Diacomit(Stiripentol) Side Effects

Common adverse reactions (≥10% incidence) include somnolence, decreased appetite, ataxia, weight loss, hypotonia, nausea, tremor, and insomnia.  

Frequent and Serious Adverse Events  

In clinical trials, somnolence (67%), appetite loss (45%), agitation (27%), ataxia (27%), and weight loss (27%) were predominant. Serious risks include neutropenia (13%), thrombocytopenia (13%), and suicidality (class-wide AED warning). Gastrointestinal effects (nausea, vomiting) and neurologic symptoms (dysarthria, tremor) are notable. Rare events include aggression and salivary hypersecretion. Long-term data show similar safety profiles in infants ≥6 months. Overdose management is supportive; no antidote exists. Drug interactions (e.g., elevated clobazam/norclobazam levels) require vigilant monitoring.