Note: This document contains side effect information about oxcarbazepine. Some dosage forms listed on this page may not apply to the brand name Trileptal.

Summary

Common side effects of Trileptal include: dizziness. Continue reading for a comprehensive list of adverse effects.

Applies to oxcarbazepine: oral conventional tablets, oral extended-release tablets, oral oral suspension.

Side effects include:

Conventional preparations: Dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, nystagmus, tremor, dyspepsia, abnormal gait.

Extended-release tablets: Dizziness, somnolence, headache, balance disorder, tremor, vomiting, diplopia, asthenia, fatigue.

For Healthcare Professionals

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

General

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

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]

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.

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

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]

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]