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Type A: augmented pharmacological effects, which are dose-dependent and predictable [5]; Type A reactions, which constitute approximately 80% of adverse drug reactions, are usually a consequence of the drug's primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin) or a low therapeutic index of the drug (e.g., nausea from digoxin), and they are therefore predictable.
Adverse Reactions - lists all side effects observed in all studies of the drug (as opposed to just the dangerous side effects which are separately listed in "Warnings" section) Use in specific populations (pregnancy, lactation (breast-feeding), females and males of reproductive potential, pediatric, geriatric)
A drug allergy is an allergy to a drug, most commonly a medication, and is a form of adverse drug reaction. Medical attention should be sought immediately if an allergic reaction is suspected. An allergic reaction will not occur on the first exposure to a substance.
Adverse drug reaction (ADR), a harmful unintended result caused by taking medication; Combined drug intoxication; Conservative management; Drug-drug interaction (DDI), an alteration of the action of a drug caused by the administration of other drugs; Paradoxical reaction, an effect of a substance opposite to what would usually be expected
The WHO Adverse Reactions Terminology (WHOART) was a dictionary meant to serve as a basis for rational coding of adverse reaction terms. The system was maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization Collaborating Centre for International Drug Monitoring. The system is no longer actively maintained since 2015.
Adverse reaction reporting is an important component of New Zealand's pharmacovigilance activities. The Centre for Adverse Reactions Monitoring (CARM) in Dunedin is New Zealand's national monitoring centre for adverse reactions. It collects and evaluates spontaneous reports of adverse reactions to medicines, vaccines, herbal products and ...
[2]: 118 The rash may also be one of the potentially lethal severe cutaneous adverse reactions, the DRESS syndrome, Stevens–Johnson syndrome, or toxic epidermal necrolysis. [3] [4] Systemic manifestations occur at the time of skin manifestations and include a high number of eosinophils in the blood, liver inflammation, and interstitial nephritis
In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose Results in death; Is life-threatening; Requires inpatient hospitalization or causes prolongation of existing hospitalization; Results in persistent or significant disability/incapacity