COMPOUNDED SEMAGLUTIDE IMPORTANT SAFETY INFORMATION

Last revised: February 19, 2025

Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo the same safety, effectiveness, or manufacturing reviews as FDA-approved medications. Your medical provider may recommend certain doses of compounded semaglutide based on your medical evaluation.

Indications and Use

Compounded semaglutide is an injectable prescription medicine that may help adults with obesity or excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.

Compounded semaglutide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management, along with a reduced-calorie diet and increased physical activity, for individuals with an initial body mass index (BMI) of:

  • 30 kg/m² or greater (obesity)

  • 27 kg/m² or greater (overweight) with at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)

Compounded semaglutide should not be used with other semaglutide-containing products or any GLP-1 receptor agonist medicines.

  • It is not known if semaglutide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products.

  • It is not known if semaglutide can be used in people who have had pancreatitis.

  • It is not known if semaglutide is safe and effective for use in children under 18 years of age.

Important Safety Information for Compounded Semaglutide Injection

Warning: Risk of Thyroid C-Cell Tumors

In animal studies, semaglutide caused thyroid tumors, including thyroid cancer. It is not known if compounded semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Tell your provider immediately if you experience:

  • A lump or swelling in your neck

  • Hoarseness

  • Trouble swallowing

  • Shortness of breath

These may be symptoms of thyroid cancer.

Do not use compounded semaglutide if:

  • You or your family have ever had medullary thyroid carcinoma (MTC).

  • You have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Is Compounded Semaglutide FDA-Approved?

Compounded semaglutide is not FDA-approved and does not undergo the same rigorous efficacy and safety checks as FDA-approved medications.

Limitations of Use

  • Should not be used in combination with other semaglutide-containing products or GLP-1 receptor agonists.

  • The safety and efficacy of coadministration with other weight loss products have not been established.

  • Has not been studied in patients with a history of pancreatitis.

Compounded medications are not FDA-approved and do not have the same indications for treatment as FDA-approved medications. These recommendations for compounded semaglutide apply while FDA-approved therapies remain on shortage.

Who Should Not Use Compounded Semaglutide?

Do not use compounded semaglutide if:

  • You or your family have ever had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

  • You have a known allergic reaction to compounded semaglutide.

How Should Compounded Semaglutide Be Administered?

  • Take compounded semaglutide with or without food.

  • Self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day each week.

  • Your medical provider will guide you on a treatment regimen, which may include dose increases every four weeks.

Do not change your dosing regimen or stop taking compounded semaglutide without consulting your provider.

What Should I Tell My Medical Provider Before Using Compounded Semaglutide?

Tell your provider about all the medications you are currently taking, including:

  • Diabetes medications, including insulin or sulfonylureas (e.g., Amaryl, Glucotrol XL)

  • Other GLP-1 medications, including Wegovy, Ozempic, Saxenda, Zepbound, Mounjaro, Victoza, Byetta, or Bydureon

  • Any other weight-loss products, including dietary supplements

Medical history to discuss with your provider:

  • Type 1 or type 2 diabetes

  • Thyroid cancer

  • Pancreatitis

  • Kidney disease

  • Diabetic retinopathy

  • Depression or suicidal thoughts

Pregnancy and Breastfeeding Considerations:

  • Compounded semaglutide should not be used during pregnancy as it may harm the unborn baby.

  • Discontinue use at least two months before a planned pregnancy.

  • If breastfeeding, consult your provider, as compounded semaglutide has been found in the milk of lactating rats.

Withholding or providing inaccurate health information can result in serious harm, including death.

Serious Side Effects to Monitor

Seek immediate medical attention if you experience:

  • Thyroid C-Cell Tumors – Lump or swelling in the neck, hoarseness, trouble swallowing, shortness of breath

  • Pancreatitis – Severe abdominal pain that does not go away, pain radiating to the back, vomiting

  • Gallbladder Disease – Upper stomach pain, jaundice, fever, clay-colored stools

  • Low Blood Sugar (Hypoglycemia) – Dizziness, blurred vision, mood changes, sweating, fast heartbeat

  • Kidney Injury – Dehydration, nausea, vomiting

  • Serious Allergic Reactions – Swelling, rash, rapid heartbeat, breathing issues

  • Diabetic Retinopathy Complications – Vision changes

  • Increase in Heart Rate – Racing heartbeat while at rest

  • Suicidal Behavior and Ideation – Sudden mood or behavior changes

Never share pens or needles, as sharing increases the risk of infection.

Most Common Side Effects of Compounded Semaglutide

  • Nausea

  • Diarrhea

  • Vomiting

  • Constipation

  • Stomach pain

  • Indigestion

  • Injection site reactions

  • Fatigue

  • Hair loss

  • Heartburn (GERD)

Report negative side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

Before Using Compounded Semaglutide

Discuss with your provider if you have:

  • Problems with your pancreas or kidneys

  • Severe stomach problems, such as gastroparesis

  • Diabetes and take insulin or sulfonylureas

  • A history of diabetic retinopathy

If you take birth control pills, consult your provider before using compounded semaglutide, as birth control pills may be less effective.

Legal Disclaimer

Ozempic® and Wegovy® are registered trademarks of Novo Nordisk. Zepbound® and Mounjaro® are registered trademarks of Eli Lilly. Lovely Meds has no affiliation with Novo Nordisk or Eli Lilly.