| Colistin | Meropenem | Tigecycline | Gentamicin | Ceftazidime-Avibactam | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
FDA | UK | IT | FDA | UK | IT | FDA | UK | IT | FDA | UK | IT | FDA | UK | IT | |
ADR features | |||||||||||||||
 Overall reports | 783 | 87 | 129 | 6013 | 445 | 494 | 1879 | 93 | 135 | 5342 | 407 | 272 | 213 | 14 | 23 |
 Overall serious reports | 737 (94.1) | 81 (93.1) | 52 (40.3) | 5840 (97.1) | 377 (84.7) | 209 (42.3) | 1701 (90.5) | 85 (91.4) | 64 (47.4) | 4901 (91.7) | 367 (90.2) | 95 (34.9) | 180 (84.5) | 14 (100) | 17 (73.9) |
 Overall Drug-SOC pairs | 2564 | 284 | 225 | 22,557 | 1019 | 761 | 5373 | 216 | 219 | 19,495 | 823 | 432 | 510 | 32 | 39 |
Age | |||||||||||||||
 0–17 years | 82 (10.5) | 21 (24.2) | 6 (4.7) | 647 (10.7) | 59 (13.3) | 43 (8.7) | 51 (2.7) | 4 (4.3) | 2 (1.5) | 654 (12.3) | 41 (10.1) | 41 (15.1) | 9 (4.2) | 5 (35.7) | 0 (0) |
 18–64 years | 396 (50.6) | 44 (50.6) | 62 (48.1) | 2596 (43.2) | 240 (53.9) | 192 (38.9) | 726 (38.6) | 45 (48.3) | 64 (47.4) | 2118 (39.6) | 191 (46.9) | 107 (39.3) | 79 (37.1) | 3 (21.4) | 8 (34.8) |
  > 65 years | 165 (21.1) | 11 (12.6) | 41 (31.8) | 1964 (32.7) | 105 (23.6) | 254 (51.4) | 583 (31.1) | 22 (23.7) | 68 (50.4) | 1645 (30.8) | 140 (34.4) | 121 (44.5) | 45 (21.1) | 2 (14.3) | 6 (26.1) |
 Unknown | 140 (17.8) | 11 (12.6) | 20 (15.4) | 806 (13.4) | 41 (9.2) | 5 (1) | 519 (27.6) | 22 (23.7) | 1 (0.7) | 925 (17.3) | 35 (8.6) | 3 (1.1) | 80 (37.6) | 4 (28.6) | 9 (39.1) |
Sex | |||||||||||||||
 Male | 369 (47.1) | 31 (35.6) | 62 (48.1) | 3014 (50.1) | 195 (43.8) | 247 (50) | 834 (44.4) | 44 (47.3) | 68 (50.4) | 2421 (45.3) | 199 (48.9) | 128 (47.1) | 88 (41.3) | 5 (35.7) | 14 (60.9) |
 Female | 306 (39.1) | 50 (57.5) | 64 (49.6) | 2433 (40.5) | 217 (48.8) | 242 (49) | 732 (39) | 44 (47.3) | 66 (48.9) | 2353 (44.1) | 183 (45) | 142 (52.2) | 65 (30.5) | 8 (57.1) | 6 (26.1) |
 Unknown | 108 (13.8) | 6 (6.9) | 3 (2.3) | 566 (9.4) | 33 (7.4) | 5 (1) | 313 (16.6) | 5 (5.4) | 1 (0.7) | 568 (10.6) | 25 (6.1) | 2 (0.7) | 60 (28.2) | 1 (7.2) | 3 (13) |