Mounjaro Safety Information

Important Safety Information for Mounjaro (tirzepatide) injection

Warning: Risk of Thyroid C-Cell Tumors

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

Tell your healthcare provider immediately if you develop a lump or swelling in your neck, persistent hoarseness, difficulty swallowing, or shortness of breath - these may be signs of thyroid cancer.

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

FDA-Approved Use

Mounjaro (tirzepatide) is approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Limitations of Use:

Not studied in patients with a history of pancreatitis.
Not indicated for the treatment of type 1 diabetes mellitus.

Who Should Not Use Mounjaro

Do not use Mounjaro if:

You or a family member has ever had medullary thyroid carcinoma (MTC).
You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
You have a known allergy to tirzepatide or any ingredient in Mounjaro.

How to Use Mounjaro

Mounjaro is injected once weekly under the skin (subcutaneous injection) in the stomach, thigh, or upper arm. Rotate the injection site each week. It can be taken with or without food.

Use Mounjaro on the same day each week, at any time of day.
Do not change your dose or stop using Mounjaro without consulting your healthcare provider.

Before Using Mounjaro - Tell Your Healthcare Provider

Inform your provider about all medications, supplements, and health conditions before starting Mounjaro, including:

Prescription or over-the-counter medicines
Vitamins, herbal, or dietary supplements

Important drug interactions include:

Diabetes medications: Using tirzepatide with insulin or sulfonylureas may increase the risk of low blood sugar.
Other GLP-1 receptor agonists: Do not combine Mounjaro with medications such as Ozempic, Wegovy, Saxenda, Victoza, Byetta, or Bydureon.
Oral medications: Mounjaro slows gastric emptying and may affect absorption of oral drugs.
Hormonal birth control: Oral contraceptives may be less effective during initiation or dose escalation. Use an alternative (non-oral) or barrier contraceptive for 4 weeks after starting Mounjaro and after each dose increase.

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

Type 1 or type 2 diabetes
Thyroid disorders or thyroid cancer
Pancreatitis
Kidney or liver disease
Gastrointestinal disease or gastroparesis
Diabetic retinopathy

If you are pregnant or planning to become pregnant, do not use Mounjaro. Weight loss during pregnancy offers no benefit and may harm the unborn baby.

If you are breastfeeding, it is not known whether Mounjaro passes into breast milk. Discuss risks and benefits with your provider.

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

Serious Side Effects - When to Seek Immediate Medical Care

Call 911 or seek emergency medical attention if you experience any of the following:

Thyroid C-cell tumors: Symptoms include a lump in the neck, hoarseness, trouble swallowing, or shortness of breath.
Pancreatitis: Severe, persistent abdominal pain (sometimes radiating to the back) with or without vomiting.
Hypoglycemia (low blood sugar): Especially when combined with insulin or sulfonylureas. Symptoms include sweating, dizziness, fast heartbeat, confusion, or blurred vision.
Severe allergic reactions: Swelling of face, lips, tongue, or throat; rash or itching; breathing problems; or fainting. Stop Mounjaro immediately and seek medical attention.
Kidney injury or dehydration: Nausea, vomiting, or diarrhea may lead to fluid loss. Stay hydrated to prevent kidney problems.
Gastrointestinal side effects: Severe nausea, vomiting, constipation, or abdominal pain. Mounjaro is not recommended in patients with severe gastrointestinal disease.
Diabetic retinopathy complications: Report any changes in vision.
Gallbladder problems: Pain in the upper stomach, yellowing of skin or eyes (jaundice), fever, or pale stools may indicate gallstones or gallbladder inflammation.

Never share your injection pen with others to avoid risk of infection.

Common Side Effects

The most common side effects of Mounjaro may include:

Nausea
Diarrhea
Decreased appetite
Vomiting
Constipation
Indigestion
Stomach pain

Most side effects are mild to moderate and tend to lessen over time. If symptoms persist, contact your healthcare provider.

Reporting Side Effects

To report adverse reactions or side effects:

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

Additional Information

This summary does not contain all possible safety information. For complete details, refer to the FDA-approved Prescribing Information or consult your licensed healthcare provider.