Compounded Tirzepatide: What You Need to Know

What is Tirzepatide?

Tirzepatide is a medication that activates two hormone pathways—GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1). This dual action helps improve blood sugar control, reduces appetite, and supports weight loss. The drug is sold under two Eli Lilly brand names: Mounjaro (for type 2 diabetes) and Zepbound (for weight management and obesity-related conditions such as sleep apnea).

What is Compounded Tirzepatide?

“Compounded tirzepatide” refers to versions of the drug prepared by compounding pharmacies rather than by Eli Lilly. Compounding is meant to customize medications for patients—for example, to avoid an inactive ingredient allergy or to provide unusual doses. During the height of tirzepatide shortages, many pharmacies began offering compounded versions to meet demand. However, compounded drugs are not FDA-approved and do not undergo the same testing for safety, quality, or consistency as brand-name products.

Who Makes It?

Several compounding pharmacies offered tirzepatide injections while the official products were in short supply. Some, like Empower Pharmacy, formulated tirzepatide with additives such as niacinamide. Now that the FDA has declared tirzepatide products no longer in shortage (as of October 2024), compounding pharmacies are largely restricted from making copy versions except in very specific cases.

How Does It Compare to Zepbound and Mounjaro?

The difference comes down to approval, oversight, and evidence:

Mounjaro is FDA-approved for type 2 diabetes and backed by strong clinical trial data.
Zepbound is FDA-approved for chronic weight management and has demonstrated substantial benefits in clinical trials.
Compounded tirzepatide has no FDA approval and is not subject to the same rigorous trials or manufacturing standards. While the active ingredient may be the same, the quality, dosing consistency, and sterility of compounded versions can vary.

In short: the branded drugs are proven, standardized, and legally protected, while compounded versions are less certain and now legally limited.

Cost and Why Compounded Versions Are Cheaper

One major reason people turned to compounded tirzepatide was price. Brand versions can cost over $1,000 per month, whereas compounded products were sometimes sold for $250–$350 per month. The lower cost comes from bypassing expenses tied to large-scale FDA-approved manufacturing, pre-filled pens, and marketing. But this affordability came at the expense of oversight, with risks of substandard or even counterfeit formulations.

Side Effects and Risks

The expected side effects of tirzepatide are similar whether it is brand or compounded: nausea, vomiting, diarrhea, constipation, appetite loss, and sometimes low blood sugar (especially when combined with insulin or sulfonylureas). Other risks include gallbladder issues, pancreatitis, and potential thyroid tumor risks in susceptible individuals.

Compounded tirzepatide carries additional risks: contamination, incorrect dosing, lack of long-term safety data, and uncertain legality now that shortages have ended. The FDA has issued warnings about counterfeit or unsafe compounded GLP-1 products, including tirzepatide.

The Bottom Line

Compounded tirzepatide filled a gap during shortages, offering lower prices but at greater risk. Now that Mounjaro and Zepbound are widely available again, compounded versions are generally not allowed unless a patient has a unique medical need that branded drugs cannot meet. Patients should weigh the lower price against the potential risks, and always confirm their prescriptions come from reputable, licensed pharmacies.