The FDA MedWatch Program

MedWatch is the Food and Drug Administration’s (FDA) medical product safety program that monitors the safety of drugs, biologics, medical devices, and other regulated products.

Both patients and providers can report adverse reactions to prescription medications, over-the-counter medicines, or medical devices directly to the FDA. This reporting helps identify and address unknown risks associated with FDA-approved medical products.

Reporting can be done through the FDA MedWatch online reporting portal, or by downloading, completing, and submitting the voluntary reporting form. Separate forms are available for providers and patients. 

Information you or your patients should report to MedWatch include:

• Unexpected side effects or adverse events: This can include anything from skin rashes to more serious side effects
• Product quality problems: If the product is defective or doesn’t work properly
• Preventable product use/medication errors: Report instances where product design or labeling could lead to errors, such as look-alike/sound-alike drug names or similar packaging
• Therapeutic failures: These can occur when a medical product doesn’t work as well when you switch from one generic to another

Please note: Patients should not use MedWatch to report problems with vaccines. Those should be reported to the Vaccine Adverse Event Reporting System (VAERS).

For more information, please visit fda.gov/medwatch. A link to the online reporting form is provided below.

MedWatch Online Voluntary Reporting Form