1. Adverse drug reactions (ADRs) refer to harmful, unintended effects of drugs that occur at normal doses used for treatment or diagnosis. 2. ADRs are commonly classified based on their onset, severity, and whether they are due to the known pharmacological effects of a drug (Type A) or unpredictable reactions (Type B). Type A reactions are more common while Type B reactions tend to be more serious. 3. The document discusses various types of ADRs in detail, their causes and risk factors. Factors like age, gender, genetic variations, concurrent diseases, and polypharmacy can increase a patient's risk of experiencing an ADR.

1. Adverse drug reactions
Memoona Rashid
Lecturer Pharmaceutics
PhD Scholar (Pharmaceutics)

2. Drugs have:
Beneficial effects
Harmful effects
Facts
Drugs save life & improve health
Drugs also threaten life
So, the important question is ALWAYS:
“Do the potential benefits of the medication
outweigh the potential risks for the

3. ADRs
Definition
 ‘An adverse drug reaction is any undesirable effect of a drug
beyond its anticipated therapeutic effects occurring during clinical
use.’
The term (ADR) usually excludes-
nontherapeutic overdosage (e.g. toxicities due to accidental
exposure or attempted suicide) and
lack of efficacy of drug

4. ADRs
WHO definition:
•It excludes therapeutic failures, overdose, drug abuse,
noncompliance, and medication errors.
•“Any response to a drug that is noxious and
unintended and that occurs at doses used in humans
for prophylaxis, diagnosis, or therapy of disease, or for
the modification of physiologic function.”

5. UK commission on Human
Medicines
An unwanted or harmful reaction experience after
the administration of a drug or combination of drugs
under normal condition of use and suspected to be
related to the drug.
Food and Drug Administration
A serious drug events (events, relating to drugs and
services) as one in which the patient outcome is
death, life threating hospitalization, disability or
congenital anomaly or require intervention to
prevent permanent impairment or damage.

6. Adverse drug events
(ADE):
Injury resulting from the medical use of a drug.
Includes Medication Error & ADR
Medication error: An injury resulting from an error in
preparing, procuring, prescribing, dispensing,
administering, or monitoring.
Adverse drug reaction (ADR): An injury resulting
from the medical use of a drug where no error is
involved.

7. Why are ADRs a problem?
ADRs are a common clinical problem.
Causes adverse consequences to patients…
From mere inconvenience to death and
Have very high incidence in clinical practice

8. How common are ADRs?
For marketed drugs in USA
Occur in 5% of all hospital admissions
10-20% of hospital inpatients
About 25% in general practice
Significant cause of death (0.5-0.9%)
• In the UK Non Steroidal Anti-Inflammatory Drug (NSAID) use
alone accounts for1
• 65,000 emergency admissions/year
• 12,000 ulcer bleeding episodes/year
• 2,000 deaths/year

9. ADRs
Consequences of ADRs:
Adversely affects patients’ quality of life
Complicate drug therapy
Decrease compliance and delay cure
Increase cost of patient care
Cause patients to lose confidence in their doctors
May mimic disease, resulting in unnecessary
investigations and delay in treatment

10. ADRs are usually classified depending on
−Onset
−Severity
−Type
ADR: Onset of event
Acute
 Within 60 minutes
Sub-acute
 1 to 24 hours
Latent
 > 2 days

11. Mild
Do not require an antidote, therapy, or prolongation of
hospitalization
Commonly known as side-effects
Moderate
Require a change in, but not necessarily cessation of the drug and may
prolong hospitalization or require special treatment
Severe
Are potentially life threatening, requiring discontinuation
of the drug and specific treatment of the adverse reaction
Lethal
Directly or indirectly contributes to the patient's death
ADR: Severity of event:

12. •Result in death
•Life-threatening
•Require hospitalization
•Prolong hospitalization
•Cause disability
•Cause congenital anomalies
•Require intervention to prevent permanent
injury
FDA: Serious ADR

13. ADRs: Types of event
2 main types:
•Type A (Augmented)
•Type B (Bizarre)
3 other sub-types:
Type C, D & E

14. ADRs
Type A (known pharmacological adverse drug reactions)
•Type A reactions represent an Augmentation of the
pharmacological actions of a drug at normal therapeutic
doses.
•Orthostatic hypotension (Phenothiazine)
•Hypoglycemia (Sulphonyl urease)
•Predictable & dose-dependent
•Occurrence rate high
•Fatal rate low
•Long Latency (sometimes)

15. Type A
Readily reversible on reducing the dose or
withdrawing the drug.
Commonest type of ADRs (accounting for over 80%
of all ADRs)
Not usually life threatening.

