Table 4.
Distribution of adverse drug events (AE) categorized according to the system organ classes (SOCs) and involving aripiprazole or risperidone as suspected drugs recognized in EudraVigilance spontaneous reporting system from 2016 to 2018 in pediatric population (3–17 years).
| System organ class | Aripiprazole N (%) | Risperidone N (%) | p |
|---|---|---|---|
| Psychiatric disorders | 606 (20.2) | 1,205 (15.0) | <0.05 |
| Nervous system disorders | 476 (15.9) | 800 (9.9) | <0.05 |
| Injury, poisoning, and procedural complications | 446 (14.9) | 1,249 (15.5) | 0.4 |
| General disorders and administration site conditions | 317 (10.6) | 473 (5.9) | <0.05 |
| Investigation | 188 (6.3) | 549 (6.8) | 0.3 |
| Metabolism and nutrition disorders | 180 (6.0) | 1,042 (12.9) | <0.05 |
| Gastrointestinal disorders | 146 (4.9) | 142 (1.8) | <0.05 |
| Reproductive system and breast disorders | 110 (3.7) | 1,590 (19.8) | <0.05 |
| Musculoskeletal and connective tissue disorders | 79 (2.6) | 117 (1.5) | <0.05 |
| Eye disorders | 65 (2.2) | 70 (0.9) | <0.05 |
| Total | 2,993 (100) | 8,047 (100) |