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Note: This document contains side effect information about oxcarbazepine. Some of the dosage forms listed on this page may not apply to the brand name Oxtellar XR.
Common side effects of Oxtellar XR include: dizziness. See below for a comprehensive list of adverse effects.
Applies to oxcarbazepine: oral suspension, oral tablet, oral tablet extended release
Along with its needed effects, oxcarbazepine (the active ingredient contained in Oxtellar XR) 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:
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:
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 Oxtellar XR) included dizziness, vomiting, nausea, diplopia, and somnolence.
The pattern of seizures following oxcarbazepine (the active ingredient contained in Oxtellar XR) discontinuation suggests a rebound phenomenon rather than a loss of therapeutic efficacy.
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
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
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.
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 (the active ingredient contained in Oxtellar XR)
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)
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)
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).
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
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
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
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
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
Common (1% to 10%): Infection, viral infection
Frequency not reported: Systemic lupus erythematosus
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
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.
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)
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
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
Frequency not reported: Renal calculus
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