Evigrade
DrugsCosmetic ingredientsCalculatorsInteractionsEvigrade SkinEvigrade Meds ↗
ConditionsJournalMethodologyPro for practitioners
ESRU

Eslicarbazepine acetate

AEMPS

Antiepileptic, carboxamide derivative

ATC code: N03AF04

Brand names: Zebinix, Aptiom, Exalief

Updated · Methodology

Indications

B

Focal epilepsy

Third line

Second-line in focal epilepsy in adults and adolescents over 6, as monotherapy or in combination. ILAE 2017 and the Spanish SEN 2024 consensus place lamotrigine, levetiracetam, and lacosamide as first-line. Eslicarbazepine is used when carbamazepine or oxcarbazepine (same class) are inadequate or intolerable – tolerability is better, with less hyponatremia and fewer skin reactions. Standard starting dose 400 mg once daily, titrated to 800–1200 mg.

Sources

  1. AEMPS: Ficha técnica de Acetato de eslicarbazepina (2024)
  2. Cochrane Database Syst Rev: Eslicarbazepine acetate add-on therapy for drug-resistant focal epilepsy. (2021)
  3. Neurology: Practice guideline update summary: Efficacy and tolerability of the new antiepileptic drugs I: Treatment of new-onset epilepsy (2018)
  4. Acta Neurol Scand: Antiepileptic monotherapy in newly diagnosed focal epilepsy. A network meta-analysis. (2019)

ICD-10: G40.2 · ICD-11: 8A60

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Mood stabilization

Not recommended

Eslicarbazepine acetate is an antiepileptic drug. It is prescribed only for focal epilepsy, as monotherapy or as add-on to other antiepileptics ( 2018, AEMPS Ficha Técnica). For mood stabilization or anxiety, no efficacy has been demonstrated: no clinical studies of such use exist. The drug has serious side effects: hyponatremia (a dangerous drop in blood sodium), skin reactions, dizziness, somnolence. If eslicarbazepine was prescribed for mood stabilization or anxiety, consider seeking a second opinion.

Sources

  1. AEMPS: Ficha técnica de Acetato de eslicarbazepina (2024)
  2. Cochrane: Omega-3 fatty acids for depression in adults (2021)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

A third-generation carboxamide developed by the Portuguese-Spanish company BIAL. A structural analogue of carbamazepine and oxcarbazepine. Stabilizes the inactivated state of voltage-gated sodium channels in neurons and reduces repetitive membrane firing. Compared with its predecessors, pharmacokinetics are more stable – once-daily dosing, and CYP enzyme induction is much weaker than with carbamazepine. Active metabolite eslicarbazepine half-life 13–20 hours.

Safety

Contraindications

  • Hypersensitivity to eslicarbazepine, oxcarbazepine, or carbamazepine
  • Severe renal impairment (eGFR under 30)
  • Second- or third-degree AV block
  • Age under 6
  • Pregnancy (when better-profile alternatives exist)

Serious adverse effects

  • Hyponatremia (higher risk in older adults and with diuretics)
  • Severe cutaneous reactions (Stevens–Johnson syndrome, DRESS, toxic epidermal necrolysis)
  • PR prolongation and AV block
  • Hepatic dysfunction
  • Suicidal thoughts
  • Leukopenia and thrombocytopenia

Common adverse effects

  • Dizziness
  • Drowsiness
  • Headache
  • Nausea and vomiting
  • Diplopia and incoordination
  • Fatigue

Pregnancy: can you take Eslicarbazepine acetate?

Eslicarbazepine is in the same class as carbamazepine and oxcarbazepine – higher malformation risk (cleft palate, neural tube). In women of reproductive age, reliable contraception is mandatory; when pregnancy is planned, switch in advance to lamotrigine or levetiracetam with better profiles. Eslicarbazepine reduces hormonal contraceptive efficacy – an additional non-hormonal method is needed.

Breastfeeding: can you take Eslicarbazepine acetate?

