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An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. [1]: 1.1 Adverse Drug Reaction (ADR) [2] ADRs may occur following a single dose or prolonged administration of a drug or may result from the combination of two or more drugs.
Drug-drug and food-drug interactions may occur, and so-called "natural drugs" used in alternative medicine can have dangerous adverse effects. For example, extracts of St John's wort (Hypericum perforatum), a phytotherapic used for treating mild depression are known to cause an increase in the cytochrome P450 enzymes responsible for the ...
CDR is one means of establishing the validity and benefits of medication in treating specific conditions [1] as well as any adverse drug reactions.The Food and Drug Administration of the United States lists positive dechallenge reactions (an adverse event which disappears on withdrawal of the medication) as well as negative (an adverse event which continues after withdrawal), as well as ...
In adverse drug reactions involving overdoses, the toxic effect is simply an extension of the pharmacological effect (Type A adverse drug reactions). On the other hand, clinical symptoms of idiosyncratic drug reactions (Type B adverse drug reactions) are different from the pharmacological effect of the drug.
Adverse drug reaction. This could occur when a patient has an allergic response to a medication. [7] Inappropriate adherence. This could occur when a patient chooses not to or forgets to take a medication. [7] Needs additional drug therapy. This could occur when a patient needs more medication to treat their condition. [7]
In medicine, a drug eruption is an adverse drug reaction of the skin. Most drug-induced cutaneous reactions are mild and disappear when the offending drug is withdrawn. [1] These are called "simple" drug eruptions. However, more serious drug eruptions may be associated with organ injury such as liver or kidney damage and are categorized as ...
Researchers participating in a clinical trial must report all adverse events to the drug regulatory authority of the respective country where the drug or device is to be registered [e.g. Food and Drug Administration (FDA) if it is US]. Serious AEs must be reported immediately; minor AEs are 'bundled' by the sponsor and submitted later.
Severe cutaneous adverse reactions (SCARs) are a group of potentially lethal adverse drug reactions that involve the skin and mucous membranes of various body openings such as the eyes, ears, and inside the nose, mouth, and lips. In more severe cases, SCARs also involves serious damage to internal organs.