Mesacron

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Mesacron

Medically reviewed

Marina Burgos

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 Mesacron

Quick Facts

Property Description
Active ingredient Mesalazine (5-aminosalicylic acid, or 5-ASA)
Form Tablets (oral), Capsules (oral), Suppositories (rectal), Enema (rectal)
Pharmacological class Aminosalicylate Anti-inflammatory Agent
Common use Calming inflammation in the bowel
Origin Synthetic

What Type of Medicine is Mesacron and Its Active Ingredient?

Mesacron is a prescription medication containing the active ingredient Mesalazine, which is chemically known as 5-aminosalicylic acid (5-ASA). It is classified as an aminosalicylate anti-inflammatory agent. Mesalazine's efficacy in modulating the body's inflammatory response at the intestinal level is widely clinically recognized. This classification confirms the drug's primary role is to manage and control chronic inflammation.

The medicine is a synthetic, single-ingredient compound designed for localized therapeutic action. Its structure distinguishes it from general steroids or broad-spectrum anti-inflammatory drugs. It is often employed in scenarios requiring long-term anti-inflammatory support directly within the lower digestive system, underscoring its role as a specialized therapeutic agent.


Mesacron: Composition, Origin, and Targeted Forms

Mesacron is formulated as a single active ingredient product (Mesalazine monotherapy) and is synthetic in origin. The brand is known for offering a complete range of specialized pharmaceutical preparations, allowing for the two primary routes of administration: oral and rectal.

The medication is available in several high-level dosage forms, including oral tablets (often with specialized coatings for delayed release), capsules, rectal suppositories, and liquid rectal suspensions (enemas). These varied forms are engineered to ensure the active 5-ASA component is released precisely where it is needed along the gastrointestinal tract, enabling highly targeted delivery to the inflamed tissue and minimizing unnecessary systemic exposure.


General Purpose: Why is Mesalazine Used?

The general purpose of Mesalazine is to provide a powerful, localized anti-inflammatory and antioxidant effect directly within the lining of the bowel. This action is essential for achieving and maintaining periods of remission in chronic conditions characterized by intestinal swelling and irritation.

The therapeutic benefit is rooted in its ability to suppress the production of key inflammatory mediators, such as prostaglandins and leukotrienes, that drive the inflammatory cycle. By delivering this focused action to the digestive system, Mesacron serves the fundamental purpose of calming the chronic irritation and helping the affected intestinal tissue to heal.

Regulatory References

  1. Mesalamine: MedlinePlus Drug Information

What side effects are possible with Mesacron?

Mesacron: Possible Side Effects and Safety Information

Mesacron (mesalazine) has an official safety profile categorized by regulatory authorities based on the frequency and system-organ class of reported adverse reactions. This classification is derived from clinical trial data and post-marketing surveillance, as documented in regulatory texts like the EMA Summary of Product Characteristics (SmPC) and FDA Prescribing Information.

Frequency-Classified Adverse Reactions

The most Common (ge 1/100 to < 1/10) reported adverse reactions include headache, abdominal pain, nausea, diarrhea, flatulence, vomiting, and general effects like fatigue and rash. Effects classified as Uncommon (ge 1/1,000 to < 1/100) include dizziness, tremor, and certain changes in blood counts like thrombocytopenia.

System-Organ Class Groupings and Serious Reactions

Adverse effects are documented across several systems, notably Gastrointestinal Disorders and Nervous System Disorders. Serious adverse reactions, though Rare or Not Known, are explicitly listed in regulatory documents. These include Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), serious blood disorders like aplastic anaemia, and organ-specific issues such as interstitial nephritis (kidney inflammation) and myocarditis (heart inflammation).

Safety Considerations and Restrictions

Official labeling includes specific safety constraints related to pre-existing conditions. Mesacron is generally advised with caution or is contraindicated in individuals with severe renal impairment or severe hepatic impairment. A specific pattern, the Acute Intolerance Syndrome, is documented, whose symptoms (e.g., fever, cramping, bloody diarrhea) may resemble a flare-up of the underlying bowel condition and is typically reported early in treatment. Monitoring of blood counts, renal function, and hepatic function is required prior to and periodically during treatment.

Overdose and Emergency Response

Mesacron Overdose and When to Seek Help

Mesacron (mesalamine/5-aminosalicylic acid or 5-ASA) has a relatively low risk of acute toxicity, but taking a dose significantly higher than prescribed can lead to an overdose. The primary concern is supportive care, as there is no specific antidote for Mesacron overdose. Management typically involves closely monitoring the patient's vital signs and organ function in a clinical setting.