16. ADRs
Type A adverse reactions:
Are of 2 types:
A) Extension of primary effect
B) Secondary effect

17. A) Extension of primary effect:
 Effects due to extension of the primary
pharmacological actions of the drug
 Augmentation of the drug's therapeutic actions
Example: Bradycardia with Propranolol
(due to effect on desirable beta1 blocking effect)

18. B) Secondary effect
Effects due to the secondary pharmacology of the drug
The action different from the drug's therapeutic actions
The action still rationalisable from the known
pharmacology of the drug
 Example: Bronchospasm with propranolol (due to effect
on undesirable beta2 blocking effect)

19. ADRs
Thus, for propranolol:
Bradycardia is primary pharmacological adverse effects
Bronchospasm is a secondary pharmacological adverse effect.
More emphasis is now placed on the secondary pharmacology
of new drugs during preclinical evaluation to anticipate
problems that might arise once the drug is given to humans.

20. ADRs
Type B adverse reactions: (unknown
pharmacological adverse drug reactions)
These are Bizarre
Not predictable i.e., cannot be predicted from the
known pharmacology of the drug.
Not dose dependent
Can’t be readily reversed
Less common but often serious
Life threatening

21. ADRs
Type B ADRs may be:
1) Idiosyncrasy
2) Drug Allergy or Hypersensitivity

22. ADRs
Idiosyncrasy: (Pharmacogenetics)
Inherent qualitative abnormal response to a drug
Due to genetic abnormality, mainly due to deficiency of
enzymes in the body
Also may be due to abnormal receptor activity
Incidence:
Happens to very small population
Rare but serious

23. ADRs
Idiosyncrasy due to enzyme abnormality
Hemolysis with primaquine
if glucose 6-phosphate dehydrogenase (G6PD) enzyme
deficiency in any person
⇓
If primaquine given
⇓
Hemolysis leading to hemolytic anemia

24. ADRs
Idiosyncrasy due to receptor abnormality
Malignant hyperthermia with general anesthetics
(Halothane)
Sudden huge rise in IC calcium concentration
Increase in muscle contraction
Increase in metabolic activities
Rise of body temperature

25. ADRs
Drug allergy
Also known as hypersensitive reaction
Due to antigen-antibody interactions
1st dose acts as an antigen
Antibody is produced against the antigen in the body
Subsequent dose causes antigen-antibody reaction
e.g. Penicillin induced anaphylaxis
(Type 1 hypersensitivity reaction)

26. ADRs
Type C or Continuous type:
Happens due to long term chronic use of a drug
Involves dose accumulation
e.g. Liver cirrhosis with Paracetamol

27. ADRs
Type D
Delayed effect
ADRs are found long term after use of drug
Teratogenesis
Carcinogenesis
Teratogenesis: birth defect that is evident after birth but the
drug taken during 1st trimester of pregnancy
Carcinigenesis: carcinoma detected long after use of a drug

28. ADRs
Teratogenesis
Teratogenesis is the abnormal congenital malformation of
fetus due to use of some drugs in 1st trimester of pregnancy
(4-10 weeks: period of organogenesis)
Teratogenic drugs:
1st detected teratogenic drug is ‘thalidomide’
It causes ‘phocomelia’--flipper-like limb defect (like penguin)
Thalidomide disaster in early ‘60s

29. ADRs
Other teratogenic drugs:
Cytotoxic (anticancer) drugs
Vitamin A (retinoid)
Antithyroid drugs
Steroid preparations
oral anticoagulants etc.
In general, all drugs should be avoided in 1st trimester of
pregnancy to avoid teratogenic risk

30. ADRs
Type E
Ending of drug use
ADRs are manifested after withdrawal of a drug which was
used for a long period
When glucocorticoid is abruptly withdrawn/discontinued
after prolonged use
Suddenly body suffers from glucocorticoid crisis
Adrenocortical insufficiency
(Adrenal insufficiency is a condition in which the adrenal glands do not
produce adequate amounts of steroid hormones, primarily cortisol;
but may also include impaired production of aldosterone (a
mineralocorticoid), which regulates sodium conservation, potassium
secretion, and water retention)

