Adverse drug event
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Revision as of 18:33, 17 November 2011 by Annathehybrid (Talk | contribs)
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
- What is a Serious Adverse Event? FDA. [1]