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Key takeaways
Ozempic was studied and approved by the FDA for the treatment of Type 2 diabetes, but it can be prescribed off-label for other uses, including weight loss.
Clinical trials of Ozempic included participants with Type 2 diabetes, so little is known about the drug’s safety and efficacy in people without diabetes.
Other drugs, like Saxenda and Wegovy, are similar to Ozempic but have been FDA approved for the treatment of obesity.
Ozempic is in high demand, and choosing another drug for weight loss frees up Ozempic for people who need it to manage their diabetes.
Ozempic (semaglutide) is an injectable drug approved by the Food and Drug Administration (FDA) to treat Type 2 diabetes and reduce the risk of major cardiovascular events in people with Type 2 diabetes and known heart disease. It’s part of a class of drugs called glucagon-like peptide 1 (GLP-1) agonists. Although GLP-1 drugs have been around since 2005, Ozempic was only made available in 2017.
Part of the way Ozempic works is by slowing down how quickly food moves through the stomach, which makes people feel full for longer and can lead to weight loss over time. Because of its weight loss effects, many people are interested in taking Ozempic to help with weight management, even if they don’t have diabetes.
Although you can take Ozempic for weight loss without diabetes, there are some things you should know before you consider it as an option to discuss with your healthcare provider.
Is Ozempic approved for weight loss?
Ozempic is not approved by the FDA for weight loss. “When a drug receives FDA approval, it means the FDA has formally authorized it for sale and use based on evidence that it’s safe and effective for that use,” says William P. Shutze, MD, vascular surgeon with Texas Vascular Associates, PA in Plano, Texas and the Society of Vascular Surgery.
Taking medication for a reason that isn’t FDA approved is considered an “off-label” use. While healthcare providers can prescribe Ozempic for off-label uses like weight loss, there are pros and cons to consider when taking it if you don’t have Type 2 diabetes.
“There are several steps to FDA approval,” Dr. Shutze continues, “including preclinical testing, multiple trials that evaluate the drug’s safety and side effects when used for a particular indication, and a final evaluation based on the manufacturer’s application of what the drug is intended to treat.”
“When the drug is approved for use by the FDA it’s authorized only for the indication(s) that are in the application. However, many drugs are found to be useful in other situations and may be prescribed by physicians for these off-label indications,” Dr. Shutze says.
That is what happened with Ozempic, according to Dr. Shutze. It was developed and approved to treat diabetes, but also routinely led to weight loss in the trial subjects who took it, causing some providers to prescribe Ozempic off-label in people who don’t have diabetes to aid in weight loss.
Why you shouldn’t take Ozempic for weight loss alone
Although using Ozempic off-label is a decision you and your healthcare provider will need to make together, there are reasons why some choose not to prescribe drugs off-label.
First, using a drug off-label—especially one that’s fairly new, like Ozempic—can be unsafe.
“Using Ozempic off-label may pose risks, as its safety and efficacy for weight loss have not been thoroughly studied,” Dr. Shutze says. “Potential side effects and long-term impacts might not be well understood for non-diabetic patients.”
Another reason why you may not want to take Ozempic only for weight loss is the drug’s overall availability. Ozempic has experienced a number of shortages since 2022, according to the National Association of Boards of Pharmacy, in part because of an increase in off-label prescribing. Ozempic shortages affect the availability for patients who need it to manage Type 2 diabetes.
Not only does off-label prescribing make it difficult for people with diabetes to continue using Ozempic without interruption, but it may also deter providers from starting new diabetic patients on Ozempic out of concern that access to the drug will be inconsistent.
Who shouldn’t take Ozempic
Even if you have Type 2 diabetes—or have a healthcare provider willing to prescribe Ozempic for off-label use—you may not be eligible to take it. Dr. Shutze says people with a history of certain cancers, including medullary thyroid carcinoma and multiple endocrine neoplasia syndrome Type 2 (MEN 2), should not take Ozempic. Neither should anyone with a known allergy to semaglutide or a history of pancreatitis or diabetic retinopathy, both of which can be made worse by Ozempic use.
