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Most drugs and procedures have a multitude of reported adverse side effects; the information leaflets provided with virtually all drugs list possible side effects. Beneficial side effects are less common; some examples, in many cases of side-effects that ultimately gained regulatory approval as intended effects, are:
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 effects, like therapeutic effects of drugs, are a function of dosage or drug levels at the target organs, so they may be avoided or decreased by means of careful and precise pharmacokinetics, the change of drug levels in the organism in function of time after administration. Adverse effects may also be caused by drug interaction. This ...
Adverse drug reaction is effects arising when drug given even in therapeutic dose either immunologically mediated reaction or pharmacologically mediated adverse response or idiosyncratic reaction due to the peculiarities of individual. Adverse event (AE) is a side effect occurring with a drug. By definition, the causal relationship between the ...
If a drug can bind to unexpected proteins, receptors, or enzymes that can alter different pathways other than those desired for treatment, severe downstream effects can develop. An example of this is the drug eplerenone (aldosterone receptor antagonist), which should increase aldosterone levels, but has shown to produce atrophy of the prostate. [3]
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.
In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects , an adverse event does not necessarily mean the medication directly caused the problem.
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)