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Trileptal

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Trileptal

Trileptal

Trileptal Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Trileptal (oxcarbazepine) is used to treat partial seizures in adults and children who are at least 2 years old. It is an anticonvulsant, or antiepileptic drug. This medication is available in generic form. Common side effects include dizziness, drowsiness, fatigue, nausea, vomiting, headache, trouble sleeping, acne, dry mouth, or constipation.

Treatment with Trileptal starts at a dose of 600 mg/day, twice daily. If needed, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the recommended daily dose is 1200 mg/day. Trileptal may interact with carbamazepine, phenobarbital, phenytoin, or valproic acid. Many other medicines may interact with oxcarbazepine. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Trileptal should be used only when prescribed. It may harm a fetus. Since untreated seizures are a serious condition that can harm both a pregnant woman and the fetus, do not stop taking this medication unless directed by your doctor. Hormonal birth control may not work if taken with this medication. Discuss birth control with your doctor. This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Our Trileptal (oxcarbazepine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Trileptal in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 a serious side effect such as:

  • 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.

Less serious 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Trileptal (Oxcarbazepine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Trileptal Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, drowsiness, fatigue, nausea, vomiting, headache, trouble sleeping, acne, dry mouth, or constipation may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Tell your doctor immediately if you develop any of these serious side effects: double vision, change in vision, involuntary eye movements, difficulty speaking, difficulty concentrating, loss of coordination, trouble walking (abnormal gait), uncontrolled muscle movements (tremor), dulled sense of touch.

Tell your doctor immediately if you develop any of these unlikely but very serious side effects: easy bleeding/bruising, chest pain, persistent sore throat, stomach/abdominal pain, bloody stool, dark urine, change in amount of urine, yellowing of eyes/skin.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: fever, rash, itching/swelling (especially of the face/tongue/throat/lymph nodes), joint/muscle pain, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Trileptal (Oxcarbazepine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Trileptal FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience

Most Common Adverse Reactions in All Clinical Studies

Adjunctive Therapy/Monotherapy in Adults Previously Treated with other AEDs

The most commonly observed ( ≥ 5%) adverse reactions seen in association with Trileptal 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 reactions 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 reactions 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 reactions 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 reactions 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 reactions 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 reactions 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 reactions 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 reactions 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 reaction 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 Tables 3, 4, 5 and 6 cannot be used to predict the frequency of adverse reactions 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 3 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 4 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.

Table 3 : Treatment-Emergent Adverse Event Incidence in a Controlled Clinical Study of Adjunctive Therapy in Adults (Events in at Least 2% of Patients Treated with 2400 mg/day of Trileptal and Numerically More Frequent than in the Placebo Group)

Body System/ Adverse Event Oxcarbazepine Dosage (mg/day)
OXC 600
N=163 %
OXC 1200
N=171 %
OXC 2400
N=126 %
Placebo
N=166 %
Body as a Whole
  Fatigue 15 12 15 7
  Asthenia 6 3 6 5
  Edema Legs 2 1 2 1
  Weight Increase 1 2 2 1
  Feeling Abnormal 0 1 2 0
Cardiovascular System
  Hypotension 0 1 2 0
Digestive System
  Nausea 15 25 29 10
  Vomiting 13 25 36 5
  Pain Abdominal 10 13 11 5
  Diarrhea 5 6 7 6
  Dyspepsia 5 5 6 2
  Constipation 2 2 6 4
  Gastritis 2 1 2 1
Metabolic and Nutritional Disorders
  Hyponatremia 3 1 2 1
Musculoskeletal System
  Muscle Weakness 1 2 2 0
  Sprains and Strains 0 2 2 1
Nervous System
  Headache 32 28 26 23
  Dizziness 26 32 49 13
  Somnolence 20 28 36 12
  Ataxia 9 17 31 5
  Nystagmus 7 20 26 5
  Gait Abnormal 5 10 17 1
  Insomnia 4 2 3 1
  Tremor 3 8 16 5
  Nervousness 2 4 2 1
  Agitation 1 1 2 1
  Coordination Abnormal 1 3 2 1
  EEG Abnormal 0 0 2 0
  Speech Disorder 1 1 3 0
  Confusion 1 1 2 1
  Cranial Injury NOS 1 0 2 1
  Dysmetria 1 2 3 0
  Thinking Abnormal 0 2 4 0
Respiratory System
  Rhinitis 2 4 5 4
Skin and Appendages
  Acne 1 2 2 0
Special Senses
  Diplopia 14 30 40 5
  Vertigo 6 12 15 2
  Vision Abnormal 6 14 13 4
  Accommodation Abnormal 0 0 2 0

Table 4 : Treatment-Emergent Adverse Event Incidence in Controlled Clinical Studies of Monotherapy in Adults Previously Treated with Other AEDs (Events in at Least 2% of Patients Treated with 2400 mg/day of Trileptal and Numerically More Frequent than in the Low Dose Control Group)

