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Drug vs. Drug

Is compounded semaglutide the same as Ozempic?

Compounded semaglutide may be easy to get online, but the FDA has issued several warnings about it
Karen Berger medical writer and reviewer headshot
By | Dec. 12, 2024
Two semaglutide autoinjectors next to each other: Is compounded semaglutide the same as Ozempic?

Key takeaways

  • Ozempic is an FDA approved drug that contains the active ingredient semaglutide. Compounded semaglutide, which is made specifically for each patient, is not FDA approved and has not undergone the same testing as Ozempic.

  • The active ingredient in Ozempic is semaglutide in its base form. Compounded semaglutide may include additional ingredients (such as vitamins) or different salt forms of semaglutide, which the FDA does not approve for compounding.

  • Some risks of compounded semaglutide include dosing errors (which can lead to serious side effects), contamination, and illegal sales of counterfeit products, which could be harmful.

  • If you are considering a compounded semaglutide product, consult a healthcare provider and only use a pharmacy they work with and trust.

In this article:

Ozempic (semaglutide) is a brand-name, once-weekly injectable prescription medication that’s used to help control blood sugar levels in adults with Type 2 diabetes, as well as to lower the risk of major adverse cardiovascular events (such as heart attack and stroke) in adults with both Type 2 diabetes and heart disease. Ozempic is also sometimes prescribed off-label (for a non-FDA-approved use) as a weight loss drug. With the popularity of glucagon-like peptide 1 receptor agonists (GLP-1 agonists) like Ozempic, you may have seen advertisements for compounded semaglutide. Although compounded semaglutide may be similar to Ozempic, it has not been tested for safety and efficacy in clinical trials and is not exactly the same. Continue reading to learn more about compounded semaglutide and how it compares to Ozempic. 

An overview of semaglutide

Novo Nordisk, the pharmaceutical company that manufactures FDA-approved semaglutide products, currently manufactures three medicines that contain semaglutide. They include the weekly injectable drugs Ozempic and Wegovy and the once-daily oral medicine Rybelsus. Wegovy is FDA-approved for weight loss and cardiovascular risk reduction, while Rybelsus, like Ozempic, is approved for Type 2 diabetes. There are no FDA-approved generic versions of these three drugs, and there are no other FDA-approved semaglutide products.

What is compounded semaglutide

According to the Food and Drug Administration (FDA), a compounded drug is a medication customized for an individual patient’s specific needs. For example, if a patient is prescribed a drug that’s available in capsule form only, a compounding pharmacy may make that patient a liquid form of a drug. A compounded drug needs to be prepared by a licensed pharmacist (or under the supervision of a pharmacist) in a compounding pharmacy or facility. 

Usually, if a drug is commercially available in pharmacies, pharmacies are not allowed to compound the drug. However, the FDA notes that when there is a shortage of a particular drug, compounding may be permitted to ensure the patient has access to treatment. This is the case with semaglutide.

RELATED: Ozempic shortage

Although compounding is perfectly legal, it is important to note that compounded drugs are not FDA approved, which means they have not been tested for safety, effectiveness, or quality control. That includes compounded semaglutide.

Compounded semaglutide vs. Ozempic 

While both medicines contain semaglutide, they are not exactly the same. Let’s review some of the similarities and differences between compounded semaglutide and Ozempic. 

Ingredients

The active ingredient in Ozempic is semaglutide, also known as semaglutide base. On the other hand, compounded semaglutide may contain additional ingredients such as vitamin B-12, vitamin B-6, L-carnitine, and others. There is no data on the safety and efficacy of semaglutide in combination with these other ingredients. The FDA also notes that some compounding facilities use different salt forms of semaglutide (such as semaglutide sodium or semaglutide acetate) rather than semaglutide base. These salt forms are not exactly the same as the active ingredient in Ozempic and are not FDA approved for use in compounding.

Forms and dosage

According to its prescribing information, Ozempic is available in the following dosages:

  • 2 mg per pen (with this pen, you can use a 0.25 mg or 0.5 mg dose)
  • 4 mg per pen (1 mg per dose)
  • 8 mg per pen (2 mg per dose)

When you take Ozempic, you dial up the appropriate dose on the pen and inject it with a new needle once a week.

