Inovelon Adverse Reactions

The clinical development program has included over 1,900 patients, with different types of epilepsy, exposed to rufinamide.
Most Common Adverse Reactions: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most commonly reported adverse reactions overall were headache, dizziness, fatigue, and somnolence. The most common adverse reactions observed at a higher incidence than placebo in patients with Lennox-Gastaut syndrome were somnolence and vomiting. Adverse reactions were usually mild to moderate in severity. The discontinuation rate in LGS due to adverse reactions was 8.2% for patients receiving rufinamide and 0% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from the rufinamide treatment group were rash and vomiting.
Adverse events that were reported in at least 2% of patients with LGS treated with rufinamide or placebo as adjunctive therapy in double-blind trials and were numerically more common in the patients treated with any dose of rufinamide are summarized in Table 2. (See Table 2.)

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Post-Marketing Experience: The following adverse reactions have been identified during post approval use of rufinamide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Decreased weight has been reported in patients receiving rufinamide both in the presence and absence of gastrointestinal symptoms.
Dermatologic: Stevens-Johnson syndrome and other serious skin rashes with mucosal involvement.