Table 6.
Distribution of adverse drug events (AEs) categorized according to the system organ classes (SOCs) and involving risperidone as a suspected drug, stratified for pediatric patients aged 3–11 and 12–17 years recognized in Eudravigilance spontaneous reporting system from 2016 to 2018.
| System organ class | Risperidone N (%) | p | ||
|---|---|---|---|---|
| Tot | 3–11 years | 12–17 years | ||
| Reproductive system and breast disorders | 1,590 (19.8) | 909 (23.3) | 681 (16.4) | <0.05 |
| Injury, poisoning and procedural complications | 1,249 (15.5) | 635 (16.3) | 614 (14.8) | >0.05 |
| Psychiatric disorders | 1,205 (15.0) | 530 (13.6) | 675 (16.3) | <0.05 |
| Metabolism and nutrition disorders | 1,042 (12.9) | 718 (18.4) | 324 (7.8) | <0.05 |
| Nervous system disorders | 800 (9.9) | 317 (8.1) | 483 (11.6) | <0.05 |
| Investigations | 549 (6.8) | 153 (4.0) | 396 (9.6) | <0.05 |
| General disorders and administration site conditions | 473 (5.9) | 194 (5.0) | 279 (6.7) | <0.05 |
| Endocrine disorders | 297 (3.7) | 150 (3.8) | 147(3.5) | >0.05 |
| Gastrointestinal disorders | 142 (1.7) | 47 (1.2) | 95 (2.3) | <0.05 |
| Musculoskeletal and connective tissue disorders | 117 (1.5) | 30 (0.8) | 87 (2.1) | <0.05 |
| Total adverse events | 8,047 | 3,901 | 4,146 | |