← Safety information

Important Safety Information

Zepbound® KwikPen

Tirzepatide injection

Boxed Warning

Boxed Warning: Risk of thyroid C-cell tumors

Tirzepatide causes thyroid C-cell tumors in rats. It is unknown whether Zepbound causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Zepbound is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Indication

Zepbound® (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or overweight with at least one weight-related condition.

Important safety information

Zepbound may cause serious side effects, including:

  • Possible thyroid tumors, including cancer. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
  • Severe stomach problems, including nausea, vomiting, and diarrhea that may lead to dehydration and kidney problems.
  • Inflammation of the pancreas (pancreatitis). Stop using and call your provider right away if you have severe upper-abdominal pain, with or without vomiting.
  • Low blood sugar (hypoglycemia), especially when used with insulin or a sulfonylurea.
  • Serious allergic reactions. Get medical help right away for swelling of the face, lips, tongue, or throat, trouble breathing, severe rash, fainting, or rapid heartbeat.
  • Acute gallbladder disease, including gallstones and inflammation of the gallbladder.
  • Vision changes in people with type 2 diabetes.
  • Depression or thoughts of suicide. Contact your provider for any mental health changes.
  • Pulmonary aspiration during general anesthesia or deep sedation. Tell anesthesia providers about Zepbound use before any surgery.

Do not use Zepbound if you

  • Or any of your family members have ever had medullary thyroid carcinoma (MTC).
  • Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Have had a serious allergic reaction to tirzepatide or any of the ingredients.

Most common side effects

  • Nausea, diarrhea, vomiting, constipation
  • Stomach pain, indigestion, bloating, gas, burping
  • Injection-site reactions, fatigue
  • Allergic reactions, hair loss, heartburn (GERD)

Before starting Zepbound, tell your provider if you

  • Have or have had problems with your pancreas, kidneys, or gallbladder
  • Have severe stomach problems such as gastroparesis or trouble digesting food
  • Have type 2 diabetes and a history of diabetic retinopathy
  • Are pregnant, plan to become pregnant, or are breastfeeding
  • Use oral contraceptives — tirzepatide may reduce their effectiveness; talk to your provider about backup contraception
  • Are taking other prescription, over-the-counter, vitamin, or herbal products

Reporting side effects

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to the manufacturer or to your NowYou care team.

Important

This summary does not include all information about this medication. It is not a substitute for the full Prescribing Information or for talking with your healthcare provider. Please read the full Prescribing Information and Medication Guide before starting treatment, and discuss any questions with your provider.

Full prescribing information

Always read the full Prescribing Information and Medication Guide before starting treatment.

This safety summary is provided for educational purposes and does not replace the full Prescribing Information, Medication Guide, or professional medical advice. Always discuss benefits, risks, and alternatives with your licensed provider.