Xcopri Side Effects

Generic name: cenobamate

Medically reviewed by Philip Thornton, DipPharm. Last updated on May 9, 2024.

Note: This document provides detailed information about Xcopri Side Effects associated with cenobamate. Some dosage forms listed on this page may not apply specifically to the brand name Xcopri.

Applies to cenobamate: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This is necessary to allow dose adjustments and to check for serious unwanted effects.

Serious skin reactions (including drug reaction with eosinophilia and systemic symptoms (DRESS) may occur during treatment with cenobamate (the active ingredient contained in Xcopri) Tell your doctor right away if you have a fever, skin rashes or blisters, or swollen, painful, or tender lymph glands in neck, armpit, or groin while using this medicine.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast or uneven heartbeat that last a long time. These may be symptoms of a heart rhythm problem called QT shortening.

If you develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, suicidal thoughts, and unusual excitement, nervousness, or irritability.

Cenobamate may cause blurred vision, double vision, or other changes in vision. It may also cause some people to become dizzy, drowsy, clumsy, or feel tired. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well.

Do not stop taking cenobamate without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping the medicine suddenly may cause your seizures to return or to occur more often.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates, medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor or dentist before taking any of the above while you are taking this medicine.

Birth control pills may not work while you are using cenobamate. To keep from getting pregnant, use another form of birth control including condoms, diaphragms, or contraceptive foams or jellies.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Xcopri

Some side effects of cenobamate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects of Xcopri

Along with its needed effects, cenobamate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cenobamate:

For healthcare professionals

Applies to cenobamate: oral tablet.

General adverse events

The most commonly reported adverse reactions have included somnolence, dizziness, fatigue, diplopia, and headache. In general, adverse reactions occurred with increased frequency at higher doses.^[Ref]

Cardiovascular

• Very common (10% or more): QT interval shortening (up to 66%)
• Common (1% to 10%): Palpitations

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.

Dermatologic

• Common (1% to 10%): Pruritus, rash including erythematous, generalized, macular, maculo-papular, morbilliform, papular, and pruritic rashes

Gastrointestinal

• Common (1% to 10%): Nausea, constipation, diarrhea, vomiting, dry mouth, abdominal pain, dyspepsia
• Frequency not reported: Appendicitis

Genitourinary

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

Hepatic

• Common (1% to 10%): Elevated transaminases (ALT and AST)
• Postmarketing reports: Hepatic failure

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 up to 2.7% of patients.

Hypersensitivity

• Uncommon (0.1% to 1%): Drug hypersensitivity reaction

Immunologic

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

During clinical trials, 1 fatality was reported due to DRESS. 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.

Metabolic

• Very common (10% or more): Hyperkalemia (up to 17%)
• Common (1% to 10%): Decreased appetite, decreased weight

Musculoskeletal

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

Nervous system

• Very common (10% or more): Somnolence (up to 37%), dizziness (up to 33%), fatigue (up to 24%), headache (up to 12%)
• Common (1% to 10%): Vertigo, balance disorder, gait disturbance, dysarthria, nystagmus, ataxia, aphasia, asthenia, dysgeusia, memory impairment, migraine, sedation, tremor

Somnolence and fatigue included asthenia, malaise, hypersomnia, sedation, and lethargy; at least 1 reaction was reported in up to 57% of patients.

Dizziness and disturbance in gait and coordination included vertigo, balance disorder, ataxia, nystagmus, and abnormal coordination; at least 1 reaction was reported in up to 52% of patients.

Cognitive dysfunction included memory impairment, disturbance in attention, amnesia, confusional state, aphasia, speech disorder, slowness of thought, disorientation, and psychomotor retardation; at least 1 reaction was reported in up to 9% of patients.

Ocular

• Very common (10% or more): Diplopia (up to 15%)
• Common (1% to 10%): Blurred/impaired vision

Other

• Common (1% to 10%): Head injury

Psychiatric

• Common (1% to 10%): Confusional state, euphoric mood, irritability, suicidal ideation
• Postmarketing reports: Psychosis (hallucinations, delusions/paranoia), hostility, aggression

Respiratory

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

See also:

Frequently asked questions

• Is Xcopri a controlled substance?
• Does Xcopri cause weight gain or weight loss?

Further information

Xcopri side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer