Esomeprazole

Durotiv, Esomeprazol, Nexium · ATC code A02BC05

Also known as: Esomeprazol, Esomeprazole magnesium · Brand names: Durotiv, Nexium, Esogasec, Esomeaxiro, Esomep, Esoval, Sempra, Ulcerex, Enpro, Esemeprol, Esmara, Esoblok, Esom, Esomen-L, Esopral …

Key facts
Active substance
Esomeprazole
ATC code
A02BC05
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Esomeprazole is a proton pump inhibitor (PPI), the S-isomer of omeprazole. Per the US label it is used for acid-related disorders such as erosive esophagitis, GERD and H. pylori eradication.

What it is used for

  • Healing of erosive esophagitis (adults and children from 1 month) and maintenance of healing (adults)
  • Symptomatic gastroesophageal reflux disease (GERD)
  • Risk reduction of NSAID-associated gastric ulcer
  • H. pylori eradication (triple therapy) to reduce the risk of duodenal ulcer recurrence
  • Pathological hypersecretory conditions including Zollinger-Ellison syndrome

Dosing

  • Healing of erosive esophagitis: 20 mg or 40 mg once daily for 4 to 8 weeks
  • Maintenance of healing and symptomatic GERD: 20 mg once daily (GERD 4 weeks)
  • H. pylori: esomeprazole 40 mg once daily plus amoxicillin 1000 mg and clarithromycin 500 mg twice daily for 10 days
  • Zollinger-Ellison syndrome: starting dosage 40 mg twice daily, individualized
  • Severe liver impairment (Child-Pugh C): maximum 20 mg once daily
  • Pediatric dosing by age and indication in the full text

Contraindications

  • Known hypersensitivity to substituted benzimidazoles or any component
  • Concomitant rilpivirine-containing products

Important warnings

  • Symptomatic response does not preclude gastric malignancy
  • Acute tubulointerstitial nephritis; discontinue if suspected
  • Clostridium difficile-associated diarrhea
  • Bone fracture, severe cutaneous adverse reactions, cutaneous and systemic lupus erythematosus
  • Vitamin B-12 deficiency, hypomagnesemia, fundic gland polyps with long-term use

Side effects

  • Most common: headache, diarrhea, abdominal pain, nausea, flatulence, constipation, dry mouth
  • Serious: tubulointerstitial nephritis, C. difficile diarrhea, fractures, severe skin reactions

Interactions

  • Rilpivirine: contraindicated
  • Clopidogrel: avoid concomitant use (impaired formation of the active metabolite)
  • Methotrexate (mainly high dose): possibly elevated and prolonged methotrexate levels

Pregnancy and breastfeeding

  • No adequate studies in pregnant women; epidemiologic data on first-trimester omeprazole show no increased risk of major malformations
  • Limited data suggest omeprazole may be present in human milk

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

  • DurotivGebro Pharma Gmbh · 2 register entries
  • Esomeprazol1a Pharma Gmbh, Teva B.V, Genericon Pharma Gesellschaft M.B.H., Tillomed Pharma Gmbh, +pharma Arzneimittel Gmbh, Actavis Group Ptc Ehf., Aristo Pharma Gmbh (Art 57), Sandoz Gmbh, Stada Arzneimittel Gmbh, Demo Abee, Krka, D.D., Novo Mesto · 16 register entries
  • NexiumGrünenthal Österreich Gmbh · 3 register entries

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

Germany

  • EsogasecAristo Pharma Gmbh (Art 57) · 1 register entry
  • EsomeaxiroMedical Valley Invest Ab · 1 register entry
  • EsomepHexal Ag · 1 register entry
  • Esomeprazol123 Acurae Pharma Gmbh, Laboratórios Azevedos - Indústria Farmacêutica, S.A., Tad Pharma Gmbh, Hexal Ag, Ratiopharm Gmbh, Ethypharm, Tillomed Pharma Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Aristo Pharma Gmbh (Art 57), Basics Gmbh, Laboratorios Normon, S.A., Adoh B.V., Demo Abee, Denk Pharma Gmbh & Co. Kg, Abz-Pharma Gmbh, Hec Pharm Gmbh, Sun Pharmaceuticals Germany Gmbh · 22 register entries
  • EsovalTowa Pharmaceutical Europe S.L. · 1 register entry
  • NexiumGrünenthal Gmbh · 3 register entries
  • SempraKrka, D.D., Novo Mesto · 1 register entry
  • UlcerexAristo Pharma Gmbh (Art 57) · 1 register entry

