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Def:
Adverse drug reaction Any noxious change which is suspected to
be due to a drug, occurs at doses normally
used in man, requires the treatment or
decrease in dose or indicates caution in
the future use of same drug.

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Side effect: Extension of pharmacological

effect within therapeutic dose which is
• WHO definition of adverse drug
undesirable but unavoidable. Side effect may
reaction: produce beneficial effect in other situation.
• Any response to a drug that is noxious and Eg. Morphine produces analgesia beside that
unintended and that occurs at does used produces constipation but in case of
in man for prophylaxis, diagnosis or traveler’s diarrhea it has a beneficial effect.
treatment.

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Atropine reduces the secretion of Unwanted / adverse effect:

exocrine glands which cause difficulty It is a harmful or seriously unpleasant
in deglutition, phonation. But during
anesthesia, atropine is used for this effect of a drug due to therapeutic
effect. So in this situation by reducing concentration of dose.
the secretion, it prevents the chance of For which reduction of dose or
airway obstruction. withdrawn of drug should be done.
H1 receptor antagonist produces It sometimes unavoidable and never
sedation. beneficial.
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Eg. any drug administration orally may Toxic effect:

produce nausea, vomiting, diarrhea. It occurs when therapeutic dose is used
Broad spectrum antibiotic produces for prolonged period or the drug is
superinfection. used in higher doses.
Diuretics: thiazide produces Ex. Chloramphenicol produces -----
hypokaelemia. Aplastic anaemia.
Anticancer drug produces severe Streptomycin produces deafness and
vomiting. vestibular damage.
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Types
Chlorpromazine ---- jaundice. • A. Augmented
Morphine ---- addiction. (Pharmacologic effects)
Aspirin ---- Salicylism. • B. Bizarre effects
Quinine ---- Cinchonism. • C. Chronic effects
• D. delayed effects
• E. end –of treatment effects

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Augmented

• A. adverse effects that are known to occur Most common,

may occur in every one.
from the pharmacology of the drug and are Predictable.
dose-related. They are seldom fatal and Dose dependent.
relatively common. Reversible and preventable
Skill management reduces its appearance.
Eg.
Antihypertensive drug ---- postural hypotension.
Antidiabetic drug ---- hypoglycaemia.
Diuretics ---- hypokalemia.

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• B Adverse effect that occur unpredictably Type B (Bizarre)

and often have a higher rate of morbidity Criteria:
and mortality. They are uncommon. Few people develop.
Not dose related.
Unpredictable.
Based on peculiarities of patient not on
drug’s known actions

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Idiosyncracy; Qualitatively and quantitatively abnormal drug

response. Abnormal or altered reaction of
The Greek word Idios meaning one’s body to a drug usually due to genetic
abnormality of some enzyme.
own, peculiar, distinct and synkrasis
Not found in majority of subjects
meaning a mixing together. Produces the uncharacteristic reaction

G – 6 PD
Primaquine Haemolysis
Deficiency
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• Drugs like primaquine, sulfonamides Drug allergy (Immunological process)

• It is acquired altered response of body due to
and dapsone may cause hemolysis or antibody formation.
methemoglobinemia in pt with glucose-6- • Unrelated to the pharmacodynamic profile of
phosphate dehydrogenase or drug
methemoglobulin reductase deficiencies. • Generally occur even with much smaller
doses
• Also called drug hypersensitivity
• The chief organs are skin, respiratory tract
and CVS (anaphylactic shock), GIT (food
allergy).

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• Most drugs are of relatively low molecular Other effects:

Three subordinate types may be recognized.
wt and only become antigenic when they
3.Type C (Continuous)
combine with other substances of high Due to long term use.
molecular wt, usually proteins. Paracetamol ----- analgesic nephropathy.
Chlorpromazine ---- tardive dyskinesia.

4. Type D (delayed)
Ex. Warfarin in pregnancy ---- teratogenesis,
carcinogenesis

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Type E (ending of use) • Chronic effects– adverse effects that only

Abrupt occur during prolonged treatment and not
Glucocorticoid Rebound with single dose.

adrenocortical • Delayed effects– adverse effects that

insufficiency. occur remote from treatment either in the
children of treated patients or in patient
with themselves years after treatment.

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Some important type B ( bizarre)

reaction
End of treatment effect– adverse effects that • Anaphylaxis– penicillins and other
occur when it is stopped suddenly (so- antimicrobial agents
called withdrawal effects)
• Foreign protein such as strptokinase or
equine antirattlesnake vaccine
• Iodinated contrast media in radiology.
•

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Drug allergy
• Anaphylactoid reaction— Type I reaction (Immediate or
• Nonimmunologic reactions resembling Anaphylactic type)
anaphylaxis but occurring without prior Generally the effects occur within
exposure. minutes.
Immediate anaphylactic reaction may
• Liver disease—( acute hepatic necrosis) occur.
• Kidney disease— Patient may die if not managed
• Bone marrow damage. immediately.
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Example of drug: penicillin, anaesthetic (i/v), iodine containing

Management: radio contrast media etc.
Penicillin injection (antigen)
Inj. Adrenaline i/m or s/c. ↓
Acts as antigen and produce corresponding antibody
Inj. Hydrocortisone 100 ml i/m or i/v. ↓
Antibody is triggered on cell membrane of mast cell & basophil.
Histamine H1 receptor antagonist i/m. ↓
Subsequent administration of penicillin
Maintenance of fluid volume. ↓
Antigen binds with antibody on mast cell and basophil membrane
O2 inhalation if needed.

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Antigen binds with antibody on mast cell and

basophil membrane
↓ • Bronchocontriction,
Antigen antibody complex causes • laryngeal edema
degranulation of cell
Vasodilatation &
↓
• increased
Release of bradykinin, histamine, leukotrines
permeability
etc
Cardio respiratory failure
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Type II reaction (antibody dependent Type II reaction (antibody dependent

cytotoxic type): cytotoxic type):
Here the aantigen-antibody complex is Here the aantigen-antibody complex is
triggered on the formed elements off triggered on the formed elements off
blood like RBC, WBC causing cell blood like RBC, WBC causing cell
damage. damage.
Eg. drug induced haemolytic anemia by Eg. drug induced haemolytic anemia by
penicillin, methyldopa. penicillin, methyldopa.

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Type III reaction (complex mediate type): Eg.

Antigen + antibody Penicillin → glomerulonephritis, serum sickness
↓
Activation of complement system
Sulfonamide → Steven Jonson Syndrome.
↓ Type IV (Delayed hypersensitivity reaction or cell
Body defense mechanism is stimulated mediated):
↓ Antigen-antibody complex
Macrophages phagocytose the complex Activates ↓
↓ T lymphocytes
During phaagocytosis, lysosomal enzyme comes out
↓
↓
Causes digestion & damage of surrounding tissue & inflammation Causes tissue damage locally
Eg. Contact dermatitis, rheumatoid arthritis, multiple
sclerosis.

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Anaphylactoid (Pseudo allergic) reaction: Example of drugs:

Aspirin & other NSAIDs, corticotrophin,
These effect mimic allergic reactions but i/v anaesthetic, morphine, tubocurarine,
have no immunological basis and are dextran, radiographic contrast media
due to genetically determined. etc.
Here release of biologically active
substances such as histamine,
leukotriens also occurs.
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