TABLE 3.
Side effects related to ZNS therapy that appear in more than 3% of participants.
| Side effects | Phase 3 trials (Murata et al., 2015) | Phase 3 trials (Murata et al., 2016) | Phase 2b/3 trials (Murata et al., 2007) | |||||||||
| PLC | ZNS 25 mg | ZNS 50 mg | Total | PLC | ZNS 25 mg | ZNS 50 mg | PLC | ZNS 25 mg | ZNS 50 mg | ZNS 100 mg | Total | |
| Total | 49.6% | 57.7% | 60.9% | 59.3% | 65.1% | 55.6% | 60.3% | 65.1% | 70.9% | 72.9% | 79.5% | / |
| Constipation | 1.5% | 1.5% | 3.1% | 2.3% | 6.3% | 1.6% | 1.6% | 3.6% | 6.3% | 8.2% | 4.8% | 6.5% |
| Nasopharyngitis | 6.9% | 7.7% | 3.9% | 5.8% | 11.1% | 4.8% | 3.2% | / | / | / | / | / |
| Bronchitis | 2.3% | 1.5% | 3.1% | 2.3% | / | / | / | / | / | / | / | / |
| Contusion | 3.1% | 2.3% | 1.6% | 1.9% | / | / | / | / | / | / | / | / |
| Blood LDH increased | 3.1% | 2.3% | 3.1% | 2.7% | / | / | / | / | / | / | / | / |
| Blood urea increased | 1.5% | 3.1% | 0.8% | 1.9% | / | / | / | / | / | / | / | / |
| Decreased appetite | 3.1% | 4.6% | 0.8% | 2.7% | 6.3% | 4.8% | 1.6% | 14.5% | 5.1% | 8.2% | 16.9% | 10.1% |
| Dyskinesia | 7.6% | 6.9% | 7.0% | 7.0% | 1.6% | 8.2% | 3.2% | / | / | / | / | / |
| Somnolence | 2.3% | 3.1% | 6.3% | 4.7% | / | / | / | 4.8% | 1.3% | 15.3% | 15.7% | 10.9% |
| Insomnia | 3.1% | 3.1% | 0.0% | 1.6% | 7.9% | 4.8% | 4.8% | / | / | / | / | / |
| Apathy | / | / | / | / | / | / | / | 6.0% | 7.6% | 7.1% | 10.8% | 8.5% |
| Dizziness | / | / | / | / | / | / | / | 7.2% | 3.8% | 5.9% | 7.2% | 5.7% |
| Weight loss | / | / | / | / | 6.3% | 0% | 4.8% | 4.8% | 7.6% | 3.5% | 9.6% | 6.9% |
| Increased in serum CK | / | / | / | / | 6.3% | 4.8% | 1.6% | 8.4% | 8.9% | 8.2% | 4.8% | 7.3% |
Only data for adverse effects with an incidence of > 5% were reported in phase 3 trials (Murata et al., 2016) and phase 2b/3 trials (Murata et al., 2007). Adverse events affecting > 5% are in bold font. ZNS, zonisamide; PLC, placebo; LDH, lactate dehydrogenase; CK, creatinine phosphokinase; /, not reported.