Table 1 Cases characteristics of 5-HT3RAs associated with cardiotoxic adverse events in the FAERS database, January 2004–March 2023.

Reports number

1135

24

15

1174

Sex

Female

582 (51.3)

14 (58.3)

8 (40.0)

604 (51.4)

Male

458 (40.4)

4 (16.7)

5 (25.0)

467 (39.8)

Unknown

95 (8.4)

6 (25.0)

2 (10.0)

103 (8.8)

Age category, years

Median (IQR)

49 (33,60)

50 (22,68)

58 (42,65)

49 (32.25,60)

< 18

103 (9.1)

0 (0.0)

1 (6.7)

104 (8.9)

18–44

209 (18.4)

4 (16.7)

2 (13.3)

215 (18.3)

45–64

290 (25.6)

2 (8.3)

3 (20.0)

295 (25.1)

65–74

75 (6.6)

4 (16.7)

1 (6.7)

80 (6.8)

≥ 75

46 (4.1)

0 (0.0)

2 (13.3)

48 (4.1)

Unknown

412 (36.3)

14 (58.3)

6 (40.0)

432 (36.8)

Reporter country

The USA

703 (61.9)

7 (29.2)

1 (6.7)

711 (60.6)

United Kingdom

194 (17.1)

2 (8.3)

1 (6.7)

197 (16.8)

Canada

43 (3.8)

0 (0.0)

0 (0.0)

43 (3.7)

France

39 (3.4)

1 (4.2)

0 (0.0)

40 (3.4)

Other country

125 (11.0)

11 (45.8)

13 (86.7)

149 (12.7)

Unknown

31 (2.7)

3 (12.5)

0 (0.0)

34 (2.9)

Reporter^a

Healthcare professional

904 (79.6)

4 (16.7)

15 (100.0)

923 (78.6)

Non-healthcare professional

186 (16.4)

19 (79.2)

0 (0.0)

205 (17.5)

Unknown

45 (4.0)

1 (4.2)

0 (0.0)

46 (3.9)

Report year

2004–2010

72 (6.3)

9 (37.5)

2 (13.3)

83 (7.1)

2011–2015

156 (13.7)

3 (12.5)

6 (40.0)

165 (14.1)

2016–2020

694 (61.1)

6 (25.0)

3 (20.0)

703 (59.9)

2021–2023

213 (18.8)

6 (25.0)

4 (26.7)

223 (19.0)

Outcomes^b

Death

186 (16.4)

9 (37.5)

1 (6.7)

196 (16.7)

Life-threatening

356 (31.4)

13 (54.2)

4 (26.7)

373 (31.8)

Hospitalization

566 (49.9)

6 (25.0)

4 (26.7)

576 (49.1)

Disability

21 (1.9)

0 (0.0)

0 (0.0)

21 (1.8)

Other serious condition

1015 (89.4)

9 (37.5)

11 (73.3)

1035 (88.2)