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Adverse effect (medicine) : ウィキペディア英語版
Adverse effect

In medicine, an adverse effect is an undesired harmful effect resulting from a medication or other intervention such as surgery.
An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or procedure, this is called a medical error and not a complication. Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. Some adverse effects occur only when starting, increasing or discontinuing a treatment.
Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with a treatment regimen. Adverse effects of medical treatment resulted in 142,000 deaths in 2013 up from 94,000 deaths in 1990 globally.
The harmful outcome is usually indicated by some result such as morbidity, mortality, alteration in body weight, levels of enzymes, loss of function, or as a pathological change detected at the microscopic, macroscopic or physiological level. It may also be indicated by symptoms reported by a patient. Adverse effects may cause a reversible or irreversible change, including an increase or decrease in the susceptibility of the individual to other chemicals, foods, or procedures, such as drug interactions.
==Classification==
In terms of drugs, adverse events may be defined as: “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.”〔
In clinical trials, a distinction is made between adverse events and serious adverse events. Generally, any event which causes death, permanent damage, birth defects, or requires hospitalization is considered an SAE.〔http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm〕 The results of these trials are often included in the labeling of the medication to provide information both for patients and the prescribing physicians.
The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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