Topiramate Pregnancy: see this medicine in the DysNet teratogen register
ATC N03AX11 · WHO DDD 0.3 g (oral) · 100 mg tablet
Class: Antiepileptics. ATC code N03AX11 stands for "topiramate" in the WHO index, whose DDD is 0.3 g by the oral route [1].
WHO Model List of Essential Medicines 2025: not listed [2].
| Country | Packs | Kind of figure | Cost per DDD | Annual cost at the WHO standard dose |
|---|---|---|---|---|
| France | 4 | List price | €1.23 | €447.13 to €449.73 |
| Spain | 14 | List price | €1.83 | €668.31 |
| United Kingdom | 1 | Reimbursement tariff | €0.14 | €51.03 £43.25 |
Names, authorisations and literature
Trade names (51)
- France (5)
- EPITOMAX, TOPIRAMATE ARROW LAB, TOPIRAMATE SANDOZ, TOPIRAMATE VIATRIS, TOPIRAMATE BGR* [4] [5]
- Spain (18)
- ACOMICIL, TOPAMAX, TOPAMAX DISPERSABLE, TOPIRAMATO AUROVITAS, TOPIRAMATO CINFA, TOPIRAMATO KERN PHARMA, TOPIRAMATO NORMON, TOPIRAMATO PENSA PHARMA, TOPIRAMATO PHARMA COMBIX, TOPIRAMATO QUALIGEN, TOPIRAMATO RATIOPHARM, TOPIRAMATO SANDOZ, TOPIRAMATO TECNIGEN, TOPIRAMATO VIATRIS, TOPIRAMATO STADA, TOPIRAMATO FARMALIDER*, TOPIRAMATO TARBIS*, TOPIRAMATO TEVA-RATIOPHARM* [6] [5]
- Italy (7)
- TOPAMAX, TOPIRAMATO AUROBINDO, TOPIRAMATO DOC GENERICI, TOPIRAMATO EG, TOPIRAMATO MYLAN GENERICS, TOPIRAMATO SANDOZ, XITOP [5]
- United States (7)
- Eprontia, Qsymia, Qudexy, Qudexy Xr, Topamax, Trokendi, Trokendi Xr [5]
- United States, discontinued (1)
- Topamax Sprinkle [5]
- Canada (13)
- AG-TOPIRAMATE TABLETS, APO-TOPIRAMATE, AURO-TOPIRAMATE, GLN-TOPIRAMATE, JAMP TOPIRAMATE TABLETS, MINT-TOPIRAMATE, MYLAN-TOPIRAMATE, NRA-TOPIRAMATE, PMS-TOPIRAMATE, PRO-TOPIRAMATE, TEVA-TOPIRAMATE, TOPAMAX, TOPIRAMATE [5]
- In other languages
- topiramato (Spanish); topiramato (Italian); topiramaat (Dutch); topiramato (Portuguese); topiramatum (Latin) [5]
Links lead to the official product page: the EPAR for the European Union, the public medicines database for France, the CIMA summary of product characteristics for Spain, the dm+d for the United Kingdom. An asterisk marks a name taken from the DysNet register only.
European public assessment reports, EPAR (0)
The European Medicines Agency's list holds no medicine with ATC code N03AX11: this medicine has no EPAR [7].
