Table 4 The signal strength of adverse events related to the neuro-psychiatric system associated with Asenapine, ranked by ROR at the PTs level in the FAERS database

Psychiatric disorders

Self esteem inflated

3

30.95 (9.81, 97.68)

30.94 (9.73, 98.34)

84.3

4.91 (3.47)

30.04 (11.48)

Psychiatric disorders

Thought blocking

7

18.45 (8.73, 38.98)

18.43 (8.75, 38.81)

113.28

4.18 (3.17)

18.11 (9.69)

Psychiatric disorders

Activation syndrome

4

15.4 (5.73, 41.35)

15.39 (5.78, 41.01)

53

3.92 (2.65)

15.17 (6.64)

Psychiatric disorders

Flight of ideas

3

11.87 (3.8, 37.05)

11.86 (3.81, 36.96)

29.49

3.55 (2.13)

11.73 (4.53)

Psychiatric disorders

Distractibility

9

11.24 (5.82, 21.69)

11.23 (5.88, 21.44)

82.91

3.47 (2.57)

11.11 (6.41)

Psychiatric disorders

Mania

106

9.92 (8.18, 12.04)

9.77 (8.03, 11.89)

827.42

3.28 (3)

9.68 (8.24)

Psychiatric disorders

Binge eating

6

9.4 (4.21, 21.01)

9.39 (4.2, 20.97)

44.58

3.22 (2.14)

9.31 (4.75)

Psychiatric disorders

Abulia

6

9.21 (4.12, 20.59)

9.21 (4.12, 20.57)

43.49

3.19 (2.12)

9.13 (4.66)

Psychiatric disorders

Hypomania

22

9.21 (6.05, 14.03)

9.18 (6.08, 13.85)

158.98

3.19 (2.59)

9.11 (6.4)

Psychiatric disorders

Schizophrenia

71

8.56 (6.77, 10.83)

8.47 (6.69, 10.72)

464.62

3.07 (2.74)

8.41 (6.91)

Psychiatric disorders

Enuresis

22

8.4 (5.52, 12.79)

8.37 (5.55, 12.63)

141.66

3.05 (2.46)

8.31 (5.85)

Psychiatric disorders

Bipolar I disorder

12

8.3 (4.7, 14.66)

8.28 (4.69, 14.62)

76.24

3.04 (2.25)

8.22 (5.11)

Psychiatric disorders

Disturbance in social behaviour

14

7.24 (4.28, 12.26)

7.23 (4.26, 12.27)

74.59

2.84 (2.11)

7.18 (4.62)

Psychiatric disorders

Feelings of worthlessness

7

7.19 (3.42, 15.13)

7.18 (3.41, 15.12)

36.99

2.84 (1.83)

7.14 (3.83)

Psychiatric disorders

Soliloquy

4

6.93 (2.59, 18.52)

6.92 (2.6, 18.44)

20.13

2.78 (1.51)

6.88 (3.02)

Psychiatric disorders

Psychiatric decompensation

9

6.44 (3.34, 12.42)

6.43 (3.37, 12.28)

41.06

2.68 (1.78)

6.4 (3.7)

Psychiatric disorders

Feeling guilty

6

5.83 (2.61, 13)

5.82 (2.61, 13)

23.82

2.53 (1.46)

5.79 (2.96)

Psychiatric disorders

Disinhibition

6

5.22 (2.34, 11.65)

5.21 (2.33, 11.64)

20.33

2.38 (1.3)

5.19 (2.65)

Psychiatric disorders

Hallucination, auditory

53

5.05 (3.85, 6.62)

5.01 (3.81, 6.59)

169.77

2.32 (1.93)

4.99 (3.98)

Psychiatric disorders

Tachyphrenia

13

4.92 (2.85, 8.49)

4.91 (2.84, 8.5)

40.31

2.29 (1.53)

4.89 (3.1)

Psychiatric disorders

Logorrhoea

12

4.9 (2.78, 8.64)

4.89 (2.77, 8.63)

36.96

2.28 (1.5)

4.87 (3.03)

Psychiatric disorders

Emotional poverty

6

4.68 (2.1, 10.44)

4.68 (2.1, 10.45)

17.27

2.22 (1.15)

4.66 (2.38)

Psychiatric disorders

Somnambulism

22

4.64 (3.05, 7.06)

4.63 (3.07, 6.99)

62.35

2.21 (1.61)

4.61 (3.25)

Psychiatric disorders

Dysphemia

13

4.26 (2.47, 7.36)

4.26 (2.46, 7.37)

32.27

2.08 (1.33)

4.24 (2.69)

Psychiatric disorders

Restlessness

100

4 (3.28, 4.87)

3.95 (3.25, 4.81)

