Off-label prescribing means using an FDA-approved drug for a condition, dose, form or population that is not in its label. It is legal and common, but the FDA has not reviewed that use, and the supporting evidence ranges from strong to thin.
Off-label prescribing means a licensed clinician prescribes an FDA-approved medication for a use that is not listed in its official label: a different condition, a different dose, a different form or a different patient group. It is legal and common in every area of medicine, because the FDA approves drugs but does not regulate how clinicians practice. What off-label use does mean is that the FDA has not determined the drug is safe and effective for that particular purpose, so the quality of the supporting evidence becomes the key question.
Before a drug can be marketed, its manufacturer must submit data showing it is safe and effective for its intended uses. The FDA explains that "safe" does not mean free of side effects; it means the agency has decided the benefits for that use outweigh the potential risks.
The result of that process is the prescribing information, often called the label. According to the FDA, it states which diseases and conditions the drug is approved to treat, how to use it for those conditions, its risks, and what clinicians should discuss with patients. Some drugs also come with patient materials such as Medication Guides and Instructions for Use.
The FDA and a 2012 review in Mayo Clinic Proceedings describe several kinds of off-label use:
| Type | Example from the sources |
|---|---|
| Different condition | A chemotherapy approved for one type of cancer used for another type |
| Different dose | A drug approved at one tablet a day prescribed at two |
| Different form | A drug approved as a capsule given as an oral solution |
| Different population | A medication studied in adults used in children |
A familiar example from weight care: Ozempic is approved for adults with type 2 diabetes, including blood sugar control and reduction of cardiovascular and kidney risks. Weight management is not one of its listed indications, so prescribing it for weight alone is off-label. Wegovy contains the same active ingredient and is approved for chronic weight management, so that use is on-label for Wegovy. For more on these names, see The GLP-1 Names Explained.
Yes, it is legal. The Mayo Clinic Proceedings review explains that the FDA controls which medications are available commercially but does not limit how clinicians prescribe them once they are on the market, and that the FDA makes clear it does not regulate the practice of medicine. Drug companies, by contrast, are not allowed to promote their products for off-label uses, which has led to large legal settlements.
It is also common. A study published in the Archives of Internal Medicine in 2006 used national data on 160 commonly prescribed drugs and estimated 150 million off-label uses in 2001, about 21 percent of overall use. Off-label use was especially frequent for some cardiac medications and anticonvulsants (46 percent each), and for individual drugs such as gabapentin (83 percent) and amitriptyline (81 percent). The Mayo review notes that it may be more common in groups that are less often included in clinical trials, such as children, pregnant patients and people with psychiatric conditions.
The FDA lists situations such as when there is no approved drug for a condition, or when a patient has tried all approved treatments without benefit. The Mayo review adds several more:
Some off-label uses become standard practice. The review notes that tricyclic antidepressants are not FDA-approved for neuropathic pain yet are considered a first-line option, and its table of common off-label uses includes trazodone for insomnia in older adults.
Why don't manufacturers simply add these uses to the label? According to the review, a new indication requires a supplemental application that is costly and time-consuming, and the expected revenue may not justify it, especially for generic drugs.
Off-label does not mean unsupported, but it does not mean proven either. In the 2006 study, 73 percent of off-label mentions had little or no scientific support. The Mayo review also notes that because off-label use is typically less critically evaluated than on-label use, it may be associated with more medication errors.
That is why the useful question is not "is this on-label?" but "what evidence supports this use for someone like me, and what are the alternatives?"
Compounded medications are prepared by pharmacies for individual patients. The FDA states that compounded drugs are not FDA-approved and that the agency does not verify their safety, effectiveness or quality before they are marketed. It describes compounding as serving patients whose needs cannot be met by an approved drug, for example someone who needs a version without a dye they are allergic to, or a liquid form for a person who cannot swallow pills.
Because a compounded product has no FDA-approved label, describing it as "on-label" or "off-label" is not quite accurate. Any compounded medication, including those available through NewDay Wellness, should be understood as not FDA-approved, with its use resting on the prescriber's judgment and the evidence for the active ingredient.
The FDA suggests these questions when an off-label use is proposed:
It is also reasonable to ask what evidence supports the use, how your response will be monitored, and what would prompt a change of plan.
Yes. Clinicians generally may prescribe an FDA-approved drug for an unapproved use when they judge it medically appropriate. The FDA does not regulate the practice of medicine, but drug companies may not promote off-label uses.
Not necessarily. It means the FDA has not reviewed that specific use, so the drug has not been shown safe and effective for it through the approval process. The evidence ranges from strong, as with some long-established uses, to limited, as with most off-label uses in a 2006 national study.
Practices vary. A 2012 review noted that no court decision to date had required clinicians to disclose off-label use through informed consent. You can always ask directly whether a use is on-label and what evidence supports it.
Compounded medications are not FDA-approved at all, so they do not have an approved label. They are a separate category, and the FDA does not verify their safety, effectiveness or quality before they are marketed.
Off-label use can be a reasonable, evidence-based choice, or a less certain one. A licensed provider can explain where a proposed treatment falls, what the evidence shows and what the alternatives are, so you can decide together. This article is educational and does not determine eligibility for any treatment.
Written by the NewDay Wellness editorial team from the sources above and checked against them before publication, and medically reviewed by Dr. Sean Arora and Dr. Shannon Arora of Arora Health & Aesthetics; see our editorial standards. This article is educational and does not diagnose conditions, establish eligibility for any medication, or replace care from a licensed provider. Compounded medications are not FDA-approved.
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