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Safety of fluoroquinolones in pediatric patients: Pharmacovigilance database analysis

Olga Butranova1, Yury Kustov1, Sergey Zyryanov1,2

  • 1Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia Named After Patrice Lumumba (RUDN), Moscow, Russia.

The International Journal of Risk & Safety in Medicine
|November 18, 2025
PubMed

Insights

Fluoroquinolones (FQs) like levofloxacin and ciprofloxacin are increasingly prescribed to children. This study found that immune and skin-related adverse drug reactions (ADRs) were most common in pediatric patients receiving FQs.

Area of Science:

  • Pharmacovigilance
  • Pediatric Pharmacology
  • Infectious Diseases

Background:

  • Rising prevalence of antibiotic-resistant bacteria necessitates increased use of fluoroquinolones (FQs) in pediatric patients.
  • National pharmacovigilance databases offer insights into the real-world safety of FQs in children.

Purpose of the Study:

  • To analyze the types and structure of adverse drug reactions (ADRs) associated with fluoroquinolone use in pediatric patients.

Main Methods:

  • Retrospective analysis of spontaneous reports from the Russian National Pharmacovigilance database (April 2019 - January 2024).
  • Inclusion of 280 pediatric spontaneous reports (SRs).

Main Results:

  • Adolescents (62.9%) were the most affected age group, with a mean age of 12.1 years.
  • Levofloxacin (49.6%), ciprofloxacin (31.1%), and moxifloxacin (15%) were the leading FQs.
  • Most frequent ADRs involved immune disorders (18.9%), gastrointestinal issues (15.0%), and skin reactions (14.7%), with urticaria and diarrhea being common.

Conclusions:

  • Levofloxacin, ciprofloxacin, and moxifloxacin are frequently associated with ADRs in pediatric patients.
  • Allergic reactions are the predominant type of ADRs observed.
  • Close monitoring of pediatric patients receiving FQs is crucial throughout treatment and post-discharge.

Keywords:
ciprofloxacinfluoroquinoloneslevofloxacinmoxifloxacinpediatricspharmacoepidemiology and pharmacoeconomicspharmacologypharmacovigilance

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