Important Safety Information
Please read this before starting GLP-1 treatment, and talk to your clinician about any questions.
Important Safety Information
Warning: possible thyroid tumors, including cancer. In studies in rodents, tirzepatide and semaglutide caused thyroid C-cell tumors. It is not known whether they cause these tumors in people. Do not use GLP-1 medication if you or a family member has ever had medullary thyroid carcinoma (MTC) or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your clinician about a lump or swelling in your neck, trouble swallowing, hoarseness or shortness of breath.
Do not use if you are pregnant, planning to become pregnant or breastfeeding, or if you have had a serious allergic reaction to tirzepatide, semaglutide or any ingredient.
Serious side effects may include
- Inflammation of the pancreas (pancreatitis). Stop and get help right away for severe stomach pain that won’t go away, with or without vomiting.
- Gallbladder problems, including gallstones: pain in the upper stomach, fever, yellowing of skin or eyes, clay-colored stools.
- Low blood sugar, especially if you also take insulin or a sulfonylurea: dizziness, sweating, confusion, shakiness, fast heartbeat.
- Kidney problems. Diarrhea, nausea and vomiting can cause dehydration, which may worsen kidney function. Drink plenty of fluids.
- Serious allergic reactions: swelling of the face, lips, tongue or throat; trouble breathing or swallowing; severe rash; fainting.
- Changes in vision in people with type 2 diabetes.
- Depression or thoughts of suicide. Watch for new or worsening mood changes and call your clinician or 988 right away.
- Food or liquid getting into the lungs during surgery or sedation. Tell every provider you take a GLP-1 before any procedure.
Common side effects
Nausea, diarrhea, vomiting, constipation, stomach pain, indigestion, burping, heartburn, reduced appetite, tiredness, hair loss and injection-site reactions. These are most common when starting or increasing a dose and often ease over time.
Before you start, tell your clinician if you
- Have or had problems with your pancreas, kidneys, gallbladder or severe stomach problems such as slowed emptying (gastroparesis)
- Have type 2 diabetes or a history of diabetic retinopathy
- Have had depression, suicidal thoughts or mental health problems
- Are scheduled for surgery or a procedure with anesthesia
- Take any other medicines, including insulin, sulfonylureas or oral birth control. Tirzepatide can make birth control pills less effective; use a non-oral method or add a barrier method for 4 weeks after starting and after each dose increase.
About compounded medications
Compounded tirzepatide and semaglutide are prepared by a state-licensed pharmacy for an individual patient. They are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality. They were not studied in the clinical trials of the brand-name medicines. Use only as prescribed, and only medication dispensed through your Rovymi care plan.
This is not all the information about these medicines. Talk with your clinician. You can report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088. In an emergency, call 911.