Warning: Risk of Thyroid C-Cell Tumors

In animal studies, tirzepatide — the active ingredient in Zepbound — caused thyroid C-cell tumors, including thyroid cancer. It is not known whether Zepbound causes thyroid tumors, including medullary thyroid carcinoma (MTC), in humans.

Tell your healthcare provider immediately if you notice a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, as these may be symptoms of thyroid cancer.

Do not use Zepbound if you or any family member has ever had medullary thyroid carcinoma (MTC) or if you have a rare endocrine condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

FDA-Approved Use

Zepbound (tirzepatide) is approved by the U.S. Food and Drug Administration (FDA) for:

• Use along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or overweight with at least one weight-related medical condition (such as high blood pressure, type 2 diabetes, or high cholesterol).

Limitations of Use:

• Zepbound should not be used together with other tirzepatide-containing products or any other GLP-1 receptor agonist.

Who Should Not Use Zepbound

Do not use Zepbound if:

• You or a family member has ever had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• You are allergic to tirzepatide or any ingredient in the medication.

How to Take Zepbound

Zepbound is administered once weekly as a subcutaneous injection in the stomach, thigh, or upper arm. It is available as a pre-filled injector pen or single-dose vial with syringe.

It may be taken with or without food. Use Zepbound on the same day each week, at any time of day.
Your healthcare provider will guide you on a dosing schedule, which may include gradual increases every four weeks.

Do not adjust your dose or stop using Zepbound without consulting your provider.

Before Using Zepbound — Tell Your Healthcare Provider

It’s important to tell your healthcare provider about all medications, vitamins, and supplements you are currently taking, including:

• Prescription or over-the-counter medicines

• Herbal or dietary supplements

Potential drug interactions include:

• Diabetes medications: Using tirzepatide with insulin or sulfonylureas (e.g., glipizide, glimepiride) may increase the risk of low blood sugar (hypoglycemia).

• Oral medications: Zepbound slows gastric emptying, which may affect the absorption of medicines taken by mouth.

• Hormonal birth control: Oral contraceptives may be less effective when starting or increasing the dose of Zepbound. Use a non-oral or barrier method for 4 weeks after starting treatment and after each dose escalation.

• Other GLP-1 medications: Do not use Zepbound with Mounjaro, Wegovy, Ozempic, Saxenda, Victoza, Byetta, or Bydureon.

• Weight-loss supplements or products: Avoid combining Zepbound with other products intended for weight management.

Provide your complete medical history, especially if you have or have had:

• Type 1 or type 2 diabetes

• Thyroid disorders or thyroid cancer

• Pancreatitis

• Gastrointestinal disease

• Kidney disease

• Diabetic retinopathy

• Depression or suicidal thoughts

Pregnancy and breastfeeding:

• Zepbound should not be used during pregnancy. Weight loss during pregnancy offers no benefit and may harm the unborn baby.

• Zepbound may reduce the effectiveness of oral contraceptives. Use a non-oral or barrier contraceptive for 4 weeks after starting and after each dose escalation.

• It is unknown if Zepbound passes into human breast milk. Discuss risks and benefits with your provider before breastfeeding.

Pregnancy registry:
Patients and providers are encouraged to report pregnancies exposed to tirzepatide by contacting Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).

Providing incomplete or inaccurate medical information may lead to serious harm.

Serious Side Effects — Seek Medical Help Immediately

Call 911 or seek emergency care if you experience:

• Thyroid C-cell tumors: Lump in neck, hoarseness, difficulty swallowing, or shortness of breath.

• Severe gastrointestinal symptoms: Persistent nausea, vomiting, diarrhea, constipation, or stomach pain. These may be more common during dose increases.

• Pancreatitis: Severe and constant abdominal pain that may radiate to the back, with or without vomiting.

• Gallbladder problems: Pain in the upper abdomen, yellowing of the skin or eyes (jaundice), fever, or clay-colored stools.

• Kidney problems or dehydration: Nausea, vomiting, or diarrhea may lead to fluid loss and worsen kidney function. Stay hydrated.

• Allergic reactions: Swelling of the face, lips, tongue, or throat; rash or itching; fast heartbeat; trouble breathing; or fainting.

• Low blood sugar (hypoglycemia): Dizziness, sweating, blurred vision, irritability, or rapid heartbeat — especially if using insulin or other diabetes medications.

• Diabetic retinopathy: Report any changes in vision.

• Mental health changes: New or worsening depression, mood swings, or suicidal thoughts. Contact your provider immediately.

• Pulmonary aspiration during anesthesia: Zepbound delays stomach emptying, which may increase aspiration risk during procedures under sedation. Notify your provider before surgery.

Never share your injection pen, syringe, or needle with anyone to prevent infection.

Common Side Effects

The most frequently reported side effects of Zepbound include:

• Nausea

• Diarrhea

• Vomiting

• Constipation

• Stomach pain

• Indigestion (heartburn)

• Injection site reactions

• Tiredness or fatigue

• Belching or bloating

• Hair loss

• Mild allergic reactions

These effects are generally mild to moderate and often improve over time. If symptoms persist, contact your healthcare provider.

Reporting Adverse Events

To report side effects or adverse reactions:

• Contact US Quick Health Support or your licensed healthcare provider, or

• Report directly to the U.S. Food and Drug Administration (FDA) at www.fda.gov/medwatch or call 1-800-FDA-1088.

Additional Information

This information is not comprehensive.
Refer to the full Prescribing Information or speak with your healthcare provider for complete safety details.