Adverse drug event

An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to 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)

Important interactions

Drug-drug interactions Drug-allergy interactions Drug-food interactions Drug-laboratory interactions Drug-tobacco interactions

References

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