Also called off label · unapproved use
Off-label use refers to prescribing an FDA-approved drug for an indication, population, dose, or route not in its approved label. It is legal for licensed clinicians but not FDA-sanctioned. For example, semaglutide for weight loss in people without diabetes was off-label before Wegovy was approved.
Research use only. This definition is an educational reference, not medical advice or dosing guidance.