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Drug vs. Drug

Zepbound vs. compounded tirzepatide

Although compounded tirzepatide may seem cheap, it isn’t FDA approved and can even be dangerous
Karen Berger medical writer and reviewer headshot
By | Feb. 13, 2025
Two semaglutide pens next to each other: Zepbound vs. compounded tirzepatide

Key takeaways

  • Zepbound is an FDA-approved brand-name prescription weight-loss drug. It is made by the pharmaceutical company Eli Lilly and Company and contains the active ingredient tirzepatide.

  • Compounded tirzepatide products are popular but are not tested or approved by the FDA. Certain compounded products may have significant risks, such as dosing errors and contamination. 

  • Due to the potential risks associated with using compounded tirzepatide, the FDA advises that consumers use FDA-approved products like Zepbound or Mounjaro when possible. 

  • Always consult your healthcare provider for information and personalized medical advice on your condition and treatment options.

In this article:

Zepbound (tirzepatide) is a popularly prescribed weekly weight-loss injection. It is classified as a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, or GIP/GLP-1 agonist. Zepbound, a brand-name drug, works by acting like natural hormones that regulate appetite and food intake, helping decrease “food noise,” or persistent thoughts about food that can often derail even the best weight loss efforts. 

Weight-loss drugs like Zepbound are all the rage right now—and at times, the demand can exceed the supply. When this happens, compounding pharmacies (such as those that work with telehealth companies) are able to make formulations of a drug that is not readily available. Although compounded versions of tirzepatide, the active ingredient in Zepbound, are becoming popular online, the two drugs are not exactly the same. 

What is compounded tirzepatide?

Eli Lilly and Company, the pharmaceutical company that manufactures FDA-approved tirzepatide products, currently makes two medicines that contain tirzepatide. They include the weekly injectable drugs Zepbound (FDA approved for weight loss and sleep apnea) and Mounjaro (FDA approved for improving blood sugar levels in people with Type 2 diabetes, but often prescribed off-label for weight loss). There are no FDA-approved generic versions of these two drugs, and there are no other FDA-approved tirzepatide products.

So, what is compounded tirzepatide, and how is it different from Zepbound? Compounding is when a pharmacist or other healthcare provider creates a medicine that is specifically tailored to the needs of an individual patient. During compounding, ingredients may be combined, mixed, or altered. 

According to the FDA, a drug may be compounded for a patient who cannot receive treatment with an FDA-approved drug. For example, someone who has an allergy to an ingredient in a medicine may have a drug compounded that does not contain that particular ingredient. Or, someone who cannot swallow a pill may have a liquid version of medicine compounded. Another common reason that someone might need a compounded drug is when there is a short supply of a drug that they can’t get from their pharmacy. 

There have been periodic shortages on Zepbound since 2022. As of Dec. 19, 2024, the FDA determined that the tirzepatide shortage has been resolved. Compounding pharmacies will be allowed to continue to compound tirzepatide for now, but it remains to be seen how long they will be able to do so and if they will be able to continue to do so by adding additional ingredients to differentiate their product from the non-compounded, non-approved version.

Are compounded drugs approved by the FDA?

Zepbound (like all FDA-approved drugs) has been extensively studied in clinical trials for safety, quality, and effectiveness. However, compounded medications—such as compounded tirzepatide—are not FDA approved. While the FDA regulates all prescription and over-the-counter drugs, they do not regulate or approve drugs made in compounding pharmacies. Because compounded drugs are not approved by the FDA, this means that the FDA has not confirmed the safety, effectiveness, and quality of these products. 

Compounded tirzepatide vs. Zepbound for weight loss

While compounded tirzepatide may be very similar to Zepbound, it is not FDA approved and is not exactly the same. Let’s look at some of the main differences. 

Ingredients

The active ingredient in Zepbound is tirzepatide. On the other hand, compounded tirzepatide may contain additional ingredients such as vitamin B-12, vitamin B-6, L-carnitine, and others—that are not found in Zepbound. There is no data on the safety and efficacy of compounded tirzepatide alone or in combination with these other ingredients. 

Dosage and forms

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

  • 2.5 mg per single-use pen 
  • 5 mg per single-use pen
  • 7.5 mg per single-use pen
  • 10 mg per single-use pen
  • 12.5 mg per single-use pen
  • 15 mg per single-use pen

Each Zepbound pen is for single use. When you receive your prescription, you will get a box containing four single-use pens, which will last for about one month (28 days). If you are prescribed a three-month supply, you will receive three boxes, each containing four pens, which will last 84 days. 

