ADR refers to adverse drug reactions, which are unintended effects that occur at standard doses used in humans. Some key points about ADRs include: 1. ADRs can be predictable or unpredictable, dose-dependent or independent. Predictable ADRs include toxicity from overdose or side effects from standard doses. 2. Types of ADRs include toxicity, intolerance, side effects, idiosyncrasy, drug allergy, chronic effects, end of treatment effects, delayed effects, and fetal effects. 3. Drug allergy is an immunologically mediated reaction that is unrelated to the drug's pharmacological effects. It requires prior sensitization and can cause various symptoms.

2. ADR is defined as
“any response to a drug that is noxious, unintended & that
occurs at doses used in man for prophylaxis, diagnosis or
therapy’’
The undesirable effects of the drug are called
Adverse Drug Reactions (A.D.R.s)

3. oetal effects
nd of treatment effects
elayed effects
hronic effects
izarre effects
ugmented pharmacological effects

4. :
Predictable
Dose dependent
1. Toxicity: At overdose
2. Intolerance: Toxicity at lesser dose; sensitivity
3. Side effects: At standard dose; Non-specificity
Type-A. Augmented pharmacological
effects

5. 1.Toxic Effect :-
• These are the result of excessive
pharmacological action of drug due to over
dosage or prolonged use.
• Over dosage may be absolute (accidental,
homicidal, suicidal) or relative (normal dose in
presence of liver or kidney failure).
• The organs with more blood supply i.e. CNS,
CVS, Kidney, liver, lungs are affected first.
• The effects are predictable.

6. POISON is a
“substance which endangers life by severely
affecting one or more vital functions”.
Poisoning:
It is the spectrum of clinical features
resulting from excess doses of drug.
PARACELSUS: It is the dose which will decide
the drug or poison.
Not only drugs but other household & industrial
chemicals, insecticides etc are frequently
involved in poisoning.

7. Treatment of Poisoning :-
i. Termination of exposure:
• Take the patient to fresh air/oxygen .
• Wash skin & eyes.
• Induce vomiting with syrup ipecac.
• Do gastric lavage.
ii. Prevent absorption of ingested poison:
• Put a suspension of 20-40 gms of activated charcoal
in 200 ml water through intragastric tube in
stomach.
• Also one can use ‘Universal Antidote’c consist of
Burned Toast, Strong Tea & Mg(OH)2 [milk of
magnesia] in the ratio of 2:1:1.

8. iii. Maintenance of patent airway:
• This is done by head & neck alignment.
• If necessary one can provide O2 by oxygen mask
or can artificially ventilate the patient through
ventilator.
iv. Maintenance of blood pressure:
• Provide necessary fluids & press or agents to
maintain the B.P.
• If heart rate is less use cardiac stimulant.

9. v. Hastening elimination of poison which is
absorbed systemically:
• Induce diuresis with diuretics like furosemide &
mannitol.
• Alter urinary pH.
a) Alkalinization for acidic drugs.
b) Acidification for basic drugs.
• Haemodialysis & haemoperfusion may be
performed.

10. 2. Intolerance:-
• It is reverse of tolerance defined as the
appearance of characteristic toxic effects of a
drug in an individual at therapeutic doses.
e.g. – Single dose of triflupromazine induces
muscular dystonias in some individuals,
specially children.
– Only few doses of carbamazepine
causes ataxia in some individuals.
– Single dose of Chloroquine cause
vomiting.

11. 3.Side Effects
• These are Unwanted but often Unavoidable
Pharmacodynamics effects that occur at
therapeutic doses.
• They can be Predicted from the pharmacological
action of a drug, are known to occur in a given
percentage of patient taking the particular drug.
• Reduction in dose will decrease or abolishes the
effects.

