Prescription medication · Mucosal Protective Agent
sucralfate
Also sold as Carafate. Sucralfate is used to treat active duodenal ulcers, which are sores in the first part of your small intestine.
Data updated 2026-05-15
- 23,037
- FDA reportsModerately reported
- 20
- InteractionsSeveral interactions
- 97% less
- Generic vs brandHuge savings
- 1
- Recall record
What the data shows
sucralfate (Carafate) is a prescription Mucosal Protective Agent, reported at a middle-of-the-pack volume (23,037 FDA reports), whose generic costs a fraction of the brand (about 97% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
sucralfate (Carafate) is a prescription Mucosal Protective Agent. Sucralfate is used to treat active duodenal ulcers, which are sores in the first part of your small intestine.
Sucralfate is a medicine that helps heal and protect ulcers in your small intestine. It creates a coating over the ulcer to shield it from stomach acid.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$4.76/unit
Generic Price
$0.17/unit
Generic Savings
97%
Generic Available
Yes (12 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Sucralfate is used to treat active duodenal ulcers, which are sores in the first part of your small intestine.
Common side effects
Constipation (2%)
Key warnings
Inadvertent injection of sucralfate has led to fatal complications, including blood clots in the lungs and brain.
The sections below are summarized in plain English from sucralfate's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Sucralfate works by forming a protective layer over the ulcer. This coating acts like a bandage, shielding the ulcer from stomach acid and enzymes. This protection helps the ulcer heal.
How to Take It
Take 1 gram of sucralfate four times a day on an empty stomach. You can take antacids for pain relief, but wait at least 30 minutes before or after taking sucralfate. Continue taking sucralfate for 4 to 8 weeks, even if you feel better, unless your doctor says your ulcer is healed. For maintenance therapy, take 1 gram twice a day.
This is a plain-language summary of sucralfate's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if sucralfate can harm an unborn baby. Talk to your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
This is a plain-language summary of sucralfate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of sucralfate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store sucralfate tablets at room temperature between 68° to 77°F (20° to 25°C).
Side Effects (from patient reports)
Based on 23,037 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for sucralfate, by number of reports
- Feeling sick to your stomach
Feeling sick to your stomach
2,262 reports
- Feeling very tired
Feeling very tired
1,733 reports
- Loose, watery stools
Loose, watery stools
1,701 reports
- General discomfort
General discomfort
1,482 reports
- Pain in your head
Pain in your head
1,381 reports
- Throwing up
Throwing up
1,355 reports
- Difficulty breathing
Difficulty breathing
1,302 reports
- Feeling unsteady or lightheaded
Feeling unsteady or lightheaded
1,040 reports
- Loss of weight
Loss of weight
1,001 reports
- Long-term kidney problems
Long-term kidney problems
984 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for sucralfate each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where sucralfate sits
sucralfate has more FDA adverse-event reports than 58% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is sucralfate; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 23,037 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1997–2025.
Total Reports
23,037
Reports Mentioning Death
2,262
9.8% of reports — not proof of cause
Hospitalization Reports
8,938
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | NAUSEA | 2,262 |
| 2 | FATIGUE | 1,733 |
| 3 | DIARRHOEA | 1,700 |
| 4 | PAIN | 1,481 |
| 5 | HEADACHE | 1,381 |
| 6 | VOMITING | 1,355 |
| 7 | DYSPNOEA | 1,302 |
| 10 | DIZZINESS | 1,039 |
| 11 | WEIGHT DECREASED | 1,001 |
| 12 | CHRONIC KIDNEY DISEASE | 984 |
| 13 | ABDOMINAL PAIN | 983 |
| 14 | MALAISE | 965 |
| 15 | PNEUMONIA | 950 |
| 16 | ASTHENIA | 938 |
| 17 | DEATH | 882 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Inadvertent injection of sucralfate has led to fatal complications, including blood clots in the lungs and brain. Sucralfate is not intended for intravenous administration.
Known Drug Interactions
albuterol, systemic and inhaled mebendazole amoxicillin medroxyprogesterone ampicillin, with or without sulbactam methylprednisolone atenolol metronidazole azithromycin metoprolol caffeine, dietary ingestion nadolol cefaclor nifedipine co-trimoxazole (trimethoprim and sulfamethoxazole) nizatidine diltiazem norfloxacin dirithromycin ofloxacin enflurane omeprazole famotidine prednisone, prednisolone felodipine ranitidine finasteride rifabutin hydrocortisone roxithromycin isoflurane Sorbitol (purgative doses do not inhibit theophylline absorption) isoniazid sucralfate isradipine terbutaline,...
Mechanism: Sucralfate can coat the stomach or bind to theophylline, which prevents the medicine from being fully absorbed into your bloodstream.
What to do: Your doctor may recommend spacing these medications several hours apart to make sure theophylline works correctly.
Antacids and Sucralfate Clinical Impact: Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen. Intervention: Concomitant administration of antacids such as magnesium oxide or aluminum hydroxide, and sucralfate with naproxen tablets and naproxen sodium tablets is not recommended.
Mechanism: Sucralfate can slow down how quickly your body absorbs naproxen, which may delay its effects.
What to do: Taking these two medications together is not recommended.
Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of sucralfate to chronic warfarin therapy.
Mechanism: This medicine may interfere with how well warfarin thins your blood, although different studies have found different results.
What to do: Your doctor should check your blood clotting speed more often if you take these two drugs together.
Drug Interactions Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline.
Mechanism: Sucralfate can block your body from absorbing ketoconazole if they are taken at the same time. This means the medicine may not work as well to treat your condition.
What to do: Ask your doctor or pharmacist how to space these medicines apart. Taking them at different times can help ensure your body absorbs the full dose of ketoconazole.
In all case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction.
Mechanism: Taking sucralfate at the same time as ciprofloxacin prevents the antibiotic from being fully absorbed into your blood. This can make the antibiotic less effective at fighting your infection.
What to do: Take ciprofloxacin at least 2 hours before you take your dose of sucralfate. This timing helps your body absorb the antibiotic properly.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take antacids with sucralfate?
How long should I take sucralfate?
What should I do if I miss a dose?
Can I take other medications with sucralfate?
What are the common side effects of sucralfate?
How does sucralfate work?
What is sucralfate used for?
Should I take sucralfate with food?
Can elderly patients take sucralfate?
What do the markings on the tablet mean?
What are the common side effects of sucralfate?
Does sucralfate interact with other medications?
What drug class is sucralfate?
Is there a generic version of sucralfate?
Is sucralfate safe during pregnancy?
Has sucralfate been recalled?
Active Recalls
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Amerisource Health Services LLC
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bisacodyl
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bismuth subsalicylate
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cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
Compare with sucralfate →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for sucralfate
The FDA label for sucralfate (sold under brand names such as Carafate) classifies it as a prescription-only medication in the Mucosal Protective Agent class. Sucralfate is used to treat active duodenal ulcers, which are sores in the first part of your small intestine. Official labeling lists 1 commonly reported side effect, including Constipation (2%).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 23,037 voluntary reports. The database also lists 20 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.17 versus $4.76 for the brand - a 97% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 3, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages