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.
| 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%) |
*More than one generic ingredient could be reported in the reports.