Reporting Adverse Events for Peptide Products

Urgent first

If you or someone else is having a severe reaction, get care before reporting anything. In the US call 911, and for poisoning or overdose questions call Poison Help at 1-800-222-1222. [1][2] See When to Seek Urgent Help After Peptides. Reporting is for afterward and is not medical care.

What an adverse event report is

An adverse event report tells a regulator that a product was followed by a harmful or unexpected problem, or that the product itself seems wrong. A single report does not prove the product caused the problem. FDA made this point itself when it described reports about compounded semaglutide: it said it could not always tell whether a product directly caused an event or whether other factors contributed. [3]

The United States route: FDA MedWatch

MedWatch is the FDA's safety reporting program for health professionals, patients and consumers. [4] It takes reports on prescription and over-the-counter medicines, including those given in a hospital or infusion center. [4] The page lists the products FDA regulates as including biologics, cosmetics, dietary supplements, drugs and medical devices. [4]

For GLP-1 medicines, FDA invites health care professionals, patients and compounders to report adverse events or quality problems to MedWatch, and gives two routes: complete the report online, or download the form and fax it to 1-800-FDA-0178. [3]

You can also contact the drug company or the pharmacy that supplied the product. Those routes are separate from FDA and are not verified here.

Which problems are worth reporting

Based on what FDA says it has received for GLP-1 products, these are the kinds of events that matter:

• Serious reactions and events that needed hospital care, such as those FDA linked to dosing errors with compounded semaglutide. [3]
• Injection-site reactions, such as redness, swelling, pain and a red lump. [3]
• Quality problems, including suspected counterfeit products, which FDA says may contain wrong, too little, too much or no active ingredient. [3]

Products sold as research chemicals or unapproved peptides

Many peptide compounds have no approved label. For BPC-157 the FDA says its review found no, or only limited, safety-related information for the proposed routes, and that compounded products raise questions about immunogenicity and peptide-related impurities. [5] That is a strong reason to report a problem and to tell your clinician exactly what was used. FDA's MedWatch page does not say here which unapproved product types it can act on, so we do not promise a response.

Other countries

We did not verify national reporting systems for this page. If you live outside the United States, look for your national medicines regulator's own "report a side effect" page, or ask a pharmacist. For general principles see Side Effects, Allergic Reactions & Reporting and Reporting Adverse Events From Therapies and Practitioners.

Keep for your own records

General good practice, not an FDA instruction: keep the product box or vial, any receipt or message, the date and time, and notes about symptoms, so you can describe them to a clinician. Do not try to test the product at home; a home check cannot show that an injectable product is safe.

Related reading

Peptide Safety: Adverse Events, Contamination and Injection Risks, Compounded and Unapproved GLP-1 Products.