A clinicoepidemiological study of fixed drug eruptions at a tertiary centre of North India

Rohini Sharma, Sameer Abrol


Background: Various studies have found the overall incidence of cutaneous adverse drug reactions (CADR’s) in developed countries as 1-3%, while the incidence in developing countries is thought to be higher between 2 and 5%. FDEs’ share is seen to be about 15 -30% of all CADR’s as reported in various studies. Aim of the research work was to study the clinical and epidemiological features of fixed drug eruptions and to identify probable culprit drug or drugs using Naranjo ADR probability scale and to provide information to the patient regarding the drug responsible for his/her drug rash.

Methods: A total of 180 patients of fixed drug eruptions were taken up for study who presented to skin OPD at a tertiary centre of North India. Diagnosis was made on the basis of history of drug intake prior to drug eruption, repetition of similar lesions on same as well as new sites on intake of same drug with improvement of skin lesions on discontinuation of the causative drug. Further on examination, skin lesions with typical morphology compatible with FDE were seen. Causality of the FDE was assessed according to the NARANJO ADR probability scale.

Results: A total of 180 patients of FDE were studied. Males outnumbered the females. The most common class of drug implicated was antimicrobials seen in 115 patients followed by NSAIDS 65 patients. Regarding the clinical presentation both skin and mucosal involvement was seen. The most common skin lesions were erythematous to hyperpigmented and violaceous macules followed by bullous FDE.

Conclusions: In summary, early recognition of FDE is important not only for the dermatologists but also for the clinicians of other specialties, so that the culprit drug is recognized and stopped immediately. Drug reactions are a common reason for litigation and has medicolegal pitfalls.


CADR, Causality, Fixed drug eruptions

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