Mesagran

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Mesagran

Medically reviewed

Laura Arias

Last updated on 22/12/2025

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 Mesagran

Quick Facts

Property Description
Active ingredient Mesalazine (5-Aminosalicylic Acid, 5-ASA)
Form Tablet Prolonged-Release (PR), Sachet (granules)
Pharmacological class Aminosalicylate Derivative (Intestinal Anti-inflammatory Agent)
Common use Managing inflammation in the lower gastrointestinal tract
Origin Synthetic Organic Compound

What is Mesagran and What is its Pharmacological Class?

Mesagran is the brand name for a prescription pharmaceutical preparation containing the active ingredient Mesalazine, which is also identified as Mesalamine or 5-Aminosalicylic Acid (5-ASA). It is fundamentally classified as an Aminosalicylate Derivative and is utilized as an Intestinal Anti-inflammatory Agent. This synthetic drug's role in inflammatory disease management is clinically recognized. Unlike prodrugs, which require a metabolic process to activate, Mesalazine is the direct anti-inflammatory substance. As an anti-inflammatory agent, Mesalazine is classified within this group of medications.

Composition and Significance of the Prolonged-Release Form

Mesagran is a single-entity medication, containing Mesalazine as its sole active substance, primarily delivered in Oral dosage forms such as the Tablet Prolonged-Release (PR) and Sachet preparations. The significance of this specific controlled-release design is a key differentiating factor. This advanced formulation, achieved through specialized excipients, ensures the drug bypasses the upper digestive tract, facilitating targeted release directly into the lower bowel. This mechanism highlights that formulation technology is used for delivering the active agent locally in the colon.

What is the General Purpose of Mesalazine in This Context?

The general purpose of the Mesalazine in Mesagran is to provide a powerful, localized anti-inflammatory effect within the bowel lining. The drug works by modulating the destructive local inflammatory response, suppressing the formation of chemical messengers like prostaglandins and leukotrienes. By inhibiting these key pathways, the medication helps to calm internal irritation and swelling. This medication has a central role in managing chronic intestinal inflammation.

Regulatory References

  1. National Institutes of Health (NIH) MedlinePlus Drug Information
  2. NIH MedlinePlus
  3. World Health Organization’s (WHO) Essential Medicines List entry for Mesalazine
  4. WHO Essential Medicines List

What side effects are possible with Mesagran?

Possible Side Effects and Safety Information

The safety profile for Mesagran (Mesalazine) is based on official government regulatory documents, outlining adverse reactions categorized by frequency and severity. It is crucial to note that this information does not constitute medical advice or instructions for use, which are the domain of a healthcare professional.

Frequency-Classified Adverse Reactions

Adverse reactions are classified by frequency based on regulatory standards (e.g., EMA/ICH guidelines):

Classification Examples of Documented Effects
Common (1/100 to 1/10) Headache, Nausea, Diarrhoea, Abdominal pain, Flatulence, Vomiting, Fatigue, Rash, Liver function tests abnormal.
Rare (1/10,000 to 1/1,000) Myocarditis, Pericarditis, Photosensitivity, Vertigo.
Very Rare (Less than 1/10,000) Aplastic Anaemia, Renal failure, Nephrotic syndrome, Oligospermia.

Serious Safety Considerations

Regulatory labeling documents severe, clinically significant adverse reactions, including: Severe Cutaneous Adverse Reactions (SCARs) such as SJS, TEN, and DRESS; Acute Intolerance Syndrome (cramping, bloody diarrhoea, fever); Organ-Specific Hypersensitivity (myocarditis, interstitial nephritis); and Severe Blood Dyscrasias (e.g., agranulocytosis).

Monitoring and Restrictions: The official safety profile requires periodic monitoring of renal and hepatic function before and during treatment. The drug is generally not recommended in confirmed severe renal or hepatic impairment. Caution is advised when used alongside nephrotoxic agents or myelotoxicity-causing drugs, as this may increase the respective risks. The label notes that the Acute Intolerance Syndrome is often associated with the initiation of therapy.

Overdose and Emergency Response

The official regulatory documentation outlining the overdose profile for Mesagran (Mesalazine) emphasizes the risk of serious organ toxicity and mandates immediate medical action. Overdose symptoms observed are often non-specific, including nausea, vomiting, abdominal pain, headache, and vertigo. In more severe cases, clinical manifestations such as confusion, seizures, and changes in respiration (e.g., fast or shallow breathing) have been documented.

