pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Characteristics of adverse event reports of alpha-adrenoreceptor antagonists and all other drugs from 2016 to 2020
| Characteristics | Total reports (n=408,077) | ||||
|---|---|---|---|---|---|
| Total of alpha-adrenoreceptor antagonists (n=6,750) | All other drugs (n=401,327) | ||||
| N | (%) | N | (%) | ||
| Age group | <.0001 | ||||
| Mean (±SD) | 68.21 | (±11.38) | 54.85 | (±19.49) | |
| 0-19 | 13 | (0.19) | 28,073 | (7.00) | |
| 20-39 | 126 | (1.87) | 51,694 | (12.88) | |
| 40-59 | 1,123 | (16.64) | 128,807 | (32.10) | |
| 60-79 | 4,572 | (67.73) | 169,467 | (42.23) | |
| ≥ 80 | 916 | (13.57) | 23,286 | (5.80) | |
| Report type | <.0001 | ||||
| Spontaneous report | 3,750 | (55.56) | 350,230 | (87.27) | |
| Research (including re-examination) | 2,971 | (44.01) | 43,575 | (10.86) | |
| Literature | 22 | (0.33) | 2,987 | (0.74) | |
| Unknown | 0 | (0.00) | 3 | (0.00) | |
| Others | 7 | (0.10) | 4,532 | (1.13) | |
| Original reporter | <.0001 | ||||
| Clinician | 2,935 | (43.48) | 89,239 | (22.24) | |
| Pharmacist | 2,222 | (32.92) | 60,458 | (15.06) | |
| Nurse | 784 | (11.61) | 221,104 | (55.09) | |
| Consumer | 259 | (3.84) | 13,853 | (3.45) | |
| Others | 36 | (0.53) | 6,966 | (1.74) | |
| Other medical specialists | 6 | (0.09) | 2,794 | (0.70) | |
| Lawyer | 0 | (0.00) | 4 | (0.00) | |
| Reporter | <.0001 | ||||
| Regional pharmacovigilance center | 3,463 | (51.30) | 326,427 | (81.34) | |
| Pharmaceutical company | 3,140 | (46.52) | 60,005 | (14.95) | |
| Medical institution | 132 | (1.96) | 12,989 | (3.24) | |
| Pharmacy | 1 | (0.01) | 11 | (0.00) | |
| Public health center | 0 | (0.00) | 1 | (0.00) | |
| Consumer | 8 | (0.12) | 822 | (0.20) | |
| Others | 6 | (0.09) | 1,072 | (0.27) | |
| Seriousness criteria | <.0001 | ||||
| None | 5,744 | (85.10) | 370,962 | (92.43) | |
| Death | 41 | (0.61) | 1,188 | (0.30) | |
| Life-threatening | 17 | (0.25) | 1,152 | (0.29) | |
| Disability | 2 | (0.03) | 267 | (0.07) | |
| Deformation | 0 | (0.00) | 3 | (0.00) | |
| Hospitalization | 649 | (9.61) | 13,072 | (3.26) | |
| Medically significant | 297 | (4.40) | 14,683 | (3.66) | |
| Report year | <.0001 | ||||
| 2016 | 945 | (14.00) | 74,802 | (18.64) | |
| 2017 | 1,253 | (18.56) | 83,496 | (20.80) | |
| 2018 | 1,321 | (19.57) | 81,465 | (20.30) | |
| 2019 | 1,363 | (20.19) | 80,837 | (20.14) | |
| 2020 | 1,868 | (27.67) | 80,727 | (20.12) | |
| Assessment | <.0001 | ||||
| Certain | 110 | (1.63) | 11,943 | (2.98) | |
| Probable | 828 | (12.27) | 117,314 | (29.23) | |
| Possible | 3,138 | (46.49) | 202,825 | (50.54) | |
| Other | 2,674 | (39.61) | 69,245 | (17.25) | |