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Table 1 Clinical characteristics of reports with deutetrabenazine from the FAERS database

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

Characteristics

Case number

Proportion (%)

Number of events

4337

 

Gender (%)

 Female

2622

60.5

 Male

1261

29.1

 Not specified

454

10.5

Weight (kg)

 < 50

14

0.3

 > 100

44

1.0

 50∼100

222

5.1

 Not specified

4057

93.5

Age(years)

 < 18

24

0.6

 18∼65

1245

28.7

 65∼85

963

22.2

 >85

41

0.9

 Not specified

2064

47.6

Reported Countries

 United States

4305

99.3

 Israel

9

0.2

 China

9

0.2

 Brazil

3

0.1

 Puerto Rico

3

0.1

 Others

8

0.1

Reporter

 Consumer

2329

53.7

 Health Professional

694

16.0

 Pharmacist

535

12.3

 Medical Doctor

391

9.0

 Other health-professional

186

4.3

 Not specified

202

4.7

Year of report

 2017

48

1.1

 2018

357

8.2

 2019

590

13.6

 2020

645

14.9

 2021

787

18.1

 2022

496

11.5

 2023

498

11.5

 2024

916

21.1

Outcomes

 Other serious outcome

853

19.7

 Hospitalization

473

10.9

 Death

271

6.2

 Disability

23

0.5

 Required Intervention to Prevent Permanent Impairment

7

0.2

 Life-Threatening

12

0.3

 Cancer

2

0.1

 Not specified

2696

62.1

Indications

 Tardive Dyskinesia

1749

40.3

 Huntington’s Disease

537

12.4

 Dyskinesia

406

9.4

 Chorea

49

1.1

 Not specified

1596

46.8