Ulsicral

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Ulsicral

Quick Facts: Ulsicral (Sucralfate)

Property Description
Active Ingredient Sucralfate
Pharmacological Class Antiulcer Agent, Cytoprotective Agent
Primary Forms Oral Suspension, Tablet, Granules
Origin Synthetic Compound
Route of Administration Oral Route

What Type of Medicine is Ulsicral (Sucralfate)?

Ulsicral is a medication specifically designed for localized support of the digestive system, classified as an antiulcer agent and, more specifically, a Cytoprotective agent. Its active substance, Sucralfate, is a complex synthetic compound derived from a sulfated sucrose base chemically bound to aluminum hydroxide, forming an aluminum salt complex. This compound is engineered for localized action within the digestive system, a property clinically recognized for its benefit in preventing irritation of damaged tissue. Unlike antacids or acid reducers, Ulsicral is designed to work primarily through physical protection, a characteristic that differentiates its therapeutic approach.


Composition and Available Forms of Ulsicral

Ulsicral is a single-ingredient product based exclusively on the active ingredient Sucralfate and is formulated for administration via the oral route. It is commonly available in several distinct dosage forms, including a liquid oral suspension, solid tablets, and dispersible granules. These options are intended to provide flexibility in delivering the substance directly to the gastrointestinal lining, where Sucralfate works by forming a protective coating over ulcers.


What is the General Purpose of Ulsicral's Localized Action?

The general purpose of Ulsicral is to offer direct, physical protection to irritated or injured surfaces, such as the lining of the stomach and duodenum. This function is achieved by Sucralfate binding selectively and rapidly to proteins present at the site of mucosal damage, where it forms a highly adherent, physical protective barrier. The core benefit of this targeted defense is that it shields the exposed tissue from continued chemical assault by corrosive digestive fluids, including stomach acid and the enzyme pepsin, thus creating a quiet environment essential for natural tissue repair.

Regulatory References

  1. Sucralfate (MedlinePlus Drug Information)

What side effects are possible with Ulsicral?

Side Effects Profile

Ulsicral (sucralfate) is generally well-tolerated due to minimal systemic absorption; however, side effects can occur, primarily affecting the gastrointestinal tract.

Frequency Adverse Reaction (System-Organ Class)
Common (1% to <10%) Constipation (Gastrointestinal)
Uncommon / Rare (<1%) Dry mouth, Nausea, Vomiting, Flatulence, Headache, Dizziness, Pruritus, Rash (Various)

Serious Adverse Reactions and Safety Precautions

Although rare, certain severe adverse effects and safety considerations are documented in official regulatory labeling:

  • Hypersensitivity: Serious allergic reactions, including urticaria, angioedema, facial swelling, laryngospasm, and respiratory difficulty, have been reported in post-marketing experience.
  • Aluminum Toxicity: Ulsicral contains aluminum, and although minimally absorbed, accumulation can occur. Caution is necessary in patients with chronic renal insufficiency or those undergoing dialysis, as increased aluminum absorption may lead to aluminum intoxication, osteodystrophy, or encephalopathy.
  • Bezoar Formation: Gastric bezoars (masses of indigestible material) have been reported, primarily in patients with conditions that impair gastric emptying, such as those receiving enteral tube feeding or with swallowing difficulties.
  • Administration Safety: Ulsicral must never be administered intravenously. Fatal complications, including pulmonary and cerebral emboli, have been reported following the inadvertent intravenous injection of the oral suspension.

Overdose and Emergency Response

The official regulatory documentation states that acute oral overdosage of Ulsicral (Sucralfate) is considered a minimal risk and is often reported as asymptomatic due to the drug’s minimal systemic absorption. When clinical manifestations do occur, they are typically limited to non-specific gastrointestinal disturbances, such as abdominal pain, nausea, vomiting, and dyspepsia. The general approach to managing oral overdosage is restricted to symptomatic and supportive treatment, as regulatory labels confirm that no specific antidote is known or recommended.

