Compounded Mounjaro: Is it safe?

In this article:

• What is compounded tirzepatide?
• Compounded tirzepatide vs. Mounjaro
• Risks of compounded tirzepatide
• Does insurance cover compounded tirzepatide?

In this article

• What is compounded tirzepatide?
• Compounded tirzepatide vs. Mounjaro
• Risks of compounded tirzepatide
• Does insurance cover compounded tirzepatide?

Mounjaro is a weekly injectable medicine that contains the active ingredient tirzepatide. It was approved by the Food and Drug Administration (FDA) in 2022 to help control blood sugar levels in adults with Type 2 diabetes, but healthcare providers often prescribe this medicine off-label (for a non-FDA-approved use) for weight loss in people with obesity (or overweight with certain medical conditions). With the exploding popularity of Mounjaro and Zepbound, you may have seen advertisements for affordable compounded versions of the drug—maybe even without a prescription. You may have also seen ads for compounded versions of GLP-1 receptor agonists Ozempic and Wegovy.

But are these products safe? The short answer is that compounded Mounjaro—more specifically, compounded tirzepatide—comes with risks, as it is not an FDA-approved drug and has not been tested for safety. Keep reading to learn more about compounded tirzepatide. 

What is compounded tirzepatide?

According to the FDA, compounded medications are made by a pharmacist or healthcare provider in pharmacies or outsourcing facilities. An ingredient may be combined, mixed, or altered in order to make a drug specifically tailored to an individual patient. In the case of compounded tirzepatide, compounding facilities may add other ingredients, such as vitamin B-12, to the product. Compounded tirzepatide may be provided to the patient in various forms, such as oral or injectable (more on that below). 

But, why would compounded tirzepatide need to be made if FDA-approved drugs like Mounjaro (or Zepbound, an FDA-approved weight-loss drug that also contains tirzepatide) are already available? The answer is that the FDA allows compounded drugs to be made when there is a shortage. When Mounjaro was first approved by the FDA, supply issues made it difficult for people to find the medicine at pharmacies. Although the FDA announced in October 2024 that the short supply issue was resolved, a pending lawsuit has prompted the FDA to reevaluate the shortage status. This means that compounding facilities can continue to make compounded tirzepatide and similar drugs, for now. 

Compounded tirzepatide vs. Mounjaro

FDA-approved drugs like Mounjaro must undergo extensive testing in clinical trials for safety, efficacy, and quality before they are approved. Compounded drugs, such as compounded tirzepatide, do not have to go through this testing and are not FDA approved. Some of the differences between compounded tirzepatide and Mounjaro include: 

• Ingredients: The active ingredient in Mounjaro is tirzepatide. In contrast, compounded tirzepatide may contain additional ingredients, such as certain vitamins or other ingredients that are not found in Mounjaro. There is no research on the safety and efficacy of compounded tirzepatide—either alone or in combination with those other ingredients. 
• Dosage forms: According to the prescribing information, Mounjaro is available as single-use pens in the following dosages: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg. Each pen is for one use only, and when you receive your prescription, you will get a box of four single-use pens, which will last 28 days. Or, if you receive a three-month supply, you will receive three boxes of four pens (12 pens total), which will last 84 days. The pens are prefilled with your prescribed dosage of Mounjaro. On the other hand, with compounded tirzepatide, various products are available, depending on the compounding facility. For example, you may receive injectable products, which may come in a prefilled syringe loaded with the correct dose, or you may receive a vial that contains multiple doses that you may need to draw up with a syringe each week. There are also oral forms of compounded tirzepatide, such as orally disintegrating tablets (tablets that dissolve in the mouth) and liquid drops. Again, none of the compounded tirzepatide products are approved by the FDA like Mounjaro is. 
• Insurance coverage and cost: Insurance coverage for Mounjaro varies by plan. You can visit the Eli Lilly and Company website to learn more about insurance coverage, as well as other ways to save. You can also contact your insurance provider directly to inquire about Mounjaro coverage and out-of-pocket costs. On the other hand, compounded tirzepatide is not typically covered by insurance plans since it is not an FDA-approved drug.
• Clinical trials: As mentioned above, Mounjaro has been extensively tested for safety, quality, and efficacy. On the other hand, compounded tirzepatide is not required to undergo this type of testing. So, if you purchase compounded tirzepatide, know that it has not been tested in clinical trials to evaluate its safety, quality, and effectiveness. 

