Table 6.

Rate of adverse drug reaction by daily dose¹⁾

		Daily dose of omeprazole
	Total (N = 7711)	10 mg (N = 2956)	20 mg (N = 4726)	40 mg2) (N = 29)
No. of patients with adverse drug reactions	71	26	45	0
No. of adverse drug reactions	73	28	45	0
Rate of adverse drug reactions	0.92%	0.88%	0.95%	0%
Preferred term3)
Diarrhoea	7 (0.09)	3 (0.10)	4 (0.08)	0
Abdominal distension	5 (0.06)	2 (0.07)	3 (0.06)	0
Drug eruption	5 (0.06)	1 (0.03)	4 (0.08)	0
Thirst	5 (0.06)	1 (0.03)	4 (0.08)	0
Pruritus	4 (0.05)	2 (0.07)	2 (0.04)	0
Upper abdominal pain	3 (0.04)	0	3 (0.06)	0
Constipation	3 (0.04)	1 (0.03)	2 (0.04)	0
Vomiting	3 (0.04)	1 (0.03)	2 (0.04)	0
Eczema	3 (0.04)	1 (0.03)	2 (0.04)	0
Rash	3 (0.04)	1 (0.03)	2 (0.04)	0
Abnormal hepatic function	2 (0.03)	0	2 (0.04)	0
Muscle pains	2 (0.03)	1 (0.03)	1 (0.02)	0

Values are n (%).

¹⁾ Some patients have more than one adverse drug reaction; events occurred in two or more patients are listed.

²⁾ 20 mg twice daily.

³⁾ MedDRA Ver12.0.