Efficacy and positive benefit/risk was not demonstrated in 2 studies (a randomized, double-blind, safety and efficacy study and an open label safety study) conducted in patients 2 -16 years The most frequently reported adverse events from the 2 studies were urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation. Information added to Pediatric Use
|