Black box warning


  • Blackbox warning
  • Boxed warning

The black box warning appears on a prescription drug's FDA label and is a summary of information designed to call attention to serious or life-threatening risks 1. Essential information is provided about the risks of taking a drug. Specific patient characteristics which increase the risk of serious effects or death may also be mentioned on this warning, for example,  younger age 2.  

DrugBank records this information from FDA labels and represents it in a concise manner by including important data found on the warning, including the risk described, and information regarding patient characteristics, [concomitant drugs], and route that are related to the risk. Some additional details extracted from the FDA label may include recommendations to reduce the risk of adverse events or recommendations to manage  the adverse effects caused by the drug.


  1. A Guide to Drug and Safety Terms at FDA [File]
  2. Prozac FDA label [File]