The primary serious concern documented in regulatory labeling is the potential for renal damage and hepatic damage following high-dose exposure to Mesalazine. This organ toxicity risk is noted to be greater for individuals with pre-existing renal or liver impairment.

Immediate medical attention is required for any suspected overdose. Regulatory guidance mandates that patients or caregivers must contact emergency services immediately if the affected individual has collapsed or has difficulty breathing. Management relies solely on symptomatic and supportive treatment, as the label confirms that no specific antidote is known. Procedures like gastric lavage or diuresis may be applied. Following acute management, monitoring of renal and hepatic function is typically required.

Therapeutic Uses of Mesagran

Mesagran is primarily indicated for providing symptomatic relief across several domains related to inflammation and pain. Its main uses center on alleviating the discomfort associated with various conditions, supporting individuals in the management of daily activities and discomfort. Specifically, Mesagran is used to manage symptoms in clinical scenarios involving acute symptomatic relief from sudden-onset pain, and to address chronic symptom domains such as ongoing pain and stiffness characteristic of long-term inflammatory issues. The medicine supports functional improvement by addressing the physical symptoms that may restrict movement. The primary benefit involves assisting individuals in maintaining or regaining mobility and physical function that may be restricted by symptoms.


Quick Fact: Relief for Pain and Inflammation

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Mesagran — Official Regulatory Information

Category Official Regulatory Statement
Populations for whom use is allowed (as stated in label) Adults are approved for use. Geriatric patients are eligible, but caution is advised, and monitoring of renal function is recommended. Children are eligible if they meet specific age and weight criteria, typically ge 5 or ge 6 years old, depending on the formulation.
Populations for whom use is contraindicated Patients with known or suspected hypersensitivity to salicylates (including Mesalazine/5-ASA) or any excipient are contraindicated. Use is also contraindicated in severe renal impairment and severe hepatic impairment.
Age-related eligibility rules Adult use is established. Pediatric use is restricted to certain age/weight minimums; use in children below the minimum age is generally not established or not recommended.
Condition-specific eligibility rules Renal and Hepatic Impairment: Contraindicated in severe cases. Caution is required in mild to moderate impairment, with function evaluation mandatory before and periodically during therapy. Caution is also advised for patients with a history of Sulfasalazine allergy.
Pregnancy and lactation eligibility status (if explicitly documented) Conditional Use: Use during pregnancy and breastfeeding is generally permitted only if the potential benefit outweighs the risk (risk/benefit assessment required). For breastfeeding, monitoring the infant for diarrhea is required, and discontinuation may be necessary.

Eligibility Classifications (High-Level)

Classification Official Regulatory Documentation
Eligibility severity classification (as defined in official documents) Contraindicated (e.g., severe organ impairment); Use with Caution (e.g., mild-to-moderate organ impairment, pregnancy); Established Use (e.g., Adults).
Regulatory basis (EMA / FDA / etc.) US FDA Prescribing Information and European Medicines Agency (EMA) Summary of Product Characteristics (SmPCs).

Connection to the Overall Eligibility Profile

Regulatory documents define who can and cannot use Mesagran by setting absolute contraindications based on hypersensitivity and severe organ failure, while establishing conditional use for groups such as pregnant or breastfeeding individuals and those with pre-existing mild-to-moderate organ impairment. Eligibility for pediatric patients is determined by regulatory-approved age and weight minimums specific to the formulation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define specific interaction patterns for the active ingredient in Mesagran, Mesalazine (5-ASA), primarily relating to potential additive toxicity and metabolic interference with co-administered medicines.

Documented Drug-Drug Interactions

Interacting Product Category Official Interaction Description
Purine Antagonists (e.g., Azathioprine, 6-Mercaptopurine) Co-administration is associated with an increased risk of myelosuppression (blood dyscrasias), including severe leucopenia. Mesalazine inhibits the TPMT enzyme, which leads to increased exposure to the cytotoxic metabolites of these drugs.
NSAIDs (e.g., Ibuprofen, Naproxen) Co-administration with known nephrotoxic agents, such as Non-Steroidal Anti-Inflammatory Drugs, may increase the risk of renal reactions or nephrotoxicity.
Anticoagulants (e.g., Warfarin) Mesalazine may potentiate the effects of blood-thinning medicines, necessitating close monitoring of coagulation parameters (INR/PT).

Other Documented Interactions

  • Laboratory Tests: Mesalazine use may cause spuriously elevated test results when specific laboratory methods (liquid chromatography with electrochemical detection) are used to measure urinary normetanephrine.
  • Food: No clinically significant interaction with food is uniformly documented across all regulatory labels for prolonged-release mesalazine formulations.

