Important Safety Information (ISI) - Zepbound®

Prescription only. For use under the supervision of a qualified healthcare provider.

BLACK BOX WARNING – Risk of Thyroid C-Cell Tumors

  • Do not use Zepbound® if you or a family member has ever had:
    • Medullary thyroid carcinoma (MTC)
    • Multiple endocrine neoplasia syndrome type 2 (MEN 2)
  • Zepbound® may cause tumors in the thyroid, including cancer.
  • In animal studies, tirzepatide caused thyroid tumors; it is not known if it causes them in humans.
  • Call your healthcare provider immediately if you notice a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

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)
  • 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/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/throat, difficulty breathing/swallowing, rash, itching, fainting, dizziness, or rapid heartbeat
  • Low blood sugar: 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.
  • Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.