Table 3.
Results of adverse events in the methylphenidate and atomoxetine groups
| Methylphenidate [n (%)] | Atomoxetine [n (%)] | |
|---|---|---|
| Total number of subjects with AEs | 255 (47.8) | 277 (56.8) |
| Decreased appetite | 174 (32.6) | 177 (36.3) |
| Abdominal pain | 12 (2.3) | 18 (3.7) |
| Vomiting | 8 (1.5) | 10 (2.0) |
| Nausea | 8 (1.5) | 12 (2.5) |
| Constipation | 2 (0.4) | 9 (1.8) |
| Weight loss | 20 (3.8) | 19 (3.9) |
| Sleep disturbances (insomnia/fractured sleep) | 64 (12.0) | 24 (4.9) |
| Somnolence | 0 | 61 (12.5) |
| Tics | 20 (3.8) | 7 (1.4) |
| Headache | 9 (1.7) | 10 (2.0) |
| Dizziness | 6 (1.1) | 10 (2.0) |
| Fatigue | 0 | 3 (0.6) |
| Psychiatric problems (irritability, aggression, emotional instability, depression, crying, anxiety, sadness, etc.) | 24 (4.5) | 71 (14.5) |
| Chest tightness/palpitation | 7 (1.3) | 3 (0.6) |
| Abnormal ECG | 15 (2.8) | 10 (2.0) |
| Transient transaminase elevation | 7 (1.3) | 3 (0.6) |
| Dry mouth | 3 (0.6) | 3 (0.6) |
| Hair pulling | 2 (0.4) | 0 |
| Eyelash pulling | 1 (0.2) | 0 |
| Eyebrow alopecia | 0 | 1 (0.2) |
| Frequent micturition | 1 (0.2) | 1 (0.2) |
| Oral ulcer | 1 (0.2) | 0 |
| Rash | 1 (0.2) | 7 (1.4) |
| Lip cracking | 1 (0.2) | 1 (0.2) |
| Skin itch | 0 | 2 (0.4) |
| Fever | 1 (0.2) | 1 (0.2) |
| Enuresis | 0 | 2 (0.4) |
| Urinary hesitancy | 0 | 1 (0.2) |
| Tinnitus | 0 | 1 (0.2) |
| Earache | 0 | 1 (0.2) |
| Hand trembling | 0 | 1 (0.2) |
AEs adverse events, ECG electrocardiogram