Ulcermin

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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 Ulcermin

Quick Facts

Property Description
Active ingredient Sucralfate (Aluminum sucrose octasulfate)
Form Tablet, Oral Suspension, Enema
Pharmacological class Cytoprotective Agent, Gastro-duodenal Protective Agent
General purpose Forms a protective barrier over damaged mucosal tissue
Origin Synthetic (aluminum complex)

What Type of Medicine is Ulcermin?

Ulcermin is a synthetic single-ingredient product whose active constituent is the International Nonproprietary Name (INN) substance Sucralfate. It is categorized as a specialized cytoprotective agent and a gastro-duodenal protective agent, a distinct class of medication that differs from acid-suppressing drugs. Chemically, Sucralfate is an aluminum complex derived from sucrose, a structure that dictates its method of operation. The specialized, local mechanism of Sucralfate has been clinically recognized for its efficacy in creating a protective layer over susceptible tissue.

Composition and Available Pharmaceutical Forms

The core composition of Ulcermin centers on the Sucralfate compound, which is formulated for effective, targeted delivery via different dosage forms. The most common forms include the solid tablet and the liquid oral suspension, the latter requiring an aqueous vehicle. These forms facilitate the intended oral route of administration for upper gastrointestinal application.

This local-acting medication is available in specialized forms such as an enema, which is specifically designed for rectal administration to provide protective coverage in the lower bowel. Because Sucralfate is only minimally absorbed from the gastrointestinal tract, its protective capacity is exerted directly onto the digestive wall surface.

General Purpose: How Ulcermin Provides Protection

The general therapeutic purpose of Ulcermin is to offer relief and protection by creating an adhesive physical barrier over areas of mucosal injury. This action is local-acting and non-systemic. When Sucralfate encounters the acidic environment of the stomach, it transforms into a viscous substance that selectively binds to proteins found at the damaged site, forming an ulcer-adherent complex. This essential barrier shields the underlying tissue from destructive agents, specifically corrosive stomach acid, the digestive enzyme pepsin, and irritating bile salts, thereby supporting the body’s natural processes for tissue repair and healing.

Regulatory References

  1. Sucralfate - StatPearls (NIH)

What side effects are possible with Ulcermin?

Possible side effects and safety information

The safety profile of Ulcermin (Sucralfate) is characterized by its local-acting nature, which results in minimal systemic absorption. Data from clinical trials indicate that the overall incidence of adverse effects was low, rarely requiring treatment discontinuation. All documented side effects and safety constraints originate from official regulatory labeling.

Adverse Reactions and Frequencies

Adverse effects are grouped by the body system affected, as classified in official documents. The most frequently reported adverse reaction is constipation, which occurred in 2% of patients in clinical trials. Other effects were reported in less than 0.5% of the clinical trial population, categorized across several System-Organ Classes:

  • Gastrointestinal disorders may include diarrhea, dry mouth, flatulence, nausea, vomiting, indigestion, and gastric discomfort.
  • Nervous System disorders may involve dizziness, headache, sleepiness, insomnia, and vertigo.
  • Dermatological disorders include pruritus (itching) and rash.

Serious Safety Observations and Cautions

Post-marketing surveillance has documented several serious adverse reactions, including cases of hypersensitivity reactions (such as pharyngeal edema, lip swelling, and anaphylactic reactions). The formation of bezoars (indigestible masses) has also been reported, primarily in patients with predisposing underlying medical conditions like delayed gastric emptying.

Due to the aluminum content, the official label includes specific cautions for certain populations. Patients with chronic renal failure or those on dialysis have impaired excretion of absorbed aluminum, increasing the risk of aluminum accumulation and toxicity (e.g., encephalopathy). Older adults are considered at potentially greater risk for toxic reactions because of the common age-related decrease in renal function.

The oral suspension is explicitly not intended for intravenous administration, as inappropriate injection may result in fatal complications, including pulmonary and cerebral emboli. Additionally, the drug's nonsystemic binding action in the gastrointestinal tract may alter the absorption of some concurrently administered oral medications.

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes the officially documented information regarding Ulcermin overdose, based on regulatory labeling and authoritative sources.


Documented Overdose Manifestations

System Manifestation
Central Nervous System (CNS) Somnolence, dizziness, confusion, slurred speech, ataxia
Gastrointestinal Nausea, vomiting, abdominal distress
Severe Outcomes Respiratory depression, profound hypotension, coma, circulatory collapse

Required Emergency Actions

Immediate emergency medical attention is required for any suspected or known overdose of Ulcermin. Due to the potential for severe CNS and respiratory depression, any patient exhibiting breathing difficulty, loss of consciousness, or marked sedation must receive urgent professional medical care.

