Zepbound®
Important Safety Information
Zepbound®
Weight ManagementSafety 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 do not require medical attention, as they may lessen as your body adjusts to the medication. You may experience more gastrointestinal (GI) side effects when you increase your dose, however it should be less over time. Reach out to your healthcare provider if you experience any unwanted side effects as there may be ways to prevent or reduce side effects.
More Common Side Effects
- Acid or sour stomach
- Belching
- Constipation
- Diarrhea
- Stomach discomfort or upset
- Stomach pain
- Hypoglycemia (low blood sugar)
- Injection-site reactions
- Gallbladder disease
- Hypersensitivity reactions
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Zepbound™ Safety Information
Zepbound™ (ZEHP-bownd) is an injectable prescription medicine that may help adults with obesity, or with excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.
Zepbound™ contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if Zepbound can be used in people who have had pancreatitis. It is not known if Zepbound is safe and effective for use in children under 18 years of age.
Warning
Zepbound™ may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
- Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
- Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.
Zepbound™ may cause serious side effects, including:
- Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound.
- Kidney problems (kidney failure). Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems.
- Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms including pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.
- Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting.
- Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction.
- Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin.
- Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.
- Depression or thoughts of suicide. You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
Common Side Effects
The most common side effects of Zepbound™ include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.
Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before Using Zepbound™
Your healthcare provider should show you how to use Zepbound before you use it for the first time.
Tell your healthcare provider if you are taking medicines to treat diabetes including insulin or sulfonylureas which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them.
If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound™ and for 4 weeks after each increase in your dose of Zepbound.
Review these questions with your healthcare provider:
- Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
- Do you take diabetes medicines, such as insulin or sulfonylureas?
- Do you have a history of diabetic retinopathy?
- Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
- Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound™ may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. It is not known if Zepbound passes into your breast milk.
Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound™ during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979).