Serious Psychiatric and Behavioral Reactions

• Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking perampanel.
• These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression.
• Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for the patient are observed while taking perampanel or after discontinuing.
• Closely monitor patients particularly during the titration period and at higher doses.
• Perampanel should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening.