Table 2

Adverse events reported in RCTs

Adverse event

RCTs

References

n treatment having event

Total n in treatment

n control having event

Total n in control

OR

95% CI

P-value

I²

Headache

32

[27,33-35,41,43-45,48,50,51,55,57,58,61,64,68,71,74-76,85,90,94,95,103,115,117]

938

9227

664

5988

0.99

0.84-1.17

0.95

43%

Dizziness

24

[37-39,41,45-48,51,53,58,60,64,72,73,78,92,96,117,119]

414

4701

275

3518

1.05

0.86-1.29

0.59

18%

Heart palpitations and chest pains

12

[32,44,45,50,57,61,68,71,74,75,102,116]

189

6249

64

3985

2.06

1.51-2.82

<0.001

0%

Nausea or vomiting

31

[24,27,31,37-39,45-48,51,53,56,58,59,62,68,71,74-76,85,90,94,95,103,115]

747

7249

388

6061

1.67

1.37-2.04

<0.001

62%

Indigestion Gastrointestinal complaints

26

[27,28,32,35,37,42,43,45,51,58,63,68,70,71,80,84,85,90,94,95,105,116,117]

930

8575

489

5882

1.54

1.25-1.89

<0.001

35%

Skin irritation

32

[39-41,43,45,47,48,51,53-55,58,59,61,64,66,68-72,74-77,87,90,93,94,102,105,117]

1550

8646

511

5497

2.80

2.28-3.44

<0.001

0%

Arthralgia

5

[43,45,61,70,90]

50

756

34

686

1.51

0.87-2.63

0.13

0%

Hiccoughs

14

[27,32,34,35,37,38,63,80,83,84,94,95,117]

934

3858

573

3424

7.68

4.59-12.85

<0.001

0%

Mouth and throat soreness

23

[27,31-35,37,42,44,46,50,57,63,67,78,80,84,85,94-96,117]

935

3858

573

3424

1.87

1.36-2.57

<0.001

66%

Mouth ulcers

6

[27,33-35,63,84]

123

61

766

610

1.49

1.05-2.20

0.02

43%

Urticaria

3

[48,70,90]

80

801

66

595

1.13

0.77-1.65

0.52

0%

Coughing

12

[44,50,57,63,67,78,79,83,84,94,116]

583

3989

309

3893

2.89

1.92-4.33

<0.001

72%

Insomnia

19

[27,28,32,35,37,42,43,45,51,58,63,68,70,71,80,84,85,90,94,95,105,116,117]

636

5805

349

3504

1.42

1.21-1.66

<0.001

65%

Sweating

3

[44,50,57]

56

355

63

337

1.29

0.51-3.21

0.58

76%

Anxiety

6

[71,76,94,103,115]

25

367

21

362

1.24

0.73-2.10

0.42

0%

Depression

9

[43,45,58,64,71,94,102,103,115]

56

937

59

897

0.82

0.53-1.26

0.37

8%

Mortality

8

[73,82,85,93,97,105,113,115]

11

1387

16

1378

0.74

0.33-1.67

0.47

0%

Mills et al. Tobacco Induced Diseases 2010 8:8   doi:10.1186/1617-9625-8-8