Adverse reaction

A response to a medicinal product 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 restoration, correction or modification of physiological function.
Serious adverse reaction: An adverse reaction which results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.
Unexpected adverse reaction: An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics.
Type A adverse reactions are those that are the result of an exaggerated but otherwise predictable pharmacological effect of the medicine. They tend to be common, dose-related, and less serious than Type B reactions
Type B adverse reactions are those that are aberrant effects of the medicine. They tend to be uncommon, not dose-related, and unpredictable.
Synonym: Adverse drug reaction