Symptoms of Overdose

Symptoms of a Mesacron overdose may include general gastrointestinal and central nervous system effects, such as:

Body System Potential Symptoms
Gastrointestinal Nausea, vomiting, abdominal pain, diarrhea
Nervous System Headache, dizziness, confusion, seizures
Other Ringing in the ears (tinnitus), rapid or shallow breathing

When to Seek Immediate Medical Attention

Always seek emergency medical help immediately if you suspect an overdose of Mesacron, even if the person does not show symptoms. Overdose is a medical emergency. You should call your local emergency services or a poison control center right away.

Immediate professional care is required if a person experiences:

  • Severe confusion or unresponsiveness.
  • Seizures or convulsions.
  • Difficulty breathing or shallow, irregular, or stopped breathing.

Keep the medicine container available to provide healthcare professionals with information on the product, dosage, and estimated amount taken.

Therapeutic Uses of Mesacron

What Mesacron Treats: Main Uses and Benefits

Mesacron (mesalazine) is a prescription medication relevant in contexts marked by increased discomfort or tension. This medicine is applied across domains where additional symptomatic support is needed in conditions characterized by periods of heightened symptoms, such as ulcerative colitis and sometimes Crohn's disease.

This medicine is commonly used to help manage symptom clusters that may become intense or disruptive, such as those that appear suddenly or fluctuate. It is relevant for easing heightened discomfort and is commonly used to help with symptoms that interfere with daily comfort.

“It supports patients in coping more steadily with symptom fluctuations and helps improve day-to-day comfort.”

It is relevant for easing the overall symptom load in situations where symptoms lead to temporary functional strain or discomfort. This supportive relief is applied in clinical settings that involve acute or unstable symptom patterns, especially those involving recurrent or episodic manifestations.


Quick Fact: Relief for Episodic Discomfort

Eligibility and Restrictions for Use

Mesacron's (Mesalazine) eligibility is defined by regulatory authorities based on a patient's existing health status and age.

Absolute Contraindications (Must Not Use)

The medicine is absolutely contraindicated for patients who have demonstrated hypersensitivity to salicylates (including 5-aminosalicylic acid, or 5-ASA). Use is also prohibited in individuals with severe renal impairment or severe hepatic impairment, as stated in official labeling.

Conditional and Restricted Use

Use of Mesacron requires caution and a risk/benefit evaluation in patients with known, non-severe liver or kidney impairment; organ function must be assessed before and periodically during therapy. Caution is also necessary for patients with a history of sulfasalazine allergy (due to cross-sensitivity risk) and those with pre-existing cardiac conditions (due to reports of myo- or pericarditis). Patients with chronic lung function impairment, such as asthma, require close monitoring.

Age and Developmental Status

Mesacron is approved for adults (18 years and older). For the pediatric population, use is established for children aged ge 5 or ge 6 years, depending on the specific formulation. However, use is not recommended for children below certain age or weight thresholds due to a lack of complete safety data. Use during pregnancy or breastfeeding is conditional and advised only when the potential benefit outweighs the possible risks.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation structures the interaction profile of Mesacron (mesalazine) around specific pharmacodynamic and pharmacokinetic concerns with other medicinal products. The following information summarizes the formally documented interactions found in government regulatory sources.

Documented Pharmacokinetic and Pharmacodynamic Interactions

Interacting Substance/Class Official Interaction Outcome
Azathioprine or 6-Mercaptopurine Co-administration may increase the risk for blood disorders, including myelotoxicity, due to mesalazine's documented in vitro inhibition of the thiopurine methyltransferase (TPMT) enzyme.
Nephrotoxic Agents (e.g., NSAIDs) Concurrent use may increase the risk of nephrotoxicity (kidney adverse reactions). This requires evaluation in patients with existing renal impairment.
Coumarin-type Anticoagulants (e.g., Warfarin) Co-administration may alter the anticoagulant effect, necessitating close monitoring of coagulation parameters like prothrombin time/INR.

Procedural and Pharmaceutical Integrity Constraints

  • Lactulose or similar agents that lower the pH of the colon may prevent the intended release of mesalazine from certain oral delayed-release tablet formulations.
  • Mesalazine is documented to interfere with specific laboratory tests, potentially causing spuriously elevated test results for urinary normetanephrine measurements when analyzed by liquid chromatography with electrochemical detection.

This structure defines the mandatory monitoring and precautions required when Mesacron is co-administered with these substances, strictly according to regulatory labels.

Mechanism of Action

How Mesacron Works

Mesacron’s mechanism involves the localized molecular action of Mesalazine (5-ASA), relying on simultaneous interaction with multiple inflammatory and protective pathways at the intestinal lining. This multi-targeted action influences the physiological response.

