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An undesirable effect that may be caused by a study drug.
See also: Adverse Events
An unintended reaction to a drug taken at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. In clinical trials, an ADR would include any injuries by overdosing, abuse/dependence, and unintended interactions with other medicinal products.
Publication Source: Committees on Human Research
Any undesirable experience associated with the use of a medicine in a patient. Adverse events can range from mild to severe. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects.
Publication Source: Guide to Drug Safety Terms at FDA
Publication Date: 2008
See also: Side Effect
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