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.

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:

More common side effects

• blurred vision
• change in walking and balance
• changes in patterns and rhythms of speech
• clumsiness or unsteadiness
• constipation
• dizziness or lightheadedness
• double vision
• feeling of constant movement of self or surroundings
• seeing double
• sensation of spinning
• shakiness and unsteady walk
• sleepiness or unusual drowsiness
• slurred speech
• trouble in speaking
• uncontrolled eye movements
• unsteadiness, trembling, or other problems with muscle control or coordination

Less common side effects

• abdominal or stomach pain
• acid or sour stomach
• back pain
• belching
• change in taste
• decreased appetite
• diarrhea
• dry mouth
• heartburn
• impaired memory
• indigestion
• itching skin
• lack or loss of strength
• loss of taste
• muscle aches
• problems with speech or speaking
• sore throat
• stomach discomfort or upset
• stuffy or runny nose

Serious side effects of Xcopri

Along with its needed effects, cenobamate (the active ingredient contained in Xcopri) 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:

Less common side effects

• fast, irregular, pounding, or racing heartbeat or pulse

Incidence not known

• black, tarry stools
• bloody or cloudy urine
• changes in behavior
• chest pain or discomfort
• chills
• confusion
• cough
• dark urine
• difficulty in breathing
• discouragement
• drowsiness
• false or unusual sense of well-being
• fast heartbeat
• feeling sad or empty
• fever
• general tiredness and weakness
• headache
• irritability
• lack of appetite
• light-colored stools
• loss of interest or pleasure
• muscle pain
• nausea and vomiting
• painful or difficult urination
• rash sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, feet, or lower legs
• swollen glands
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• thoughts of killing oneself
• tiredness
• trouble concentrating
• trouble sleeping
• unusual tiredness or weakness
• unusual weight gain
• upper right abdominal or stomach pain
• yellow eyes and skin

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

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