Table 2.
Distribution of adverse drug reactions (ADRs) for medicines prescribed off-label by therapeutic group and seriousness
| Therapeutic group (ATC level 1) | Total ADRs | Total ADRs Off-label prescriptions | Serious ADRs Off-label prescriptions | Non serious ADRs Off-label prescriptions |
|---|---|---|---|---|
| n | n (%) | n (%) | n (%) | |
| Alimentary tract and metabolism (A) | 106 | 47 (44) | 34 (72) | 13 (28) |
| Blood and blood forming organs (B) | 5 | 4 (80) | 1 (25) | 3 (75) |
| Cardiovascular system (C) | 33 | 14 (42) | 7 (50) | 7 (50) |
| Dermatological (D) | 77 | 69 (90) | 32 (46) | 37 (54) |
| Genito-urinary system, sex hormones (G) | 101 | 100 (99) | 76 (76) | 24 (24) |
| Systemic hormonal preparations (H) | 50 | 18 (36) | 9 (50) | 9 (50) |
| Anti-infectives for systemic use (J) | 2927 | 30 (1) | 17 (56) | 13 (43) |
| Antineoplastic, immunomodulating agents (L) | 86 | 60 (70) | 37 (62) | 23 (38) |
| Musculoskeletal system (M) | 57 | 45 (79) | 32 (71) | 13 (29) |
| Nervous system (N) | 750 | 191 (25) | 108 (57) | 83 (44) |
| Antiparasitic (P) | 51 | 2 (4) | 0 (0) | 2 (100) |
| Respiratory system (R) | 106 | 40 (38) | 17 (43) | 23 (58) |
| Sensory organs (S) | 5 | 5 (100) | 0 (0) | 5 (100) |
| Various (V) | 144 | 133 (92) | 80 (60) | 53 (40) |
| Total | 4386 | 758 (17) | 450 (59) | 308 (41) |