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

Turkey

  • EnproBİLİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • EsemeprolCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • EsmaraPENSA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • EsoblokDEVA HOLDİNG A.Ş. · 1 register entry
  • EsomNOBEL İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
  • Esomen-LGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 2 register entries
  • EsopralTERRA İLAÇ VE KİMYA SAN. TİC. A.Ş. · 6 register entries
  • EsoproABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • EsovipCELTİS İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • EspovilWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • EssiumPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • EswazolTAWALU PHARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Show all 21 brand names
  • GeniumGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 1 register entry
  • JectosemTÜM-EKİP İLAÇ A.Ş. · 1 register entry
  • MasecrisAROMA İLAÇ SAN. LTD. ŞTİ. · 1 register entry
  • NexfulINCPHARMA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
  • NexiumASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 4 register entries
  • NexstepNEUTEC İLAÇ SAN. TİC. A.Ş · 4 register entries
  • RefastilVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • RefloselOSEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • SitarolWORLD MEDICINE İLAÇLARI LTD. ŞTİ. · 1 register entry

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

USA

  • NexiumAstraZeneca Pharmaceuticals LP · 1 register entry

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

Brand names in 28 more European countries
Belgium
Esomeprazol Ab, Esomeprazole Ab, Esomeprazole Eg, Esomeprazole Teva, Esomeprazole Viatris, Nexiam
Bulgaria
Esomeprazole Tchaikapharma, Refstop, Гастроцид Езо, Езомепразол Алуфарма, Езомепразол Екофарм, Езомепразол Полфарма, Езомепразол Ромфарм, Езопраджен, Еманера, Нексиум, Нексопрал, Ормус, Ремезолин, Хелидес
Croatia
Cidiref, Emanera, Naxesy, Nexium
Cyprus
Demolox, Esomeprazole Krka, Esomeprazole Sapiens, Esomeprazole Tad, Nexium
Czechia
Emanera, Esomeprazole Olikla, Esurap, Helides
Denmark
Abigerd, Dansiglat, Esogrc, Esomel, Esomeprazol, Esomeprazole, Esoref, Nexium, Nexizol, Ulcerex
Estonia
Elfimest, Escadra, Esomeprazole Actavis, Esomeprazole Sandoz, Esomeprazole Stada, Nexium, Nexmezol
Finland
Acidal, Esomeprazol Actavis, Esomeprazol Hexal, Esomeprazol Krka, Esomeprazol Oresund Pharma, Esomeprazol Orion, Esomeprazol Ratiopharm, Esomeprazol Sandoz, Esomeprazole Demo S.A., Esomeprazole Orifarm, Esopraz, Nexium
France
Celardes, Esodomin, Esomeprazole, Etizol, Inexium, Mezgosal, Moesan, Pamezol, Precolzac, Zacoperc
Greece
Demolox, Epivetier, Esolib, Helides, Nexium, Solezol
Hungary
Emanera, Emozul, Esomeprazol Actavis, Esomeprazol Sandoz, Nexium
Iceland
Esomeprazol Actavis, Esomeprazol Hexal, Esomeprazol Krka, Esomeprazol Medical Valley, Esomeprazole Jubilant, Esoprax, Etizol, Nexium, Prazolene
Ireland
Emazole, Escadra, Esomeprazole Accord Healthcare Ireland, Esomeprazole Aristo, Esomeprazole Brillpharma (Ireland), Esomeprazole Chefaro Ireland, Esomeprazole Clonmel, Esomeprazole Demo, Esomeprazole Jubilant, Esomeprazole Krka, Esomeprazole Pinewood Laboratories, Esomeprazole Ticerin Laboratórios Azevedos - Indústria Farmacêutica, Esomeprazole Tillomed, Nexazole, Nexium
Italy
Abigerd, Ariliar, Axagon, Esodor, Esomeflux, Esomenar, Esomeprazol Sun, Esomeprazolo Accord, Esomeprazolo Almus Pharma, Esomeprazolo Alter, Esomeprazolo Aristo, Esomeprazolo Cipla Europe, Esomeprazolo Demo, Esomeprazolo Doc, Esomeprazolo Eg, Esomeprazolo Git, Esomeprazolo Krka, Esomeprazolo Laboratori Alter, Esomeprazolo Mylan Generics, Esomeprazolo Pensa Pharma, Esomeprazolo Pharmacare, Esomeprazolo Sandoz, Esomeprazolo Sun, Esomeprazolo Tecnigen, Esomeprazolo Teva Italia, Esomeprazolo Tillomed, Esomeprazolo Zentiva, Esopir, Esopral, Ezoran, Gastres, Lucen, Nexium
