Observed/reported adverse drug reactions (ADRs) from RCTs and prospective cohort studies
| Denominators | |||||
|---|---|---|---|---|---|
| Adverse effects | No. of patients with ADRs | No. of studies reporting ADR | No. of studies looking for ADR | Total no. of patients | Incidence (%) |
| Vomiting | 151 | 14 | 19 | 2810 | 5.4 |
| Disturbance in behaviour | 113 | 6 | 16 | 2390 | 4.7 |
| Sleep disturbance | 101 | 2 | 14 | 2342 | 4.3 |
| Nausea | 45 | 4 | 15 | 2428 | 1.9 |
| Increased appetite | 40 | 3 | 15 | 2378 | 1.7 |
| Abdominal pain | 32 | 5 | 16 | 2514 | 1.3 |
| Facial swelling and flushing | 27 | 2 | 15 | 2378 | 1.1 |
| Infection | 20 | 5 | 13 | 2242 | 0.9 |
| Facial erythema | 13 | 1 | 14 | 2328 | – |
| Others gastrointestinal | 7 | 1 | 13 | 2242 | – |
| Cough | 5 | 2 | 13 | 2242 | 0.2 |
| Drowsiness | 5 | 1 | 13 | 2242 | – |
| Throat irritation | 2 | 1 | 13 | 2242 | – |
| Diarrhoeal | 2 | 1 | 14 | 2328 | – |
| Excessive urination | 1 | 1 | 13 | 2242 | – |
| Rash | 1 | 1 | 13 | 2242 | – |
RCT, randomised controlled trial.