Compounded tirzepatide contains the same active ingredient as Mounjaro, but its dosage and some ingredients may differ from Mounjaro. The Food and Drug Administration (FDA) does not regulate the safety, effectiveness, or quality of compounded tirzepatide.

Mounjaro is a brand-name prescription drug that contains the active ingredient tirzepatide. It’s approved by the FDA to help manage blood sugar levels in adults who have type 2 diabetes, along with diet and exercise.

Some doctors also prescribe Mounjaro off-label for weight loss. With off-label use, doctors prescribe a drug for a purpose other than what it’s approved to help treat or prevent.

Continue reading to learn what compounded tirzepatide is and how it compares with Mounjaro.

Drug compounding is a process in which a licensed pharmacist creates a custom alternative to an FDA-approved drug. (You still need a doctor’s prescription to get compounded tirzepatide.)

The compounded drug contains the same active ingredient as the FDA-approved drug. But it might differ from the FDA-approved drug in quality, ingredients, dosage, and form. So compounded tirzepatide is not the same as Mounjaro.

You might need to have an FDA-approved drug compounded for reasons such as these:

  • You have an allergy to an ingredient in the FDA-approved drug, which the compounded drug can avoid.
  • You cannot take the FDA-approved drug in its form (such as an injection) and need an alternative form.
  • The FDA-approved drug is not medically appropriate for you to take.
  • The FDA has declared a shortage of the FDA-approved drug and is allowing pharmacies to provide compounded versions.

Some compounded drugs may be less expensive than FDA-approved drugs, but insurance may not cover compounded drugs. Your insurance provider or doctor can tell you more about costs and possible coverage.

Two women engaged in conversation, one wearing street clothes and the other holding a stethoscope and wearing scrubs and a lab coatShare on Pinterest
Getty Images/Fly View Productions

Compounded tirzepatide is not approved by the FDA. This means the FDA does not regulate the safety, quality, or effectiveness of the drug. Instead, each state regulates its compounding pharmacies. Regulations for these pharmacies may vary from state to state.

Improper compounding practices may result in contamination or cause the drug to contain the wrong quantities of the active ingredient. Either situation could be dangerous.

In fact, the FDA has expressed concerns about compounded versions of GLP-1 drugs such as tirzepatide. (“GLP-1” means “glucagon-like peptide-1 receptor agonist.”) Further, the FDA has received reports of negative side effects from compounded tirzepatide.

Unlike FDA-approved drugs, compounded tirzepatide won’t come with a package insert when the prescription is dispensed. It’s important to discuss using compounded tirzepatide with a doctor before you begin treatment with it.

A specialty pharmacy provides medications for complex health needs. Some specialty pharmacies or other state-licensed pharmacies may supply compounded tirzepatide. A licensed pharmacist may also compound drugs in a nonpharmacy facility.

Because compounded drugs are custom-made, a prescription for a compounded drug may take longer to fill than a prescription for an FDA-approved drug. It’s important to research a pharmacy before purchasing any compounded drugs. You can also ask a healthcare professional for their recommendations.

Compounded tirzepatide has not undergone the same clinical testing as Mounjaro. This means compounded tirzepatide has no clinical evidence on its effectiveness for weight loss.

Mounjaro may reduce body weight in people with type 2 diabetes. But the FDA does not verify the effectiveness or safety of compounded tirzepatide.

Compounded tirzepatide has no standard dosage, and its dosage could differ from the dosage of Mounjaro. The FDA has received reports of side effects with compounded tirzepatide. These side effects might be due to the use of compounded tirzepatide doses that are higher than the prescribed doses for FDA-approved Mounjaro.

The recommended starting dosage for Mounjaro is 2.5 milligrams (mg) once weekly. Your doctor may increase your dosage in increments up to a maximum dose of 15 mg once weekly.

The FDA has received reports of side effects that may relate to compounded tirzepatide, including:

  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • constipation

Some symptoms were severe enough for people to seek medical attention. Side effects may vary depending on the dosage, form, and ingredients of compounded tirzepatide.

The most common side effects of Mounjaro include:

  • nausea
  • diarrhea
  • reduced appetite
  • vomiting
  • constipation
  • indigestion
  • abdominal pain

Compounded drugs may contain additional ingredients, such as certain vitamins. Some online sellers compound tirzepatide with vitamin B12. Information from these sellers suggests that the addition of vitamin B12 enhances overall treatment benefits.

Vitamin B12 is an essential nutrient for DNA and energy production and for the health of your blood and nerve cells. But researchers don’t have enough clinical evidence to confirm the safety and effectiveness of compounded tirzepatide with vitamin B12.

Although shortages of brand-name tirzepatide injections have occurred, the FDA declared the shortage resolved in 2024. At that time, the FDA announced that compounding pharmacies could no longer produce compounded tirzepatide.

When an FDA-approved drug is in shortage, compounders are allowed to prepare compounded versions of it. If the drug is not in shortage, the FDA supports the use of the compounded drug only if an FDA-approved drug cannot meet an individual’s medical needs.

If FDA-approved tirzepatide injections return to the FDA’s drug shortage list, compounders may be able to make compounded tirzepatide again. If that happens, compounded tirzepatide must meet federal law conditions.

Compounded tirzepatide is a custom-made drug. It contains tirzepatide, which is the active ingredient in the brand-name drug Mounjaro. If you cannot take Mounjaro for medical reasons, you may need compounded tirzepatide. The FDA might also allow compounded tirzepatide to be dispensed if it declares a shortage of FDA-approved tirzepatide injections.

The FDA does not regulate the safety, effectiveness, or quality of compounded drugs. You will need a prescription for compounded tirzepatide from a licensed healthcare professional. The drug may be dispensed by a specialty pharmacy or another licensed compounding facility.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.