Adverse Effects and Hypersensitivity
2024-04-26 9:08 AM
Learning Objectives:
1. Define the terms "side effect" and "adverse effect" of a drug:
• Side effect: Undesirable, non-deleterious drug effects occurring after adm
related to the pharmacological properties of the drug.
• Adverse effect: Undesirable, deleterious drug effects occurring after admin
can be predictable (dose-dependent) or unpredictable.
2. Categorize adverse effects into pharmacological, immunological, or cytotoxic:
• Pharmacological: Result from specific effects of the drug or its metabolites
• Immunological: Result from activation of the immune system by the drug.
• Cytotoxic: Result from direct cell damage caused by the drug or its metabo
3. Describe the main features of overdose toxicity of a drug:
• Overdose toxicity occurs after administration of doses higher than therape
• Toxic effects may be an extension of therapeutic effects or unrelated and
• Severity is directly proportional to the administered dose.
4. Define LD50, TD50, and ED50; estimate TD50 and ED50 from given data:
• LD50: Dose at which 50% of subjects die (lethal dose).
• TD50: Dose at which 50% of subjects exhibit toxic effects (toxic dose).
• ED50: Dose at which 50% of subjects exhibit therapeutic effects (effective
• These doses can be estimated from quantal dose-response curves.
5. Define therapeutic index and estimate it from given data:
• Therapeutic index: Ratio of median toxic dose to median therapeutic dose
• Indicates the safety margin of a drug; higher values indicate greater safety
• Calculated based on the chosen toxic and therapeutic effects.
6. Describe drug idiosyncrasy, list common instances, and explain underlying mech
• Idiosyncrasy: Genetically based abnormal response to a drug.
• Low incidence, dose-dependent, more severe in genetically susceptible ind
• Mechanisms may involve pharmacogenetics and are often obscure.
7. Define drug allergy, describe main features, list common types, and explain und
• Immunologically mediated adverse drug effect upon re-exposure to the dr
• Occurs after sensitization phase, involves antigen-antibody reaction.
• Four main mechanisms: Type I (immediate), Type II (cytotoxic), Type III (im
cell-mediated).
8. Define teratogen and teratogenesis, give examples, relate effects to embryo-fet
• Teratogen: Agent causing abnormal fetal development or malformations.
• Effects depend on gestational stage; direct and indirect effects possible.
• Mechanisms include interference with normal cellular processes, often rel
2024-04-26 9:08 AM
Learning Objectives:
1. Define the terms "side effect" and "adverse effect" of a drug:
• Side effect: Undesirable, non-deleterious drug effects occurring after adm
related to the pharmacological properties of the drug.
• Adverse effect: Undesirable, deleterious drug effects occurring after admin
can be predictable (dose-dependent) or unpredictable.
2. Categorize adverse effects into pharmacological, immunological, or cytotoxic:
• Pharmacological: Result from specific effects of the drug or its metabolites
• Immunological: Result from activation of the immune system by the drug.
• Cytotoxic: Result from direct cell damage caused by the drug or its metabo
3. Describe the main features of overdose toxicity of a drug:
• Overdose toxicity occurs after administration of doses higher than therape
• Toxic effects may be an extension of therapeutic effects or unrelated and
• Severity is directly proportional to the administered dose.
4. Define LD50, TD50, and ED50; estimate TD50 and ED50 from given data:
• LD50: Dose at which 50% of subjects die (lethal dose).
• TD50: Dose at which 50% of subjects exhibit toxic effects (toxic dose).
• ED50: Dose at which 50% of subjects exhibit therapeutic effects (effective
• These doses can be estimated from quantal dose-response curves.
5. Define therapeutic index and estimate it from given data:
• Therapeutic index: Ratio of median toxic dose to median therapeutic dose
• Indicates the safety margin of a drug; higher values indicate greater safety
• Calculated based on the chosen toxic and therapeutic effects.
6. Describe drug idiosyncrasy, list common instances, and explain underlying mech
• Idiosyncrasy: Genetically based abnormal response to a drug.
• Low incidence, dose-dependent, more severe in genetically susceptible ind
• Mechanisms may involve pharmacogenetics and are often obscure.
7. Define drug allergy, describe main features, list common types, and explain und
• Immunologically mediated adverse drug effect upon re-exposure to the dr
• Occurs after sensitization phase, involves antigen-antibody reaction.
• Four main mechanisms: Type I (immediate), Type II (cytotoxic), Type III (im
cell-mediated).
8. Define teratogen and teratogenesis, give examples, relate effects to embryo-fet
• Teratogen: Agent causing abnormal fetal development or malformations.
• Effects depend on gestational stage; direct and indirect effects possible.
• Mechanisms include interference with normal cellular processes, often rel
