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Oxcarbazepine Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 4, 2024.

Applies to oxcarbazepine: oral suspension, oral tablet, oral tablet extended release.

Precautions

It is very important that your doctor check you or your child's progress at regular visits. This is to make sure the medicine is working properly and to allow for changes in your dose. Blood tests will also be needed to check for unwanted effects.

Tell your doctor if you become pregnant while using this medicine. Your doctor may need you to be monitored carefully during your pregnancy and after giving birth.

Hyponatremia (low sodium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child develop confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, muscle pain or cramps, nausea or vomiting, weakness, or swelling of the face, ankles, or hands while using this medicine.

This medicine may cause serious types of allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching, hives, hoarseness, trouble breathing or swallowing, or any swelling of your face, eyes, lips, tongue, arms, or legs while you are using this medicine.

This medicine may cause drug reaction with eosinophilia and systemic symptoms (DRESS). It is a serious allergic reaction that may affect several parts of the body (eg, liver, kidneys, muscle, joints). Check with your doctor right away if you or your child have more than one of the following symptoms: dark urine, extra fluid around the face, fever, headache, itching, joint swelling, muscle aches, rash, stomach pain, swollen glands, unusual tiredness, or yellow eyes or skin.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Do not stop using this medicine suddenly without talking first to your doctor. You may need to slowly decrease your dose before stopping it completely.

This medicine may cause some people to become dizzy, drowsy, lightheaded, clumsy, unsteady, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you or your child have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor before using this medicine with other medicines that affect the central nervous system (CNS). The use of other medicines that affect the CNS with oxcarbazepine may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Oral contraceptives (birth control pills) containing estrogen, ethinyl estradiol, levonorgestrel, or progestin, contraceptive progestin injections (eg, Depo-Provera®), and contraceptive implant forms of progestin (eg, Norplant®) may not work properly if you take them while you are taking oxcarbazepine. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking oxcarbazepine. If you have any questions about this, check with your doctor.

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.

Serious side effects of oxcarbazepine

Along with its needed effects, oxcarbazepine 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 oxcarbazepine:

More common side effects

  • change in vision
  • change in walking or balance
  • clumsiness or unsteadiness
  • cough
  • crying
  • dizziness
  • double vision
  • false sense of well-being
  • feeling of constant movement of self or surroundings
  • fever
  • mental depression
  • sensation of spinning
  • sneezing
  • sore throat
  • uncontrolled back-and-forth or rolling eye movements

Less common side effects

  • agitation
  • awkwardness
  • bloody or cloudy urine
  • blurred vision
  • bruising
  • confusion about identity, place, and time
  • decreased urination
  • difficulty with focusing the eyes
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast or irregular heartbeat
  • frequent falls
  • frequent urge to urinate
  • headache
  • hoarseness
  • increased thirst
  • loss of consciousness
  • memory loss
  • muscle cramps
  • pain or burning while urinating
  • pain or tenderness around the eyes or cheekbones
  • problems with coordination
  • shaking or trembling of the arms, legs, hands, and feet
  • seizures
  • skin rash
  • stuffy or runny nose
  • tightness in the chest
  • trouble with walking
  • troubled breathing
  • unusual feelings
  • unusual tiredness or weakness

Rare side effects

  • anxiety
  • bleeding or crusting sores on the lips
  • burning feeling in the chest or stomach
  • chest pain
  • chills
  • hives or welts, itching
  • irritability
  • joint pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • muscle pain or weakness
  • purple spots on the skin
  • rectal bleeding
  • redness, blistering, peeling, or loosening of the skin
  • restlessness
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach upset
  • swelling of the legs
  • swollen glands

Incidence not known

  • black, tarry stools
  • bloating
  • constipation
  • dark urine
  • decrease in height
  • decreased awareness or responsiveness
  • difficulty swallowing
  • dry skin and hair
  • fainting
  • feeling cold
  • hair loss
  • hostility
  • indigestion
  • loss of appetite
  • loss of consciousness
  • muscle stiffness or twitching
  • nausea
  • pain in the back, ribs, arms, or legs
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pounding, slow heartbeat
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • severe sleepiness
  • swelling of the face, ankles, or hands
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • unusual bleeding or bruising
  • unusual drowsiness, dullness, or feeling of sluggishness
  • vomiting
  • weight gain
  • yellow eyes or skin

Other side effects of oxcarbazepine

Some side effects of oxcarbazepine 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

  • burning feeling in the chest or stomach
  • sleepiness or unusual drowsiness
  • stomach pain

Less common side effects

  • acne
  • back pain
  • belching
  • bloody nose
  • change in your sense of taste
  • diarrhea
  • difficulty with speaking
  • dryness of the mouth
  • feeling of warmth and redness of the face, neck, arms, and occasionally chest
  • heartburn
  • increased sweating
  • increased urination
  • itching of the vagina
  • trouble sleeping

For healthcare professionals

Applies to oxcarbazepine: oral suspension, oral tablet, oral tablet extended release.

