Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sucralfate
Drug ID BADD_D02081
Description Sucralfate is a medication that is widely used to prevent and treat a number of diseases in the gastrointestinal tract such as duodenal ulcers [FDA label], gastro-esophageal reflux disease (GERD), gastritis, peptic ulcer disease, stress ulcer, in addition to dyspepsia [A177655]. It is considered a _cytoprotective agent_, protecting cells in the gastrointestinal tract from damage caused by agents such as gastric acid, bile salts, alcohol, and acetylsalicylic acid (aspirin), among other substances [A177655, F4519]. 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].
Indications and Usage The sucralfate suspension [FDA label] and tablet [F4534] are used for the treatment of active duodenal ulcer for up to 8 weeks. The tablet form may be used at a lower dose for healed duodenal ulcers, for the purpose of maintaining healing and preventing recurrence [F4519, F4534]. 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].
Marketing Status approved
ATC Code A02BX02
DrugBank ID DB00364
KEGG ID D00446
MeSH ID D013392
PubChem ID 121494085
TTD Drug ID D06ULU
NDC Product Code 38779-0318; 69984-001; 58914-170; 60687-738; 63739-193; 72189-234; 50090-5287; 62135-436; 55512-0002; 17856-1011; 0093-2210; 70771-1833; 0615-4517; 63629-1307; 63629-9152; 0378-9205; 70934-525; 0395-8155; 38779-3219; 49452-7401; 62991-1148; 69238-1656; 71335-2114; 71610-541; 10695-162; 0904-7269; 55512-0020; 55603-225; 55603-611; 59762-0401; 63629-9153; 68094-043; 80425-0091; 55512-0009; 51655-031; 58914-171; 66689-305; 68788-8946; 70518-0775; 72189-429; 80425-0213; 55512-0019; 55603-215; 66039-946; 29033-003; 60687-695; 69339-148; 80425-0188; 10695-091; 55512-0021; 58914-172; 0121-0974; 51079-753; 53002-4930; 55154-5790; 68788-8316; 70518-3690; 72578-081; 51655-475; 55154-4379; 63739-943; 71610-017; 51552-0039; 55603-805; 50090-6455; 0254-1011
UNII XX73205DH5
Synonyms Sucralfate | Aluminum Sucrose Sulfate | Sulfate, Aluminum Sucrose | Basic Aluminum Sucrose Sulfate | Ulsanic | Ulcerban | Ulcogant | Antepsin | Carafate
Chemical Information
Molecular Formula C12H54Al9O55S8
CAS Registry Number 54182-58-0
SMILES C(C1C(C(C(C(O1)OC2(C(C(C(O2)COS(=O)(=O)O[Al])OS(=O)(=O)O[Al])OS(=O)(=O)O[Al])COS (=O)(=O)O[Al])OS(=O)(=O)O[Al])OS(=O)(=O)O[Al])OS(=O)(=O)O[Al])OS(=O)(=O)O[Al].O. O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.[Al]
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Nausea07.01.07.001--
Pruritus23.03.12.0010.000394%
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Rash23.03.13.0010.000255%Not Available
Respiratory disorder22.02.07.002--Not Available
Retching07.01.07.0020.000394%Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Seizure17.12.03.0010.000116%
Somnolence19.02.05.003; 17.02.04.006--
Swelling08.01.03.0150.000394%Not Available
Swelling face10.01.05.018; 08.01.03.100; 23.04.01.018--Not Available
Throat irritation22.12.03.029; 07.05.05.0370.000255%Not Available
Urticaria23.04.02.001; 10.01.06.0010.000394%
Vertigo17.02.12.002; 04.04.01.003--
Vomiting07.01.07.0030.000394%
Epigastric discomfort07.01.02.004--Not Available
Oesophageal disorder07.11.02.0010.000116%Not Available
Complication associated with device08.07.01.011--Not Available
Gastric mucosal calcinosis07.11.03.013; 14.04.01.0190.000116%Not Available
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