COMPOUNDED TIRZEPATIDE (GLP-1/GIP): PATIENT INFORMATION

This page is a general educational summary and does not promote any specific product. It does not cover every detail or possible side effect, and it is not medical advice. Always follow the guidance of your healthcare provider.

ABOUT COMPOUNDED MEDICATIONS

State and federal law allow compounded drugs to be prescribed in certain situations. However, compounded drugs are not FDA-approved, and the FDA does not review them for safety, effectiveness, or manufacturing quality.

After evaluating your health, your provider will decide whether compounded tirzepatide is right for you and, if so, recommend a dose and formulation suited to your needs.

WHAT IS COMPOUNDED TIRZEPATIDE?

Compounded tirzepatide is an injectable prescription medicine that acts on two hormone receptors, GLP-1 and GIP. Depending on your health needs and goals, your provider may prescribe it alongside a reduced-calorie diet and more physical activity. Because it is not FDA-approved, it has no officially approved uses the way an FDA-approved drug does.

Limitations of use

  • Do not use it with any other tirzepatide product or any other GLP-1 or GIP receptor agonist.
  • Its safety and effectiveness when combined with other prescription, over-the-counter, or herbal weight-loss products are unknown.
  • It has not been studied in people who have had pancreatitis, so it is not known whether it is safe for them.
WARNING: RISK OF THYROID C-CELL TUMORS

Do not use compounded tirzepatide if you or anyone in your family has ever had medullary thyroid carcinoma (MTC), a type of thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), an inherited endocrine condition.

GLP-1 medicines have been linked to MTC, mostly in laboratory studies in rodents. Whether this risk applies to people is not yet known. Tell your provider right away if you notice a lump or swelling in your neck, hoarseness that is unusual or doesn't go away, trouble swallowing, or shortness of breath. These can be signs of thyroid cancer.

WHO SHOULD NOT USE IT

Do not use compounded tirzepatide if:

  • You or a family member has ever had medullary thyroid carcinoma (MTC), or you have MEN 2.
  • You have had an allergic reaction to compounded tirzepatide.
HOW TO USE IT

Read the instructions that come with your medication and use it exactly as your provider directs.

  • Never share: Never share a vial, needle, or syringe with anyone. Sharing can spread infection.
  • If you take too much: Call your provider, get medical advice promptly, or contact Poison Control right away at 1-800-222-1222.
BEFORE YOU START: WHAT TO TELL YOUR PROVIDER

Your medications

Compounded tirzepatide can interact with other drugs. Tell your provider about everything you take, including prescription and over-the-counter medicines, vitamins, and herbal or dietary supplements. Be sure to mention:

  • Diabetes medicines such as insulin or sulfonylureas. These raise your risk of low blood sugar, so ask your provider how to recognize and manage it.
  • Birth control pills. They may not work as well while you use compounded tirzepatide. Your provider may suggest another form of birth control for 4 weeks after you start and for 4 weeks after each dose increase.
  • Any current or recent weight-loss prescription, compounded or brand-name. Do not take two of these medicines together. Using more than one GLP-1/GIP medicine at a time raises the risk of serious side effects. You will be asked to show proof of the prescription, including the dose.

Your medical history

Share your full medical history, especially if you have ever had:

  • Type 1 or type 2 diabetes
  • Diabetic retinopathy (diabetes-related eye disease)
  • Thyroid cancer
  • Pancreatitis or other pancreas problems
  • Kidney disease
  • Severe stomach problems, such as slow stomach emptying (gastroparesis) or trouble digesting food
  • Depression
  • Suicidal thoughts or behavior

Leaving out or misstating health information to get treatment can lead to serious harm, including death.

