Oxcarbazepine is an active pharmaceutical ingredient in the Carboxamide Derivatives group (N03AF). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised May 15, 2026[1]
Oxcarbazepine Mylan is indicated for the treatment of partial seizures with or without secondarily generalised tonic-clonic seizures. Oxcarbazepine Mylan is indicated for use as monotherapy or adjunctive therapy in adults and in children of 6 years of age and above.
How to take
GB
CACanada· Health Canada
12 products
Uses
CAOfficial regulatory label· revised February 10, 2026[2]
AND CLINICAL USE...................................................................................... 3 CONTRAINDICATIONS........................................................................................................... 3 WARNINGS AND PRECAUTIONS..........................................................................................
3 ADVERSE REACTIONS........................................................................................................... 14 DRUG INTERACTIONS............................................................................................................
24 DOSAGE AND ADMINISTRATION........................................................................................ 26 OVERDOSAGE..........................................................................................................................
29 ACTION AND CLINICAL PHARMACOLOGY...................................................................... 29 STORAGE AND STABILITY................................................................................................... 32 DOSAGE FORMS, COMPOSITION AND PACKAGING.......................................................
USUnited States· FDA
5 products
Uses
USOfficial regulatory label· revised May 29, 2025[3]
1 INDICATIONS AND USAGE Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.
Oxcarbazepine tablets are indicated for: • Adults:
Monotherapy or adjunctive therapy in the treatment of partial-onset seizures • Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4 to 16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years ( 1 )
How to take
Drug interactions
Known interactions involving Oxcarbazepine. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]Health Canada (DPD) · 02439743 · revised February 10, 2026
[3]FDA DailyMed · 0abe9478-4084-28… · revised May 29, 2025 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
In mono- and adjunctive therapy, treatment with Oxcarbazepine Mylan is initiated with a clinically effective dose given in two divided doses. The dose may be increased depending on the clinical response of the patient. When other antiepileptic medicinal products are replaced by Oxcarbazepine Mylan, the dose of the concomitant antiepileptic medicinal products(s) should be reduced gradually on initiation of Oxcarbazepine Mylan therapy.
5). Therapeutic drug monitoring The therapeutic effect of oxcarbazepine is primarily exerted through the active metabolite 10-monohydroxy derivative (MHD) of oxcarbazepine (see section 5). Plasma level monitoring of oxcarbazepine or MHD is not routinely warranted.
4). In such situations, the dose of oxcarbazepine may be adjusted (based on plasma levels measured 2-4 hours post dose) to maintain peak MHD plasma levels< 35 mg/L. Adults Monotherapy Recommended initial dose Oxcarbazepine Mylan should be initiated with a dose of 600 mg/day (8-10 mg/kg/day) given in 2 divided doses.
Maintenance dose If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals from the starting dose to achieve the desired clinical response. Therapeutic effects are seen at doses between 600 mg/day and 2,400 mg/day.
Controlled monotherapy trials in patients not currently being treated with antiepileptic medicinal products showed 1,200 mg/day to be an effective dose; however, a dose of 2,400 mg/day has been shown to be effective in more refractory patients converted from other antiepileptic medicinal products to oxcarbazepine monotherapy.
Maximum recommended dose In a controlled hospital setting, dose increases up to 2400 mg/day have been achieved over 48 hours. Adjunctive therapy Recommended initial dose Oxcarbazepine Mylan should be initiated with a dose of 600 mg/day (8-10 mg/kg/day) given in 2 divided doses.
Maintenance dose If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals from the starting dose to achieve the desired clinical response. Therapeutic responses are seen at doses between 600 mg/day and 2,400 mg/day.
Maximum recommended dose Daily doses from 600 to 2,400 mg/day have been shown to be effective in a controlled adjunctive therapy trial, although most patients were not able to tolerate the 2,400 mg/day dose without reduction of concomitant antiepileptic medicinal products, mainly because of CNS-related adverse events.
