What is a black box warning?

A life-threatening adverse event that may result from taking a particular medication

  • This is the most serious warning granted by the FDA (Food and Drug Administration)1
  • This warning is denoted by a black box around its perimeter
  • These adverse events are typically witnessed after the drug has been released on the market
  • A black box warning is required if a fatal adverse event (risk) should be considered versus the benefit of taking the medication2


Where should I go to find information about black box warnings?


Should I be concerned about taking my medication if it has a black box warning?

  • Black box warnings are important to be aware of, but the adverse event in a black box warning rarely occurs.
  • Talk to your pharmacist or prescriber about how serious the black box warning is in comparison to your disease state.

1. O’Connor NR. FDA boxed warnings: how to prescribe drugs safely. Am Fam Physician [Internet]. 2010 Feb 1 [cited 2012 Jul 11];81(3):298-303. Available from: http://www.aafp.org.db.usip.edu/afp/2010/0201/p298.html.

2. Guidance for industry warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products—content and format. U.S.Department of Health and Human Services Food and Drug Administration [Internet]. 2011 Oct [cited 2012 Jul 11]: 11-12. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf