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Safety of fluconazole in paediatrics: a systematic review

Oluwaseun Egunsola1, Abiodun Adefurin, Apostolos Fakis

  • 1Academic Division of Child Health, Derbyshire Children's Hospital, University of Nottingham, Derby, DE22 3DT, UK. oluwaseun.egunsola@nottingham.ac.uk

European Journal of Clinical Pharmacology
|January 18, 2013
PubMed

Insights

Fluconazole is generally safe for pediatric patients, with hepatotoxicity and gastrointestinal issues being the most common adverse events. Awareness of potential drug interactions is crucial for managing toxicity risks in children.

Area of Science:

  • Pediatric Pharmacology
  • Antifungal Drug Safety
  • Clinical Pediatrics

Background:

  • Fluconazole is a widely used antifungal medication.
  • Assessing its safety profile in pediatric populations is essential.
  • Understanding adverse events and drug interactions informs clinical practice.

Purpose of the Study:

  • To evaluate the safety of fluconazole in neonates and children.
  • To identify adverse events (AEs) associated with fluconazole treatment.
  • To document drug interactions in pediatric patients receiving fluconazole.

Main Methods:

  • Systematic literature review of EMBASE, MEDLINE, Cochrane, and CINAHL databases.
  • Inclusion of studies involving pediatric patients (≤17 years) with quality safety reporting.
  • Analysis of 90 articles reporting on 4,209 pediatric patients.

Main Results:

  • Hepatotoxicity was the most frequent AE (47.6%), with no statistically significant difference compared to placebo or other antifungals.
  • Gastrointestinal events also showed no statistical difference in risk.
  • 41 drug withdrawals occurred, 17 due to elevated liver enzymes; 5 drug interactions were reported.

Conclusions:

  • Fluconazole demonstrates a relatively safe profile for pediatric use.
  • Hepatotoxicity and gastrointestinal toxicity are the primary adverse events to monitor.
  • Clinicians must remain vigilant regarding potential drug interactions that may lead to toxicity.
Abstract

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