" /> Adverse Reaction - CISMeF





Preferred Label : Adverse Reaction;

NCIt synonyms : Adverse Effect; ADR; AR;

NCIt definition : Any noxious and unintended response(s) to a medical product or procedure, for which a causal relationship with this product or procedure is at least a reasonable possibility i.e., the relationship cannot be ruled out.;

Alternative definition : CDISC-GLOSS: A response to a medicinal product, devices, or procedures, which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. In the context of drug development, the term is used as a synonym of adverse drug reaction. (After ICH E2A); NCI-GLOSS: An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse effects do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe.;

NCIt note : WHO Technical Report 498 definition the post-marketing setting: A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.; The old term Side Effect is retired and should not be used.;

Codes from synonyms : CDR0000044922;

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27/04/2024


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