Difference between revisions of "Adverse drug event"

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'''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:
 
'''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
+
* Death
Life-threatening
+
* Life-threatening
Congenital Anomaly/Birth Defect
+
* Congenital Anomaly/Birth Defect
Required Intervention to Prevent Permanent Impairment or Damage (Devices)
+
* Required Intervention to Prevent Permanent Impairment or Damage (Devices)
Other Serious (Important Medical Events)
+
* Other Serious (Important Medical Events)
  
 
== Important interactions ==
 
== Important interactions ==

Revision as of 18:32, 17 November 2011

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]