Dual Inhibition of Inflammatory Eicosanoids

Mesalazine acts as an inhibitor on both the Lipoxygenase (LOX) and Cyclooxygenase (COX) enzyme pathways within the Arachidonic Acid Cascade, reducing the synthesis of signaling molecules like leukotrienes and prostaglandins. This action restricts the chemical signals that drive immune cell accumulation, resulting in a modulated inflammatory response at the tissue level.

Genetic and Nuclear Control of Inflammation

The molecule also operates at the cellular level, inhibiting the transcription factor NF-kappaB, which suppresses the production of cytokines. Simultaneously, Mesalazine acts as an agonist on PPAR-gamma receptors to promote specific gene expression. This dual action provides a cellular-level influence over the inflammatory cascade, modulating factors relevant to intestinal epithelial integrity and stability.

Localized Cellular Protection

Furthermore, Mesalazine acts as a direct antioxidant and free radical scavenger. By neutralizing the highly reactive oxygen species and free radicals generated by the inflammatory process, the drug provides a protective shield to the epithelial cells. This cellular protection contributes to a reduction in local oxidative stress.

Dosage and Administration Information

How Mesacron is Used: Official Administration Guidelines

Mesalazine (Mesacron) is administered through Oral (tablets, capsules, granules) or Rectal (suppositories, enemas) routes, a dual approach designed for targeted delivery along the gastrointestinal tract.

Dosing and Frequency Patterns

The standard protocol for using this medicine is divided into two distinct phases: Induction and Maintenance. For inducing remission, oral dosing typically falls within the range of 2.4 g to 4.8 g daily, often taken once daily or in divided doses depending on the specific formulation. Following the induction period (which may last up to 6 to 8 weeks), the long-term use for maintaining remission usually employs a lower dose, such as 1.5 g to 2.4 g daily. Rectal forms, utilized for more distal disease, are generally administered as a 1 g to 4 g dose once daily, typically at bedtime.

Administration Conditions and Integrity

Specific administration rules ensure the drug's specialized delivery mechanism works as intended. All delayed-release and extended-release tablets or capsules must be swallowed whole; they must not be crushed, broken, or chewed. Certain formulations are required to be taken with food, while others may be taken without. Rectal suppositories and enemas are designed for optimal effect when retained for an extended period, which is why administration at bedtime is often specified in the instructions.

Special Procedural Rules

If a dose is missed, it should be taken as soon as it is remembered, unless the time for the next scheduled dose is near; in this scenario, the missed dose should be skipped, and the schedule resumed. Dosing must not be doubled to compensate. Pediatric use rules often require a weight-based dose for children who can swallow the tablets whole. Caution is required, and function must be evaluated prior to and periodically during treatment for patients with renal or hepatic impairment.

Recent Clinical Evidence

Mesacron: Recent Clinical Evidence

Research evidence / Overview of studies

This section summarizes research that has explored the compound's activity and clinical endpoints evaluated in trials across various patient groups.


Compound Activity (Basis for Study)

The compound was investigated based on its proposed activity as a COX-2 selective inhibitor. Research has examined the compound's potential effects across several indications.


Clinical Study Endpoints

A body of evidence from clinical trials has investigated the compound's use in the management of acute pain. Research has explored whether changes in pain scores were reported, with some studies focusing on the period starting within the first hour of dosing.

Osteoarthritis (OA): Pain Outcomes Investigated

A meta-analysis of four randomized controlled trials (RCTs) examined whether the compound was associated with changes in function variables and pain scores compared to placebo across a 6-week treatment course. Furthermore, studies compared the compound's outcomes and reported adverse events with those of non-selective NSAIDs.

Rheumatoid Arthritis (RA): Outcomes Related to Joint Swelling

One key study investigated whether the compound was associated with a change in joint count measures, examining patients with moderate to severe disease.


Safety and Tolerability: Observed Adverse Events Profile

Clinical data from trials suggested a favorable profile of reported adverse events. The most frequently reported adverse events included specific gastrointestinal events and headache. The compound's use has been evaluated in long-term studies, and monitoring was performed on a regular basis in the trials.

Research has explored cardiovascular outcomes, and trials have generally excluded patients with a recent history of cardiovascular events.

