Nonsteroidal anti-inflammatory drug (NSAID) associated fixed drug eruption (FDE) in children attending dermatology OPD of a tertiary care hospital of Eastern India: a cross-sectional observational study


  • Ranjita Santra Department of Clinical and Experimental Pharmacology, Calcutta School of Tropical Medicine, Kolkata-700012, West Bengal, India
  • Shirsendu Mondal Department of Pharmacology, Medical College, Kolkata-700012, West Bengal, India
  • Patralekha Raychaudhuri Department of Pharmacology, Calcutta National Medical College, Kolkata-700014, West Bengal, India


Nonsteroidal anti-inflammatory drug, Fixed drug eruptions, Children, Causality assessment, Eastern India


Background: Although extensively studied in adults, Nonsteroidal anti-inflammatory drug (NSAID) hypersensitivity in children, especially in young children, remains a poorly defined area in both its clinical and epidemiologic aspects.

Methods: The present observational study was conducted in the department of Dermatology of a tertiary care hospital in Eastern India. Twenty children (20) were screened with suspected NSAID-associated fixed drug eruption (FDE) in the outpatient department. A thorough history taking and clinical examination was performed for each of the cases of FDE.  These cases were then managed conservatively after discontinuation of the suspected medication. Rechallenge with the putative offending drug was not done due to ethical reasons. WHO-UMC   Causality Assessment criteria and Naranjo probability scale were used for causality assessment of each of the cases of FDE. The severity of reported reactions was assessed by using Modified Hartwig and Siegel Scale and Preventability of the ADRs was assessed by Modified Schumock and Thornton Scale.

Results: Patients aged between 5 to 12 years and with a male preponderance of 3:2. The offending NSAID was ibuprofen for 8 of the patients, paracetamol and diclofenac for 4 each and ketorolac for 4 of the patients. These patients were prescribed the offending drugs for fever, rheumatoid arthritis and minor trauma. For each patient, history and clinical signs was consistent with the diagnosis of drug-induced FDEs. Causality assessment for each of the cases revealed ‘possible’ association predominantly (80%). Severity of the suspected ADR (adverse drug reaction) assessed using Modified Hartwig and Siegel Scale, revealed that the ADRs were mild(30%) to moderate (70%) in severity and of ‘probable’ preventibility (90%).

Conclusions: 20 new cases of NSAID-induced FDEs over a period of 6 months suggest that this is not a rare entity as was presumed. There is a growing need for a strict monitoring of such off label offending drugs, known to cause ADRs especially among pediatric patients to ensure safe and rational therapeutics. 


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How to Cite

Santra, R., Mondal, S., & Raychaudhuri, P. (2017). Nonsteroidal anti-inflammatory drug (NSAID) associated fixed drug eruption (FDE) in children attending dermatology OPD of a tertiary care hospital of Eastern India: a cross-sectional observational study. International Journal of Basic & Clinical Pharmacology, 3(1), 211–214. Retrieved from



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