Daily doses above 2,400 mg/day have not been studied systematically in clinical trials. Elderly (65 years old and above) No special dose recommendations are necessary in elderly patients because therapeutic doses are individually adjusted.
Dosage adjustments are recommended in elderly patients with renal impairment (creatinine clearance less than 30 ml/min) (see information below on dosage in renal impairment). Close monitoring of sodium levels is required inpatients at risk of hyponatraemia see section
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 15, 2026[1]
Summary of the safety profile The most commonly reported adverse reactions are somnolence, headache, dizziness, diplopia, nausea, vomiting and fatigue occurring in more than 10% of patients. The safety profile is based on adverse events (AEs) from clinical trials assessed as related to oxcarbazepine.
In addition, clinically meaningful reports on adverse experiences from named patient programs and post-marketing experience were taken into account. Adverse drug reactions are listed by MedRA system organ class. Tabulated list of adverse reactions Frequency estimate*:- very common: ≥ 1/10; common: ≥1/100 - <1/10; uncommon: ≥1/1,000 - <1/100; rare: ≥ 1/10,000 - < 1/1,000; very rare: < 1/10,000 Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Blood and lymphatic system disorders Uncommon:
Rare: Very rare: Leucopenia Bone marrow depression, aplastic anaemia, agranulocytosis, pancytopenia, neutropenia.
Thrombocytopenia Immune system disorders Rare:
Very rare: Anaphylactic reactions Hypersensitivity# Endocrine disorders Common: Uncommon: Weight increased Hypothyroidism Metabolism and nutrition disorders Common: Rare: Hyponatraemia† Inappropriate ADH secretion like syndrome with signs and symptoms of lethargy, nausea, dizziness, decrease in serum (blood) osmolality, vomiting, headache, confusional state or other neurological signs and symptoms.
g. nervousness), affect lability, confusional state, depression, apathy.
Nervous system disorders Very common:
Common: Somnolence, headache, dizziness. Ataxia, tremor, nystagmus, disturbance in attention, amnesia, speech disorders (including dysarthria); more frequent during up titration of oxcarbazepine dose Eye disorders Very common: Common: Diplopia.
Vision blurred, visual disturbance. Ear and labyrinth disorders Common: vertigo.
Cardiac disorders Very rare:
Atrioventricular block, arrhythmia.
Vascular disorders Uncommon:
Hypertension Gastrointestinal disorders Very common: Common: Very rare: Vomiting, nausea Diarrhoea, abdominal pain, constipation. Pancreatitis and/or lipase and/or amylase increase.
Hepatobiliary disorders Very rare:
Hepatitis.
Skin and subcutaneous tissue disorders Common:
Uncommon: Rare: Very rare: Rash, alopecia, acne. Urticaria. 4).
Musculoskeletal and connective tissue disorders Rare:
Very rare: There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with oxcarbazepine. The mechanism by which oxcarbazepine affects bone metabolism has not been identified.
Systemic lupus erythematosus.
General disorders and administration site conditions Very common:
Common: Fatigue. Asthenia.
Investigations Uncommon:
Rare: Hepatic enzymes increased, blood alkaline phosphatase increased. Decrease in T4 (with unclear clinical significance). Injury, poisoning and procedural complications Uncommon Fall Description of selected adverse reactions #Hypersensitivity (including multi-organ hypersensitivity) characterised by features such as rash, fever.
g. g. g. g. g. g. pulmonary oedema, asthma, bronchospasms, interstitial lung disease, dyspnoea), angioedema. 4). In most cases, the hyponatriaemia is asymptomatic and does not require adjustment of therapy. g. blurred vision), hypothyroidism, vomiting, and nausea.
4). 1).
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised May 15, 2026[1]
4. Patients with hepatic impairment No dosage adjustment is required for patients with mild to moderate hepatic impairment. 2). 2). Dose escalation in renally impaired patients may require more careful observation. Paediatric population Recommended initial dose In mono- and adjunctive therapy, Oxcarbazepine Mylan should be initiated with a dose of 8-10 mg/kg/day given in 2 divided doses.
