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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

Misoprostol was initially approved by the FDA for stomach ulcers and is routinely prescribed off-label to induce labor, treat postpartum hemorrhage, and prepare the cervix for IUD insertion.

From Slate • May 18, 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

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

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