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Table 3 Summary of all reported adverse events in the included trials

From: Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis

Event

No. of trials reporting the event

SSRI

Placebo

Relative risk (95% CI)

Number needed to harm (NNH)

P value

Number of participants with the event

Number of participants randomised

Number of participants with the event

Number of participants randomised

Abnormal ejaculation

15

183

3236

7

1903

5.43 [3.22, 9.14]

19

P < 0.00001

Tremor

28

301

3502

61

2929

3.16 [2.37, 4.21]

16

P < 0.00001

Anorexia

19

220

2350

42

1680

2.78 [2.03, 3.79]

15

P < 0.00001

Nausea

78

2524

12,257

779

8491

2.48 [2.22, 2.77]

9

P < 0.00001

Somnolence

59

1336

10,351

345

6674

2.25 [2.00, 2.53]

13

P < 0.00001

Sweating

34

440

5274

124

3478

2.20 [1.80, 2.70]

21

P < 0.00001

Asthenia

23

497

3968

155

2265

1.71 [1.43, 2.04]

18

P < 0.00001

Diarrhoea

58

1458

11,056

561

7099

1.66 [1.51, 1.83]

19

P < 0.00001

Constipation

50

606

6698

273

4892

1.60 [1.35, 1.89]

29

P < 0.00001

Insomnia

69

1500

11,934

582

7956

1.49 [1.35, 1.64]

19

P < 0.00001

Dizziness

55

849

8900

398

6161

1.39 [1.24, 1.57]

33

P < 0.00001

Dry mouth

73

1376

11,303

693

7904

1.37 [1.25, 1.49]

30

P < 0.00001

Libido decreased

8

78

1481

11

1083

3.48 [1.92, 6.32]

24

P < 0.0001

Sexual dysfunction

6

96

719

16

389

2.85 [1.77, 4.59]

11

P = 0.0001

Appetite decreased

8

68

932

24

885

2.63 [1.66, 4.17]

22

P < 0.0001

Fatigue

26

409

5098

153

3545

1.69 [1.32, 2.17]

27

P < 0.0001

Vomiting or upset stomach

20

189

2376

101

2037

1.55 [1.16, 2.08]

34

P = 0.003

Flu syndrome

7

57

1069

19

822

2.13 [1.28, 3.54]

34

P = 0.004

Drowsiness

5

38

253

19

256

1.90 [1.18, 3.04]

14

P = 0.004

Blurred/abnormal vision or dry eyes

17

116

1862

55

1566

1.55 [1.15, 2.10]

37

P = 0.004

Nervousness

22

484

3863

147

2043

1.35 [1.10, 1.66]

19

P = 0.004

Back pain

11

85

2404

71

1594

0.66 [0.48, 0.91]

109

P = 0.01

Headache

72

2386

11,085

1427

7805

1.08 [1.01, 1.14]

31

P = 0.02

Dyspepsia

23

331

4304

159

2956

1.29 [1.04, 1.59]

44

P = 0.02

Weight loss

3

26

562

9

560

2.48 [1.17, 5.25]

34

P = 0.02

Hypertension

4

17

933

25

761

0.51 [0.28, 0.93]

69

P = 0.03

Central or peripheral nervous system

4

104

221

16

57

1.58 [1.03, 2.43]

6

P = 0.04

Lightedness/faint feeling

3

9

147

1

144

4.81 [1.06, 21.72]

19

P = 0.04

Accidental injury

3

15

672

23

516

0.50 [0.25, 0.99]

45

P = 0.05

Agitation

5

67

613

22

398

1.60 [1.01, 2.54]

19

P = 0.05

Impotence

3

19

868

1

603

3.12 [0.99, 9.88]

50

P = 0.05

Taste perversion

2

9

389

1

390

5.80 [1.02, 33.03]

49

P = 0.05

Shaking

2

7

121

0

116

7.19 [0.91, 57.03]

18

P = 0.06

Rhinitis

14

197

3004

171

1969

0.78 [0.63, 0.97]

47

P = 0.06

Palpitations

10

63

1572

30

1292

1.55 [0.97, 2.50]

60

P = 0.07

Infection

7

104

997

57

612

1.31 [0.97, 1.75]

90

P = 0.08

Amnesia

2

5

484

12

486

0.44 [0.16, 1.20]

70

P = 0.11

Psychiatric adverse effects

1

19

40

7

26

1.76 [0.87, 3.60]

5

P = 0.12

Sleep distrurbance

3

15

240

7

223

1.98 [0.83, 4.73]

33

P = 0.13

Sinusitis

4

35

751

38

629

0.69 [0.43, 1.11]

