off label

Definition

Outside of regulatorily approved indications, but (unless otherwise specified) within the bounds of reasonable use as defined by a licensed prescriber.

Example Sentences

• "The use of colchicine for gout is FDA approved, whereas the use of colchicine for pericarditis is off label (but is widely respected)."
• "Off label use of colchicine for pericarditis is widely respected."
• "Use of a strong opioid such as fentanyl for mild headache is not only off label but also unprofessional."