off label

adjective

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

“Off label use of colchicine for pericarditis is widely respected.”

Meanings

adjectiveoff label (not comparable)

alternative off-label

  1. not comparablemedicineOutside of regulatorily approved indications, but (unless otherwise specified) within the bounds of reasonable use as defined by a licensed prescriber.

    Off label use of colchicine for pericarditis is widely respected.

    2 more examples

    The use of colchicine for gout is FDA approved, whereas the use of colchicine for pericarditis is off label (but is widely respected).

    Use of a strong opioid such as fentanyl for mild headache is not only off label but also unprofessional.

adverboff label (not comparable)

alternative off-label

  1. not comparablemedicineOutside 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.

Translations

French hors indication, hors AMM
  • hors indicationoutside of regulatorily approved indications
  • hors AMMoutside of regulatorily approved indications
German zulassungsüberschreitend
  • zulassungsüberschreitendoutside of regulatorily approved indications
Spanish desvirtuado, fuera de indicación
  • desvirtuadooutside of regulatorily approved indications
  • fuera de indicaciónoutside of regulatorily approved indications
Cite this entry
APA

off label. (n.d.). In WatkinsX Dictionary. Retrieved November 2, 2026, from https://dictionary.watkinsx.com/word/off%20label

MLA

“off label.” WatkinsX Dictionary, https://dictionary.watkinsx.com/word/off%20label. Accessed November 2, 2026.

Chicago

WatkinsX Dictionary, s.v. “off label,” accessed November 2, 2026, https://dictionary.watkinsx.com/word/off%20label.

Source: off label on Wiktionary, CC BY-SA 4.0.