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

Get emergency medical help if you have any of these signs of an allergic reaction while taking oxcarbazepine (the active ingredient contained in Trileptal) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Contact your doctor right away if you have headache, trouble concentrating, memory problems, weakness, loss of appetite, feeling unsteady, confusion, hallucinations, fainting, shallow breathing, and/or increased or more severe seizures.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• increased seizures;

• swollen glands, fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• severe tingling, numbness, pain, muscle weakness;

• urinating less than usual or not at all;

• chest pain, dry cough, wheezing, feeling short of breath;

• upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• headache, mental slowness, trouble concentrating;

• problems with speech, balance, or walking;

• dizziness, drowsiness, tired feeling;

• mild nausea, vomiting, upset stomach, diarrhea;

• blurred vision, double vision;

• tremors or shaking; or

• skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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 information does not endorse drugs, diagnose patients, or recommend therapy. This drug 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 drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information 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 drugs you are taking, check with your doctor, nurse, or pharmacist.