220.25

1.98 (1.69)

3.94 (3.34)

Psychiatric disorders

Delusion

33

3.37 (2.39, 4.75)

3.36 (2.41, 4.69)

54.51

1.74 (1.26)

3.35 (2.51)

Psychiatric disorders

Euphoric mood

24

3.2 (2.14, 4.78)

3.19 (2.16, 4.72)

35.98

1.67 (1.1)

3.18 (2.27)

Psychiatric disorders

Psychotic disorder

60

3.09 (2.39, 3.98)

3.06 (2.37, 3.95)

83.47

1.61 (1.25)

3.06 (2.47)

Psychiatric disorders

Personality change

20

3.09 (1.99, 4.79)

3.08 (2, 4.74)

28.01

1.62 (1)

3.07 (2.13)

Psychiatric disorders

Agitation

145

2.96 (2.51, 3.49)

2.91 (2.49, 3.4)

183.14

1.54 (1.3)

2.91 (2.53)

Nervous system disorders

Anosognosia

18

29.13 (18.22, 46.57)

29.04 (18.14, 46.48)

473.65

4.82 (4.16)

28.25 (19.07)

Nervous system disorders

Akathisia

238

24.91 (21.85, 28.41)

23.96 (21.3, 26.95)

5122.13

4.55 (4.36)

23.42 (20.99)

Nervous system disorders

Oromandibular dystonia

8

14.62 (7.27, 29.4)

14.6 (7.21, 29.57)

99.92

3.85 (2.9)

14.41 (8.03)

Nervous system disorders

Spasmodic dysphonia

3

14.3 (4.57, 44.7)

14.29 (4.58, 44.54)

36.56

3.82 (2.39)

14.1 (5.43)

Nervous system disorders

Sedation

217

13.51 (11.79, 15.49)

13.06 (11.39, 14.98)

2391.47

3.69 (3.49)

12.9 (11.51)

Nervous system disorders

Cogwheel rigidity

7

10.38 (4.93, 21.88)

10.37 (4.92, 21.84)

58.69

3.36 (2.36)

10.28 (5.51)

Nervous system disorders

Drooling

44

9.89 (7.34, 13.32)

9.82 (7.32, 13.18)

345.43

3.28 (2.86)

9.73 (7.59)

Nervous system disorders

Dystonia

114

7.65 (6.36, 9.22)

7.53 (6.31, 8.98)

642.03

2.9 (2.64)

7.48 (6.4)

Nervous system disorders

Facial spasm

6

7.57 (3.39, 16.92)

7.57 (3.39, 16.91)

33.95

2.91 (1.84)

7.52 (3.84)

Nervous system disorders

Grimacing

4

7.12 (2.66, 19.05)

7.12 (2.67, 18.97)

20.89

2.82 (1.55)

7.08 (3.11)

Nervous system disorders

Restless legs syndrome

90

7.06 (5.73, 8.7)

6.97 (5.73, 8.48)

458.08

2.79 (2.49)

6.93 (5.82)

Nervous system disorders

Dysgeusia

345

6.77 (6.07, 7.55)

6.43 (5.83, 7.09)

1586.92

2.68 (2.52)

6.4 (5.84)

Nervous system disorders

Sudden onset of sleep

6

6.27 (2.81, 14)

6.26 (2.8, 13.98)

26.39

2.64 (1.57)

6.23 (3.18)

Nervous system disorders

Extrapyramidal disorder

109

5.52 (4.56, 6.67)

5.43 (4.46, 6.61)

393.5

2.44 (2.16)

5.41 (4.61)

Nervous system disorders

Head titubation

5

5.25 (2.18, 12.65)

5.25 (2.17, 12.68)

17.11

2.39 (1.23)

5.23 (2.5)

Nervous system disorders

Parkinsonism

31

4.76 (3.34, 6.78)

4.74 (3.33, 6.75)

91.19

2.24 (1.74)

4.72 (3.51)

Nervous system disorders

Neuroleptic malignant syndrome

36

4.6 (3.31, 6.38)

4.57 (3.27, 6.38)

100.19

2.19 (1.72)

4.56 (3.46)

Nervous system disorders

Dyskinesia

107

3.8 (3.14, 4.6)

3.75 (3.08, 4.56)

216.06

1.9 (1.63)

3.74 (3.19)

Nervous system disorders

Tardive dyskinesia

75

3.1 (2.47, 3.9)

3.08 (2.48, 3.82)

105.34

1.62 (1.29)

3.07 (2.54)

Nervous system disorders

Dysarthria

73

2.91 (2.31, 3.67)

2.89 (2.28, 3.66)

90.17

1.53 (1.2)

2.88 (2.37)