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Sucralfate

Sucralan, Sucralfat Genericon · ATC code A02BX02

Also known as: Sucralfat · Brand names: Sucralan, Sucralfat Genericon, Sucrabest, Antepsin, Sukrat, Carafate

Key facts
Active substance
Sucralfate
ATC code
A02BX02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Sucralfate is a locally acting mucosal protective agent (aluminium–sucrose complex). Per the US label it is used to treat duodenal ulcer and as maintenance therapy after healing.

What it is used for

  • Short-term treatment (up to 8 weeks) of active duodenal ulcer
  • Maintenance therapy at reduced dosage after healing of acute duodenal ulcers

Dosing

  • Active duodenal ulcer (adults): 1 g four times per day on an empty stomach
  • Continue for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopy
  • Maintenance: 1 g twice a day
  • Antacids as needed, but not within one-half hour before or after sucralfate
  • Elderly: cautious dose selection, usually at the low end of the range

Contraindications

  • Known hypersensitivity to the active substance or any excipient

Important warnings

  • Small amounts of aluminum are absorbed; excretion is impaired in chronic renal failure or dialysis
  • Concomitant aluminum-containing antacids increase the aluminum burden
  • Bezoars, mainly with delayed gastric emptying or enteral tube feeding
  • Not for intravenous use; inadvertent injection has caused fatal emboli

Side effects

  • Most frequent: constipation
  • Rare: diarrhea, nausea, vomiting, gastric discomfort, flatulence, dry mouth, pruritus, rash, dizziness, headache
  • Hypersensitivity reactions including dyspnea, lip swelling and urticaria reported

Interactions

  • Reduced absorption of e.g. cimetidine, digoxin, fluoroquinolones, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline and theophylline
  • Warfarin: cases of subtherapeutic prothrombin times reported
  • Aluminum-containing antacids: increased aluminum burden

Pregnancy and breastfeeding

  • No evidence of fetal harm in animal studies; no adequate studies in pregnant women
  • Unknown whether excreted in human milk; caution when nursing

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)

This product has no separate US patient information.

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

  • SucralanG.L. Pharma Gmbh · 1 register entry
  • Sucralfat GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry

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

Germany

  • SucrabestCombustin Pharmazeutische Präparate Gmbh · 1 register entry

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

Turkey

  • AntepsinBİLİM İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • SukratHÜSNÜ ARSAN İLAÇLARI A.Ş. · 3 register entries

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

USA

  • CarafateAllergan, Inc. · 2 register entries

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

Brand names in 11 more European countries
Denmark
Antepsin, Peptonorm
Finland
Antepsin, Peptonorm
France
Keal, Ulcar
Greece
Peptonorm
Hungary
Peptonorm
Iceland
Antepsin
Italy
Antepsin, Sucralfato Doc Generici, Sucramal, Sucrate
Netherlands
Sucralfaat Sandoz, Sucralfaat Teva, Sucralphate Aurobindo
Norway
Antepsin
Portugal
Sucralfato Generis, Sucralfato Jaba, Ulcermate, Ulcermin, Ulcimer
Sweden
Andapsin

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

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. Sucralfate (Mylan Institutional Inc.) – Prescribing Information, 2025-07-22. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=989ca8a8-3ad6-4ee4-aa9c-eed731828753
  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.