Abstract

Background: Pharmacovigilance relates to the activities concerning the detection,
assessment, understanding and prevention of these adverse drug reactions. The present
study was conducted to asses adverse drug reactions in known population.
Materials & Methods: 250 adverse drug reactions reported in 1 year were recorded.
The data were obtained from the ADR monitoring centre. Each ADR was assessed for
demographic data, relationship to drugs as per causality assessment, and frequency of
ADRs.
Results: Age group 20-40 years had 35 male and 30 female, 40-60 years had 40 male and
55 females and >60 years had 45 male and 45 females. ADRs were reported in oncology
in 12, dermatology in 45, ENT in 30, orthopaedics in 20, general surgery in 50, general
medicine in 43, gynaecology in 35 and psychiatry in 15 cases. Type of reaction was
nausea/ vomiting in 45%, rash in 30%, headache in 12%, abdominal pain in 4%,
diarrhoea in 5% and constipation in 4%. Common drugs leading to ADRs were
NSAIDs in 35%, antibiotics in 20%, anti- hypertensive in 8%, anti- diabetics in 12%,
anti- tubercular in 15% and CNS drugs in 10%. The difference was significant (P<
0.05).
Conclusion: Common drugs leading to ADRs were NSAIDs, antibiotics, antihypertensive,
anti- diabetics, anti- tubercular and CNS drugs.