Table 1 AE signals of rebamipide (analysis of drug–AE pairs classified as certain, probable, or possible).

From: Frequently reported adverse events of rebamipide compared to other drugs for peptic ulcer and gastroesophageal reflux disease

AEs

Cases (rebamipide)

PRR

ROR

IC 95% CI

Label

Somnolence

1194

2.66

2.86

0.94

Yes

Dyspepsia/indigestion/GI distress

1115

2.13

2.26

0.73

Yes

Dry mouth

482

4.34

4.50

1.29

No

Face edema

247

2.78

2.82

0.86

Yes†

Generalized edema

166

3.44

3.48

1.00

Yes†

Malaise/feeling queasy

116

2.18

2.19

0.53

Yes

Peripheral edema

62

2.28

2.29

0.46

Yes†

Periorbital edema

54

2.07

2.08

0.33

Yes†

Thirst

43

5.16

5.18

1.02

Yes

Dermatitis

37

2.01

2.01

0.20

No

Purpura/petechia

31

2.14

2.15

0.21

No

  1. AE adverse event, CI confidence interval, GI gastrointestinal, IC information component, PRR proportional reporting ratio, ROR reporting odds ratio.
  2. †Labels including edema.
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