MedWatch Online Voluntary Reporting Form

Welcome

Health professionals, consumers and patients can voluntarily report observed or suspected adverse events for human medical products to FDA. Voluntary reporting can help FDA identify unknown risk for approved medical products. Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (Health Professional) or 3500B (Consumer/Patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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.

Note that submissions for these products through MedWatch will be accepted and directed to the correct center or office.

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