What it means
The FDA approves each drug for specific uses based on the evidence submitted. Once a drug is approved, health care providers may generally prescribe it for an unapproved use when they judge it medically appropriate for a patient.
The FDA has not reviewed whether a drug is safe and effective for an off-label use. Sometimes good evidence exists and the label simply has not been updated; sometimes evidence is thin.
A common example is a diabetes-approved GLP-1, such as Ozempic, prescribed only for weight loss. The same ingredient may be approved for weight management under a different brand name and dose, so the off-label version is not automatically the same treatment.
Insurers often decline to cover off-label prescriptions. Before agreeing, the FDA suggests asking what the drug is approved for, what evidence supports the off-label use, what other options exist and whether insurance will pay.
Why it matters
Off-label GLP-1 prescriptions are common, but they are often not covered and were not studied for that exact use.