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Safety of fluconazole in paediatrics: a systematic review

Egunsola, Oluwaseun; Adefurin, Abiodun; Fakis, Apostolos; Jacqz-Aigrain, Evelyne; Choonara, Imti; Sammons, Helen


Oluwaseun Egunsola

Abiodun Adefurin

Apostolos Fakis

Evelyne Jacqz-Aigrain

Imti Choonara

Helen Sammons


To determine the safety of fluconazole in neonates and other paediatric age groups by identifying adverse events (AEs) and drug interactions associated with treatment.

A search of EMBASE (1950–January 2012), MEDLINE (1946–January 2012), the Cochrane database for systematic reviews and the Cumulative Index to Nursing and Allied Health Literature (1982–2012) for any clinical study about fluconazole use that involved at least one paediatric patient (≤17 years) was performed. Only articles with sufficient quality of safety reporting after patients’ exposure to fluconazole were included.

We identified 90 articles, reporting on 4,209 patients, which met our inclusion criteria. In total, 794 AEs from 35 studies were recorded, with hepatotoxicity accounting for 378 (47.6 %) of all AEs. When fluconazole was compared with placebo and other antifungals, the relative risk (RR) of hepatotoxicity was not statistically different [RR 1.36, 95 % confidence interval (CI) 0.87–2.14, P = 0.175 and RR 1.43, 95 % CI 0.67–3.03, P = 0.352, respectively]. Complete resolution of hepatoxicity was achieved by 84 % of patients with follow-up available. There was no statistical difference in the risk of gastrointestinal events of fluconazole compared with placebo and other antifungals (RR 0.81, 95 % CI 0.12–5.60, P = 0.831 and RR 1.23, 95 %CI 0.87–1.71, P = 0.235, respectively). There were 41 drug withdrawals, 17 (42 %) of which were due to elevated liver enzymes. Five reports of drug interactions occurred in children.

Fluconazole is relatively safe for paediatric patients. Hepatotoxicity and gastrointestinal toxicity are the most common adverse events. It is important to be aware that drug interactions with fluconazole can result in significant toxicity.


Egunsola, O., Adefurin, A., Fakis, A., Jacqz-Aigrain, E., Choonara, I., & Sammons, H. (2013). Safety of fluconazole in paediatrics: a systematic review. European Journal of Clinical Pharmacology, 69(6), doi:10.1007/s00228-012-1468-2

Journal Article Type Article
Publication Date Jun 1, 2013
Deposit Date Apr 15, 2014
Publicly Available Date Apr 15, 2014
Journal European Journal of Clinical Pharmacology
Print ISSN 0031-6970
Electronic ISSN 0031-6970
Publisher Humana Press
Peer Reviewed Peer Reviewed
Volume 69
Issue 6
Keywords Fluconazole, Safety, Neonates, Paediatrics, Hepatotoxicity
Public URL
Publisher URL
Copyright Statement Copyright information regarding this work can be found at the following address:


Egunsola_Safety_of_flucanozole.pdf (253 Kb)

Copyright Statement
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