Adverse events (%) according to FDA and EMEA standards
| Adverse reaction* (FDA) | Undesirable effects† (EMEA) | |||
|---|---|---|---|---|
| Levetiracetam (n=769) | Placebo (n=439) | Levetiracetam (n=672) | Placebo (n=351) | |
| *Adverse reaction: any event reported during clinical trial; FDA, Food and Drug Administration; †undesirable effect: all adverse events at least possibly related to the study drug; EMEA=European Medicinal Evaluation Agency. | ||||
| Note: Adverse reactions and undesirable effects are derived from three efficacy and one safety, double blind placebo controlled trials. Patient numbers differ because the FDA included the crossover part of the study in the analysis, and these patients were counted twice. | ||||
| Somnolence | 15 | 8 | 12 | 9 |
| Asthenia | 15 | 9 | 7 | 3 |
| Dizziness | 9 | 4 | 14 | 8 |
| Infection | 13 | 8 | — | — |