SynthesisEuropean journal of clinical pharmacology2013
Safety of fluconazole in paediatrics: a systematic review.
Synthesis in European journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 60 citations in OpenAlex.
- Association between antibiotic exposure and adverse outcomes of children and pregnant women: evidence from an umbrella review.World journal of pediatrics : WJP · 2023Pooled it
- Pooled it
- Systematic review of the toxicity of short-course oral corticosteroids in children.Archives of disease in childhood · 2016Pooled it
- Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: a randomized, open-label clinical trial.British journal of clinical pharmacology · 2018Trial
- High Burden of Invasive Fungal Infection in Korean Pediatric Liver Transplant Recipients: A Single-Center Retrospective Cohort Study (2012-2023).Yonsei medical journal · 2026Article
- Ergosterol-Dependent Membrane Stress and Calcineurin-HSP90 Signaling Govern Fluorinated Sulfone-Induced Cell Death in Candida albicans.Mycopathologia · 2026Article
- Intralobar pulmonary sequestration coexisting with pulmonary cryptococcosis: A case report and literature review.Experimental and therapeutic medicine · 2026Article
- Irrational and Inappropriate Use of Antifungals in the NICU: A Narrative Review.Antibiotics (Basel, Switzerland) · 2026Review
- Therapeutic Drug Monitoring of Antimicrobial Drugs in Children with Cancer: A New Tool for Personalized Medicine.Paediatric drugs · 2025Review
- In vitro screening of UGT2B10 in silico prioritized putative ligands from drugs used in the pediatric hematopoietic stem cell transplantation setting.Pharmacology research & perspectives · 2024Article
- Fluconazole Analogs and Derivatives: An Overview of Synthesis, Chemical Transformations, and Biological Activity.Molecules (Basel, Switzerland) · 2024Review
- Case Report: Itraconazole Oral Solution Continuous Therapy for Infantile Tinea Capitis.The American journal of tropical medicine and hygiene · 2024Article
- Serial evaluation of liver enzyme activities in dogs with pulmonary coccidioidomycosis administeredFrontiers in veterinary science · 2024Article
- Plasma and Cerebrospinal Fluid Concentrations of Micafungin Administered at High Doses in Critically Ill Infants with Systemic Candidiasis: A Pooled Analysis of Two Studies.Pharmaceuticals (Basel, Switzerland) · 2023Article
- A potential implication of UDP-glucuronosyltransferase 2B10 in the detoxification of drugs used in pediatric hematopoietic stem cell transplantation setting: an in silico investigation.BMC molecular and cell biology · 2022Article
- Review of Fluconazole Treatment and Prophylaxis for Invasive Candidiasis in Neonates.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021Review
- Antifungal Activity of Essential Oils Against Candida Species Isolated from Clinical Samples.Mycopathologia · 2019Article
- Fluconazole use during breastfeeding.Canadian family physician Medecin de famille canadien · 2015Article
- Activity of Polyphenolic Compounds against Candida glabrata.Molecules (Basel, Switzerland) · 2015Article
- Antifungal prescribing pattern and attitude towards the treatment of oral candidiasis among dentists in Jordan.International dental journal · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo determine the safety of fluconazole in neonates and other paediatric age groups by identifying adverse events (AEs) and drug interactions associated with treatment.
methodsA 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.
resultsWe 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.
conclusionFluconazole 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.