off label

English

Alternative forms

• off-label (in attributive position)

Adjective

off label (not comparable)

1. (medicine, of a prescription medication) 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.

Translations

outside of regulatorily approved indications

• French: hors indication, hors AMM
• German: zulassungsüberschreitend

Adverb

off label (not comparable)

1. (medicine, of a prescription medication) 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.