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Important Safety Information

Compounded semaglutide and compounded tirzepatide injection · Last updated August 18, 2026

Boxed warning — risk of thyroid C-cell tumors

In rodents, semaglutide and tirzepatide cause dose-dependent and treatment-duration-dependent thyroid C-cell tumors. It is unknown whether these medications cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Do not use these medications if you or any of your family have ever had MTC, or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you develop a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

Do not use if you

  • Have a personal or family history of MTC or have MEN 2
  • Have had a serious allergic reaction to semaglutide, tirzepatide, or any of their ingredients
  • Are pregnant, planning to become pregnant, or breastfeeding — these medications may harm your unborn baby; stop treatment at least 2 months before a planned pregnancy
  • Have a history of pancreatitis (tell your provider — treatment may not be appropriate)
  • Have type 1 diabetes or a history of diabetic ketoacidosis
  • Are under 18 years of age

Warnings

GLP-1 medications may cause serious side effects, including: inflammation of the pancreas (severe abdominal pain that will not go away, with or without vomiting — stop use and get medical help right away); gallbladder problems including gallstones (pain in the upper stomach, fever, yellowing of the skin or eyes, clay-colored stools); kidney problems, including worsening kidney failure with dehydration from nausea, vomiting, or diarrhea; low blood sugar, especially if used with insulin or a sulfonylurea (dizziness, sweating, shakiness, confusion, fast heartbeat); serious allergic reactions (swelling of the face, lips, tongue, or throat; trouble breathing; severe rash — get emergency help immediately); changes in vision in patients with type 2 diabetes; increased heart rate; and depression or thoughts of suicide — pay attention to sudden changes in mood, behavior, or feelings, and contact your provider right away if they occur. If you have thoughts of suicide or self-harm, call or text 988.

These medications delay gastric emptying, which may affect absorption of oral medications. Tell your provider about all medicines you take, including insulin, sulfonylureas, and birth control pills (tirzepatide may reduce the effectiveness of oral contraceptives — use a backup method for 4 weeks after starting and after each dose increase). Stop use before scheduled surgeries with anesthesia and follow your care team's instructions.

Common side effects

The most common side effects include nausea, vomiting, diarrhea, constipation, stomach pain, indigestion, injection-site reactions, fatigue, and headache. These are most likely when starting treatment or increasing your dose, and usually lessen over time. Contact your care team if side effects persist or worsen — dose adjustments often help.

About compounded medications

Compounded semaglutide and compounded tirzepatide are prepared by U.S. state-licensed compounding pharmacies. Compounded medications are permitted under Section 503A/503B of the Federal Food, Drug, and Cosmetic Act but are not FDA-approved and have not been evaluated by the FDA for safety, efficacy, or quality. Your provider will discuss whether a compounded medication or an FDA-approved alternative (such as Wegovy® or Zepbound®) is appropriate for you. This page is a summary and does not replace the counseling provided by your clinician and pharmacist or the medication guide included with your prescription.

If you believe you are experiencing a medical emergency, call 911 or go to the nearest emergency room. To report a suspected adverse reaction, contact your care team at help@lelandhealth.com or report to the FDA MedWatch program at 1-800-FDA-1088.