Body System/ Adverse Event Oxcarbazepine Dosage (mg/day)
2400
N=86 %
300
N=86 %
Body as a Whole
  Fatigue 21 5
  Fever 3 0
  Allergy 2 0
  Edema Generalized 2 1
  Pain Chest 2 0
Digestive System
  Nausea 22 7
  Vomiting 15 5
  Diarrhea 7 5
  Dyspepsia 6 1
  Anorexia 5 3
  Pain Abdominal 5 3
  Mouth Dry 3 0
  Hemorrhage Rectum 2 0
  Toothache 2 1
Hemic and Lymphatic System
  Lymphadenopathy 2 0
Infections and Infestations
  Infection Viral 7 5
  Infection 2 0
Metabolic and Nutritional Disorders
  Hyponatremia 5 0
  Thirst 2 0
Nervous System
  Headache 31 15
  Dizziness 28 8
  Somnolence 19 5
  Anxiety 7 5
  Ataxia 7 1
  Confusion 7 0
  Nervousness 7 0
  Insomnia 6 3
  Tremor 6 3
  Amnesia 5 1
  Convulsions Aggravated 5 2
  Emotional Lability 3 2
  Hypoesthesia 3 1
  Coordination Abnormal 2 1
  Nystagmus 2 0
  Speech Disorder 2 0
Respiratory System
  Upper Respiratory Tract Infection 10 5
  Coughing 5 0
  Bronchitis 3 0
  Pharyngitis 3 0
Skin and Appendages
  Hot Flushes 2 1
  Purpura 2 0
Special Senses
  Vision Abnormal 14 2
  Diplopia 12 1
  Taste Perversion 5 0
  Vertigo 3 0
  Earache 2 1
  Ear Infection NOS 2 0
Urogenital and Reproductive System
  Urinary Tract Infection 5 1
  Micturition Frequency Vaginitis 2 2 1 0

Controlled Clinical Study of Monotherapy in Adults Not Previously Treated with other AEDs

Table 5 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.

Table 5 : Treatment-Emergent Adverse Event Incidence in a Controlled Clinical Study of Monotherapy in Adults Not Previously Treated with Other AEDs (Events in at Least 2% of Patients Treated with Trileptal and Numerically More Frequent than in the Placebo Group)

Body System/ Adverse Event Oxcarbazepine
N=55 %
Placebo
N=49 %
Body as a Whole
  Falling Down NOS 4 0
Digestive System
  Nausea 16 12
  Diarrhea 7 2
  Vomiting 7 6
  Constipation 5 0
  Dyspepsia 5 4
Musculoskeletal System
  Pain Back 4 2
Nervous System
  Dizziness 22 6
  Headache 13 10
  Ataxia 5 0
  Nervousness 5 2
  Amnesia 4 2
  Coordination Abnormal 4 2
  Tremor 4 0
Respiratory System
  Upper Respiratory Tract Infection 7 0
  Epistaxis 4 0
  Infection Chest 4 0
  Sinusitis 4 2
Skin and Appendages
  Rash 4 2
Special Senses
  Vision Abnormal 4 0

Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients Previously Treated with other AEDs

Table 6 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.

Table 6 : Treatment-Emergent Adverse Event Incidence in Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients Previously Treated with Other AEDs (Events in at Least 2% of Patients Treated with Trileptal and Numerically More Frequent than in the Placebo Group)

Body System/ Adverse Event Oxcarbazepine
N=171%
Placebo
N=139%
Body as a Whole
  Fatigue 13 9
  Allergy 2 0
  Asthenia 2 1
Digestive System
  Vomiting 33 14
  Nausea 19 5
  Constipation 4 1
  Dyspepsia 2 0
Nervous System
  Headache 31 19
  Somnolence 31 13
  Dizziness 28 8
  Ataxia 13 4
  Nystagmus 9 1
  Emotional Lability 8 4
  Gait Abnormal 8 3
  Tremor 6 4
  Speech Disorder 3 1
  Concentration Impaired 2 1
  Convulsions 2 1
  Muscle Contractions Involuntary 2 1
Respiratory System
  Rhinitis 10 9
  Pneumonia 2 1
Skin and Appendages
  Bruising 4 2
  Sweating Increased 3 0
Special Senses
  Diplopia 17 1
  Vision Abnormal 13 1
  Vertigo 2 0

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.

Hematologic and Lymphatic System: 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 [see WARNINGS AND PRECAUTIONS]

Anaphylaxis: [see WARNINGS AND PRECAUTIONS]

Digestive System: pancreatitis and/or lipase and/or amylase increase

Hematologic and Lymphatic Systems: aplastic anemia [see WARNINGS AND PRECAUTIONS]

Metabolism: hypothyroidism

Skin and Appendages: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Trileptal (Oxcarbazepine) »

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Trileptal - User Reviews

Trileptal User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Trileptal sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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