Any noxious and unintended response associated with the use of a drug in humans. NOTE: 1. Post-approval: an adverse event that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function. 2. Pre-approval: an adverse event that occurs at any dose and where a causal relationship is at least a reasonable possibility. 3. FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, "whether or not considered to be drug-related." CDISC recognizes that current usage incorporates the concept of causality. [WHO Technical Report 498(1972); ICH E2A]

C142385

CDISC-GLOSS

Any detrimental or unintended response associated with the use of a medication in humans.

adverse drug experience

Adverse Drug Experience

adverse drug reaction (ADR)

Adverse Drug Reaction

ADR

Adverse Drug Reaction

Adverse Drug Reaction

Thesaurus:C142385

Finding

C0041755