What an approved use is
Before approval, a company has to submit clinical data and other information showing that a medicine is safe and effective for its intended uses. The FDA adds that safe does not mean free of side effects; it means the agency has judged that, for that particular use, the benefits outweigh the potential risks [1].
The result is the approved labeling. It lists the conditions the medicine is approved to treat, how to use it for them, its risks and what providers should discuss with patients; some medicines also have a Medication Guide or Instructions for Use written for patients [1]. For a use on that list, the FDA says, its benefits and risks have been carefully evaluated and the decision is backed by strong scientific data [1].
What counts as off-label
The FDA describes three common forms of unapproved use of an approved medicine [1]:
- A different condition: the medicine is approved for one disease and used for another.
- A different form or route: for example, a medicine approved as a capsule is given as a liquid instead.
- A different dose: the patient is told to take more, less or more often than the label describes.
More examples from the NIH
The NIDDK, the NIH institute for diabetes, digestive and kidney diseases, describes off-label use in weight management in similar terms. A clinician might prescribe a medicine approved for a different medical problem, combine two or more medicines, or prescribe one for longer than the FDA approved [2].
NIDDK adds that you should feel comfortable asking whether a medicine you are prescribed is approved for treating overweight and obesity, and that it is worth learning about a medicine before using it [2]. Its own table notes, for example, that semaglutide is approved for type 2 diabetes under the Ozempic® and Rybelsus® names and for weight management as Wegovy® [2].
Why it is allowed
From the FDA’s perspective, health care providers may generally prescribe an approved medicine for an unapproved use when they judge it medically appropriate for their patient [1].
The FDA gives two typical reasons: there may be no approved treatment for a condition, or approved treatments may have been tried without benefit. Whatever the reason, the FDA reminds patients that it has not determined the medicine to be safe and effective for that unapproved use [1].
What each US GLP-1 label is approved for
On-label depends on the product, not the molecule. The table summarises section 1 of each US prescribing information checked for this article, with any limitation of use and the label’s statement on children. Anything outside a row is, by definition, outside that product’s approved labeling.
| Product (ingredient, label date) | Approved uses | Limitation of use or children |
|---|---|---|
| Ozempic® injection (semaglutide, 05/2026) [6] | Blood sugar control in adults with type 2 diabetes; lowering the risk of major heart events in adults with type 2 diabetes and heart disease; lowering the risk of kidney decline, kidney failure and heart death in adults who have both type 2 diabetes and chronic kidney disease | Safety and efficacy in children not established (8.4) |
| Rybelsus® and Ozempic® tablets (semaglutide, 1/2026) [7] | Blood sugar control in adults with type 2 diabetes; lowering the risk of major heart events in adults with type 2 diabetes at high risk | Not established in children (8.4) |
| Wegovy® injection (semaglutide, 06/2026) [8] | Lowering the risk of major heart events in adults with heart disease and obesity or overweight; weight reduction and maintenance in adults and children 12 and older with obesity and in adults with overweight plus a related condition; MASH with moderate to advanced fibrosis in adults, under accelerated approval | Not recommended with other semaglutide products or any other GLP-1 receptor agonist |
| Wegovy® tablets (semaglutide, 06/2026) [8] | Lowering the risk of major heart events, as for the injection; weight reduction and maintenance in adults only | Same limitation as the injection |
| Mounjaro® (tirzepatide, 08/2026) [9] | Blood sugar control in type 2 diabetes, for adults and for children from age 10; lowering the risk of major heart events in adults with type 2 diabetes at high risk | No limitation of use listed |
| Zepbound® (tirzepatide, 08/2026) [10] | Weight reduction and maintenance in adults with obesity, or overweight plus a related condition; moderate to severe obstructive sleep apnoea in adults with obesity | Not recommended with other tirzepatide products or any GLP-1 receptor agonist; not established in children (8.4) |
| Saxenda® (liraglutide, 02/2026) [11] | Weight reduction and maintenance in adults, and in children 12 and older weighing more than 60 kg with obesity | Not recommended with other liraglutide products or any other GLP-1 receptor agonist |
| Victoza® (liraglutide, 10/2025) [12] | Blood sugar control in type 2 diabetes, for adults and for children from age 10; lowering the risk of major heart events in adults with type 2 diabetes and heart disease | Not recommended with other liraglutide products |
| Foundayo™ (orforglipron, 07/2026) [13] | Weight reduction and maintenance in adults with obesity, or overweight plus a related condition | Not recommended with another GLP-1 receptor agonist; not established in children (8.4) |
Same molecule, different labels
The table shows how a single ingredient can be on-label in one product and outside the label of another. Semaglutide for weight reduction is an approved use of Wegovy®, not of Ozempic®, whose label is written for type 2 diabetes [6][8]. Tirzepatide for blood sugar control in type 2 diabetes is a Mounjaro® use; Zepbound®’s label is written for weight and sleep apnoea [9][10].
