Semaglutide is a generic medication. Its brand names are approved for the treatment of type 2 diabetes and obesity. Compounded semaglutide is not FDA-approved, could come with risks, and may lead to adverse effects.

In the United States, semaglutide isn’t available as a generic drug. It’s sold with a prescription under the following brand names:

Compounding involves mixing or altering drug ingredients to create a medication for a specific need. The practice is common during medication shortages, but it doesn’t come without concerns.

Compounded medications aren’t approved by the Food and Drug Administration (FDA) and don’t undergo the same rigorous safety and effectiveness testing as approved medications. Because of this, compounded drugs may be more prone to contamination or mislabeling.

The FDA advises against using a compounded medication when an FDA-approved medication is available. It also warns that potential complications are possible since the organization does not regulate compounded drugs.

For semaglutide, the FDA has received reports of:

  • adverse effects after use of compounded semaglutide
  • compounded versions that contain ingredients different from the marketed active ingredients
  • fraudulent and unapproved marketed semaglutide with too little, too much, or no active semaglutide

In a 2023 case series, researchers reported three instances of incorrectly administered compounded semaglutide obtained from an aesthetic spa. Users developed gastrointestinal symptoms lasting for days that included:

  • nausea
  • vomiting
  • abdominal pain

Two people self-administered more than 10 times the recommended semaglutide dose. One of them required intravenous (IV) administration of fluids.

Branded semaglutide, like Ozempic and Wegovy, comes in a prefilled injection pen, which acts as a safety feature to prevent overdosing. The reported compounded semaglutide didn’t have this system.

Novo Nordisk produces all three branded semaglutide medications available in the United States. According to its website, the company has filed nine legal proceedings against medical spas, weight loss clinics, and other companies for the unlawful sale of compounded semaglutide medications.

If you decide to take a compounded drug, the FDA recommends working with a state-licensed pharmacy in the United States. That way, the FDA and state authorities may assess the quality of drug manufacturing.

Compounded semaglutide is a custom-made medication that may include the same active ingredient as the original drug, but it isn’t regulated for safety and effectiveness. Compounded semaglutide isn’t approved by the FDA.

All semaglutide medications, including compounded medications, require a prescription in the United States. Some online retailers based outside the United States may sell semaglutide without asking for a prescription, but importing these medications into the United States is illegal and often dangerous.

Compounded semaglutide medications are often significantly cheaper than branded alternatives. They can also help increase availability when branded medications are in short supply.

Compounded semaglutide produced by reputable manufacturers contains the same active ingredient as branded alternatives. Some manufacturers may combine semaglutide with vitamin B12 to help reduce the risk of vitamin B12 deficiency, which can occur in people taking semaglutide or other medications that fall into the same class of drugs.

Semaglutide salts in compounded semaglutide

Semaglutide isn’t currently available as a generic drug. Some experts have raised concerns about where compounding facilities find semaglutide if Novo Nordisk, its sole manufacturer, isn’t providing the active ingredient.

The FDA has found many cases of unscrupulous sellers using the salt forms of semaglutide, such as semaglutide sodium and semaglutide acetate, instead of the base form found in branded medications.

According to the FDA, compounded semaglutide versions that contain the salt forms of the drug “have not been shown to be safe and effective.”

General side effects of semaglutide include:

  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • constipation

Semaglutide can also lead to complications in some people, including:

In rodents, semaglutide has been linked to an increased risk of thyroid C-cell tumors. It’s not clear if semaglutide also increases the risk of thyroid cancer in humans. It may be a good idea to avoid semaglutide if you have a family history of:

Compounded semaglutide may cause additional side effects and complications, especially when ingredients and drug applicators aren’t of optimal quality.

Insurance plans rarely provide coverage for medications used solely for weight loss. For example, weight loss drugs are excluded from coverage from the government programs Medicaid and Medicare.

Some insurance companies may offer coverage for semaglutide to treat type 2 diabetes. Providers that offer coverage for branded semaglutide may also offer coverage for compounded semaglutide in limited cases.

For example, Cigna provides coverage for compounded medication when you have documentation that you can’t take or are intolerant to all FDA-approved commercially available alternatives. They may have additional requirements for coverage.

If you have questions about insurance coverage for compounded semaglutide, consider reviewing your plan’s coverage literature or calling the company directly. Some questions you may want to ask include:

  • Is compounded semaglutide covered under my plan for all uses?
  • If so, do I need to submit specific documentation from my doctor to get coverage approved?
  • Does my deductible apply to compounded semaglutide?
  • How much will I have to pay out of pocket for compounded semaglutide after meeting the deductible?

Compounded semaglutide isn’t FDA-approved, and the FDA only recommends taking compounded medications if FDA-approved alternatives are unavailable.

If you decide to get compounded semaglutide, it’s important to make sure you work with a state-licensed pharmacy based in the United States. You should also be aware of the potential risks of compounded semaglutide, including adverse effects from incorrect dosage and undisclosed ingredients.