A crucial warning documented in the label addresses the risk of misuse: the inappropriate intravenous administration of the oral suspension has led to fatal complications, including pulmonary and cerebral emboli. For this reason, the medication is mandated to be administered only by the oral route.

Immediate medical attention is required for any suspected overdose. Individuals are advised to contact the poison control helpline. Immediate emergency services (911) must be sought if the person is severely compromised, exhibiting signs such as collapse, seizure, or difficulty breathing. Furthermore, a specific overdose consideration exists for patients with chronic renal failure or those on dialysis; these individuals are at heightened risk of aluminum accumulation and toxicity (e.g., osteodystrophy) due to impaired aluminum excretion.

Therapeutic Uses of Ulsicral

What Ulsicral Treats: Main Uses and Benefits

Ulsicral is applied across therapeutic domains involving localized tissue discomfort within the digestive tract. The medication is used to provide supportive management for conditions presenting with localized discomfort. The medication is commonly used to treat active duodenal ulcer, is relevant for easing symptoms of esophagitis, and may assist with managing the potential for ulcer recurrence.

Symptom Support and Tissue Management

Ulsicral supports the patient during the period of tissue repair by contributing to the easing of the overall symptom load of upper abdominal pain and discomfort associated with tissue breaks. This supportive relief extends to pronounced, distressing symptoms of mucosal irritation, including intense heartburn, which helps address symptoms related to inflammatory or irritative states. The use of Ulsicral is generally focused on managing symptoms that helps patients cope more steadily with symptom fluctuations arising from tissue damage.

Quick Fact: Symptom Support for Upper GI Discomfort

Symptom Domain Primary Benefit Provided
Active Ulceration Pain Supports comfort during tissue repair
Heartburn/Irritation Assists with managing continuous acid effects
Recurrence Risk Applied for supportive management in maintenance therapy

Regulatory References

  1. U.S. National Library of Medicine

Eligibility and Restrictions for Use

Who can and cannot use Ulsicral (Sucralfate) — official eligibility information

Ulsicral is an oral medication that forms a protective barrier over ulcers. Eligibility for its use is defined by official regulatory documents, primarily focusing on contraindications and the need for caution in specific populations.

Eligibility Status Patient Group/Condition
Contraindicated Individuals with known hypersensitivity reactions to sucralfate or any of its inactive ingredients.
Use with Caution Chronic Renal Failure or Dialysis Patients: Caution is required due to the risk of aluminum accumulation and toxicity (e.g., bone or brain issues), as aluminum is poorly excreted in impaired kidney function.
Requires Special Review Elderly Patients: Dose selection should be cautious, typically starting at the lowest end of the range, due to the higher likelihood of decreased renal function. Renal function monitoring may be useful.
Use Only If Clearly Needed Pregnant Patients (Category B): The drug should be used during pregnancy only if clearly needed.
Physician Review Required Pediatric Patients: A physician should review the safety precautions when considering use in this population.

The primary barrier to use is a hypersensitivity reaction. For patients with impaired kidney function, the aluminum component of Ulsicral necessitates its restricted use with caution. The potential for aluminum toxicity, which can lead to serious health issues, is the main constraint for both chronic renal failure and dialysis patients.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Ulsicral (sucralfate) has documented interactions with several categories of medicinal products, primarily by reducing their absorption from the stomach and intestines. This effect occurs because Ulsicral forms a complex that can bind to other oral medicines.


Clinically Significant Interaction Domains

Interaction Domain Practical Constraint/Requirement
Reduced Absorption of Oral Drugs Many oral medicines require separation of administration time (e.g., 2 hours before or after Ulsicral) to maintain their effectiveness.
Aluminum Absorption/Toxicity Risk is heightened in patients with advanced kidney impairment or those taking other aluminum-containing products.

Interacting Products and Substances

Specific Interacting Medicines explicitly listed in regulatory documents include digoxin, phenytoin, levothyroxine, and warfarin. The efficacy of these agents, especially those with a narrow therapeutic window, may be reduced if not taken separately from Ulsicral.

