Important Safety Information for Zepbound® (tirzepatide)

Atlas HRT safety summary derived from the Zepbound® Prescribing Information and Medication Guide revised 08/2026. Last reviewed September 11, 2026.

What is the FDA-approved use of Zepbound®?

Zepbound® is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to 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® 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.

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®.

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).

Tell your healthcare provider about all the medicines you take

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.

What are the most serious side effects to watch for?

Zepbound® may cause serious side effects, including:

• 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. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
• 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), fever, yellowing of skin or eyes (jaundice), 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 nausea or vomiting. Sometimes 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, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, very rapid heartbeat.
• 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, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness, 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®.
• 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.

Do not share your Zepbound® KwikPen® or needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

What are the most 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, 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.

Pregnancy and breastfeeding

Before using Zepbound®, tell your healthcare provider if you:

• 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 is 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 call 1-844-524-0039 or email at MILEregistry@thermofisher.com or visit https://pregnancyregistry.lilly.com/zepbound.
• 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®.