Nebenwirkungen · Levetiracetam ratiopharm
Levetiracetam ratiopharm 100 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 31
HOS-213859 · Präparat HOS-155212
The adverse reaction profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications. Safety results in paediatric patients in placebo-controlled clinical studies were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse reactions which were more common in children than in adults. In children and adolescents aged 4 to 16 years, vomiting (very common, 11.2 %), agitation (common, 3.4%), mood swings (common, 2.1 %), affect lability (common, 1.7 %), aggression (common, 8.2 %), abnormal behaviour (common, 5.6 %), and lethargy (common, 3.9 %) were reported more frequently than in other age ranges or in the overall safety profile. In infants and children aged 1 month to less than 4 years, irritability (very common, 11.7 %) and coordination abnormal (common, 3.3 %) were reported more frequently than in other age groups or in the overall safety profile.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-01-26T17:59:00Z · SHA-256 f83b9a6129b8ef5144ae86c3c40558f640cbeaa7f135ea04834f52af3d8864f5 · Passage 5187dbc2956259cd97ec9079684061cefd8ddead2a73ff157c0b219484f66cf3 · Zeichen 9766–10723 im Abschnitt