COMPOUNDED SEMAGLUTIDE: IMPORTANT SAFETY INFORMATION

ABOUT THIS INFORMATION

This page is for general education only. It does not promote any product, is not medical advice, and does not replace guidance from your healthcare provider. It summarizes key points and does not list every possible risk or side effect.

Compounded semaglutide is a prescription medicine given by injection. It belongs to a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. Your provider may prescribe it, along with a lower-calorie diet and more physical activity, based on your individual health needs and goals.

Compounded drugs are not FDA approved. The FDA does not review them for safety, effectiveness, or quality, and they do not go through the same testing as FDA-approved medicines. They also do not carry official approved uses (indications). Federal and state law allow providers to prescribe compounded drugs in certain situations. After a medical evaluation, your provider will decide whether this medicine is right for you, including the dose and formulation.

WARNING: RISK OF THYROID C-CELL TUMORS

GLP-1 medicines may be linked to a type of thyroid cancer called medullary thyroid carcinoma (MTC). So far this has mainly been seen in studies in rodents, and the risk to people is not yet known.

  • Do not use compounded semaglutide if you or anyone in your family has ever had MTC, or if you have an inherited endocrine condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Tell your provider right away if you notice a lump or swelling in your neck, hoarseness that is unusual or won't go away, trouble swallowing, or shortness of breath. These can be signs of thyroid cancer.
WHO SHOULD NOT USE IT

Do not use compounded semaglutide if:

  • You or a family member has ever had medullary thyroid carcinoma (MTC), or you have MEN 2.
  • You have had an allergic reaction to compounded semaglutide.

Limitations of use

  • Do not combine it with any other semaglutide product or any other GLP-1 or GLP-1/GIP receptor agonist medicine.
  • Its safety and effectiveness alongside other weight-loss products (prescription, over-the-counter, or herbal) are unknown.
  • It has not been studied in people who have had pancreatitis.

Current or recent weight-loss prescriptions

If you have a current or recent prescription for any weight-loss medicine, whether compounded or brand-name, tell your provider right away and do not take both. You will be asked to show proof of that prescription, including the dose. Taking two or more GLP-1 or GLP-1/GIP medicines at once raises the risk of serious side effects.

WHAT TO TELL YOUR PROVIDER BEFORE STARTING

Share your full medical history honestly. Leaving out or misstating health information to get treatment can lead to serious harm, including death.

Your health history. Tell your provider if you have ever had:

  • Type 1 or type 2 diabetes
  • Thyroid cancer
  • Pancreatitis or other pancreas problems
  • Kidney disease
  • Diabetic retinopathy
  • Severe stomach problems, such as slow stomach emptying (gastroparesis) or trouble digesting food
  • Depression, or suicidal thoughts or behavior

Your medicines. Compounded semaglutide can interact with other drugs. List everything you take, including prescriptions, over-the-counter medicines, vitamins, and herbal or dietary supplements. In particular:

  • Diabetes medicines such as insulin or sulfonylureas can raise your risk of low blood sugar. Ask your provider how to recognize and manage it.
  • Birth control pills may work less well while you use this medicine. Your provider may suggest a different method for 4 weeks after you start and for 4 weeks after each dose increase.

Pregnancy and breastfeeding. Tell your provider if you are pregnant, planning a pregnancy, or breastfeeding.

  • Do not use it during pregnancy. It may harm an unborn baby, and weight loss offers no benefit during pregnancy. Tell your provider if you become pregnant while using it.
  • If you could become pregnant, or could father a child, ask whether to stop the medicine before a planned pregnancy.
  • It is not known whether it passes into breast milk. Your provider may advise against it if you breastfeed or feed your baby pumped breast milk, and can help you choose the best way to feed your baby.
HOW TO USE IT

Read the instructions that come with your medicine, and use it exactly as your provider directs.

Never share: Never share a vial, needle, or syringe with anyone. Sharing can spread infection.

If you take too much, call your provider, get medical advice promptly, or call Poison Control at 1-800-222-1222.

COMMON SIDE EFFECTS

Most common side effects are mild and tend to ease within the first several weeks. Many people have no serious side effects, and your provider prescribed this medicine because they judged the benefits to outweigh the risks for you.

Common side effects include:

  • Nausea (usually lessens over time), vomiting, diarrhea, or constipation
  • Stomach pain, upset stomach, bloating, or acid reflux
  • Headache, tiredness, or dizziness
  • Swelling, redness, or itching where you inject

Tell your provider or pharmacist promptly if any of these last or get worse. Ongoing vomiting or diarrhea can cause dehydration, so contact your provider if you notice unusual thirst, dry mouth, or dizziness or lightheadedness.

SERIOUS SIDE EFFECTS TO WATCH FOR

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

You or a caregiver should watch closely for these, especially when you first start and after any dose change.

  • Serious allergic reaction (rare): Swelling of the face, lips, tongue, or throat; severe rash or itching; very fast heartbeat; trouble breathing or swallowing; fainting or severe dizziness. Stop the medicine and get emergency help right away.
  • Pancreatitis (inflamed pancreas): Severe stomach pain that won't go away, sometimes spreading to the back, with or without vomiting. Get medical help right away.
  • Gallbladder problems, including gallstones: Pain in the upper stomach, yellow skin or eyes (jaundice), fever, clay-colored stools, nausea or vomiting that won't stop. Some cases need surgery. Get medical help right away.
  • Thyroid tumors: Lump or swelling in the neck, lasting hoarseness, trouble swallowing, shortness of breath. Call your provider right away.
  • Low blood sugar (hypoglycemia): Sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, mood changes, tingling hands or feet. Risk is higher if you have type 2 diabetes and take other glucose-lowering medicines. Check your blood sugar; tell your provider right away.
  • Kidney problems: A change in how much you urinate. Vomiting, diarrhea, and nausea can cause dehydration, which may worsen existing kidney problems; drink plenty of water. Call your provider right away.
  • Vision changes (diabetic retinopathy): Blurred or decreased vision, especially if you have type 2 diabetes. Call your provider right away.
  • Faster heart rate: A racing heartbeat while at rest. Call your provider right away.
  • Mood changes, suicidal thoughts or behavior: New, worsening, or worrying changes in mood, behavior, thoughts, or feelings, including depression or thoughts of suicide. Call your provider right away.

This is not a complete list, and symptoms may vary. If you notice any other effects, contact your provider or pharmacist.

REPORTING SIDE EFFECTS AND EMERGENCIES
  • Medical emergency: call 911 or get immediate medical care.
  • Questions about side effects: call your provider for medical advice.
  • Report side effects to the FDA: call 1-800-FDA-1088 or visit www.fda.gov/medwatch.
LEGAL DISCLAIMER

Compounded GLP-1 (semaglutide) is not approved by the FDA. The FDA does not evaluate compounded products for safety, effectiveness, or quality.

Last Updated: October 27, 2026