Compounded Tirzepatide — Important Safety Information

Last revised: February 19, 2025

Compounded medications are permitted under federal law but are not FDA-approved and do not undergo the same safety, effectiveness, or manufacturing review as FDA-approved medicines. Licensed prescribers may determine appropriate dosing of compounded tirzepatide following a clinical review, as required by law.

Indications and Use

Compounded tirzepatide is an injectable prescription medicine that may assist adults with:

Obesity (BMI ≥ 30 kg/m²), or

Overweight (BMI ≥ 27 kg/m²) with at least one weight-related condition (e.g., high blood pressure, type 2 diabetes, or high cholesterol).

It must be used with a reduced-calorie diet and increased physical activity.

Compounded tirzepatide should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines.

Safety in children under 18 has not been established.

Boxed Warning — Risk of Thyroid C-Cell Tumors

In animal studies, tirzepatide caused thyroid tumors, including thyroid cancer. It is not known if compounded tirzepatide will cause thyroid tumors in humans.

Do not use if you or your family have ever had:

Medullary thyroid carcinoma (MTC), or

Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Seek medical help immediately if you experience:

A lump/swelling in your neck

Hoarseness or trouble swallowing

Shortness of breath

Important Warnings

Do not use compounded tirzepatide if you:

Have a history of MTC or MEN 2

Have had a serious allergic reaction to tirzepatide

Discuss your full medical history with your prescriber, especially if you have:

Type 1 or type 2 diabetes

Kidney disease

Diabetic retinopathy

Gastrointestinal disease

Pancreatitis

Depression or suicidal thoughts

Pregnancy and Breastfeeding

Compounded tirzepatide should not be used during pregnancy.

Birth control pills may be less effective; consider non-oral methods for at least 4 weeks after starting or increasing your dose.

It is not known if tirzepatide passes into breast milk.

Administration

Self-administered as a once-weekly subcutaneous injection (stomach, thigh, or upper arm).

Use on the same day each week.

Do not change your dose or stop without speaking to your prescriber.

Possible Side Effects

Serious Risks

Thyroid tumors

Pancreatitis (severe abdominal pain, nausea, vomiting)

Gallbladder disease (pain, jaundice, fever)

Kidney injury (dehydration, vomiting)

Severe allergic reactions (swelling, rash, difficulty breathing)

Low blood sugar (especially with insulin or sulfonylureas)

Vision changes (diabetic retinopathy complications)

Mood changes or suicidal thoughts

Common Side Effects

Nausea, diarrhea, vomiting, constipation

Stomach pain, indigestion, heartburn

Fatigue

Hair loss

Injection site reactions

Report side effects to the FDA: www.fda.gov/medwatch

or call 1-800-FDA-1088.