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Oxcarbazepine (ox kar BAY zeh peen) has been approved by the FDA as monotherapy OR adjunctive therapy in the treatment of focal seizures in adults, as monotherapy in the treatment of focal seizures in children 4–16 years old, and as adjunctive therapy in the treatment of focal seizures in children 2–16 years old. Extended-release tablets are also available to treat focal-onset seizures in patients 6 years or older.

Your epilepsy treatment should always be discussed with your healthcare provider before use. Based on their judgment and knowledge, a drug may be prescribed for other epilepsy types not included in the indications. For more information, please see the prescribing information.

How can you take oxcarbazepine? (Available formulations)

Oxcarbazepine is available as a tablet, an oral solution, and an extended-release tablet taken crushed or whole and with or without food. The tablet and oral solution can be taken with or without food. The extended-release tablet is taken whole and on an empty stomach.

Who should not take oxcarbazepine?

If you are allergic to oxcarbazepine, any of the inactive ingredients, or eslicarbazepine acetate, then you should not take it.

Other considerations may influence whether you should take oxcarbazepine. Tell your healthcare provider if you:

  • have or have had depression, mood problems, or suicidal thoughts or behavior.
  • have liver problems.
  • have kidney problems.
  • are allergic to carbamazepine.
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed.

What is important to know about taking oxcarbazepine?

Do not stop taking oxcarbazepine suddenly unless directed to do so by your healthcare provider.

As with all antiseizure medications, oxcarbazepine should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus. You should not stop using oxcarbazepine suddenly unless your healthcare provider tells you to stop the medicine because of a serious side effect.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking oxcarbazepine with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you take: drugs that cause sleepiness or dizziness or alcohol.

Women or those who are/plan to become pregnant
Use in pregnancy

Data on a limited number of pregnancies from pregnancy registries suggest congenital malformations associated with oxcarbazepine monotherapy use (e.g., craniofacial defects such as oral clefts and cardiac malformations such as ventricular septal defects). In animal studies, there were instances of developmental issues at clinically relevant doses. However, having a seizure during pregnancy could harm both the pregnant individual and the baby. Tell your healthcare provider right away if you become pregnant. Do not start or stop taking seizure medication during pregnancy without your healthcare provider’s advice.

If you become pregnant while taking oxcarbazepine, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiseizure medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

Use during breastfeeding

Oxcarbazepine and its active metabolite are excreted in human milk. Because of the potential for serious adverse reactions to oxcarbazepine in nursing infants, a decision you should talk to your healthcare provider about the risks. Your healthcare provider will consider the developmental and health benefits of breastfeeding along with your need for oxcarbazepine and the potential effect on the infant from oxcarbazepine or from your epilepsy.

Effect on birth control and fertility

Oxcarbazepine may decrease the effectiveness of hormonal contraceptives, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using oxcarbazepine, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

What are the side effects of oxcarbazepine?

Oxcarbazepine is approved by the FDA because it is safe and effective for the majority of people who take it. However, there are risks associated with all medicines. Some side effects caused by oxcarbazepine can be very serious, and even life-threatening. It is important to be informed about these serious reactions and to be aware of their symptoms.

Common side effects

The most common side effects that were reported in studies of oxcarbazepine are dizziness, drowsiness (somnolence), diplopia (double vision), fatigue, nausea, vomiting, problems with movement and balance (ataxia), abnormal vision, headache, rapid and uncontrolled eye movement (nystagmus), tremor, and abnormal gait.

Rare, but serious side effects
Other serious reactions, including serious blood or liver problems

Rare but life-threatening reactions involving the immune system or multi-organ hypersensitivity, which can cause serious blood or liver problems have been reported with oxcarbazepine use. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you experience fever, frequent infections, severe muscle pain, swelling of your face, eyes, lips, or tongue, swollen lymph glands, unusual bruising or bleeding, weakness, fatigue, yellowing of your skin, or the white part of your eyes, trouble walking or seeing, seizures happening more often, or pain/tenderness in the area toward the top of your stomach (enlarged liver/spleen).

Suicidal thoughts or behaviors

Studies have found that people who take antiseizure medications including oxcarbazepine may have suicidal thoughts or behaviors, which occur in approximately 1 in 500 patients. If you experience any thoughts or impulses to hurt yourself, you should contact your healthcare provider immediately.

Hyponatremia

Oxcarbazepine may cause hyponatremia (low sodium levels in the blood). Symptoms of low blood sodium included nausea, tiredness (lack of energy), headache, confusion, and more frequent or more severe seizures. Your healthcare provider may do blood tests to check your sodium levels during your treatment with oxcarbazepine. You should tell your healthcare provider if you have any of these side effects and if they bother you or they do not go away. Some other medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking.

Cross hypersensitivity reaction to carbamazepine

Approximately 25% to 30% of people who have had hypersensitivity reactions to carbamazepine will experience hypersensitivity reactions with oxcarbazepine. For this reason, you should let your healthcare provider know about any prior experience with carbamazepine. If you have a history of hypersensitivity reactions to carbamazepine, you should only be treated with oxcarbazepine if the potential benefit justifies the potential risk. If signs or symptoms of hypersensitivity develop, oxcarbazepine should be discontinued immediately.

Serious dermatological reactions

Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with oxcarbazepine use. Such serious skin reactions may be life-threatening, and some patients have required hospitalization with very rare reports of fatal outcomes. The median time of onset for reported cases was 19 days after treatment initiation. Recurrence of the serious skin reactions following rechallenge with oxcarbazepine has also been reported.

Cognitive/neuropsychiatric adverse reactions

The use of oxcarbazepine has been associated with central nervous system-related adverse reactions. The most significant of these can be classified into 3 general categories: 1) cognitive symptoms including psychomotor slowing, difficulty with concentration, and speech or language problems, 2) somnolence or fatigue, and 3) coordination abnormalities, including problems with movement and balance (ataxia) and gait disturbances.

Hematologic events

Rare reports of pancytopenia (decrease in all 3 blood cell types), agranulocytosis (a disease with decreased white blood cells), and leukopenia (low white blood cells) have been seen in patients treated with oxcarbazepine during postmarketing experience. Discontinuation of the drug should be considered if any evidence of these hematologic (blood-related) events develops.