Trileptal Side Effects

Generic Name: oxcarbazepine

Note: This page contains side effects data for the generic drug oxcarbazepine. It is possible that some of the dosage forms included below may not apply to the brand name Trileptal.

It is possible that some side effects of Trileptal 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 (the active ingredient contained in Trileptal) 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 (the active ingredient contained in Trileptal) included dizziness, vomiting, nausea, diplopia, and somnolence.[Ref]

Nervous system

The pattern of seizures following oxcarbazepine (the active ingredient contained in Trileptal) discontinuation suggests a rebound phenomenon rather than a loss of therapeutic efficacy.[Ref]

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

Psychiatric

Common (1% to 10%): Insomnia, Nervousness, agitation, abnormal thinking, anxiety, confusion, insomnia, emotional lability, depression, apathy, confusion, impaired concentration
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.[Ref]

Common (1% to 10%): Acne, alopecia, purpura, rash, bruising, increased sweating
Uncommon (0.1% to 1%): Urticaria
Very rare (less than 0.01%): Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme
Frequency not reported: Contact dermatitis, eczema, facial rash, folliculitis, heat rash, photosensitivity reaction, genital pruritus, psoriasis, purpura, erythematous rash, maculopapular rash, vitiligo, skin procedure
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), angioedema, anaphylactic reactions.
Frequency not reported: Drug rash with eosinophilia and systemic symptoms (DRESS)[Ref]

Rare cases of anaphylaxis and angioedema 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): Nausea, vomiting, abdominal pain
Common (1% to 10%): Diarrhea, dyspepsia, constipation, gastritis, anorexia, dry mouth, rectum hemorrhage, toothache, taste perversion, upper abdominal pain
Frequency not reported: Blood in stool, cholelithiasis, colitis, duodenal ulcer, dysphagia, enteritis, eructation, esophagitis, flatulence, gastric ulcer, gingival bleeding, gum hyperplasia, hematemesis, hemorrhoids, hiccup, dry mouth, biliary pain, right hypochondrium pain, retching, sialoadenitis, stomatitis, ulcerative stomatitis, dental oral procedure[Ref]

Cardiovascular

Common (1% to 10%): Leg edema, hypotension, generalized edema, chest pain, hot flushes
Very rare (less than 0.01%): Arrhythmia, atrioventricular block, hypertension
Frequency not reported: Precordial chest pain, bradycardia, cardiac failure, cerebral hemorrhage, postural hypotension, palpitation, syncope, tachycardia[Ref]

Genitourinary

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

Hematologic

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

Hepatic

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

Immunologic

Common (1% to 10%): Viral infection, infection
Frequency not reported: Systemic lupus erythematosus[Ref]

Metabolic

Common (1% to 10%): Weight increase, hyponatremia, thirst
Frequency not reported: Weight decrease, increased appetite, hyperglycemia, hypocalcemia, hypoglycemia, hypokalemia, hypothyroidism, decrease in T4 with unclear clinical significance
Postmarketing reports: Increased lipase, increased amylase[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%): Muscle weakness, sprains and strains, back pain, involuntary muscle contractions
Frequency not reported: Tetany, musculoskeletal procedure
Postmarketing reports: Decreased bone mineral density, osteopenia, osteoporosis and fractures (long-term therapy)[Ref]

Ocular

Very common (10% or more): Diplopia, abnormal vision, abnormal accommodation, nystagmus
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
Common (1% to 10%): Asthenia, feeling abnormal, fever, earache, ear infection not otherwise specified, falling down not otherwise specified, drug intolerance
Frequency not reported: Malaise, feeling drunk, 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%): Rhinitis, coughing, bronchitis, pharyngitis, epistaxis, chest infection, sinusitis, pneumonia, nasopharyngitis
Frequency not reported: Asthma, dyspnea, 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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