Cutaneous adverse drug reactions in a tertiary care setup: A cross-sectional observational single-center-based study in Eastern India

Abstract

Background: Cutaneous adverse drug reactions (cADRs) constitute a significant cause of mortality and morbidity, adding to the economic burden for the patients. cADRs have varied and diverse presentations of morphology and severity. The present study aimed to explore the spectrum of cADRs reported in a tertiary care setup in Eastern India. Methods: A cross-sectional, single-center-based observational study was undertaken which included all the patients reporting with suspected cADRs. The patient details, ADR characteristics, and other relevant details were noted. Detailed pharmacovigilance workup, including causality, severity, and preventability assessment, was performed. Data were statistically analyzed. Results: 0.16% incidence of cADRs was observed, with the most common form being urticaria, followed by fixed drug eruption, maculopapular rash, and erythroderma. The most common drug class suspected to cause cADR was antimicrobials, followed by corticosteroids and nonsteroidal anti-inflammatory drugs. While most reactions were of moderate grade in severity, majority of the reactions were under “possible” causal category. 22.1% of the reported cADRs were not preventable. Conclusion: Proper diagnosis and optimum management of cutaneous ADRs are critically challenging and important.