Maintenance dose In adjunctive therapy trials, a maintenance dose of 30-46 mg/kg/day, achieved over two weeks, is shown to be effective and well tolerated in children. Therapeutic effects were seen at a median maintenance dose of approximately 30 mg/kg/day.
2). Oxcarbazepine Mylan is recommended for use in children of 6 years of age and above. Safety and efficacy have been evaluated in controlled clinical trials involving approximately 230 children aged less than 6 years (down to 1 month).
Oxcarbazepine is not recommended in children aged less than 6 years since safety and efficacy have not been adequately demonstrated. All the above dosing recommendations (adults, elderly and children) are based on the doses studied in clinical trials for all age groups.
However, lower initiation doses may be considered where appropriate. Method of administration Oral use. Oxcarbazepine Mylan can be taken with or without food. The tablets are scored and can be broken in two halves in order to make it easier for the patient to swallow the tablet.
However, the tablet cannot be divided into equal doses. For children, who cannot swallow tablets or where the required dose cannot be administered using tablets, other oxcarbazepine containing pharmaceutical forms are available. 1. 4 Special warnings and precautions for use Hypersensitivity Class I (immediate) hypersensitivity reactions including rash, pruritus, urticaria, angioedema and reports of anaphylaxis have been received in the post-marketing period.
Cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of oxcarbazepine. If a patient develops these reactions after treatment with oxcarbazepine, the drug should be discontinued and an alternative treatment started.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 15, 2026[1]
1.
This is not medical advice. Consult a qualified healthcare professional.
40 REFERENCES............................................................................................................................ 48 PART III: CONSUMER INFORMATION.............................................................................
50 __________________________________________________________________________________________________________________ PrOxcarbazepine Tablets Page 3 of 53 Pr OXCARBAZEPINE (Oxcarbazepine Tablets) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Nonmedicinal Ingredients Oral Tablets, 150 mg, 300 mg and 600 mg hypromellose, microcrystalline cellulose, crospovidone, colloidal silica anhydrous, magnesium stearate, titanium dioxide, macrogol 8000, iron oxide yellow, iron oxide red, talc.
INDICATIONS AND CLINICAL USE Adults:
Oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures.
Pediatrics (6 to 16 years of age):
Oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures.
Geriatrics (> 65 years of age):
Evidence from clinical studies indicates that there are differences in the pharmacokinetic profile of oxcarbazepine in the geriatric population relative to younger adults, which may be associated with differences in safety or effectiveness.
A brief discussion can be found in the appropriate sections (See WARNINGS AND PRECAUTIONS, Special Populations-Geriatrics; ACTIONS AND CLINICAL PHARMACOLOGY; DOSAGE AND ADMINISTRATION, Dosing Considerations). CONTRAINDICATIONS Patients with a known hypersensitivity to oxcarbazepine or eslicarbazepine acetate or to any of the components of Oxcarbazepine Tablets.
For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
WARNINGS AND PRECAUTIONS HEMATOLOGIC:
Although reported infrequently, serious adverse effects have been observed during the use of oxcarbazepine. Agranulocytosis and aplastic anemia have occurred very rarely. Leucopenia, thrombocytopenia and hepatitis have also been reported.
However, in the majority of cases, leucopenia and thrombocytopenia were transient and did not signal the onset of either aplastic anemia or agranulocytosis. It is important that oxcarbazepine be used carefully and close clinical and frequent laboratory supervision should be maintained throughout treatment in order to detect as early as possible signs and __________________________________________________________________________________________________________________ PrOxcarbazepine Tablets Page 4 of 53 symptoms of a possible blood dyscrasia.
Oxcarbazepine should be discontinued if any evidence of significant bone marrow depression appears (see WARNINGS AND PRECAUTIONS).
