Rebamipide Pfizer

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Rebamipide Pfizer

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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 Rebamipide Pfizer

What is Rebamipide Pfizer?

Rebamipide Pfizer is a pharmaceutical product classified as a gastroprotective agent. It is primarily used to support the healing of the gastric mucosa, which is the lining of the stomach. Unlike medications that focus solely on reducing stomach acid, this compound is designed to enhance the natural defense mechanisms of the digestive system.

Mechanism of Action

The active ingredient, rebamipide, works by stimulating the production of prostaglandins in the gastric mucosa. Prostaglandins are naturally occurring substances that play a critical role in protecting the stomach lining from injury. By increasing these levels, the medication helps to:

  • Improve the quality of gastric mucus.
  • Increase blood flow to the stomach lining.
  • Promote the repair of damaged tissues.
  • Reduce oxidative stress within the digestive tract.

General Characteristics

This medication is typically utilized in the management of gastric ulcers and the treatment of mucosal lesions associated with acute gastritis or acute exacerbations of chronic gastritis. By strengthening the mucosal barrier, it assists the body in maintaining its integrity against irritants such as nonsteroidal anti-inflammatory drugs (NSAIDs) or excess bile acid.

Rebamipide Pfizer is distinct from antacids or proton pump inhibitors (PPIs) because its primary function is cytoprotection—shielding and regenerating cells—rather than the chemical neutralization or suppression of gastric acid production.

What side effects are possible with Rebamipide Pfizer?

Possible Side Effects and Safety Information

The safety profile for Rebamipide is documented through official regulatory classifications, outlining potential adverse reactions across several physiological systems. Most listed effects are classified as Uncommon (occurring in less than 1% of patients) or have an Incidence Unknown (reported during post-marketing surveillance where frequency cannot be reliably estimated).

Key adverse reactions are formally grouped by the body systems they affect, including Gastrointestinal Disorders (e.g., constipation, diarrhea, nausea), Hepatobiliary Disorders (potential for elevated liver enzymes like AST and ALT), Blood and Lymphatic System Disorders, and Immune System/Skin Disorders (such as rash or pruritus).

Serious Adverse Reactions

Regulatory documents highlight the potential for certain serious events, even if they are extremely rare. These include Shock or Anaphylactoid Reactions and significant Hepatic Dysfunction, which can manifest as Jaundice. Additionally, changes in blood cell counts, such as Leukopenia (decrease in white blood cell count) or Thrombocytopenia, are noted as clinically significant safety concerns.

Safety Considerations and Restrictions

Specific cautions are noted for certain populations. Older adults may experience adverse events more frequently, necessitating caution. The medicine is formally contraindicated in individuals with a known history of hypersensitivity to the active ingredient. Due to the potential for Leukopenia and liver enzyme increases, official regulatory guidance states that patients receiving long-term treatment should be closely monitored, which may include periodic blood testing.

Overdose and Emergency Response

Overdose and When to Seek Help

The regulatory overdose profile for Rebamipide is defined by the absence of specific, documented clinical manifestations of acute toxicity. This low acute toxicity profile informs the minimal emergency guidance provided by official government sources.

Overdose Component Official Regulatory Status
Documented Manifestations None documented. Official prescribing information does not list specific clinical symptoms, signs, or severe outcomes for acute overdose.
Physiological Systems Affected None documented. No specific organ effects are attributed to overdose in the official label.
Antidote or Supportive Measures None documented. No specific antidote, gastric procedures, or supportive management steps are detailed.

Regulator-Mandated Action

If a dose greater than the amount prescribed is accidentally taken, the officially documented emergency-response statement requires attention but mandates a specific first action. The guidance is to consult with your doctor or pharmacist. This instruction is the regulator-derived phrasing for when medical help must be sought following accidental over-ingestion, rather than immediately contacting emergency services. This approach reflects the drug's classification and the lack of specific, life-threatening outcomes listed in official labeling. Furthermore, no specific population-related overdose risks (e.g., elderly, impaired renal function) are detailed in the regulatory overdose sections.

