Abstract
The use-results surveillance study of Farom® dry syrup for pediatric (faropenem, FRPM) was conducted from the time of sale in 1999 to 2002, covering 3, 823 cases at 630 institutions nationwide. Of these, safety was analyzed in 3, 612 and efficacy in 3, 422. Results for safety were as follows: 1. The incidence of adverse drug reactions (ADRs), including abnormal laboratory findings in the Use-results surveillance data, was 10.19%(368 cases), higher than 8.18%(48/587) inpremarketing studies.
2. Major of ADRs were gastrointestinal disorders at 9.83%(355 cases) including diarrhoea, wastery stool, loose stools and mushy stool. Other ADRs were skin and appendages disorders at 0.42%(15 cases).
These symptom were slight, and resolved after administration of this agent was stopped. We confirmed a higher incidence of ADRs in younger patients, i.e., less than 3 years old patient, and these ADRs was almost appeared within 3 days.
