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

＊

腹部不快感

＊

腹部不快感
腹部膨満

＊

腹部膨満
腹痛

＊

腹痛
下腹部痛

＊

下腹部痛
上腹部痛

＊

便秘

注)

244

171

2

417

10.23%

11.76%

7.36%

29 (1.73%)

-

3 (0.08%)

1 (0.06%)

-

4 (0.07%)

1 (0.06%)

-

1 (0.02%)

2 (0.05%)
1 (0.03%)

注)

便秘 注
下痢

副作用等の種類別発現症例数（発現割合）
49 (1.23%)
-

注)

注)

)

消化不良
胃酸過多

-

3 (0.05%)

-

1 (0.02%)

2 (0.12%)

-

11 (0.19%)

1 (0.06%)

-

3 (0.05%)

2 (0.05%)

1 (0.06%)

-

3 (0.05%)

1 (0.03%)

1 (0.06%)

-

2 (0.04%)

2 (0.05%)

1 (0.06%)

-

3 (0.05%)

7 (0.18%)

5 (0.30%)

-

12 (0.21%)

1 (0.03%)
11 (0.28%)

悪心

-

2 (0.05%)

1 (0.03%)

＊

1 (0.06%)

78 (1.38%)

9 (0.23%)

11 (0.28%)

＊

合計
5,667

6.13%

副作用等の種類
胃腸障害

併用薬剤の使用状況
あり
不明・未記載
1,672
17

なし
3,978

-

1 (0.02%)

7 (0.42%)

-

-

18 (0.32%)

1 (0.06%)

-

1 (0.02%)

-

-

1 (0.02%)

7 (0.42%)

-

18 (0.32%)

＊

口内炎

-

1 (0.06%)

-

1 (0.02%)

＊

嘔吐

-

1 (0.06%)

-

1 (0.02%)

＊

排便困難

1 (0.03%)

-

1 (0.02%)

＊

軟便

1 (0.03%)

2 (0.12%)

29 (0.73%)

28 (1.67%)

皮膚および皮下組織障害
＊

＊

3 (0.05%)
58 (1.02%)

2 (0.05%)

1 (0.06%)

-

3 (0.05%)

3 (0.18%)

-

4 (0.07%)

-

1 (0.02%)

皮膚乾燥

1 (0.03%)

1 (0.06%)

-

2 (0.04%)

3 (0.08%)

2 (0.12%)

-

5 (0.09%)

-

1 (0.02%)

1 (0.03%)
)

1 (0.03%)
1 (0.03%)

多汗症
そう痒症

11 (0.28%)

発疹

12 (0.30%)
-

皮膚刺激

1 (0.03%)

蕁麻疹
＊

1 (5.88%)

1 (0.03%)

皮膚乾燥 注
紅斑
＊

-

ざ瘡 注
皮膚炎

ざ瘡
)

＊

-

-

色素沈着障害
筋骨格系および結合組織障害

2 (0.05%)

-

16 (0.96%)

1 (5.88%)

1 (0.02%)
28 (0.49%)

9 (0.54%)

-

1 (0.06%)

-

1 (0.02%)

-

1 (0.02%)

-

21 (0.37%)

1 (0.06%)

-

1 (0.02%)

3 (0.18%)

-

5 (0.09%)

背部痛

-

2 (0.12%)

-

2 (0.04%)

＊

顎痛

-

1 (0.06%)

-

1 (0.02%)

＊

筋骨格硬直

1 (0.02%)

注)

筋骨格硬直
生殖系および乳房障害

1 (0.03%)

-

-

1 (0.03%)

-

-

129 (3.24%)

＊

乳房腫瘤

1 (0.03%)

＊

乳房痛

1 (0.03%)

＊

乳房痛
乳房腫脹

＊

乳房腫脹
月経困難症

注)

注)

-

2 (11.76%)
-

1 (0.02%)
237 (4.18%)
1 (0.02%)

2 (0.12%)

-

3 (0.05%)

2 (0.12%)

-

2 (0.04%)

1 (0.03%)

3 (0.18%)

-

4 (0.07%)

3 (0.08%)

5 (0.30%)

-

8 (0.14%)

6 (0.15%)

3 (0.18%)

-

9 (0.16%)

月経過多

17 (0.43%)

12 (0.72%)

-

29 (0.51%)

月経障害

37 (0.93%)

19 (1.14%)

月経遅延

33 (0.83%)

32 (1.91%)

不規則月経

1 (0.03%)

＊

不正子宮出血

9 (0.23%)

＊

乳頭痛

＊

排卵痛

-

頻発月経
＊

106 (6.34%)

＊

子宮痛

＊

腟分泌物

＊

排卵障害

)

-

58 (1.02%)
65 (1.15%)

-

1 (0.02%)

10 (0.60%)

-

19 (0.34%)
1 (0.02%)

1 (0.06%)

-

1 (0.03%)

2 (0.12%)

-

3 (0.05%)

20 (0.50%)

21 (1.26%)

-

41 (0.72%)

-

月経前症候群
月経前症候群 注
陰部そう痒症

-

2 (11.76%)

4 (0.10%)
1 (0.03%)
1 (0.03%)
-

25

33

1 (0.06%)

-

1 (0.02%)

1 (0.06%)

-

5 (0.09%)

1 (0.06%)

-

2 (0.04%)

1 (0.06%)

-

1 (0.02%)

4 (0.24%)

-

5 (0.09%)

1 (0.06%)

-

1 (0.02%)