12. Drug allergy is of 4 types:
Type I: Anaphylaxis
Type II: Blood cytolysis
Type III: Complex (AG:AB) mediated reaction
Type IV: Delayed hypersensitivity
Unpredictable Non dose dependent
2. Drug allergy
1. Idiosyncracy
Type -B. Bizarre effects

13. 1.Idiosyncrasy:-
It is defined as genetically determined abnormal reactivity
towards a chemical.
e.g. – B1.Idiosyncrasy:
It is defined as genetically determined abnormal reactivity
towards a chemical.
e.g. – Barbiturates causes excitement, mental confusion in
some persons.
– Quinine causes cramps, diarrhoea, purpura, asthma &
vascular collapse in some patients.
arbiturates causes excitement, mental confusion in some
persons.
– Quinine causes cramps, diarrhoea, purpura, asthma &
vascular collapse in some patients.

14. 2.Drug Allergy:-
• It is an immunologically mediated reaction producing
symptoms which are unrelated to the Pharmacodynamics
effects of the drug & are largely independent of dose.
• It is also known as drug hypersensitivity.
• It occurs in fraction of population exposed to drug &
cannot be produced in other individuals at any dose
• Prior sensitization is needed & a latent period of 1-2 wks
is required after first exposure.
• Drug or its metabolite acts as Antigen or more commonly
hapten (incomplete antigen drugs have small molecule
binds with an endogenous protein & acts as antigen)
induces production of antibody or sensitized lymphocytes
• Chemically related drugs show cross sensitivity

15. TYPES & MECHANISM OF ALLERGIC REACTION:
A.Humoral (Antibody mediated)
1. Type-I Reactions (Anaphylactic)
• IgE mediated reactions takes place on the
surface of mast cells.
• Release of mediators like Histamine, Serotonin,
Leukotrienes, Prostaglandins, Platelet
activating factor etc occurs.
• It results in Urticaria, Itching, Angioedema,
Asthma, Rhinitis or Anaphylactic Shock.
• Also known as Immediate hypersensitivity.

16. 2. Type-II reactions (Cytolytic):
• IgG, IgM mediated reaction, takes place on the
surface of specific tissue cell.
• Complement system is activated & cytolysis of
specific cell occurs.
• It results in Thrombocytopenia, Granulocytosis,
Aplastic anemia, Hemolysis, Organ damage etc.

17. 3. Type-III reactions (Retarded, Arthus)
• IgG mediated.
• The antigen: IgG complex binds complement
& get precipitated on vascular endothelium
giving rise to a destructive inflammatory
response.
• It results in rashes, serum sickness (fever,
arthralgia, lymphadenopathy), Stevens –
Johnson syndrome etc.
• Reaction subside in 1-2wks.

18. B.CELL MEDIATED:
4.Type-IV reactions(delayed hypersensitivity)
• Sensitized T – lymphocyte mediated.
• Antigen binds the receptors present on the
surface of T – cells and led to the generation
of Lymphokines which attracts granulocytes &
produces an inflammatory response.
• It results in contact dermatitis, rashes fever,
photosensitization.

19. Stop culprit drug, mild reactions subsides itself.
In mild Type I reactions Antihistaminics (Avil) are
beneficial.
In case of life threatening reactions following
measures have to be taken.
Administer O2 at high flow rate.
Put the patient to reclining position.
Perform Cardio – Pulmonary resuscitation if
necessary.
Treatment of drug allergy

20. Inject Adrenaline 0.5mg (1:1000) i/m, repeat
it at every 5-10 min in case the patient is not
improving.
Inject H1 – Antihistaminic (Chlorpheniamine)
i.m. / slow i.v.
Inject I.V. Glucocorticoids which acts slowly but
valuable for prolonged/recurrent rxn.
Adrenaline is effective in Type I reaction
whereas Glucocorticoids are effective in Type
II,III & IV reactions.

21. Duration dependent
• Adverse effects of prolonged treatment
• This occurs due to long term (continuous) use of
drug
e.g. Corticosteroids on long term use causes
immunosuppression & Cushing’s syndrome
Type-C. Chronic effects (Continuous)

22. 8. Drug dependence:
It is a state in which the drugs are used for
personal satisfaction & rated as high priority
than face of known risks to health.
Drugs capable of altering mood & feelings
are the main culprit.
Different terminologies used are:
(a)Psychological dependences:
• It is the condition when the individual believes
that his well being is achieved only through the
actions of the drug.

