Table 3 Number of adverse drug reactions and severe adverse reactions stratified by system organ class
System organ class (descending order) | All | Number of AEDs related to the ADR | ||
|---|---|---|---|---|
One AEDs | Two AEDs | More than three AEDs | ||
Number (severea) | Number (severea) | Number (severea) | Number (severea) | |
Psychiatric disorders | 1633 (84) | 813 (29) | 710 (39) | 110 (16) |
Neurological disorders | 1222 (93) | 630 (46) | 500 (37) | 92 (10) |
Gastrointestinal disorders | 564 (68) | 244 (26) | 280 (31) | 40 (11) |
Skin and appendage disorders | 341 (131) | 183 (67) | 132 (50) | 26 (14) |
Body as a whole - general disorders | 260 (19) | 137 (10) | 108 (5) | 15 (4) |
Metabolic and nutritional disorders | 257 (19) | 131 (8) | 107 (8) | 19 (3) |
Liver and biliary disorders | 236 (33) | 135 (17) | 84 (12) | 17 (4) |
Vision disorders | 88 (6) | 28 (2) | 45 (3) | 15 (1) |
Reproductive disorders | 88 (16) | 48 (9) | 36 (4) | 4 (3) |
Blood disorders | 81 (25) | 32 (15) | 37 (9) | 12 (1) |
Musculoskeletal disorders | 65 (11) | 39 (5) | 23 (4) | 3 (2) |
Urinary tract disorders | 55 (9) | 30 (5) | 23 (3) | 2 (1) |
Hearing, vestibular and special senses disorders | 49 (2) | 32 (1) | 16 (1) | 1 (0) |
Cardiovascular disorders | 42 (2) | 26 (2) | 13 (0) | 3 (0) |
Vascular, bleeding and clotting disorders | 36 (2) | 19 (1) | 16 (1) | 1 (0) |
Respiratory disorders | 15 (4) | 9 (1) | 4 (2) | 2 (1) |
Immune disorders and infections | 13 (9) | 8 (6) | 4 (3) | 1 (0) |
Congenital disorders | 4 (4) | 2 (2) | 2 (2) | 0 (0) |
Total | 5049 (537) | 2546 (252) | 2140 (214) | 363 (71) |