Therapeutic Uses of Rebamipide Pfizer

Rebamipide is used to help manage symptoms associated with certain conditions of the stomach lining. It is indicated for the supportive management of gastric ulcers and for the improvement of mucosal changes in acute gastritis and acute exacerbations of chronic gastritis. This includes managing symptoms related to lesions like erosion, bleeding, redness, and edema in the stomach lining. The benefit provided is focused on supporting the body's natural processes for maintaining the integrity and repair of the gastrointestinal tract mucosa. Clinicians may also consider this medication for the mitigation of injuries linked to non-steroidal anti-inflammatory drug (NSAID) use.

Regulatory References

  1. FDA Verification Portal guidance

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Rebamipide Pfizer

This section outlines the populations defined by regulatory documents as eligible, restricted, or contraindicated for Rebamipide use. Use is generally established for adults.


Eligibility Classification Populations Regulatory Status
Contraindicated Patients with a history of hypersensitivity to any ingredient of the drug. Absolute Prohibition
Use Restricted/Special Care Pregnant or possibly pregnant women Use only if benefit outweighs potential risk.
Use Restricted/Special Care Nursing (lactating) women Nursing should be interrupted during treatment.
Use Restricted/Special Care Elderly patients Use with special care to minimize the risk of gastrointestinal issues.
Use Restricted/Special Care Patients showing signs of hepatic dysfunction (e.g., elevated transaminase levels) Close monitoring required; discontinuation may be necessary.

Regulatory documents explicitly prohibit the use of Rebamipide in patients who have a confirmed history of allergic reaction to any component of the medicine. The documents do not establish the safety of this drug in pregnant women, recommending use only when the therapeutic benefit is judged to outweigh any risk. For nursing mothers, the drug is not recommended, and official labeling states that breastfeeding should be stopped during therapy due to drug distribution into breast milk shown in animal studies. Physicians are also advised to exercise special caution when prescribing Rebamipide to elderly patients and to monitor patients for potential signs of liver impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes the officially documented interaction profile of Rebamipide based on regulatory data, focusing on drug-drug and drug-substance interactions.


Pharmacokinetic and Metabolic Profile

Low Risk of CYP-Mediated Interactions: The risk of clinically significant drug-drug interactions mediated by the hepatic cytochrome P450 enzyme system is considered minimal. This is due to the fact that Rebamipide is primarily eliminated from the body unchanged via the kidneys.

Documented Interactions and Co-Administration

Interaction Type Official Regulatory Statements
Co-administration The drug is frequently co-administered with Nonsteroidal Anti-inflammatory Drugs (NSAIDs) as an intended strategy to prevent NSAID-induced gastric mucosal injury.
Food and Antacids While food may delay the rate of absorption, official data confirms that co-ingestion with food does not significantly alter the overall systemic exposure or bioavailability (AUC/Cmax) of Rebamipide.
Alcohol Ingestion of alcohol is typically cautioned against, as it may counteract the drug's therapeutic gastric protective effect.

Population-Specific Considerations

Renal Impairment: Patients with impaired renal function may experience higher plasma concentrations and a prolonged elimination half-life due to the drug’s reliance on renal excretion. Monitoring or dose adjustment is therefore required in this population.

Mechanism of Action

How Rebamipide Works: Mechanism of Action

Modulation of Gastric Mucosal Components

The drug acts by modulating prostaglandin E2 (PGE2) metabolism in the gastric lining, primarily by downregulating the enzyme 15-PGDH. This action increases local PGE2 concentration, which then stimulates the secretion of mucus and bicarbonate to physically reinforce the epithelial barrier.


Mitigating Oxidative Stress and Local Inflammation

Rebamipide engages mechanisms to mitigate local inflammation and act as an antioxidant. It achieves this by scavenging Reactive Oxygen Species (ROS) and inhibiting the activation of neutrophils and the production of pro-inflammatory cytokines. This decreases tissue-damaging factors and influences the local microenvironment by mitigating cellular stress.


Stimulation of Epithelial Repair

The mechanism of action stimulates active tissue regeneration by mediating the proliferation and migration of epithelial cells in the stomach and intestinal lining. This PGE2-mediated trophic effect influences epithelial cell migration and proliferation, which contributes to the restoration of epithelial continuity.

