Zepbound® (Tirzepatide) Safety Information

Do Not Use Zepbound® If You Have:

Type 1 diabetes

Diabetic ketoacidosis

Diabetic retinopathy

Kidney disease

Thyroid cancer

Pancreatitis

Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

A serious allergic reaction to tirzepatide or any ingredient in Zepbound®

Before Using Zepbound®

Tell your healthcare provider if you have:

Pancreas, kidney, or gallbladder problems

Severe stomach problems (including gastroparesis or difficulty digesting food)

A history of diabetic retinopathy

Depression, suicidal thoughts, or other mental health changes

Any other medical condition or allergies

Also tell your healthcare provider if you:

Take diabetes medicines such as insulin or sulfonylureas (may increase risk of low blood sugar)

Take birth control pills. Effectiveness may decrease for 4 weeks after starting or increasing your Zepbound® dose; you may need an alternative form of contraception

Take any prescription, over-the-counter, or herbal medicines

Are pregnant, planning to become pregnant, or breastfeeding (Zepbound® may harm your unborn baby; it is unknown if it passes into breast milk)

Pregnancy Exposure Registry: If you take Zepbound® while pregnant, you may be eligible to enroll in a registry that monitors health outcomes for you and your baby. Call Lilly at 1-800-LillyRx (1-800-545-5979).

Serious Warnings: Call Your Doctor Immediately If You Experience:

Thyroid C-cell tumor symptoms (see Black Box Warning above)

Severe stomach problems: pain or discomfort that will not go away

Pancreatitis: severe abdominal pain (with or without vomiting) that may radiate to your back

Gallbladder disease: upper abdominal pain, fever, yellowing skin or eyes, clay-colored stools

Kidney problems or kidney failure: especially if dehydrated from nausea, vomiting, or diarrhea

Serious allergic reaction: swelling of face, lips, tongue, or throat; difficulty breathing or swallowing; rash, itching, fainting, dizziness, or rapid heartbeat

Low blood sugar (hypoglycemia): dizziness, sweating, confusion, blurred vision, slurred speech, shakiness, rapid heartbeat, hunger, irritability, especially if on insulin or sulfonylureas

Changes in vision (especially if you have type 2 diabetes)

Depression or suicidal thoughts: changes in mood, behavior, or thoughts

Common Side Effects

Some people have no side effects. The most common include:

Nausea, vomiting, diarrhea, constipation, abdominal pain

Indigestion, acid reflux, belching, sour stomach

Injection site reactions

Fatigue

Allergic reactions

Hair loss

Heartburn

Gallbladder disease symptoms

Low blood sugar (in people with type 2 diabetes on certain medications)

Side effects often lessen over time as your body adjusts. Contact your healthcare provider if they persist or worsen.

Other Safety Notes

Zepbound® should be used with a reduced-calorie diet and increased physical activity.

Do not use with other tirzepatide-containing products or any GLP-1 receptor agonists.

Safety with other prescription, over-the-counter, or herbal weight-loss products is unknown.

Zepbound® has not been studied in children under 18.

Your healthcare provider should train you on proper injection technique before your first dose.

Emergency Information

In a medical emergency, call 911 or go to the nearest emergency room.

To report side effects, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.