31. Who is most at risk from ADRs?
Patients who;
are young, or old or female
are taking multiple therapies
50% of patients on 5 drugs or more
have more than one medical problem
have a history of allergy or a previous reaction to drugs

32. What should raise suspicion of an ADR?
A symptom that….
appears soon after a new drug is started
appears after a dosage increase
disappears when the drug is stopped
reappears when a drug is restarted
ADEs: Most Commonly Involved Drugs:
Antibiotics
Antineoplastics
Cardiovascular drugs
Hypoglycemics
NSAID/Analgesics
CNS drugs

33. Most Common ADEs:
Gastrointestinal tract events 22.1%
Electrolyte/renal 16.7%
Hemorrhagic 12.7%
Metabolic/endocrine 9.5%
Dermatologic (skin) /allergic 7.9%

34. Causes of ADRs
ADRs may be due to:
Patient cause
Drug cause
Prescriber’s error---
Type C D & E
Polypharmacy
Predisposing factors:
Age
Gender
Multiple disease
Race and genetic Polyphorphism
Allergy

35. Patient factors
Sometimes ADR’s are associated with the patient’s clinical
conditions.
•Example: A patient is using tramadol (opioid analgesic) to
reduce pain, but the opioid on the same side also decreases
the GIT motility leads to constipation cause ADR in patients
suffering from piles and hemorrhoids.
Age
There are two major age groups pediatrics and geriatrics. In
pediatrics the ADR’s common because of negligence. While in
geriatric body is compromised with age.
•Example:
• Iodine toxicity by iodine in baby.
• Nephrotoxicity by aminoglycosides in geriatrics.

36. Gender
•ADR’s are 1.5 – 1.6 times happens more in females than men.
•Example: Isotretinoin in contraindicated in pregnancy, and pregnancy is to
the females.
Genes
•ADR is sometimes the result of different genetic variation of individuals.
•Example: Anaphylactic shock of Penicillin in certain individuals is the best
example.
Special population
It includes pregnant and lactating females.
Example:
If a mother is taking BZD and she is on breast feeding so her child might
develop addiction.
Concomitant disease
•A patient’s parallel disease also aggravates the situation and results into
ADR.
Example: An asthmatic patient taking opioids may suffer from severe
respiratory depression.

37. Poly pharmacy
•Poly pharmacy means taking multiple drugs at the
same time. ADR’s are most of the time results of
poly pharmacy.
•Example: A hypertensive patient taking diuretic and
ACE inhibitor together might have severe
hypotension.
Drug interactions
• ADR is also originated due to pharmacokinetic or
pharmacodynamic drug interactions.
• Example: an obese patient taking grape fruit juice with
simvastatin. There will be high plasma levels of simvastatin
due to decreased metabolism by grape fruit juice, leading to
muscular weakness.

38. B) Pharmaceutical factor:
Due to wrong pharmaceutical preparation
Slow release NSAID
⇓
Release in high concentration due to faulty preparation
⇓
GIT bleeding

39. Drug related Factors predisposing to ADRs
Pharmacokinetic factor:
Due to decrease kinetic activities
Sulfonylurea
⇓
Decreased elimination in renal insufficiency
⇓
Hypoglycaemia

40. Absorption
• BA depends on oral absorption of drug
Factors which can affects the absorption
• GIT motility
• Absorptive capacity of GIT mucosa
• First pass metabolism in liver and gut wall.
Distribution:
Depends on factors such as
•Blood flow
•Plasma protein
•Tissue binding

41. Drug Metabolism

42. Phases of drug metabolism
• Phase I
Oxidation
Reduction
Hydrolysis
• Phase II
Sulphation
Glucuronidation
Acetylation
Methylation

43. Microsomal oxidation
Four CYP enzyme are mainly invoved in 90% metabolism of drugs
•Cyp1A2, Cyp3A4
•Cyp2C9, Cyp2C19
•Cyp2D6 (65 commonly used drugs metabolized by this
enzyme)
Debrisoquinne poor metabolizers
postural hypotension
•Cyp2E1

44. Hydrolysis
•Suxamethonium (Short acting neuromuscular blocking
agent) This drug metabolized by enzyme
pseudocholinestrase (this enzyme have different
genetic forms).
• Some Individuals are homozygous in UK population
(1 out of 2500 have chances of prolonged blockade).
•In heterozygous individual can or cannot have
prolonged blockade.

