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Table 6 Top 30 most frequent adverse events for deutetrabenazine excluding common medication co-usage at the PT level from FAERS data

From: Real-world safety analysis of deutetrabenazine post-marketing: a disproportionality study leveraging the FDA Adverse Event Reporting System (FAERS) database

Preferred terms (PTs)

Case reports

ROR (95% CI)

PRR (95% CI)

EBGM

(EBGM05)

IC (IC025)

Drug Ineffective*

573

2.81 (2.58–3.06)

2.7 (625.68)

2.69 (2.51)

1.43 (-0.24)

Dyskinesia*

240

48.94 (43.01–55.68)

47.67 (10820.89)

47.03 (42.21)

5.56 (3.89)

Death*

229

1.77 (1.56–2.02)

1.75 (75.24)

1.75 (1.57)

0.81 (-0.86)

Depression*

223

8.3 (7.27–9.49)

8.12 (1394.17)

8.11 (7.25)

3.02 (1.35)

Tremor*

178

8.66 (7.46–10.04)

8.51 (1178.69)

8.49 (7.49)

3.09 (1.42)

Somnolence*

174

6.45 (5.55–7.5)

6.35 (785.14)

6.34 (5.59)

2.66 (1)

Suicidal Ideation*

169

15.9 (13.65–18.52)

15.62 (2304.7)

15.55 (13.69)

3.96 (2.29)

Insomnia*

147

4.35 (3.7–5.12)

4.3 (372.86)

4.29 (3.75)

2.1 (0.44)

Fatigue

141

1.19 (1–1.4)

1.18 (4.08)

1.18 (1.03)

0.24 (-1.42)

Fall*

134

2.92 (2.46–3.47)

2.89 (166.8)

2.89 (2.51)

1.53 (-0.13)

Off Label Use

127

0.76 (0.64–0.91)

0.76 (9.37)

0.76 (0.66)

-0.39 (-2.05)

Anxiety*

107

2.75 (2.27–3.33)

2.73 (117.58)

2.73 (2.32)

1.45 (-0.22)

Feeling Abnormal*

107

3.3 (2.73–4)

3.28 (169.68)

3.27 (2.79)

1.71 (0.04)

Product Use In Unapproved Indication*

105

1.94 (1.6–2.35)

1.93 (46.94)

1.92 (1.64)

0.94 (-0.72)

Dizziness*

103

1.57 (1.29–1.9)

1.56 (20.86)

1.56 (1.33)

0.64 (-1.02)

Product Use Issue*

94

3.21 (2.62–3.93)

3.19 (141.41)

3.19 (2.69)

1.67 (0.01)

Gait Disturbance*

85

3.18 (2.57–3.94)

3.16 (125.93)

3.16 (2.64)

1.66 (-0.01)

Diarrhoea

75

0.76 (0.61–0.95)

0.76 (5.63)

0.76 (0.63)

-0.39 (-2.06)

Hospitalisation*

75

2.87 (2.29–3.6)

2.86 (90.6)

2.85 (2.36)

1.51 (-0.15)

Nausea

74

0.69 (0.55–0.87)

0.69 (10.33)

0.69 (0.57)

-0.53 (-2.2)

Confusional State*

69

3.32 (2.62–4.21)

3.31 (111.17)

3.3 (2.71)

1.72 (0.06)

Headache

68

0.77 (0.61–0.98)

0.77 (4.53)

0.77 (0.63)

-0.37 (-2.04)

Tardive Dyskinesia*

65

41.18 (32.22–52.64)

40.89 (2500.29)

40.42 (32.92)

5.34 (3.67)

Wrong Technique In Product Usage Process*

64

1.51 (1.18–1.93)

1.5 (10.83)

1.5 (1.22)

0.59 (-1.08)

Restlessness*

62

13.28 (10.34–17.06)

13.2 (696.6)

13.15 (10.67)

3.72 (2.05)

Parkinsonism*

62

50.41 (39.2–64.83)

50.07 (2939.11)

49.36 (39.99)

5.63 (3.96)

Therapeutic Product Effect Incomplete*

62

3.6 (2.8–4.62)

3.58 (115.55)

3.58 (2.9)

1.84 (0.17)

Speech Disorder*

60

8.9 (6.9–11.48)

8.85 (416.94)

8.83 (7.14)

3.14 (1.48)

Product Dose Omission Issue

59

1.03 (0.8–1.33)

1.03 (0.05)

1.03 (0.83)

0.04 (-1.63)

Balance Disorder*

58

5.01 (3.87–6.48)

4.98 (184.42)

4.97 (4.01)

2.31 (0.65)

  1. Asterisks (*) indicate statistically significant signals. Abbreviations: ROR, reporting odds ratio; PRR, proportional reporting ratio; EBGM, empirical Bayesian geometric mean; EBGM05, the lower limit of the 95% confidence interval of EBGM; IC, information component; IC025, the lower limit of the 95% confidence interval of the IC