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.