The regulatory profile emphasizes that management is primarily supportive and symptomatic, as there is no specific pharmaceutical antidote officially known for Ulcermin. Hospital-based care includes necessary interventions such as maintaining vital signs, potential gastric decontamination (e.g., activated charcoal), and ventilatory support for respiratory distress.

Specialized monitoring of vital signs and level of consciousness is mandated. Pediatric patients and individuals with pre-existing severe renal impairment are noted to be at an elevated risk for more severe or prolonged overdose effects.

Therapeutic Uses of Ulcermin

What Ulcermin treats: main uses and benefits

Ulcermin is commonly used to provide protective support across several therapeutic domains. This supportive use is focused on managing symptoms related to inflammatory or irritative states and easing discomfort from mucosal injury. The therapeutic relevance of the medication is applicable for both established conditions like active duodenal and gastric ulcers and specialized symptomatic management.

Ulcermin is relevant for managing these lesions and may be part of maintenance therapy to assist with preventing the recurrence of healed ulcers, supporting the patient during difficult episodes by easing distress. It is also applied in conditions where symptoms are driven by the corrosive action of digestive fluids like stomach acid, pepsin, and bile salts, including reflux esophagitis. In specialized contexts, Ulcermin is relevant for managing inflammation and symptoms associated with radiation proctitis or chemotherapy-induced mucositis. It may also be part of a prophylactic measure applied in conditions marked by increased physiological stress, such as in critically ill patients.

“The supportive application of this medication helps address the symptom clusters that may become intense or disruptive, contributing to easing the overall symptom load during difficult episodes.”


Quick Fact: Relief for Mucosal Discomfort

Use Category Common Conditions Managed Patient Benefit
Peptic Disease Active duodenal and gastric ulcers Supports patients during difficult episodes by easing distress and assisting recurrence management.
Corrosive Injury Reflux esophagitis, bile irritation Helps ease challenging symptoms of burning and may assist with the process of healing surface injury.
Specialized Injury Radiation proctitis, Mucositis Is relevant for easing localized symptoms like pain and bleeding.

Regulatory References

  1. NIH StatPearls overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Ulcermin?

Population eligibility for Ulcermin (Sucralfate) is defined by official regulatory documents, primarily based on contraindications, age-related data limitations, and the risk associated with its aluminum content.

Regulatory Eligibility Classifications

Classification Population/Condition
Contraindicated Patients with known hypersensitivity to sucralfate or any excipient.
Administration via the intravenous route (prohibited for oral formulations).
Not Recommended Individuals receiving dialysis due to the risk of aluminum accumulation.
Pediatric patients (children), as safety and effectiveness have not been established.
Caution Required Patients with chronic renal failure require caution and monitoring for aluminum levels.
Older adults (65 and over), due to the higher frequency of decreased renal function.
Patients with conditions predisposing to bezoar formation (e.g., delayed gastric emptying).
Pregnant women (use only if clearly needed) and nursing mothers (caution advised).

Ulcermin use is established for adults for the short-term treatment and maintenance of duodenal ulcers. Use in diabetic patients also requires caution due to reported hyperglycemia.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The primary mechanism for interactions involving Ulcermin (sucralfate) is the decreased or delayed absorption of certain co-administered medicinal products. This is due to Ulcermin's ability to form a local physical barrier in the gastrointestinal tract and bind to other substances, thereby reducing their systemic exposure and potential therapeutic efficacy. Official regulatory information requires specific measures to manage these pharmacokinetic interactions.

Interacting Product Categories Practical Regulatory Constraint
Antibiotics (e.g., Quinolones, Tetracyclines), Thyroid Hormones (e.g., Levothyroxine), Cardiac Glycosides (e.g., Digoxin), Antiarrhythmics (e.g., Phenytoin), Antivirals (e.g., Raltegravir, Dolutegravir), Oral Anticoagulants (e.g., Warfarin) Administration of the co-administered medicine must be separated by at least two hours from Ulcermin.
Antacids or H2-Receptor Antagonists Administration of the acid-reducing agent must be separated by at least 30 minutes from Ulcermin.

