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Oxcarbazepine Side Effects

It is possible that some side effects of oxcarbazepine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

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

As well as its needed effects, oxcarbazepine may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking oxcarbazepine, check with your doctor immediately:

More common
  • Change in vision
  • change in walking or balance
  • clumsiness or unsteadiness
  • cough, fever, sneezing, or sore throat
  • crying
  • dizziness
  • double vision
  • false sense of well-being
  • feeling of constant movement of self or surroundings
  • mental depression
  • sensation of spinning
  • uncontrolled back-and-forth and/or rolling eye movements
Less common
  • Agitation
  • awkwardness
  • bloody or cloudy urine
  • blurred vision
  • bruising
  • confusion
  • convulsions (seizures)
  • decreased urination
  • difficulty with focusing eyes
  • disorientation
  • 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
  • itching of the vagina
  • 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
Rare
  • Anxiety
  • bleeding or crusting sores on the lips
  • burning feeling in the chest or stomach
  • chest pain
  • chills
  • hives or itching
  • irritability
  • joint pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • 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

Some oxcarbazepine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Abdominal or stomach pain
  • burning feeling in the chest or stomach
  • nausea and vomiting
  • sleepiness or unusual drowsiness
Less common
  • Acid or sour stomach
  • acne
  • back pain
  • belching
  • bloody nose
  • blurred vision
  • change in your sense of taste
  • constipation
  • 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
  • trouble with sleeping

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 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]

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]

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

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%): 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]

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

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]

References

1. "Product Information. Trileptal (oxcarbazepine)" Novartis Pharmaceuticals, East Hanover, NJ.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Oxtellar XR (OXcarbazepine)." Supernus Pharmaceuticals Inc, Rockville, MD.

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

5. 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 87 (1993): 224-7

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

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

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

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

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