Important Safety Information
Compounded GLP-1 (Semaglutide)
Prescription only. For use under the supervision of a qualified healthcare provider.
Black Box Warning: Risk of Thyroid C-Cell Tumors
- Do not use compounded semaglutide if you have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- In animal studies, compounded semaglutide caused thyroid C-cell tumors. It is not known if this occurs in humans.
- Call your healthcare provider immediately if you notice 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 medullary thyroid carcinoma (MTC)
- Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Are pregnant or planning to become pregnant
- Are breastfeeding
- Have had a serious allergic reaction to semaglutide or any of its ingredients
Before Using Compounded GLP-1
Tell your healthcare provider about your full medical history, including if you have:
- Kidney, liver, or pancreas problems
- A history of pancreatitis or gallbladder disease
- Severe gastrointestinal disease
- A history of diabetic retinopathy
- Depression, suicidal thoughts, or behavior changes
Discuss all prescription and non-prescription medications, vitamins, and supplements you take, especially:
- Insulin or insulin secretagogues (e.g., sulfonylureas)
- Thyroid hormone medication
- Medications with a narrow therapeutic range (e.g., warfarin)
Pregnancy, Breastfeeding & Contraception
- Do not use if you are pregnant, planning to become pregnant, or breastfeeding.
- Stop treatment at least 2 months before trying to conceive.
- Use effective contraception while on treatment.
- This medication may cause fetal harm.
Serious Warnings: Call Your Doctor Immediately If You Experience:
- Thyroid C-cell tumor symptoms (see Black Box Warning above)
- Pancreatitis: severe abdominal or back pain that does not go away, with or without vomiting
- Gallbladder disease: pain in the upper right stomach, fever, yellowing of skin or eyes, nausea or vomiting
- Kidney problems: reduced urination, swelling, fatigue, especially if dehydrated from nausea, vomiting, or diarrhea
- Diabetic retinopathy changes: sudden vision changes
- Serious allergic reaction: swelling of face, lips, tongue, or throat; difficulty breathing or swallowing; rash, itching, fainting, dizziness, or rapid heartbeat
- Hypoglycemia (especially if also taking insulin or sulfonylureas): dizziness, confusion, sweating, rapid heartbeat, shakiness, headache
- Worsening depression or suicidal thoughts
If any of these occur, stop treatment and seek immediate medical attention.
Common Side Effects
Some people experience no side effects. The most common include:
- Nausea, vomiting, diarrhea, constipation, abdominal pain
- Headache, dizziness, fatigue
- Indigestion, upset stomach, acid reflux
- Decreased appetite
- Injection site reactions
Side effects are usually mild to moderate and tend to decrease over time. Contact your provider if symptoms persist or worsen.
Drug Interactions
- Compounded semaglutide slows gastric emptying, which may impact the absorption of oral medications.
- Dose adjustments may be required for insulin, sulfonylureas, thyroid hormone, and medications with a narrow therapeutic index.
- Monitor closely if on warfarin or other blood thinners.
Important Note on Compounded Medications
Compounded semaglutide is prepared by a licensed compounding pharmacy and is not evaluated by the FDA for safety or effectiveness. It is not equivalent to FDA-approved semaglutide products such as Wegovy® or Ozempic®.
Emergency Information
- In case of a medical emergency, call 911 or go to the nearest emergency room.
- To report side effects, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
For informational purposes only. Not a substitute for medical advice, diagnosis, or treatment. Consult a licensed provider. In emergencies, call 911.