What can you take instead of Ozempic for weight loss
If you can’t take Ozempic or your healthcare provider won’t prescribe it off-label, there are alternatives to Ozempic that assist with weight loss (and in some cases, are even FDA approved for that indication).
Other injectable GLP-1 agonists approved for weight loss in adults and children ages 12 and older are Saxenda (liraglutide) and Wegovy (semaglutide). Both work like Ozempic to delay gastric emptying and suppress the appetite center of the brain.
Difference between Ozempic and Wegovy
Wegovy has the same active ingredient as Ozempic: semaglutide. But, unlike Ozempic, it is FDA approved for chronic weight management in adults and children ages 12 and older who have a body mass index (BMI) of 30 or greater. It is also approved to treat adults with a BMI of 27 or more with at least one health condition, such as high blood pressure or diabetes, related to their weight. In March of 2024, an additional indication was approved by the FDA: to lower the risk of major cardiovascular events in adults with known heart disease and obesity or overweight.
Since Ozempic and Wegovy are both semaglutide drugs, you may wonder why they aren’t FDA approved to treat the same conditions. “It’s a great question that many people ask,” says Danielle Kelvas, MD, a primary care physician with The HCG Institute in Tennessee, and CEO and Founder of DKMD Consulting. Dr. Kelvas notes that the difference between Ozempic and Wegovy largely comes down to the intricacies of the FDA approval process.
“When a drug is in the pipeline of a clinical trial, the FDA requires the pharmaceutical company to be very specific in their hypothesis and tested patient population,” she explains. “Ozempic was only tested on patients with Type 2 diabetes. Therefore, it is only FDA approved for that use and at very particular doses.”
“But Wegovy was tested on a broader patient population (including people diagnosed with obesity),” Dr. Kelvas says. And though both drugs contain the same active ingredient, the dosage and dose forms are slightly different.
Wegovy is a single-dose, prefilled injection pen (versus Ozempic’s multi-dose pen) that’s typically prescribed at higher maintenance doses than Ozempic. Wegovy is also approved for use in adults and children ages 12 and older, while Ozempic is only for adults ages 18 and older. In terms of cost, Wegovy is a little bit more expensive, with a list price of $1,349 for a month’s supply compared to Ozempic’s list price of $935. However, most people don’t pay the list price if their health insurance covers weight-management medications. Insurance coverage varies by policy.
RELATED: How to get Wegovy covered by insurance
Other Ozempic alternatives for weight loss
“Outside of the GLP-1 agonist category, there are several other drugs that may be able to help you manage your weight,” Dr. Kelvas says. Examples include:
- Wellbutrin, an antidepressant that can be used off-label for weight loss and smoking cessation
- Metformin, which is FDA approved to treat Type 2 diabetes and is also often used off-label for polycystic ovarian syndrome (PCOS)
- Contrave, a combination of Wellbutrin and naltrexone, a drug developed for the treatment of substance disorders
- Qsymia, a combination of the prescription weight loss drug phentermine and the anti-epilepsy drug Topamax (topiramate), which aids in weight loss when combined with a proper diet and exercise It may also decrease binge eating.
Speaking of proper diet and exercise, it’s important to remember that no medication alone can help you improve your overall health. Lifestyle changes continue to play a significant role in lowering body weight, managing blood sugar, and improving other health metrics like blood pressure and cholesterol, no matter which drug you may be taking.
Bottom line
Ozempic is only FDA approved for the treatment of Type 2 diabetes. Taking Ozempic for weight loss is an off-label indication and should only be done after careful consideration and under the guidance of a healthcare provider. Consider other suitable alternatives. Taking Ozempic off-label contributes to drug shortages, making it harder for people with Type 2 diabetes to manage their condition when they can’t access their medication.
Sources
- Ozempic (semaglutide) approved in the US, Novo Nordisk (2017)
- Once-weekly Ozempic® (semaglutide) injection mechanism of action, Novo Nordisk
- Diabetes drug shortages and fake Ozempic, National Association of Boards of Pharmacy (2023)
- Metformin, StatPearls (2023)
- Naltrexone, StatPearls (2023)