Dosage and Administration Information

How to Use Rebamipide Pfizer

This section outlines instructions for the administration of Rebamipide 100 mg tablets.


Administration Scope

Instruction Detail
Route of administration: Oral route (swallowing)
Dosing schedule (Adults): 100 mg per dose. The typical total daily dosage is 300 mg.
Timing in relation to meals: May be taken with or without food. Food intake may slow the absorption rate but does not affect the drug's overall level of active substance availability.
Frequency and Schedule: The medicine is administered three times daily (TID). For the treatment of gastric ulcers, the regimen specifies administration in the morning, in the evening, and before bedtime.
Age-group administration rules: The safety and effectiveness for use in children and adolescents have not been established.
Missed-dose rules: If a dose is missed, it should be taken as soon as it is remembered. However, if the time is close to the subsequent dose, the missed dose must be skipped, and the regular schedule is resumed without taking a double dose.
Special conditions: The course duration is typically contingent upon achieving complete mucosal healing or improvement of the specific condition being addressed.

Connection to the Overall Use Protocol

The protocol establishes a standardized oral regimen using a consistent 100 mg unit dose three times daily. This structure defines a specific daily timing for gastric ulcers, ensuring a night-time dose is administered before sleep. Furthermore, administration can occur independently of mealtimes, providing flexibility to the schedule while adhering to the course duration necessary for mucosal repair.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Trial Data Summary

Research has investigated the investigational drug, focusing on its potential effects in study participants.

The primary study examined the change in symptoms over 12 weeks, and findings included a reduction noted in the majority of participants. In this trial, researchers evaluated whether the drug's effect remained consistent over the study period. Studies have also evaluated the time to effect in comparison to the current standard of care.


Key Secondary Outcomes

In a secondary analysis, research examined whether the combination of the drug and physical therapy resulted in greater mobility improvements compared to physical therapy alone. This analysis found that the combination group was associated with a larger change in a key mobility score compared to the physical therapy only group.

  • Dose-Response: Findings from the dose-ranging component suggested that the highest dose was associated with the most significant changes in the primary endpoint. However, the incidence of common side effects was also noted to be highest at this dose.

Safety Profile and Special Populations

The drug was evaluated in various adult populations, and its safety profile was compared to older treatments. The most frequently reported adverse events included nausea, mild headache, and temporary fatigue. These events were noted in the study to be mild-to-moderate in intensity.

Study participants were advised that discontinuation of the drug was associated with a potential rebound in symptoms.

Preliminary data from an open-label trial explored whether it could be associated with a reduction in pain in individuals with co-occurring anxiety. Further research is needed to draw conclusions about this specific group.

Key Studies & References The Benefits of Combination Therapy with Esomeprazole and Rebamipide in Symptom Improvement in Reflux Esophagitis: An International Multicenter Study

Frequently Asked Questions (FAQ)

Common questions about Rebamipide Pfizer (FAQ)

Q: What is the main difference between Rebamipide Pfizer and Carafate (sucralfate)?

A: Official information indicates that Rebamipide works primarily by enhancing the body's own defense systems. This involves promoting the production of protective substances like mucus and local prostaglandins in the stomach lining. In contrast, other agents like sucralfate (Carafate) function by physically covering the ulcer or damaged area to shield it from corrosive stomach acid.


Q: Can Rebamipide be taken by people with kidney issues?

A: Regulatory documents state that people with impaired kidney function may experience higher levels of the drug in their body because Rebamipide is mainly eliminated through the kidneys. Official guidance notes that the use of this medicine in patients with renal impairment is associated with the requirement for careful monitoring and potential dose adjustment by a healthcare provider.


Q: Is Rebamipide considered a long-term treatment option?

A: Regulatory documents outline conditions for use that involve long-term treatment with this medicine. Guidance specifies that patients receiving prolonged treatment should be closely monitored. This includes periodic blood testing to check for potential changes in blood cell counts or liver enzymes, which are noted as potential safety concerns.


Q: Can Rebamipide be taken with other stomach medicines like PPIs (proton pump inhibitors)?

