Adverse Drug Reaction (ADR)
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An Adverse Drug Reaction (ADR) is an Adverse Drug Event in which the injury caused by taking a Medication.
- Example(s):
- a Type A ADR (augmented pharmacologic effects - dose dependent and predictable),
- a Type B ADR (Idiosyncratic),
- …
- Counter-Example(s):
- See: Pharmacovigilance, Medication, Drug, Side Effect, Drug Therapy, EudraVigilance, Iatrogenesis, Lethal Dose, Paradoxical Reaction, Polypharmacy, Toxicity, Toxicology.
References
2021a
- (Stoppler, 2021) ⇒ https://www.medicinenet.com/adverse_reaction/definition.htm Reviewed on 3/29/2021.
- QUOTE: In pharmacology, any unexpected or dangerous reaction to a drug. An unwanted effect caused by the administration of a drug. The onset of the adverse reaction may be sudden or develop over time.
Also called an adverse drug event (ADE), adverse drug reaction (ADR), adverse effect or adverse event.
- QUOTE: In pharmacology, any unexpected or dangerous reaction to a drug. An unwanted effect caused by the administration of a drug. The onset of the adverse reaction may be sudden or develop over time.
2021b
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Adverse_drug_reaction Retrieved:2021-11-13.
- An adverse drug reaction (ADR) is an injury caused by taking medication.[1] ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term differs from the term “side effect” because side effects can be beneficial as well as detrimental.[2] The study of ADRs is the concern of the field known as pharmacovigilance. An adverse drug event (ADE) refers to any injury occurring at the time a drug is used, whether or not it is identified as a cause of the injury. An ADR is a special type of ADE in which a causative relationship can be shown. ADRs are only one type of medication-related harm, as harm can also be caused by omitting to take indicated medications.
- ↑ "Guideline For Good Clinical Practice" (PDF). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 10 June 1996. p. 2. Retrieved 12 July 2014.
- ↑ Nebeker JR, Barach P, Samore MH (May 2004). “Clarifying adverse drug events: a clinician's guide to terminology, documentation, and reporting". Annals of Internal Medicine. 140 (10): 795–801. doi:10.7326/0003-4819-140-10-200405180-00017. PMID 15148066. S2CID 32296353
2021c
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-13.
- Adverse drug reaction
- In the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase "responses to a medicinal product" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Regarding marketed medicinal products: A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function. (ICH E6)
- Adverse drug reaction