pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Characteristics of adverse event reports of calcineurin inhibitors from 2017 to 2021
| Characteristic | Total, n (%) | Cyclosporine, n (%) | Tacrolimus, n (%) | |
|---|---|---|---|---|
| Number of reports | 24,688 | 5,982 (24.2) | 18,706 (75.8) | - |
| Age, years | <.0001 | |||
| Mean, SD | 47.9, 20.2 | 46.1, 22.0 | 48.3, 19.7 | |
| <40 | 5,489 (22.2) | 1,354 (22.6) | 4,135 (22.1) | |
| 40–69 | 11,096 (44.9) | 2,127 (35.6) | 8,969 (47.9) | |
| ≥70 | 2,012 (8.1) | 505 (8.4) | 1,507 (8.1) | |
| Unknown | 6,091 (24.7) | 1,996 (33.4) | 4,095 (21.9) | |
| Gender | <.0001 | |||
| Male | 11,792 (47.8) | 2,638 (44.1) | 9,154 (48.9) | |
| Female | 9,775 (39.6) | 2,555 (42.7) | 7,220 (38.6) | |
| Others | 8 (<0.1) | 3 (0.1) | 5 (0.0) | |
| Unknown | 3,121 (12.6) | 786 (13.1) | 2,332 (12.5) | |
| Country | <.0001 | |||
| North America | 13,270 (53.8) | 3,305 (55.2) | 9,965 (53.3) | |
| South America | 785 (3.2) | 76 (1.3) | 709 (3.8) | |
| Europe | 5780 (23.4) | 1,253 (21.0) | 4,527 (24.2) | |
| Asia | 3,988 (16.2) | 1,174 (19.6) | 2814 (15.0) | |
| Others | 514 (2.1) | 81 (1.4) | 433 (2.3) | |
| Unknown | 351 (1.4) | 93 (1.6) | 258 (1.4) | |
| Date of administration (year) | <.0001 | |||
| 2021 | 4,884 (19.8) | 1,186 (19.8) | 3,698 (19.8) | |
| 2020 | 5,750 (23.3) | 1,687 (28.2) | 4,063 (21.7) | |
| 2019 | 5,170 (20.9) | 1,470 (24.6) | 3,700 (19.8) | |
| 2018 | 4,875 (19.7) | 768 (12.8) | 4,107 (22.0) | |
| 2017 | 3,978 (16.1) | 865 (14.5) | 3,113 (16.6) | |
| Others | 7 (0.0) | 3 (0.1) | 4 (0.0) | |
| Unknown | 24 (0.1) | 3 (0.1) | 21 (0.1) | |
| Number of adverse events per report, median (range) | 2.0 (1–179) | 2.0 (1–56) | 2.0 (1–46) | <.0001 |
| Indication for the use of CNI | <.0001 | |||
| Prophylaxis against transplant rejection | 10,448 (42.1) | 1,384 (23.0) | 9,064 (48.3) | |
| Autoimmune disease | 1,408(5.7) | 760 (12.6) | 648 (3.5) | |
| Immunosuppression | 4,047 (16.3) | 577 (9.6) | 3,470 (18.5) | |
| Treatment of graft versus host disease | 385 (1.6) | 132 (2.2) | 253 (1.3) | |
| Others | 2,157 (8.7) | 1,000 (16.6) | 1,157 (6.2) | |
| Unknown | 6,357 (25.6) | 2,170 (36.0) | 4,187 (22.3) | |
| Reporter | <.0001 | |||
| Healthcare professionals | 19,101 (77.4) | 4,304 (71.9) | 14,797 (79.1) | |
| Consumers | 4,559 (18.5) | 1,474 (24.6) | 3,085 (16.5) | |
| Others | 7 (0.0) | 3 (0.1) | 4 (0.0) | |
| Unknown | 1,021 (4.1) | 201 (3.4) | 820 (4.4) |
SD, standard deviation; CNI, calcineurin inhibitor