Table 2.
Adverse effects reported in trials of LEV in infants and children with epilepsy
| Study | Ages | Top 3 AE’s (%)* | Other AE’s (>5% prev) |
|---|---|---|---|
| Kossoff 200169 | 5–17 yr (case series) | Acute psychosis | |
| Glauser 200234 | 6–12 yr | HA (33.3), URI (33.3), somnolence/fatigue (25), anorexia (25) | Sleep problems, general behavioral, pyrexia, nasopharyngitis, convulsion, nervousness, diarrhea, otitis media |
| Wheless 200238 | 6 mo–14 yr | Somnolence/fatigue (15.4), aggression (12.8), gen behavioral (38.5)** | HA, cognitive disturbance, hyperactivity, decreased concentration |
| Youroukos 200370 | 12 yr (case report) | Acute psychosis | |
| Tan 200437 | <10 yr | N/A | |
| Grosso 200518 | 6 mo–16 yr | Somnolence/fatigue (14), irritability (14) | |
| Lagae 20053 | 6 mo–16 yr | Somnolence/fatigue (7.8), aggression (5) | |
| Mandelbaum 20055 | 9 mo–23 yr | Aggression (32), somnolence/fatigue (20) | |
| Opp 20054 | <18 yr | Somnolence/fatigue (24), aggression (10.5), gen behavioral (5) | |
| Coppola 200751 | 3–14 yr | Anorexia (14.3) | |
| Grosso 200735 | <4 yr | Somnolence/fatigue (45), nervousness (36), cognitive disturbance (29) | Anorexia |
| Callenbach 20089 | 4–16 yr | Somnolence/fatigue (48.5), hyperactivity (33.3), irritability (30.3) | Aggression, anorexia, HA, nausea/ vomit, general behavioral, cognitive disturbance, constipation, nervousness, decreased concentration, tremor, weight change, drooling, hair loss, problems with gums |
| Pina-Garza 200910 | 1 mo–<4 yr | Somnolence/fatigue (13.3), irritability (11.7), pyrexia (5) | |
| Tamarelle 200971 | 5 yr (case report) | Depression | |
| Pina-Garza 201031 | 1 mo–<4 yr | Pyrexia (39.5), Sri (27.6), nausea/vomit (18.4) | Somnolence/fatigue, sleep problems, irritability, constipation, nasopharyngitis, convulsion, otitis media |
| Chhun 201136 | 6 mo–15 yr | Hyperactivity (14.6), somnolence/fatigue (9.7), sleep problems (8.7) | Anorexia |
| Schiemann-Delgado 201211 | 4–16 yr | HA (24.3), pyrexia (23.3), Sri (21.4) | Upper abdominal pain, somnolence/ fatigue, aggression, nausea/vomit, general behavioral, irritability, convulsion, nasopharyngitis, diarrhea, rash |
Notes: *Only AE’s with ≥5% prevalence reported here;
**
number of included patients with aggression-related AE.
Abbreviation: AE, Adverse effect; HA, headache; LEV, levetiracetam; N/A, No side effects with >5% prevalence reported; URI, upper respiratory infection.