International Clinical and Medical Case Reports Journal (ISSN: 2832-5788) | Volume 5, Issue 3 | Research Article | Open Access
Syed Afzal Uddin Biyabani*
Syed Afzal Uddin Biyabani1*, Zunera Fatima1, Vanishree P Babladi1, Pooja V Salimath1, Hafsa Naema2, Safa Wasay3
¹Research Scholar, Department of Pharmacy Practice, Rajiv Gandhi University of Health Sciences, Kalaburagi, Karnataka, India
1PharmD Graduate, Department of Pharmacy Practice, Deccan School of Pharmacy, Hyderabad, Telangana, India 1Assistant Professor, Department of Pharmacy Practice, Matoshree Taradevi Institute of Phar maceutical Sciences, Kalaburagi, Karnataka, India
1Associate Professor and Research Scholar, Department of Pharmacy Practice, Matoshree Taradevi Rampure Institute of Pharmaceutical Sciences, Kalaburagi, Karnataka, India
2PharmD Graduate, Department of Pharmacy Practice, Matoshree Taradevi Rampure Institute of Pharmaceutical Sciences, Kalaburagi, Karnataka, India
3PharmD Scholar, Department of Pharmacy Practice, Jawaharlal Nehru Technological University, Hyderabad, Telangana, India
*Correspondence to: Syed Afzal Uddin Biyabani
Fulltext PDFBackground: Adverse drug reactions (ADRs) remain a significant cause of morbidity and hospital burden worldwide. Antibiotics are among the most frequently prescribed medications in hospital settings and are commonly associated with ADRs. Monitoring antibiotic-induced ADRs through pharmacovigilance programs is essential to improve patient safety and optimize therapeutic outcomes.
Objective: To evaluate the pattern, causality, severity, and preventability of antibiotic-induced adverse drug reactions in hospitalized patients at a tertiary care teaching hospital.
Methods: A prospective observational study was conducted among 100 hospitalized patients who developed ADRs following antibiotic therapy. Data were collected using a structured ADR reporting form. Demographic characteristics, weight distribution, organ systems affected, types of antibiotics, ADR severity, causality assessment, preventability, and management strategies were analysed. Causality was assessed using the Naranjo algorithm, severity using Hartwig severity scale, and preventability using the Modified Schumock and Thornton scale. Data were analysed using descriptive statistics.
Results: Among 100 ADR cases, females accounted for 72% and males 28%. The majority of patients weighed 51–60 kg (34%), followed by 41–50 kg (26%). Gastrointestinal reactions were the most frequently observed ADRs (22%), followed by dermatological (19%) and CNS reactions (18%). According to Rawlins and Thompson classification, Type B reactions were predominant (55%), followed by Type A reactions (35%). Severity assessment revealed 44% severe ADRs, 44% moderate, 8% mild, and 4% significant reactions. Causality analysis using the Naranjo scale indicated that 89% of ADRs were probable, 6% possible, 4% doubtful, and 1% highly probable. Preventability assessment demonstrated that 30% ADRs were preventable, 60% probably preventable, and 10% not preventable. Bactericidal antibiotics accounted for 76% of ADRs, whereas bacteriostatic drugs contributed 24%. Management strategies included drug withdrawal combined with symptomatic treatment (40%) as the most common intervention.
Conclusion: Antibiotic-associated ADRs remain a significant concern in hospitalized patients, with gastrointestinal and dermatological manifestations being most common. Early detection, systematic pharmacovigilance, and rational antibiotic use are essential to reduce the burden of ADRs and enhance patient safety.
Adverse drug reactions, Antibiotics, Pharmacovigilance, Causality assessment, Severity analysis
Syed Afzal Uddin Biyabani, Zunera Fatima, Vanishree P Babladi, Pooja V Salimath, Hafsa Naema, Safa Wasay. Pattern, Causality and Severity Assessment of Antibiotic-Induced Adverse Drug Reactions in a Tertiary Care Teaching Hospital: A Prospective Observational Study. Int Clinc Med Case Rep Jour. 2026;5(3):1-12.