Population-Specific Cautions: Interaction risks, especially those related to nephrotoxicity with agents like NSAIDs, require enhanced caution and monitoring in patients with known renal dysfunction or hepatic impairment.

Mechanism of Action

How Mesagran Works

Mesalazine (5-ASA) exerts a localized effect within the lining of the lower bowel, modulating the complex molecular and cellular events of inflammation through a multi-faceted mechanism.


Molecular Control of Inflammatory Chemicals

Mesalazine primarily acts by inhibiting key enzymes like Cyclooxygenase (COX) and Lipoxygenase (LOX). This action directly reduces the production of pro-inflammatory mediators, such as prostaglandins and leukotrienes, thereby restricting the chemical signals that contribute to vasodilation and increased vascular permeability.


Suppression of Immune Signaling Pathways

The drug further modulates inflammation by inhibiting the activation of the central transcription factor, NF-kappaB, and acting as an agonist for PPAR-gamma. This molecular modulation results in reduced gene expression for key pro-inflammatory proteins, including cytokines (e.g., TNF-alpha), which are primary messengers in the recruitment and activation of inflammatory immune cells.


Protection from Oxidative Stress

Mesalazine provides a protective effect by functioning as a scavenger for Reactive Oxygen Species (ROS), or free radicals, which are chemicals produced by immune cells that cause oxidative damage to mucosal tissue. Neutralizing these radicals supports the maintenance of intestinal epithelial integrity, influencing the cellular environment in the presence of inflammation.

Dosage and Administration Information

Administration Overview

Mesagran is typically administered in accordance with professional healthcare guidance to ensure the medication is integrated effectively into a patient's routine. The method of administration is designed to support consistent delivery of the active components.

General Application Principles

When using Mesagran, it is standard practice to maintain a regular schedule. Consistency helps in monitoring the body's response to the treatment over time. The medication is usually taken with water, and depending on the specific formulation, it may be associated with meal times or taken on an empty stomach as indicated by the prescribing clinician.

Handling and Storage

To maintain the integrity of the medication, Mesagran should be handled with care. Proper storage is essential for preserving the chemical stability of the product. This generally involves:

  • Keeping the medication in its original packaging until use.
  • Storing the product at room temperature, away from excessive heat or direct sunlight.
  • Ensuring the storage area is dry and protected from moisture.

Practical Considerations

Patients are encouraged to familiarize themselves with the physical characteristics of their specific form of Mesagran, such as the appearance of the tablets or granules. If a routine involves multiple medications, organizing Mesagran in a manner that prevents confusion is a common strategy for successful long-term management. Regular consultations with healthcare providers allow for the review of the administration process and the address of any practical concerns that may arise during the course of use.

Recent Clinical Evidence

Mesagran: Recent Clinical Evidence

This section summarizes the structure of the clinical research for Mesalazine, detailing what studies explored and what research gaps remain. This information describes group patterns observed in research and does not determine whether an individual will respond similarly.


Evidence for use in Ulcerative Colitis (UC)

Research has explored two main areas for Mesalazine in Ulcerative Colitis (UC): inducing inactivity during periods of increased symptom activity, and maintaining inactivity over time. Short-term randomized controlled trials (RCTs) explored outcomes related to clinical remission status and mucosal healing in adults and children with active UC. The research structure also includes the long-term observation of Mesalazine, with studies monitoring the recurrence of episodic changes in patients whose symptoms were already quiet over follow-up periods that can extend to several years. Findings describe patterns related to achieving and sustaining the absence of disease activity.


Evidence for use in Crohn's Disease (CD)

The research structure for Mesagran in Crohn's Disease (CD) is distinct. Studies explored this medication primarily in the specific clinical setting after patients had undergone surgery to remove a diseased section of the bowel. These post-surgical studies tracked outcomes related to the recurrence of clinical symptoms using disease activity indices over a medium-term follow-up.


Long-Term Studies and Follow-Up Duration

Much of the research, particularly in the maintenance setting, was observed in studies that extended up to one year and beyond, helping to contextualize long-term patient-reported experiences. Research provides insight into short-term changes measured during the study period.


What Research Shows is Still Uncertain

While studies contribute to the broader evidence landscape, certainty remains low in several areas. Evidence is limited for managing active Crohn's Disease when inactivity is not achieved through surgery. Furthermore, research is still emerging regarding the optimal dosing strategy and how the various available oral and rectal formulations compare directly for long-term durability. Data for special populations, such as older adults or individuals with certain coexisting conditions, also remain insufficient when compared to the large volume of data available for general adult populations.

