Clinical Research Glossary

off-label off-label


The use of a treatment in a different way or for a condition other than what it is approved for.

Example of off-label in a sentence

Doctors can prescribe a medicine or other treatments off-label.

More Info

The “label” in “off-label” refers to the specific, intended use that the medicine or product has been approved for. This approval is given by regulators, health authorities, or government agencies. This applies to drugs and devices.

A doctor may prescribe a drug off-label when there is reason to believe that the drug could be helpful when used in a new or different way or for a different condition, as in a different age group, dosage, way to take it, or condition.

Other info to think about when joining a study

Some research studies are investigating a treatment that is being given as an “off-label” use.

You can ask the study team what the treatment is approved for and what its intended use is. You may also want to ask why they want to use this treatment off-label and what information they may have that could suggest it would work off-label.

A graphic of a lightbulb with a question mark in it to represent an invitation to submit ideas for the image.
Do you have an idea for an image that could explain this concept? Contact us.

Was this entry helpful?

Thanks for your feedback!