Histopathological and clinical correlation of cutaneous adverse drug reaction

Pooja Singh, Amit Jaiswal, Kapil Arora


Background: The aim was to study the histopathological features of cutaneous adverse drug reactions (ADRs) and its correlation to clinical presentation.

Methods: We carried our study on 80 patients of drug reactions presented in OPD over a period of 24 months. We noted offending drug, time gap between drug intake and appearance of lesion clinically and performed biopsy to study histopathological patterns and their utility as an aid to diagnosis. WHO-UMC causality assessment method was used in few cases with due diligence. AGEP (acute generalized exanthematous pustulosis) validation score of the EuroSCAR study group was used and SCORTEN for prognosis of SJS/TEN (Stevens-Johnson syndrome/toxic epidermal necrolysis). Histopathological correlation and clinical correlation were statistically analysed.

Results: The most common histopathological finding was vacuolar interface dermatitis and presence of eosinophils. The most common drug responsible was antimicrobials. Histopathological findings were most consistent in cases of FDE and AGEP and differentiating viral exanthems from maculopapular rash was challenging. Erythroderma showed varying patterns of histopathology

Conclusions: Identification of histopathological patterns and clinical correlation is important for distinguishing between cutaneous ADR and the other inflammatory dermatoses. Drug reactions pose clinical challenge thus clinicopathological correlation can help in reaching diagnosis.


Drug eruption, Histopathology, Skin, Cutaneous

Full Text:



Deepa A. Phramacovigilance-an industry prospective. Navi Mumbai: Pharma publisher; 2012.

Patidar D, Rajput SM, Nirmal PN, Wenny S. Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India. Interdiscip Toxcicol. 2013;6:41-6.

Srinivasan R, Ramya G. Adverse drug reaction-Causality assessment. IJRPC. 2011;1:606-12.

Nayak S, Acharjya B. Adverse cutaneous drug reaction. Indian J Dermatol. 2008;53:2-8.

Kurle DG, Jalgaonkar SV, Daberao VN, Chikhalkar SB, Raut SB. Study of clinical and histopathological pattern, severity, causality and cost analysis in hospitalised patients with cutaneous adverse drug reactions in a tertiary care hospital. Int J Pharm Sci Res. 2018;9(5):1857-64.

Anjaneyan G, Gupta R, Vora RV. Clinical study of adverse cutaneous drug reactions at a rural based tertiary care centre in Gujarat. Natl J Physiol Pharm Pharmacol. 2013;3:129-36.

Noel MV, Sushma M, Guido S. Cutaneous adverse drug reactions in hospitalized patients in a tertiary care center. Indian J Pharmacol. 2004;36:292-5.

Tejashwani, Patel D, Bhuptani N. An observational study of cutaneous adverse drug reactions in tertiary hospital. Int J Res Dermatol. 2018;4:254-8.

Rahmati M, Shadnia S, Abdollahi M. Drug-induced skin events in hospitalized patients in Tehran, Iran: A 6-year case series study. Arch Med Sci. 2009;1:91-6.

Gohel D, Bhatt SK, Malhotra S. Evaluation of dermatological adverse drug reaction in the outpatient department of dermatology at a tertiary care hospital. Indian J Pharm Pract. 2014;7:42-9.

Modi A, Desai M, Shah S, Shah B. Analysis of Cutaneous Adverse Drug Reactions Reported at the Regional ADR Monitoring Center. Indian J Dermatol. 2019;64(3):250.

Saha A, Das NK, Hazra A, Gharami RC, Chowdhury SN, Datta PK. Cutaneous adverse drug reaction profile in a tertiary care out patient setting in Eastern India. Indian J Pharmacol. 2012;44:792-7.

Maria S, Cupolilo N, Wkhlu G, Sdwwhuqv K, Iurp E, Zlwk S, et al. Histological patterns of cutaneous adverse drug reactions. HU Revista, Juiz de. 2009;35(4):296-303.

Weyers W, Metze D: Histopathology of drug eruptions -general criteria, common patterns, and differentia diagnosis. Dermatol Pract concept. 2011;1(1):33-47.

Weinborn M, Barbaud A, Truchetet F, Beurey P, Germain L, Cribier B. Histopathological study of six types of adverse cutaneous drug reactions using granulysin expression. Int J Dermatol. 2016;55(11):1225-33.