OBJECTIVE: To evaluate the efficacy and tolerability of levetiracetam (LEV) in the treatment of epilepsy as a monotherapy in children. METHODS: hirty-two children with epilepsy (age ranged from 8 months to 12 years) and who had received LEV monotherapy were investigated by a self-controlled and open-label research. LEV was administered at a dose of 10 mg/kg?d, and increased by 10 mg/kg?d per week till to the target dose (20-40 mg/kg?d), with a mean dose of 35 mg/kg?d. RESULTS: Thirty-one patients were followed up for more than three months. Twenty-five patients (80.6%) had at least 50% reduction in seizures, 22 cases (70.9%) became seizure-free, and LEV therapy was discontinued in 5 patients (16.1%) due to either an inadequate seizure control or aggravated seizures. The therapy-related adverse events included mood and behavioral changes (6/31, 19.4%), asthenia (2/31, 6.5%), somnolence (2/31, 6.5%), and skin rashes (1/31, 3.2%). The adverse effects were spontaneously disappeared or disappeared after reducing the LEV dose. CONCLUSIONS: LEV monotherapy is effective and safe for the control of partial and generalized tonic-clonic seizures in children with epilepsy. LEV appears to be a promising anti-epileptic drug for monotherapy in children with epilepsy.