Table 2 Signal detection between any proton pump inhibitor (PPI) and reported fracture adverse events as classified by MedDRA’s 8 High Level Terms (HLT) and corresponding 61 Preferred Terms (PT), by overall and age groups.

From: Proton Pump Inhibitors and the Risk for Fracture at Specific Sites: Data Mining of the FDA Adverse Event Reporting System

Fracture Site

Proportional Rate Ratio (PRR) by Age Groups (years)

Overall

≤49

50–69

≥70

N

PRR(χ2)

N

PRR(χ2)

N

PRR(χ2)

N

PRR(χ2)

Skull and face fractures

113

1.7(29.5)

22

1.2(0.6)

35

1.9(12.1)

39

2.3(25.5)

 Skull fractured base

8

2.8(7.9)

2

2.1(1.0)

3

5.1(7.1)

3

3.7(4.6)

 Skull fracture

24

1.2(0.7)

8

1.2(0.2)

5

0.9(<0.1)

7

1.5(1.1)

 Facial bones fracture

81

1.8(25.7)

12

1.0(<0.1)

27

2.0(12.2)

29

2.5(22.5)

 Fractured skull depressed

0

—

0

—

0

—

0

—

Thoracic cage fractures non-spinal (excl pathological)

437

2.5(323.5)

52

1.6(11.8)

165

2.6(139.0)

137

2.9(143.0)

 Sternal fracture

22

1.9(9.5)

6

2.8(5.7)

11

3.1(12.7)

3

1.0(<0.1)

 Rib fracture

423

2.5(325.4)

47

1.6(8.9)

160

2.6(136.9)

135

3.0(151.3)

 Flail chest

2

2.5(1.5)

0

—

1

13.5(5.8)

1

2.3(0.6)

Spinal fractures (excl pathological)

517

2.2(290.7)

52

1.6 (9.3)

181

2.6(155.4)

188

2.4(136.5)

 Spinal fracture

323

2.3(209.9)

30

1.6(5.4)

108

2.9(112.0)

117

2.5(91.4)

 Cervical vertebral fracture

50

1.8(16.3)

7

1.3(0.5)

14

1.9(5.3)

17

2.5(12.6)

 Thoracic vertebral fracture

58

2.6(47.7)

4

1.1(0.1)

26

3.2(31.7)

21

2.9(21.0)

 Lumbar vertebral fracture

68

1.9(27.3)

7

1.7(1.9)

29

2.6(23.5)

24

1.9(8.7)

 Fractured sacrum

43

3.6(64.0)

5

3.1(5.7)

15

3.4(20.1)

18

5.0(41.6)

 Fractured coccyx

13

1.2(0.6)

3

1.2(0.1)

4

1.1(<0.1)

3

1.1(<0.1)

Pelvic fractures

200

2.1(98.4)

11

1.0(<0.1)

54

2.2(30.3)

90

2.3(55.1)

 Pelvic fracture

160

1.9(62.6)

10

1.2(0.2)

40

2.0(18.0)

70

1.9(29.0)

 Ilium fracture

4

1.4(0.3)

0

—

2

1.8(0.6)

1

1.4(0.1)

 Pubis fracture

26

3.8(41.5)

0

—

11

4.4(21.6)

13

4.2(24.0)

 Acetabulum fracture

14

3.6(21.1)

1

0.9(0.01)

4

2.8(3.9)

7

7.9(26.6)

 Fractured ischium

2

1.0(<0.1)

0

—

1

1.2(<0.1)

1

1.5(0.2)

Upper limb fractures

768

1.8(249.3)

87

1.2(3.4)

287

1.9(123.5)

270

2.4(179.5)

 Upper Limb fracture

282

1.7(69.6)

22

0.9(0.3)

106

1.8(34.2)

108

2.5(81.9)

 Clavicle fracture

57

1.7(15.1)

11

1.3(0.9)

20

1.9(8.2)

15

2.1(7.8)

 Scapula fracture

14

2.7 (12.5)

3

2.5(2.3)

8

5.4(20.5)

2

1.6(0.4)

 Humerus fracture

114

2.2(61.4)

10

1.3(0.6)

44

2.5(32.7)

41

2.3(25.7)

 Forearm fracture

10

1.8(3.3)

2

2.1(1.0)

6

4.3(11.4)

2

1.1(<0.1)

 Radius fracture

65

2.6(51.6)

10

1.9(3.9)

23

2.4(15.8)

26

3.6(38.3)

 Ulna fracture

30

3.0(32.3)

5

2.3(3.2)

17

5.3(43.0)

4

1.3(0.3)

 Wrist fracture

205

1.9(78.7)

21

1.5(3.2)

75

1.9(28.4)

82

2.6(66.4)

 Hand fracture

100

1.9(38.9)