Key Studies & References

  1. PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board in the Netherlands Mezavant 1200 mg, gastro-resistant, prolonged rele - Geneesmiddeleninformatiebank

Frequently Asked Questions (FAQ)

Common questions about Mesagran (FAQ)

Q: How does Mesagran differ from other similar medications I've heard about?

Mesagran contains the active ingredient Mesalazine (also known as 5-ASA), which is classified as an aminosalicylate. This drug is chemically related to Sulfasalazine, a separate medicine. A key difference described in official product information is that Mesagran uses a controlled-release formulation designed to deliver the medicine directly to the lower bowel lining.

Q: Are there any common foods or drinks that interact with Mesagran?

Official regulatory documents generally state that there is no clinically significant interaction with food uniformly documented. However, some specific dosage forms may have instructions on administration, which are described in the official product information. Furthermore, official guidance often emphasizes the need for adequate fluid intake when taking the medication.

Q: Is Mesagran effective for everyone who uses it?

Studies and official information indicate that, as with any medicine, individual response can vary. While clinical trials support its effectiveness across large groups of patients, the medication is not guaranteed to be effective for every person. Regulatory documents describe an Acute Intolerance Syndrome that can occur, which may be associated with prompt discontinuation if symptoms are suggestive of this syndrome.

Q: Does Mesagran interact with supplements like vitamins or herbal products?

Official regulatory sources note that there is insufficient information to confirm the safety of taking Mesagran with all complementary medicines, herbal remedies, or supplements. This is because these products are often not tested in the same manner as prescription medications. Official guidance describes that patients often discuss all products they are taking with their healthcare professional.

Q: Is it normal to feel slightly dizzy when standing up while on Mesagran?

Official adverse reaction reports confirm that dizziness is a known adverse reaction associated with the active ingredient Mesalazine. A more specific type of dizziness called Vertigo (a sensation of whirling) has been listed as a rare effect. The official information does not define the normality of feeling dizzy specifically when standing up.

Q: Is Mesagran a newly approved drug, or has it been around for a while?

The active ingredient in Mesagran, Mesalazine, has an established and authoritative role in the management of chronic intestinal inflammation. This is underscored by its inclusion on the World Health Organization’s (WHO) List of Essential Medicines, confirming its long-standing clinical significance.

Q: Is the research evidence for Mesagran considered strong by medical authorities?

The active ingredient is listed on the WHO Essential Medicines List, confirming its central role and strong clinical basis for approved uses. However, official clinical evidence summaries also indicate that certainty remains low in some areas, such as defining the optimal dosing strategy or its use in specific, smaller patient populations.

Q: Are there different brand names for the same medicine as Mesagran?

Yes. Regulatory documents state that the active ingredient is officially known as Mesalazine, which is also referred to as Mesalamine or 5-Aminosalicylic Acid (5-ASA). This single active ingredient is manufactured and sold by various companies globally under multiple different brand names.

Q: What does 'use conditions' mean in relation to Mesagran?

According to official regulatory documents, 'use conditions' refers to the established instructions for administering the drug safely and effectively. This includes the precise dosage amounts for treating different disease stages, the frequency of taking the medicine, and specific procedural constraints like swallowing tablets whole or ensuring adequate fluid intake.

Q: Is Mesagran used for any purpose besides the conditions listed on the label?

Mesagran is prescribed only for the approved conditions (indications) described in its official regulatory labeling, such as managing inflammation in the lower bowel. Information regarding the use of this medication for any condition outside of these approved indications is not contained in government regulatory documents.

Q: How quickly can I expect Mesagran to start working?

Official patient information suggests that the medicine will begin working right away on the internal inflammation. However, it is described that it may take a week or more before symptoms begin to show improvement, with a full resolution of symptoms sometimes taking several months.

Q: How long does the effect of a single dose of Mesagran typically last?

The duration of the effect is related to the specialized formulation of the medicine. The prolonged-release design of Mesagran means it is engineered to deliver the drug over an extended timeframe, often allowing for a once-daily administration schedule for some formulations, as reflected in the official dosage instructions.

Q: What happens if I miss taking Mesagran once?

Official regulatory guidance states that if a dose is missed, it should be taken as soon as it is remembered, unless it is nearly time for the next scheduled dose. Regulatory guidance states that it is not recommended to take two doses at the same time or double up to make up for a missed dose.