Literature (PubMed, 6,593 papers)
PubMed counts 6,593 papers on this medicine [8]. The selection gives the most recent of each type; the Method page says how it is made. See the search in PubMed ↗
Cochrane reviews (45)
- Spary-Kainz U, et al. Long-term effects of weight-reducing drugs in people with hypertension. Cochrane Database Syst Rev. 2026. PubMed 42318855 ↗ doi ↗
- Gerardi C, et al. Pharmacological interventions for the treatment of obesity in children and adolescents. Cochrane Database Syst Rev. 2026. PubMed 42125960 ↗ doi ↗
- Greene MC, et al. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries. Cochrane Database Syst Rev. 2023. PubMed 37158538 ↗ doi ↗
- Bäcke P, et al. Pharmacological interventions for pain and sedation management in newborn infants undergoing therapeutic hypothermia. Cochrane Database Syst Rev. 2022. PubMed 36354070 ↗ doi ↗
- Agarwal SM, et al. Pharmacological interventions for prevention of weight gain in people with schizophrenia. Cochrane Database Syst Rev. 2022. PubMed 36190739 ↗ doi ↗
Systematic reviews and meta-analyses (375)
- Pringsheim T, et al. Systematic Review of Pharmacologic Treatment for Migraine Prevention in Adults: Report of the AAN Guidelines Subcommittee and the American Headache Society. Neurology. 2026. PubMed 42673559 ↗ doi ↗
- Fluyau D, et al. Pharmacological interventions for alcohol use disorder on quality of life: a meta-analysis of randomized controlled trials. Alcohol Alcohol. 2026. PubMed 42831801 ↗ doi ↗
- Jurković M, et al. Economic evaluations of antiobesity medications: A systematic literature review. Br J Clin Pharmacol. 2026. PubMed 42764443 ↗ doi ↗
- Haakonsen MVM, et al. Management of Non-REM parasomnias: A systematic review of evidence-based treatment approaches. Sleep Med Rev. 2026. PubMed 42772083 ↗ doi ↗
- Stogios N, et al. Pharmacological Interventions for Weight Reduction in Patients With Schizophrenia Treated With Antipsychotics: A Systematic Review and Network Meta-Analysis. JAMA Psychiatry. 2026. PubMed 42418179 ↗ doi ↗
Practice guidelines (40)
- Qaseem A, et al. Pharmacologic Treatments With Lifestyle Modifications in Nonpregnant Adults With Overweight or Obesity in Outpatient Settings: A Living Clinical Guideline From the American College of Physicians (April 2026). Ann Intern Med. 2026. PubMed 42296496 ↗ doi ↗
- Alexander L, et al. Joint TOS/OMA/OAC Expert Guidance Statement on the Pharmacological Management of United States Adults With Overweight or Obesity Using the GRADE Approach. Obesity (Silver Spring). 2026. PubMed 41782434 ↗ doi ↗
Names and identifiers
- INN
- topiramate source ↗
- CAS
- 97240-79-4
- ATC
- N03AX11 (systemic)
- SNOMED CT
- 108400009, 386844006
- RxNorm
- 38404 ↗
- Wikidata
- Q221174 ↗
- Wikipedia
- en.wikipedia.org/wiki/Topiramate ↗
Names and identifiers taken from the DysNet register [5].
Health technology assessments (3)
The opinions of the assessment bodies of the pilot countries and of Germany, with a link to each opinion. The status shown is the one each body publishes.
France, HAS Transparency Committee (1)
SMR: actual clinical benefit. ASMR: improvement in actual clinical benefit, from I (major) to V (none). Opinions taken from the BDPM [4].
- CT-16155 · 27 September 2017 · Renouvellement d'inscription (CT) · SMR Important · EPITOMAX
Wording of the opinion, in French
SMR : Le service médical rendu par EPITOMAX reste important en prophylaxie de la migraine et dans le traitement de l’épilepsie, y compris des crises associées au syndrome de Lennox-Gastaut.
England, NICE (0)
NICE has published no technology appraisal that names this medicine among the technologies appraised [9].
Scotland, SMC (2)
- SMC 297/06 · 11 September 2006 · topiramate 25, 50mg tablets, 25, 50mg sprinkle capsules (Topamax) · restricted · Full
Indication
Prophylaxis of migraine headache in adults
- SMC 75/03 · 12 January 2004 · Topiramate (Topamax) · restricted · Full
Indication
Epilepsy
- SMC advice [10]
Germany, G-BA (0)
The G-BA has run no early benefit assessment (AMNOG) of this medicine on its own [11].
Spain, AEMPS therapeutic positioning reports (0)
The AEMPS database of therapeutic positioning reports holds no report on this medicine [12].
How the figure is computed
Example, France: the pack TOPIRAMATE ARROW LAB 100 mg, comprimé pelliculé, plaquette(s) polyamide aluminium PVC de 30 comprimé(s), costs €12.25. It holds 3 g, which is 10 DDD. The cost per DDD is €12.25 ÷ 10 = €1.23, and the annual cost at the WHO standard dose, list price, is that cost × 365 = €447.13.
