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Oxcarbazepine

Trileptal · ATC code N03AF02

Also known as: Oxcarbazepin · Brand names: Trileptal, Apydan Extent, Timox, Apilep, Epsile, Oxcaril

Key facts
Active substance
Oxcarbazepine
Drug class
Anticonvulsant agent
ATC code
N03AF02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Oxcarbazepine is an antiepileptic drug. Per the US label, it is used as monotherapy or adjunctive therapy for partial-onset seizures in adults and children.

What it is used for

  • Partial-onset seizures in adults: monotherapy or adjunctive therapy
  • Children aged 4 years and above: monotherapy
  • Children aged 2 years and above: adjunctive therapy

Dosing

  • Adjunctive therapy, adults: start 600 mg/day given twice a day, increase by at most 600 mg/day weekly; maximum recommended 1,200 mg/day
  • Conversion to monotherapy: start 600 mg/day, up to 2,400 mg/day, withdrawing other AEDs over 3 to 6 weeks
  • Initiation of monotherapy: 600 mg/day, increased by 300 mg/day every third day to 1,200 mg/day
  • Children: weight-based dosing per the full prescribing information
  • Creatinine clearance <30 mL/min: start at one-half the usual dose (300 mg/day) and increase slowly
  • Adjust with strong CYP3A4 or UGT inducers

Contraindications

  • Hypersensitivity to oxcarbazepine, any component, or eslicarbazepine acetate

Important warnings

  • Clinically significant hyponatremia (sodium <125 mmol/L), usually within the first 3 months; SIADH reported
  • Anaphylaxis and angioedema; cross-hypersensitivity with carbamazepine
  • Serious dermatological reactions, DRESS/multi-organ hypersensitivity, hematologic events
  • Suicidal behavior and ideation; cognitive and neuropsychiatric adverse reactions
  • Avoid abrupt withdrawal (risk of increased seizure frequency)

Side effects

  • Most common: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia
  • Abnormal vision, headache, nystagmus, tremor, abnormal gait
  • Hyponatremia

Interactions

  • Phenytoin: levels rise with oxcarbazepine above 1,200 mg/day; monitor
  • Hormonal contraceptives may be less effective
  • Strong CYP3A4 and UGT inducers reduce oxcarbazepine effect

Pregnancy and breastfeeding

  • Pregnant patients should be encouraged to enroll in the antiepileptic drug pregnancy registry; details in the full prescribing information

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • TrileptalNovartis Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Apydan ExtentDesitin Arzneimittel Gmbh · 1 register entry
  • Oxcarbazepin1 A Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Ratiopharm Gmbh, Adoh B.V., Viatris Germany Gmbh, Aliud Pharma Gmbh · 6 register entries
  • TimoxDesitin Arzneimittel Gmbh · 2 register entries
  • TrileptalNovartis Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • ApilepSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • EpsileBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • OxcarilİLKO İLAÇ SAN.VE TİC. A.Ş. · 3 register entries
  • TrileptalNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • TrileptalNovartis Pharmaceuticals Corporation · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 24 more European countries
Belgium
Oxcarbazepine Viatris, Trileptal
Bulgaria
Трилептал
Croatia
Trileptal
Cyprus
Oxcarbazepine Jubilant, Trileptal
Denmark
Apydan, Oxcarbazepin Jubilant, Oxcarbazepin Orion, Oxcarbazepin Viatris, Trileptal
Estonia
Apydan, Trileptal
Finland
Apydan, Oxcarbazepin Orion, Trileptal
France
Oxcarbazepine Sandoz, Oxcarbazepine Viatris, Trileptal
Greece
Trileptal
Hungary
Trileptal
Iceland
Oxcarbazepine Jubilant, Trileptal
Ireland
Trileptal
Italy
Oxcarbazepina Tecnigen, Tolep, Zigabal
Latvia
Trileptal
Lithuania
Trileptal
Netherlands
Oxcarbazepine Adoh, Oxcarbazepine Jubilant, Oxcarbazepine Sandoz, Oxcarbazepine Viatris, Trileptal
Norway
Trileptal
Poland
Karbagen, Oxepilax, Trileptal
Portugal
Epilfarmo, Oxcarbazepina Biofarmoz, Proaxen, Zigabal
Romania
Trileptal
Slovakia
Trileptal
Slovenia
Karbox
Spain
Oxcarbazepina Cinfa, Oxcarbazepina Normon, Oxcarbazepina Pensa, Oxcarbazepina Tecnigen, Oxcarbazepina Viatris, Trileptal
Sweden
Trileptal

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. U.S. Food and Drug Administration. Oxcarbazepine (Sun Pharmaceutical Industries, Inc.) – Prescribing Information, 2026-06-03. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7ecd5eef-46f4-407f-9b63-ba65adb3eced
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC N03AF.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.