Table 1.
ADRs | Unlabelled ADRs | |||||
---|---|---|---|---|---|---|
ATC groups | No. of reports | N | % | ADRs/report | N | % |
Alimentary tract and metabolism (A) | 37 | 90 | 11 | 2.4 | 16 | 8 |
Blood and blood-forming organs (B) | 3 | 7 | <1 | 2.3 | 0 | 0 |
Cardiovascular system (C) | 41 | 76 | 10 | 1.9 | 10 | 5 |
Dermatological (D) | 11 | 22 | 3 | 2 | 14 | 7 |
Genitourinary system and sex hormones (G) | 13 | 25 | 3 | 1.9 | 16 | 9 |
Systemic hormonal preparations (H) | 9 | 26 | 3 | 2.9 | 12 | 6 |
Anti-infective for systemic use (J) | 25 | 59 | 7 | 2.4 | 15 | 8 |
Antineoplastic and immunomodulating agents (L) | 14 | 33 | 4 | 2.4 | 1 | <1 |
Musculoskeletal system (M) | 33 | 53 | 7 | 1.6 | 0 | 0 |
Nervous system (N) | 116 | 316 | 40 | 2.7 | 64 | 34 |
Antiparasitic products (P) | 3 | 5 | <1 | 1.7 | 2 | 1 |
Respiratory system (R) | 26 | 59 | 7 | 2.3 | 19 | 10 |
Sensory organs (S) | 2 | 5 | <1 | 1.5 | 3 | 2 |
Herbal products | 7 | 18 | 2 | 2.6 | 16 | 9 |
Total | 340 | 794 | 2.3 | 188 | 100 |
ADR, adverse drug reaction; ATC, Anatomical Therapeutic Chemical.