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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 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 events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are merely documented ...
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:
The core side effects of NSAAs such as gynecomastia, sexual dysfunction, and hot flashes occur at similar rates with the different drugs. [ 48 ] [ 49 ] Conversely, bicalutamide is associated with a significantly lower rate of diarrhea compared to flutamide.
Adverse event (AE) is a side effect occurring with a drug. By definition, the causal relationship between the AE and the drug is unknown. An investigator must establish causality and severity and then report it, especially during clinical trials (not necessarily after marketing is approved).
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
A 2001 study estimated that 1% of hospital admissions result in an adverse event due to negligence. [22] Identification or errors may be a challenge in these studies, and mistakes may be more common than reported as these studies identify only mistakes that led to measurable adverse events occurring soon after the errors.