73

P = 0.13

Urinary frequency

4

40

695

19

624

1.80 [0.82, 3.96]

37

P = 0.13

Anxiety

17

150

2983

89

2250

1.27 [0.91, 1.77]

94

P = 0.15

Appetie increased

3

5

335

10

330

0.49 [0.17, 1.43]

65

P = 0.19

Coughing

1

8

100

4

96

1.92 [0.60, 6.17]

27

P = 0.27

Tinnitus

2

4

319

1

319

2.84 [0.44, 18.44]

107

P = 0.27

Adverse events overall

4

32

232

14

160

1.36 [0.77, 2.39]

20

P = 0.29

Unpleasant taste

1

2

21

0

20

4.77 [0.24, 93.67]

11

P = 0.30

Congestive heart failure

1

0

335

2

336

0.20 [0.01, 4.16]

168

P = 0.30

Gastrointestial

4

66

194

14

91

1.53 [0.65, 3.62]

6

P = 0.33

Autonomic nervous system

1

10

40

4

26

1.63 [0.57, 4.64]

11

P = 0.36

Respiratory disorder

10

244

2764

107

1276

0.90 [0.73, 1.12]

227

P = 0.36

Vasodialtion

4

11

368

4

355

1.75 [0.44, 6.94]

54

P = 0.43

Flatulence

6

94

1763

34

972

1.24 [0.72, 2.16]

55

P = 0.44

Malaise

1

0

21

1

20

0.32 [0.01, 7.38]

20

P = 0.48

Depression aggrevated

1

6

337

1

180

1.95 [0.31, 12.35]

82

P = 0.48

Female genital disorders

1

7

310

1

149

1.93 [0.31, 12.10]

63

P = 0.48

Weight gain

1

3

129

5

129

0.60 [0.15, 2.46]

65

P = 0.48

Tachycardia

6

9

989

6

996

1.43 [0.52, 3.96]

326

P = 0.49

Arrhythmia

1

0

335

1

336

0.33 [0.01, 8.18]

336

P = 0.50

Atrial fibrillation

1

1

335

0

336

3.01 [0.12, 73.60]

335

P = 0.50

Abnormal electrocardiogram

1

1

335

0

336

3.01 [0.12, 73.60]

335

P = 0.50

Migraine

1

1

129

0

129

3.00 [0.12, 72.96]

129

P = 0.50

Chest discomfort

1

1

21

0

20

2.86 [0.12, 66.44]

21

P = 0.51

Rash

5

9

280

12

282

0.79 [0.37, 1.70]

97

P = 0.55

Vertigo

1

10

337

3

180

1.58 [0.32, 7.68]

77

P = 0.57

Dysuria

1

2

21

1

20

1.90 [0.19, 19.40]

23

P = 0.58

Pruritus (Itching)

3

8

187

10

185

0.79 [0.30, 2.10]

89

P = 0.63

Orthostatic hypotension

2

6

466

3

309

1.37 [0.37, 5.02]

316

P = 0.64

Upper respiratory tract infection

14

164

2380

123

1882

0.95 [0.75, 1.20]

282

P = 0.68

Body as a whole

1

6

40

3

26

1.30 [0.36, 4.75]

29

P = 0.69

Loose stools

1

3

100

2

96

1.44 [0.25, 8.43]

110

P = 0.69

Gastritis

1

3

62

5

138

1.34 [0.33, 5.41]

83

P = 0.69

Cardiovascular disorder

2

10

444

3

355

0.81 [0.22, 2.95]

72

P = 0.75

Pain

5

65

893

59

729

0.95 [0.68, 1.34]

123

P = 0.77

Abnormal thinking

1

7

335

8

336

0.88 [0.32, 2.39]

344

P = 0.80

Abnormal acne

1

3

32

1

14

1.31 [0.15, 11.54]

45

P = 0.81

Confusion

4

5

640

5

621

0.87 [0.28, 2.74]

4187

P = 0.81

Myalgia

5

34

692

26

572

0.93 [0.45, 1.94]

272

P = 0.85

Irritability

6

18

643

20

642

0.92 [0.38, 2.27]

317

P = 0.86

Numbness

2

12

272

8

269

0.77 [0.04, 13.27]

70

P = 0.86

Abdominal pain

9

98

1967

52

1150

1.02 [0.73, 1.44]

218

P = 0.89

Trauma

2

47

883

14

267

0.95 [0.41, 2.20]

1261

P = 0.90

Eructation (burping)

1

5

100

5

96

0.96 [0.29, 3.21]

480

P = 0.95

Over sedation

3

24

677

7

514

1.91 [0.83, 4.39]

46

P =0.13