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
  • 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

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.

Nervous system side effects have included dizziness (up to 49%), somnolence (up to 36%), headache (up to 32%), ataxia (up to 31%), nystagmus (up to 26%), abnormal gait (up to 17%), tremor (up to 16%), emotional lability (up to 8%), confusion (up to 7%), nervousness (up to 7%), anxiety (up to 7%), sedation (up to 6%), insomnia (up to 6%), amnesia (up to 5%), aggravated convulsions (up to 5%), abnormal thinking (up to 4%), abnormal coordination (up to 4%), tremor (up to 4%), hypoesthesia (up to 3%), speech disorder (up to 3%), dysmetria (up to 3%), abnormal coordination (up to 2%), confusion (up to 2%), cranial injury (up to 2%), agitation (up to 2%), impaired concentration (up to 2%), convulsions (up to 2%), and involuntary muscle contractions (up to 2%). Generalized tonic-clonic seizures following acute withdrawal have also been reported.


Dermatologic side effects have included Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) that have been reported in both children and adults in association with oxcarbazepine (the active ingredient contained in Trileptal) use. The median time of onset for reported cases was 19 days. Rash (up to 4%), bruising (up to 4%), increased sweating (up to 3%), hot flushes (up to 2%), purpura (up to 2%), and acne (up to 2%) have also been reported.

These serious skin reactions may be life-threatening and some of the patients have required hospitalization with very rare reports of fatal outcome. Recurrence of the serious skin reactions following rechallenge with oxcarbazepine has also been reported. If a patient develops a skin rash while taking oxcarbazepine, consideration should be given to discontinuing oxcarbazepine and prescribing another antiepileptic medication.


Multi-organ hypersensitivity reactions are variable in expression and other organ system symptoms not noted may occur. If this reaction is suspected, oxcarbazepine (the active ingredient contained in Trileptal) should be discontinued and an alternative treatment should be started. Although there are no case reports to indicate cross sensitivity with other drugs that produce this syndrome, experience with drugs associated with multi-organ hypersensitivity would indicate this to be a possibility.

General side effects have included multi-organ hypersensitivity reactions that have been reported in close temporal association (median time to detection of 13 days) to the initiation of oxcarbazepine therapy in adult and pediatric patients. While there have been a limited number of reports, many of these cases resulted in hospitalization and some were considered life threatening. Signs and symptoms of this disorder were diverse. However, patients typically presented with fever and rash associated with organ system involvement. Other associated manifestations included lymphadenopathy, hepatitis, liver function test abnormalities, hematological abnormalities (including eosinophilia, thrombocytopenia, and neutropenia), pruritus, nephritis, oliguria, hepatorenal syndrome, arthralgia, and asthenia.

Fatigue (up to 21%), asthenia (up to 6%), falling down (up to 4%), fever (up to 3%), generalized edema (up to 2%), leg edema (up to 2%), allergy (up to 2%), increased weight (up to 2%), chest pain (up to 2%), and an abnormal feeling (up to 2%) have also been reported.


Ocular side effects have included diplopia (up to 40%), abnormal vision (up to 14%), and abnormal accommodation (up to 2%).


Gastrointestinal side effects have included vomiting (up to 36%), nausea (up to 29%), abdominal pain (up to 13%), diarrhea (up to 7%), dyspepsia (up to 6%), constipation (up to 6%), anorexia (up to 5%), dry mouth (up to 3%), gastritis (up to 2%), rectal hemorrhage (up to 2%), and toothache (up to 2%).


Other side effects have included vertigo, taste perversion, earache, ear infection, pancreatitis and/or lipase and/or amylase increase, and folic acid deficiency.


Respiratory side effects have included upper respiratory tract infections (up to 10%), rhinitis (up to 10%), coughing (up to 5%), epistaxis (up to 4%), chest infection (4%), sinusitis (up to 4%), bronchitis (up to 3%), pharyngitis (up to 3%), and pneumonia (up to 2%).


Immunologic side effects have included viral infection (up to 7%) and infection (up to 2%).


Metabolic side effects have included hyponatremia (up to 23%) and thirst (up to 2%).


Genitourinary side effects have included urinary tract infections (up to 5%), micturition frequency (up to 2%), and vaginitis (up to 2%).


Musculoskeletal side effects have included back pain (up to 4%), muscle weakness (up to 2%), and sprains and strains (up to 2%).


Cardiovascular side effects have included hypotension (up to 2%).


Hematologic side effects have included lymphadenopathy (up to 2%). Hematologic side effects reported postmarketing have included bone marrow depression, agranulocytosis, aplastic anemia, pancytopenia, and neutropenia.


Endocrine side effects have included lower serum testosterone, lower free androgen indexes, and a high frequency of elevated levels of androstenedione. Hypothyroidism has been reported postmarketing.

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