Adverse Drug Reactions is an untended noxious response occurring after the normal use of drug, which is
suspected to be associated with the drug.
Classified as: [ Type A (Augmented) most common and related to the drugs pharmacological effect; dose dependent [ Type B (Bizarre) which are rare & unpredictable; dose independent According to World Health Organization (WHO) ADR is: [ A response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function. ADR applies to the patients point of view. Adverse effect applies to the drug According to UKs Yellow Card Scheme: [ A side effect is an unintended effect of a drug related to its pharmacological properties and can include unexpected benefits of treatment. Classification of ADR Type of Reaction Features Example Type A: Augmented Common Predictable effect Dose-dependent Low morbidity Low mortality Bradycardia associated with beta-adrenergic receptor antagonist Type B: Bizarre Uncommon Unpredictable Dose-independent High morbidity High mortality Anaphylaxis associated with a penicillin antibiotic Type C: Chronic or Continuous Uncommon Related to the cumulative dose Hypothalamic pituitary adrenal axis suppression by corticosteroids Type D: Delayed Uncommon Usually dose related Occurs or becomes apparent sometime after use of the drug Carcinogenesis Type E: End of Use Uncommon Occurs soon after withdrawal of the drug Opiate withdrawal syndrome Type F: Failure Common Dose-related Often caused by drug interactions Failure of oral contraceptive in presence of enzyme inducer Type G: Genetic or Genomic reactions
Classifications of Immunological Reactions Classification Mechanism (Enzyme) Symptoms/Signs & Examples Type I (Immediate) IgE Pruritis, urticaria, bronchoconstriction, angioedema, hypotension, shock; eg. Penicillin, anaphylaxis Type II (Cytotoxic) IgG or IgM Haemolytic anaemia and thrombocytopaenia; eg. Associated with cephalosphorins, penicillins and rifampicin Type III (Immune Complex) IgG or IgM Cutaneous vasculitis, serum sickness; eg. Associated with chlorpromazine and sulphonamides Type IV (Delayed type) T-cells Occur after 7 20 days. Macular rashes and organ failure, including Stevens-Johnson syndrome and toxic epidermal necrolysis; eg. Associated with neomycin and sulphonamides