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. 2020 Dec 21;14:574652. doi: 10.3389/fnins.2020.574652

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.