Oral terbinafine-, fluconazole-, ravuconazole-, oteseconazole-induced hepatotoxicity and acute kidney injury in the treatment of onychomycosis: a pharmacovigilance study

This thesis is submitted in partial fulfillment of the requirements for the degree of Bachelor of Pharmacy, 2023.

Библиографические подробности
Главный автор: Rahman, Towsifur
Другие авторы: Talukder, Mesbah
Формат: Диссертация
Язык:English
Опубликовано: Brac University 2024
Предметы:
Online-ссылка:http://hdl.handle.net/10361/23171
id 10361-23171
record_format dspace
spelling 10361-231712024-06-06T21:04:22Z Oral terbinafine-, fluconazole-, ravuconazole-, oteseconazole-induced hepatotoxicity and acute kidney injury in the treatment of onychomycosis: a pharmacovigilance study Rahman, Towsifur Talukder, Mesbah School of Pharmacy, Brac University Antifungal-induced hepatotoxicity Oral terbinafine Ravuconazole Oteseconazole Fluconazole FDA adverse event reporting system Kidney injury Acute renal failure Kidneys--Wounds and injuries This thesis is submitted in partial fulfillment of the requirements for the degree of Bachelor of Pharmacy, 2023. Cataloged from the PDF version of thesis. Includes bibliographical references (pages 29-41). Onychomycosis is a fungal infection in the nails. Oral antifungal therapies of onychomycosis; terbinafine, fluconazole, ravuconazole, otesaconazole may cause liver and acute kidney injury (AKI). This project aims to identify the signals of hepatotoxicity and AKI of these antifungals in the FDA Adverse Event Report System (FAERS) database. We included FAERS records, calculating reporting odds ratios (RORs), and associated 95% confidence interval (CI). Statistical significance was considered when the lower limit of 95% CI exceeded 1.0. Isoniazid and gentamicin were added as controls for the adverse events. Terbinafine's ROR (95% CI) was 5.20 (2.70, 10.01), and fluconazole's was 1.15 (0.58, 2.31) in hepatotoxicity. No signal was detected for AKI for these two antifungals. Isoniazid showed 3.32, and 15.01 times more hepatotoxicity; gentamicin showed 4.06, and 5.24 times more AKI-causing than terbinafine and fluconazole respectively. No clinical data for ravuconazole and otesaconazole was found. The study supported the association between terbinafine and hepatotoxicity. It found no association between the drugs causing AKI. Towsifur Rahman B. Pharmacy 2024-06-06T03:24:58Z 2024-06-06T03:24:58Z ©2023 2023-02 Thesis ID: 19146076 http://hdl.handle.net/10361/23171 en Brac University theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. 54 pages application/pdf Brac University
institution Brac University
collection Institutional Repository
language English
topic Antifungal-induced hepatotoxicity
Oral terbinafine
Ravuconazole
Oteseconazole
Fluconazole
FDA adverse event reporting system
Kidney injury
Acute renal failure
Kidneys--Wounds and injuries
spellingShingle Antifungal-induced hepatotoxicity
Oral terbinafine
Ravuconazole
Oteseconazole
Fluconazole
FDA adverse event reporting system
Kidney injury
Acute renal failure
Kidneys--Wounds and injuries
Rahman, Towsifur
Oral terbinafine-, fluconazole-, ravuconazole-, oteseconazole-induced hepatotoxicity and acute kidney injury in the treatment of onychomycosis: a pharmacovigilance study
description This thesis is submitted in partial fulfillment of the requirements for the degree of Bachelor of Pharmacy, 2023.
author2 Talukder, Mesbah
author_facet Talukder, Mesbah
Rahman, Towsifur
format Thesis
author Rahman, Towsifur
author_sort Rahman, Towsifur
title Oral terbinafine-, fluconazole-, ravuconazole-, oteseconazole-induced hepatotoxicity and acute kidney injury in the treatment of onychomycosis: a pharmacovigilance study
title_short Oral terbinafine-, fluconazole-, ravuconazole-, oteseconazole-induced hepatotoxicity and acute kidney injury in the treatment of onychomycosis: a pharmacovigilance study
title_full Oral terbinafine-, fluconazole-, ravuconazole-, oteseconazole-induced hepatotoxicity and acute kidney injury in the treatment of onychomycosis: a pharmacovigilance study
title_fullStr Oral terbinafine-, fluconazole-, ravuconazole-, oteseconazole-induced hepatotoxicity and acute kidney injury in the treatment of onychomycosis: a pharmacovigilance study
title_full_unstemmed Oral terbinafine-, fluconazole-, ravuconazole-, oteseconazole-induced hepatotoxicity and acute kidney injury in the treatment of onychomycosis: a pharmacovigilance study
title_sort oral terbinafine-, fluconazole-, ravuconazole-, oteseconazole-induced hepatotoxicity and acute kidney injury in the treatment of onychomycosis: a pharmacovigilance study
publisher Brac University
publishDate 2024
url http://hdl.handle.net/10361/23171
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