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We defined an ADR as an appreciably harmful or unpleasant reaction caused by a drug that is serious enough to warrant the discontinuation or revision of treatment.
An ADR is defined as "an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product" [ 4].
The majority of the studies (n=8) used either the WHO definition 1 or that proposed by Edwards and Aronson: An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen or withdrawal of the product.
Edwards and Aronson defined an adverse drug reaction as " an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product" [ 63].
44 An adverse drug reaction (ADR) is defined as "an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product".
Thus, our definition of ADRs was consistent with the more recent and clearer version: "An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product".
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CEO of Professional Science Editing for Scientists @ prosciediting.com