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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.


off label British  

adjective

  1. (of a prescription drug) relating to use, or being used, in ways for which it has not been approved

"Collins English Dictionary — Complete & Unabridged" 2012 Digital Edition © William Collins Sons & Co. Ltd. 1979, 1986 © HarperCollins Publishers 1998, 2000, 2003, 2005, 2006, 2007, 2009, 2012

Example Sentences

Examples are provided to illustrate real-world usage of words in context. Any opinions expressed do not reflect the views of Dictionary.com.

See Examples For:

The 26-year-old, who underwent a heart transplant in 2012, began taking an off-label prescription for everolimus, a generic version of Novartis’s anti-rejection drug Zortress, a year later.

From MarketWatch ● Aug. 13, 2026

Given that MOTS-c is already widely used off-label and no research has shown evidence of harmful side effects, Cohen said in his remarks that he believed “quality-controlled, prescriber-supervised” compounding was the safest way forward.

From Los Angeles Times ● Aug. 6, 2026

But doctors prescribing the drugs off-label say the risks of obesity complications for some patients are too serious not to try a treatment that can be so effective.

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

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

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

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