Adverse drug event

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

• Drug-drug interaction
• Drug-allergy interaction
• Drug-food interaction
• Drug-laboratory interaction
• Drug-tobacco interaction

References

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