Analysis of Seriousness and Preventability of Adverse Drug Reactions in Patients at a Tertiary Care Teaching Hospital: A Case Series.

Authors

Raja Vikram Prasad, Akshay Kumar V, Vivekanandan Kalaiselvan, C Deepalatha, Jaishree Suresh, Sandeep Kodali, Shreya Nallapati, G Jyoshna

Published in

Cureus. Volume 18. Issue 7. Pages e112392. Epub Jul 10, 2026.

Abstract

This case series describes three serious adverse drug reactions (ADRs) reported from tertiary care teaching hospitals and analyses their seriousness and preventability. The cases included fixed drug eruption associated with paracetamol/amoxicillin exposure, Stevens-Johnson syndrome/toxic epidermal necrolysis following ceftriaxone administration, and acute renal failure after intake of a fixed-dose combination of diclofenac and paracetamol. Clinical details, suspected drugs, management, outcomes, and pharmacovigilance reporting were reviewed. Seriousness, causality, and preventability were assessed using standard pharmacovigilance criteria, including the Uppsala Monitoring Centre causality assessment approach. All three cases required hospital-based management, and two involved severe cutaneous adverse reactions requiring multidisciplinary care. The cases highlight the contribution of irrational prescribing, inappropriate drug combinations, and delayed recognition to preventable serious ADRs. Early withdrawal of the suspected drug, timely reporting to pharmacovigilance centres, multidisciplinary management, rational prescribing, adherence to clinical protocols, and patient awareness are essential to reduce recurrence and improve medication safety.

PMID:
42605428
Bibliographic data and abstract were imported from PubMed on 17 Aug 2026.

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