Risks of compounded tirzepatide

Although any drug comes with possible risks, there are additional risks that are associated with using compounded tirzepatide, such as dosing errors and contamination. You can discuss your concerns with your healthcare provider. 

Dosing errors

With compounded tirzepatide, dosing errors can occur due to confusion over measuring the correct dose or even using the wrong syringe. Dosing errors are associated with more serious side effects—and these side effects can last up to several weeks since tirzepatide stays in the body for a long time. In some cases, patients had side effects that required medical attention or had to go to the hospital. This issue has even prompted some countries, like Australia, to ban compounded tirzepatide. Adverse effects have included nausea, vomiting, stomach pain, fainting, headache, dehydration, gallstones, and inflammation of the pancreas. Dosing errors have also occurred in patients using compounded semaglutide, which many companies sell as an alternative to the FDA-approved GLP-1 diabetes and weight loss medications Ozempic or Wegovy (both of which are made by the pharmaceutical company Novo Nordisk). 

Contamination and other safety issues

With compounded tirzepatide, there is a risk of contamination and a lack of sterility, which can lead to serious health problems. For example, the FDA has reported that one company was using non-sterile products, which resulted in contamination of their compounded drugs. Using a non-sterile injectable drug can lead to serious health complications, including infections and potentially life-threatening sepsis. Eli Lilly, the manufacturer of Mounjaro and Zepbound, has reported instances where bacteria or high levels of impurities were found in compounded tirzepatide. Also, some compounded products have contained the wrong active ingredient, and in at least one case, the compounded product did not contain any active ingredient at all.

Illegal sales

The FDA has found illegally marketed tirzepatide that may be counterfeit, contain harmful or incorrect ingredients, or have the wrong amount of the active ingredient (or none at all). The agency has issued warnings to compounding facilities selling drugs labeled “for research purposes” or “not for human consumption.” Despite these warnings, some of these products have been sold directly to consumers for use in humans. The FDA advises against using these products due to potential harm.

False claims and lack of prescription needed

Some companies that sell compounded tirzepatide issue false claims that their products are FDA-approved—or equivalent to FDA-approved medications like Zepbound or Mounjaro. These claims are untrue, as the only FDA-approved tirzepatide products are the brand-name drugs made by Eli Lilly: Mounjaro and Zepbound. There are no generics of these drugs at this time. Also, in some cases, compounded tirzepatide has been marketed without the need for a prescription from a licensed healthcare provider. This is risky, as compounded drugs, like all drugs, should only be used under the supervision of a healthcare professional.

Does insurance cover compounded tirzepatide?

In many cases, insurance plans do not cover compounded tirzepatide. This is because the compounded product is not approved by the FDA, so its safety and efficacy have not been proven. 

Even if your insurance does provide some coverage for compounded tirzepatide, it is important to understand the health risks of using this product. Unlike FDA-approved medicines like Mounjaro or Zepbound, compounded tirzepatide is not required to undergo rigorous testing for safety, quality, and efficacy. These risks may outweigh any cost savings. 

Bottom line

While Mounjaro is an FDA-approved drug that has been extensively tested in clinical trials, compounded tirzepatide products have not been tested and are not FDA-approved. These products are not exactly the same as Mounjaro and are associated with certain risks. If you’re still considering compounded tirzepatide despite its potential risks, ask your healthcare provider if they work with a trusted, preferred compounding pharmacy. If you use an online pharmacy, check with the FDA for more information. You should always avoid online pharmacies that are not licensed or reputable—as well as those that advertise compounded tirzepatide without a prescription—as these factors greatly increase the risk of unsafe or counterfeit medications.