Chapter 3

Adverse Reactions

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 Adverse Reactions
Side Effects
Predictable
Dose-related
Acts on nontarget organs
Examples include stomachache, headache,
nausea, vomiting, local effects

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 Adverse Reactions
Toxic Reactions
Predictable
Dose-related
Acts on target organs
Extension of the drugs pharmacologic effects
Examples include hypoglycemia with an oral
hypoglycemic agent or insulin

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 Adverse Reactions
Allergic Reactions
Not predictable
Not dose-related

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 Adverse Reactions
Allergic Reactions
Type 1
Mediated by immunoglobulin E (IgE) antibodies
Anaphylactic shock or immediate hypersensitivity
reactions
Type 2
Complement-dependent reactions involving IgG or
IgM antibodies
Examples include penicillin-induced hemolytic
anemia

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 Adverse Reactions
Allergic Reactions
Type III
Mediated by IgG
It is manifested as serum sickness
Type IV
Delayed hypersensitivity reaction
Mediated by T lymphocytes and macrophages
Examples include allergic contact dermatitis

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 Adverse Reactions
Idiosyncratic Reactions
This is a reaction that is neither a side effect or
an allergic reaction .
Some are genetically determined abnormal
reactions.
Some are due to an immunologic mechanism.

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Toxicologic Evaluation of Drugs
Therapeutic Index (TI = LD50)
ED50
An approximate statement of the relative safety of
the drug expressed as the ratio of the lethal or toxic
dose to the therapeutic dose of a drug
LD50: Minimum dose causing death in 50% of a
sample population
ED50: Dose required to produce a specified
intensity of effect in 50% of a sample population

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 Drug Testing
Phase I Trials
Determines the biologic effects, safe dose range in
humans, and toxic effects of the drug
Phase II Trials
The main purpose of this phase is to test for drug
effectiveness and adverse effects
Phase III Trials
Patients with the actual drug indication receive the drug.
The drug is evaluated for safety and efficacy
Phase IV Trials
Postmarketing surveillance

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