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Important Safety Information

These safety guides do not list every possible reaction. Reach out to your healthcare provider for clarification or additional information. If you experience a medical emergency, such as anaphylaxis (a severe allergic reaction), difficulty breathing, swelling of your face, lips, tongue, or throat, or any other life-threatening symptoms, please call 911 immediately or seek care at your nearest emergency department.

If you are experiencing suicidal thoughts or a mental health crisis, please reach out immediately to the 988 Suicide Prevention Lifeline at 800-273-8255 or text HOME to the Crisis Text Line at 741741. These services are free and confidential.

In the event of a poison emergency, call the national, toll-free Poison Help line at 1-800-222-1222. This number connects you to your local poison center.

Safety guides

Compounded Tirzepatide Important Safety Information

Your health and safety are important to us. Before starting compounded tirzepatide, please review the following information to understand the possible risks, side effects, and precautions associated with your medication.

Compounded tirzepatide is a prescription medication prepared by a compounding pharmacy for an individual patient's medical needs. Tirzepatide is the active ingredient in the FDA-approved brand-name medication ZEPBOUND®. Compounded products prepared with tirzepatide base contain that same active ingredient, but compounded tirzepatide is not ZEPBOUND, is not an FDA-approved generic version of ZEPBOUND, and has not been established to be equivalent to ZEPBOUND.

Compounded medications are not FDA-approved. This means the FDA has not reviewed or approved the compounded product for safety, effectiveness, quality, or consistency before it is marketed. The information below is based on known safety risks of tirzepatide, FDA-approved tirzepatide labeling, and FDA safety communications about compounded GLP-1 medications. Compounded tirzepatide does not have its own FDA-approved prescribing information.

Please review the FDA-approved ZEPBOUND Medication Guide for additional information about tirzepatide: https://uspl.lilly.com/zepbound/zepbound.html (opens in new tab)

1. Important safety warnings

Thyroid tumors, including thyroid cancer

Tirzepatide caused thyroid tumors in animal studies. It is not known whether tirzepatide causes thyroid cancer in humans. Do not use compounded tirzepatide if:

  • You or a family member has had medullary thyroid carcinoma (MTC), a specific type of thyroid cancer.
  • You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • You have had a serious allergic reaction to tirzepatide or any ingredient in your compounded medication.

Contact your healthcare provider if you notice a lump or swelling in your neck, persistent hoarseness, difficulty swallowing, or difficulty breathing.

Important: FDA-approved tirzepatide products carry a boxed warning about the risk of thyroid C-cell tumors. This warning is relevant when counseling patients about compounded tirzepatide because it contains the same active ingredient.

Pancreatitis (inflammation of the pancreas)

Tirzepatide may cause pancreatitis, which can be serious. Stop taking compounded tirzepatide and contact your healthcare provider immediately if you develop severe, persistent stomach pain, especially if the pain spreads to your back. This may occur with or without nausea or vomiting.

Gallbladder problems

Tirzepatide may increase your risk of gallstones or gallbladder inflammation. Contact your healthcare provider if you experience upper abdominal pain, especially on the right side, fever, yellowing of your skin or eyes, or persistent nausea or vomiting.

Low blood sugar (hypoglycemia)

Tirzepatide can cause low blood sugar, especially in people with diabetes who also take insulin or certain diabetes medications, such as sulfonylureas. Symptoms may include shakiness, sweating, dizziness, headache, hunger, weakness, confusion, irritability, or a fast heartbeat. If you have diabetes, monitor your blood sugar as instructed. Your healthcare provider may need to adjust your other diabetes medications. Severe low blood sugar causing seizures, loss of consciousness, or inability to swallow safely requires emergency medical attention.

Kidney problems and dehydration

Nausea, vomiting, and diarrhea can cause dehydration, which may lead to kidney problems, including acute kidney injury. Drink fluids regularly, especially when experiencing stomach-related side effects. Contact your healthcare provider if you cannot keep fluids down, have persistent vomiting or diarrhea, experience dizziness, or notice significantly decreased urination.

