adverse reaction

ADVERSE REACTION

Adverse Effect

Adverse Reaction

adverse effect

ADR

AR

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.

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41332

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.

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)

C41332

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C54452

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61410

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C54599

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C67497

CDISC-GLOSS

FDA

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.

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.

adverse reaction

ADVERSE REACTION

Adverse Effect

Adverse Reaction

adverse effect

ADR

AR

Adverse Reaction

Adverse_Reaction

Adverse Reaction

Thesaurus:C41332

Finding

C0559546

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41331