DERMATOLOGIC:
Serious and sometimes fatal dermatologic reactions, including Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have been reported with oxcarbazepine. Human Leukocyte Antigens (HLA)-A*3101 and HLA-B*1502 may be risk factors for the development of serious cutaneous adverse drug reactions.
Retrospective genome-wide studies in Japanese and Northern European populations reported an association between severe skin reactions (SJS, TEN, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Acute Generalized Exanthematous Pustulosis (AGEP) and maculopapular rash) associated with carbamazepine use and the presence of the HLA-A*3101 allele in these patients.
Similarly, in studies that included small samples of patients of Han Chinese ancestry a strong association was found between the risk of developing SJS/TEN and the presence of the HLA-B*1502 allele. The HLA-B*1502 allele is found almost exclusively in individuals with ancestry across broad areas of Asia†.
It is therefore, recommended that physicians consider HLA-B*1502 genotyping as a screening tool in genetically at-risk populations (see WARNINGS AND PRECAUTIONS - Ancestry and Allelic Variations in the HLA-B Gene). Until further information is available, the use of oxcarbazepine and other anti-epileptic drugs associated with SJS/TEN should be avoided in patients who test positive for the […]
USOfficial regulatory label· revised May 29, 2025[3]
2 DOSAGE AND ADMINISTRATION Adults : initiate with a dose of 600 mg/day, given twice a day • Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. 7 ) Pediatrics : initiation with 8 to 10 mg/kg/day, given twice a day.
For patients aged 2 to < 4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight. 4 ). 1 Adjunctive Therapy for Adults Initiate oxcarbazepine tablets with a dose of 600 mg/day, given twice a day.
If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the maximum recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day show somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of central nervous (CNS) effects.
2 ) ]. 2 Conversion to Monotherapy for Adults Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets at 600 mg/day (given in a twice a day regimen) while simultaneously initiating the reduction of the dose of the concomitant AEDs.
The concomitant AEDs should be completely withdrawn over 3 to 6 weeks, while the maximum dose of oxcarbazepine tablets should be reached in about 2 to 4 weeks. Oxcarbazepine tablets may be increased as clinically indicated by a maximum increment of 600 mg/day at approximately weekly intervals to achieve the maximum recommended daily dose of 2400 mg/day.
A daily dose of 1200 mg/day has been shown in one study to be effective in patients in whom monotherapy has been initiated with oxcarbazepine tablets. Patients should be observed closely during this transition phase. 3 Initiation of Monotherapy for Adults Patients not currently being treated with AEDs may have monotherapy initiated with oxcarbazepine tablets.
In these patients, initiate oxcarbazepine tablets at a dose of 600 mg/day (given a twice a day); the dose should be increased by 300 mg/day every third day to a dose of 1200 mg/day. Controlled trials in these patients examined the effectiveness of a 1200 mg/day dose; a dose of 2400 mg/day has been shown to be effective in patients converted from other AEDs to oxcarbazepine tablets monotherapy (see above).
4 Adjunctive Therapy for Pediatric Patients (Aged 2 to 16 Years) In pediatric patients aged 4 to 16 years, initiate oxcarbazepine tablets at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given twice a day. 1 to 39 kg-1200 mg/day • 39 kg-1800 mg/day In the clinical trial, in which the intention was to reach these target doses, the median daily dose was 31 mg/kg with a range of 6 to 51 mg/kg.
In pediatric patients aged 2 to < 4 years, initiate oxcarbazepine tablets at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given twice a day. 3 ) ]. The maximum maintenance dose of oxcarbazepine tablets should be achieved over 2 to 4 weeks and should not exceed 60 mg/kg/day in a twice a day regimen.
In the clinical trial in pediatric patients (2 to 4 years of age), in which the intention was to reach the target dose of 60 mg/kg/day, 50% of patients reached a final dose of at least 55 mg/kg/day. Under adjunctive therapy (with and without enzyme-inducing AEDs), when normalized by body weight, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to < 4 years of age may require up to twice the oxcarbazepine dose per body weight compared to adults; and children 4 to ≤ 12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults.
