Adverse events
Adverse Events
Adverse events (pronounced ad-verse ee-vents), also known as Adverse Effects or Side Effects, are unwanted or harmful occurrences that may occur during treatment with a drug or other medical intervention. The term is often used in Pharmacovigilance and Clinical Trials to describe any unfavorable and unintended sign, symptom, or disease associated with the use of a medical product, whether or not it is considered related to the product.
Etymology
The term "adverse event" originates from the Latin words "adversus" meaning "opposite" and "eventus" meaning "outcome". It was first used in the medical field in the mid-20th century to describe negative outcomes in patients receiving medical treatment.
Related Terms
- Adverse Drug Reaction: A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.
- Serious Adverse Event: An adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
- Unexpected Adverse Event: An adverse event, the nature or severity of which is not consistent with the applicable product information or other relevant sources of information.
- Preventable Adverse Event: An adverse event that could have been prevented with the appropriate care and following the correct procedure.
See Also
- Pharmacovigilance
- Clinical Trials
- Adverse Drug Reaction
- Serious Adverse Event
- Unexpected Adverse Event
- Preventable Adverse Event
External links
- Medical encyclopedia article on Adverse events
- Wikipedia's article - Adverse events
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