off label
Outside of regulatorily approved indications, but (unless otherwise specified) within the bounds of reasonable use as defined by a licensed prescriber.
Adjective
- Outside of regulatorily approved indications, but (unless otherwise specified) within the bounds of reasonable use as defined by a licensed prescriber.
- 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.
Forms
Adverb
- Outside of regulatorily approved indications, but (unless otherwise specified) within the bounds of reasonable use as defined by a licensed prescriber.
- While the drug is approved for use in treating stomach cancer, many doctors prescribe it off label for other cancers as well.