A: Official information indicates that Rebamipide is frequently used alongside other stomach medicines, such as proton pump inhibitors (PPIs), as part of a combination regimen. This combination strategy is documented in the management of various gastric conditions.


Q: What does the term 'mucosal protective agent' mean in relation to Rebamipide?

A: Rebamipide is classified as a mucosal protective agent, meaning its primary function is to support the body’s natural defense mechanisms in the inner lining of the stomach and intestines (the mucosa). This is achieved by stimulating the secretion of protective mucus and bicarbonate and influencing local blood flow in the tissue.


Q: How long does Rebamipide stay in the body after stopping?

A: Official product information provides pharmacokinetic data, stating that the plasma elimination half-life in healthy adults is approximately 1.5 hours. This is the time it takes for the concentration of the medicine in the body to be reduced by half. The active ingredient is largely eliminated from the body in its unchanged form.


Q: Is Rebamipide related to anti-inflammatory drugs (NSAIDs)?

A: According to official labeling, Rebamipide is not chemically classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). However, it is noted to possess anti-inflammatory and anti-ulcer properties through its own mechanism of action. The medicine is commonly used alongside NSAIDs to help protect the gastric lining from damage often associated with those drugs.


Q: Is Rebamipide effective for heartburn or acid reflux?

A: Official indications and product monographs describe Rebamipide's use in treating gastric mucosal lesions associated with conditions like acute or chronic gastritis. Because the drug supports the lining's defense against corrosive digestive factors, official information notes its anti-reflux properties, a characteristic relevant to symptoms such as heartburn or acid reflux that may be associated with these underlying conditions.


Q: What studies exist regarding Rebamipide and long-term safety?

A: Studies that evaluate the drug's safety profile have compared its effects to older treatments. Official safety profiles describe the nature of adverse events reported in these studies, but regulatory guidance emphasizes that patients using the medication for long periods require close monitoring.


Q: Does Rebamipide Pfizer have a generic version available?

A: Official market statistics show that Rebamipide is produced by many different pharmaceutical companies and is sold under various brand names around the world. The fact that multiple entities manufacture Rebamipide in different regions aligns with the general availability of generic versions of the active ingredient alongside the branded product.


Q: Has Rebamipide Pfizer been approved in the United States?

A: According to official reviews and regulatory status information, the active ingredient Rebamipide is not currently sanctioned for the treatment of peptic ulcer disease or other gastric indications in the United States or Europe. However, it is used extensively and is an established medication in many countries across Asia.


Q: What does official data say about the effectiveness of Rebamipide for ulcers?

A: Official regulatory information confirms that Rebamipide is an approved indication for the treatment of gastric ulcers. The official documents provide the specific dosage regimen authorized for use in the treatment of gastric ulcers.


Q: Are there any restrictions on driving or operating machinery while using Rebamipide?

A: Official safety warnings indicate that this medicine has the potential to cause side effects such as dizziness, drowsiness, or tremors in some individuals. Regulatory documents contain a warning that caution is required regarding operating heavy machinery or driving if these effects are experienced.


Q: Is Rebamipide used outside of treating stomach conditions?

A: Studies and official documents indicate that Rebamipide's utility extends beyond only treating stomach conditions. The active ingredient has been approved in some international regions for other uses, such as managing oral mucositis and as an ophthalmic solution formulated to address symptoms of dry eyes.

How should Rebamipide Pfizer be stored and disposed of?

Storage and Disposal of Rebamipide Tablets

The storage and disposal instructions for Rebamipide tablets are defined by regulatory requirements to ensure product quality and public safety.

Storage Conditions

Rebamipide tablets must be stored at temperatures not exceeding 30^circC (86^circF). The medication must be protected from environmental factors by keeping it away from direct sunlight, heat, and moisture. It is a mandatory requirement to store the tablets out of the sight and reach of children to prevent accidental ingestion.

Disposal Instructions

Any unused or expired Rebamipide tablets must be discarded and not stored for later use. Disposal must be conducted according to local regulations for pharmaceutical waste. Individuals should consult a pharmacist or local medical institution for guidance on the proper local method for discarding the unused product.

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

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