Trileptal Side Effects

Generic name: oxcarbazepine

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

Note: This document provides detailed information about Trileptal.

Applies to oxcarbazepine: oral suspension, oral tablet, oral tablet extended release Side Effects associated with oxcarbazepine. Some dosage forms listed on this page may not apply specifically to the brand name Trileptal.

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 (the active ingredient contained in Trileptal) 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 Trileptal

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:

Other side effects of Trileptal

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:

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 (the active ingredient contained in Trileptal) included dizziness, vomiting, nausea, diplopia, and somnolence.^[Ref]

Nervous system

• Very common (10% or more): Abnormal gait, ataxia, dizziness, headache, nystagmus, somnolence, tremor
• Common (1% to 10%): Abnormal coordination, abnormal EEG, amnesia, ataxia, balance disorder, convulsions aggravated, cranial injury not otherwise specified, dysmetria, gait disturbance, hypoesthesia, impaired concentration, involuntary muscle contractions, speech disorder, taste perversion
• Frequency not reported: Aura, depressed level of consciousness, dystonia, extrapyramidal disorder, hemiplegia, hyperreflexia, hyperkinesia, hyporeflexia, hypokinesia, hypotonia, migraine, muscle hypertonia, neuralgia, oculogyric crisis, paralysis, syncope, tinnitus^[Ref]

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

Psychiatric

• Common (1% to 10%): Abnormal thinking, agitation, anxiety, apathy, confusion, depression, insomnia, emotional lability, nervousness
• Frequency not reported: Aggressive reaction, anguish, anxiety, aphasia, delirium, delusion, dysphonia, euphoria, hysteria, manic reaction, panic disorder, paroniria, personality disorder, psychosis, stupor, suicidal behavior and ideation^[Ref]

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

• Common (1% to 10%): Acne, alopecia, bruising, increased sweating, purpura, rash
• Uncommon (0.1% to 1%): Urticaria
• Very rare (less than 0.01%): Angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)
• Frequency not reported: Contact dermatitis, eczema, erythematous rash, facial rash, folliculitis, genital pruritus, heat rash, maculopapular rash, photosensitivity reaction, psoriasis, purpura, skin procedure, vitiligo
• Postmarketing reports: Acute generalized exanthematous pustulosis (AGEP)^[Ref]

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

• Common (1% to 10%): Allergy
• Very rare (less than 0.01%): Hypersensitivity (including multi-organ hypersensitivity), anaphylactic reactions
• Frequency not reported: Drug rash with eosinophilia and systemic symptoms (DRESS)^[Ref]

Rare cases of anaphylaxis have been reported in patients after taking the first or subsequent doses of oxcarbazepine (the active ingredient contained in Trileptal)

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

• Very common (10% or more): Abdominal pain, nausea, vomiting
• Common (1% to 10%): Constipation, diarrhea, dyspepsia, dry mouth, gastritis, rectum hemorrhage, toothache, upper abdominal pain
• Frequency not reported: Biliary pain, blood in stool, cholelithiasis, colitis, duodenal ulcer, dysphagia, enteritis, eructation, esophagitis, flatulence, gastric ulcer, gingival bleeding, gum hyperplasia, hematemesis, hemorrhoids, right hypochondrium pain, retching, sialoadenitis, stomatitis, ulcerative stomatitis, dental oral procedure
• Postmarketing reports: Pancreatitis^[Ref]

Cardiovascular

• Common (1% to 10%): Chest pain, generalized edema, hot flushes, hypotension, leg edema
• Very rare (less than 0.01%): Arrhythmia, atrioventricular block, hypertension
• Frequency not reported: Bradycardia, cardiac failure, cerebral hemorrhage, palpitation, postural hypotension, precordial chest pain, tachycardia^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection, micturition frequency, vaginitis
• Frequency not reported: Decreased/increased libido, dysuria, female reproductive procedure, intermenstrual bleeding, leukorrhea, menorrhagia, micturition frequency, polyuria, priapism, renal pain, urinary tract pain^[Ref]

Hematologic

• Common (1% to 10%): Lymphadenopathy
• Uncommon (0.1% to 1%): Leucopenia
• Very rare (less than 0.01%): Agranulocytosis, aplastic anemia, bone marrow depression, neutropenia, pancytopenia, thrombocytopenia^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Increased blood alkaline phosphatase, increased hepatic enzymes
• Very rare (less than 0.01%): Hepatitis
• Frequency not reported: Increased GGT, increased serum transaminase^[Ref]

Immunologic

• Common (1% to 10%): Infection, viral infection
• Frequency not reported: Systemic lupus erythematosus^[Ref]

Metabolic

• Common (1% to 10%): Anorexia, hyponatremia, thirst, weight increase
• Frequency not reported: Decrease in T4 with unclear clinical significance, hyperglycemia, hypocalcemia, hypoglycemia, hypokalemia, hypothyroidism, increased appetite, tetany, weight decrease
• Postmarketing reports: Increased amylase, increased lipase^[Ref]

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

• Common (1% to 10%): Back pain, muscle weakness, sprains and strains
• Frequency not reported: Musculoskeletal procedure
• Postmarketing reports: Decreased bone mineral density, osteopenia, osteoporosis and fractures (long-term therapy)^[Ref]

Ocular

• Very common (10% or more): Abnormal accommodation, abnormal vision, diplopia
• Common (1% to 10%): Blurred vision, visual impairment/disturbance
• Frequency not reported: Cataract, conjunctival hemorrhage, eye edema, hemianopia, mydriasis, photophobia, scotoma, xerophthalmia^[Ref]

Other

• Very common (10% or more): Fatigue, vertigo
• Common (1% to 10%): Asthenia, drug intolerance, earache, ear infection not otherwise specified, falling down not otherwise specified, feeling abnormal, fever
• Frequency not reported: Feeling drunk, malaise, otitis externa, ptosis, rigors^[Ref]

Renal

• Frequency not reported: Renal calculus^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection
• Common (1% to 10%): Bronchitis, chest infection, coughing, epistaxis, nasopharyngitis, pneumonia, pharyngitis, rhinitis, sinusitis
• Frequency not reported: Asthma, dyspnea, hiccup, laryngismus, pleurisy^[Ref]

See also:

Frequently asked questions

• How long does Trileptal withdrawal last?
• How long does it take for Trileptal to work?
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Further information

Trileptal 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.

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