Adverse Reaction of Pharmaceutical Dosages Forms

Definition

An adverse reaction is an undesirable effect reasonably associated with the use of the drug that may occur as part of the Pharmacological action of the drug or may be unpredictable in its occurrence.

“Serious adverse experience” means any experience that suggests a significant hazard, contra-indication, side effect, or precaution.

With respect to human clinical experience, a serious adverse drug experience includes any experience that is fatal or life-threatening, is permanently disabling, requires in patient hospitalization, or is a congenital anomaly, cancer, or overdose. With respect to results obtained from tests in laboratory animals, a serious adverse drug experience includes any experience suggesting a significant risk for human subjects, including any finding of mutagenicity teratogenicity, or carcinogenicity.

An adverse Drug Reaction is any response to a drug that is noxious and unintended and that occurs at doses used in man for prophylaxis, diagnosis or therapy of disease.

Classification of Adverse Reactions

Adverse reactions may be categorized by organ system, by the severity of the reaction, by frequency or by toxicological mechanism or by the combination of these as appropriate. Adverse reactions are more popularly categorized by frequency, where frequency information from adequate clinical studies is available. It is generally listed in decreasing order of frequency.

The most frequent adverse reactions: The most frequent adverse reactions are where these occur in about one-third of patients i.e. 1 in 30 patients or less than one-tenth of patients.

Less frequent adverse reactions: Less frequent adverse reactions are the adverse reactions, which occur in approximately 1 in 100 patients.

Rare adverse reactions: Rare adverse reactions are the adverse reactions, which occur rarely in approximately 1 in 1000 patients.

The above figures are shown to reflect general experience and they should not falsely imply a greater degree of accuracy that actually exists.

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