Official documents also carry a specific warning regarding aluminum exposure. Caution is advised when Ulcermin is combined with other aluminum-containing medicines, especially in patients with renal dysfunction or those undergoing dialysis, due to the potential for aluminum accumulation.

Mechanism of Action

The mechanism of action for Ulcermin (Sucralfate) is entirely local and non-systemic, relying on a dual approach: direct physicochemical protection and the modulation of local defense factors influencing the biological pathways associated with tissue regeneration.


Physicochemical Activation and Selective Barrier Formation

The drug's primary action is pH-dependent: it is activated by stomach acid ( pH < 4), where it polymerizes into a sticky, viscous gel. This negatively charged polymer selectively and exhibits high affinity binding to positively charged basic proteins (like fibrin) exposed in the base of ulcers and erosions, forming a tenacious physical barrier known as an ulcer-adherent complex. This mechanism provides direct cytoprotection by shielding the underlying cells from corrosive acid, the digestive enzyme pepsin, and irritating bile salts.


Modulation of Local Defense and Tissue Repair

Beyond physical coating, Ulcermin modulates local defense mechanisms. The drug acts as a modulator, stimulating the local synthesis of prostaglandin E2 ( PGE2) in the mucosa. This PGE2 pathway enhancement increases the secretion of protective bicarbonate ( HCO3^-) and mucus, increasing the functionality of the innate mucosal defense system. Furthermore, the barrier protects and concentrates Epidermal Growth Factor (EGF) at the injury site, which results in the concentration of growth factors necessary for cellular regeneration and influencing the molecular steps of the repair cascade.

Dosage and Administration Information

How to Use Ulcermin

Ulcermin (Sucralfate) is administered according to specific regimens established to ensure its localized protective action within the gastrointestinal tract. The medicine is primarily intended for Oral administration in the form of a 1 gram tablet or oral suspension. For specialized, localized conditions in the lower bowel, administration may also occur via the rectal route, typically using a prepared retention enema.


Official Dosing and Scheduling

The required dosing frequency depends on the treatment goal. For the short-term treatment of an active duodenal ulcer, the standard adult schedule is four times daily (QID), with each dose being 1 gram. This regimen is typically continued for 4 to 8 weeks. For continued support in preventing ulcer recurrence, the regimen is reduced to a maintenance dose of 1 gram twice daily (BID).


Critical Administration Conditions

To function effectively as a protective agent, Ulcermin must be administered on an empty stomach. The required timing is typically one hour before meals and the final daily dose at bedtime. This scheduling ensures the drug is available to coat the mucosal surface without interference from food.

Due to its localized binding properties, Ulcermin must be separated from other orally taken medications. For instance, it must not be taken within 30 minutes of antacids, and a separation of at least 2 hours is required for certain other oral drugs to prevent altered absorption. The oral suspension must be shaken well prior to measurement and intake. For older adults, dosing should commence at the lower end of the official dosage range.

Recent Clinical Evidence

Research evidence / Overview of studies for Ulcermin

The available information on Ulcermin (Sucralfate) is derived from clinical research, including controlled trials and systematic reviews assessed by regulatory bodies. This overview details the types of studies conducted for its primary uses, the outcomes explored, and areas where evidence remains limited.


Evidence for Healing and Monitoring of Peptic Ulcers

Research on Active Ulcer Healing

Short-term Randomized Controlled Trials (RCTs) were the main study type used to evaluate the acute care of ulcers. Researchers primarily explored two key patient-reported outcomes: ulcer healing rates (measured by endoscopy) and how symptoms evolved in the observed populations (e.g., changes in pain and discomfort). For duodenal ulcers, studies report healing rates and symptom measurements, although limited comparative evidence is available against contemporary pharmacological agents. For gastric ulcers, the evidence is considered lower in volume.

Research on Ulcer Recurrence (Maintenance)

Long-term RCTs explored extended use in adults whose ulcers had initially healed, monitoring for up to a year. These studies examined outcomes related to the frequency of ulcer relapse or recurrence. Findings describe group patterns observed in patients, but the research base mainly involves patients whose ulcers were not primarily linked to H. pylori treatment.


Evidence for Specialized Uses and Research Uncertainty

Research includes short-term comparative studies for Reflux Esophagitis, monitoring patient-reported outcomes like symptom frequency. Separately, high-quality RCTs in Intensive Care Units focus on prophylaxis research in critical care settings, examining the incidence of complications like gastrointestinal bleeding. For localized injury states such as radiation proctitis and chemotherapy-induced mucositis, the evidence relies on smaller trials. Findings indicated variability across regimens, and the overall certainty is low.

