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Cenobamate Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 16, 2020.

For the Consumer

Applies to cenobamate: oral tablet

Warning

Cenobamate can cause serious or life-threatening allergic reactions that can affect your liver, blood cells, or other parts of the body. Call your doctor or get emergency medical help if you have symptoms such as: severe weakness or muscle pain, a fever, swollen glands, unusual bruising or bleeding, swelling in your face or throat, trouble breathing, hives or a rash, yellowing of your skin or eyes, or any illness that does not get better.

Some people have thoughts about suicide while taking cenobamate. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not stop using cenobamate suddenly. Follow your doctor's instructions about tapering your dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Cenobamate can cause serious or life-threatening allergic reactions that can affect your liver, blood cells, or other parts of the body. Call your doctor or get emergency medical help if you have symptoms such as:

  • fast or pounding heartbeats, fluttering in your chest, and sudden dizziness (like you might pass out);

  • feeling very weak or tired;

  • severe muscle pain;

  • fever, swollen glands, sore throat;unusual bruising or bleeding;

  • painful sores in your mouth or around your eyes;

  • swelling in your face, mouth, or throat;

  • trouble breathing or swallowing;

  • hives or a rash;

  • yellowing of your skin or eyes;

  • any infection or illness that does not get better; or

  • nervous system problems--dizziness, trouble walking, loss of coordination, vision problems, drowsiness, tiredness, problems with thinking or memory.

Common side effects may include:

  • feeling tired;

  • dizziness, drowsiness;

  • double vision; or

  • headache.

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 cenobamate: oral tablet

General

The most commonly reported adverse reactions have included somnolence, dizziness, fatigue, diplopia, and headache.[Ref]

Nervous system

During clinical trials, at least one adverse reaction related to somnolence and fatigue (i.e., asthenia, malaise, hypersomnia, sedation, and lethargy) was reported in 31%, 36%, and 57% of patients receiving 100 mg/day, 200 mg/day, and 400 mg/day, respectively, compared to 19% of patients who received placebo. Reactions were serious in 0.4% drug-treated patients (compared to no patients who received placebo). Discontinuations due to somnolence and fatigue-related adverse reactions occurred in 2% patients on therapy compared to 1% of patients who received placebo.

During clinical trials, at least one adverse reaction related to dizziness and disturbance in gait and coordination (i.e., dizziness, vertigo, balance disorder, ataxia, nystagmus, gait disturbance, and abnormal coordination) was reported in 21%, 31%, and 52% of patients receiving 100 mg/day, 200 mg/day, and 400 mg/day, respectively, compared to 18% of patients who received placebo. Reactions were serious in 2% drug-treated patients (compared to no patients who received placebo). Discontinuations due to dizziness and disturbance in gait and coordination occurred in 5% patients on therapy compared to 1% of patients who received placebo.

During clinical trials, at least one adverse reaction related to cognitive dysfunction (i.e., memory impairment, disturbance in attention, amnesia, confusional state, aphasia, speech disorder, slowness of thought, disorientation, and psychomotor retardation) was reported in 6%, 6%, and 9% of patients receiving 100 mg/day, 200 mg/day, and 400 mg/day, respectively, compared to 2% of patients who received placebo. Discontinuations due to cognitive dysfunction related event occurred in 0.4% patients on therapy compared to 0% of patients who received placebo.

Very common (10% or more): Somnolence (37%), dizziness (33%), headache (12%), fatigue (24%)

Common (1% to 10%): Vertigo, balance disorder, gait disturbance, dysarthria, nystagmus, ataxia, aphasia, asthenia, dysgeusia, memory impairment, migraine, sedation, tremor

Psychiatric

Common (1% to 10%): Confusional state, euphoric mood, irritability, suicidal ideation

Immunologic

Frequency not reported: Drug reaction with eosinophilia and systemic symptoms (DRESS)

During clinical trials, DRESS was reported including 1 fatality. The patient who died had been titrated rapidly. This finding does not establish that the risk is prevented by a slower titration, however it is recommended to follow the dosage and titration dosing guidelines.

Ocular

Very common (10% or more): Diplopia (15%)

Common (1% to 10%): Blurred vision

During clinical trials, at least one adverse reaction related to visual impairment (i.e., diplopia, blurred vision, and impaired vision) was reported in 9%, 9%, and 18% of patients receiving 100 mg/day, 200 mg/day, and 400 mg/day, respectively, compared to 2% of patients who received placebo. Discontinuations due to cognitive dysfunction related event occurred in 0.5% patients on therapy compared to 0% of patients who received placebo.

Cardiovascular

In a QT study, a higher percentage of subjects taking this drug at 200 mg and 500 mg had QT shortening of greater than 20 msec compared to placebo (31% vs 6%) and (66% vs 17%), respectively. Reductions of the QTc interval below 300 msec were not observed.

Common (1% to 10%): Palpitations

Frequency not reported: QTc shortening

Metabolic

Increased potassium levels (greater than 5 meq/L) occurred in 17% of patients (compared to 7% receiving placebo). A dose-related occurrence was observed in 1 trial with 8.3%, 9.1%, and 10.8% of patients receiving 100, 200, or 400 mg/day reporting at least one potassium value greater than 5 meq/L. Two patients had a maximum potassium value of 5.9 meq/L.

Very common (10% or more): Hyperkalemia (17%)

Common (1% to 10%): Decreased appetite, weight decreased

Gastrointestinal

Common (1% to 10%): Nausea, constipation, diarrhea, vomiting, dry mouth, abdominal pain, dyspepsia

Frequency not reported: Appendicitis

During clinical trials, 2.9 cases of appendicitis/1000 patient-years of exposure occurred; this is in excess of the expected background rate in the general population.

Musculoskeletal

Common (1% to 10%): Back pain, musculoskeletal chest pain

Genitourinary

Common (1% to 10%): Urinary tract infection, pollakiuria, dysmenorrhea

Respiratory

Common (1% to 10%): Nasopharyngitis, pharyngitis, hiccups, dyspnea

Other

Common (1% to 10%): Head injury

Dermatologic

Common (1% to 10%): Pruritus, popular rash

Hepatic

The maximum ALT elevation was 7.6 times the upper limit (7.6 x ULN) of normal and this occurred in patients receiving 400 mg/day. ALT elevations of 3 x ULN occurred in 0.9%, 1.8%, and 2.7% of patients receiving 100, 200, and 400 mg/day, respectively.

Common (1% to 10%): Elevated transaminases

References

1. "Product Information. Xcopri (cenobamate)." SK Life Science, Inc., Paramus, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.