Mannesse et al listed criteria for the diagnosis of an adverse drug reaction (ADR). The authors are from University Hospital Rotterdam and Erasmus University in Rotterdam.
Features of an adverse drug reaction:
(1) The patient is having an undesirable clinical effect following the administration of a drug (abnormal signs and/or symptoms with or without abnormal laboratory test result)
(2) The undesirable clinical effect is not due to intentional overdose, substance abuse, or therapeutic failure.
(3) The undesirable clinical effects cannot be explained by an alternative diagnosis (not in original text).
where:
• Therapeutic failure may be due to inappropriate prescription.
Criteria for a severe ADR - one or both of the following:
(1) results in hospital admission
(2) potentially life-threatening
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