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Adverse Drug Reaction

Meaning

An Adverse Drug Reaction (ADR) is a clinically significant, unintended, and harmful response to a medicinal product administered at a normal therapeutic dose. This event necessitates a modification of the patient’s treatment regimen, such as dose reduction, specific supportive care, or complete discontinuation of the medication. The term is reserved for effects where a causal relationship with the drug is suspected or established, distinguishing it from an unrelated adverse event.