How to Report Side Effects to FDA (MedWatch)

What you can report

MedWatch takes reports of serious reactions, product quality problems and product use errors with drugs and other medical products¹. The consumer form, Form FDA 3500B, lists four reasons to use it³:

• a bad side effect, including new or worse symptoms
• using a product the wrong way, in a way that could have led to a problem
• a problem with the quality of a product
• problems after switching from one maker to another

Compounded products count. The form has a box for a compounded product, and FDA asks patients to report problems with compounded GLP-1 drugs^3,4. For what FDA has posted on those products, see the dated list of FDA alerts.

Three ways to send it

• Online. The MedWatch online form is open to patients and consumers. FDA calls it the quickest route^1,2.
• Fax. Download the form, fill it in, and fax it to 1-800-FDA-0178^2,4.
• Phone. Call 1-800-FDA-1088, the toll-free line printed on the form as 1-800-332-1088^2,3.

What the form asks for

Fill in as much as you can. Send the report even if some parts are blank³. The form asks for³:

• product name, as printed on the box, bottle or package
• who makes or compounds it, and whether it is compounded
• lot number, expiration date and strength from the label
• how much you used, how often, and how (for example, by injection)
• when you started, and when you stopped or cut back
• what happened, and on what date

Photos of all sides of the product help FDA review the report³. Keep the product, but do not send it to FDA³.

Who sees your report

FDA enters each report in a database. An FDA evaluator, often a pharmacist, doctor or nurse, compares it with similar reports². Your name and contact details may go to the product's maker unless you ask otherwise on the form³. FDA contacts you only if it needs more information³.

Your clinician can help

FDA encourages you to take the form to your doctor, who can add details from your medical record¹. Your provider does not have to report, and you can file it yourself¹. MedWatch does not give medical advice, so contact your clinician first about a symptom that worries you².

Pull the details from your log

A dated log makes the "what happened and when" part faster. The side effect log keeps your notes with dates, and the peptide tracker keeps each shot, vial and site. Open the tracker (free, no account) to start one.