Adverse Drug Reactions & Its
Classification
SUBJECT: PHARMACOLOGY
It is an unintended, undesirable reaction or effect of the drug, that occurs during
the medication phase. It can be mild to severe or even cause fatal consequences.
ADR are a subset of ADE ( Adverse Drug Event).
According to the World Health Organization (WHO):
"An Adverse Drug Reaction is a response to a medicine which
is noxious and unintended, and which occurs at doses normally
used in humans for the prophylaxis, diagnosis, or therapy of
disease, or for the modification of physiological function.”
Incidence & Risk Factors:
Mild ADR are common, occurs upto 20 - 25% in case
High changes in patient taking multiple medicines (polypharmacy)
The acceptability of adverse drug reaction depends upon risk - benefit ratio; (
i.e Balance between the potential risks (harmful effects) of a drug and its
expected therapeutic benefits (positive outcomes). A drug is considered
acceptable for use only if the benefits outweigh the risks. Healthcare
providers carefully evaluate this ratio before prescribing any medication.
Eg: Chemotherapy Drugs
Benefit: Kills or reduces cancer cells and increases survival chances.
Risk (ADR): Can cause severe side effects like hair loss, vomiting, bone
marrow suppression, and risk of infections
Adverse Drug Reactions & Its Classification 1