Categories with Documented Interactions include quinolone antibiotics (e.g., ciprofloxacin, norfloxacin), tetracyclines, H2-receptor antagonists (e.g., cimetidine), and certain antiretrovirals. Official requirements mandate administering quinolones at least 2 hours before or 6 hours after Ulsicral to ensure adequate drug exposure.

Timing-based rules are central to managing the interaction profile, stipulating that other oral medicines must be taken at least two hours apart from Ulsicral to mitigate the risk of reduced systemic absorption.

Mechanism of Action

Ulsicral (Sucralfate) acts through a localized, cytoprotective mechanism that is non-systemic and dependent on gastric acidity. When exposed to an acidic environment ( pH < 4), the drug rapidly polymerizes into a highly viscous, negatively charged polyanion. This complex exhibits a strong, selective electrostatic affinity for positively charged proteins (e.g., fibrinogen) concentrated in the base of mucosal lesions, forming a durable physical shield over the damaged tissue.

This barrier simultaneously reduces chemical and enzymatic contact by non-competitively inhibiting the enzyme Pepsin A and adsorbing Bile Salts. Beyond physical shielding, the drug locally modulates mucosal homeostasis by stimulating the synthesis and release of Prostaglandin E2 ( PGE2). This activity augments the secretion of protective mucus and bicarbonate and improves local mucosal blood flow, collectively supporting the conditions that facilitate natural cell regeneration and the restoration of mucosal barrier function. The mechanism's activation is constrained if gastric pH is maintained above 4.0.

Dosage and Administration Information

How to Use Ulsicral: Official Administration Guidelines

Ulsicral (sucralfate) is an oral medication. Adherence to the prescribed dose and timing is required for effective use.

Dosage and Schedule

The recommended adult dosage for Ulsicral is based on the treatment phase:

Treatment Phase Adult Oral Dosage Frequency Duration
Active Duodenal Ulcer 1 gram Four times per day 4 to 8 weeks
Duodenal Ulcer Maintenance 1 gram Two times per day Long-term

Treatment for active ulcers should continue for 4 to 8 weeks unless medical confirmation of healing is demonstrated.


Procedural Instructions

Administration Rule Requirement
Timing (Meals) Administer Ulsicral on an empty stomach.
Antacids Do not take antacids within one-half hour before or after Ulsicral.
Preparation If using the oral suspension, shake the liquid well before each dose.

Special Population and Missed Dose

  • Elderly Patients: Dose selection should be cautious, typically starting at the lower end of the dosing range, due to the higher frequency of age-related decreases in organ function.
  • Missed Dose: If you miss a dose, skip the missed dose if it is almost time for your next scheduled dose. Do not take two doses at the same time to make up for a missed dose.

Recent Clinical Evidence

The research base for Ulsicral (Sucralfate) has been conducted on specific conditions characterized by localized irritation or breaks in the digestive lining. The studies collected so far provide context on how symptoms change and how tissue healing is measured in observed populations. It is important to remember that study results reflect the specific conditions under which they were conducted and research does not determine whether an individual will respond similarly.


Evidence for Use in Treating Active Duodenal Ulcer

Research primarily involved short-term Randomized Controlled Trials (RCTs) focusing on adults with confirmed duodenal ulcers. These studies explored metrics including the rate and speed of ulcer healing, as assessed through endoscopy, and monitored patient-reported outcomes describing discomfort over observation periods generally lasting 4 to 8 weeks. The research examined healing rates in populations where certain other studied treatments, such as H2 receptor antagonists, were also evaluated. What remains uncertain is the full context of results from older studies due to changes in H. pylori management, and these acute treatment studies often have limited follow-up durations.


Evidence for Management of Symptomatic Esophagitis

For symptomatic esophagitis, evidence is derived from a combination of RCTs, pilot studies, and multicenter studies. Researchers examined patients presenting with conditions linked to inflammatory states, such as confirmed reflux esophagitis. Study outcomes were studied for metrics like endoscopic grading of tissue improvement and patient-reported outcomes describing perceived discomfort, such as intense heartburn. Comparative evidence is lacking when looking specifically at modern, high-dose acid-reducing medications like Proton Pump Inhibitors (PPIs).