Pregnancy and breastfeeding

  • If you are pregnant: Do not use compounded tirzepatide. It may harm an unborn baby, and losing weight during pregnancy offers no benefit. Tell your provider right away if you become pregnant during treatment.
  • If you are planning a pregnancy: Whether you would carry the pregnancy or father the child, ask your provider whether to stop the medication beforehand.
  • If you are breastfeeding: It is not known whether compounded tirzepatide passes into breast milk. Your provider may advise against using it while breastfeeding or feeding your baby breast milk, so discuss the best way to feed your baby.
SIDE EFFECTS

Common side effects

Most common side effects are mild and tend to fade after the first few weeks. They include nausea, vomiting, diarrhea, constipation, stomach pain, upset stomach, bloating, reflux, headache, tiredness, and dizziness. You may also have redness, swelling, or itching where you inject.

Nausea usually improves as you keep using the medication. If any side effect lasts or gets worse, tell your provider or pharmacist promptly. Your provider prescribed this medication because they judged that its benefits outweigh the risks for you, and many people who use it have no serious side effects.

Watch for dehydration

Vomiting or diarrhea that doesn't stop can dehydrate you. Drink plenty of water, and contact your provider promptly if you notice unusual thirst, dry mouth, dizziness, or lightheadedness.

Tell your provider right away if you have

  • Signs of kidney problems, such as a change in how much you urinate
  • Vision changes, such as blurred or reduced vision
  • A fast heartbeat
  • Mood or mental changes, such as depression or thoughts of suicide
  • Signs of low blood sugar: sudden sweating, shakiness, fast heartbeat, hunger, blurred vision, dizziness, or tingling in your hands or feet

Get medical help right away if you have

  • Signs of pancreas or gallbladder disease, such as nausea or vomiting that won't stop, or severe stomach pain
  • Signs of a serious allergic reaction, which is rare: rash, itching or swelling (especially of the face, tongue, or throat), severe dizziness, or trouble breathing
SERIOUS RISKS TO MONITOR

You or a caregiver should watch closely for these, especially when you first start treatment and after any dose change.

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

  • Thyroid C-cell tumors: Do not use if you or a family member has had MTC, or if you have MEN 2. Report any neck lump or swelling, hoarseness, trouble swallowing, or shortness of breath.
  • Pancreatitis (inflamed pancreas): Watch for severe stomach pain that won't go away, sometimes spreading to your back, with or without vomiting.
  • Gallbladder disease: This medication can cause gallbladder problems, including gallstones, and some need surgery. Tell your provider right away if you have upper stomach pain, yellowing of your skin or eyes (jaundice), fever, or pale, clay-colored stools.
  • Low blood sugar (hypoglycemia): The risk is higher if you have type 2 diabetes and take another medicine that lowers blood sugar. Check your blood sugar, and watch for dizziness, blurred vision, mood changes, sweating, or a fast heartbeat.
  • Kidney injury: If you have kidney problems, fluid loss from diarrhea, nausea, or vomiting can make them worse. Drinking plenty of water helps lower this risk.
  • Serious allergic reactions: Stop using the medication right away if you have swelling of the face, lips, tongue, or throat; a severe rash or itching; a very fast heartbeat; trouble breathing or swallowing; or fainting or dizziness.
  • Diabetic eye complications: If you have type 2 diabetes, tell your provider right away about any change in your vision.
  • Faster heart rate: Tell your provider right away if your heart races while you are at rest.
  • Suicidal thoughts or behavior: Pay attention to any change in your mood, behavior, thoughts, or feelings, especially sudden ones. Call your provider right away about any mental change that is new, getting worse, or worries you.
REPORTING SIDE EFFECTS AND EMERGENCIES

This is not a complete list of side effects. If you notice anything not listed here, contact your provider or pharmacist. In the US, call your provider for medical advice about side effects. You can also report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

If you are having a medical emergency, call 911 or get medical care immediately.

LEGAL DISCLAIMER

Compounded GLP-1/GIP (tirzepatide) is not FDA-approved. The FDA does not evaluate compounded products for safety, effectiveness, or quality.

Last Updated: October 27, 2026