Severe stomach or intestinal problems

Tirzepatide slows stomach emptying and may cause nausea, vomiting, diarrhea, constipation, and abdominal discomfort. Sometimes these symptoms can be severe. Tell your healthcare provider if you have severe or persistent digestive symptoms. Tirzepatide is not recommended for people with severe gastroparesis, a condition in which the stomach empties very slowly.

Serious allergic reactions

Serious allergic reactions, including anaphylaxis and swelling beneath the skin, have been reported with tirzepatide. Stop using compounded tirzepatide and seek emergency medical care if you experience swelling of your face, lips, tongue, or throat; trouble breathing or swallowing; severe rash or itching with other allergic symptoms; or fainting. Compounded formulations may contain additional ingredients that could also cause allergic reactions.

Vision changes in people with type 2 diabetes

Rapid improvements in blood sugar may worsen diabetic retinopathy, a diabetes-related eye condition. If you have type 2 diabetes, especially if you have a history of diabetic retinopathy, tell your healthcare provider about any changes in your vision. Continue recommended eye examinations.

Surgery, anesthesia, and sedation

Tirzepatide slows stomach emptying, which may increase the risk of food or liquid entering your lungs during procedures involving general anesthesia or deep sedation. Tell your surgeon, anesthesiologist, dentist, or other healthcare professional that you take compounded tirzepatide before any planned procedure. Follow their specific instructions about your medication and fasting.

2. Pregnancy, breastfeeding, and birth control

Pregnancy precautions

Tirzepatide may harm an unborn baby. There is not enough information from human pregnancies to fully determine its risks.

  • If you are pregnant, planning to become pregnant, or think you may be pregnant, tell your healthcare provider.
  • If you become pregnant while taking compounded tirzepatide, stop taking the medication and contact your healthcare provider promptly.
  • Discuss your pregnancy plans with your healthcare provider before starting or continuing treatment.
Pregnancy exposure registry

A pregnancy exposure registry is available for patients exposed to FDA-approved ZEPBOUND during pregnancy. The registry collects information about pregnancies exposed to tirzepatide to help researchers better understand potential effects on pregnant patients and their babies.

ZEPBOUND Pregnancy Exposure Registry: 1-800-LillyRx (1-800-545-5979)

If you become pregnant while using compounded tirzepatide, contact your healthcare provider to discuss reporting the exposure and whether you are eligible to participate in the registry. Eligibility for patients using compounded products is not established.

Breastfeeding

It is not known whether tirzepatide may affect a breastfed baby or milk production. Small amounts of tirzepatide may be present in breast milk.

Birth control precautions

Tirzepatide may reduce the effectiveness of oral hormonal contraceptives, including birth control pills, because it slows stomach emptying. If you use oral hormonal birth control, you should switch to a non-oral contraceptive method or use an additional barrier method, such as condoms:

  • For 4 weeks after starting compounded tirzepatide.
  • For 4 weeks after every dose increase.

Non-oral hormonal contraceptives are not expected to be affected in the same way. Discuss your birth control options with your healthcare provider.

3. Other medications and drug interactions

Tirzepatide can affect how your body absorbs certain medications because it slows stomach emptying. Before starting compounded tirzepatide, tell your healthcare provider about all prescription medications, over-the-counter medications, vitamins, and supplements you take.

Do not combine compounded tirzepatide with ZEPBOUND, Mounjaro, another tirzepatide-containing medication, or other GLP-1 medications unless your healthcare provider specifically directs a change in treatment. Your healthcare provider may need to adjust or monitor certain medications, especially insulin, sulfonylureas, and oral medications requiring careful monitoring. If you take oral hormonal contraceptives, follow the additional birth control precautions described in Section 2.

4. Common side effects

Common side effects associated with tirzepatide include:

  • Nausea, vomiting, or diarrhea
  • Constipation, stomach pain, bloating, or gas
  • Heartburn, indigestion, or burping
  • Fatigue
  • Injection-site reactions
  • Allergic or hypersensitivity reactions
  • Hair loss

Many digestive side effects occur when first starting tirzepatide or increasing the dose. Contact your healthcare provider if symptoms are severe, persistent, or interfere with eating or drinking. Because compounded products may contain additional ingredients or differ in preparation, other side effects or reactions may occur.

