Compounded tirzepatide is not FDA-approved and is not the same as brand-name Mounjaro® or Zepbound®. It is available only by prescription after review by a licensed provider.
Possible Thyroid Tumors, Including Cancer
In animal studies, tirzepatide caused thyroid C-cell tumors. It is not known whether it causes these tumors, including medullary thyroid carcinoma (MTC), in people. Tell your provider right away if you notice a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
Do not use tirzepatide if you:
-
Or any family member have ever had medullary thyroid carcinoma (MTC)
-
Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
-
Have had a serious allergic reaction to tirzepatide or any of its ingredients
Tirzepatide is not recommended for people with severe stomach or intestinal problems, including gastroparesis (slow stomach emptying).
Serious Side Effects
-
Pancreatitis: Stop using tirzepatide and seek medical care right away if you have severe stomach pain that won’t go away, with or without vomiting. The pain may spread to your back.
-
Gallbladder problems: Tell your provider if you have pain in your upper stomach, fever, yellowing of your skin or eyes, or clay-colored stools.
-
Low blood sugar: Your risk is higher if you also take insulin or medications that increase insulin, such as sulfonylureas. Signs include dizziness, shakiness, sweating, confusion, headache, fast heartbeat, and irritability. Your provider may need to adjust your other medications.
-
Kidney problems: Nausea, vomiting, and diarrhea can cause dehydration, which may lead to kidney problems or worsen existing kidney disease. Drink plenty of fluids and tell your provider if you have trouble staying hydrated.
-
Serious allergic reactions: Stop using tirzepatide and get emergency help if you have swelling of your face, lips, tongue, or throat, trouble breathing or swallowing, severe rash or itching, fainting, or a very fast heartbeat.
-
Mood changes: Tell your provider about any new or worsening depression, unusual changes in mood or behavior, or thoughts of self-harm.
-
Anesthesia or sedation: Tell all your healthcare providers you use tirzepatide before any surgery or procedure, since it may increase the risk of food or liquid entering your lungs.
Common Side Effects
The most common side effects include nausea, vomiting, diarrhea, constipation, and stomach pain. These often lessen over time or with dose adjustments. Tell your provider if side effects are bothersome or don’t go away.
Pregnancy, Breastfeeding, and Birth Control
Tirzepatide may harm an unborn baby. Tell your provider if you are pregnant, plan to become pregnant, or are breastfeeding. Tirzepatide may make birth control pills less effective. If you use birth control pills, talk with your provider about adding a non-pill or backup method, especially when starting treatment and after each dose increase.
Medications and Other Conditions
Tell your provider about all medications you take, including prescription drugs, over-the-counter medicines, and supplements. Tirzepatide slows stomach emptying, which may affect how your body absorbs other medications.
Talk With Your Provider
Your provider will discuss the potential benefits and risks of tirzepatide with you. Tirzepatide is intended to be used alongside a healthy diet and regular physical activity. Contact your provider with any questions or concerns, and call 911 for any medical emergency.
Reporting Side Effects
Please tell your provider about any side effects. You can also report them directly to the FDA’s MedWatch program at 1-800-FDA-1088 or www.fda.gov/medwatch.