Key Studies & References

  1. COX Inhibitors - StatPearls - NCBI Bookshelf (Review on COX-2 Mechanism, Acute Pain, and Cardiovascular Risk)
  2. Cyclooxygenase-2–selective inhibitors in the management of acute and perioperative pain (Review of COX-2 Mechanism and Acute Pain Efficacy)
  3. The role of COX-2 in acute pain and the use of selective COX-2 inhibitors for acute pain relief (Review of COX-2 for Acute Pain and GI Safety)
  4. Rheumatoid Arthritis - StatPearls - NCBI Bookshelf (General RA Disease Measures and NSAID role)
  5. Efficacy and safety outcomes of long-term anti-thrombotic treatment of chronic coronary artery disease: A systematic review and network meta-analysis (Reference for general CV risk assessment in long-term treatment)

Frequently Asked Questions (FAQ)

Common questions about Mesacron (FAQ)


Q: Is it normal to feel a bit nauseous when first taking Mesacron?

According to the official product information derived from clinical data, nausea is classified as a Common side effect, meaning it has been frequently reported in clinical data. However, the specific timing of the onset (e.g., when first starting treatment) is not always detailed in official product summaries.


Q: What happens if I accidentally miss a dose of Mesacron?

Regulatory instructions state that if a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the patient should resume the regular schedule. Official product summaries indicate that a dose should not be doubled to compensate for the missed one.


Q: Do I need to take Mesacron with food, or does it matter?

Administration requirements for Mesacron depend entirely on the specific formulation being used. Official labeling indicates that certain delayed-release or extended-release products require taking with food, while other forms may be taken with or without food. Patients should refer to and follow the instructions provided with their specific Mesacron product.


Q: What is the typical time frame for seeing the full benefits of Mesacron?

Clinical studies have shown that a therapeutic response, meaning an objective improvement in the condition, can often be observed within 3 to 21 days after beginning treatment for active disease. The time to see full benefits is usually associated with the initial treatment period. However, the exact time frame varies by individual.


Q: Can Mesacron affect my sleep?

The official list of common side effects does not typically include specific sleep disorders like insomnia. However, adverse reactions like dizziness, tremor, and fatigue are listed as common or uncommon effects. These effects are related to the nervous system, but official sources do not explicitly detail the impact on sleep quality.


Q: How quickly should I expect to feel better after starting Mesacron?

Clinical studies indicate that an objective therapeutic response has been observed as early as 3 to 21 days after starting treatment. The goal of the medication is to reduce inflammation, but the point at which subjective improvement is noticed is not specified in regulatory documentation.


Q: Is Mesacron safe to use long-term?

Mesacron is indicated for the maintenance of remission, which involves ongoing use to manage chronic conditions. While it is indicated for the maintenance of remission, specific formulations may have established safety data only for limited periods (e.g., up to six weeks) in some studies. Ongoing medical monitoring is typically required during any extended treatment.


Q: Can Mesacron affect fertility or family planning?

Animal studies performed with the active ingredient showed no effects on fertility or reproductive performance in male or female test subjects at tested doses. Official labels indicate that there is no evidence to suggest that the medication reduces fertility in men or women.


Q: Has Mesacron been studied in pregnant or breastfeeding populations?

Regulatory documents mention that limited human data is available regarding the use of Mesacron during pregnancy, though animal studies have generally not indicated direct harm. Low concentrations of the active ingredient and its metabolite are also known to be excreted into human milk.


Q: Can Mesacron cause sensitivity to the sun?

Photosensitivity (increased sensitivity to sunlight) is noted as a warning in some official labeling for Mesacron. Official regulatory warnings note that patients are advised to take precautions such as avoiding prolonged sun exposure, wearing protective clothing, and using broad-spectrum sunscreen when outdoors.


Q: Is there a difference in effectiveness between brand-name Mesacron and the generic version?

The effectiveness of this medication relies on its specialized and targeted release system in the body. Because of this, generic formulations with different proprietary release mechanisms are not generally recommended to be considered interchangeable by regulatory guidance. They should be prescribed and dispensed by their specific name.

How should Mesacron be stored and disposed of?

How to Store and Dispose of Mesacron?

The official storage and disposal requirements for Mesacron (mesalazine) are defined by mandatory constraints outlined in regulatory documents.

Official Storage Requirements

Item Requirement
Temperature Store below 25 C (77 F) or 30 C, depending on the formulation.
Protection Must be stored in the original package or outer carton to protect the product from light and moisture.
Handling The medicine must not be frozen or refrigerated (except where specified for certain rectal forms).
Stability Rectal enemas must be used immediately after opening the protective foil and should be discarded if the contents appear dark brown.
Safety As with all medicines, Mesacron must be stored out of the sight and reach of children.

Official Disposal Rules

Any unused or expired Mesacron product must be disposed of strictly in accordance with local requirements for pharmaceutical waste, often involving take-back programs. There are generally no special requirements for handling the used product as hazardous waste.

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

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