France
Public price in France, including VAT and the per-pack dispensing fee. Source [4], read on 9 October 2026. ATC match: through the active substance (BDPM substance code), since the BDPM gives no ATC code.
Show the 4 packs
| Product | Pack | Price | DDD per pack | Cost per DDD | Annual cost at the WHO standard dose | Source line |
|---|---|---|---|---|---|---|
| TOPIRAMATE ARROW LAB 100 mg, comprimé pelliculéARROW GENERIQUES | plaquette(s) polyamide aluminium PVC de 30 comprimé(s) | €12.25 | 10 | €1.23 | €447.13 | CIS 64696702 / CIP13 3400930194850substance code 20890 (TOPIRAMATE) in CIS_COMPO_bdpm |
| EPITOMAX 100 mg, comprimé pelliculéJANSSEN CILAG | plaquette(s) thermoformée(s) aluminium de 28 comprimé(s) | €11.50 | 9.33 | €1.23 | €449.73 | CIS 61913385 / CIP13 3400935634429substance code 20890 (TOPIRAMATE) in CIS_COMPO_bdpm |
| TOPIRAMATE VIATRIS 100 mg, comprimé pelliculéVIATRIS SANTE | plaquette(s) aluminium de 28 comprimé(s) | €11.50 | 9.33 | €1.23 | €449.73 | CIS 66961409 / CIP13 3400938270884substance code 20890 (TOPIRAMATE) in CIS_COMPO_bdpm |
| TOPIRAMATE SANDOZ 100 mg, comprimé pelliculéSANDOZ | flacon(s) polyéthylène haute densité (PEHD) de 28 comprimé(s) | €11.50 | 9.33 | €1.23 | €449.73 | CIS 68353836 / CIP13 3400939016955substance code 20890 (TOPIRAMATE) in CIS_COMPO_bdpm |
Spain
Retail price including VAT (PVP IVA). Source [13][6], read on 9 October 2026. ATC match: ATC code of each national code, checked in CIMA.
Show the 14 packs
| Product | Pack | Price | DDD per pack | Cost per DDD | Annual cost at the WHO standard dose | Source line |
|---|---|---|---|---|---|---|
| TOPIRAMATO SANDOZ 100 mg comprimidos recubiertos con pelicula , 60 comprimidos (frasco)SANDOZ FARMACEUTICA, S.A | 60 comprimidos | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 652462AEMPS CIMA, registration 69177 |
| Topiramato STADA 100 mg comprimidos recubiertos con pelicula, 60 comprimidosSTADA, S.L | 60 comprimidos | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 658719AEMPS CIMA, registration 68593 |
| TOPIRAMATO KERN PHARMA 100 mg comprimidos recubiertos con pelicula, 60 comprimidosKERN PHARMA, S.L. | 60 comprimidos | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 658916AEMPS CIMA, registration 68723 |
| TOPIRAMATO VIATRIS 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG. 60 comprimidosVIATRIS PHARMACEUTICALS, S.L. | 60 comprimidos | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 659432AEMPS CIMA, registration 69036 |
| TOPIRAMATO CINFA 100 mg comprimidos recubiertos con pelicula, 60 comprimidos (frasco)CINFA S.A. | 60 comprimidos | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 659618AEMPS CIMA, registration 69137 |
| ACOMICIL 100 mg comprimidos recubiertos con pelicula , 60 comprimidos (frasco)ADAMED LABORATORIOS, S.L.U | 60 comprimidos | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 660633AEMPS CIMA, registration 69661 |
| TOPIRAMATO TECNIGEN 100 mg comprimidos recubiertos con pelicula , 60 comprimidosTECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA S.A. | 60 comprimidos | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 662549AEMPS CIMA, registration 70646 |
| TOPIRAMATO NORMON 100 mg comprimidos recubiertos con pelicula , 60 comprimidosNORMON S.A. | 60 comprimidos | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 662697AEMPS CIMA, registration 70765 |
| TOPAMAX 100MG 60 COMPRIMIDOS RECUBIERTOSJANSSEN CILAG S.A. | 60 COMPRIMIDOS | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 664011AEMPS CIMA, registration 61875 |
| TOPIRAMATO QUALIGEN 100 mg comprimidos recubiertos con pelicula , 60 comprimidos (Blister)NEURAXPHARM SPAIN, S.L.U | 60 comprimidos | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 664940AEMPS CIMA, registration 70890 |
