loading...| Preferred Name |
Adverse Drug Reaction |
|
| Synonyms |
adverse drug experience Adverse Drug Experience adverse drug reaction (ADR) Adverse Drug Reaction ADR |
|
| Definitions |
Any detrimental or unintended response associated with the use of a medication in humans. |
|
| ID |
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C142385 |
|
| ALT_DEFINITION |
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] |
|
| code |
C142385 |
|
| Concept_In_Subset | ||
| Contributing_Source |
CDISC-GLOSS |
|
| DEFINITION |
Any detrimental or unintended response associated with the use of a medication in humans. |
|
| FULL_SYN |
adverse drug experience Adverse Drug Experience adverse drug reaction (ADR) Adverse Drug Reaction ADR |
|
| label |
Adverse Drug Reaction |
|
| Preferred_Name |
Adverse Drug Reaction |
|
| prefixIRI |
Thesaurus:C142385 |
|
| Semantic_Type |
Finding |
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| UMLS_CUI |
C0041755 |
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| subClassOf |