The term “off-label medication” may imply you’re doing something you shouldn’t, but prescribing drugs this way is actually a practice healthcare providers do day-in and day-out. It simply means that the condition they’re prescribing the medication for literally isn’t on the drug label—hence, it’s off-label. And the practice is fairly common: Research shows that 21% to 32.2% of all prescriptions in the U.S. are written for off-label use, including off-label weight-loss medication.
Here’s what the experts say about why this happens, whether it’s safe, and what to know before you consider taking a drug off-label for weight loss.
What off-label really means
When a medication is FDA-approved, that means it’s been found to be safe and effective for a specific condition. That intended use is what shows up on approved drug labeling and is, generally, what doctors use when deciding which medicine to prescribe for which condition.
But there isn’t a law saying that providers can only prescribe a medication for its FDA-approved conditions. In fact, the FDA says that once a drug is approved, a healthcare provider can prescribe it for other uses as long as it’s medically appropriate. Any time that happens, it’s known as off-label use.
“Off-label just means that the medication is being used in a manner that it wasn't specified in the FDA-packaging approval,” says Dr. Lydia Alexander, M.D., an obesity medicine specialist and president-elect of the American Board of Obesity Medicine. There are various reasons why a doctor may prescribe a drug for an off-label use, including that:
- A drug may not have been studied and approved for specific groups of people, like young children or pregnant women
- It has been shown to have additional benefits
- An on-label drug isn’t covered by your insurance but an off-label one is
- Your medical condition doesn’t have any approved drugs yet
- You tried all the available on-label medications without success
- Your healthcare provider wants you to take the drug at a different dose than what’s on the label
In certain cases, a drug manufacturer may perform additional studies to show a drug is safe and effective for an off-label use and apply for it to get approved for that purpose by the FDA. This can take time and money, though, so it’s only done if the company thinks it will be worth it.
How might off-label medications help with weight loss?
While FDA-approved drugs to treat obesity are growing, there are still situations where a doctor may prescribe a drug off-label to treat the condition. Insurance is one consideration, as some plans only cover off-label versions of drugs that can help with weight management. Ultimately, this is a discussion for you and your healthcare provider. Prescription medications sometimes prescribed off-label for weight loss include the following:
- Glucagon-like peptide-1 (GLP-1) receptor agonists are prescription medications that activate receptors in the brain, regulating blood sugar, reducing appetite, and ultimately leading to weight loss and maintenance. While Wegovy (semaglutide) and Saxenda (liraglutide) are approved for weight loss, the brand names Ozempic (semaglutide) and Victoza (liraglutide) are only FDA-approved to treat type 2 diabetes. That said, they have also demonstrated efficacy for weight loss and maintenance, and may be covered by insurance in situations where weight-management medications are not. In those cases, a doctor may prescribe Ozempic and Victoza off-label for weight loss. Similarly, Trulicity (dulaglutide), another GLP-1 agonist, and Mounjaro (tirzepatide), a dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) agonist, are both FDA-approved for type 2 diabetes, but providers may prescribe them off-label for obesity because they’ve been shown to support weight loss and maintenance.
- Topamax (topiramate) is FDA-approved to treat epilepsy and migraines. It’s approved for weight loss when paired with phentermine in the drug Qsymia (phentermine-topiramate), but providers may also prescribe topiramate for weight loss on its own off-label. When topiramate was approved in 1996 for epilepsy, researchers began to see that weight loss often occurred as a side effect. “We have a good amount of literature that shows for patients who've had bariatric surgery and start to regain weight, [using] topiramate is a good medication to use to help stop that weight regain,” says Angela Golden, a family nurse practitioner and owner of an obesity treatment center in Flagstaff, Arizona.
- Naltrexone, a medication used for alcohol addiction, and bupropion, an antidepressant, are combined to make Contrave (naltrexone-buproprion), an FDA-approved weight-loss drug. But, says Alexander, your provider may prescribe the two medications separately—and technically off-label—if your insurance doesn’t cover Contrave.
But wait–read this before you start an off-label medication for weight loss
Anytime your doctor prescribes you a new medication—on-label or off—ask these questions:
- Is it safe? Any drug approved by the FDA has gone through rigorous safety tests, but every drug has the potential for side effects. Talk to your provider about what those side effects may be and which medication option for weight management is best for you.
- Has it been studied for off-label use? Just because the FDA has not approved a drug for a specific health condition doesn’t mean that there isn't any research on its efficacy and safety for that condition. Ask your healthcare provider what they know about the drug’s efficacy and research the drug on fda.gov to fill in any holes and get more answers.
- Why this medication versus one that’s FDA-approved? If your provider recommends an off-label medication for weight loss, ask them for their reasons.
Is it cheaper to take off-label weight-loss medication?
This all depends on whether your insurance covers the off-label medication. Sometimes the medication that’s FDA-approved for obesity isn’t covered by a patient’s insurance, but a medication that’s not approved for obesity is covered. This may be one consideration when a healthcare provider determines which medication is right for you.
It’s best to talk about the cost of any medication, including off-label ones, with both your healthcare provider and your insurance provider. They can help you understand the potential costs and explore options for reducing those out-of-pocket expenses.
The bottom line
Healthcare providers may sometimes prescribe a medication off-label, which means they’re prescribing it for a condition that the FDA has not approved. They do this for various reasons, including to save a patient money if the off-label medication is covered by insurance while alternatives are not. Regardless of whether a medication is taken on-label or off-label, however, choosing a medication is a highly personal decision that’s between a healthcare provider and their patient.