Skip to main content

Table 4 Incidence of adverse events (≥ 5% in either of the studies)

From: Long-term oral blonanserin treatment for schizophrenia: a review of Japanese long-term studies

System organ class

Preferred term (adverse events)

BNS01 study

BNS02 study

 

N = 321

N = 61

n

(%)

n

(%)

Extrapyramidal system

115

35.8

32

52.5

 Akathisia

62

19.3

21

34.4

 Tremor

61

19.0

17

27.9

 Bradykinesia

49

15.3

10

16.4

 Dyslalia

33

10.3

4

6.6

 Salivary hypersecretion

29

9.0

8

13.1

 Gait abnormal

26

8.1

5

8.2

 Dyskinesia

21

6.5

6

9.8

 Musculoskeletal stiffness

20

6.2

4

6.6

 Dystonia

12

3.7

6

9.8

Psychoneurologic system

 Insomnia

119

37.1

31

50.8

 Somnolence

84

26.2

24

39.3

 Headache

79

24.6

12

19.7

 Anxiety

75

23.4

27

44.3

 Nervousness

64

19.9

14

23.0

 Depression

34

10.6

16

26.2

 Delusion

8

2.5

4

6.6

General symptom

 Malaise

71

22.1

13

21.3

 Dizziness

66

20.6

13

21.3

 Feeling hot

41

12.8

6

9.8

 Asthenia

38

11.8

10

16.4

Circulatory system

 Tachycardia

26

8.1

7

11.5

Digestive system

 Constipation

75

23.4

12

19.7

 Diarrhea

63

19.6

11

18.0

 Nausea

62

19.3

8

13.1

 Anorexia

53

16.5

9

14.8

 Thirst

50

15.6

15

24.6

 Abdominal pain

41

12.8

8

13.1

 Increased appetite

21

6.5

5

8.2

 Toothache

21

6.5

2

3.3

 Vomiting

18

5.6

2

3.3

Endocrine system

  

 Menstrual disorder

8

2.5

5

8.2

Others

 Nasopharyngitis

116

36.1

17

27.9

 Hyperprolactinemia

95

29.6

21

34.4

 Back pain

39

12.1

1

1.6

 Pyrexia

38

11.8

2

3.3

 Hypertriglyceridemia

36

11.2

5

8.2

 Creatine phosphokinase increased

34

10.6

6

9.8

 Eczema

31

9.7

1

1.6

 Pharyngitis

28

8.7

4

6.6

 ALT (GPT) increased

28

8.7

3

4.9

 Rhinitis

27

8.4

6

9.8

 Chest pain

24

7.5

4

6.6

 Upper respiratory tract infection

23

7.2

5

8.2

 Weight increased

23

7.2

5

8.2

 Arthralgia

22

6.9

1

1.6

 Gamma-glutamyltransferase increased

21

6.5

2

3.3

 Hypotension

21

6.5

4

6.6

 Fungal skin infection

20

6.2

3

4.9

 Pain

19

5.9

0

0.0

 Purpura

18

5.6

1

1.6

 Cough

18

5.6

2

3.3

 Hypertension

18

5.6

1

1.6

 AST (GOT) increased

17

5.3

3

4.9

 Conjunctivitis

16

5.0

0

0.0

 Accommodation disorder

12

3.7

9

14.8

 White blood cell count increased

10

3.1

8

13.1

Extrapyramidal adverse drug reactions

115

35.8

32

52.5