Adverse Drug Event

Adverse drug reaction (ADR) has been defined as ‘any noxious change which is suspected to be due to a drug, occurs at doses normally used in man, requires treatment or decrease in dose or indicates caution in the future use of the same drug.


Term ‘adverse drug event’ (ADE) has been used to mean ‘any untoward medical occurrence that may present during treatment with a medicine, but which does not necessarily have a causal relationship with the treatment’.


The idea is to record all adverse events first, and look for causality only while analyzing pooled data.