24

1.8(7.3)

34

1.9(11.7)

20

2.3(12.9)

 Scapulothoracic dissociation

0

—

0

—

0

—

0

—

Lower limb fractures

1714

1.5(270.0)

161

1.1(1.6)

662

1.7(177.0)

609

1.9(237.7)

 Lower limb fracture

202

1.4(24.0)

25

0.9(0.1)

94

1.8(30.7)

41

1.6(7.8)

 Hip fracture

497

1.7(136.7)

23

1.4(2.4)

121

1.6(24.4)

264

2.3(159.9)

 Femoral neck fracture

81

1.5(12.5)

4

1.0(0.0)

25

2.1(13.1)

43

1.5(5.8)

 Femur fracture

454

1.3(24.8)

32

1.4(2.9)

203

1.6(40.2)

177

1.7(44.1)

 Patella fracture

35

1.7(8.2)

3

0.9(0.1)

17

2.1(8.3)

10

1.9(3.4)

 Tibia fracture

92

1.9(37.8)

9

0.8(0.6)

42

2.1(21.8)

29

3.6(42.3)

 Fibula fracture

71

2.2(39.7)

11

1.4(0.9)

34

2.4(23.1)

14

2.5(10.8)

 Ankle fracture

223

1.5(31.1)

22

0.6(4.7)

103

1.6(23.3)

42

1.8(12.4)

 Foot fracture

291

1.8(97.1)

56

1.5(8.4)

149

2.2(79.3)

39

1.9(15.8)

Fractures NEC (excl pathological)

638

1.9(277.9)

80

1.7(18.8)

269

2.6(225.7)

185

2.3(115.8)

 Periprosthetic fracture

4

4.9(9.1)

0

—

2

3.9(3.3)

2

13.5(11.6)

 Fracture displacement

18

4.2(33.4)

1

2.7(0.9)

8

3.6(11.9)

8

5.4(20.5)

 Compression fracture

169

3.7(256.9)

17

4.2(31.4)

73

5.4(185.3)

53

2.9(54.3)

 Bone fragmentation

28

3.6(41.5)

2

1.7(0.5)

18

5.5(47.3)

4

1.9(1.4)

 Avulsion fracture

5

2.7(4.5)

1

1.4(0.1)

2

3.9(3.3)

2

4.5(4.1)

 Jaw fracture

77

2.5(61.0)

12

1.7(3.2)

37

2.9(38.5)

17

3.1(20.2)

 Bone fissure

6

1.3(0.3)

1

2.3(0.6)

1

0.4(0.7)

3

2.5(2.3)

 Complicated fracture

3

3.5(0.1)

0

—

2

13.5(11.6)

1

3.4(1.3)

 Epiphyseal fracture

1

3.4(1.3)

1

3.4(1.3)

0

—

0

—

 Fracture

168

1.3(13.9)

12

1.0(0.0)

64

2.3(38.1)

51

1.6(11.4)

 Impacted fracture

1

2.7(0.9)

0

—

0

—

0

—

 Multiple fractures

59

1.7(15.0)

8

1.0(0.0)

23

2.2(13.0)

18

2.5(14.1)

 Open fracture

13

1.9(5.1)

3

1.6(0.5)

3

1.3(0.2)

3

2.5(2.3)

 Stress fracture

116

1.9(40.8)

17

3.1(19.7)

55

2.0(24.0)

30

2.5(23.7)

 Torus fracture

1

3.4(1.3)

1

4.5(2.0)

0

—

0

—

 Traumatic fracture

11

1.5(1.9)

0

—

4

1.5(0.6)

4

2.2(2.2)

 Greenstick fracture

0

—

0

—

0

—

0

—

Pathological fractures and complications

277

2.6(223.3)

32

1.8(10.3)

119

2.7(103.8)

94

3.6(137.4)

 Pathological fracture

188

3.1(218.6)

20

2.5(14.9)

78

3.2(93.5)

72

4.3(137.6)

 Pseudarthrosis

8

2.3(5.3)

3

4.1(5.3)

4

3.2(4.8)

1

1.1(<0.1)

 Osteoporotic fracture

31

2.3(19.7)

5

1.2(0.1)

7

2.3(4.4)

12

3.7(18.4)

 Fracture nonunion

39

2.2(21.8)

4

1.6(0.9)

24

2.3(15.8)

6

2.2(3.3)

 Fracture malunion

2

0.8(0.1)

0

—

1

0.8(<0.1)

0

—

 Fracture delayed union

20

1.7(5.1)

1

0.9(0.01)

11

1.7(3.1)

7

2.3(4.2)

 Synostosis

1

0.5(0.6)

0

—

0

—

1

—

  1. Around 82% of reports have age information. Bold indicates statistically significant signals.
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