Important Safety Information About Compounded Tirzepatide Products

Please note that compounded medications are not FDA-approved and do not undergo the same clinical testing for safety and efficacy as FDA-approved drugs. However, your healthcare provider may still prescribe compounded tirzepatide based on your medical consultation.

Tirzepatide is a dual-action medication that targets both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors. It is used for long-term weight management in conjunction with a reduced-calorie diet and increased physical activity for individuals with a body mass index (BMI) of:

  • 30 kg/m² or higher (obesity) or
  • 27 kg/m² or higher (overweight) with at least one related condition, such as hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.

Speak with your healthcare provider to determine if tirzepatide is right for you.

Possible Serious Side Effects:

  • Thyroid tumors, including cancer: If you experience swelling in your neck, hoarseness, trouble swallowing, or shortness of breath, contact your healthcare provider, as these could be symptoms of thyroid cancer. In animal studies, tirzepatide caused thyroid C-cell tumors, but it is unclear if it poses the same risk in humans.


Who Should Not Use Tirzepatide:

  • Do not use tirzepatide if you or a family member has a history of medullary thyroid carcinoma (MTC) or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Avoid tirzepatide if you’ve had a severe allergic reaction to the medication in the past.


Before Starting Tirzepatide:

Inform your healthcare provider if you have:

  • A history of pancreas or kidney issues
  • Severe stomach issues, such as gastroparesis or difficulty digesting food
  • Diabetic retinopathy
  • Depression, suicidal thoughts, or other mental health concerns
  • If you are pregnant, planning to become pregnant, or breastfeeding. Tirzepatide is not recommended during pregnancy due to potential risks, and it is not known if it passes into breast milk.


Potential Drug Interactions:

Let your provider know about all medications and supplements you take, as tirzepatide may interact with other treatments, including diabetes medications like insulin or sulfonylureas, increasing your risk of low blood sugar.

Serious Side Effects:

  • Thyroid C-Cell Tumors: As noted, tirzepatide may increase the risk of thyroid tumors. Report any symptoms such as a lump in your neck or difficulty swallowing.
  • Gastroparesis: Symptoms may include feeling full quickly, prolonged fullness, nausea, and vomiting. Tirzepatide is not recommended for those with severe gastrointestinal issues.
  • Pancreatitis: Contact your healthcare provider if you experience severe, persistent stomach pain, with or without vomiting.
  • Gallbladder issues: Tirzepatide may cause gallbladder problems, including gallstones. Watch for symptoms like upper abdominal pain, jaundice, or clay-colored stools.
  • Low blood sugar (hypoglycemia): If you are taking other diabetes medications, be aware of symptoms like dizziness, sweating, confusion, and fast heartbeat.
  • Kidney problems: Nausea, vomiting, and diarrhea can lead to dehydration, worsening kidney issues. Make sure to stay hydrated.
  • Allergic reactions: Seek immediate medical attention if you experience facial swelling, difficulty breathing, or a rapid heartbeat.
  • Vision changes in type 2 diabetes: Report any changes in vision to your healthcare provider.
  • Depression or suicidal thoughts: Monitor for sudden changes in mood or behavior and inform your healthcare provider immediately.


Common Side Effects:

The most common side effects of tirzepatide include nausea, diarrhea, vomiting, constipation, stomach pain, indigestion, injection site reactions, tiredness, allergic reactions, belching, heartburn, and hair loss. Discuss any side effects that concern you with your healthcare provider.

For medical emergencies, call 911 or seek immediate help. You are encouraged to report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Tirzepatide Administration:
Tirzepatide is administered once weekly as a subcutaneous injection in the stomach, thigh, or upper arm. Follow your healthcare provider’s instructions on how to self-administer the medication. Do not change your dosage or stop taking tirzepatide without consulting your provider.

Mechanism of Action:
Tirzepatide works by binding to and activating both GIP and GLP-1 receptors, which help regulate blood sugar levels and appetite. These receptors are naturally targeted by incretin hormones released after eating, making tirzepatide part of the incretin mimetic class of drugs.

This information is not comprehensive. Speak with your healthcare provider for more details and to address any concerns about tirzepatide treatment.