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
4,958

＊

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

)

)

73

5

417

12.23%

4.46%

7.36%

便秘 注
下痢

副作用等の種類別発現症例数（発現割合）
66 (1.33%)

12 (2.01%)

-

3 (0.06%)

1 (0.17%)

-

4 (0.07%)

-

-

1 (0.02%)

3 (0.06%)

-

-

3 (0.05%)

1 (0.02%)

-

-

1 (0.02%)

-

11 (0.19%)

1 (0.17%)

3 (0.06%)

-

-

3 (0.05%)

3 (0.06%)

-

-

3 (0.05%)

3 (0.06%)
10 (0.20%)
1 (0.02%)

)

78 (1.38%)

1 (0.02%)

1 (0.02%)

)

合計
5,667

339

10 (0.20%)

)

合併症
不明・未記載
112

6.84%

副作用等の種類
胃腸障害

あり
597

16 (0.32%)

1 (0.17%)
2 (0.34%)
2 (0.34%)

-

2 (0.04%)

-

3 (0.05%)

-

12 (0.21%)

-

1 (0.02%)

-

18 (0.32%)
1 (0.02%)

＊

消化不良

1 (0.02%)

-

-

＊

胃酸過多

1 (0.02%)

-

-

1 (0.02%)

-

18 (0.32%)

14 (0.28%)

悪心

4 (0.67%)

＊

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

2 (0.04%)

1 (0.17%)

45 (0.91%)

11 (1.84%)

皮膚および皮下組織障害
＊

3 (0.06%)

ざ瘡

2 (0.04%)

)

ざ瘡 注
皮膚炎
＊

1 (0.02%)

＊

＊
＊

2 (0.04%)

皮膚乾燥
皮膚乾燥 注
紅斑

4 (0.08%)

)

1 (0.02%)

多汗症

＊

2 (1.79%)
-

3 (0.05%)
58 (1.02%)
3 (0.05%)

-

4 (0.07%)

-

-

1 (0.02%)

-

-

2 (0.04%)

1 (0.17%)
-

1 (0.89%)
-

5 (0.09%)
1 (0.02%)
1 (0.02%)

そう痒症

20 (0.40%)

6 (1.01%)

2 (1.79%)

28 (0.49%)

発疹

15 (0.30%)

5 (0.84%)

1 (0.89%)

21 (0.37%)

皮膚刺激

1 (0.02%)

-

-

1 (0.02%)

蕁麻疹

1 (0.02%)

-

-

1 (0.02%)

色素沈着障害

1 (0.02%)

-

-

1 (0.02%)
5 (0.09%)

3 (0.06%)

2 (0.34%)

-

背部痛

1 (0.02%)

1 (0.17%)

-

2 (0.04%)

顎痛

1 (0.02%)

-

1 (0.02%)

筋骨格系および結合組織障害
＊

2 (0.34%)

-

1 (0.02%)

筋骨格硬直
)

筋骨格硬直 注
生殖系および乳房障害

189 (3.81%)

1 (0.17%)
44 (7.37%)

-

1 (0.02%)

-

1 (0.02%)

4 (3.57%)

237 (4.18%)

＊

乳房腫瘤

1 (0.02%)

-

-

1 (0.02%)

＊

乳房痛

3 (0.06%)

-

-

3 (0.05%)

＊

乳房痛 注
乳房腫脹

＊

乳房腫脹 注
月経困難症

1 (0.02%)

)

4 (0.08%)

1 (0.17%)
-

-

2 (0.04%)

-

4 (0.07%)

-

8 (0.14%)

7 (0.14%)

1 (0.17%)

7 (0.14%)

1 (0.17%)

月経過多

23 (0.46%)

6 (1.01%)

月経障害

43 (0.87%)

12 (2.01%)

3 (2.68%)

58 (1.02%)

月経遅延

55 (1.11%)

9 (1.51%)

1 (0.89%)

65 (1.15%)

)

1 (0.02%)

不規則月経

13 (0.26%)

6 (1.01%)

1 (0.89%)
-

9 (0.16%)
29 (0.51%)

-

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 (0.17%)

-

3 (0.05%)

32 (0.65%)

9 (1.51%)

-

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 (0.02%)

-

-

1 (0.02%)

5 (0.10%)

-

-

5 (0.09%)

1 (0.02%)
-

＊

子宮痛

＊

腟分泌物

4 (0.08%)

＊

排卵障害

1 (0.02%)

19

28

1 (0.17%)

-

2 (0.04%)

1 (0.17%)

-

1 (0.02%)

1 (0.17%)
-

-

5 (0.09%)

-

1 (0.02%)