Table 1 Characteristics of the 169,563 MedDRA Adverse Event Reports involving at least one proton pump inhibitor (PPI) ingredient, comparing reports with a fracture and all reports with ADEs.

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

Characteristic

Reports with a fracture (%) N = 3,782

All reports (%) N = 169,563

Age (median), years

 0–19 (7)

14 (0.4%)

3,466 (2.0%)

 20–29 (24)

24 (0.6%)

3,953 (2.3%)

 30–39 (36)

87 (2.3%)

7,706 (4.5%)

 40–49 (46)

271 (7.2%)

16,783 (9.9%)

 50–59 (55)

627 (16.6%)

28,932 (17.1%)

 60–69 (64)

809 (21.4%)

33,086 (19.5%)

 70–79 (75)

768 (20.3%)

27,397 (16.2%)

 80 + (84)

510 (13.5%)

15,427 (9.1%)

 missing

672 (17.8%)

32,813 (19.4%)

Self-report

438 (11.58%)

15,273 (9.01%)

Females (%)

2,895 (76.5%)

100,192 (59.1%)

 Self-report by female

361

10,652

Males (%)

851 (22.5%)

65432 (38.6%)

 Self-report by male

77

4,553

Active PPI Ingredient*

 Omeprazole

1,421 (34.0%)

59,356 (33.7%)

 Esomeprazole

1,220 (29.2%)

49,678 (28.2%)

 Pantoprazole

748 (17.9%)

30,142 (17.1%)

 Lansoprazole

607 (14.5%)

29,486 (16.7%)

 Rabeprazole

180 (4.3%)

7,552 (4.3%)

 Dexlansoprazole

9 (<0.1%)

59 (<0.1%)

  1. *More than one generic ingredient could be reported in the reports.
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