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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

Metformin is commonly used to treat type 2 diabetes and is already prescribed off-label to as many as 13,000 Australians with type 1 diabetes.

From Science Daily • Apr. 15, 2026

It’s widely assumed many fund investors use these ETFs off-label, hoping for results over longer periods.

From Barron's • Mar. 23, 2026

In the case of weight-loss drugs in particular, drugmakers have been contending with an off-label industry in the US that popped up legally in response to shortages and has been tough to stamp out.

From BBC • Mar. 23, 2026

Much of that success can be attributed to widespread use of Wegovy and Zepbound and the off-label prescription of GLP-1s approved for diabetes.

From MarketWatch • Mar. 18, 2026

He co-wrote a study finding that evidence is limited for off-label use of gabapentinoid drugs—including gabapentin and another drug in the same class, pregabalin—for most pain-related conditions.

From The Wall Street Journal • Dec. 25, 2025