Important Safety Information

Draft pending clinical and legal review. The safety language below must be confirmed by the Medical Group and pharmacy against current FDA labeling before it is published. It is provided here for review and is not medical advice.

This page covers the compounded semaglutide and tirzepatide offered through Ryo. Read it before you order, and talk with your provider about your full medical history.

What these medications are used for

Semaglutide and tirzepatide are used for chronic weight management in appropriate patients, alongside diet and increased physical activity.

Boxed-warning class risk: thyroid tumors

These medications carry a class risk of thyroid C-cell tumors. Do not use them if you or a family member have had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Seek care for a neck mass, trouble swallowing, or hoarseness that will not go away.

Other serious risks

• Inflammation of the pancreas (pancreatitis).
• Gallbladder problems.
• Kidney problems from dehydration caused by nausea, vomiting, or diarrhea.
• Low blood sugar (hypoglycemia), especially if combined with insulin or a sulfonylurea.
• Serious allergic reactions.
• Vision changes.

Pregnancy and breastfeeding

These medications may harm an unborn baby. Stop use and call your provider if you are pregnant or planning to become pregnant, and discuss breastfeeding with your provider.

Common side effects

Nausea, vomiting, diarrhea, constipation, stomach pain, headache, and fatigue. These are not all of the possible side effects.

Compounded medication: not FDA-approved

The semaglutide and tirzepatide offered through Ryo are compounded preparations prepared by a licensed pharmacy. Compounded drugs are not FDA-approved. The FDA does not review compounded drugs for safety, effectiveness, or quality before they are marketed. [Counsel and pharmacy to state and maintain the legal basis for compounding (503A patient-specific or 503B outsourcing facility) and keep it current as shortage listings change.]

Reporting side effects

Contact your provider about any side effect. For a medical emergency or suspected overdose, call 911 or your poison control center. You may also report side effects to the FDA at MedWatch (1-800-FDA-1088).

This is not a complete list of risks. Read all information provided with your medication and ask your provider any questions.