Research Gaps and Uncertainties

Findings highlight areas where the evidence base for Ulsicral still has limitations. Limited information is available for long-term outcomes across all indications, and the evidence is largely focused on short-term changes and acute episodes. Sample sizes were modest in some trials, meaning the level of certainty remains low in certain areas. Data for certain groups, such as those with complex comorbidities, remain insufficient, and the results apply only to the populations studied.

Key Studies & References

  1. Sucralfate for Esophagitis (Review of Efficacy and Comparison)

Frequently Asked Questions (FAQ)

Common questions about Ulsicral (FAQ)


Q: Is Ulsicral the same kind of medicine as other similar-sounding ones?

A: Ulsicral (sucralfate) is officially classified as an antiulcer, cytoprotective agent. This means its primary action is local, forming a physical barrier over damaged tissue in the stomach and duodenum. This mechanism differs from antacids and acid-reducing medicines, which primarily work by neutralizing or reducing stomach acid.


Q: How quickly can I expect Ulsicral to start having an effect?

A: Studies on Ulsicral's action report that the protective effect typically begins within 1 to 2 hours after administration. The coating that shields the injured tissue is designed to last for up to 6 hours. This timeframe reflects when the protective action begins.


Q: Does Ulsicral usually cause drowsiness or affect driving?

A: Official reports indicate that dizziness and sleepiness (somnolence) are listed as less common or rare side effects. Patients who experience central nervous system effects are advised to use caution when performing hazardous tasks such as driving. This guidance is based on the potential impact of these effects.


Q: Is Ulsicral available to buy over the counter, or is it prescription-only?

A: Ulsicral (sucralfate) is not available for purchase without a doctor's order. It is an oral prescription-only medication. The official regulatory status requires it to be obtained with a valid prescription.


Q: Are there any specific foods or drinks that should be avoided while using Ulsicral?

A: Official prescribing information does not list any specific foods that must be avoided while using Ulsicral. Official guidelines indicate it is administered on an empty stomach to ensure its optimal protective action. Although Ulsicral does not interact with alcohol, alcohol is generally recognized as a substance that may irritate or worsen the symptoms of ulcers.


Q: Does taking Ulsicral affect birth control or fertility?

A: Studies conducted in animals did not show any indication that Ulsicral impairs fertility. Specific information regarding its potential effects on the efficacy of oral birth control medications is not explicitly addressed in regulatory documents.


Q: What are the most common reasons a doctor would prescribe Ulsicral?

A: Regulatory documents indicate Ulsicral is FDA-approved for two main purposes. This includes the short-term treatment of an active duodenal ulcer, which typically lasts up to 8 weeks. It is also approved for maintenance therapy to help prevent the ulcer from recurring after it has healed.


Q: Can I stop taking Ulsicral abruptly, or does it require a gradual reduction?

A: Official guidelines emphasize adherence to the full prescribed duration of treatment. Compliance with the full prescribed course is intended to support the healing process. The prescribing information does not contain explicit instructions for gradual dose reduction or weaning off the medicine.


Q: Is it normal to feel a change in appetite while taking Ulsicral?

A: Official adverse event reports have noted instances of changes in appetite, including both lack of appetite and increased hunger. While this is not listed as a common side effect, official reports acknowledge its occurrence.


Q: Can Ulsicral be used by people with liver conditions?

A: Ulsicral is minimally absorbed into the body and is not metabolized by the liver. However, in populations where organ function is decreased, such as the elderly, medical caution is often advised. General caution may reflect the potential for decreased hepatic function in these groups.


Q: Does Ulsicral interact with common pain relievers like ibuprofen?

A: Ulsicral's binding action can reduce the absorption of many oral medicines, including some non-steroidal anti-inflammatory drugs (NSAIDs) such as naproxen. Since Ulsicral can affect the effectiveness of other oral medicines, separation by at least two hours is generally required for most oral medications.


Q: Can Ulsicral be taken safely with vitamins or herbal supplements?

