PATTERN OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE TEACHING HOSPITAL: A CROSS-SECTIONAL STUDY
Objective: The aim of this study was to carry out adverse drug reactions (ADRs) monitoring in various departments of a tertiary care teaching hospital.
Methods: A cross-sectional study was conducted on ADRs reported in the hospital from December 2012 to May 2013 after obtaining Institutional
Ethics Committee approval.
Results: A total of 40 ADRs were reported, 47.50% were males and 52.50% were females. The female adult population was 45%. The majority of ADRs
were due to antimicrobial agents especially beta-lactam antibiotics (42.5%) followed by NSAIDs (7.50%). A maximum number of patients (75%)
were reported with dermatological manifestations. The department of medicine reported the highest number of ADRs (37.5%). As per Naranjo's
probability scale, 62.5% reports were assessed as probable. 62.5% reports were documented as mild according to Modified Hartwig's criteria for
Conclusion: This study was done to sensitize the practicing physicians on the importance of adverse drug monitoring and reporting.
Keywords: Pharmacovigilance, Adverse drug reactions, Tertiary care teaching hospital, Antimicrobial agents.
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Table 1: Types of reactions for drugs in reported ADRs
Number of ADRs (%)
Ceftriaxone with sulbactam, Ceftriaxone, Ceftriaxone with tazobactam, Cefotaxime, Phenytoin, Ciprofloxacin, Cotrimoxazole, Metronidazole
Erythematous skin lesion
Diclofenac sodium, Cotrimoxazole, Paracetamol, Phenytoin, Carbamezapine, Clindamycin
Chest tightness and pain
ADRs: Adverse drug reactions
Table 2: List of organs system in ADRs
Number of ADRs (%)
Central nervous system
Eyes, ears, nose and throat
ADRs: Adverse drug reactions
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