Trileptal Side Effects

Generic Name: oxcarbazepine

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 Trileptal.

Some side effects of Trileptal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

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

Along with its needed effects, oxcarbazepine (the active ingredient contained in Trileptal) 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:

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 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:

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

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.

General

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

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

Gastrointestinal

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

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

Respiratory

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

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

Metabolic

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

Genitourinary

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

Musculoskeletal

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

Cardiovascular

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

Hematologic

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

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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