Zepbound® (tirzepatide) - Safety Information

Safety Information

Do not use if you have been diagnosed with the following:

  • Diabetic ketoacidosis

  • Type 1 diabetes

  • Diabetic retinopathy

  • Kidney disease

  • Multiple endocrine neoplasia syndrome type 2 (MEN 2)

  • Thyroid cancer

  • Pancreatitis

Some side effects may occur that typically do not require medical attention, as they may improve as your body adapts to the medication. Gastrointestinal (GI) symptoms may increase temporarily when your dose is raised but often lessen over time. If you experience any unwanted effects, contact your healthcare provider — they may be able to suggest ways to prevent or minimize side effects. You’re also welcome to reach out to us with any questions about your treatment or symptoms.

More common side effects

  • Acid or sour stomach

  • Belching

  • Constipation

  • Diarrhea

  • Stomach discomfort or upset

  • Abdominal pain

  • Low blood sugar (hypoglycemia)

  • Reactions at the injection site

  • Gallbladder problems

  • Allergic reactions

Other side effects not listed here may also occur. If you experience anything unusual, consult your healthcare provider.

Call your doctor for medical advice about side effects. You may report adverse effects to the FDA by calling 1-800-FDA-1088.

For a full list of possible side effects, visit: https://www.mayoclinic.org

Zepbound® Safety Information:

Zepbound® (ZEHP-bownd) is a prescription injectable medicine used to support weight loss in adults with obesity or excess weight who also have weight-related health concerns. It is intended to be used alongside a reduced-calorie diet and increased physical activity.

Zepbound® contains tirzepatide and should not be combined with other tirzepatide-based products or any GLP-1 receptor agonist medications. The safety and effectiveness of Zepbound® when used with other weight-loss medications — including prescription, over-the-counter, or herbal products — are unknown. It is also unknown whether Zepbound® can be used safely in individuals with a history of pancreatitis or in patients under 18 years of age.

Warning

Zepbound® may increase the risk of thyroid tumors, including thyroid cancer. Be aware of symptoms such as a lump in the neck, hoarseness, difficulty swallowing, or shortness of breath. Contact your doctor if you experience any of these signs.

Do not use Zepbound® if:

  • You or a family member have a history of medullary thyroid carcinoma (MTC)

  • You have been diagnosed with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

  • You’ve had a serious allergic reaction to tirzepatide or any ingredient in Zepbound®

Zepbound® may cause serious side effects, including:

Severe stomach issues. Some users have reported significant digestive discomfort. Tell your provider if symptoms are severe or persistent.

Kidney complications. Prolonged vomiting, diarrhea, or nausea may lead to dehydration and affect kidney function. Stay well-hydrated.

Gallbladder disease. Alert your doctor if you experience upper abdominal pain, fever, yellow skin or eyes, or light-colored stools.

Pancreatitis. Seek immediate care if you develop intense stomach pain that radiates to your back, with or without vomiting.

Severe allergic reactions. Stop using Zepbound® and get emergency care if you experience facial or throat swelling, trouble breathing, rashes, dizziness, or a fast heartbeat.

Low blood sugar (hypoglycemia). This risk increases if used alongside insulin or sulfonylureas. Watch for shakiness, sweating, confusion, or blurred vision.

Vision changes in diabetic patients. Report any changes in eyesight to your provider.

Depression or suicidal thoughts. Be aware of changes in mood or behavior and consult your provider if symptoms arise or worsen.

Common Side Effects

The most commonly reported side effects of Zepbound® include:

  • Nausea

  • Diarrhea

  • Vomiting

  • Constipation

  • Abdominal pain

  • Indigestion

  • Tiredness

  • Injection site reactions

  • Allergic reactions

  • Belching

  • Hair loss

  • Heartburn

This is not a complete list. Talk to your healthcare provider about any side effect that is bothersome or doesn’t go away.

Tell your doctor if you experience any side effects. You may also report them to the FDA at 1-800-FDA-1088 or by visiting www.fda.gov/medwatch.

Before using Zepbound®

Your provider will guide you through the correct use of Zepbound® before you begin treatment.

Inform your provider if you are using medications for diabetes — especially insulin or sulfonylureas — as these can increase your risk of low blood sugar. Discuss strategies for managing blood sugar with your care team.

If you use oral contraceptives, Zepbound® may reduce their effectiveness. Your provider may recommend a backup method of birth control for four weeks after starting Zepbound®, and after each increase in dose.

Review these important questions with your healthcare provider:

  • Do you have a history of pancreatic, kidney, or severe gastrointestinal issues such as gastroparesis or difficulty digesting food?

  • Are you using insulin or other diabetes medications?

  • Do you have a history of diabetic eye disease?

  • Are you taking any other prescription, over-the-counter, or herbal supplements?

  • Are you pregnant, trying to become pregnant, or breastfeeding?

Zepbound® may harm your unborn child. If you become pregnant while taking this medication, notify your healthcare provider. It is not known if Zepbound® passes into breast milk.

Pregnancy Exposure Registry

A pregnancy registry is available to monitor outcomes in women who use Zepbound® during pregnancy. Speak with your provider about enrolling, or call Lilly at 1-800-LillyRx (1-800-545-5979).

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.