What does off-label use mean?

Definitions for off-label use

Here are all the possible meanings and translations of the word off-label use.


  1. Off-label use

    Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration. In the United States, the Food and Drug Administration Center for Drug Evaluation and Research reviews a company's New Drug Application for data from clinical trials to see if the results support the drug for a specific use or indication. If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route of administration, and other information to be included on the drug's label. More detail is included in the drug's package insert. The FDA approves a drug for prescription use, and continues to regulate the pharmaceutical industry's promotional practices for that drug through the work of the Office of Prescription Drug Promotion

U.S. National Library of Medicine

  1. Off-Label Use

    The practice of prescribing or using a drug outside the scope of the drug's official approved label as designated by a regulatory agency concerning the treatment of a particular disease or condition.


  1. Chaldean Numerology

    The numerical value of off-label use in Chaldean Numerology is: 6

  2. Pythagorean Numerology

    The numerical value of off-label use in Pythagorean Numerology is: 5

Images & Illustrations of off-label use

  1. off-label useoff-label useoff-label use


Find a translation for the off-label use definition in other languages:

Select another language:

Discuss these off-label use definitions with the community:

Word of the Day

Would you like us to send you a FREE new word definition delivered to your inbox daily?

Please enter your email address:     


Use the citation below to add this definition to your bibliography:


"off-label use." Definitions.net. STANDS4 LLC, 2018. Web. 19 Mar. 2018. <https://www.definitions.net/definition/off-label use>.

Are we missing a good definition for off-label use? Don't keep it to yourself...

Nearby & related entries:

Alternative searches for off-label use:

Thanks for your vote! We truly appreciate your support.