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Topiramate

Topamax, Topilex, Topiramat · ATC code N03AX11

Also known as: Topiramat · Brand names: Topamax, Topilex, Migräne, Topiramate Ratiopharm, As-Topiram, Epimax, Letop, Noromat, Rapinorm, Topimol, Xamate, Qudexy XR

Key facts
Active substance
Topiramate
Drug class
Anticonvulsant agent
ATC code
N03AX11
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Topiramate is an antiepileptic drug. Per the US label it is used to treat seizures in patients 2 years and older and for the preventive treatment of migraine from 12 years.

What it is used for

  • Initial monotherapy for partial-onset or primary generalized tonic-clonic seizures from 2 years of age
  • Adjunctive therapy for partial-onset and primary generalized tonic-clonic seizures and Lennox-Gastaut seizures from 2 years of age
  • Preventive treatment of migraine from 12 years of age

Dosing

  • Monotherapy (adults and children 10 years and older): target 400 mg/day in two divided doses, titrated over 6 weeks starting at 25 mg twice daily
  • Children 2 to 9 years: weight-based, starting at 25 mg/day nightly (details in the full text)
  • Adjunctive therapy, adults: 200 to 400 mg/day in two divided doses; start 25 to 50 mg/day, increase by 25 to 50 mg/day weekly
  • Migraine prevention: 100 mg/day in two divided doses, titrated over 4 weeks starting at 25 mg in the evening
  • Creatinine clearance less than 70 mL/min/1.73 m²: one-half the usual adult dose; a supplemental dose may be needed with hemodialysis

Contraindications

  • Hypersensitivity to topiramate or any inactive ingredient (anaphylaxis and angioedema have occurred)

Important warnings

  • Acute myopia with secondary angle closure glaucoma, typically within 1 month; discontinue as rapidly as possible
  • Visual field defects, oligohidrosis and hyperthermia (especially in children)
  • Metabolic acidosis; suicidal behavior and ideation
  • Cognitive and neuropsychiatric adverse reactions; kidney stones
  • Hyperammonemia and encephalopathy, particularly with valproic acid; serious skin reactions and DRESS

Side effects

  • Monotherapy 400 mg/day, most common: paresthesia, weight loss and anorexia
  • Others: cognitive problems, mood changes, fatigue
  • Serious: angle closure glaucoma, metabolic acidosis, kidney stones, hyperthermia

Interactions

  • Phenytoin and carbamazepine markedly decrease topiramate levels
  • Valproic acid: hypothermia and hyperammonemia with or without encephalopathy
  • Hormonal contraceptives: decreased efficacy and breakthrough bleeding may occur; other carbonic anhydrase inhibitors: caution

Pregnancy and breastfeeding

  • Can cause fetal harm: increased risk of major malformations (including oral clefts) and of being small for gestational age
  • Excreted in human milk; diarrhea and somnolence reported in breastfed infants

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

  • TopamaxJanssen-Cilag Pharma Gmbh · 1 register entry
  • TopilexG.L. Pharma Gmbh · 1 register entry
  • Topiramat1a Pharma Gmbh, Teva B.V, Sandoz Gmbh, Stada Arzneimittel Gmbh · 4 register entries

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

Germany

  • MigräneAliud Pharma Gmbh, Stadapharm Gmbh · 2 register entries
  • TopamaxJanssen-Cilag Gmbh · 1 register entry
  • Topiramat1 A Pharma Gmbh, Puren Pharma Gmbh & Co. Kg, Glenmark Arzneimittel Gmbh, Hormosan Pharma Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Stadapharm Gmbh, Aliud Pharma Gmbh · 8 register entries
  • Topiramate RatiopharmRatiopharm Gmbh · 1 register entry

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

Turkey

  • As-TopiramAPOTEX İLAÇ SAN VE TİC. LTD. ŞTİ. · 4 register entries
  • EpimaxTERRA İLAÇ VE KİMYA SAN. TİC. A.Ş. · 2 register entries
  • LetopSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • NoromatBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • RapinormWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • TopamaxJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 4 register entries
  • TopimolNEUTEC İLAÇ SAN. TİC. A.Ş · 8 register entries
  • XamateGENVEON İLAÇ SAN. VE TİC. A.Ş. · 4 register entries

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

USA

  • Qudexy XRUpsher-Smith Laboratories, LLC · 1 register entry

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

Brand names in 27 more European countries
Belgium
Topamax, Topiramate Eg
Bulgaria
Topilex, Талопам
Croatia
Topamax
Cyprus
Topamax, Topiramate Aurobindo
Czechia
Tolepso, Topamax, Topilex, Topimark, Topiramat Actavis, Topiramat Sandoz, Topiramate Farmax, Topiramate Viatris
Denmark
Maritop, Topimax, Topiramat Actavis, Topiramat Aristo, Topiramat Orion, Topiramat Pharmathen
Estonia
Topamax, Topiramate Elvim, Topiramate Orion
Finland
Topimax, Topiramat Orion, Topiramat Ratiopharm, Topiramat Sandoz
France
Epitomax, Topiramate Arrow, Topiramate Bgr, Topiramate Sandoz, Topiramate Viatris
Greece
Jadix, Topamac, Topepil, Toramat
Hungary
Etopro, Topamax, Topiramate Svus
Iceland
Topimax, Topiramat Actavis, Topiramate Alvogen
Ireland
Topamax
Italy
Topamax, Topiramato Aurobindo, Topiramato Doc Generici, Topiramato Eg, Topiramato Mylan Generics, Topiramato Sandoz, Xitop
Latvia
Topamax, Topiramat Orion, Topiramate Elvim
Lithuania
Topamax, Topiramat Orion, Topiramate Elvim
Luxembourg
Topamax
Malta
Topamax, Topiramate Accord Healthcare, Topiramate Aurobindo Pharma (Malta)
Netherlands
Topamax, Topiramaat Accord, Topiramaat Aurobindo, Topiramaat Doc Generici, Topiramaat Glenmark, Topiramaat Sandoz, Topiramaat Viatris
Norway
Topimax, Topiramat Sandoz, Topiramat Teva
Poland
Etopro, Oritop, Topamax, Topiramat Accord, Topiramate Farmax, Toramat
Portugal
Topamax, Topiramato Alter, Topiramato Aurovitas, Topiramato Azevedos, Topiramato Bluepharma, Topiramato Ciclum, Topiramato Clindonim, Topiramato Farmoz, Topiramato Genedec, Topiramato Generis Phar, Topiramato Sandoz, Topiramato Strami, Topiramato Svus, Topiramato Teva, Topiramato Tolife, Topiramato Tomix, Topiramato Wynn
Romania
Topilex, Topiramat Teva
Slovakia
Talopam, Topimark
Slovenia
Topamax
Spain
Acomicil, Topamax, Topiramato Aurovitas, Topiramato Cinfa, Topiramato Farmalider, Topiramato Kern Pharma, Topiramato Normon, Topiramato Pensa Pharma, Topiramato Pharma Combix, Topiramato Qualigen, Topiramato Ratiopharm, Topiramato Sandoz, Topiramato Stada, Topiramato Tarbis, Topiramato Tecnigen, Topiramato Viatris
Sweden
Topimax, Topiramat, Topiramate Ratiopharm

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

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Sources

  1. U.S. Food and Drug Administration. Topiramate (Glenmark Pharmaceuticals Inc., USA) – Prescribing Information, 2026-04-29. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=872927eb-0b61-44bb-9892-3c700b6f2181
  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 N03AX.

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.