PharmacovigilanceWHO, 2002 :The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Adverse reactionWHO, (1972):'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 modifications of physiological function'.
Adverse event: Unintended effect occurring at normal dose related to the pharmacological properties.
Serious adverse event or reaction: Any untoward medical occurrence that at any dose;
Results in death; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent of significant disability or incapacity.
Unexpected adverse reaction: Not consistent with applicable product information or characteristics of drug.
Signal: Reported information on possible causal relationship between an adverse event and drug Previously unknown or incompletely documented; More than one report is needed.
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