23. • It starts as liking for a drug & progress to
compulsive use of drug.
• Reinforcement- It is the ability of the drug to
produce effects that make the user wish it to
take again.
e,g.Opioids,Cocaine.
(b) Physical dependence:
It is an altered physiological state produced by
repeated administration of a drug which
necessitates the continued presence of drug to
maintain physiological equilibrium.

24. Discontinuation of the drug results in a
characteristic“ Withdrawal Syndrome”
e.g. Opioid, barbiturates, alcohol & other CNS
depressants.
(c) Drug abuse: It refers to use of a drug by self-
medication in a manner & ammount that
deviates from the approved medical & social
patterns in a given culture at a given time. For
regulatory agencies like Narcotics department,
Drug abuse refers to use of an illicit drug.

25. (d)Drug addiction: It is a pattern of compulsive
drug use characterized by its importance &
involvement over other activities. CNS
stimulants & Euphoria producing drugs are
more liable to produce addiction.
(e) Drug habituation: It is minor degree of drug
addiction with less intensive involvement with
the drug, so that its withdrawal produces mild
discomfort only. E.g. Tea, Coffee, tobacco etc.

26. In this ADR appear after the use of drug is over
e.g.-Carcinogenicity: by radio-isotopes
Mutagenicity: by anticancer drugs
Carcinogenicity & mutagenicity:-
It refers to the capacity of a drug to cause cancer
or genetic defects respectively. The reactive
intermediates produced after oxidation are mainly
responsible for it.
e.g. Anticancer drugs, Radioisotopes, Estrogen,
Tobacoo etc.
Type-D. Delayed effects

27. When there is abrupt discontinuation of drug
Withdrawal Syndrome
e.g. Clonidine which is used to BP, on sudden
stopping causes rebound    in BP
 Also seen with drugs causing
addiction e.g. Morphine
Type-E. End of treatment effects

28. Drug withdrawal reaction:-
The drug whom use alters the homeostasis at
different level are liable to produce drug withdrawal
reaction whenever discontinued.
There discontinuation leads to worsening of the
clinical condition for which they were used
e.g. Corticosteroid withdrawal.
Clonidine withdrawal.
β – Blockers withdrawl.
Antiepileptics withdrawl.

29. • Because of drug use by mother
• Effect depends upon the time of use:
1. First ½ month: Abortion e.g. by Methotrexate
2. From ½ - 2 month (Period of Organogenesis):
Teratogenicity e.g. by Thalidomide, Retinoids
3. 2 months onwards: Abnormal growth & dev. e.g.
Propranolol cause IUGR, Teracyclines cause bone & teeth
abnormalities
Type-F. Foetal effects:

30. 2/18/2018 30dr. hitesh mishra
It refers to the capacity of a drug to cause foetal
abnormalities when administered to a pregnant
woman. Drug can affect the foetus at 3 stages .
i. Fertilization & implantation – conception to 17
days – results in failure of pregnancy which often
go unnoticed.
ii. Organogenesis – 18-55 days – results in
deformities.
iii. Growth & development – 56 days onward –results
in development & functional abnormalities. E.g.
Thalidomide, Anticancer drugs, Tetracyclines,
Steroidal hormones etc.
Tetratogenecity

31. -The study of Adverse Drug Reactions, their monitoring
and measures is called as:-
Pharmacovigilance
Who defined-
‘Science and activities relating to the detection, assessment
understanding & prevention of adverse effects or any other
drug related problems’
Uppsala monitoring centre (sweden)- international
Collaborating centre
Central Drugs standard control Organization(CDSCO)-
india

32. How to prevent ADR
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34. How to decrease the incidence of ADR
Take detail drug history of patient.
In case of prescribing more than one drug,
rule out the drug interaction between two
drugs.
Use accurate drug administration technique.
For drugs with narrow safety margin go for
TDM.