Off label


  • off label drug use
  • off label indication
  • off label use
  • off-label
  • off-label indication
  • off-label use
  • OLDU
  • unapproved indication
  • unapproved use

In DrugBank, the term "off label" may be found in the "Pharmacology" or the "Indications" section of a drug entry. Though the definition for this term can vary and is not well standardized  1, DrugBank generally uses this term to identify the use of a drug for a specific indication that is not currently approved by the US Food and Drug Administration (FDA). Other resources, such as clinical trials, textbooks, and case reports are used in DrugBank to provide the off label information in our database.

The term "off label"  can also refer to the use of a currently available medication in a patient population (for example, pediatric), dosage, or dosage form that does not have FDA approval, but has been documented in various literature sources.


  1. Wittich CM, Burkle CM, Lanier WL: Ten common questions (and their answers) about off-label drug use. Mayo Clin Proc. 2012 Oct;87(10):982-90. doi: 10.1016/j.mayocp.2012.04.017. Epub 2012 Aug 6. [Article]