The U.S. Food and Drug Administration (FDA) approved NEXIUM® delayed release capsules in children ages 12 to 17 for the short-term treatment of gastroesophageal reflux disease (GERD). NEXIUM was tested in adolescents ages 12 to 17 in a randomized, double-blind parallel group study in which a total of 149 patients, ages 12 to 17, with clinically diagnosed GERD were treated with either NEXIUM 20mg or NEXIUM 40 mg once a day for up to eight weeks. Reported side effects included headache, abdominal pain, diarrhea and nausea.
Drug makers don't yet know if NEXIUM® is safe or effective for treating GERD in children under 12 years old.
