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MedWatch Form FDA 3500: Health Professional Reporting

FDA's MedWatch program uses Form FDA 3500 for voluntary reports from health professionals about adverse events, product quality problems and product use or medication errors. A clinician meets it after a serious reaction or problem involving a drug, biologic, device, cosmetic or other FDA-regulated product. The form states that a report does not admit that the clinician or the product caused the event.

Who completes it

The physician, pharmacist, nurse or other health professional completes sections A through G, filling in only those that apply. Section E is for medical devices and section D for all other products.

Submitting and payment

How to submit it
Submit through MedWatch Online, FDA's preferred route, or complete the PDF and send it to the MedWatch Program by fax or mail; reports can also be made by phone.
Who pays
FDA lists no fee or payment for voluntary MedWatch reports.

Good to know

  • Report even if you are not certain the product caused the event or you lack some details. FDA asks especially for serious events such as death, hospitalization or disability.
  • Use a separate form for each patient. The event description allows up to 4,000 characters, and photos of the product help FDA's review.
  • Do not send the product to FDA. Section C asks whether it is available for evaluation or was returned to the manufacturer.
  • The patient's identity is held in strict confidence, but the reporter's identity may be shared with the manufacturer unless you check the box in section G.

Get the official form

Download the current version from the source each time; forms change without notice.

MedWatch Form FDA 3500 - Voluntary Reporting (for use by health professionals)

Official pagePDF

How this list is checked

A form is listed only after its name and number were confirmed on the issuing agency’s or insurer’s own website, or in the form itself. Each entry links to that source. The list was last checked in October 2026. Forms and their requirements change without notice, so check the official page for the current version before you complete one.

Vero is not affiliated with, or endorsed by, the agencies and insurers listed here. Read our editorial policy.

Frequently asked questions

What is the difference between FDA 3500, 3500A and 3500B?

Form 3500 is for voluntary reports by health professionals. Form 3500A is for mandatory reports by manufacturers, user facilities and IND researchers when electronic submission is not required. Form 3500B is a consumer-friendly version for patients, and it is the version FDA offers in Spanish.

Should vaccine reactions be reported on Form FDA 3500?

No. FDA directs vaccine adverse events to VAERS. Tobacco and vaping products go to the Safety Reporting Portal, and animal drugs and pet food to the Center for Veterinary Medicine. Nirsevimab given alone, without vaccines, is reported through MedWatch.

Is my name shared when I file a MedWatch report?

Possibly. FDA holds the patient's identity in strict confidence, but the reporter's identity, including a self-reporter's, may be shared with the manufacturer unless you ask otherwise. Section G has a box to mark if you do not want your identity disclosed to the manufacturer. The current edition is dated 09/2025.