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.
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Brac University
2024
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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 |
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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 |
work_keys_str_mv |
AT rahmantowsifur oralterbinafinefluconazoleravuconazoleoteseconazoleinducedhepatotoxicityandacutekidneyinjuryinthetreatmentofonychomycosisapharmacovigilancestudy |
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