Table 1 Basic information on ADEs related to asenapine from the FAERS database

Sex

 Female

3484 (51.98)

 Male

1863 (27.79)

 Unknown

1356 (20.23)

Age

 <18

135 (2.01)

 18 ~ 45

1574 (23.48)

 45 ~ 65

1052 (15.69)

 65 ~ 75

144 (2.15)

 >=75

74 (1.10)

 Unknown

3724 (55.56)

Reporter

 Physician

2914 (43.47)

 Consumer

2297 (34.27)

 Other health-professional

1040 (15.52)

 Pharmacist

316 (4.71)

 Unknown

131 (1.95)

 Lawyer

3 (0.04)

 Registered Nurse

2 (0.03)

Reported countries

 Other

3630 (54.15)

 United States

2498 (37.27)

 Japan

402 (6.00)

 Canada

100 (1.49)

 Australia

73 (1.09)

Route

 Sublingual

3658 (54.57)

 Other

2247 (33.52)

 Oral

798 (11.91)

Outcomes

 Other serious

1495 (48.81)

 Hospitalization

903 (29.48)

 Death

244 (7.97)

 Life threatening

221 (7.22)

 Disability

175 (5.71)

 Required intervention to Prevent Permanent Impairment/Damage

22 (0.72)

 Congenital anomaly

3 (0.10)

Adverse event occurrence time - medication date (days)

 <7

855 (31.51)

 7 ~ 27

181 (6.67)

 28 ~ 59

106 (3.91)

 >=60

181 (6.67)

 Unknown

1390 (51.23)

Indications

 Affective disorder

43 (0.63)

 Anxiety

45 (0.65)

 Bipolar disorder

1711 (24.89)

 Bipolar I disorder

389 (5.66)

 Bipolar II disorder

33 (0.48)

 Delirium

13 (0.19)

 Delusion

10 (0.15)

 Depression

129 (1.88)

 Drug use for unknown indication

681 (9.91)

 Hallucination

512 (0.17)

 Insomnia

34 (0.49)

 Major depression

37 (0.54)

 Mania

80 (1.16)

 Mental disorder

18 (0.26)

 Mood altered

10 (0.15)

 Obsessive-compulsive disorder

11 (0.16)

 Others

206 (3.00)

 Paranoia

15 (0.22)

 Post-traumatic stress disorder

20 (0.29)

 Product used for unknown indication

1246 (18.13)

 Psychotic disorder

108 (1.57)

 Schizoaffective disorder

135 (1.96)

 Schizoaffective disorder bipolar type

11 (0.16)

 Schizophrenia

802 (11.67)

 Schizophrenia, paranoid type

13 (0.19)

 Sleep disorder

15 (0.22)

 Unknown

1046 (15.22)