2 )]. 5 Conversion to Monotherapy for Pediatric Patients (Aged 4 to 16 Years) Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets at approximately 8 to 10 mg/kg/day given twice a day, while simultaneously initiating the reduction of the dose of the concomitant AEDs.
The concomitant AEDs can be completely withdrawn over 3 to 6 weeks, while oxcarbazepine tablets may be increased as clinically indicated by a maximum increment of 10 mg/kg/day at approximately weekly intervals to achieve the recommended daily dose.
Patients should be observed closely during this transition phase. The recommended total daily dose of oxcarbazepine tablets is shown in Table 1. 6 Initiation of Monotherapy for Pediatric Patients (Aged 4 to 16 Years) Patients not currently being treated with AEDs may have monotherapy initiated with oxcarbazepine tablets.
In these patients, initiate oxcarbazepine tablets at a dose of 8 to 10 mg/kg/day given twice a day. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown in the table below. 3 ) ]. 3 ) ]. Oxcarbazepine oral suspension and oxcarbazepine tablets may be interchanged at equal doses.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 1,375 reports total. [4]
Seizure 167
Drug Ineffective 166
Off Label Use 163
Somnolence 85
Nausea 65
Hyponatraemia 64
Fatigue 63
Product Dose Omission Issue 62
Headache 60
Dizziness 57
Fall 53
Drug Interaction 49
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised May 29, 2025[3]
gov/medwatch. 1 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 oxcarbazepine: 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. 0%). Monotherapy in Adults Not Previously Treated With Other AEDs The most common (≥ 5%) adverse reactions with oxcarbazepine 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. 4%). Adjunctive Therapy/Monotherapy in Pediatric Patients 4 Years Old and Above Previously Treated With Other AEDs The most common (≥ 5%) adverse reactions with oxcarbazepine in these patients were similar to those seen in adults.
Approximately 11% of these 456 pediatric patients discontinued treatment because of an adverse reaction. 1%). Monotherapy in Pediatric Patients 4 Years Old and Above Not Previously Treated With Other AEDs The most common (≥ 5%) adverse reactions with oxcarbazepine in these patients were similar to those in adults.
2% of 152 pediatric patients discontinued treatment because of an adverse reaction. 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 oxcarbazepine 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. 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 oxcarbazepine or placebo as adjunctive treatment and were numerically more common in the patients treated with any dose of oxcarbazepine.
Table 4 lists adverse reactions in patients converted from other AEDs to either high-dose oxcarbazepine (2400 mg/day) or low-dose (300 mg/day) oxcarbazepine. Note that in some of these monotherapy studies patients who dropped out during a preliminary tolerability phase are not included in the tables.
Adverse Reactions in Controlled Clinical Studies of Monotherapy With Oxcarbazepine in Adults Previously Treated With Other Antiepileptic Drugs Body system/ Adverse reaction Oxcarbazepine dosage (mg/day) Oxcarbazepine 2400 mg/day N = 86 % Oxcarbazepine 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 Abbreviation: NOS, not otherwise specified.
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 oxcarbazepine or placebo and were numerically more common in the patients treated with oxcarbazepine.
Table 5:
Adverse Reactions in a Controlled Clinical Study of Monotherapy With Oxcarbazepine in Adults Not Previously Treated With Other Antiepileptic Drugs Body system/ Adverse reaction 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 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 Abbreviation: NOS, not otherwise specified.
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 oxcarbazepine or placebo as adjunctive treatment and were numerically more common in the patients treated with oxcarbazepine.
Table 6:
Adverse Reactions in Controlled Clinical Studies of Adjunctive Therapy/Monotherapy With Oxcarbazepine in Pediatric Patients Previously Treated With Other Antiepileptic Drugs Body system/ Adverse reaction 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 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 Oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine in their causation cannot be reliably determined.
