Table 4 The top 30 signal strength of adverse events of deutetrabenazine ranked by the number of case reports at the PTs level in FAERS database

Drug Ineffective*

603

2.5 (2.31–2.72)

2.42 (513.66)

2.42 (2.26)

1.27 (-0.39)

Dyskinesia*

288

50.24 (44.64–56.53)

48.9 (13298.97)

48.11 (43.59)

5.59 (3.92)

Depression*

288

9.17 (8.16–10.31)

8.95 (2034.27)

8.93 (8.09)

3.16 (1.49)

Death*

243

1.6 (1.41–1.82)

1.59 (53.46)

1.59 (1.43)

0.67 (-1)

Tremor*

207

8.58 (7.48–9.85)

8.44 (1356.04)

8.41 (7.5)

3.07 (1.41)

Somnolence*

199

6.29 (5.47–7.24)

6.19 (867.28)

6.18 (5.5)

2.63 (0.96)

Suicidal Ideation*

197

15.81 (13.73–18.21)

15.53 (2667.91)

15.46 (13.73)

3.95 (2.28)

Insomnia*

189

4.78 (4.14–5.52)

4.71 (553.92)

4.71 (4.17)

2.23 (0.57)

Fatigue*

176

1.26 (1.09–1.47)

1.26 (9.56)

1.26 (1.11)

0.33 (-1.33)

Fall*

155

2.88 (2.46–3.38)

2.85 (187.49)

2.85 (2.5)

1.51 (-0.15)

Off Label Use

140

0.71 (0.61–0.84)

0.72 (15.7)

0.72 (0.63)

-0.48 (-2.14)

Anxiety*

127

2.78 (2.34–3.32)

2.76 (143.17)

2.76 (2.38)

1.46 (-0.2)

Feeling Abnormal*

122

3.21 (2.69–3.84)

3.19 (183.37)

3.18 (2.74)

1.67 (0)

Product Use In Unapproved Indication*

121

1.9 (1.59–2.28)

1.89 (51.12)

1.89 (1.63)

0.92 (-0.75)

Dizziness*

121

1.57 (1.31–1.88)

1.56 (24.69)

1.56 (1.34)

0.64 (-1.02)

Product Use Issue*

102

2.97 (2.44–3.61)

2.95 (131.65)

2.95 (2.5)

1.56 (-0.11)

Gait Disturbance*

99

3.16 (2.59–3.85)

3.14 (144.71)

3.14 (2.66)

1.65 (-0.02)

Diarrhoea

90

0.78 (0.63–0.96)

0.78 (5.66)

0.78 (0.66)

-0.36 (-2.02)

Nausea

90

0.71 (0.58–0.88)

0.72 (10.2)

0.72 (0.6)

-0.48 (-2.15)

Confusional State*

89

3.66 (2.97–4.51)

3.64 (170.36)

3.63 (3.05)

1.86 (0.2)

Hospitalisation*

82

2.67 (2.15–3.32)

2.66 (85.23)

2.66 (2.22)

1.41 (-0.25)

Headache

79

0.76 (0.61–0.95)

0.77 (5.67)

0.77 (0.64)

-0.38 (-2.05)

Restlessness*

77

14.08 (11.25–17.63)

13.99 (924.52)

13.92 (11.54)

3.8 (2.13)

Tardive Dyskinesia*

76

41.13 (32.77–51.63)

40.85 (2913.99)

40.3 (33.32)

5.33 (3.67)

Balance Disorder*

75

5.52 (4.4–6.93)

5.49 (275.38)

5.48 (4.53)

2.46 (0.79)

Agitation*

73

7.74 (6.15–9.75)

7.7 (424.52)

7.68 (6.33)

2.94 (1.27)

Speech Disorder*

72

9.11 (7.22–11.49)

9.06 (514.88)

9.03 (7.44)

3.18 (1.51)

Product Dose Omission Issue

72

1.07 (0.85–1.35)

1.07 (0.34)

1.07 (0.88)

0.1 (-1.57)

Wrong Technique In Product Usage Process*

70

1.4 (1.11–1.78)

1.4 (8.09)

1.4 (1.15)

0.49 (-1.18)

Parkinsonism*

68

47.18 (37.1–60)

46.88 (3005.86)

46.16 (37.75)

5.53 (3.86)