Helpful Insights forPatients and Caregivers

What You Need to Know About Off-Label Usage of Medication

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. 

References

  1. Howland RH. Off-label medication use. J Psychosoc Nurs Ment Health Serv. 2012;50(9):11-3. DOI: 10.3928/02793695-20120807-05. PubMed PMID: 22897212.
  2. Gazarian M, Kelly M, McPhee JR, Graudins LV, Ward RL, Campbell TJ. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust. 2006;185(10):544-8. PubMed PMID: 17115966.
  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.
  4. Kairuz TE, Gargiulo D, Bunt C, Garg S. Quality, safety and efficacy in the 'off-label' use of medicines. Curr Drug Saf. 2007;2(1):89-95. PubMed PMID: 18690954.