safety information
Compounded • Not FDA-evaluated

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.