Rufinamide is a unique anticonvulsant that is used in combination with other agents as therapy of severe forms of seizure disorders. Rufinamide therapy is associated with a low rate of transient serum enzyme elevations and with rare instances of clinically apparent liver injury.


Rufinamide (roo fin' a mide) is a unique triazole derivative that appears to act by prolonging the inactivation of voltage gated sodium channels in the central nervous system, thus slowing the rate of neurotransmission and decreasing rapid, repetitive neuronal firing. Rufinamide was approved for use in the United States in 2008 as an anticonvulsant to be used in combination with other agents (adjunctive therapy) for Lennox-Gastaut syndrome in adults and children 1 year of age and older. Rufinamide is available in tablets of 200 and 400 mg and as an oral suspension of 40 mg/mL under the brand name Banzel. The typical dose in children is 10 mg/kg in two divided doses daily, which can be increased to a maximum of 45 mg/kg daily. In adults the dose is 400 to 800 mg daily in two divided doses, which can be increased to a maximum of 3200 mg daily. Side effects may include headache, dizziness, somnolence, ataxia, tremor, fatigue, nausea and rash. Rare, but potentially severe adverse events include depression, suicidal thoughts and behavior, mood changes and hypersensitivity reactions including Stevens Johnson syndrome.


In prelicensure clinical trials, addition of rufinamide to standard anticonvulsant therapy was reported to be associated with only rare elevations in ALT above 3 times the upper limit of normal (ULN). Rufinamide was not linked to instances of clinically apparent liver injury, but a pooled analysis of more than 200 children mentioned that two patients needed to discontinue therapy early because of liver related adverse events, one of which was described as “toxic hepatitis”. Since approval, there have been no reports of clinically apparent liver injury associated with rufinamide use, but it has had limited use in epilepsy. Rufinamide has been linked to instances of severe cutaneous reactions, including Stevens Johnson syndrome which often has some degree of associated liver injury. Thus, rufinamide may cause liver injury, but it is rare.

Likelihood score: E* (unproven but suspected cause of clinically apparent liver injury).

Mechanism of Injury

Rufinamide is metabolized by the liver, largely by CYP 2C19, but has not been reported to have significant drug interactions. The possible mechanism of hepatic injury from rufinamide is not known, but may relate to a toxic or immunogenic metabolite.

Outcome and Management

There is no information on the possible cross sensitivity to hepatotoxicity between rufinamide and other anticonvulsants, but its structure would not suggest that there would not be shared sensitivity with the more commonly used medications for seizures.

Drug Class: Anticonvulsants



Rufinamide – Banzel®




Product labeling at DailyMed, National Library of Medicine, NIH



References updated: 06 June 2018

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