look alike or have similar brand or generic names. Mistakes also can be caused by difficulty with a device due to hard-to-read controls or displays, which may cause you to record a test result that is not correct.
• Therapeutic failures. These problems can include when a medical product does not seem to work as well when you switch from one generic to another.

Types of FDA Regulated Products You Can Report Through MedWatch

• Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.
• Biologics such as blood components, blood/plasma derivatives, blood transfusions, gene therapies, and human cells and tissue transplants.
• Medical devices such as diabetes glucose-test kit, hearing aids, breast pumps, and many more products.
• Combination products such as prefilled drug syringe, auto-injectors, metered-dose inhalers, contact lens coated with a drug and nasal-spray.
• Special nutritional products such as dietary supplements, medical foods and infant formulas.
• Cosmetics such as moisturizers, makeup, shampoos, conditioners, hair dyes and tattoos.
• Food such as beverages and ingredients added to foods.

Where to Report Other FDA Regulated Product Safety Information

Other products that the FDA regulates such as Tobacco Products, Vaccines and Animal/Livestock medicine and feed utilize different reporting pathways. It is recommended that reports concerning these products be submitted directly to the appropriate portals below.

• Tobacco, E-cigarettes or Vaping: Report problems or adverse health events and tobacco product problems, include problems with e-cigarettes (also known as "vapes"), e-liquids, heated tobacco products, cigarettes, roll-your-own cigarettes, cigars, little cigars, pipes, waterpipes (also known as hookah), chewing tobacco, snuff, or snus. Report issues to the Safety Reporting Portal.
• Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html.
• Animal Drug, Device, Pet Food and Livestock Feed Problems (pet food and livestock feed): For information on how to report visit www.fda.gov/vetproductreporting.