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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

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

More recently, it’s become an off-label success story after doctors realized a side effect of taking the drug was hair growth.

From MarketWatch • Apr. 27, 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