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1. ADVERSE DRUG REACTION
KAISH PATHAN 1
Seminar/Assignment-I (MPL204T)
For the Subject
CLINICAL RESEARCH AND
PHARMACOVIGILANCE
Submitted to
Drs. Kiran & Pallavi Patel Global
University (KPGU)
Guided by:
Mrunali Nemade
Assistant Professor
M Pharm.
KSP
Presented by:
Kaish Pathan
M. Pharm Sem-II
Pharmacology Branch
En. No. 2103314001
Krishna School of Pharmacy & Research (KSP)
Krishna Edu Campus ,Vadodara Mumbai NH#8, Varnama, Vadodara

2. CONTENTS
• OBJECTIVE
• DEFINATIONS
• CLASSIFICATION OF ADR
• SIDE EFFECTS
• SUMMARY
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3. OBJECTIVES
• Definitions of terms related to Adverse Drug Reactions (ADRs).
• Classification of ADRs.
• Discussion on each type of ADRs with examples.
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4. DEFINITIONS
• Adverse Event (AE) : Any untoward medical occurrence that may present
during treatment with pharmaceutical product which does not necessarily
have a causal relationship with this treatment.
• Adverse Drug Reaction (ADR): Any noxious change which is suspected to
be due to drug, occurs at doses normally used in man, requires treatment or
decrease in dose or indicates caution in future use of same drug.
• Therefore an adverse drug reaction is adverse event with causal link of drug.
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5. KAISH PATHAN 5
DRUG ADMINISTERED

6. KAISH PATHAN 6
DRUG CONTINUED
WORSENING OF
SYMPTOMS
ANY POSSIBLE CAUSES?
UNDERLYING CONDITION
DRUG DISCONTINUED
SYMPTOMS IMPROVED
SYMPTOMS RECUR
+VE CHANGES

8. CLASSIFICATION OF ADR
DEPENDING ON…
• ONSET OF EVENT: Acute (>60 mins), Sub-acute (1-24 hr.) and latent
(>2 days).
• TYPE OF REACTION: Type A (Augmented), B (Bizarre), C (Chemical),
D (Delayed), E (Exit), F (Familial), G (Genotoxicity), H (Hypersensitivity), U
(Un classified).
• SEVERITY: Minor, Moderate, Severe, Lethal ADR.
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9. TYPE A (AUGMENTED)
• Reactions which can be predicted from known pharmacology of drug.
• Dose dependent.
• Can be alleviated by dose reduction.
o EXAMPLES:
• Anticoagulants Bleeding.
• Beta blockers Bradycardia
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10. TYPE B (BIZZARE)
• Cannot be predicted from pharmacology of the drug.
• Not dose dependent.
• Host dependent factors important predisposition.
o EXAMPLE:
• Penicillin Anaphylaxis.
• Anticonvulsant Hypersensitivity.
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11. TYPE C (CHEMICAL)
• Biological characteristics can be predicted from chemical structure of drug.
o EXAMPLE:
• Paracetamol Hepatotoxicity.
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12. TYPE D (DELAYED) REACTION
• Occurs after many years of treatment.
• Can be due to accumulation.
o EXAMPLE:
• Chemotherapy Secondary tumor.
• Phenytoin during pregnancy Teratogenicity.
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13. TYPE E (END OF TREATMENT)
• Occurs on withdrawal especially when drug is stopped abruptly.
o EXAMPLE:
• Phenytoin withdrawal Seizures.
• Steroid withdrawal Adrenocorticoid insufficiency.
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14. CLASSIFICATION DEPRNDING ON
SEVERITY
❖ MINOR: No therapy, no antidote or prolongation of hospitalization
required.
❖ MODERATE: Requires change in drug therapy, specific treatment or
prolong hospital stay by at least 1 day.
❖ SEVERE: Potentially life threatening causes permanent damage or requires
intensive medical treatment.
❖ LETHAL: Directly or indirectly contributes to death of patient.
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15. SIDE EFFECTS
• Unwanted but unavoidable pharmacodynamic effects that occur at
therapeutic doses.
• Predicted from pharmacological profile of drug.
• Known to occur in given percentage of drug recipient.
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16. • EXAMPLE:
• Side Effect based on therapeutic effect:
✓ Atropine (Preanesthetic) Dryness of mouth.
• Side Effect based on different action:
✓ Estrogen (anti ovulatory) Nausea.
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17. CONTD..
• DRUG DISCOVERY:
• Occasionally “adverse” effect may be exploited to develop an entirely new
indication of drug.
• E.g.:
✓ Unwanted hair growth during Minoxidil treatment of severely hypertensive
patient Development of drug for hair growth.
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18. • SECONDARY EFFECTS:
• Indirect consequences of primary action of drug.
• EXAMPLE:
• Tetracycline Suppression of bacterial flora Superinfection.
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19. TOXIC EFFECT
• Result of excessive pharmacological action of drug due to overdose or
prolong use.
• Over dosage maybe :
1. Absolute (Accidental, Homicidal, Suicidal).
2. Relative ( Gentamycin in renal failure).
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20. • RESULT FROM:
• Extension of therapeutic effect:
e.g. Barbiturates Coma.
• Functional alteration:
e.g. Atropine Delirium.
• Drug induced tissue damage:
e.g. Paracetamol Hepatic necrosis.
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21. INTOLERENCE
• Appearance of characteristic toxic effects of drug in individual at therapeutic
doses.
• Converse of tolerance.
• Indicates low threshold of individual.
o E.g.
• Carbamazepine ( few doses) Ataxia in some individuals.
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22. IDOSYNCRACY
• Genetically determined abnormal reactivity to a chemical.
• Certain bizarre drug effects due to peculiarities of an individual for which
no definite genotype has been described are also included.
• E.g.
• Barbiturates Excitement and mental confusion in some individuals.
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23. DRUG ALLERGY
• Immunologically mediated reaction producing stereotype symptoms,
unrelated to pharmacodynamic profile of drug.
• Generally occur even with much smaller doses.
• Also called drug hypersensitivity.
o TYPES:
• Type 1: Immediate anaphylactic (IgE)
e.g. Penicillin Anaphylaxis
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24. KAISH PATHAN 24
• TYPE 2: Cytotoxic Antibody (IgG, IgM)
e.g. Methyldopa Hemolytic Anemia.
• TYPE 3: Serum sickness (IgG, IgM)
e.g. Procainamide Induced lupus.
• TYPE 4: Delayed Hypersensitivity (T Cells)
e.g. Contact Dermatitis

25. KAISH PATHAN 25
❖ PHOTOSENSITIVITY:
• Cutaneous reaction resulting from drug induced sensitization of skin to UV
radiation.
❖ PHOTOTOXIC:
• Drug or metabolite accumulates in skin absorbs light and undergoes chemical
reaction resulting in tissue damage.
• E.g.
Tetracycline (Esp. Demeclocycline), and Tar products.
❖ PHOTO ALLERGIC:
• Drug or its metabolite induces cell mediated immune response which on
exposure to light produces contact dermatitis.
• E.g.
Sulfonamides, Sulfonylureas.

30. THANK YOU
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