Safety and tolerability of a 6-week course of oseltamivir prophylaxis for seasonal influenza in children

Influenza Other Respir Viruses. 2013 Jan;7(1):11-3. doi: 10.1111/j.1750-2659.2012.00367.x. Epub 2012 Apr 23.

Abstract

In an open-label study, 49 children aged 1-12 years received oseltamivir (30-75 mg once daily depending on bodyweight) for 6 weeks for influenza prophylaxis. Seventeen participants reported 22 adverse events (AEs); in three participants, AEs were considered probably drug related (nausea or vomiting). No serious AEs were reported. The tolerability profile was similar to pooled safety data from treatment studies (duration of 5 days) in children.

Trial registration: ClinicalTrials.gov NCT00412555.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Antiviral Agents / administration & dosage
  • Antiviral Agents / adverse effects*
  • Antiviral Agents / therapeutic use*
  • Chemoprevention
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Infant
  • Influenza, Human / prevention & control*
  • Male
  • Oseltamivir / administration & dosage
  • Oseltamivir / adverse effects*
  • Oseltamivir / therapeutic use*
  • Seasons
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Oseltamivir

Associated data

  • ClinicalTrials.gov/NCT00412555