With compounded semaglutide, various products are available, depending on the supplier. These options may include injectable products and noninjectable products, such as orally disintegrating tablets (tablets that dissolve in the mouth), sublingual tablets (tablets placed under the tongue to dissolve), or oral drops. For injected compounded semaglutide products, some suppliers may provide prefilled syringes, while others offer vials that contain multiple doses, requiring you to draw up each dose with a syringe. 

Safety and efficacy

Ozempic has been tested in various clinical trials for safety and efficacy. In these trials, researchers find out important information such as side effects and how well the drug works. Compounded semaglutide products are not required to go through the same type of testing, so they are not evaluated for safety, effectiveness, or quality, in the same ways that FDA-approved drugs like Ozempic are. 

RELATED: Is compounded semaglutide safe?

Insurance coverage and cost

Insurance coverage for Ozempic varies. Some plans may cover Ozempic for diabetes but not for weight loss, while others will cover Ozempic for any reason. Based on your plan, Ozempic may require prior authorization, which means the healthcare provider will need to tell the insurance company why you need this medicine before the insurance company decides to pay for it. You can visit the Novo Nordisk website to find out more about insurance coverage and other ways to save on Ozempic. You can also contact your plan directly for up-to-date coverage and cost information.

On the other hand, compounded semaglutide is generally not covered by insurance.

What are the risks of compounded semaglutide?

If you’re strongly considering compounded semaglutide, it is important to discuss your decision with your healthcare provider, who can help you determine whether it is safe for you. Taking compounded semaglutide poses multiple risks, including the following: 

  • Dosing errors: Some compounded versions of semaglutide require you to measure and self-administer the doses yourself, leading to dosing errors and accidental overdose. Dosing errors can also lead to more severe side effects, which can last up to a few weeks, as semaglutide stays in the body for a long time. In some cases, patients needed medical attention or had to go to the hospital. Reports of adverse effects have included nausea, vomiting, stomach pain, fainting, headache, dehydration, gallstones, and inflammation of the pancreas. Dosing errors have also been found with compounded tirzepatide, which many companies offer as an alternative to Mounjaro or Zepbound. 
  • Illegal sales: The FDA has found illegally marketed semaglutide that may be counterfeit, contain incorrect or harmful ingredients, or have too little, too much, or even none of the active ingredient at all. The FDA has issued warnings to companies that have illegally sold drugs labeled “for research purposes” or “not for human consumption.” Some of these products have been sold directly to consumers for human use, even though they were specifically labeled not to be used in humans. The FDA warns these products can be harmful and should not be used.
  • Contamination: One company was found to use nonsterile products, resulting in contamination of the medicine. Injecting a nonsterile medication could result in serious complications like infections and sepsis. Additionally, Novo Nordisk has reported cases where impurities have been found in compounded semaglutide products—with one product tested found to have more than 24% impurities. 
  • False claims and lack of prescription needed: Some companies make false claims that their compounded semaglutide products are FDA approved or equivalent to FDA-approved medicines. Additionally, compounded semaglutide has been marketed without requiring a prescription from a healthcare provider. This can be dangerous, as compounded medicines, like all medicines, should only be used under the supervision of a licensed healthcare provider.

Bottom line

The FDA strongly recommends using an FDA-approved semaglutide drug like Ozempic when it is available instead of compounded semaglutide. Compounded products are associated with significant risks and are not FDA approved. If you are considering using compounded semaglutide, consult with a licensed healthcare provider. They can guide you on the safest course of action, which often includes using FDA-approved treatments. 

If you choose to use compounded semaglutide, ask your healthcare provider if they have a trusted, preferred pharmacy they work with on a regular basis. The FDA has a resource you can use to identify safe online pharmacies and report those that are unsafe. Always avoid online pharmacies or ads that are not licensed or reputable—and those that advertise compounded semaglutide without a prescription—as these factors increase the risk of counterfeit or unsafe medications.

Consult your healthcare provider for more information and medical advice about Ozempic or compounded semaglutide.