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Drug vs. Drug

Compounded tirzepatide vs. Mounjaro

Compounded tirzepatide is not FDA approved like Mounjaro is
Karen Berger medical writer and reviewer headshot
By | Feb. 14, 2025
Two autoinjector pens: Compounded tirzepatide vs. Mounjaro

Key takeaways

  • Mounjaro (tirzepatide) is an FDA-approved brand-name prescription medicine used for Type 2 diabetes. It is often prescribed off-label for weight loss.

  • Compounded tirzepatide products are very popular but have not been tested or approved by the FDA. Compounded products may carry significant risks such as contamination and the possibility of dosing errors, which can cause serious health problems. 

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

In this article:

Mounjaro (tirzepatide) is a popularly prescribed weekly injectable medicine used for Type 2 diabetes. It is also commonly prescribed off-label (for non-FDA-approved use) to help with weight loss and weight management in people with obesity or who are overweight with weight-related medical conditions. Mounjaro is classified as a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. The growing popularity of Mounjaro, Zepbound (which also contains tirzepatide), and GLP-1 receptor agonists such as Ozempic and Wegovy has led to periodic shortages, making it difficult at times to find these medicines in pharmacies. Enter compounding pharmacies, which create compounded versions of drugs like tirzepatide. Compounded tirzepatide and Mounjaro are both used as Type 2 diabetes and weight loss medications, but they are not exactly the same. 

What is compounded tirzepatide?

Eli Lilly and Company is the pharmaceutical company that makes two tirzepatide products that are approved by the Food and Drug Administration (FDA):

  • Mounjaro, which is approved by the FDA for improving blood sugar levels in people with Type 2 diabetes, and is often prescribed off-label for weight loss
  • Zepbound, which is FDA approved for weight loss, as well as for obstructive sleep apnea in adults with obesity

Currently, there are no FDA-approved generic versions of the drugs Mounjaro or Zepbound, and there are not any other FDA-approved tirzepatide products available besides brand-name Mounjaro and Zepbound.

So, what is compounded tirzepatide, and why is it made when there are already FDA-approved tirzepatide products available? Compounded medications are made by a pharmacist or other healthcare provider in a pharmacy or outsourcing facility, who creates a medicine specifically tailored to the needs of an individual patient. Ingredients may be combined, mixed, or altered during the compounding process. In the instance of compounded tirzepatide particularly, compounding pharmacies make their own version of the medicine. In some cases, they will add additional ingredients, such as vitamins. 

According to the FDA, a compounded drug may be made for a patient who cannot receive treatment with an FDA-approved medicine for various reasons, such as:

  • Different formulations: For example, an oral liquid can be made for someone who cannot swallow pills.
  • Ingredient modifications: A medication can be made without a particular ingredient for patients who are allergic to it.
  • Drug shortages: A compounded version may be created when an FDA-approved drug is unavailable due to short supply issues.

Although there have been periodic tirzepatide shortages (meaning the two FDA-approved drugs Mounjaro and Zepbound), the FDA announced on Dec. 19, 2024, that the shortage is 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 FDA-approved product.

Compounded tirzepatide vs. Mounjaro for weight loss

While compounded tirzepatide products may be very similar to Mounjaro, they are not FDA approved and are not exactly the same. Compounded tirzepatide also tends to be marketed toward people interested in weight loss, and Mounjaro is FDA approved to treat Type 2 diabetes. Let’s look at some of the differences, such as ingredients, dosage forms, and cost. 

Ingredients

The active ingredient in Mounjaro is tirzepatide. Compounded tirzepatide may be made alone as a single active ingredient, or it may contain additional ingredients such as vitamin B-12—that are not found in Mounjaro. Because the FDA does not regulate compounded drugs, there is no data on the safety and effectiveness of compounded tirzepatide, either alone or in combination with other ingredients. 

Dosage and forms

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

  • 2.5 milligrams (mg) per single-use injection pen 
  • 5 mg per single-use injection pen
  • 7.5 mg per single-use injection pen
  • 10 mg per single-use injection pen
  • 12.5 mg per single-use injection pen
  • 15 mg per single-use injection pen

Each Mounjaro pen is for single use only. When you receive your Mounjaro prescription from the pharmacy, you will get a box containing four single-use pens, which will last for 28 days. Or, if you are prescribed a three-month supply, you will receive three boxes of Mounjaro, each with four pens. The three-month supply lasts 84 days. 

On the other hand, various compounded tirzepatide products are available, depending on the compounding facility. Some examples include:

  • Orally disintegrating tablets (tablets that dissolve in the mouth)
  • Oral liquid drops
  • Injectable prefilled syringes that are loaded with the required dose
  • Injectable medicine that comes in a multiple-dose vial, requiring you to draw up your weekly dose with a syringe

Safety and efficacy

Mounjaro, like all FDA-approved drugs, has been tested extensively in clinical trials for safety, quality, and efficacy. In these studies, researchers find out important information about the drug, such as adverse effects, other safety considerations, and how well the drug works. On the other hand, compounded drugs are not subject to the same kind of regulation and do not require FDA approval. Therefore, compounded tirzepatide products are not required to undergo testing for safety, effectiveness, or quality in the same way as an FDA-approved drug like Mounjaro. 

Insurance coverage and cost

Insurance coverage for Mounjaro will vary by plan. You can check the Eli Lilly and Company website to find out about insurance coverage. You can also reach out to your insurance provider to ask about Mounjaro coverage and your out-of-pocket costs. However, compounded tirzepatide products are not usually covered by insurance plans, since they are not FDA-approved drugs.

RELATED: How to save on Mounjaro

Is compounded tirzepatide safe?

As of Nov. 30, 2024, the FDA has received more than 200 reports of adverse events from compounded tirzepatide and almost 400 similar reports from compounded semaglutide. There are some risks associated with compounded tirzepatide (as well as similar drugs like compounded semaglutide), such as:

  • Dosing errors resulting from incorrectly measuring the dose, which can lead to serious side effects from taking too much medicine (With Mounjaro, the dose is loaded into the prefilled pen, so it is unlikely you will inject an incorrect dose.)
  • Ingredients, such as retatrutide, that are labeled “for research purposes” or “not for human consumption” and have been found in compounded products that are provided to patients 
  • Contaminated and non-sterile products, which can be dangerous
  • Counterfeit drugs, that may contain the wrong drug, too much or too little of the drug, or no drug at all—along with illegal sales that do not require a prescription

In addition to these risks, remember that compounded tirzepatide products have not been tested or FDA approved, so it is not known if the product you receive is safe, effective, and of high quality. 

If you do choose to use a compounding pharmacy despite these risks, consult your healthcare provider to see if they have a legitimate, trusted compounding pharmacy they partner with. And if you use an online pharmacy, use the FDA’s BeSafeRx campaign resources to help you make a safe choice. Always avoid online pharmacies that are not licensed or reputable—as well as compounding pharmacies or facilities that advertise compounded tirzepatide without a prescription—as these factors greatly increase the risk of counterfeit or unsafe medications.

Bottom line: Is compounded tirzepatide the same as Mounjaro?

Mounjaro is an FDA-approved medication. Like all FDA-approved drugs, Mounjaro has undergone extensive clinical trials to ensure its safety, quality, and efficacy. Compounded tirzepatide products, which are specially made by compounding pharmacies or facilities, are not FDA-approved or regulated and have not been tested in clinical trials. These compounded versions are not exactly the same as Mounjaro and are associated with additional risks. Consult your healthcare provider for more information and medical advice about the best treatment option for your condition.

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