Forms can differ within one brand too. The Wegovy® injection is approved for weight in children aged 12 and older with obesity, while the Wegovy® tablets are approved for weight in adults only [8]. And the Wegovy® label notes that its use in people with type 1 diabetes has not been evaluated (section 5.4) [8].
Regions differ as well. The European summary of product characteristics for Mounjaro® lists both type 2 diabetes, from age 10, and weight management in adults in its section 4.1 [14]. A use that is off-label for one brand name in the US can therefore be on-label under the same brand name in Europe. Each regulator’s own document is what counts where you live.
What off-label is not
Off-label use concerns medicines the FDA has approved. It is different from using a product that has never been approved at all. The FDA states that compounded drugs are not FDA approved, which means the agency does not review them for safety, effectiveness or quality before they are marketed [5]. Our article on compounded GLP-1s covers that topic.
It is also different from expanded access, sometimes called compassionate use. That is a pathway for a person with a serious or immediately life-threatening condition to receive an investigational product, one not yet approved, outside a clinical trial when no comparable alternative exists [4].
Off-label use is not something companies may advertise. The FDA explains that, by law, a drug developer is prohibited from advertising unapproved uses of its product, and that advertising must be truthful about effectiveness and side effects [3].
How common it is, and the evidence behind it
One frequently cited estimate comes from a cross-sectional study of a national US survey of office-based prescribing in 2001. It found that about 21% of uses of 160 commonly prescribed drugs were off-label, and that 73% of those off-label uses had little or no scientific support [15]. The data are old and did not include today’s GLP-1 medicines, so the figures describe prescribing in general, not any particular drug.
Different dosing is one form of off-label use with a GLP-1 example on record. The FDA has received adverse event reports possibly linked to compounded semaglutide or tirzepatide given at doses beyond the approved label: larger single doses, more frequent doses or faster increases; some of these events were serious [5].
Questions the FDA suggests asking
If an unapproved use comes up, the FDA lists questions worth raising with your provider [1]:
- What is this medicine actually approved for?
- Are there other approved medicines or therapies for my condition?
- What studies support this use, and are there clinical trials I could join?
- Is it likely to work better than an approved treatment?
- What are the possible benefits and risks for me?
- Will my insurance cover it for this use?
Where to look up an approved use
Section 1, Indications and Usage, of a product’s prescribing information is the authoritative list, and the Highlights page at the front summarises it. The FDA points to its Drugs@FDA database, the DailyMed label library and its list of Medication Guides as places to find approved labeling [1]. A pharmacist can also confirm which product and which use a prescription refers to.
Ozempic®, Rybelsus®, Wegovy®, Saxenda® and Victoza® are registered trademarks of Novo Nordisk A/S. Mounjaro® and Zepbound® are registered trademarks and Foundayo™ a trademark of Eli Lilly and Company. PepLabo is not affiliated with or endorsed by Novo Nordisk or Eli Lilly and Company.
