Trileptal Side Effects
Generic name: oxcarbazepine
Medically reviewed by Drugs.com. Last updated on Nov 2, 2023.
Note: This document contains side effect information about oxcarbazepine. Some dosage forms listed on this page may not apply to the brand name Trileptal.
Applies to oxcarbazepine: oral suspension, oral tablet, oral tablet extended release.
Serious side effects of Trileptal
Along with its needed effects, oxcarbazepine (the active ingredient contained in Trileptal) 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:
- Change in vision
- change in walking or balance
- clumsiness or unsteadiness
- double vision
- false sense of well-being
- feeling of constant movement of self or surroundings
- mental depression
- sensation of spinning
- sore throat
- uncontrolled back-and-forth or rolling eye movements
- bloody or cloudy urine
- blurred vision
- 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
- 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
- skin rash
- stuffy or runny nose
- tightness in the chest
- trouble with walking
- troubled breathing
- unusual feelings
- unusual tiredness or weakness
- bleeding or crusting sores on the lips
- burning feeling in the chest or stomach
- chest pain
- hives or welts, itching
- 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
- 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
- dark urine
- decrease in height
- decreased awareness or responsiveness
- difficulty swallowing
- dry skin and hair
- feeling cold
- hair loss
- loss of appetite
- loss of consciousness
- muscle stiffness or twitching
- 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
- weight gain
- yellow eyes or skin
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:
- Burning feeling in the chest or stomach
- sleepiness or unusual drowsiness
- stomach pain
- back pain
- bloody nose
- change in your sense of taste
- difficulty with speaking
- dryness of the mouth
- feeling of warmth and redness of the face, neck, arms, and occasionally chest
- increased sweating
- increased urination
- itching of the vagina
- trouble sleeping
For Healthcare Professionals
Applies to oxcarbazepine: oral suspension, oral tablet, oral tablet extended release.
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]
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]
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]
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]
Common (1% to 10%): Acne, alopecia, bruising, increased sweating, purpura, rash
Uncommon (0.1% to 1%): Urticaria
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]
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.
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]
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]
Common (1% to 10%): Chest pain, generalized edema, hot flushes, hypotension, leg edema
Very rare (less than 0.01%): Arrhythmia, atrioventricular block, hypertension
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]
Common (1% to 10%): Lymphadenopathy
Uncommon (0.1% to 1%): Leucopenia
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]
Common (1% to 10%): Infection, viral infection
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]
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]
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]
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]
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]
Frequency not reported: Renal calculus[Ref]
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]
Frequently asked questions
- How long does Trileptal withdrawal last?
- How long does it take for Trileptal to work?
- Does Trileptal cause weight gain?
- Is Oxtellar XR the same as Trileptal?
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Related treatment guides
1. Friis ML, Kristensen O, Boas J, Dalby M, Deth SH, Gram L, Mikkelsen M, Pedersen B, Sabers A, Worm-Petersen J, et al. Therapeutic experiences with 947 epileptic out-patients in oxcarbazepine treatment. Acta Neurol Scand. 1993;87:224-7.
2. Van Amelsvoort T, Bakshi R, Devaux CB, Schwabe S. Hyponatremia associated with carbamazepine and oxcarbazepine therapy: a review. Epilepsia. 1994;35:181-8.
3. Product Information. Trileptal (oxcarbazepine). Novartis Pharmaceuticals. 2001.
4. Cerner Multum, Inc. UK Summary of Product Characteristics.
5. Cerner Multum, Inc. Australian Product Information.
6. Product Information. Oxtellar XR (oxcarbazepine). Supernus Pharmaceuticals Inc. 2014.
7. Azar NJ, Wright AT, Wang L, Song Y, Abou-Khalil BW. Generalized tonic-clonic seizures after acute oxcarbazepine withdrawal. Neurology. 2008;70(22 Pt 2):2187-8.
8. Ryan M, Adams AG, Larive LL. Hyponatremia and leukopenia associated with oxcarbazepine following carbamazepine therapy. Am J Health Syst Pharm. 2001;58:1637-9.
9. Woster P, Carrazana EJ. Oxcarbazepine and hyponatremia. Am J Health Syst Pharm. 2002;59:467.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.