Eslicarbazepine and its metabolite pass into milk. Infant drowsiness and feeding problems are possible. Use cautiously in lactation, monitor infant activity and weight; switch to a better-profile drug when feasible.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take once daily, with or without food. With eGFR 30–60, halve the dose; do not use at eGFR under 30. Check sodium 2 weeks after start or dose increase, then every 3 months – hyponatremia risk, particularly with thiazide diuretics or baseline hyponatremia. In patients of Asian descent, test HLA-B*1502 before initiation – carriers have higher severe cutaneous reaction risk (as with carbamazepine).
Label mentions25 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • ModerateCarbamazepine
    «Carbamazepina: En un estudio en sujetos sanos, la administración concomitante de 800 mg de acetato de eslicarbazepina una vez al día y de 400 mg de carbamazepina dos veces al día dio lugar a una…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCarbamazepine
    «DRUG INTERACTIONS: Carbamazepine: May need dose adjustment for eslicarbazepine acetate or carbamazepine. ( 2.3 , 5.6 , 7.1 )»

    FDA, section 7 · Open on DailyMed

  • ModerateClobazam
    «CYP2C19 Substrates: Eslicarbazepine acetate can inhibit CYP2C19, which can cause increased plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., phenytoin, clobazam, and…»

    FDA, section 7 · Open on DailyMed

  • Moderatediuréticosclass named in the label
    «Hiponatremia: Se ha notificado hiponatremia como reacción adversa en 1,5% de los pacientes tratados con eslicarbazepina. En la mayoría de los casos la hiponatremia es asintomática; sin embargo, puede…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateLovastatin
    «CYP3A4 Substrates: In vivo studies suggest that eslicarbazepine acetate can induce CYP3A4, decreasing plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., simvastatin…»

    FDA, section 7 · Open on DailyMed

  • ModerateOmeprazole
    «CYP2C19 Substrates: Eslicarbazepine acetate can inhibit CYP2C19, which can cause increased plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., phenytoin, clobazam, and…»

    FDA, section 7 · Open on DailyMed

  • ModeratePhenobarbital
    «DRUG INTERACTIONS: Phenobarbital or Primidone: Higher dosage of eslicarbazepine acetate may be necessary. ( 2.3 , 7.1 )»

    FDA, section 7 · Open on DailyMed

  • ModeratePhenytoin
    «El acetato de eslicarbazepina es ampliamente metabolizado a eslicarbazepina, que se elimina principalmente por glucuronidación. La eslicarbazepina in vitro es un inductor débil de CYP3A4 y…»

    AEMPS, section 4.5 · Open on CIMA

  • ModeratePhenytoin
    «DRUG INTERACTIONS: Phenytoin: Higher dosage of eslicarbazepine acetate may be necessary and dose adjustment may be needed for phenytoin. ( 2.3 , 7.1 , 7.2 )»

    FDA, section 7 · Open on DailyMed

  • ModerateRosuvastatin
    «Rosuvastatina: Hubo una reducción media del 36 - 39% en la exposición sistémica en voluntarios sanos cuando se coadministró con acetato de eslicarbazepina 1.200 mg una vez al día. El mecanismo de…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateSimvastatin
    «El acetato de eslicarbazepina es ampliamente metabolizado a eslicarbazepina, que se elimina principalmente por glucuronidación. La eslicarbazepina in vitro es un inductor débil de CYP3A4 y…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateSimvastatin
    «CYP3A4 Substrates: In vivo studies suggest that eslicarbazepine acetate can induce CYP3A4, decreasing plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., simvastatin…»

    FDA, section 7 · Open on DailyMed

  • ModerateWarfarin
    «Warfarina: La administración conjunta de 1.200 mg de acetato de eslicarbazepina una vez al día con warfarina mostró una disminución pequeña (23%) pero estadísticamente significativa en la exposición…»

    AEMPS, section 4.5 · Open on CIMA

  • MinorTopiramate
    «Topiramato: En un estudio en sujetos sanos, la administración concomitante de 1.200 mg de acetato de eslicarbazepina una vez al día y topiramato no mostró ningún cambio significativo en la exposición…»

    AEMPS, section 4.5 · Open on CIMA

  • anticonceptivos hormonalesclass named in the label
    «Anticonceptivos orales: La administración de 1.200 mg de acetato de eslicarbazepina una vez al día a mujeres que usaban un anticonceptivo oral combinado mostró una disminución promedio del 37% y 42%…»

    AEMPS, section 4.5 · Open on CIMA

  • antidepresivos tricíclicosclass named in the label
    «Inhibidores de la monoaminooxidasa (IMAO): Basándose en la relación estructural del acetato de eslicarbazepina con los antidepresivos tricíclicos, teóricamente es posible una interacción entre el…»

