Safety
Important Safety Information
Read this before starting treatment, and talk to your Provider about any questions.
Boxed warning: risk of thyroid C-cell tumors. In studies in rodents, semaglutide and tirzepatide caused thyroid C-cell tumors. It isn’t known whether they cause these tumors, including medullary thyroid carcinoma (MTC), in people. Do not use these medications if you or a family member has ever had MTC, or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your Provider if you get a lump or swelling in your neck, trouble swallowing, hoarseness, 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 ingredient.
- Are pregnant or planning to become pregnant. Stop at least 2 months before a planned pregnancy.
Serious side effects
- Pancreatitis. Stop and seek care if you have severe stomach pain that won’t go away, with or without vomiting.
- Gallbladder problems, including gallstones. Symptoms include upper stomach pain, fever, yellowing skin or eyes, and clay-colored stools.
- Low blood sugar, especially if you also take insulin or a sulfonylurea.
- Kidney problems. Diarrhea, nausea, and vomiting can cause dehydration. Drink fluids.
- Serious allergic reactions. Get emergency help for swelling of the face, lips, tongue, or throat, or trouble breathing.
- Changes in vision in people with type 2 diabetes.
- Increased heart rate.
- Depression or thoughts of suicide. Watch for changes in mood and contact your Provider right away.
- Aspiration during anesthesia. Tell your surgeon or anesthesiologist that you take a GLP-1 medication before any procedure.
Common side effects
Nausea, diarrhea, vomiting, constipation, stomach pain, indigestion, headache, fatigue, dizziness, bloating, belching, and injection-site reactions.
Before starting, tell your Provider if you
- Have or have had problems with your pancreas, kidneys, or gallbladder.
- Have type 2 diabetes with diabetic retinopathy.
- Have severe stomach problems such as slowed emptying (gastroparesis).
- Are breastfeeding or plan to breastfeed.
- Take any other medications, including oral birth control. Tirzepatide may make oral birth control less effective for 4 weeks after starting and after each dose increase.
About compounded medications
Compounded semaglutide and tirzepatide are not FDA-approved. The FDA does not verify the safety, effectiveness, or quality of compounded drugs. Safety information above is based on the FDA-approved versions of these active ingredients.
You are encouraged to report negative side effects of prescription drugs to the FDA at MedWatch (fda.gov/medwatch) or 1-800-FDA-1088.