安全性解析対象症例数
副作用等の発現症例数
副作用等の発現割合

なし
4,855

あり
700

＊

腹部不快感

＊

腹部不快感 注
腹部膨満

＊

腹部膨満 注
腹痛

＊

腹痛 注
下腹部痛

＊

下腹部痛 注
上腹部痛

＊

便秘

)

)

318

91

8

417

13.00%

7.14%

7.36%

便秘 注
下痢

副作用等の種類別発現症例数（発現割合）
58 (1.19%)

18 (2.57%)

2 (0.04%)

2 (0.29%)

4 (0.07%)

-

1 (0.02%)

3 (0.06%)

-

-

3 (0.05%)

1 (0.02%)

-

-

1 (0.02%)

-

11 (0.19%)

2 (0.29%)

3 (0.06%)

-

-

3 (0.05%)

3 (0.06%)

-

-

3 (0.05%)

-

2 (0.04%)

2 (0.29%)

3 (0.06%)
8 (0.16%)
1 (0.02%)

)

78 (1.38%)

-

-

-

)

2 (1.79%)

1 (0.02%)

9 (0.19%)

)

合計
5,667

6.55%

副作用等の種類
胃腸障害

アレルギー歴
不明・未記載
112

15 (0.31%)

3 (0.43%)
2 (0.29%)

1 (0.89%)
1 (0.89%)

3 (0.05%)
12 (0.21%)
1 (0.02%)
18 (0.32%)

＊

消化不良

-

1 (0.14%)

-

＊

胃酸過多

-

1 (0.14%)

-

1 (0.02%)

3 (0.43%)

-

18 (0.32%)

15 (0.31%)

悪心

1 (0.02%)

＊

口内炎

1 (0.02%)

-

-

1 (0.02%)

＊

嘔吐

1 (0.02%)

-

-

1 (0.02%)

＊

排便困難

1 (0.02%)

-

-

1 (0.02%)

＊

軟便

1 (0.02%)

2 (0.29%)

40 (0.82%)

16 (2.29%)

皮膚および皮下組織障害
＊

3 (0.06%)

ざ瘡
ざ瘡 注
皮膚炎

3 (0.06%)

皮膚乾燥

2 (0.04%)

)

＊

-

皮膚乾燥 注
紅斑
＊

＊

1 (0.02%)

多汗症

-

-

1 (0.14%)

1 (0.02%)
4 (0.08%)

-

1 (0.02%)
2 (0.04%)
5 (0.09%)

6 (0.86%)

色素沈着障害

1 (0.89%)

1 (0.02%)

15 (0.31%)

筋骨格系および結合組織障害

3 (0.05%)
4 (0.07%)

-

発疹

-

-

1 (0.14%)
10 (1.43%)

1 (0.02%)

3 (0.05%)
58 (1.02%)

-

17 (0.35%)

皮膚刺激

2 (1.79%)

2 (0.29%)

そう痒症

蕁麻疹
＊

-

3 (0.06%)

)

1 (0.14%)

-

1 (0.14%)

1 (0.89%)
-

1 (0.02%)
28 (0.49%)
21 (0.37%)

-

1 (0.02%)

-

1 (0.02%)

-

1 (0.02%)

-

5 (0.09%)

背部痛

2 (0.04%)

-

-

2 (0.04%)

＊

顎痛

1 (0.02%)

-

-

1 (0.02%)

＊

筋骨格硬直

1 (0.02%)

-

-

1 (0.02%)

)

筋骨格硬直 注
生殖系および乳房障害

-

1 (0.14%)

183 (3.77%)

50 (7.14%)

4 (3.57%)

乳房腫瘤

1 (0.02%)

＊

乳房痛

1 (0.02%)

2 (0.29%)

-

3 (0.05%)

1 (0.02%)

1 (0.14%)

-

2 (0.04%)

＊

乳房痛 注
乳房腫脹

3 (0.06%)

1 (0.14%)

-

4 (0.07%)

5 (0.10%)

3 (0.43%)

-

8 (0.14%)

＊

乳房腫脹 注
月経困難症

7 (0.14%)

2 (0.29%)

-

9 (0.16%)

月経過多

22 (0.45%)

7 (1.00%)

-

29 (0.51%)

月経障害

45 (0.93%)

11 (1.57%)

2 (1.79%)

58 (1.02%)

月経遅延

49 (1.01%)

14 (2.00%)

2 (1.79%)

65 (1.15%)

)

1 (0.02%)

不規則月経

16 (0.33%)

3 (0.43%)

-

1 (0.02%)
237 (4.18%)

＊

)

-

-

1 (0.02%)

-

1 (0.02%)

-

19 (0.34%)

-

1 (0.02%)

＊

不正子宮出血

＊

乳頭痛

1 (0.02%)

＊

排卵痛

2 (0.04%)

1 (0.14%)

-

3 (0.05%)

30 (0.62%)

11 (1.57%)

-

41 (0.72%)

頻発月経
＊

-

月経前症候群
月経前症候群 注
陰部そう痒症

)

-

1 (0.14%)

-

1 (0.02%)

4 (0.08%)

1 (0.14%)

-

5 (0.09%)

1 (0.02%)

1 (0.14%)

-

2 (0.04%)

1 (0.14%)

-

1 (0.02%)

-

＊

子宮痛

＊

腟分泌物

3 (0.06%)

＊

排卵障害

1 (0.02%)

16

24

2 (0.29%)
-

-

5 (0.09%)

-

1 (0.02%)