45. Acetylation
• Drugs metabolized by acetylation
Isoniazide, Dapsone, Hydralazine
Enzyme N- acetyl transferase
In UK half of population are slow acetylator
Isoniazide Peripheral Neuropathy
Dapsone Hematological disorder

47. 2. Hepatic Encephalopathy:
• In patients with, or on the border line of, hepatic
encephalopathy, the brain is more sensitive to
the effects of drugs with sedative actions. If such
drugs are used, coma can result. It is therefore
wise to avoid Opioids & other Narcotic
Analgesics and Barbiturates.
3. Sodium and Water Retention:
• In hepatic cirrhosis, sodium and water retention
can be exacerbated by certain drugs. Drugs that
should be avoided or used with care include
NSAIDS, Corticosteroids, Carbamazepine and
formulations containing large amount of sodium.

50. Factors involved in drug allergy concern the
•Drug and Patients:
THE DRUG:
•Macromolecules such as PROTEINS (vaccines and
enzymes such as streptokinase), POLYPEPTIDES
(insulin and dextrans) can themselves be
immunogenic.
THE PATIENTS:
•There are genetic factors that make some patients
more likely to develop allergic reactions than others:
A history of allergic disorders

52. • Manifest as Urticaria, Rhinitis, Bronchial Asthma, Angio-
oedema and Anaphylactic Shock.
• Drugs likely to cause type 1 are Penicillins, Streptomycin,
Local Anaesthetics etc.
Type 11 Reactions (Cytotoxic
Reactions):
• A circulating antibody of the IgG, IgM, or IgA class interact
with an antigen formed by hapten.
• Complement is then activated and cell lysis occurs.
Example: Thrombocytopenia, Haemolytic Anaemia

53. Type 111 Reactions
(Immune Complex Reactions):
• Antibody (IgG) combines with antigen i.e. the hapten-
protein complex in circulation
• Complex thus formed is deposited in the tissues,
complement is activated, and damage to capillary
endothelium results.
•Serum sickness is the typical drug reaction of this type.
•Penicillins, Sulfonamides & Antithyroiddrugs may
be responsible.

54. Type 1V reactions
(Cell Mediated):
• T-lymphocytes are sensitized by a hapten-protein antigenic complex.
• Inflammatory response ensues when lymphocytes come in contact
with the antigen.
• E.g. Dermatitis caused by local anesthetic creams, topical antibiotics
and antifungal creams.
Pseudo Allergic Reactions:
• Term applied to reactions that resemble allergic reactions clinically
but for which no immunological basis can be found.
• Asthma and Skin Rashes caused by aspirin are the examples.

55. BLOOD DISORDERS:
• Thrombocytopenia, Neutropenia, Hemolytic Anaemia, and Aplastic
Anaemia can all occur as adverse drug reactions.
RESPIRATORY DISORDERS:
• Asthma occurring as a pseudo allergic reaction to Aspirin, other
NSAIDS and Tartarzine is an e.g. adverse drug reaction.

56. Red cell enzyme defects
Porphyria
Malignant hyperthermia
•RED CELL ENZYME DEFECTS:
• Unusual drug reaction occur in individuals whose erythrocytes are
deficient in any one of three different but functionally related
enzymes.
• Glucose-6-phosphate dehydrogenase
• Glutathione reductase
• Methaemoglobin reductase

57. Glucose-6-phosphate dehydrogenase deficiency:
•G6PD deficient erythrocytes when exposed to
oxidizing agents undergoes Haemolysis.
•The prevalence of this defect varies with race.
•There are two varieties of deficiency:
Black variety
Mediterranean variety
•Blacks have normal G6PD production but its
degradation is accelerated.
•Mediterranean have abnormal G6PD production.

