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sucralfate

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Brand names: Carafate

Mucosal Protective Agent Rx

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.

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.

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.

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.

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.

Storage

Store sucralfate tablets at room temperature between 68° to 77°F (20° to 25°C).

Side Effects (from patient reports)

Based on 14,827 FDA adverse event reports.

Feeling sick to your stomach
2,262
Feeling very tired
1,733
Loose, watery stools
1,701
General discomfort
1,482
Pain in your head
1,381
Throwing up
1,355
Difficulty breathing
1,302
Medication not working
1,293
Using medication for unapproved purpose
1,278
Feeling unsteady or lightheaded
1,040

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

Death-Related Reports

2,262

Hospitalization Reports

8,938

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 14,611 (67%)
Male 7,071 (33%)

Age Distribution

0–17 491
18–44 2,121
45–64 5,620
65–74 3,727
75+ 2,817

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
8 DRUG INEFFECTIVE 1,293
9 OFF LABEL USE 1,279
10 DIZZINESS 1,039
11 WEIGHT DECREASED 1,001
12 CHRONIC KIDNEY DISEASE 984
13 ABDOMINAL PAIN 983
14 MALAISE 965
15 PNEUMONIA 950

Reactions in Death Reports

DEATH 879
PNEUMONIA 177
RENAL FAILURE 168
NAUSEA 148
GASTROINTESTINAL HAEMORRHAGE 135
ANAEMIA 130
DYSPNOEA 129
ACUTE KIDNEY INJURY 123
FATIGUE 122
CHRONIC KIDNEY DISEASE 121

Reactions in Hospitalization Reports

NAUSEA 1,051
DIARRHOEA 803
VOMITING 778
PNEUMONIA 762
DYSPNOEA 717
FATIGUE 715
PAIN 702
ABDOMINAL PAIN 607
HEADACHE 580
PYREXIA 577

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, s...

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.

moderate naproxen

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.

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Common Questions

Can I take antacids with sucralfate?
Yes, you can take antacids for pain relief, but wait at least 30 minutes before or after taking sucralfate.
How long should I take sucralfate?
Continue taking sucralfate for 4 to 8 weeks, even if you feel better, unless your doctor tells you otherwise.
What should I do if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Can I take other medications with sucralfate?
Sucralfate can affect how your body absorbs some medicines. Take other medicines 2 hours before or after taking sucralfate.
What are the common side effects of sucralfate?
The most common side effect is constipation.
How does sucralfate work?
Sucralfate forms a protective layer over the ulcer, shielding it from stomach acid and helping it heal.
What is sucralfate used for?
Sucralfate is used to treat and prevent duodenal ulcers.
Should I take sucralfate with food?
No, take sucralfate on an empty stomach.
Can elderly patients take sucralfate?
Yes, but elderly patients should start with a lower dose.
What do the markings on the tablet mean?
The tablets are marked with "N" and "S1" on one side.
What are the common side effects of sucralfate?
The most commonly reported side effects of sucralfate include Constipation (2%). Based on 14,827 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does sucralfate interact with other medications?
Yes, sucralfate has 20 known drug interactions. Notable interactions include theophylline, naproxen, warfarin. Always inform your doctor about all medications you are taking.
What drug class is sucralfate?
sucralfate belongs to the Mucosal Protective Agent drug class. It requires a prescription (Rx). Sucralfate is used to treat active duodenal ulcers, which are sores in the first part of your small intestine.
Is there a generic version of sucralfate?
Yes, generic sucralfate is available from 12 manufacturers. The generic costs $0.17 per unit compared to $4.76 for the brand version, saving approximately 97%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is sucralfate safe during pregnancy?
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. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has sucralfate been recalled?
There is 1 recall associated with sucralfate products. CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. Check the recalls section below for full details and affected products.

Active Recalls

Class II October 9, 2025

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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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 14,827 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

All federal data sources used on this page