| TOPIRAMATO RATIOPHARM 100 mg comprimidos recubiertos con pelicula , 60 COMPRIMIDOSTEVA PHARMA, S.L.U | 60 COMPRIMIDOS | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 671943AEMPS CIMA, registration 67991 |
| TOPIRAMATO PHARMA COMBIX 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA , 60 comprimidos (blister Al/Al con desecante)COMBIX, S.L.U | 60 comprimidos | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 690376AEMPS CIMA, registration 73765 |
| TOPIRAMATO PENSA PHARMA 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG , 60 comprimidosTOWA PHARMACEUTICAL, S.A. | 60 comprimidos | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 708047AEMPS CIMA, registration 69425 |
| TOPIRAMATO AUROVITAS 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG 60 comprimidosAUROVITAS SPAIN, S.A.U | 60 comprimidos | €36.62 | 20 | €1.83 | €668.31 | Código Nacional 727284AEMPS CIMA, registration 84609 |
United Kingdom
Drug Tariff basic price paid to the pharmacy, excluding VAT (Part VIIIA Category M). Source [14][15], read on 9 October 2026. ATC match: ATC code of the virtual product (VMP) in the dm+d.
Show the 1 pack
| Product | Pack | Price | DDD per pack | Cost per DDD | Annual cost at the WHO standard dose | Source line |
|---|---|---|---|---|---|---|
| Topiramate 100mg tablets | 60 tablet | £2.37 | 20 | £0.12 | £43.25€51.03 | VMPP SNOMED 1209511000001105dm+d browser, VMP 1655 |
References
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- Base de données publique des médicaments [Internet]. Paris: Ministère du Travail, de la Santé, des Solidarités et des Familles; 2026 [updated 2026 Oct 8; cited 2026 Oct 9]. Available from: https://base-donnees-publique.medicaments.gouv.fr/telechargement
- DysNet, the dysmelia network. Teratogen register [Internet]. [place unknown]: DysNet; 2026 [updated 2026 Sep 12; cited 2026 Oct 9]. Available from: https://www.dysnet.org/knowledge/teratogens/
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- European Medicines Agency. Download medicine data [Internet]. Amsterdam: EMA; 2026 [updated 2026 Oct 9; cited 2026 Oct 9]. Available from: https://www.ema.europa.eu/en/medicines/download-medicine-data
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- National Institute for Health and Care Excellence. Technology appraisal guidance [Internet]. London: NICE; [cited 2026 Oct 9]. Available from: https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance
- Scottish Medicines Consortium. Medicines advice [Internet]. Glasgow: SMC; [cited 2026 Oct 9]. Available from: https://scottishmedicines.org.uk/medicines-advice/
- Gemeinsamer Bundesausschuss. Nutzenbewertung nach § 35a SGB V: Apixaban [Internet]. Berlin: G-BA; [cited 2026 Oct 9]. Available from: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/
- Agencia Española de Medicamentos y Productos Sanitarios. Informes de posicionamiento terapéutico [Internet]. Madrid: AEMPS; [cited 2026 Oct 9]. Available from: https://www.aemps.gob.es/medicamentos-de-uso-humano/evaluacion-de-tecnologias-sanitarias/informes-de-posicionamiento-terapeutico/
- Ministerio de Sanidad. Nomenclátor de facturación de octubre 2026 [Internet]. Madrid: Ministerio de Sanidad; 2026 [cited 2026 Oct 9]. Available from: https://www.sanidad.gob.es/profesionales/nomenclator.do
- NHS Business Services Authority. Drug Tariff Part VIIIA, October 2026 [Internet]. Newcastle upon Tyne: NHSBSA; 2026 [cited 2026 Oct 9]. Available from: https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff/drug-tariff-part-viii
- NHS Business Services Authority. dm+d browser: NHS dictionary of medicines and devices [Internet]. Newcastle upon Tyne: NHSBSA; [updated 2026 Oct 1; cited 2026 Oct 9]. Available from: https://dmd-browser.nhsbsa.nhs.uk/