Adverse drug event

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An adverse event (ADE) is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to U.S. Food and Drug Administration (FDA) when the patient outcome is:

  • Death
  • Life-threatening
  • Congenital Anomaly/Birth Defect
  • Required Intervention to Prevent Permanent Impairment or Damage (Devices)
  • Other Serious (Important Medical Events)

Clinical Decision Support

Rules for ADE are often used in clinical decision support systems.

Important interactions



  1. What is a Serious Adverse Event? FDA. [1]