苯巴那酯(cenobamate)的副作用和常见不良反应

Author: Medicalhalo

Release time: 2025-10-19 11:44:20

Understanding side effects is key not only for patients to make informed treatment decisions, but also for long-term disease management.

Common side effects of cenobamate

As the body gradually adapts to the drug, these adverse side effects will gradually disappear. Medical staff will also provide patients with corresponding prevention or relief suggestions based on the actual situation. If you have persistent or major trouble with the following symptoms, you should seek medical treatment promptly.

‌1. More common side effects‌

Blurred vision, changes in gait and balance, changes in speech patterns and rhythm, clumsiness or unsteadiness, constipation, dizziness or top-heavyness, double vision, constant feeling of movement of yourself or your surroundings, double vision, spinning sensation, tremors and unsteady posture, drowsiness or unusual sleepiness, slurred speech, difficulty speaking, uncontrolled eye movements, unsteadiness, tremors, or other muscle control/coordination problems.

‌2. Less common side effects:

Abdominal pain or stomach pain, hyperacidity or acid reflux, back pain, burping, taste change, loss of appetite, diarrhea, dry mouth, heartburn, memory loss, indigestion, itchy skin, fatigue, loss of taste, muscle aches, speech impairment, sore throat, stomach discomfort, nasal congestion or runny nose.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Severe side effects of cenobamate

Although not all patients will experience it, you should contact your doctor immediately if the following occurs:

‌1. Less common but serious side effects:

Rapid, irregular, violent or palpitating heartbeat.

According to clinical research data, the drug may also cause serious adverse reactions such as QT interval shortening (the incidence rate is as high as 66%), abnormal liver function (ALT up to 7.6 times the normal value), and the rare DRESS syndrome (drug hypersensitivity reaction with eosinophilia and systemic symptoms).

2. The incidence is unknown

‌Black tar-like stool‌(melena), light-colored stool‌, right upper quadrant or stomach pain‌, nausea and vomiting‌, lack of appetite‌, hematuria or turbidity Turbid urine, dark urine, difficulty or pain during urination, behavioral changes, confusion, drowsiness, abnormal euphoria, low mood or feeling of emptiness, irritability, loss of interest or pleasure, suicidal thoughts, Trouble concentrating, insomnia, chest pain or discomfort, chills, difficulty breathing, fast heartbeat, fever, general fatigue, headache, muscle pain, unusual fatigue or weakness, abnormal weight gain Addition, rash/sore throat, sores/white spots on lips or mouth, edema of face/feet/legs, swollen lymph nodes (with tenderness in neck/armpits/groin), yellow eyes and skin (jaundice).

Recommendations for the management of cenobamate side effects for medical professionals

1. General adverse events

The most common adverse reactions include drowsiness, dizziness, fatigue, double vision and headache. Generally speaking, the higher the dose, the higher the incidence of adverse reactions.

2. Cardiovascular system

Very common (≥10%): QT interval shortening (incidence up to 66%).

Common (1%-10%): palpitations.

The QT study showed that compared with the placebo group, the proportion of patients with QT interval shortening >20 msec was higher in the 200 mg dose group (31% vs 6%) and higher in the 500 mg dose group (66% vs 17%). No shortening of the QTc interval below 300 msec was observed.

3. Skin system

Pruritus and rash (including erythematous, systemic, maculopapular, maculopapular, morbilliform, papular and pruritic rashes).

4. Gastrointestinal system

Nausea, constipation, diarrhea, vomiting, dry mouth, abdominal pain, indigestion, and occasionally appendicitis.

5. Genitourinary system

Urinary tract infection, frequent urination, and dysmenorrhea.

6. Liver system

Elevated aminotransferases (ALT and AST).

‌Post-Marketing Report‌: Hepatic failure.

The maximum ALT elevation reached 7.6 times the upper limit of normal (7.6×ULN) and occurred in patients with a dose of 400 mg/day. The incidence of ALT elevation in 3×ULN is as high as 2.7%.

7. Hypersensitivity reaction

Uncommon (0.1%-1%): drug hypersensitivity reaction.

8. Immune system

Occasionally: drug reaction with eosinophilia and systemic symptoms (DRESS).

One case of death due to DRESS was reported in the clinical trial, and the patient titrated quickly. Although it is not certain that slow titration prevents this risk, following dosing and titration guidelines is recommended.

9. Metabolic system

Very common (≥10%): hyperkalemia (incidence up to 17%).

Common (1%-10%): loss of appetite and weight loss.

10. Musculoskeletal system

Back pain, musculoskeletal chest pain.

11. Nervous system

Very common (≥10%): drowsiness (up to 37%), dizziness (up to 33%), fatigue (up to 24%), headache (up to 12%).

‌Common (1%-10%)‌: dizziness, balance disorder, gait disorder, dysarthria, nystagmus, ataxia, aphasia, weakness, taste disorder, memory loss, migraine, sedation, tremor.

Drowsiness and fatigue include weakness, malaise, drowsiness, sedation and somnolence, with the reporting rate of at least one reaction being as high as 57%.

Dizziness and gait/coordination disorders include vertigo, balance disorders, ataxia, nystagmus, and coordination abnormalities, and the reporting rate of at least one reaction is as high as 52%.

Cognitive dysfunction includes memory loss, attention disorder, amnesia, confusion, aphasia, speech impairment, slow thinking, disorientation and psychomotor retardation, with the reporting rate of at least one reaction being as high as 9%.