MedWatch Online Voluntary Reporting Form
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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.
While not mandatory, FDA encourages reporters to provide their contact information in case FDA needs to gather more information. Note that reporters can request, within the report, FDA not release their contact information to the manufacturer.
Begin Online Report
(FDA Form 3500B) En español para el consumidor / paciente (formulario 3500B de la FDA)
Click here to continue filling out an incomplete report. You will need Report ID and Report Date. You will have 3 days to complete this report from the start date.
MedWatch Online allows reporters to start a report and complete it within 3 days. Reporters can save an incomplete report and provide an email address to receive instructions on how to complete & submit a report with Report ID and Report Date.
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.