Histopathological signs of inflammation of the glandular stomach were observed in male rats at an exposure of approximately 1.9 (valsartan) and 2.6 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine. At higher exposures, ulceration and erosion of the stomach mucosa were observed in both females and males. Similar changes were also seen in the valsartan alone group (exposure 8.5-11.0 times the clinical dose of 160 mg valsartan).