1 )]. , fluid restriction). Laboratory data from clinical trials suggest that oxcarbazepine use was associated with decreases in T 4, without changes in T 3 or TSH. 2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of oxcarbazepine.
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. 4 )] , Acute Generalized Exanthematous Pustulosis (AGEP) Musculoskeletal, Connective Tissue and Bone Disorders: There have been reports of decreased bone mineral density, osteoporosis, and fractures in patients on long-term therapy with oxcarbazepine.
Injury, Poisoning, and Procedural Complications: fall Nervous System Disorders: dysarthria
USOfficial regulatory label· Warnings and precautions· revised May 29, 2025[3]
6 ) • Cognitive/Neuropsychiatric Adverse Reactions: May cause cognitive dysfunction, somnolence, and coordination abnormalities. 1 Hyponatremia Clinically significant hyponatremia (sodium < 125 mmol/L) can develop during oxcarbazepine use.
5% of oxcarbazepine-treated patients (38/1524) had a sodium of less than 125 mmol/L at some point during treatment, compared to no such patients assigned placebo or active control (carbamazepine and phenobarbital for adjunctive and monotherapy substitution studies, and phenytoin and valproate for the monotherapy initiation studies).
Clinically significant hyponatremia generally occurred during the first 3 months of treatment with oxcarbazepine, although there were patients who first developed a serum sodium < 125 mmol/L more than 1 year after initiation of therapy.
Most patients who developed hyponatremia were asymptomatic, but patients in the clinical trials were frequently monitored and some had their oxcarbazepine dose reduced, discontinued, or had their fluid intake restricted for hyponatremia.
Whether or not these maneuvers prevented the occurrence of more severe events is unknown. Cases of symptomatic hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH) have been reported during postmarketing use.
In clinical trials, patients whose treatment with oxcarbazepine was discontinued due to hyponatremia generally experienced normalization of serum sodium within a few days without additional treatment. , nausea, malaise, headache, lethargy, confusion, obtundation, or increase in seizure frequency or severity).
2 Anaphylactic Reactions and Angioedema Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of oxcarbazepine. Angioedema associated with laryngeal edema can be fatal.
If a patient develops any of these reactions after treatment with oxcarbazepine, the drug should be discontinued and an alternative treatment started. 3 )]. 3 Cross Hypersensitivity Reaction to Carbamazepine Approximately 25% to 30% of patients who have had hypersensitivity reactions to carbamazepine will experience hypersensitivity reactions with oxcarbazepine.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised May 29, 2025[3]
3 ) ]. 2 )
This is not medical advice. Consult a qualified healthcare professional.
g. 8). Hypersensitivity reactions, including multi-organ hypersensitivity reactions, may also occur in patients without a history of hypersensitivity to carbamazepine. 8). In general, if signs and symptoms suggestive of hypersensitivity reactions occur Oxcarbazepine Mylan should be withdrawn immediately.
Dermatological effects Serious dermatological reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome) and erythema multiforme, have been reported very rarely in association with the use of oxcarbazepine.
Patients with serious dermatological reactions may require hospitalisation, as these conditions may be life- threatening and very rarely be fatal. Oxcarbazepine associated cases occurred in both children and adults. The median time to onset was 19 days.
Several isolated cases of recurrence of the serious skin reaction when rechallenged with oxcarbazepine were reported. Patients who develop a skin reaction with oxcarbazepine should be promptly evaluated and oxcarbazepine withdrawn immediately unless the rash is clearly not drug related.
In case of treatment withdrawal, consideration should be given to replacing oxcarbazepine with other antiepileptic drug therapy to avoid withdrawal seizures. 3). HLA-B*1502 allele – in Han Chinese, Thai and other Asian populations HLA-B*1502 in individuals of Han Chinese and Thai origin has been shown to be strongly associated with the risk of developing the severe cutaneous reactions known as Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), when treated with carbamazepine.
The chemical structure of oxcarbazepine is similar to that of carbamazepine, and it is possible that patients who are positive for HLAB*1502 may also be at risk for SJS/TEN after treatment with oxcarbazepine. There are some data that suggest that such an association exists for oxcarbazepine.