58. Methaemoglobin reductase deficiency
• If Methaemoglobin is not reduced to Haemoglobin
continously accumulation of Methaemoglobin takes place
resulting in impairment of O2 delivery to tissues, causing
HYPOXAEMIA.
• Inheritance of defect is autosomal recessive.
Porphyria:
• Porphyrias constitute a group of disorders of haem-
biosynthesis.
• Different types of porphyrias are there.
• Each type of Porphyria is associated with a different
abnormality of an enzyme in haem-biosynthetic pathway.
• Drugs to be avoided in porphyria : Barbiturates, Dapsone,
Chloramphenicol, Diclofenac etc.

59. Malignant hyperthermia:
•It is an autosomal dominant generic disorder of
skeletal muscles that occurs in susceptible
individuals undergoing General Anesthesia with
inhaled agents (halogenated) and muscle relaxants
like Succinylcholine.
•This rare condition of uncontrolled release of calcium
by sarcoplasmic reticulum of skeletal muscles leads
to muscles spasm, hyperthermia and autonomic
liability.
•Dantrolene is indicated in life threatening
situations.

60. ADRs in pediatrics
•Pediatrics:
•Neonate: birth – 4 weeks
•Infant: 1 month – 1 year
•Child: 1 year – 12 year
In neonates, there is a low level of acid, low bile
secretion, low muscle mass (soft) and the heart
beat is fast. They have very fine skin thus increased
chances of absorption.

61. •Corticosteroids [topical absorption]
(eg.betnovate-betamethasone, clobivate):-
these steroids are absorbed into the
generalized blood circulation. One of the main
side effect of corticosteroids is that they have a
feedback mechanism in which when exogenous
steroids are administered, there is a decrease
in the endogenous corticosteroids which leads
to adrenal suppression and thus lead to the
inability to fight stress conditions such as
infections.

62. • Prilocaine+lidocaine [topical absorption] (local anesthetic):-
absorption leads to methemoglobinemia (altered Hb structure)
leading to decreased capability to release oxygen causing
hypoxia.
• Piodine [topical absorption]:- contains iodine which causes
iodine toxicity (iodine poisoning include burning of the mouth, throat,
and stomach, fever, nausea, vomiting, diarrhea, a weak pulse), cyanosis (a
bluish discoloration of the skin due to poor circulation or inadequate oxygenation of
the blood),and coma.
• Low acid level:- decreased breakdown of penicillin G
• Enteric coated:- not dissolved in acid as in peds, body is more
alkaline thus there is premature metabolism of enteric coated
dosage forms.
• Low muscle mass:- IV route is preferred as IM is painful due to
low muscle mass.

63. •Morphine:-
During labor, morphine is usually used to reduce pain
which adversely affects the fetus by causing
respiratory depression. Since neonates’ BBB is weak,
lipid soluble and water soluble drugs are able to cross
and enter the brain.
•Drugs that have a high protein binding capacity-
Digoxin, Theophylline, Phenytoin:
Show a high concentration in blood due to the
presence of a low number of plasma proteins in peds.

64. Septran syrup: (contains sulfonamides)-
•sulfonamide is conjugated with glucoronic acid to
facilitate excretion. Neonates have an impaired hepatic
function to form conjugates. Billirubin accumulates
because it is more lipid soluble which will lead to
jaundice and billirubin encephalopathy (kernicterus).
UV light is used to treat which converts billirubin to
water soluble isomers.
•Chloramphenicol:- causes grey baby syndrome due to
excessive chloramphenicol in the body. Billirubin will
conjugate with glucoronic acid thus chloramphenicol
will be left unconjugated and will accumulate in the
body.

65. •Benzyl alcohol: (in bacteriostatic water for
injection)- benzyl alcohol is converted into its
metabolite ( Benzyl Alcohol is metabolized to Benzoic
Acid, which reacts with glycine and excreted as
hippuric acid in the human body) by the enzyme
alcohol dehydrogenase [to facilitate its excretion]
which neonates lack. This leads to its accumulation
which causes acidosis, CVS collapse, and respiratory
collapse.
Atomoxitine (BN:Strattra, Inhibit both norepinephrine
and serotonin transporters ):- used to treat attention
deficit hyperactivity disorder (ADHD). Atomoxitine is
converted to its inactive metabolite by the enzyme
2D6 which is deficient in peds thus there is
accumulation of atomoxitine which causes
hypertension, CVS problems and hepatotoxicity.

66. •Caffeine:- caffeine is converted into its inactive
metabolite by the enzyme 1A2 which is deficient in
peds leading to the accumulation of caffeine causing
arrhythmias and seizures.
•Aspirin: causes Reyes syndrome (salicylism [nausea,
vomiting, tinnitus, dizziness].