    AEMPS, section 4.5 · Open on CIMA

  • Digoxin
    «Digoxina: Un estudio en sujetos sanos no mostró que la administración de 1.200 mg de acetato de eslicarbazepina tuviera efecto alguno sobre la farmacocinética de la digoxina, lo que sugiere que el…»

    AEMPS, section 4.5 · Open on CIMA

  • Ethinylestradiol
    «Anticonceptivos orales: La administración de 1.200 mg de acetato de eslicarbazepina una vez al día a mujeres que usaban un anticonceptivo oral combinado mostró una disminución promedio del 37% y 42%…»

    AEMPS, section 4.5 · Open on CIMA

  • Ethinylestradiol
    «Oral Contraceptives: Because concomitant use of eslicarbazepine acetate and ethinylestradiol and levonorgestrel is associated with lower plasma levels of these hormones, females of reproductive…»

    FDA, section 7 · Open on DailyMed

  • hormonal contraceptivesclass named in the label
    «DRUG INTERACTIONS: Hormonal Contraceptives: Eslicarbazepine acetate may decrease the effectiveness of hormonal contraceptives. ( 7.4 , 8.3 )»

    FDA, section 7 · Open on DailyMed

  • IMAOclass named in the label
    «Inhibidores de la monoaminooxidasa (IMAO): Basándose en la relación estructural del acetato de eslicarbazepina con los antidepresivos tricíclicos, teóricamente es posible una interacción entre el…»

    AEMPS, section 4.5 · Open on CIMA

  • Lamotrigine
    «Lamotrigina: La glucuronidación es la principal vía metabólica tanto para la eslicarbazepina como la lamotrigina, y en consecuencia podría esperarse una interacción. Un estudio en sujetos sanos con…»

    AEMPS, section 4.5 · Open on CIMA

  • Levetiracetam
    «Valproato y levetiracetam: Un análisis farmacocinético de la población en estudios de fase III con pacientes epilépticos adultos indicó que la administración concomitante de valproato o levetiracetam…»

    AEMPS, section 4.5 · Open on CIMA

  • Levonorgestrel
    «Anticonceptivos orales: La administración de 1.200 mg de acetato de eslicarbazepina una vez al día a mujeres que usaban un anticonceptivo oral combinado mostró una disminución promedio del 37% y 42%…»

    AEMPS, section 4.5 · Open on CIMA

  • Levonorgestrel
    «Oral Contraceptives: Because concomitant use of eslicarbazepine acetate and ethinylestradiol and levonorgestrel is associated with lower plasma levels of these hormones, females of reproductive…»

    FDA, section 7 · Open on DailyMed

Check interaction with another drug

Opens the checker prefilled with this drug. Pick the second one from your regimen.

Open checker

Summary of a multi-drug list →

Medicine list: everything you take in one place →

Frequently asked

What is Eslicarbazepine acetate used for?

Eslicarbazepine acetate is evaluated for the following indications with varying evidence strength: Focal epilepsy (evidence tier B), Mood stabilization (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Eslicarbazepine acetate?

Common side effects of Eslicarbazepine acetate (≥ 1 in 100): Dizziness, Drowsiness, Headache, Nausea and vomiting, Diplopia and incoordination, Fatigue. See the Safety section for uncommon and serious reactions.

Is Eslicarbazepine acetate safe during pregnancy?

Eslicarbazepine is in the same class as carbamazepine and oxcarbazepine – higher malformation risk (cleft palate, neural tube). In women of reproductive age, reliable contraception is mandatory; when pregnancy is planned, switch in advance to lamotrigine or levetiracetam with better profiles. Eslicarbazepine reduces hormonal contraceptive efficacy – an additional non-hormonal method is needed.

Is Eslicarbazepine acetate compatible with breastfeeding?

Eslicarbazepine and its metabolite pass into milk. Infant drowsiness and feeding problems are possible. Use cautiously in lactation, monitor infant activity and weight; switch to a better-profile drug when feasible.

Who should not take Eslicarbazepine acetate?

Eslicarbazepine acetate is contraindicated in: Hypersensitivity to eslicarbazepine, oxcarbazepine, or carbamazepine; Severe renal impairment (eGFR under 30); Second- or third-degree AV block; Age under 6; Pregnancy (when better-profile alternatives exist). Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Gabapentin, Lacosamide, Lamotrigine, Levetiracetam, Pregabalin, Valproic acid, Phenobarbital, Phenytoin