Sucralfate 4% in Emulsifying ointment
Requires a prescription from a doctor or prescriber
Local preparations for anal and rectal disorders
Safety information for pregnancy and breastfeeding
Pregnancy
This drug is considered a pregnancy Category B drug.
Breastfeeding
Whether this drug is excreted in human milk is currently unknown.
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Sucralfate
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Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Sucralfate
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Clinical guidelines and formulary information
British National Formulary
Sucralfate
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
6-20 h
Mechanism
The mechanism of action of this drug in the healing duodenal ulcers is not yet c…
Food interactions
2 warnings
Human targets
4 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
0.001%
Half-life
6-20 h
Protein binding
Volume of distribution
Metabolism
Elimination
48 hours
Clearance
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Sucralfate has been shown to be a well-tolerated and safe drug. It is sold under many brands and is available in both tablet and suspension forms. It was approved by the FDA 1982 in tablet form, and in 1994 for the suspension form [L6073][L6076].
Sucralfate is also used in the prevention and/or treatment of gastro-esophageal reflux disease (GERD), gastritis, peptic ulcer disease, stress ulcer, in addition to dyspepsia [A177655, F4519].
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 861 interactions
Overdosage has never been observed with sucralfate F4519. It is unlikely, as administering a maximum dose of up to 12 g/kg/body weight in several animal species did not result in death. The lethal dose could not be determined in these studies F4519.
It is likely that overdose of sucralfate in humans would result in constipation, and supportive treatment would be advised F4519.
Use in pregnancy
This drug is considered a pregnancy Category B drug. Studies have been performed in rodents and rabbits at doses up to 50 times the recommended human dose. No harm to the fetus has been observed in the abovementioned studies. Sufficient and well-controlled clinical trials have not been performed in pregnant women.
Due to the fact that the results of animal studies are not always relevant to human response, sucralfate should be used during pregnancy only if it is deemed essential for the mother's health [FDA label].
Use in nursing
Whether this drug is excreted in human milk is currently unknown. Many drugs are excreted in breast milk, therefore, if sucralfate is administered to a lactating and nursing woman, caution should be observed [FDA label].
Carcinogenesis
24 month toxicity studies were performed in rodents, and the dose of sucralfate reached up to 1 g/kg (equivalent to 12 times the recommended human dose). No signs of sucralfate-related tumors were noted[FDA label].
Studies in both humans and animals have indicated that sucralfate forms a complex that binds to protein-rich exudate found on the surface of ulcers. It binds to albumin and fibrinogen [A11831][A177685] preventing blood clot lysis by stomach acid (hydrochloric acid). Sucralfate increases the tissue levels of fibroblast growth factors and epidermal growth factors,[A16738][A16741] leading to an increase in prostaglandins at the gastrointestinal tract lining, which promotes the healing of gastrointestinal ulcers.[A177655]
In the laboratory setting, a sucralfate-albumin film provides a barrier against the entry of hydrogen ions, which are a component of gastric acid. In humans, sucralfate, given at therapeutic doses for ulcers, decreases pepsin activity in gastric fluids by 32% [FDA label]. Pepsin has been shown to be damaging to tissues, further aggravating ulcer lesion inflammation [A177667]. Bile salts have been implicated in mucosal injury to the gastrointestinal tract [A177697][A177700]. Sucralfate has also been shown to adsorb bile salts in the laboratory, setting, which could further contribute to its beneficial effects in ulcer healing [FDA label].
How the body processes this drug — absorption, distribution, metabolism, and elimination
In dialyzed patients diagnosed with chronic renal failure, aluminum toxicity related to sucralfate has been observed and reported. The daily amount of aluminum ingestion (including sucralfate) should be carefully examined before administering sucralfate in combination with other drugs also containing aluminum, including various antacids F4519.
Proteins and enzymes this drug interacts with in the body
PMID:8663044
Also acts as an integrin ligand which is required for FGF2 signaling .
PMID:28302677
Binds to integrin ITGAV:ITGB3 .
PMID:28302677
Plays an important role in the regulation of cell survival, cell division, cell differentiation and cell migration .
PMID:28302677 PMID:8663044
Functions as a potent mitogen in vitro .
PMID:1721615 PMID:3732516 PMID:3964259
Can induce angiogenesis .
PMID:23469107 PMID:28302677
Mediates phosphorylation of ERK1/2 and thereby promotes retinal lens fiber differentiation PMID:29501879
Was originally thought to be essential for platelet aggregation, based on in vitro studies using anticoagulated blood. However, subsequent studies have shown that it is not absolutely required for thrombus formation in vivo. Enhances expression of SELP in activated platelets via an ITGB3-dependent pathway.
Maternal fibrinogen is essential for successful pregnancy. Fibrin deposition is also associated with infection, where it protects against IFNG-mediated hemorrhage. May also facilitate the antibacterial immune response via both innate and T-cell mediated pathways
ATC A02BX02
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Sucralfate
Additional database identifiers
Drugs Product Database (DPD)
2023
ChemSpider
32701653
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8887
GeneCards
PGA5
Guide to Pharmacology
2390
UniProt Accession
PEPA5_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3676
GenAtlas
FGF2
GeneCards
FGF2
GenBank Gene Database
X04431
GenBank Protein Database
31362
UniProt Accession
FGF2_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3229
GenAtlas
EGF
GeneCards
EGF
GenBank Gene Database
X04571
GenBank Protein Database
31121
UniProt Accession
EGF_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3661
GenAtlas
FGA
GeneCards
FGA
GenBank Gene Database
AF361104
GenBank Protein Database
13591824
UniProt Accession
FIBA_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3662
GenAtlas
FGB
GeneCards
FGB
GenBank Gene Database
J00129
GenBank Protein Database
182430
UniProt Accession
FIBB_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3694
GenAtlas
FGG
GeneCards
FGG
GenBank Gene Database
M10014
GenBank Protein Database
182439
UniProt Accession
FIBG_HUMAN
International reference pricing
Reference pricing from DrugBank. Prices are indicative and may not reflect current UK costs.
Source: DrugBank. Used under CC BY-NC 4.0 academic licence for non-commercial purposes.
DrugBank citations
If you use DrugBank data in your research, please cite the following publications: