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• off-label
  off-label

  adjective

  of, relating to, or denoting a drug prescribed for a particular indication even though the drug has not yet received approval from the Food and Drug Administration for that disease, condition, or symptom.
• off label
  off label

  adjective

  (of a prescription drug) relating to use, or being used, in ways for which it has not been approved

off-label

American  

[awf-ley-buhl, of‑] / ˈɔfˈleɪ bəl, ˈɒf‑ /

adjective

Informal.

1. of, relating to, or denoting a drug prescribed for a particular indication even though the drug has not yet received approval from the Food and Drug Administration for that disease, condition, or symptom.

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off label British  

adjective

1. (of a prescription drug) relating to use, or being used, in ways for which it has not been approved

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Example Sentences

Researchers at the University of Connecticut report that the treatment caused significant brain damage in mice, raising concerns about its growing use in longevity research and off-label anti-aging therapies.

From Science Daily • May 27, 2026

And, thanks to the condition being underresearched, treatment was mostly with off-label fixes.

From Slate • May 23, 2026

Among so-called peptide users, often people involved in the fitness or looksmaxxing communities, off-label use of retatrutide has become popular.

From MarketWatch • May 21, 2026

She said medical spas are prescribing off-label drugs that don’t meet the criteria set out by the FDA that justify a prescription.

From The Wall Street Journal • May 17, 2026

They have launched direct-to-consumer sales websites, struck distribution deals with retail giants such as Walmart and Costco, and launched court battles against off-label rivals.

From BBC • Mar. 23, 2026