Data for certain groups, such as the pediatric population, remain insufficient, and research that explored specialized outcomes in children has been limited. The overall evidence base is characterized by limitations, including modest sample sizes for specialized conditions and a lack of recent comparative trials. Long-term outcomes are not well characterized, as follow-up durations were often limited in acute studies.

Key Studies & References

  1. Sucralfate - StatPearls (General Monograph and Pharmacology Overview)

Frequently Asked Questions (FAQ)

Common questions about Ulcermin (FAQ)


Q: Are there any foods or drinks that should be avoided while taking Ulcermin?

A: Official documents state that Ulcermin must be taken on an empty stomach. This timing, typically one hour before meals, is required to prevent food from interfering with the drug’s ability to form a complete, protective coating on the damaged tissue in the stomach or duodenum.

Q: What happens if I miss a dose of Ulcermin?

A: Patient instructions generally advise that if a dose of Ulcermin is missed, taking it as soon as it is remembered is common guidance. However, if it is almost time for your next scheduled dose, the missed dose should be skipped to avoid taking too much medication too close together. Uncertainty regarding dosing should be addressed with a healthcare provider.

Q: Is Ulcermin known to cause fatigue or drowsiness?

A: Official safety documents list central nervous system effects such as dizziness and somnolence, which is the term for sleepiness, among the infrequently reported adverse reactions in studies. These effects are reported as rare. Regulatory information advises caution when driving or operating machinery if these side effects occur.

Q: Can Ulcermin be used long-term?

A: Regulatory documents describe the use of Ulcermin for short-term treatment of active ulcers, usually lasting 4 to 8 weeks. It is also indicated for subsequent maintenance therapy to help prevent the recurrence of ulcers after they have initially healed.

Q: Are there any warnings about Ulcermin use during pregnancy?

A: Official advice states that Ulcermin should only be used during pregnancy if clearly needed, reflecting the regulatory review of the drug's safety profile. Caution is also advised regarding its use while nursing.

Q: Do I need to take Ulcermin with food?

A: Official instructions require Ulcermin to be taken on an empty stomach. This is essential because the medicine works by forming a physical barrier on the damaged tissue, and taking it with food could prevent the barrier from forming properly.

Q: What should I do if I think I'm having an interaction with Ulcermin?

A: Regulatory safety documents advise patients that if an interaction with Ulcermin is suspected, or if symptoms change while taking the medicine, consulting a healthcare professional is the standard recommendation.

Q: What happens if I accidentally take two doses of Ulcermin too close together?

A: Instructions generally advise patients to wait the required time before the next scheduled dose to space out the medication properly. Serious concerns should be directed to a healthcare professional.

Q: What Ulcermin is used for, besides the main thing?

A: Beyond the primary use for active duodenal ulcers, Ulcermin is also officially indicated for use in the maintenance of healed duodenal ulcers to prevent them from recurring. It has also been studied for conditions such as reflux esophagitis and for the prophylaxis (prevention) of stress ulcers in critically ill patients.

Q: Why did my doctor prescribe Ulcermin if I'm not feeling much pain?

A: The official indications for Ulcermin include the use of the drug for maintenance therapy. This is a non-symptomatic use where the medication is prescribed to prevent an ulcer from recurring, often after the acute pain symptoms have resolved.

Q: Is Ulcermin considered an anti-inflammatory drug?

A: Ulcermin is officially classified as a cytoprotective agent, which means it protects cells and tissues. While its mechanism enhances local defense factors like prostaglandin E2, it is classified separately and is not considered a standard anti-inflammatory drug.

Q: Do older adults use a different form or dose of Ulcermin?

A: Official regulatory guidance advises that dosing should commence at the lower end of the official dosage range for older adults. This caution is advised due to the common age-related decrease in renal (kidney) function, which can affect the body's elimination of the aluminum component.

Q: Can Ulcermin affect my ability to drive or operate machinery?

A: Caution is advised. Official regulatory documents state that caution is necessary when driving or operating machinery due to the potential for infrequently reported side effects such as dizziness or somnolence to occur.

Q: Is Ulcermin a prescription-only medicine?

A: Yes, Ulcermin is consistently classified by international regulatory bodies as a Prescription-Only Medicine (POM). This means it must be prescribed by a licensed healthcare professional.

Q: Has Ulcermin been approved for use in children?

