Table 2 ADE reports and clinical information

Gender

 Female

10,314(27.53)

5679(32.76)

7944(45.42)

 Male

19,125(51.04)

10,796(62.28)

5958(34.06)

 Unknown

8032(21.44)

860(4.96)

3590(20.52)

Age(years)

 0–5

1073(2.86)

409(2.36)

129(0.74)

 6–12

9049(24.15)

5510(31.79)

496(2.84)

 13–18

3835(10.23)

2760(15.92)

471(2.69)

 ≥19

5721(15.27)

4395(25.35)

7613(43.52)

 Unknow

17,793(47.48)

4261(24.58)

8783(50.21)

Year

 2004(Q1-Q3)

340(0.91)

4995(28.81)

159(0.91)

 2005

464(1.24)

3414(19.69)

143(0.82)

 2006

650(1.73)

459(2.65)

97(0.55)

 2007

786(2.10)

386(2.23)

269(1.54)

 2008

824(2.20)

320(1.85)

113(0.65)

 2009

797(2.13)

421(2.43)

184(1.05)

 2010

801(2.14)

229(1.32)

128(0.73)

 2011

2334(6.23)

265(1.53)

114(0.65)

 2012

2570(6.86)

289(1.67)

195(1.11)

 2013

2891(7.72)

274(1.58)

374(2.14)

 2014

2720(7.26)

346(2.00)

490(2.80)

 2015

3486(9.30)

4117(23.75)

996(5.69)

 2016

2376(6.34)

373(2.15)

1186(6.78)

 2017

4365(11.65)

260(1.50)

1582(9.04)

 2018

2996(8.00)

217(1.25)

2066(11.81)

 2019

2063(5.51)

223(1.29)

1630(9.32)

 2020

1612(4.30)

183(1.06)

1715(9.80)

 2021

1511(4.03)

177(1.02)

1816(10.38)

 2022

1792(4.78)

198(1.14)

2482(14.19)

 2023

2093(5.59)

189(1.09)

1753(10.02)

Reporter

 Consumer

21,533(57.47)

6832(39.41)

11,010(62.94)

 Physician

6744(18.00)

4409(25.43)

2414(13.80)

 Other health-professional

3696(9.86)

1014(5.85)

961(5.49)

 Pharmacist

3587(9.57)

604(3.48)

1933(11.05)

 Unknown

1787(4.77)

4465(25.76)

1139(6.51)

 Lawyer

89(0.24)

10(0.06)

17(0.10)

 Registered Nurse

35(0.09)

1(0.01)

18(0.10)

Reported countries

 United States

21,563(57.55)

5440(31.38)

15,452(88.34)

 Sweden

368(0.98)

70(0.40)

 Turkey

291(0.78)

 Switzerland

151(0.40)

 Spain

139(0.37)

 Denmark

123(0.33)

 Australia

121(0.32)

 Norway

99(0.26)

 South Africa

96(0.26)

 Israel

72(0.19)

 Italy

51(0.14)

 Other

10,510(28.05)

11,139(64.26)

1853(10.59)

 Japan

714(1.91)

167(0.96)

 France

612(1.63)

 Brazil

568(1.52)

 Canada

565(1.51)

139(0.80)

125(0.71)

 Netherlands

529(1.41)

 Germany

459(1.22)

134(0.77)

62(0.35)

 United Kingdom

440(1.17)

246(1.42)

Outcomes

 Other serious

11,458(65.79)

3978(64.92)

4264(53.59)

 Hospitalization

3689(21.18)

1401(22.86)

1192(14.98)

 Death

767(4.40)

198(3.23)

1475(18.54)

 Life threatening

686(3.94)

318(5.19)

264(3.32)

 Disability

595(3.42)

154( 2.51)

619(7.78)

 Required intervention to Prevent Permanent Impairment/Damage

135(0.78)

59(0.96)

122(1.53)

 Congenital anomaly

87(0.50)

20(0.33)

21(0.26)

Route

 Oral

13,164(35.13)

2957(17.06)

7133(40.77)

 Respiratory (inhalation)

10(0.03)

33(0.19)

 Transdermal

12,831(34.24)

 Other

10,913(29.12)

14,355(82.81)

10,233(58.49)

 Intravenous

210(0.56)

28(0.16)

  Oropharingeal

130(0.35)

  Transplacental

128(0.34)

23(0.13)

39(0.22)

  Parenteral

19(0.11)

  Nasal

40(0.11)

11(0.06)

  Nopical

32(0.09)

  Intra-arterial

15(0.04)

Indications

 Attention deficit/hyperactivity disorder (ADHD)

20,927(55.43)

11,460(65.36)

7,567(42.54)

 Narcolepsy/hypersomnia/somnolence

434(1.16)

-

517(2.91)

 Depression

222(0.59)

109(0.62)

154(0.86)

 Autism spectrum disorder

217(0.58)

85(0.35)

-

 Fatigue

78(0.21)

-

91(0.51)