Phrase guide

off label

adj · adv · 2 senses · updated from the 2026-07-25 local source snapshot

Definitions and examples are grouped by meaning. Pronunciation, history, word forms, translations, descendants, synonyms, antonyms, derived terms, and related words appear whenever the source provides them.

Sound

Pronunciation

Each Play button uses your device's default local English voice, or a natural local fallback. The selected voice name appears after playback. This is synthesized speech, not a source recording.

No pronunciation record was provided for this word.

1

adj

Meaning 1

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

Definition source: English Wiktionary via Wiktextract

Usage: not-comparable

Topics: medicine, sciences

Examples

  • 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.

Meaning relationships

Synonyms: none provided

Antonyms: none provided

2

adv

Meaning 2

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

Definition source: English Wiktionary via Wiktextract

Usage: not-comparable

Topics: medicine, sciences

Examples

  • While the drug is approved for use in treating stomach cancer, many doctors prescribe it off label for other cancers as well.

Meaning relationships

Synonyms: none provided

Antonyms: none provided

History

Etymology

No etymology was provided for this word.

Across languages

Translations

5 source translations are retained for this English entry.

  • French: hors indication — outside of regulatorily approved indications
  • French: hors AMM — outside of regulatorily approved indications
  • German: zulassungsüberschreitend — outside of regulatorily approved indications
  • Spanish: desvirtuado — outside of regulatorily approved indications
  • Spanish: fuera de indicación — outside of regulatorily approved indications