Abstract
Objective: To study the incidence and pattern of adverse effects of Antifungal drug Fluconazole and to assess the severity of its adverse effects.
 Methodology: The study was approved by Institutional ethics committee and informed consent was obtained from all willing participants. Patients fulfilling inclusion and exclusion criteria were enrolled. Age sex, diagnosis, dose and duration of treatment were recorded. 2ml of blood was collected for liver function test. The adverse drug reaction (ADR) was documented. The causality assessment was done by WHO assessment scale and severity assessment by using modified Hartwig severity assessment scale.
 Results: In this study, most of the patients were in 31-40 years age group. Among the 100 patients who were on Fluconazole 58 developed adverse drug reactions. 64 percentage of ADRs were reported in patients with treatment duration of more than 12 weeks. The most common adverse drug effect documented was abdominal pain followed by headache. Increase in serum transaminases was noted in 7 percentage of patients who were taking Fluconazole for more than 12 weeks, which did not require treatment termination or dosage alteration. Most of the ADRs were in possible category of causality assessment scale. In severity assessment most of the ADRs were in mild category.
 Conclusion: Adverse drug reaction to Fluconazole was mostly noted in patients who were on treatment for more than12 weeks of which elevated serum transaminases were observed in 8 patients. Hence regular liver function monitoring is advised in all patients receiving Fluconazole for more than 12 weeks to prevent further liver damage.
 Keywords: Adverse drug reaction, Fluconazole
Highlights
An adverse drug reaction is defined by WHO as “a response to a drug that is noxious and unintended and occurs at doses normally used in humans for the prophylaxis, diagnosis and treatment of disease, or for modification of physiological function[1]Generally the drugs acts by interfering with one or more aspects of molecular and cellular function, all of them have the risk of producing some reaction which may not be desirable all the times.[2]About 10-15% of all patients receiving medications are affected by ADR
Among the 100 patients who were on Fluconazole 58 developed adverse drug reactions. 64 percentage of ADRs were reported in patients with treatment duration of more than 12 weeks
Adverse drug reaction to Fluconazole was mostly noted in patients who were on treatment for more than[12] weeks of which elevated serum transaminases were observed in 8 patients
Summary
An adverse drug reaction is defined by WHO as “a response to a drug that is noxious and unintended and occurs at doses normally used in humans for the prophylaxis, diagnosis and treatment of disease, or for modification of physiological function[1]Generally the drugs acts by interfering with one or more aspects of molecular and cellular function, all of them have the risk of producing some reaction which may not be desirable all the times.[2]About 10-15% of all patients receiving medications are affected by ADR. An adverse drug reaction is defined by WHO as “a response to a drug that is noxious and unintended and occurs at doses normally used in humans for the prophylaxis, diagnosis and treatment of disease, or for modification of physiological function[1]. The drugs acts by interfering with one or more aspects of molecular and cellular function, all of them have the risk of producing some reaction which may not be desirable all the times.[2]. ADR accounts for 5 to 9 % of hospital expenditure and almost 1 lakh death globally per year. ADRs has been recognised as a major public health issue since they contribute to a sizeable percentage of hospital admissions and an economic burden to the society.[3]. Fluconazole is a bis-triazole broad spectrum antifungal agent discovered by Richardson et al during a programme initiated by Pfizer Central Research in 19784 Its antifungal activity is achieved by preventing fungal membrane sterol synthesis through the inhibition of cytochrome P450 (CYP)-dependent lanosterol C14αdemethylase which is involved in the conversion of lanosterol to ergosterol, resulting in inhibition of fungal cell replication.[5,6]
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