Important Safety Information
Last updated: June 4, 2026
ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH PROVIDER WITH ANY QUESTIONS YOU MAY HAVE REGARDING A MEDICAL CONDITION. THIS PAGE IS INFORMATIONAL AND IS NOT A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE.
About Compounded GLP-1 Medications
Compounded semaglutide and compounded tirzepatide are not FDA-approved. The FDA does not evaluate compounded medications for safety, effectiveness, or quality. Compounded medications are prepared by state-licensed pharmacies pursuant to a prescription written by a licensed provider for an individual patient. Semaglutide and tirzepatide are the active ingredients also found in certain FDA-approved branded products; compounded versions are different from those branded products.
Boxed Warning - Risk of Thyroid C-Cell Tumors
In rodent studies, GLP-1 receptor agonists caused thyroid C-cell tumors. It is unknown whether these medications cause such tumors, including medullary thyroid carcinoma (MTC), in humans. Do not use if you or a family member has a history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Do Not Use If
- You or a family member has had MTC or MEN 2;
- You have had a serious allergic reaction to semaglutide, tirzepatide, or any of their ingredients;
- You are pregnant, planning to become pregnant, or breastfeeding.
Warnings & Precautions
Tell your provider before and during treatment about all your medical conditions. Serious risks may include: inflammation of the pancreas (pancreatitis); gallbladder problems; low blood sugar (hypoglycemia), especially when used with insulin or a sulfonylurea; acute kidney injury (often related to dehydration from nausea, vomiting, or diarrhea); serious allergic reactions; diabetic retinopathy complications; and gallbladder disease. Stop use and seek medical attention for severe, persistent abdominal pain or signs of an allergic reaction.
Common Side Effects
The most common side effects include nausea, vomiting, diarrhea, constipation, abdominal pain, indigestion, decreased appetite, fatigue, and injection-site reactions. These often lessen over time.
Drug Interactions & Other Medications
Tell your provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and supplements. These medications may affect how other medicines are absorbed because they slow stomach emptying.
Pregnancy & Breastfeeding
Do not use if you are pregnant, may become pregnant, or are breastfeeding. Tell your provider if you become pregnant during treatment.
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. If you are experiencing a medical emergency, call 9-1-1 immediately.