Trileptal Side Effects

Generic Name: oxcarbazepine

Please note - some side effects for Trileptal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Trileptal - for the Consumer

Trileptal

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Trileptal:

Acne; constipation; dizziness; drowsiness; dry mouth; headache; indigestion; nausea; stomach pain; tiredness; tremor; trouble sleeping; unusual walk; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blood in stool; chest pain; dark urine; decreased urination; difficulty speaking; double vision, changes in vision, or involuntary eye movement; dulled sense of touch; fever, chills, or sore throat; joint pain; loss of coordination; low sodium levels (nausea; general body discomfort; headache; lack of energy; confusion; decreased consciousness; increased frequency or severity of seizures); mental/mood changes; nosebleed; red, swollen, blistered, or peeling skin; seizures; stomach pain; suicidal thoughts or actions; swollen lymph nodes; trouble walking; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness; yellowing of the skin or eyes.

Trileptal Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Trileptal Suspension:

Acne; constipation; dizziness; drowsiness; dry mouth; headache; indigestion; nausea; stomach pain; tiredness; tremor; trouble sleeping; unusual walk; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blood in stool; chest pain; dark urine; decreased urination; difficulty speaking; double vision, changes in vision, or involuntary eye movement; dulled sense of touch; fever, chills, or sore throat; joint pain; loss of coordination; low sodium levels (nausea; general body discomfort; headache; lack of energy; confusion; decreased consciousness; increased frequency or severity of seizures); mental/mood changes; nosebleed; red, swollen, blistered, or peeling skin; seizures; stomach pain; suicidal thoughts or actions; swollen lymph nodes; trouble walking; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness; yellowing of the skin or eyes.

Trileptal Side Effects - for the Professional

Trileptal

Most Common Adverse Events in All Clinical Studies

Adjunctive Therapy/Monotherapy in Adults Previously Treated with other AEDs:  The most commonly observed (≥5%) adverse experiences seen in association with Trileptal® (oxcarbazepine) and substantially more frequent than in placebo-treated patients were: Dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, abnormal gait.

Approximately 23% of these 1,537 adult patients discontinued treatment because of an adverse experience. The adverse experiences most commonly associated with discontinuation were: Dizziness (6.4%), diplopia (5.9%), ataxia (5.2%), vomiting (5.1%), nausea (4.9%), somnolence (3.8%), headache (2.9%), fatigue (2.1%), abnormal vision (2.1%), tremor (1.8%), abnormal gait (1.7%), rash (1.4%), hyponatremia (1.0%).

Monotherapy in Adults Not Previously Treated with other AEDs: The most commonly observed (≥5%) adverse experiences seen in association with Trileptal in these patients were similar to those in previously treated patients.

Approximately 9% of these 295 adult patients discontinued treatment because of an adverse experience. The adverse experiences most commonly associated with discontinuation were: Dizziness (1.7%), nausea (1.7%), rash (1.7%), headache (1.4%).

Adjunctive Therapy/Monotherapy in Pediatric Patients 4 Years Old and Above Previously Treated with other AEDs: The most commonly observed (≥5%) adverse experiences seen in association with Trileptal in these patients were similar to those seen in adults.

Approximately 11% of these 456 pediatric patients discontinued treatment because of an adverse experience. The adverse experiences most commonly associated with discontinuation were: Somnolence (2.4%), vomiting (2.0%), ataxia (1.8%), diplopia (1.3%), dizziness (1.3%), fatigue (1.1%), nystagmus (1.1%).

Monotherapy in Pediatric Patients 4 Years Old and Above Not Previously Treated with other AEDs: The most commonly observed (≥5%) adverse experiences seen in association with Trileptal in these patients were similar to those in adults.

Approximately 9.2% of 152 pediatric patients discontinued treatment because of an adverse experience. The adverse experiences most commonly associated (≥1%) with discontinuation were rash (5.3%) and maculopapular rash (1.3%).

Adjunctive Therapy/Monotherapy in Pediatric Patients 1 Month to <4 Years Old Previously Treated or Not Previously Treated with other AEDs: The most commonly observed (≥5%) adverse experiences seen in association with Trileptal in these patients were similar to those seen in older children and adults except for infections and infestations which were more frequently seen in these younger children.

Approximately 11% of these 241 pediatric patients discontinued treatment because of an adverse experience. The adverse experiences most commonly associated with discontinuation were: Convulsions (3.7%), status epilepticus (1.2%), and ataxia (1.2%).

Incidence in Controlled Clinical Studies: The prescriber should be aware that the figures in Tables4, 5, 6 and 7 cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and nondrug factors to the adverse event incidences in the population studied.

Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Adults Previously Treated with other AEDs: Table 4 lists treatment-emergent signs and symptoms that occurred in at least 2% of adult patients with epilepsy treated with Trileptal or placebo as adjunctive treatment and were numerically more common in the patients treated with any dose of Trileptal. Table 5 lists treatment-emergent signs and symptoms in patients converted from other AEDs to either high dose Trileptal or low dose (300 mg) Trileptal. Note that in some of these monotherapy studies patients who dropped out during a preliminary tolerability phase are not included in the tables.

