A randomized, double-blind, placebo-controlled trial evaluating the safety of early oseltamivir treatment among children 0-9 years of age hospitalized with influenza in El Salvador and Panama.

•Few data exist on oseltamivir efficacy and tolerability in hospitalized children.•This randomized trial did not achieve the target sample size to evaluate efficacy.•However, oseltamivir was well tolerated among hospitalized children 0–9 years.•The most commonly reported non-serious adverse events were diarrhea and vomiting.•Most adverse events were mild or moderate and deemed unrelated to study medication.