Skip to main content

Table 4 Top 20 signals on the PT level

From: Comparison of serious adverse effects of methylphenidate, atomoxetine and amphetamine in the treatment of ADHD: an adverse event analysis based on the FAERS database

PT

SOC

N

ROR(95% CI)

PRR(c2)

Methylphenidate

    

Application site erythema

General disorders and administration site conditions

1625

35.87(34.09, 37.74)

35.29(50495.59)

Decreased appetite

Metabolism and nutrition disorders

1403

3.72(3.53, 3.93)

3.68(2734.41)

Aggression

Psychiatric disorders

1284

14.79(13.98, 15.64)

14.61(15812.71)

Abnormal behaviour

Psychiatric disorders

1252

17.59(16.62, 18.62)

17.38(18675.74)

Agitation

Psychiatric disorders

1052

8.14(7.66, 8.65)

8.06(6410.23)

Psychomotor hyperactivity

Nervous system disorders

890

31.39(29.33, 33.61)

31.12(24386.89)

Irritability

Psychiatric disorders

850

8.04(7.51, 8.61)

7.98(5109.68)

Application site pruritus

General disorders and administration site conditions

786

19.84(18.47, 21.32)

19.69(13408.18)

Suicidal ideation

Psychiatric disorders

751

4.78(4.44, 5.13)

4.75(2203.39)

Application site irritation

General disorders and administration site conditions

622

29.57(27.27, 32.07)

29.39(16087.06)

Tachycardia

Cardiac disorders

592

3.92(3.61, 4.25)

3.9(1268.39)

Anger

Psychiatric disorders

566

9.39(8.64, 10.21)

9.35(4141.04)

Tic

Psychiatric disorders

544

62.75(57.38, 68.63)

62.41(29125.73)

Disturbance in social behaviour*

Psychiatric disorders

523

151.61(137.41, 167.28)

150.81(59364.37)

Drug abuse

Psychiatric disorders

455

3.15(2.88, 3.46)

3.14(661.84)

Crying

General disorders and administration site conditions

448

6.83(6.22, 7.5)

6.8(2188.35)

Application site pain

General disorders and administration site conditions

441

11.31(10.29, 12.43)

11.26(4030.68)

Hallucination

Psychiatric disorders

428

3.46(3.15, 3.81)

3.45(740.33)

Suicide attempt

Psychiatric disorders

394

3.78(3.42, 4.17)

3.77(796.2)

Psychotic disorder

Psychiatric disorders

339

6.65(5.98, 7.41)

6.64(1601.36)

Atomoxetine

    

Somnolence

Nervous system disorders

1130

6.23(5.87, 6.61)

6.12(4823.54)

Feeling abnormal

General disorders and administration site conditions

1039

4.56(4.29, 4.85)

4.49(2815.5)

Suicidal ideation

Psychiatric disorders

900

10.8(10.11, 11.55)

10.64(7779.42)

Abnormal behaviour

Psychiatric disorders

890

23.2(21.69, 24.81)

22.82(18127.52)

Insomnia

Psychiatric disorders

874

3.54(3.31, 3.79)

3.5(1561.34)

Aggression

Psychiatric disorders

863

18.43(17.22, 19.72)

18.14(13714.84)

Anger

Psychiatric disorders

510

15.83(14.5, 17.28)

15.68(6896.61)

Decreased appetite

Metabolism and nutrition disorders

664

3.27(3.03, 3.53)

3.241029.45)

Irritability

Psychiatric disorders

571

10.05(9.25, 10.91)

9.95(4550.63)

Abdominal pain upper

Gastrointestinal disorders

565

3.07(2.82, 3.33)

3.05(776.62)

Anger

Psychiatric disorders

510

15.83(14.5, 17.28)

15.68(6896.61)

Psychomotor hyperactivity

Nervous system disorders

500

32.03(29.28, 35.03)

31.73(14381.9)

Mood swings

Psychiatric disorders

491

16.29(14.9, 17.82)

16.15(6859.6)

Agitation

Psychiatric disorders

487

6.96(6.36, 7.61)

6.9(2443.11)

Crying

General disorders and administration site conditions

479

13.7(12.51, 15)

13.59(5506.4)

Heart rate increased

Investigations

412

4.57(4.14, 5.03)

4.54(1133.05)

Hyperhidrosis

Skin and subcutaneous tissue disorders

373

3.07(2.77, 3.4)

3.05(514.84)

Tic

Psychiatric disorders

354

73.01(65.5, 81.39)

72.53(23120.59)

Retching

Gastrointestinal disorders

329

17.54(15.72, 19.56)

17.43(5001.47)

Dry mouth

Gastrointestinal disorders

327

4.53(4.06, 5.05)

4.51(889.68)

Amphetamine

    

Headache

Nervous system disorders

2127

3.65(3.5, 3.81)

3.55(3919.96)

Feeling abnormal

General disorders and administration site conditions

1375

5.87(5.56, 6.19)

5.74(5374.13)

Anxiety

Psychiatric disorders

1167

4.26(4.02, 4.51)

4.19(2834.53)

Somnolence

Nervous system disorders

1090

5.79(5.45, 6.15)

5.7(4207.24)

Drug abuse

Psychiatric disorders

819

10.39(9.69, 11.13)

10.25(6764.25)

Irritability

Psychiatric disorders

776

13.28(12.36, 14.26)

13.1(8554.81)

Palpitations

Cardiac disorders

447

4.02(3.66, 4.41)

3.99(999.51)

Migraine

Nervous system disorders

419

4.88(4.43, 5.37)

4.85(1273.82)

Agitation

Psychiatric disorders

389

5.35(4.84, 5.91)

5.31(1356.03)

lethargy

Nervous system disorders

386

6.95(6.28, 7.68)

6.91(1936.68)

Heart rate increased

Investigations

366

3.91(3.53, 4.33)

3.89(783.59)

Anger

Psychiatric disorders

347

10.3(9.27, 11.46)

10.24(2862.8)

Completed suicide

Psychiatric disorders

311

3.72(3.33, 4.17)

3.71(613.83)

Aggression

Psychiatric disorders

289

5.81(5.18, 6.53)

5.79(1137.77)

Dry mouth

Gastrointestinal disorders

277

3.7(3.28, 4.16)

3.68(540.06)

Feeling jittery

General disorders and administration site conditions

265

14.13(12.51, 15.96)

14.07(3166.26)

Abnormal behaviour

Psychiatric disorders

237

5.78(5.09, 6.57)

5.76(926.74)

Therapeutic product effect decreased

General disorders and administration site conditions

223

6.1(5.34, 6.96)

6.07(939.41)

Mood swings

Psychiatric disorders

214

6.75(5.9, 7.72)

6.73(1035.89)

  1. Note foot N, number of adverse event reported
  2. *: the instruction does not mention