With compounded tirzepatide, various products are available, depending on the supplier. These options may include injectable products and non-injectable products, such as orally disintegrating tablets (tablets that dissolve in the mouth) or liquid drops. For injected compounded tirzepatide products, some suppliers may provide prefilled syringes that come measured with your required dose, while others offer vials that contain multiple doses, requiring you to draw up your weekly dose with a syringe. 

Safety and efficacy

Zepbound has been extensively tested in various clinical trials for safety, quality, and efficacy. In these trials, researchers learn important information, such as adverse effects and how well the drug works. Compounded tirzepatide products are not required to undergo the same type of testing, meaning they are not evaluated for safety, effectiveness, or quality in the same way as an FDA-approved drug like Zepbound is. 

Insurance coverage and cost

Insurance coverage for Zepbound varies. Some plans may cover Zepbound, while others may require prior authorization or not cover weight-loss drugs at all. You can visit the Eli Lilly website to find out more about insurance coverage. There are also other ways to save. You can also contact your plan directly for up-to-date coverage and cost information. On the other hand, compounded tirzepatide is generally not covered by insurance plans, as it is not an FDA-approved drug.

Is compounded tirzepatide safe?

You may be considering compounded tirzepatide, but it is important to note that, because these products are not approved by the FDA, they are not guaranteed to be as safe as a tirzepatide product that is FDA approved, like Zepbound or Mounjaro. Here are some of the potential risks of compounded tirzepatide: 

  • Dosing errors: These can occur due to confusion over measuring the correct dose or using the wrong syringe. Dosing errors have also been associated with more severe side effects, which can last up to a few weeks, as tirzepatide stays in the body for a long time. In some cases, patients needed medical care or had to go to the hospital because of the side effects from dosing errors (which has prompted some countries, like Australia, to ban compounded tirzepatide). Reports of adverse effects have included nausea, vomiting, stomach pain, fainting, headache, dehydration, gallstones, and inflammation of the pancreas. Dosing errors have also occurred with compounded semaglutide, which many companies offer as an alternative to the GLP-1 medications Ozempic or Wegovy (these brand-name drugs are made by Novo Nordisk). 
  • Contamination and other safety concerns: The FDA has reported that one company was using non-sterile products, resulting in contamination of their compounded products. Injecting a non-sterile drug into your body could result in serious complications like infections and sepsis. Additionally, Eli Lilly has reported cases where bacteria or high levels of impurities have been found in compounded tirzepatide products. What’s more, some compounded products have contained the wrong active ingredient, and in at least one case, the compounded product did not contain any medicine at all.
  • Illegal sales: The FDA has reported finding illegally marketed tirzepatide 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 patients for human use, regardless of being specifically labeled not to be used in humans. The FDA warns consumers that these products can be harmful and should not be used.
  • False claims and lack of prescription needed: Some companies that sell compounded tirzepatide make false claims that their products are FDA approved or equivalent to FDA-approved medicines like Zepbound or Mounjaro. Additionally, in some instances, compounded tirzepatide has been marketed without requiring a prescription from a licensed healthcare provider. This can be dangerous, as compounded products, like all medicines, should only be used under the supervision of a healthcare provider.

Where should I get compounded tirzepatide?

Because of the significant risks associated with compounded tirzepatide, the FDA strongly recommends using an FDA-approved tirzepatide drug like Zepbound or Mounjaro when it is available. Risks of compounded tirzepatide include dosing errors, contamination or impurities, and unapproved ingredients or formulations. It is important to understand that compounded tirzepatide products have not undergone the extensive testing required for FDA approval like Zepbound and Mounjaro have. If you are considering using compounded tirzepatide, consult your healthcare provider. They can guide you on the safest course of action, which often includes using FDA-approved treatments. If you still choose to use compounded tirzepatide, ask your healthcare provider if they have a trusted, preferred pharmacy they regularly use. If you use an online pharmacy, visit the FDA website for more information. Avoid online pharmacies that are not licensed or reputable—and those that advertise compounded tirzepatide without a prescription—as these factors increase the risk of counterfeit or unsafe medications.

Bottom line: Is compounded tirzepatide the same as Zepbound?

While Zepbound is an FDA-approved drug that has been extensively tested for safety, quality, and effectiveness, compounded tirzepatide products are not regulated by the FDA and are not FDA-approved. Therefore, compounded tirzepatide is associated with significant potential risks. Always consult your healthcare provider for personalized medical advice regarding weight management and your weight loss medications.