What it is
Tirzepatide is a dual agonist of the GIP and GLP-1 receptors. These two gut hormone receptors are involved in appetite and blood sugar regulation.
How it works
- Tirzepatide activates both the glucose-dependent insulinotropic polypeptide (GIP) receptor and the glucagon-like peptide-1 (GLP-1) receptor [1].
- This page does not present clinical trial results. Trial results for approved products apply to those products, not to compounded tirzepatide.
Regulatory status
FDA has approved separate tirzepatide medicines for specific uses. Compounded tirzepatide is not FDA approved, and FDA states unapproved versions do not undergo its review for safety, effectiveness and quality [2]. Where prescribed, compounded versions are prepared by state-licensed 503A compounding pharmacies.
Safety and side effects
The approved tirzepatide label carries a boxed warning: in rats, tirzepatide causes thyroid C-cell tumors, and it is unknown whether it causes these tumors, including medullary thyroid carcinoma (MTC), in humans. The approved product is contraindicated in people with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [1]. The label also warns about severe gastrointestinal reactions, acute kidney injury due to volume depletion, acute gallbladder disease, acute pancreatitis, serious allergic reactions, low blood sugar when used with insulin or an insulin secretagogue, diabetic retinopathy complications in people with type 2 diabetes, and pulmonary aspiration during general anesthesia or deep sedation [1]. Its most common adverse reactions include nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, allergic reactions, belching, hair loss and acid reflux. Most nausea, vomiting and diarrhea occurred during dose escalation and decreased over time [1]. FDA recommends discarding a multiple-dose vial of compounded GLP-1 medication within 28 days after first use [2]. FDA says compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug [2]. A licensed healthcare provider should review your history, medications and goals.
Is it right for you?
Only a licensed healthcare provider can decide whether any treatment is appropriate for you.
Frequently asked questions
Is compounded tirzepatide approved by FDA?
No. FDA has approved separate tirzepatide medicines, but compounded versions are not FDA approved [2].
What are the common side effects?
The approved label lists nausea, diarrhea, vomiting, constipation, abdominal pain and dyspepsia among the most common adverse reactions. Most nausea, vomiting and diarrhea occurred during dose escalation. It also carries a boxed warning about thyroid C-cell tumors seen in rats [1].
Do I need a prescription for Tirzepatide?
Yes. Prescription only, requires evaluation by a licensed provider. A provider decides whether it is appropriate for you.
Sources
- FDA prescribing information, ZEPBOUND (tirzepatide) injection, revised 02/2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s042lbl.pdf
- FDA: FDA's concerns with unapproved GLP-1 drugs. https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
Tirzepatide content on this page is for education. Compounded medications are not FDA approved. Prescription only, requires evaluation by a licensed provider. Educational content only, not medical advice.