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Journal of Pharmaceutical Research

Article

Journal of Pharmaceutical Research

Year: 2026, Volume: 25, Issue: 2, Pages: 108-111

Case Report

A Rare ADR of Co-amoxiclav induced Stevens-Johnson Syndrome in a Young Patient: A Case Report

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This work is licensed under a CC BY-NC-ND 4.0.

Abstract

Stevens-Johnson Syndrome is a severe, life-threatening mucocutaneous disease associated with significant morbidity and mortality. Co-amoxiclav (Amoxicillin and Clavulanic acid) is one of the commonly prescribed antimicrobials. Previous incidence recorded with Co-amoxiclav is very rare (1 per million)[1]. A 13-year-old child presented to a local physician with a history of fever and sore throat, for which he was prescribed tablet Co-amoxiclav twice a day. After three days, he initially developed a maculopapular erythematous rash with central blisters first appearing over his four limbs, spread to chest and back and involved a total body area of around 70% on the 5th day. This further progressed to involve oral lesions, bilateral conjunctival congestion, and genital mucosa on Day 6. Patient was admitted for managing the case and a causality assessment was done using the Naranjo Adverse Drug Reaction Probability Scale resulting in a score of "7," indicating the ADR was "probable". The patient was managed with intravenous steroids, antibiotics, intravenous fluids, and other conservative measures. The child recovered and was discharged on 9th day of hospitalization. This ADR was reported to the Indian Pharmacopoeia Commission through the VigiFlow platform as part of India's Pharmacovigilance Program. A validated mathematical tool named "severity-of-illness score for toxic epidermal necrolysis (SCORTEN)" for the prognostication of SJS/TEN patients, predicted the mortality to be around 3.2%. This case highlights the potential for commonly used drugs like Co-amoxiclav to cause severe side effects such as SJS[3]. It underscores the importance of active pharmacovigilance for all medications and vigilant ADR monitoring and management.

Keywords: Co-amoxiclav, Stevens-Johnson Syndrome, Adverse Drug Reactions, Pharmacovigilance

References

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Copyright

© 2026 Published by Krupanidhi College of Pharmacy. This is an open-access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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