Q: Is it necessary to avoid alcohol completely while taking Mesagran?

Official regulatory documents do not explicitly state a mandatory, complete prohibition of alcohol use for all patients. However, the regulatory guidance suggests that patients discuss the use of alcohol with their healthcare professional to ensure they understand their individual health risk profile.

Q: Where can I find the official regulatory information about Mesagran?

Official regulatory documents detailing Mesagran's approved use, safety, and pharmacology are published by government sources globally. These include the U.S. FDA DailyMed and the European EMA Summary of Product Characteristics (SmPC). Patient-friendly summaries are also often available through authoritative sources like the NIH MedlinePlus.

Q: Does Mesagran affect alertness or ability to drive?

Official regulatory documents explicitly state that the active ingredient, Mesalazine, is considered to have no effect or only a negligible influence on a person’s ability to drive vehicles or operate heavy machinery.

Q: Does Mesagran cause weight changes?

Official regulatory reports document that changes in weight have been reported as adverse reactions associated with the active ingredient. These postmarketing reports list both weight gain and decreased weight or a change in appetite among the documented effects.

Q: How is Mesagran described in official patient information leaflets?

Official patient information leaflets use plain, accessible language to describe the drug's role as an anti-inflammatory used to manage chronic intestinal conditions. This documentation provides easy-to-understand details on the purpose, the correct method of administration, and a summary of the most common and rare side effects.

Q: What are the most commonly reported reasons for stopping Mesagran treatment?

Regulatory warnings require prompt discontinuation of the medication if two serious events are suspected. These are the appearance of an Acute Intolerance Syndrome (which can present as a sudden worsening of the underlying condition) or the first signs of a Severe Cutaneous Adverse Reaction (SCAR) or other serious hypersensitivity reaction.

Q: What should be done if an existing medical condition seems worse after starting Mesagran?

Regulatory labeling states that if an acute reaction is suspected—such as the Acute Intolerance Syndrome—which can sometimes present as symptoms mimicking a worsening of the underlying condition, the drug should be promptly discontinued. If this occurs, regulatory warnings state that medical evaluation should be sought immediately.

Q: Does Mesagran cause changes in mood or behavior?

Official regulatory postmarketing reports document psychiatric adverse reactions associated with the active ingredient. These reported effects include changes in mood or behavior such as anxiety, insomnia, depression, confusion, and nervousness.

Q: Can Mesagran be taken with antacids or medicines for heartburn?

According to regulatory-linked patient information, certain specialized formulations of Mesagran should not be taken at the same time as antacids or medicines for heartburn. This is because antacids may interfere with the controlled-release mechanism, which is a procedural constraint designed to protect the medicine's targeted delivery.

Q: What is the purpose of the black box warning on Mesagran's official documents?

The U.S. FDA Boxed Warning is the most serious safety alert required by regulation. Its purpose is to draw attention to a drug's risks of serious or potentially life-threatening adverse effects to ensure that health professionals and patients use the medicine with the highest level of caution and monitoring.

Q: Does taking Mesagran require lifestyle changes?

Regulatory documentation includes specific procedural requirements, such as ensuring adequate fluid intake when taking the medicine. Furthermore, caution is advised regarding sun exposure due to a documented risk of photosensitivity, which may involve wearing protective clothing or using sunscreen.

Q: Are there specific instructions for what to do in case of an accidental overdose of Mesagran?

Official patient information states that taking up to one extra dose is unlikely to cause problems. However, if a patient is concerned about taking too much, the guidance describes contacting a healthcare professional for advice immediately.

Q: Does Mesagran affect blood pressure?

Official adverse reaction reports document that the active ingredient has been associated with effects on blood pressure. These documented adverse reactions include both Hypertension (high blood pressure) and Hypotension (low blood pressure).

How should Mesagran be stored and disposed of?

How to Store and Dispose of Mesagran

Official regulatory documents detail specific conditions required for the storage and disposal of Mesagran (Mesalazine) to maintain its integrity.


Storage Requirements

Mesagran must be stored at controlled room temperature, generally below 25 C or 30 C. It is mandatory to protect the medication from moisture and light, which requires keeping it in its original package and ensuring the container is tightly closed.

Storage in extreme cold is prohibited, as the label specifies Do not freeze. All forms of Mesagran must be stored out of the sight and reach of children.


Disposal

Unused or expired Mesagran product must be disposed of in accordance with local requirements for pharmaceutical waste. This complies with standard regulatory guidance for discarding unused medicinal products.

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

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