Trileptal Side Effects Center

Last updated on RxList: 10/5/2022
Trileptal Side Effects Center

What Is Trileptal?

Trileptal (oxcarbazepine) is an anticonvulsant, or antiepileptic drug, used to treat partial seizures in adults and children who are at least 2 years old. Trileptal is available in generic form.

What Are Side Effects of Trileptal?

Trileptal may cause serious side effects including:  

  • skin rash,
  • fever,
  • swollen glands,
  • flu-like symptoms,
  • muscle aches,
  • severe weakness,
  • unusual bruising, and
  • yellowing of your skin or eyes

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Trileptal include:

  • dizziness,
  • drowsiness,
  • tired feeling,
  • fatigue,
  • nausea,
  • vomiting,
  • upset stomach,
  • diarrhea,
  • headache,
  • mental slowness,
  • trouble concentrating,
  • trouble sleeping,
  • shaking,
  • acne,
  • skin rash,
  • blurred or double vision,
  • dry mouth,
  • constipation, and
  • problems with speech, balance, or walking.
Tell your doctor if you have serious side effects of Trileptal including:
  • changes in vision,
  • involuntary eye movements,
  • difficulty speaking,
  • difficulty concentrating,
  • loss of coordination,
  • trouble walking (abnormal gait),
  • uncontrolled muscle movements (tremor),
  • dulled sense of touch,
  • easy bleeding or bruising,
  • chest pain,
  • persistent sore throat,
  • stomach or abdominal pain,
  • bloody stool,
  • dark urine,
  • change in amount of urine, or
  • yellowing of eyes or skin.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Trileptal

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.

What Drugs, Substances, or Supplements Interact with Trileptal?

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.

Trileptal During Pregnancy or Breastfeeding

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 breastfeeding.

Additional Information

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.

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Trileptal Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Call your doctor right away if you have nausea, lack of energy, confusion, feeling tired or irritable, severe weakness, muscle pain, or increased 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.

Common side effects may include:

  • dizziness, drowsiness, tiredness;
  • balance or coordination problems;
  • nausea, vomiting;
  • tremors or shaking;
  • double vision; or
  • 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.

SLIDESHOW

What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow
Trileptal Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

  • Hyponatremia [see WARNINGS AND PRECAUTIONS]
  • Anaphylactic Reactions and Angioedema [see WARNINGS AND PRECAUTIONS]
  • Cross Hypersensitivity Reaction to Carbamazepine [see WARNINGS AND PRECAUTIONS]
  • Serious Dermatological Reactions [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
  • Cognitive/Neuropsychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see WARNINGS AND PRECAUTIONS]
  • Hematologic Events [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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.

Most Common Adverse Reactions In All Clinical Studies

Adjunctive Therapy/Monotherapy In Adults Previously Treated With Other AEDs

The most common (≥ 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions with TRILEPTAL: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus tremor, and abnormal gait.

Approximately 23% of these 1537 adult patients discontinued treatment because of an adverse reaction. 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%), and hyponatremia (1.0%).

Monotherapy In Adults Not Previously Treated With Other AEDs

The most common (≥ 5%) adverse reactions 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 reaction. The adverse reactions most commonly associated with discontinuation were: dizziness (1.7%), nausea (1.7%), rash (1.7%), and headache (1.4%).

Adjunctive Therapy/Monotherapy In Pediatric Patients 4 Years Old And Above Previously Treated With Other AEDs

The most common (≥ 5%) adverse reactions 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 reaction. 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%), and nystagmus (1.1%).

Monotherapy In Pediatric Patients 4 Years Old And Above Not Previously Treated With Other AEDs

The most common (≥ 5%) adverse reactions with TRILEPTAL in these patients were similar to those in adults.

Approximately 9.2% of 152 pediatric patients discontinued treatment because of an adverse reaction. 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 common (≥ 5%) adverse reactions 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 reaction. The adverse reactions most commonly associated with discontinuation were: convulsions (3.7%), status epilepticus(1.2%), and ataxia (1.2%).

Controlled Clinical Studies Of Adjunctive Therapy/Monotherapy In Adults Previously Treated With Other AEDs

Table 3 lists adverse reactions 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 adverse reactions in patients converted from other AEDs to either high-dose TRILEPTAL (2400mg/day) or low-dose (300 mg/day) 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: Adverse Reactions in a Controlled Clinical Study of Adjunctive Therapy With TRILEPTAL in Adults

Body System/ Adverse Reaction TRILEPTAL Dosage (mg/day)
TRILEPTAL 600
N = 163 %
TRILEPTAL 1200
N= 171 %
TRILEPTAL 2400
N = 126 %
Placebo
N= 166 %
Body as a Whole
Fatigue 15 12 15 7
Asthenia 6 3 6 5
Leg Edema 2 1 2 1
Increased Weight 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
Abdominal Pain 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
Abnormal Gait 5 10 17 1
Insomnia 4 2 3 1
Tremor 3 8 16 5
Nervousness 2 4 2 1
Agitation 1 1 2 1
Abnormal Coordination 1 3 2 1
Abnormal EEG 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
Abnormal Thinking 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
Abnormal Vision 6 14 13 4
Abnormal Accommodation 0 0 2 0

Table 4: Adverse Reactions in Controlled Clinical Studies of Monotherapy With TRILEPTAL in Adults Previously Treated With Other AEDs

