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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

It is often used off-label in younger children with obesity.

From The Wall Street Journal ● Jun. 22, 2026

In May, Canada became the first country in the G7 to approve a generic semaglutide injection, intended for type 2 diabetes patients but can be prescribed off-label for weight loss.

From BBC ● Jun. 3, 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

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

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

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