General adverse events

The most commonly observed side effects were dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, abnormal gait, headache, balance disorder, and asthenia. In clinical trials in children aged 1 month to 4 years, the most commonly reported side effect was somnolence.

The side effects most commonly associated with discontinuation of oxcarbazepine included dizziness, vomiting, nausea, diplopia, and somnolence.[Ref]

Nervous system

The pattern of seizures following oxcarbazepine discontinuation suggests a rebound phenomenon rather than a loss of therapeutic efficacy.[Ref]

Psychiatric

Pooled analyses of 199 placebo-controlled clinical trials of 11 different antiepileptic drugs lasting a median of 12 weeks showed that patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks.[Ref]

Dermatologic

Patients with the Human Leukocyte Antigen (HLA) allele B*1502 or HLA-A*3101 may be at an increased risk for Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The presence of the HLA-A*3101 allele may also increase the risk for drug rash with eosinophilia (DRESS), or less severe acute generalized exanthematous pustulosis (AGEP) and maculopapular rash.

Rare cases of angioedema have been reported in patients after taking the first or subsequent doses of oxcarbazepine.[Ref]

Hypersensitivity

Rare cases of anaphylaxis have been reported in patients after taking the first or subsequent doses of oxcarbazepine.

Multi-organ hypersensitivity is generally characterized by signs and symptoms such as abnormal liver function tests, rash, and fever. Other organs or symptoms that may be affected include the blood and lymphatic system (e.g., lymphadenopathy, eosinophilia, leucopenia, splenomegaly), liver (e.g., abnormal liver function tests, hepatitis), muscles and joints (e.g., joint swelling, myalgia, arthralgia), nervous system (e.g., hepatic encephalopathy), kidney (e.g., proteinuria, interstitial nephritis, renal failure), and lungs (e.g., dyspnea, pulmonary edema, asthma, bronchospasms, interstitial lung disease).[Ref]

Gastrointestinal

Cardiovascular

Genitourinary

Hematologic

Hepatic

Immunologic

Metabolic

Hyponatremia associated with signs and symptoms such as seizures, confusion, depressed level of consciousness, encephalopathy, vision disorders, vomiting, nausea, and folic acid deficiency have been reported very rarely.[Ref]

Musculoskeletal

Ocular

Other

Renal

Respiratory

See also:

References

1. Friis ML, Kristensen O, Boas J, Dalby M, Deth SH, Gram L, Mikkelsen M, Pedersen B, Sabers A, Worm-Petersen J, et al. (1993) "Therapeutic experiences with 947 epileptic out-patients in oxcarbazepine treatment." Acta Neurol Scand, 87, p. 224-7

2. Van Amelsvoort T, Bakshi R, Devaux CB, Schwabe S (1994) "Hyponatremia associated with carbamazepine and oxcarbazepine therapy: a review." Epilepsia, 35, p. 181-8

3. (2001) "Product Information. Trileptal (oxcarbazepine)." Novartis Pharmaceuticals

4. Cerner Multum, Inc. "UK Summary of Product Characteristics."

5. Cerner Multum, Inc. "Australian Product Information."

6. (2014) "Product Information. Oxtellar XR (oxcarbazepine)." Supernus Pharmaceuticals Inc

7. Azar NJ, Wright AT, Wang L, Song Y, Abou-Khalil BW (2008) "Generalized tonic-clonic seizures after acute oxcarbazepine withdrawal." Neurology, 70(22 Pt 2), p. 2187-8

8. Ryan M, Adams AG, Larive LL (2001) "Hyponatremia and leukopenia associated with oxcarbazepine following carbamazepine therapy." Am J Health Syst Pharm, 58, p. 1637-9

9. Woster P, Carrazana EJ (2002) "Oxcarbazepine and hyponatremia." Am J Health Syst Pharm, 59, p. 467

Further information

Oxcarbazepine 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.