Body System/ Adverse Reaction TRILEPTAL 2400 mg/day
N = 86 %
TRILEPTAL 300 mg/day
N = 86 %
Body as a Whole
Fatigue 21 5
Fever 3 0
Allergy 2 0
Generalized Edema 2 1
Chest Pain 2 0
Digestive System
Nausea 22 7
Vomiting 15 5
Diarrhea 7 5
Dyspepsia 6 1
Anorexia 5 3
Abdominal Pain 5 3
Dry Mouth 3 0
Hemorrhage Rectum 2 0
Toothache 2 1
Hemic and Lymphatic System
Lymphadenopathy 2 0
Infections and Infestations
Viral Infection 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
Aggravated Convulsions 5 2
Emotional Lability 3 2
Hypoesthesia 3 1
Abnormal Coordination 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
Abnormal Vision 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 2 1
Vaginitis 2 0

Controlled Clinical Study Of Monotherapy In Adults Not Previously Treated With Other AEDs

Table 5 lists adverse reactions 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: Adverse Reactions in a Controlled Clinical Study of Monotherapy With TRILEPTAL in Adults Not Previously Treated With Other AEDs

Body System/ Adverse Reaction TRILEPTAL
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
Back Pain 4 2
Nervous System
Dizziness 22 6
Headache 13 10
Ataxia 5 0
Nervousness 5 2
Amnesia 4 2
Abnormal Coordination 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 adverse reactions 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: Adverse Reactions in Controlled Clinical Studies of Adjunctive Therapy/Monotherapy With TRILEPTAL in Pediatric Patients Previously Treated With Other AEDs

Body System/ Adverse Reaction TRILEPTAL
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
Abnormal Gait 8 3
Tremor 6 4
Speech Disorder 3 1
Impaired Concentration 2 1
Convulsions 2 1
Involuntary Muscle Contractions 2 1
Respiratory System
Rhinitis 10 9
Pneumonia 2 1
Skin and Appendages
Bruising 4 2
Increased Sweating 3 0
Special Senses
Diplopia 17 1
Abnormal Vision 13 1
Vertigo 2 0

Other Events Observed In Association With The Administration Of TRILEPTAL

In the paragraphs that follow, the adverse reactions, other than those in the preceding tables or text, that occurred in a total of 565 children and 1574 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, esophagi is, 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, extra pyramidal 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

Laboratory Tests

Serum sodium levels below 125 mmol/L have been observed in patients treated with TRILEPTAL [see WARNINGS AND PRECAUTIONS]. Experience from clinical trials indicates that serum sodium levels return toward normal when the TRILEPTAL dosage is reduced or discontinued, or when the patient was treated conservatively (e.g., fluid restriction).

Laboratory data from clinical trials suggest that TRILEPTAL use was associated with decreases in T4, without changes in T3 or TSH.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of TRILEPTAL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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]

Cardiovascular System: atrioventricular block

Immune System Disorders: anaphylaxis [see WARNINGS AND PRECAUTIONS]

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

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

Metabolism and Nutrition Disorders: hypothyroidism and syndrome of inappropriate antidiuretic hormone secretion(SIADH)

Skin and Subcutaneous Tissue Disorders: erythema multiforme, Stevens-Johnson syndrome, toxic epidermalnecrolysis [see WARNINGS AND PRECAUTIONS], Acute Generalized Exanthematous Pustulosis (AGEP)

Musculoskeletal, Connective Tissue and Bone Disorders: There have been reports of decreased bone mineraldensity, osteoporosis and fractures in patients on long-term therapy with TRILEPTAL.

Injury, Poisoning, and Procedural Complications: fall

Nervous System Disorders: dysarthria

DRUG INTERACTIONS

Effect Of TRILEPTAL On Other Drugs

Phenytoin levels have been shown to increase with concomitant use of TRILEPTAL at doses greater than 1200mg/day [see CLINICAL PHARMACOLOGY]. Therefore, it is recommended that the plasma levels of phenytoin be monitored during the period of TRILEPTAL titration and dosage modification. A decrease in the dose of phenytoinmay be required.

Effect Of Other Drugs On TRILEPTAL

Strong inducers of cytochrome P450 enzymes and/or inducers of UGT (e.g., rifampin, carbamazepine, phenytoin and phenobarbital) have been shown to decrease the plasma/serum levels of MHD, the active metabolite of TRILEPTAL (25% to 49%) [see CLINICAL PHARMACOLOGY]. If TRILEPTAL and strong CYP3A4 inducers, or UGT inducers are administered concurrently, it is recommended that the plasma levels of MHD be monitored during the period of TRILEPTAL titration. Dose adjustment of TRILEPTAL may be required after initiation, dosage modification, or discontinuation of such inducers.

Hormonal Contraceptives

Concurrent use of TRILEPTAL with hormonal contraceptives may render these contraceptives less effective [see Use In Specific Populations and CLINICAL PHARMACOLOGY]. Studies with other oral or implant contraceptives have not been conducted.

Drug Abuse And Dependence

Abuse

The abuse potential of TRILEPTAL has not been evaluated in human studies.

Dependence

Intragastric injections of oxcarbazepine to 4 cynomolgus monkeys demonstrated no signs of physical dependence asmeasured by the desire to self-administer oxcarbazepine by lever pressing activity.

Read the entire FDA prescribing information for Trileptal (Oxcarbazepine)

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© Trileptal Patient Information is supplied by Cerner Multum, Inc. and Trileptal Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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