Table 1.
Adverse events (%) reported in clinical trials of the VNS Therapy system in patients with epilepsy or depression (reprinted with permission from Ben Menachem 3)
| Adverse event | 3 months | 12 months | 5‐year follow‐up | |
|---|---|---|---|---|
| Epilepsy | Depression | Epilepsy | Epilepsy | |
| Cough | 21 | 15 | 1.5 | |
| Voice alteration | 62 | 60 | 55 | 18.7 |
| Dyspnea | 16 | 23 | 13 | 2.3 |
| Pain | 17 | 27 | 15 | 4.7 |
| Paresthesia | 25 | 15 | 1.5 | |
| Headache | 20 | 30 | 16 | – |
| Pharyngitis | 9 | 10 | – | |
| Depression | 3 | 5 | – | |
| Infection | 4 | 3 | 6 | – |
| Deaths | 2 patients (1 SUDEP, 1 pneumonia) | 4 patients (1 SUDEP, 3 status epilepticus) | ||
SUDEP, sudden, unexpected, unexplained death in epilepsy.