67. •Fluoroquinolones (eg.ciprofloxacin):-[quinolones
should be used with caution in children up to 12 years
unless life threatening] they cause arthropathy-
cartilage damage (Arthropathy is a collective term for any
disease of the joints , Arthritis is a form of arthropathy that
involves inflammation of one or more joints, while the
term arthropathy may be used regardless of whether there is
inflammation or not).
•Tetracyclines:- form chelates with calcium in bones.

68. ADRs in geriatrics
Alzheimer Glaucoma Arthritis Renal failure
Dementia Auditory dysfunction Hypertension (HTN) cancer
Parkinsonism Loss of teeth Diabetes Pedal edema
Anxiety Increased
susceptibility for
infections
Ischemic heart
disease (IHD)
Depression Decreased GIT
motility
Cirrhosis - shrinkage
of liver
Psychosis COPD Disc slip
Conditions in geriatrics

69. NSAIDS
•Patient has ulcer + arthritis. NSAIDS decrease
prostaglandin synthesis thus may cause ulcers.
•Options:
• Add PPI or H2 antagonists
• Add prostaglandin (mucoprotectant)
• Paracetamol + tramadol (opioid analgesic)
• Paracetamol + topical NSAID
•Prostaglandins: Rotec (misoprostol+diclofenac)- leads
to bleeding since misoprostol is a potent smooth
muscle contractor.

70. •Hypertension + arthritis- NSAIDS.
These will reduce PG production in the kidney which
will decrease vasodilation and decrease blood flow to
kidney, decreasing urine formation and increasing
blood volume, worsening hypertension.
•Patient has decreased GFR + arthritis
NSAIDS will decrease GFR, decreasing urine formation
and increasing blood volume, leading to hypertension.

71. •Cancer- geriatrics are not usually given anti cancer
drugs due to their inability to bear the severe side
effects.
•Infection + auditory dysfunction- aminoglycosides
cause ototoxicity leading to auditory dysfunction.
•Patient has pedal edema + COPD- corticosterioids
have a glucocorticoid and mineralocorticoid activity.
The mineralocorticoid activity will cause sodium
retention causing an increased water retention and
leading up to pedal edema (is the accumulation of fluid
in the feet and lower legs. It is typically caused by one of
two mechanisms. The first is venous edema, caused by
increased capillary filtration and retention of protein-poor
fluid from the venous system into the interstitial space).
•Liver cirrhosis + infection- use of antibiotics should be
decreased

72. •Anxyiety + COPD- benzodiazepenes (anxiolytics) cause
respiratory depression.
•IHD+depression- TCAs cause torsades de point
arrhythmia (prolong QT interval)
•Hypertension + COPD- propranolol which is a non
selective beta blocker and is very lipophilic therefore
enters CNS. Will cause severe bronchoconstiction.
•Calcium channel blocker (eg. Verapamil) + decreased
GIT function- verapamil acts on myocytes and
decreases heart rate and also decreases GIT motility
which will cause severe constipation.

73. • Anticholinergics (hyoscyamine, atropine, ipratropium,
nortriptyline, triptyline, chlorpheniramine, benztropine)- will
cause decreased motility.
• Statins + smoking:- cause muscle weakness and
rhabdomyolysis
• Digoxin: have an increased toxicity in geriatrics due to low
blood volume eventually leading up to arrhythmias.
• Benzodiazepines eg.diazepam (long acting-50hr):- phase I
metabolism in elderly does not function well to remove drug so
diazepam (which is metabolized by phase I) will accumulate in
the body. Phase II functions better thus lorazepam (which is
intermediate acting and metabolized by phase II) would be a
better option for elderly.

74. Example of F-failure
•IHD+Alzheimer (dementia-memory loss)- increased
stress which causes sympathetic stimulation and
increased cardiac activity leading to angina (pain)
and eventually myocardial infarction (necrosis of
cells)
•IHD + parkinsonism
•IHD + eye sight

75. Ensuring safe use of drugs in
geriatrics
• Quality of life-
• Chemotherapy adversely affects the quality of the life of patient.
• Hip joint osteoporosisreplace hip joint instead of chronic use of
NSAIDs
• Avoid unnecessary use of drugs:
• Mild hypertension: modify lifestyle instead of taking antihypertensive
drugs
• Pedal edema: raise the legs, wear tight stockings, place feet in warm
water
• Instead of taking sedatives, try to sleep without them
• Treat the cause instead of treating the symptoms.
• Dyspepsia , antacids shouldn’t be taken, instead, avoid the causative
food.