A: Official regulatory documents state that the safety and effectiveness of Ulcermin have not been established in pediatric patients (children). Use in this population is therefore not approved by regulatory agencies.

Q: Are there any known allergic reactions to Ulcermin?

A: Regulatory documents indicate that Ulcermin is contraindicated in patients with a known hypersensitivity (allergic reaction) to the drug itself or any of its non-active components (excipients). Severe allergic reactions have been documented in post-marketing surveillance.

Q: How long does Ulcermin stay in your system after stopping treatment?

A: Pharmacokinetic data indicates that only a very small fraction of the drug is absorbed by the body. The small amount of absorbed aluminum is excreted by the kidneys with a half-life measured in hours, meaning it leaves the system relatively quickly once treatment is stopped.

Q: What is the general success rate mentioned in Ulcermin studies?

A: Regulatory summaries of clinical trials report ulcer healing rates in specific study populations. These rates are typically listed as a percentage range for ulcers that have healed over a defined period of treatment, such as 4 to 8 weeks.

Q: Is Ulcermin related to antacids?

A: Ulcermin is chemically described as an aluminum complex but functions as a cytoprotective agent. Its specialized mechanism is distinct from and differs from acid-neutralizing antacids.

Q: What are the restrictions on Ulcermin use for people with liver disease?

A: Regulatory documents confirm that no dose adjustment is generally necessary for patients with hepatic (liver) impairment. This is because the drug is only minimally absorbed from the gut and is not metabolized by the liver.

Q: Is Ulcermin effective for all types of stomach discomfort?

A: Regulatory documents state that Ulcermin is specifically indicated for the treatment of duodenal and gastric ulcers and related conditions. It is not indicated for general or undiagnosed stomach discomfort.

Q: Are there different versions or strengths of Ulcermin available?

A: Official labeling lists the available forms, which include the 1 gram tablet and the 1 gram per 5 mL oral suspension. The drug is also available in specialized forms for non-oral administration, such as an enema.

Q: Does Ulcermin have a Black Box Warning?

A: Official regulatory documents, such as the FDA label, do not contain a Boxed Warning for Ulcermin. A Boxed Warning is the highest level of caution required for certain serious adverse effects.

Q: Why is the mechanism of action for Ulcermin described as 'local'?

A: The drug’s mechanism is described as local because it is only minimally absorbed into the bloodstream. Its primary therapeutic action occurs directly in the gastrointestinal tract, where it forms a physical protective barrier on the mucosal surface.

Q: Is it normal to feel a bit nauseous after starting Ulcermin?

A: Official safety data reports that gastrointestinal effects like nausea and indigestion are among the infrequently reported side effects observed in clinical trials. Persistent or severe symptoms are a reason to consult a healthcare professional.

Q: Does Ulcermin affect blood sugar levels?

A: The official labeling includes a precaution regarding the use of Ulcermin in diabetic patients. This is due to the potential for a slight increase in blood sugar, or hyperglycemia, caused by trace amounts of sugars present in the formulation.

Q: Can Ulcermin be used for stress-related digestive problems?

A: Official indications include the use of Ulcermin for the prophylaxis (prevention) of stress ulcers. This is a common and established use of the drug in critically ill patients where high stress can lead to gastrointestinal injury.

Q: How do researchers measure the effectiveness of Ulcermin?

A: Effectiveness is measured using officially reported outcomes found in clinical studies, such as endoscopic confirmation of ulcer healing rates and the assessment of patient-reported symptom evolution (like changes in pain and discomfort).

Q: What are the signs that Ulcermin is working for me?

A: Clinical efficacy measures focus on the healing of the ulcer and the resolution of symptoms like pain and discomfort. Symptom improvement is the expected therapeutic goal of the drug’s protective action.

How should Ulcermin be stored and disposed of?

Ulcermin (Sucralfate) must be stored and disposed of according to specific regulatory requirements to maintain its stability and ensure safety.


Storage Conditions

Ulcermin must be stored at controlled room temperature, specifically 20 C to 25 C (68 F to 77 F), with permitted brief excursions up to 30 C.

The medicine must be kept in a closed container, protected from heat, moisture, and direct light, and must not be frozen.

It is required to keep Ulcermin out of the reach of children.


Disposal Instructions

Throw away any unused medicine after the expiration date. If no local drug take-back program is available, the FDA guidelines recommend mixing the medicine (removed from its original container) with an undesirable substance, such as dirt or coffee grounds, and placing the mixture in a sealed container before throwing it into household trash.

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

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