WARNINGS
What is the most important information I should know about ZEPBOUND?
ZEPBOUND may cause serious side effects, including:
Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats, ZEPBOUND and medicines that work like ZEPBOUND caused thyroid tumors, including thyroid cancer. It is not known if ZEPBOUND will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use ZEPBOUND if you or any of your family have ever had a type of thyroid cancer called MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Do not use ZEPBOUND if:
you or any of your family have ever had a type of thyroid cancer called MTC or if you have an endocrine system condition called MEN 2.
you have had a serious allergic reaction to tirzepatide or any of the ingredients in ZEPBOUND. See the end of this Medication Guide for a complete list of ingredients in ZEPBOUND. See “What are the possible side effects of ZEPBOUND?” for symptoms of a serious allergic reaction.
USES
What is ZEPBOUND?
ZEPBOUND is an injectable prescription medicine that may help adults with:
obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
moderate to severe obstructive sleep apnea (OSA) and obesity to improve their OSA.
ZEPBOUND 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 for use in children.
HOW TO USE
How should I use ZEPBOUND?
Read the Instructions for Use that comes with ZEPBOUND.
Use ZEPBOUND exactly as your healthcare provider tells you to.
Your healthcare provider should show you how to prepare to inject your dose of ZEPBOUND before injecting the first time.
Use ZEPBOUND with a reduced-calorie diet and increased physical activity.
Inject ZEPBOUND under the skin (subcutaneously) of your stomach (abdomen), thigh, or another person should inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously).
Use ZEPBOUND 1 time each week, at any time of the day.
You may change the day of the week you use ZEPBOUND as long as the time between the 2 doses is at least 3 days (72 hours).
If you miss a dose of ZEPBOUND, take the missed dose as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and take your next dose on the regularly scheduled day. Do not take 2 doses of ZEPBOUND within 3 days (72 hours) of each other.
ZEPBOUND may be taken with or without food.
Change (rotate) your injection site with each weekly injection. You may use the same area of your body but be sure to choose a different injection site in that area. Do not use the same site for each injection.
If you take too much ZEPBOUND, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What are the possible side effects of ZEPBOUND?
ZEPBOUND may cause serious side effects, including:
See “What is the most important information I should know about ZEPBOUND?”
severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use ZEPBOUND. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration.
gallbladder problems. Gallbladder problems have happened in some people who use ZEPBOUND. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:
pain in your upper stomach (abdomen)
yellowing of skin or eyes (jaundice)
fever
clay-colored stools
inflammation of your 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. You may feel the pain from your abdomen to your back.
serious allergic reactions. Stop using ZEPBOUND and get medical help right away if you have any symptoms of a serious allergic reaction including:
swelling of your face, lips, tongue or throat
fainting or feeling dizzy
problems breathing or swallowing
very rapid heartbeat
severe rash or itching
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 an insulin or sulfonylurea.
Signs and symptoms of low blood sugar may include:
dizziness or light-headedness
blurred vision
anxiety, irritability, or mood changes
sweating
slurred speech
hunger
confusion or drowsiness
shakiness
weakness
headache
fast heartbeat
feeling jittery
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 any changes in your mood, behaviors, feelings, or thoughts. Call your healthcare provider right away if you have any changes to your mental health that are new, worse, or worry you.
food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). ZEPBOUND may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking ZEPBOUND before you are scheduled to have surgery or other procedures.
The most common side effects of ZEPBOUND include:
nausea
stomach (abdominal) pain
allergic reactions
diarrhea
indigestion
belching
vomiting
injection site reaction
hair loss
constipation
feeling tired
heartburn
Talk to your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ZEPBOUND. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ZEPBOUND.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZEPBOUND for a condition for which it was not prescribed. Do not give ZEPBOUND to other people, even if they have the same condition you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ZEPBOUND that is written for health professionals.
What are the ingredients in ZEPBOUND?
Active ingredient: tirzepatide
Inactive ingredients: sodium chloride, sodium phosphate dibasic heptahydrate, and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH.
OVERDOSE
If you take too much ZEPBOUND, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
MISSED DOSE
If you miss a dose of ZEPBOUND, take the missed dose as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and take your next dose on the regularly scheduled day. Do not take 2 doses of ZEPBOUND within 3 days (72 hours) of each other.
STORAGE
How should I store ZEPBOUND?
Store ZEPBOUND in the refrigerator between 36 degrees F to 46 degrees F (2 degrees C to 8 degrees C). Store ZEPBOUND in the original carton until use to protect it from light.
If needed, each single-dose pen or single-dose vial can be stored at room temperature up to 86 degrees F (30 degrees C) for up to 21 days. If ZEPBOUND is stored at room temperature, it should not be returned to the refrigerator.
Discard if not used within 21 days after removing from the refrigerator.
Do not freeze ZEPBOUND. Do not use ZEPBOUND if frozen.
Keep ZEPBOUND and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 09/2025
Prescribing Information: revision date 09/2025
Concomitant Use with Insulin or an Insulin Secretagogue (e.g., Sulfonylurea)
ZEPBOUND lowers blood glucose. When initiating ZEPBOUND, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (e.g., sulfonylureas) to reduce the risk of hypoglycemia.
Oral Medications
ZEPBOUND delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with ZEPBOUND.
Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with ZEPBOUND.
Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception, for 4 weeks after initiation with ZEPBOUND and for 4 weeks after each dose escalation. Hormonal contraceptives that are not administered orally should not be affected.
Before using ZEPBOUND, tell your healthcare provider about all of your medical conditions, including if you:
have or have had problems with your pancreas.
have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
have a history of diabetic retinopathy.
are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).
are pregnant or plan to become pregnant. ZEPBOUND may harm your unborn baby. Tell your healthcare provider if you become pregnant while using ZEPBOUND.
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 Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
Birth control pills by mouth may not work as well while using ZEPBOUND. If you take birth control pills by mouth, 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. Talk to your healthcare provider about birth control methods that may be right for you while using ZEPBOUND.
are breastfeeding or plan to breastfeed. ZEPBOUND may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using ZEPBOUND.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZEPBOUND may affect the way some medicines work, and some medicines may affect the way ZEPBOUND works.
Before using ZEPBOUND, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