The prevalence of HLA-B*1502 carrier is about 10% in Han Chinese and Thai populations. Whenever possible, these individuals should be screened for this allele before starting treatment with carbamazepine or a chemically-related active substance.
If patients of these origins are tested positive for HLAB*1502 allele, the use of oxcarbazepine may be considered if the benefits are thought to exceed risks. g. above 15% in the […]
For this reason, patients should be specifically questioned about any prior experience with carbamazepine, and patients with a history of hypersensitivity reactions to carbamazepine should ordinarily be treated with oxcarbazepine only if the potential benefit justifies the potential risk.
8 )]. 4 Serious Dermatological Reactions Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with oxcarbazepine use.
Such serious skin reactions may be life threatening, and some patients have required hospitalization with very rare reports of fatal outcome. The median time of onset for reported cases was 19 days after treatment initiation. Recurrence of the serious skin reactions following rechallenge with oxcarbazepine has also been reported.
The reporting rate of TEN and SJS associated with oxcarbazepine use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate estimates by a factor of 3- to 10-fold. 5 to 6 cases per million-person years.
Therefore, if a patient develops a skin reaction while taking oxcarbazepine, consideration should be given to discontinuing oxcarbazepine use and prescribing another antiepileptic medication. Association With HLA-B*1502 Patients carrying the HLA-B*1502 allele may be at increased risk for SJS/TEN with oxcarbazepine treatment.
Human Leukocyte Antigen (HLA) allele B*1502 increases the risk for developing SJS/TEN in patients treated with carbamazepine. The chemical structure of oxcarbazepine is similar to that of carbamazepine. Available clinical evidence, and data from nonclinical studies showing a direct interaction between oxcarbazepine and HLA-B*1502 protein, suggest that the HLA-B*1502 allele may also increase the risk for SJS/TEN with oxcarbazepine.
The frequency of HLA-B*1502 allele ranges from 2% to 12% in Han Chinese populations, is about 8% in Thai populations, and above 15% in the Philippines, and in some Malaysian populations. Allele frequencies up to about 2% and 6% have been reported in Korea and India, respectively.
The frequency of the HLA-B*1502 allele is negligible in people from European descent, several African populations, indigenous peoples of the Americas, Hispanic populations, and in Japanese (< 1%). Testing for the presence of the HLA-B*1502 allele should be considered in patients with ancestry in genetically at-risk populations, prior to initiating treatment with oxcarbazepine.
The use of oxcarbazepine should be avoided in patients positive for HLA-B*1502 unless the benefits clearly outweigh the risks. Consideration should also be given to avoid the use of other drugs associated with SJS/TEN in HLA-B*1502 positive patients, when alternative therapies are otherwise equally acceptable.
Screening is not generally recommended in patients from populations in which the prevalence of HLAB* 1502 is low, or in current oxcarbazepine users, as the risk of SJS/TEN is largely confined to the first few months of therapy, regardless of HLA-B*1502 status.
The use of HLA-B*1502 genotyping has important limitations, and must never substitute for appropriate clinical vigilance and patient management. The role of other possible factors in the development of, and morbidity from, SJS/TEN, such as AED dose, compliance, concomitant medications, comorbidities, and the level of dermatologic monitoring have not been well characterized.
5 Suicidal Behavior and Ideation Antiepileptic drugs, including oxcarbazepine, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
7) of suicidal thinking or behavior compared to patients randomized to placebo. 24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated.
There were 4 suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs, and persisted for the duration of treatment assessed.
Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed.
The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed.
Table 2 shows absolute and relative risk by indication for all evaluated AEDs. 9 The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Anyone considering prescribing oxcarbazepine or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.
Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.
Behaviors of concern should be reported immediately to healthcare providers. 4 ) and Clinical Studies ( 14 ) ]. But if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered. 7 Cognitive/Neuropsychiatric Adverse Reactions Use of oxcarbazepine has been associated with CNS-related adverse reactions.
