Helpful Insights forPatients and Caregivers

Key Reminder

  • Off-label use means that an approved drug is used in a way that is not approved by the FDA.
  • This may include:
    • use of a medication for an unapproved indication or disease
    • use of a medication at an unapproved dose
    • use of a medication in an unapproved dosage form
  • Consider asking your doctor about off-label use of medications that you are prescribed. 


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  3. Wittich CM, Burkle CM, Lanier WL. Ten common questions (and their answers) about off-label drug use. Mayo Clin Proc. 2012;87(10):982-90. DOI: 10.1016/j.mayocp.2012.04.017. PubMed PMID: 22877654; PubMed Central PMCID: PMC3538391.
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