sucralfate
Pharmaranks rates Sucralfate 3.1/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Sucralfate is an aluminum complex used to treat Duodenal Ulcer, Esophagitis, Gastritis, Pneumonia.
Aluminum Complex · by Glenmark Pharms Ltd
Generic of Carafate
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Sucralfate
- Drug class
- Aluminum Complex
- Form
- Tablet
- Strength
- Sucralfate 1GM/10ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- duodenal ulcer, esophagitis, gastritis
- Manufacturer
- Glenmark Pharms Ltd
- What the pharmacy pays
- ~$5.49 for 30 — not your price
- FDA application
- ANDA212141
What is Sucralfate?
From the FDA label:Sucralfate oral suspension contains sucralfate and sucralfate is an α-D-glucopyranoside-β-D- fructofuranosyl,-octakis (hydrogen sulfate), aluminum complex. Sucralfate, USP is white or almost white, amorphous powder. Practically insoluble in water, in ethanol (96%) and in methylene chloride. It dissolves in dilute solutions of mineral acids and alkali hydroxides. Sucralfate oral suspension for oral administration contains 1 g of sucralfate per 10 mL. Sucralfate oral suspension also contains: colloidal silicon dioxide, FD&C Red #40, glycerin, methylparaben, methylcellulose, microcrystalline cellulose, purified water, simethicone emulsion, sorbitol solution and tutti frutti flavor. Additionally, tutti frutti flavor contains artificial flavors, benzyl alcohol, dl-alpha-tocopherol, maltodextrin and propylene glycol. Therapeutic category: antiulcer. structure
How to use
Active Duodenal Ulcer: The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day. Sucralfate oral suspension should be administered 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 oral suspension. 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. 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 Glenmark Pharmaceutical Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Side effects
Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2,700 patients treated with sucralfate, 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, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting 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 oral suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria. Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate. Cases of hyperglycemia have been reported with 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.
Warnings
Important safety information
Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of sucralfate oral suspension. Administer sucralfate oral suspension only by the oral route. Do not administer intravenously.
Who should not take Sucralfate
Sucralfate oral suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.
Overdose — what happens if you take too much
Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral 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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
May treat (source: NIH RxClass)
See how Sucralfate ranks — best-rated aluminum complex for:
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Sucralfate treat?
- Sucralfate (Sucralfate) may be used to treat duodenal ulcer, esophagitis, gastritis, pneumonia, stomach ulcer, stomatitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Sucralfate rated?
- pharmaranks gives Sucralfate a composite score of 3.1 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Sucralfate cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $5.49 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Sucralfate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Sucralfate. To pay less, Sucralfate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Sucralfate?
- Sucralfate is marketed by Glenmark Pharms Ltd. You can see Glenmark Pharms Ltd's full profile, rating, and other products on pharmaranks.
- Is Sucralfate a brand-name or generic drug?
- Sucralfate is a generic medication; its active ingredient is Sucralfate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Sucralfate available over the counter?
- No. Sucralfate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Sucralfate come in?
- Sucralfate is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Sucralfate?
- Sucralfate is classified as aluminum complex, per the FDA's Established Pharmacologic Class.
- Is Sucralfate FDA-registered?
- Sucralfate is on record with the U.S. FDA under application number ANDA212141. You can verify this on its official FDA label.
- Has Sucralfate been recalled by the FDA?
- Sucralfate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Sucralfate safe?
- There's no single safe-or-not verdict. pharmaranks gives Sucralfate a recall-safety score of 62/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Sucralfate?
- Sucralfate's side effects are taken directly from its FDA label. From the label: Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2,700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%). Constipation was the most frequent complaint (2%).… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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sucralfate
62/100