A COMPARATIVE STUDY ON SAFETY PROFILE OF ORAL ANTIFUNGALS TERBINAFINE AND FLUCONAZOLE IN CASES OF DERMATOPHYTOSIS

Abstract

Objective: This study aimed to compare the safety profile of oral terbinafine and fluconazole in patients with
dermatophytosis.
Method: This prospective observational study was conducted at the dermatology outpatient department of Santosh Medical
College and Hospital, Ghaziabad. A total of 156 patients were included in this study. The participants were divided into two
groups, A and B. Group A patients were treated with 250 mg terbinafine PO daily, and Group B was treated with
fluconazole 150 mg PO daily for two-week duration. Follow-ups were done on the first, second, and fourth weeks to
monitor the ADRs. The causality of ADRs was assessed using the WHO-UMC evaluation criteria, whereas the severity of
ADRs was assessed using the Hartwig and Siegel scale.
Results: In Group A, 6 (7.79%) of the patients experienced ADRs, with the most common being headache 3 (27.27%) and
vomiting 3 (27.27%). Group B had a 24 (30.38%) incidence of ADRs, with xerosis being the leading ADRs in 9 (23.08%)
of cases. Female participants in both groups had a higher incidence of ADRs than male participants. In the 18–28 years age
Group, ADRs were observed in 3 (50.00%) patients in Group A and 11 (45.83%) patients in Group B. Among individuals
aged 29-38 years, ADRs occurred in 2 (33.33%) patients in Group A and 8 (33.33%) patients in Group B. In the 39-48
years age Group, A single female patient (16.67%) in Group A experienced ADRs, while 3 (12.50%) patients in Group B
experienced ADRs. Among those aged 49-58 years, 2 (8.33%) patients in Group B experienced ADRs. The Causality
assessment indicated that the majority of ADRs in both groups were categorized as possible, while in the severity
assessment, most ADRs were classified as mild.
Conclusion: Terbinafine and fluconazole both showed ADRs however, fluconazole had a higher incidence, particularly in
female patient.