ADVERSE EFFECTS

OF DRUGS
Dr Krishna Badal
 ADVERSE EFFECT
 It is defined as any undesirable or unwanted effect
due to drug administration.

 WHO suggested definition of ADR and AE as follows:

 Adversedrug reaction(ADR): Any response which is

noxious, unintended and which occurs at doses
normally used in humans for prophylaxis, diagnosis
or therapy of disease, or for modification of
physiological function.

 Adverseevent(AE): Any untoward medical

occurrence that may present during the treatment
with a pharmaceutical product but which does not
necessarily have causal relationship with the
treatment.
 TYPES
 Predictable (Type A or Augmented reactions):
 These are predictable reactions to a drug which
are related to its pharmacological actions. They
include side effects, secondary and toxic effects.

 Unpredictable reactions (Type B or Bizarre

reactions):
 These are unpredictable reactions to a drug.
They are not related to pharmacological actions
or dose of the drug. E.g., allergic and
idiosyncratic reactions.
 ADVERSE EFFECT
 Adverse drug effects include:
 Side effect:
 These are unwanted pharmacological effects of a
drug, which are seen with therapeutic doses.
E.g., atropine used in the treatment of heart
block also produces dry mouth, blurring of vision,
urinary retention which are the side effects.
 Secondary effects:
 The primary action of drug may result in other
effects. E.g., immuno- suppression by
corticosteroids can lead to development of
opportunistic infections, E.g., oral candidiasis.
 ADVERSE EFFECT
 Toxic effects:
 These are the effects of a drug, which are either of
overdose or chronic use. E.g., bleeding due to chronic
use/ over dosage of anticoagulants and nephrotoxicity
with aminoglycosides especially in patients with renal
failure.
 Drug allergy:
 It is an abnormal response(local or systemic),
mediated by the immune system to a drug/ foreign
Ag.
 ADVERSE EFFECT
 Idiosyncrasy:
 Itis usually a genetically determined abnormal
reaction to the drugs, e.g.,
 aplastic anemia caused by chloramphenicol,
 succinylcholine apnoea,
 haemolytic anaemia seen with primaquine and
sulphonamides.
 Iatrogenic diseases:
 Itis physician-induced disease due to drug
therapy, E.g., parkinsonism due to
metoclopramide; acute gastritis and peptic ulcer
due to NSAID’s.
 TERATOGENICITY
 Certain drugs when given during pregnancy may
cross the placenta and produce various unwanted
effects in the fetus. This is called teratogenesis.

 Administration of drugs during early pregnancy

(conception to 16days) could result in abortion;
during 2-8 weeks of gestation, it can affect
organogenesis and produce structural
abnormalities; during 2nd and 3rd trimester, drugs
can affect growth and development of the fetus.
 TERATOGENICITY
 Hence some drug administration during
pregnancy should be restricted.
 Teratogenic effect of some drugs:

Drugs Teratogenic effect

Thalidomide phocomelia

Tetracyclines Yellowish discoloration of

teeth

Antithyroid drugs Fetal goiter

 TERATOGENICITY
 Carcinogenicity and Mutagenicity:
 The ability of a drug to cause cancer is
carcinogenicity and the agent is known as
carcinogen.
 The abnormalities of genetic material in a cell
produced by a drug are known as mutagenicity.
 E.g., Anticancer drugs
 ADVERSE EFFECT
 Photosensitivity reactions-
 Itis a drug-induced cutaneous reaction following
exposure to ultraviolet radiation, E.g.,
demeclocycline, doxycycline.

 Hepatotoxicity-
 some of the hepatotoxic drugs are Isoniazid,
rifampicin, pyrazinamide, halothane,
paracetamol.
 ADVERSE EFFECT
 Nephrotoxicity:
 Aminoglycosides,Amphotericin B, cisplatin,
Cyclosporine, heavy metals cause
nephrotoxicity.

 Ototoxicity:
 itcan occur with Aminoglycosides, loop
diuretics, cisplatin.

 Ocular toxicity:
 Ethambutol, chloroquine, glucocorticoids can
cause ocular toxicity.