Controlled Clinical Study of Monotherapy in Adults Not Previously Treated with other AEDs: Table 6 lists treatment-emergent signs and symptoms in a controlled clinical study of monotherapy in adults not previously treated with other AEDs that occurred in at least 2% of adult patients with epilepsy treated with Trileptal or placebo and were numerically more common in the patients treated with Trileptal.

Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients Previously Treated with other AEDs:  Table 7 lists treatment-emergent signs and symptoms that occurred in at least 2% of pediatric patients with epilepsy treated with Trileptal or placebo as adjunctive treatment and were numerically more common in the patients treated with Trileptal.

Other Events Observed in Association with the Administration of Trileptal

In the paragraphs that follow, the adverse events, other than those in the preceding tables or text, that occurred in a total of 565 children and 1,574 adults exposed to Trileptal and that are reasonably likely to be related to drug use are presented. Events common in the population, events reflecting chronic illness and events likely to reflect concomitant illness are omitted particularly if minor. They are listed in order of decreasing frequency. Because the reports cite events observed in open label and uncontrolled trials, the role of Trileptal in their causation cannot be reliably determined.

Body as a Whole:  Fever, malaise, pain chest precordial, rigors, weight decrease.

Cardiovascular System:  Bradycardia, cardiac failure, cerebral hemorrhage, hypertension, hypotension postural, palpitation, syncope, tachycardia.

Digestive System:  Appetite increased, blood in stool, cholelithiasis, colitis, duodenal ulcer, dysphagia, enteritis, eructation, esophagitis, flatulence, gastric ulcer, gingival bleeding, gum hyperplasia, hematemesis, hemorrhage rectum, hemorrhoids, hiccup, mouth dry, pain biliary, pain right hypochondrium, retching, sialoadenitis, stomatitis, stomatitis ulcerative.

Hemic and Lymphatic System:  Leukopenia, thrombocytopenia.

Laboratory Abnormality:  Gamma-GT increased, hyperglycemia, hypocalcemia, hypoglycemia, hypokalemia, liver enzymes elevated, serum transaminase increased.

Musculoskeletal System:  Hypertonia muscle.

Nervous System:  Aggressive reaction, amnesia, anguish, anxiety, apathy, aphasia, aura, convulsions aggravated, delirium, delusion, depressed level of consciousness, dysphonia, dystonia, emotional lability, euphoria, extrapyramidal disorder, feeling drunk, hemiplegia, hyperkinesia, hyperreflexia, hypoesthesia, hypokinesia, hyporeflexia, hypotonia, hysteria, libido decreased, libido increased, manic reaction, migraine, muscle contractions involuntary, nervousness, neuralgia, oculogyric crisis, panic disorder, paralysis, paroniria, personality disorder, psychosis, ptosis, stupor, tetany.

Respiratory System:  Asthma, dyspnea, epistaxis, laryngismus, pleurisy.

Skin and Appendages:  Acne, alopecia, angioedema, bruising, dermatitis contact, eczema, facial rash, flushing, folliculitis, heat rash, hot flushes, photosensitivity reaction, pruritus genital, psoriasis, purpura, rash erythematous, rash maculopapular, vitiligo, urticaria.

Special Senses:  Accommodation abnormal, cataract, conjunctival hemorrhage, edema eye, hemianopia, mydriasis, otitis externa, photophobia, scotoma, taste perversion, tinnitus, xerophthalmia.

Surgical and Medical Procedures:  Procedure dental oral, procedure female reproductive, procedure musculoskeletal, procedure skin.

Urogenital and Reproductive System:  Dysuria, hematuria, intermenstrual bleeding, leukorrhea, menorrhagia, micturition frequency, pain renal, pain urinary tract, polyuria, priapism, renal calculus.

Other:  Systemic lupus erythematosus.

Post-Marketing and Other Experience

The following adverse events not seen in controlled clinical trials have been observed in named patient programs or post-marketing experience:

Body as a Whole: Multi-organ hypersensitivity disorders characterized by features such as rash, fever, lymphadenopathy, abnormal liver function tests, eosinophilia and arthralgia.

Anaphylaxis.

Skin and Appendages: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Side Effects by Body System

Nervous system

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%).

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 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

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.

Multi-organ hypersensitivity reactions are variable in expression and other organ system symptoms not noted may occur. If this reaction is suspected, oxcarbazepine 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.

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 (up to 15%), taste perversion (up to 5%), vertigo (up to 3%), earache (up to 2%), and ear infection (up to 2%).

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%). A case of leukopenia associated with oxcarbazepine following carbamazepine therapy has also been reported.

Endocrine

Endocrine side effects including lower serum testosterone, lower free androgen indexes, and a high frequency of elevated levels of androstenedione.

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