A: Official regulatory texts advise that Ulsicral can bind to and reduce the absorption of other oral agents, including non-prescription products. Patients are advised to discuss the use of all supplements with a healthcare provider, and time separation is usually required to ensure adequate absorption.


Q: Can Ulsicral cause problems with sleep?

A: Official labeling for Ulsicral lists insomnia (difficulty sleeping) as an adverse effect. This effect is reported as rare or less common. Any new or worsened sleeping difficulties are a matter for consultation with a healthcare professional.


Q: Does Ulsicral cause weight gain or weight loss?

A: Post-marketing reports have noted instances of unexplained weight loss in individuals using Ulsicral. The official documentation does not provide the frequency of this occurrence.


Q: How long does Ulsicral stay in the body after the last dose?

A: Ulsicral has minimal systemic absorption, meaning very little of the drug actually enters the bloodstream. The small amount that is absorbed is rapidly eliminated through the urine, with an elimination half-life that is not considered clinically significant.


Q: Does Ulsicral affect blood sugar levels?

A: Official regulatory information notes that cases of hyperglycemia (high blood sugar) have been reported in diabetic patients using Ulsicral. Because of this, blood glucose monitoring for diabetic patients may be useful when taking Ulsicral.


Q: How often do people using Ulsicral report severe side effects?

A: Constipation is listed as a common adverse effect, occurring in 1% to 10% of users. Severe adverse effects like serious allergic reactions and aluminum toxicity are typically reported in post-marketing or spontaneous case reports, meaning their exact frequency is often not known or calculated.


Q: Is it true that Ulsicral has been around for a long time?

A: Yes, regulatory records indicate that the tablet formulation of Ulsicral (sucralfate) was approved by the FDA prior to January 1, 1982. This means the medicine has been documented and studied for a considerable period of time.


Q: Can Ulsicral be crushed or split if the pill is too large?

A: Official guidance indicates that Ulsicral tablets do not dissolve well when intact but can be dispersed in a small amount of water to create a slurry. This preparation method may be used for patients who have difficulty swallowing the tablet form.


Q: Does Ulsicral interact with alcohol consumption?

A: There are no known pharmacological interactions between Ulsicral and alcohol consumption. However, alcohol is generally recognized as a substance that may irritate the gastrointestinal lining and potentially worsen the underlying condition, such as ulcers.


Q: Are generic versions of Ulsicral as effective as the brand name?

A: In the United States, the FDA ensures that all approved generic versions of Ulsicral meet strict standards for quality and purity. Generic products that meet these criteria are considered to be therapeutically equivalent to the brand-name product.


Q: Is Ulsicral safe to use for people with high blood pressure?

A: High blood pressure is not listed as a contraindication in official documentation. However, in the elderly, caution is advised in dose selection, reflecting the greater frequency of decreased cardiac function. Use of Ulsicral in the presence of pre-existing conditions like high blood pressure is a matter for consultation.


Q: Can Ulsicral be taken by people with heart conditions?

A: Heart conditions are not listed as a contraindication for Ulsicral use. Official labeling advises caution when determining the dose for elderly patients due to the higher likelihood of decreased cardiac function. The use of Ulsicral in the presence of pre-existing heart conditions is a matter for consultation with a healthcare professional.

How should Ulsicral be stored and disposed of?

Official Storage and Disposal Requirements

Storage conditions for Ulsicral (sucralfate) are defined by government regulatory documents to maintain drug quality and ensure safety. The medication must be stored at room temperature in its original container, which should be tightly closed. It is mandatory to keep the container away from excess heat and moisture; the liquid form must specifically not be frozen.

Child Safety and Handling

To prevent accidental ingestion, the medication must be kept out of the reach of children, preferably in a secured location utilizing locked safety caps.

Proper Disposal

The preferred method for disposing of unused or expired Ulsicral is through an authorized drug take-back program. If a take-back program is not available and the medicine is not on the official flush list, it should be mixed with an undesirable substance (such as dirt or used coffee grounds), sealed in a container, and placed in the household trash. The medication must not be flushed down a toilet or sink.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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