Objective: We review the efficacy and safety of Pelargonium sidoides preparation EPs 7630 in children, adolescents, and adult patients with acute bronchitis (AB), acute rhinosinusitis (ARS), and acute tonsillopharyngitis (ATP). Methods: Double-blind, randomized, placebo-controlled trials were eligible for inclusion. Suitable trials were entered into meta-analyses performed separately for each indication. Efficacy analyses were based on change of disease specific symptom scores and on complete remission. Safety was analyzed based on the pooled data from all eligible trials, by comparing the incidence of adverse events in a set of pre-defined system groups between EPs 7630 and placebo. Results: 13 trials with a total of 3,392 participants were included, 10 of which could be entered into meta-analyses of efficacy (AB: 6/8 trials; ARS: 2/2 trials; ATP: 2/3 trials). In ARS, all trials included adults only, whereas studies in ATP had been conducted with children only. Compared to placebo, the analysis of safety showed slightly higher rates of events belonging to the known spectrum of adverse drug reactions to the herbal product, but risk increases ?1% could be excluded for all investigated system groups except gastrointestinal disorders and epistaxis. No serious adverse drug reactions were reported in any trial. In the meta-analyses of efficacy, EPs 7630 was superior to placebo in reducing both symptom severity and time until complete recovery for all indications investigated. Significant advantages for the herbal drug were also observed for time until the onset of a meaningful treatment effect, global therapy outcome, and days off work, school, or kindergarten. In AB, efficacy could also be shown for both subsets defined by age. Conclusion: EPs 7630 is an efficacious, safe, and well-tolerated herbal medicine in the management of acute respiratory tract infections such as AB, ARS, and ATP in children, adolescents and adults.