76. •Concomitant diseaserenal, hepatic
• Reduce dose
•Packaging and labellingchild resistant containers
should be avoided in arthritis patients. Blister packing
is also not recommended. Alzheimer disease patients
medications are organized by days (eg.advent).
•Titration of dose: start with low dose and gradually
increase. Eg. ACE inhibitors for hypertension. Avoid
rapid escalation of dose.
•Drug history drug allergies, reactions
•Keep a record of the patient surgeries, therapy, etc.
(medical history)
•Review regularly.

77. ADR’S in Pregnancy
Pregnancy is a period during which a females develops a baby in her womb. It
is usually of 9 months and 10 days or 37 weeks. The pregnancy is divided into
three segments called trimesters.
• 1st trimester: In first trimester the single cell mass is converting into
undifferentiated multiple cells. Everything is under the control of genes.
Therefore in this stage teratogenic and congenital disease can occur.
•2nd trimester: In the second trimester the process of organogenesis takes
place within the fetus.
•3rd trimester: In the third trimester, maturation cells and organs of the baby
takes place. It behaves as an individual.
The most drugs affects the first trimester of the pregnancy and thus said to
be as teratogenic drugs.

78. Drugs affecting in 1st trimester
Vitamin A (retinoic acid)
•It is used for anti-acne purposes. It is contraindicated in
pregnancy for being teratogenic.
Warfarin
•A pregnant female taking warfarin to avoid heart disease. A
child born will be having hypoplasia (is underdevelopment or
incomplete development of a tissue or organ) of nose. It is
called Fetal Warfarin Syndrome. Anoxaprin must be used. It is
a low molecular weight heparin used as an alternative for
warfarin to decrease the chances of heart disease.
ACE inhibitors
They causes problems in the fetus during multiplication of
cells.
Diuretic: Diuretic causes the loss of amniotic fluid in which
the baby grows and leads to miscarriage.

79. Ethynyl estradiol
It is a contraceptive. A female taking this drug, when she
delivers a girl, after birth the girl will be having chances of
developing genital cancers after hitting adultery.
Thalidomide
It is now a days used for cancer treatment. It is category X
drug. It causes Phocomelia in the baby (deformation of
forelimbs and hind limbs).
Ethanol + cigarette smoking
A female taking ethanol or doing cigarette smoking during
pregnancy, there is a chance that the baby will develop
neurological disorder or heart problem.
Cytotoxic drugs
They are administered after the estimation of risks to benefit
ratio.

80. Drugs affecting in 3rd trimester
Morphine
It is given during labor. It causes severe respiratory
depression in child.
Sleeping pills
If a pregnant female is taking sleeping pills (BZD), the child
after birth may be sedative all the time or develops addition.
Lactation: BZD are also secreted in maternal milk so the
drugs will transfer from mother to the child during breast
feeding and produces sedation in the child.
Rotic tablet
It contains misoprostol and diclofenac. The drug causes
premature contraction of uterus in the mother and causes
abortion.

81. ADRs
Prevention of ADRs
Whenever a drug is given a risk is taken
Risks may be avoidable or unavoidable
30-50% ADRs are preventable
Drug interaction
Inappropriate medication
Unnecessary medication
Reduction of ADRs can be achieved by:
Better knowledge of diseases
Better knowledge of drugs
Site-specific delivery
Informed, careful and responsible prescribing

82. Management of ADRs:
Discontinue the offending agent if:
it can be safely stopped
the event is life-threatening or intolerable
there is a reasonable alternative
Continue the medication (modified as needed) if:
it is medically necessary
there is no reasonable alternative
the problem is mild and will resolve with time

83. Management of ADRs:
Discontinue non-essential medications
Administer appropriate treatment
Provide supportive or palliative care
Generally,
For dose-related ADRs:
Modify the dose or reduce precipitating factors
For ADRs unrelated to dose:
The drug usually should be withdrawn and re-exposure should
be avoided.

84. Thank you very much