5. Important instructions for taking compounded tirzepatide

Compounded tirzepatide is commonly prescribed as an injection under the skin once weekly. However, compounded formulations, concentrations, and administration instructions may vary. Always follow the specific prescription and instructions provided by your healthcare provider and dispensing pharmacy.

Dosing and administration safety

Compounded tirzepatide may be supplied in a vial rather than a prefilled injection pen. Some products require patients to measure their dose using a syringe. Unlike FDA-approved products, compounded tirzepatide may be available in different concentrations. This creates a risk of dosing errors if the wrong amount of medication is drawn into the syringe.

Important precautions:

  • Confirm your prescribed dose in milligrams (mg).
  • Verify the concentration of your medication and the correct volume or syringe units needed for your dose.
  • Use only the syringe and measuring instructions provided or approved by your healthcare provider or pharmacy.
  • Do not assume that syringe units are the same as milligrams of medication.
  • Do not use dosing instructions from another patient's prescription or a previous vial with a different concentration.
  • Never estimate or guess your dose.
  • If your prescription, concentration, syringe, or instructions change, confirm the correct dose before your next injection.
  • Do not increase your dose or inject more frequently than prescribed.

If you are unsure how much medication to draw into your syringe, do not inject until you have confirmed the correct amount with your healthcare provider or pharmacist.

Safe injection practices
  • Wash your hands before preparing your injection.
  • Use a new, sterile needle and syringe for every injection.
  • Follow your pharmacy's instructions for preparing the medication and cleaning the vial stopper.
  • Inject only under the skin, as directed.
  • Rotate injection sites between your abdomen, thigh, or upper arm.
  • Do not inject into the exact same spot each time.
  • Never share needles, syringes, or medication vials with another person.
  • Dispose of used needles and syringes in an approved sharps container.

6. When to seek medical attention

Seek emergency medical attention

Call 911 or seek emergency medical care if you experience:

  • Difficulty breathing or swelling of your face, lips, tongue, or throat.
  • A severe allergic reaction, including fainting or loss of consciousness.
  • Severe low blood sugar causing seizures, unconsciousness, or inability to swallow safely.
  • Any other life-threatening symptoms.
Stop compounded tirzepatide and seek immediate medical evaluation

Stop taking compounded tirzepatide and contact your healthcare provider immediately if you experience:

  • Severe or persistent abdominal pain, especially if the pain spreads to your back, which may indicate pancreatitis.
  • Severe abdominal pain with or without nausea or vomiting.

If symptoms are severe or you cannot obtain prompt medical evaluation, seek emergency care.

Contact your healthcare provider promptly

Contact your healthcare provider if you experience:

  • Persistent vomiting, diarrhea, or inability to keep fluids down.
  • Signs of dehydration, including significantly decreased urination or severe dizziness.
  • Upper abdominal pain, fever, or yellowing of the skin or eyes, which may indicate gallbladder problems.
  • New or worsening changes in vision.
  • A lump or swelling in your neck, persistent hoarseness, or difficulty swallowing.
  • Repeated episodes of low blood sugar.
  • Increasing redness, warmth, swelling, pain, or drainage at an injection site, especially with fever.
  • Pregnancy or suspected pregnancy. Stop taking compounded tirzepatide and contact your healthcare provider promptly.
If you suspect a dosing error or overdose

If you believe you injected too much compounded tirzepatide, used the wrong concentration, or made an error when measuring your dose:

  • Do not take another dose until you have received medical guidance.
  • Contact your healthcare provider or Poison Help at 1-800-222-1222 immediately, even if you do not have symptoms.
  • Seek emergency medical care if you develop severe vomiting, severe abdominal pain, confusion, loss of consciousness, or other serious symptoms.
  • Keep your medication vial, syringe, and prescription information available so healthcare professionals can determine what medication and dose you received.
Read the full Tirzepatide protocol page