Table 3 The top 30 signal strength of adverse events of Asenapine ranked by ROR at the PTs level in FAERS database

Gastrointestinal disorders

Hypoaesthesia oral

354

94.64 (85.03, 105.35)

92.43 (83.8, 101.95)

30964.65

6.48 (6.33)

89.4 (81.74)

Gastrointestinal disorders

Glossoptosis

3

62.39 (19.86, 195.98)

62.37 (20.01, 194.39)

177.08

5.93 (4.5)

60.99 (23.4)

Gastrointestinal disorders

Tooth discolouration

41

61.7 (45.25, 84.12)

61.53 (44.97, 84.19)

2387.19

5.91 (5.47)

60.18 (46.43)

Gastrointestinal disorders

Oral dysaesthesia

3

58.35 (18.59, 183.14)

58.33 (18.71, 181.8)

165.48

5.84 (4.4)

57.12 (21.94)

Gastrointestinal disorders

Tongue blistering

34

55.58 (39.56, 78.09)

55.46 (39.74, 77.39)

1781.76

5.76 (5.28)

54.36 (40.91)

Gastrointestinal disorders

Tongue exfoliation

5

52.2 (21.54, 126.48)

52.18 (21.6, 126.05)

246.24

5.68 (4.51)

51.21 (24.42)

Gastrointestinal disorders

Tongue spasm

4

49.38 (18.37, 132.77)

49.37 (18.53, 131.54)

186.15

5.6 (4.32)

48.5 (21.2)

Gastrointestinal disorders

Tongue ulceration

30

35 (24.41, 50.2)

34.94 (24.55, 49.72)

976.36

5.11 (4.6)

34.5 (25.52)

Gastrointestinal disorders

Protrusion tongue

5

29.39 (12.17, 70.95)

29.38 (12.16, 70.97)

135.59

4.86 (3.7)

29.07 (13.91)

Nervous system disorders

Anosognosia

18

78.56 (49.16, 125.56)

78.47 (49.02, 125.6)

1337.86

6.25 (5.59)

76.28 (51.53)

Nervous system disorders

Akathisia

238

65.77 (57.77, 74.86)

64.74 (56.44, 74.26)

14589.06

5.98 (5.8)

63.24 (56.75)

Nervous system disorders

Oromandibular dystonia

8

39.48 (19.64, 79.36)

39.46 (19.49, 79.91)

295.55

5.28 (4.33)

38.9 (21.69)

Nervous system disorders

Spasmodic dysphonia

3

38.62 (12.35, 120.73)

38.61 (12.39, 120.34)

108.37

5.25 (3.82)

38.08 (14.67)

Nervous system disorders

Sedation

217

35.78 (31.27, 40.95)

35.28 (30.76, 40.47)

7137.58

5.12 (4.93)

34.84 (31.12)

Nervous system disorders

Cogwheel rigidity

7

28.04 (13.32, 59.06)

28.03 (13.31, 59.03)

180.59

4.79 (3.79)

27.75 (14.88)

Nervous system disorders

Drooling

44

26.61 (19.76, 35.82)

26.53 (19.77, 35.6)

1070.76

4.72 (4.29)

26.29 (20.5)

Psychiatric disorders

Self esteem inflated

3

83.61 (26.5, 263.81)

83.59 (26.3, 265.69)

237.47

6.34 (4.9)

81.12 (31.01)

Psychiatric disorders

Thought blocking

7

49.81 (23.58, 105.22)

49.79 (23.64, 104.86)

328.61

5.61 (4.6)

48.91 (26.16)

Psychiatric disorders

Activation syndrome

4

41.59 (15.49, 111.67)

41.58 (15.61, 110.79)

156.03

5.36 (4.08)

40.97 (17.93)

Psychiatric disorders

Flight of ideas

3

32.06 (10.27, 100.07)

32.05 (10.28, 99.89)

89.19

4.99 (3.56)

31.69 (12.22)

Psychiatric disorders

Distractibility

9

30.35 (15.73, 58.55)

30.33 (15.58, 59.06)

252.45

4.91 (4.01)

30.01 (17.31)

Respiratory, thoracic and mediastinal disorders

Pharyngeal hypoaesthesia

21

90.36 (58.48, 139.62)

90.24 (58.63, 138.89)

1793.38

6.45 (5.84)

87.35 (60.7)

Respiratory, thoracic and mediastinal disorders

Larynx irritation

3

54.43 (17.35, 170.71)

54.42 (17.46, 169.62)

154.21

5.74 (4.31)

53.37 (20.51)

Respiratory, thoracic and mediastinal disorders

Oropharyngeal blistering

21

47.25 (30.68, 72.76)

47.18 (30.65, 72.61)

933

5.54 (4.93)

46.39 (32.32)

Investigations

Acid base balance abnormal

4

72.58 (26.88, 195.95)

72.56 (26.7, 197.16)

274.91

6.14 (4.86)

70.69 (30.79)

Investigations

Blood prolactin abnormal

17

62.58 (38.68, 101.25)

62.51 (38.3, 102.04)

1005.78

5.93 (5.26)

61.12 (40.87)

Investigations

Antipsychotic drug level below therapeutic

5

30.24 (12.52, 73.03)

30.23 (12.51, 73.03)

139.77

4.9 (3.74)

29.91 (14.3)

Vascular disorders

Orthostatic hypertension

6

40.26 (17.98, 90.16)

40.24 (18.02, 89.88)

226.23

5.31 (4.23)

39.67 (20.2)

Metabolism and nutrition disorders

Water intoxication

9

75.59 (38.97, 146.63)

75.55 (38.8, 147.11)

644.03

6.2 (5.29)

73.52 (42.23)

Injury, poisoning and procedural complications

Mucosal excoriation

4

327.7 (116.08, 925.13)

327.62 (115.94, 925.8)

1161.67

8.19 (6.85)

292.31 (122.66)