Fycompa Side Effects

Generic name: perampanel

Note: This document contains side effect information about perampanel. Some of the dosage forms listed on this page may not apply to the brand name Fycompa.

Some side effects of Fycompa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to perampanel: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking perampanel (the active ingredient contained in Fycompa) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using perampanel and call your doctor at once if you have a side effect such as:

• changes in mood, behavior, or personality;

• anger, aggression, anxiety, trouble sleeping, feeling hostile or irritable;

• talking more than usual;

• unusual thoughts, paranoid behavior, panic attacks;

• thoughts about suicide, or thoughts about hurting someone else;

• trouble walking, loss of balance or coordination;

• an accidental fall; or

• severe dizziness, spinning sensation, feeling like you might pass out.

Common side effects may include:

• mild dizziness;

• drowsiness, tiredness;

• nausea;

• weight gain; or

• headache, joint pain, back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to perampanel: oral tablet

Gastrointestinal

Common (1% to 10%): Nausea (up to 8%), vomiting (up to 4%), constipation (up to 3%)

Metabolic

Common (1% to 10%): Weight gain (up to 4%), peripheral edema (up to 2%), hyponatremia (up to 2%)

Musculoskeletal

Common (1% to 10%): Back pain (up to 5%), myalgia (up to 3%), pain in extremity (up to 3%), arthralgia (up to 2%), musculoskeletal pain (up to 2%)

Nervous system

Very common (10% or more): Dizziness (up to 43%), somnolence (up to 18%), headache (up to 13%), fatigue (up to 12%)

Common (1% to 10%): Ataxia (up to 8%), vertigo (up to 5%), gait disturbance (up to 4%), dysarthria (up to 4%), balance disorder (up to 3%), hypoesthesia (up to 3%), hypersomnia (up to 3%), asthenia (up to 2%), abnormal coordination (up to 2%), memory impairment (up to 2%), paresthesia (up to 2%)

Ocular

Common (1% to 10%): Blurred vision (up to 4%), diplopia (up to 3%)

Other

Common (1% to 10%): Falls (up to 10%), head injury (up to 3%), contusion (up to 2%), limb injury (up to 2%), skin laceration (up to 2 %)

Psychiatric

Common (1% to 10%): Irritability (up to 12%), anxiety (up to 4%), aggression (up to 3%), anger (up to 3%), confusional state (up to 2%), euphoric state (up to 2%), mood altered (up to 2%)

Respiratory

Common (1% to 10%): Upper respiratory tract infection (up to 4%), cough (up to 4%), oropharyngeal pain (up to 2%)

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