Latvia
Elfimest, Escadra, Esomeprazole Actavis, Esomeprazole Hexal, Esomeprazole Sandoz, Esomeprazole Stada, Esomeprazole Unifarma, Nexmezol
Liechtenstein
Nexium Control
Lithuania
Elfimest, Escadra, Esepa, Esomeprazole, Nexium, Nexmezol
Luxembourg
Esomeprazol Ab, Esomeprazol Ratiopharm, Esomeprazole Eg, Esomeprazole Viatris, Nexiam
Malta
Emazole, Esomeprazole Clonmel, Esomeprazole Ticerin Laboratórios Azevedos, Tazokap
Netherlands
Esobax, Esomeprazol Accord, Esomeprazol Adoh, Esomeprazol Alter, Esomeprazol Aristo, Esomeprazol Auro, Esomeprazol Aurobindo, Esomeprazol Brillpharma, Esomeprazol Cipla, Esomeprazol Demo, Esomeprazol Focus Care, Esomeprazol I.V. Cf, Esomeprazol Jubilant, Esomeprazol Liconsa, Esomeprazol Pch, Esomeprazol Pharmathen, Esomeprazol Sandoz, Esomeprazol Stada, Esomeprazol Sun, Esomeprazol Tillomed, Esomeprazol Viatris, Esomeprazol Xiromed, Esoval, Maagzuurremmende, Nexium, Omzar
Norway
Esogrc, Esomeprazol Actavis, Esomeprazol Cipla, Esomeprazol Krka, Esomeprazol Oresund Pharma, Esomeprazol Sun, Esomeprazol Viatris, Esomeprazole Demo S.A., Esomeprazole Orifarm, Nexium, Nexizol
Poland
Alugastrin, Emanera, Esogasec, Esomeprazol, Esomeprazole Adamed, Esomeprazole Zentiva, Esopol, Helides, Mesopral, Ortanol, Stomezul, Texibax
Portugal
Demoel, Esomeprazol Accord, Esomeprazol Alter, Esomeprazol Amperlem, Esomeprazol Aristo, Esomeprazol Aurovitas, Esomeprazol Azevedos, Esomeprazol Basi, Esomeprazol Bluepharma, Esomeprazol Ciclum, Esomeprazol Cinfa, Esomeprazol Codramol, Esomeprazol Demo, Esomeprazol Emozul, Esomeprazol Farmalider, Esomeprazol Generis, Esomeprazol Gp, Esomeprazol Hikma, Esomeprazol Kiddir Sandoz, Esomeprazol Krka, Esomeprazol Liconsa, Esomeprazol Lumec, Esomeprazol Muskhin Axone, Esomeprazol Mylan, Esomeprazol Normon, Esomeprazol Omnicals, Esomeprazol Pharmacare, Esomeprazol Ratiopharm, Esomeprazol Ripzen, Esomeprazol Stada, Esomeprazol Ticerin Laboratórios Azevedos - Indústria Farmacêutica, Esomeprazol Tolife, Esomeprazol Zentiva, Kiddir, Nexium
Romania
Emanera, Esomeprazol Rompharm, Esomeprazol Sun, Esomeprazol Terapia, Helides, Nexium
Slovakia
Dereflin, Emanera, Esomeprazole Olikla, Esozoll
Slovenia
Emozul, Eslaver, Esmera, Esomeprazol Lek, Esomeprazol Stada, Esomeprazol Teva, Esora, Espela, Faras, Nexium, Nillar, Peros, Prazos, Sempra
Spain
Axiago, Emanera, Esocoda, Esomeprazol Almus, Esomeprazol Alter, Esomeprazol Aristo, Esomeprazol Aurovitas Spain, Esomeprazol Cinfa, Esomeprazol Combix, Esomeprazol Davur, Esomeprazol Demo, Esomeprazol Farmalider, Esomeprazol Kern Pharma, Esomeprazol Krka, Esomeprazol Liderfarm, Esomeprazol Mabo, Esomeprazol Normogen, Esomeprazol Normon, Esomeprazol Pensa, Esomeprazol Ratiopharm, Esomeprazol Sandoz, Esomeprazol Stada, Esomeprazol Stadafarma, Esomeprazol Sun, Esomeprazol Tecnigen, Esomeprazol Teva, Esomeprazol Viatris, Esomeprazol Vir, Nexium, Noecel
Sweden
Axiago, Cativa, Esomep, Esomeprazol Actavis, Esomeprazol Cipla, Esomeprazol Hexal, Esomeprazol Jubilant, Esomeprazol Krka, Esomeprazol Medical Valley, Esomeprazol Net, Esomeprazol Oresund Pharma, Esomeprazol Stada, Esomeprazol Sun, Esomeprazol Viatris, Esomeprazole Demo S.A., Esomeprazole Orifarm, Esomeprazole Sun, Esopral, Nexium, Nexizol, Refexxin, Ulcerex

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

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Sources

  1. U.S. Food and Drug Administration. Esomeprazole magnesium (Cipla USA Inc.) – Prescribing Information, 2025-01-02. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e89589f1-945e-429a-819e-61755cba77fa
  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/

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.