Important Safety Information for Compounded GLP-1 Medications

Atlas HRT safety summary derived from the FDA page “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss” (content current as of 09/01/2026) and the FDA-approved labeling of the GLP-1 receptor agonist class. Last reviewed September 11, 2026.

Compounded semaglutide and compounded tirzepatide are not FDA-approved, and the FDA has not reviewed them for safety, effectiveness or quality.

What the FDA says about compounded GLP-1 medications

FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs, including semaglutide and tirzepatide, as an option for weight loss.

This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed.

Compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.

Patients should obtain a prescription from their doctor and fill the prescription at a state-licensed pharmacy.

However, compounded drugs are not FDA approved.

This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.

Adverse events reported to the FDA

FDA has received reports of adverse events related to compounded versions of semaglutide and tirzepatide.

However, federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA so it is likely that adverse events from compounded versions of these drugs are underreported.

Many of the adverse events reported for compounded products appear to be consistent with adverse events related to the FDA-approved versions of these products.

As of May 31, 2026, the FDA has received: 990 reports of adverse events associated with compounded semaglutide; more than 730 reports of adverse events associated with compounded tirzepatide.

It is not always possible to determine if the adverse event directly resulted from use of the drug or if other factors may have contributed to these adverse events.

Dosing errors and salt forms

FDA received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products.

These dosing errors resulted from patients measuring and self-administering incorrect doses of the drug, and in some cases, health care professionals miscalculating doses of the drug.

The agency also encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide or tirzepatide.

The agency is aware that some semaglutide products sold by compounders may be the salt forms.

These salt forms, including semaglutide sodium and semaglutide acetate, are different active ingredients than are used in the approved drugs.

The agency does not have information on whether these salts have the same chemical and pharmacologic properties as the active ingredient in the approved drug, and we are not aware of any lawful basis for their use in compounding.

Storage and multiple-dose vials

Injectable GLP-1 drugs require refrigeration as indicated in their package inserts.

The agency recommends patients not use any injectable GLP-1 drug that arrives warm or with insufficient refrigeration, as this can affect the drug’s quality.

Generally, FDA recommends that vials containing multiple doses of sterile medications be used within 28 days after the first use because there is an increased risk of contamination after 28 days.

Always use a new, sterile needle and syringe for each dose.

Class safety information from the approved products’ labeling

The FDA-approved medicines in the GLP-1 receptor agonist class carry a boxed warning about thyroid C-cell tumors: in rodents, these medicines caused thyroid tumors, including thyroid cancer, and it is not known whether they do so in people.

Their labels state that they must not be used by anyone who, or whose family member, has had medullary thyroid carcinoma, or by anyone with Multiple Endocrine Neoplasia syndrome type 2.

Serious side effects listed in those labels include inflammation of the pancreas (pancreatitis), gallbladder problems, kidney problems from dehydration, low blood sugar when used with other diabetes medicines such as an insulin or a sulfonylurea, severe stomach problems, serious allergic reactions, changes in vision in people with type 2 diabetes, a faster heart rate, and food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sedation.

The labels state that these medicines may harm an unborn baby and that weight loss offers no benefit to a pregnant patient.

A compounded medication has no FDA-reviewed labeling of its own; the class information above is taken from the approved products’ labeling for context.

Compounded medications are prepared by a licensed pharmacy for an individual patient and are not FDA-approved. The FDA does not review them for safety, effectiveness or quality before they reach patients. Compounded medications are not generic versions of, and have not been shown to be equivalent to, any FDA-approved drug.