pharmacopeia
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/api/v1/drug/sucralfate

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Binding Activity.

Indications

Sourced from openFDA
  • Sucralfate tablets are indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.ICD-10: K26.9

Contraindications

Sourced from openFDA
  • Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.contraindicated

Dosage & administration

Sourced from openFDA

Active Duodenal Ulcer. The recommended adult oral dosage for duodenal ulcer is 1 g four times per day on an empty stomach. Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. Maintenance Therapy: The recommended adult oral dosage is 1 g twice a day. Elderly: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (See PRECAUTIONS, Geriatric Use ). Call your doctor for medical advice about side effects. You may report side effects to Nostrum Laboratories, Inc. at quality@nostrumpharma.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Adverse reactions

Sourced from openFDA

Adverse reactions to sucralfate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate tablets, adverse effects were reported in 129 (4.7%). Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system: Gastrointestinal: diarrhea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth Dermatological: pruritus, rash Nervous System: dizziness, insomnia, sleepiness, vertigo Other: back pain, headache Post-marketing : cases of hypersensitivity have been reported with the use of sucralfate tablets, including dyspnea, lip swelling, pruritus, rash, and urticaria. Cases of anaphylactic reactions, bronchospasm, laryngeal edema, edema of the mouth, pharyngeal edema, respiratory tract edema and swelling of the face have been reported with an unknown oral formulation of sucralfate. Bezoars have been reported in patients treated with sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings. Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic effects Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Overdosage

Sourced from openFDA

Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral toxicity studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.

Approval history

Sourced from openFDA
  • Oct 30, 1981NDANDA018333Abbvie
  • Dec 16, 1993NDANDA019183Abbvie
  • Mar 29, 1996ANDAANDA070848Teva
  • Jun 8, 1998ANDAANDA074415Chartwell Rx
  • Dec 2, 2019ANDAANDA209356Amneal
  • Mar 15, 2022ANDAANDA211884Vistapharm Llc
  • Apr 15, 2022ANDAANDA215576Amneal Pharms
  • Sep 12, 2022ANDAANDA212913Mylan

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
23,408 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea2,3129.9%
  2. 2Fatigue1,7677.5%
  3. 3Diarrhoea1,7357.4%
  4. 4Pain1,5016.4%
  5. 5Headache1,4086.0%
  6. 6Vomiting1,3865.9%
  7. 7Dyspnoea1,3285.7%
  8. 8Drug Ineffective1,3165.6%
  9. 9Off Label Use1,3085.6%
  10. 10Dizziness1,0594.5%
  11. 11Weight Decreased1,0114.3%
  12. 12Abdominal Pain1,0014.3%
  13. 13Chronic Kidney Disease9854.2%
  14. 14Malaise9844.2%
  15. 15Pneumonia9644.1%

Literature

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Recent PubMed references pinned to Sucralfate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 27 ClinicalTrials.gov registrations naming Sucralfate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Sucralfate work?
Mechanism-of-action class: Binding Activity.
What is Sucralfate used for?
According to FDA labeling, Sucralfate carries indications including: Sucralfate tablets are indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sucralfate?
Sucralfate is classified as Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD), Aluminum Complex, Binding Activity, Gastric Acid Alteration.
What are the brand names for Sucralfate?
Sucralfate is marketed under brand names including Carafate.
What are the contraindications for Sucralfate?
Sucralfate labeling lists contraindications including: Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.. Always consult the full prescribing information and a clinician.
Note. Data for sucralfate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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