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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

See Examples For:

off-label off label

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

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

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

The Food and Drug Administration hasn’t approved atropine for this use, but ophthalmologists sometimes prescribe a very low dose off label.

From The Wall Street Journal ● Dec. 28, 2025

TikTok has helped fuel a trend of doctors prescribing the drug off label to people for weight loss, leading to a medication shortage for diabetic patients.

From Los Angeles Times ● Jan. 25, 2023

Since sodium phenylbutyrate is approved for another purpose, doctors are allowed to prescribe it off label for ALS.

From Washington Post ● Sep. 7, 2022

Doctors can prescribe it off label — as they already do when prescribing it as part of a mifepristone-misoprostol combo or when using it to induce labor.

From The Verge ● May 5, 2022

“I have never seen a case before this where the judge was asked to force someone to engage in an off label use,” he said.

From Seattle Times ● Oct. 16, 2021