The most significant of these can be classified into three general categories: 1) cognitive symptoms, including psychomotor slowing, difficulty with concentration, and speech or language problems; 2) somnolence or fatigue; and 3) coordination abnormalities, including ataxia and gait disturbances.
Patients should be monitored for these signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on oxcarbazepine to gauge whether it adversely affects their ability to drive or operate machinery.
Adult Patients In one large, fixed-dose study, oxcarbazepine was added to existing AED therapy (up to three concomitant AEDs). By protocol, the dosage of the concomitant AEDs could not be reduced as oxcarbazepine was added, reduction in oxcarbazepine dosage was not allowed if intolerance developed, and patients were discontinued if unable to tolerate their highest target maintenance doses.
In this trial, 65% of patients were discontinued because they could not tolerate the 2400 mg/day dose of oxcarbazepine on top of existing AEDs. The adverse events seen in this study were primarily CNS related and the risk for discontinuation was dose related.
1% of oxcarbazepine-treated patients and 4% of placebo-treated patients experienced a cognitive adverse reaction. 5 times greater on oxcarbazepine than on placebo. In addition, 26% of oxcarbazepine-treated patients and 12% of placebo-treated patients experienced somnolence.
The risk of discontinuation for somnolence was about 10 times greater on oxcarbazepine than on placebo. 4% of placebo-treated patients experienced ataxia or gait disturbances. The risk for discontinuation for these events was about 7 times greater on oxcarbazepine than on placebo.
In a single placebo-controlled monotherapy trial evaluating 2400 mg/day of oxcarbazepine, no patients in either treatment group discontinued double-blind treatment because of cognitive adverse events, somnolence, ataxia, or gait disturbance.
1% of patients in the 2400 mg/day group discontinued double-blind treatment because of somnolence or cognitive adverse reactions compared to 0% in the 300 mg/day group. In these trials, no patients discontinued because of ataxia or gait disturbances in either treatment group.
Pediatric Patients A study was conducted in pediatric patients (3 to 17 years old) with inadequately controlled partial-onset seizures in which oxcarbazepine was added to existing AED therapy (up to 2 concomitant AEDs). By protocol, the dosage of concomitant AEDs could not be reduced as oxcarbazepine was added.
Oxcarbazepine was titrated to reach a target dose ranging from 30 mg/kg to 46 mg/kg (based on a patient’s body weight with fixed doses for predefined weight ranges). 1% of patients treated with placebo. 0% of placebo-treated patients experienced somnolence (no patient discontinued due to a cognitive adverse reaction or somnolence).
0% of placebo-treated patients experienced ataxia or gait disturbances. 8%) placebo-treated patient discontinued due to ataxia or gait disturbances. 8 Drug Reaction With Eosinophilia and Systemic Symptoms/Multi-Organ Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, has occurred with oxcarbazepine.
Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.
Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. , fever, lymphadenopathy) may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately.
Oxcarbazepine should be discontinued if an alternative etiology for the signs or symptoms cannot be established. 9 Hematologic Events Rare reports of pancytopenia, agranulocytosis, and leukopenia have been seen in patients treated with oxcarbazepine during postmarketing experience.
Discontinuation of the drug should be considered if any evidence of these hematologic events develops. 10 Seizure Control During Pregnancy Due to physiological changes during pregnancy, plasma levels of the active metabolite of oxcarbazepine, the 10-monohydroxy derivative (MHD), may gradually decrease throughout pregnancy.
It is recommended that patients be monitored carefully during pregnancy. Close monitoring should continue through the postpartum period because MHD levels may return after delivery. 11 Risk of Seizure Aggravation Exacerbation of or new onset primary generalized seizures has been reported with oxcarbazepine.
The risk of aggravation of primary generalized seizures is seen especially in children but may also occur in adults. In case of seizure aggravation, oxcarbazepine should be discontinued.