Is it safe to use compounded semaglutide?

Medically reviewed by Dr. Jamie Winn
Jul 11, 2023

Compounded medications are custom-made drugs that are tailored to individual patients. Specialized compounding pharmacies can make alternative versions of the drug the patient needs. This can be useful if the patient is allergic to certain dyes present in the original formulation or if they need a liquid version of a pill or capsule. They are often prescribed when there are drug shortages of popular medications. In the case of semaglutide, the off-label use of Ozempic as a weight-loss drug and the popularity of Wegovy in the treatment of obesity has put them both on the FDA’s drug shortages list. Compounding pharmacies jumped at the chance to help fill the need for these medications. However, these compounded forms of semaglutide are not FDA-approved drugs and are not considered safe and effective. This led to the FDA issuing a warning for people to avoid compound semaglutide products due to these concerns.

What is semaglutide used for?

Semaglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist and is the active ingredient in 3 different medications: Rybelsus, Ozempic, and Wegovy. All three brand-name medications are manufactured by Novo Nordisk and there are no approved generic versions. Other GLP-1 agonists include Mounjaro (tirzepatide), Saxenda (liraglutide), Victoza (liraglutide), and Trulicity (dulaglutide).

Ozempic is an injectable medication that was approved by the U.S. Food and Drug Administration (FDA) to lower blood sugar levels in adults with type 2 diabetes (T2DM). It is also approved to lower the risk of major cardiovascular events such as heart attack and stroke in adults with T2DM and heart disease.

Rybelsus is a tablet and is the only GLP-1 agonist that can be taken orally. It is approved as a type 2 diabetes drug that helps improve blood glucose control in adults.

Wegovy is an injectable medication that is approved for chronic weight management in adults and certain pediatric patients 12 years of age and older.

All 3 medications should be taken along with a healthy diet and exercise.

What are some possible side effects of compounded semaglutide?

The side effects you may experience will depend on several factors such as the condition being treated and the dose prescribed by your healthcare provider. Some possible side effects of compounded semaglutide include:

Nausea, vomiting, diarrhea
Stomach pain
Constipation
Injection site reactions

Rarely, compounded semaglutide may cause some more serious adverse events such as:

Serious, life-threatening allergic reactions
Increased risk of certain thyroid tumors
Inflammation of the pancreas (pancreatitis)
Vision changes
Low blood sugar (hypoglycemia), especially if it is used with insulin or an insulin secretagogue
Kidney damage
Gallbladder problems including gallstones
Increased risk of suicidal thoughts and behaviors

What does the FDA say about compounded semaglutide?

Compounded drugs are not FDA-approved, and the FDA does not verify the quality, effectiveness, or safety of these drugs. However, when there is a drug shortage, certain pharmacies can make a compounded form of that medication if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act.

The FDA has received reports of adverse events after the use of compounded semaglutide. There are also reports that some compounding pharmacies may be using salt forms of semaglutide, such as semaglutide sodium and semaglutide acetate, which are different active ingredients from those in FDA-approved semaglutide products. These salt forms have not undergone clinical trials so it is not known if it is safe and effective to use.

The only manufacturer of semaglutide products, Novo Nordisk, stated that they do not provide the ingredient to these compounding pharmacies. So it is not known where they are getting it from and whether it is semaglutide at all.

Novo Nordisk has also stated they have begun legal proceedings against some medical spas, compounding pharmacies, and weight loss clinics in the US to stop the sales of “non-FDA approved compounded products claiming to contain semaglutide”.

Should I use compounded semaglutide?

While cheaper prices and shortages of Ozempic and Wegovy make it tempting to use a compounded version of semaglutide, there are too many concerns to say it is a good idea. We do not know exactly where they are getting the ingredients to make these products and they have not been tested and proven to be safe and effective. There are also alternative medications that could be used for type 2 diabetes and weight loss. Talk with your doctor or pharmacist about other medications you can take if you cannot find Ozempic or Wegovy.

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