Compounded Semaglutide Safety Information

Under federal law, your healthcare provider is permitted to prescribe compounded semaglutide for you if it is determined to be medically necessary and appropriate based on your medical evaluation. However, compounded drugs are not FDA-approved and do not undergo safety, effectiveness, quality, or manufacturing review.

Warning: May increase risk of thyroid C-Cell Tumors

• In laboratory animals, semaglutide exposure led to the development of of thyroid C-cell tumors. It is not known if semaglutide increases the risk of tumors of the thyroid gland, including medullary thyroid carcinoma (MTC, a type of thyroid cancer), in humans.
• Do not take compounded semaglutide if you or anyone in your family has ever had MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Tell your provider immediately if you experience any of the following symptoms, as they may be symptoms of thyroid cancer:
  • A lump or swelling in the neck
  • Hoarseness
  • Difficulty swallowing
  • Shortness of breath

Do not take compounded semaglutide if:

• You or anyone in your family has ever had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You are allergic to semaglutide or any of the ingredients in compounded semaglutide injections. Ask your pharmacist for a list of ingredients, but they may include di-sodium hydrogen phosphate dihydrate, sodium chloride, benzyl alcohol, hydrochloric acid, sodium hydroxide pellets and water.
• You have type 1 diabetes mellitus.

Compounded semaglutide uses and limitations

• Uses: Compounded semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. It is used alongside a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity), and in adults with an initial BMI of 27 kg/m2 or greater (overweight) who also have at least one weight-related comorbid condition, such as hypertension, type 2 diabetes mellitus, or dyslipidemia.
• Limitations: 
  • Compounded semaglutide should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist.
  • The safety and efficacy of using compounded semaglutide in combination with other products for weight loss have not been established.
  • Compounded semaglutide has not been studied in patients with a history of pancreatitis.
  • Compounded semaglutide should not be used in patients with type 1 diabetes mellitus.

Important information to give your provider: 

• All of the drugs you are currently taking or plan to take: prescription medications, over-the-counter medications, vitamins, as well as nutritional supplements and herbal products
• Your complete medical history: failure to provide accurate information about your health and medical history in order to obtain treatment is dangerous and may result in injury or harm, including, in some cases, death.
• Whether you are pregnant, planning to become pregnant, or breastfeeding
  • Pregnant: When pregnancy is recognized, stop using compounded semaglutide. Losing weight during pregnancy does not provide any benefits, and compounded semaglutide may cause fetal harm.
  • Planning to become pregnant: Stop using compounded semaglutide at least two months before a planned pregnancy, since compounded semaglutide can stay in the bloodstream for an extended period.
  • Breastfeeding: Tell your provider if you are breastfeeding before taking semaglutide. In lab studies, semaglutide was found in the milk of lactating rats.

Let your provider know if you have a diagnosis or history of:

• Medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Allergy to semaglutide or any other GLP-1 drug or any of the ingredients in compounded semaglutide injections. Ask your pharmacist for a list of ingredients, but they may include di-sodium hydrogen phosphate dihydrate, sodium chloride, benzyl alcohol, hydrochloric acid, sodium hydroxide pellets and water.
• Diabetes Type 1 or 2
• Pancreatitis
• Gastroparesis (slowed emptying of your stomach) or other severe problems with your stomach, such as problems with digesting food
• Gallbladder issues
• Kidney disease
• Diabetic retinopathy
• Eating disorders
• Mental health issues, including depression
• Suicidal thoughts, ideation, or behavior, including suicidal attempts

Drug interactions to consider

• Medications taken by mouth: Compounded semaglutide may impact the absorption of medications that are taken by mouth at the same time, because it delays gastric emptying. Talk to your provider about the best schedule for taking your medications.
• Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL) - blood sugar levels can drop dangerously low if these medications are combined with compounded semaglutide
• Other medications in the same drug class (GLP-1 or GLP-1/GIP receptor agonist medications), such as liraglutide, dulaglutide, tirzepatide, Wegovy, Ozempic, Saxenda, Victoza, Trulicity, Byetta, or Bydureon
• Other weight loss products, including dietary supplements

Serious side effects to watch for when taking compounded semaglutide

You or a caregiver should watch carefully for these side effects, especially at the beginning of treatment or when changing dosage.

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

• Thyroid C-Cell Tumors:  Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In rodent studies, semaglutide caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza and Saxenda) after the drug was put on the market. However, it is unknown whether semaglutide causes thyroid C-cell tumors in humans.  Patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) should not take compounded semaglutide.
• Inflammation of Pancreas (Acute Pancreatitis):  Stop using compounded semaglutide right away if pancreatitis is suspected and do not resume if pancreatitis is confirmed. Signs of acute pancreatitis include severe abdominal pain that does not go away, sometimes radiating to the back. May or may not be accompanied by vomiting. ‍
• Acute Gallbladder Disease: Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools. These symptoms may indicate gallbladder problems, including gallstones. Some gallbladder problems require surgery.

• Low Blood Sugar (hypoglycemia):  Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat. Compounded semaglutide lowers blood glucose and can cause blood sugar levels todrop dangerously low in patients with type 2 diabetes who also take another glucose control medication.
• Acute Kidney Injury:  If you have have kidney problems, symptoms such as diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause your kidney problems to worsen. Drink plenty of water to help reduce your chance of dehydration.
• Serious Allergic Reactions:  If you experience symptoms of a serious allergic reaction, stop using compounded semaglutide right away. Symptoms include swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, feeling dizzy or fainting.
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes:  If you have type 2 diabetes, tell your provider right away if you experience changes in vision. Diabetic retinopathy damages blood vessels in the retina and can cause scarring of the retina, sometimes resulting in a serious condition called retinal detachment.
• Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.
• Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
• Never Reuse or Share Needles or Syringes: Reusing or sharing needles or syringes poses a risk of infection.

Common side effects that can occur with compounded semaglutide

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Headache
• Fatigue
• Dyspepsia (indigestion / upset stomach)
• Dizziness
• Abdominal distension
• Eructation (burping)
• Hypoglycemia in patients with type 2 diabetes
• Flatulence
• Gastroenteritis
• Gastroesophageal reflux disease

Please report negative side effects of prescription products by contacting FDA MedWatch at 1-800-FDA-1088 or visiting fda.gov/medwatch.

This information is for guidance only and is not comprehensive. For more information, please refer to any additional materials provided by your pharmacy or contact your prescriber or pharmacist.

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