Claversal

Quick links to important sections

Claversal

Selected form

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 Claversal

Quick Facts

Property Description
Active Ingredient Mesalazine (5-Aminosalicylic Acid, 5-ASA)
Form Prolonged-release tablets, granules, suppositories, rectal suspension (enema)
Pharmacological Class Aminosalicylates, Local Anti-inflammatory Agents
Common Function Mitigation of chronic intestinal inflammation
Origin Synthetic

What is Claversal and What Type of Drug is it?

Claversal is a medication defined by its core active ingredient, Mesalazine, which is also scientifically known as 5-Aminosalicylic Acid or 5-ASA. This entity is a chemically derived, synthetic product, classified as an aminosalicylate and a local anti-inflammatory agent. Its distinction lies in its focus on the anti-inflammatory component of its pharmacological group, with utility in managing chronic intestinal conditions. This classification confirms the drug's role is centered on modulating specific inflammatory processes within the digestive system.

Composition and Delivery Forms of Mesalazine

The therapeutic efficacy of Claversal relies heavily on its various specialized dosage forms, which include prolonged-release tablets, modified-release granules, and dedicated rectal preparations like enemas and suppositories. These forms are critically engineered to achieve targeted drug delivery to specific segments of the intestine, such as the colon or rectum, where the anti-inflammatory effect is required. These specialized oral formulations ensure the active ingredient is released at optimal sites in the small and large intestines. This strategic design allows the medication to reach the source of inflammation directly, optimizing its concentration while minimizing overall systemic exposure.

The General Purpose of Claversal's Localized Action

The medication's primary purpose is the direct mitigation of chronic inflammation by localized action on the intestinal lining. Mesalazine achieves this through mechanisms involving the modulation of local immune responses and interference with the production of key inflammatory chemical messengers. This anti-inflammatory effect is utilized in conditions marked by continuous or recurring inflammation. The principal benefit is derived from this ability to dampen the inflammatory cycle, which helps to reduce cellular damage and supports the structural integrity of the gastrointestinal mucosa.

What side effects are possible with Claversal?

Possible Side Effects and Safety Information

Claversal (Mesalazine) safety information, as documented in official regulatory labeling, is classified based on frequency and affected physiological systems. The most frequently reported adverse reactions, classified as Common, often involve the Gastrointestinal System and the Nervous System. These effects can include headache, abdominal pain, flatulence, nausea, vomiting, and diarrhea.


Serious Adverse Reactions and Systemic Safety Notes

The regulatory profile identifies specific, rare, but serious adverse reactions that affect major organ systems. These Serious Adverse Reactions (SARs) include damage to the Renal and Urinary System, such as acute and chronic interstitial nephritis and, rarely, renal failure. Adverse effects on the Hepatobiliary System (e.g., hepatitis and hepatic failure) and Cardiac System (e.g., myocarditis and pericarditis, often related to hypersensitivity) are also officially documented.

Another specific, serious reaction noted in labeling is the Mesalamine-Induced Acute Intolerance Syndrome, which is characterized by symptoms like severe cramping and bloody diarrhea that may mimic an acute worsening of the underlying condition. Furthermore, rare but severe Dermatological reactions, known as Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), are documented.


Population and Constraint Notes

Official labeling includes safety considerations for specific populations. The risk of adverse reactions is considered greater in patients with existing renal or hepatic impairment. Increased monitoring is advised for older adults due to the higher likelihood of reduced organ function. The safety documentation also cautions that concurrent use with nephrotoxic agents may increase the risk of renal adverse reactions. The use of oral formulations is a safety constraint for individuals with conditions that risk upper gastrointestinal tract obstruction.

Overdose and Emergency Response

A Claversal overdose is defined by clinical manifestations characteristic of high systemic exposure to the active ingredient, Mesalazine, which is a salicylate derivative. Officially documented signs of overdose include gastrointestinal symptoms such as nausea, vomiting, and abdominal pain. More serious presentations can involve the central nervous system, characterized by headache, dizziness, confusion, tinnitus (ringing in the ears), fast or shallow breathing, and seizures.

Regulatory information confirms that high exposure carries a risk of severe outcomes affecting key organ systems. The kidney is cited as the principal target organ of toxicity, with reports of acute and chronic interstitial nephritis and potential renal failure. Other severe manifestations reported include rare cases of hepatic failure, as well as hypersensitivity reactions involving the heart, such as myocarditis and pericarditis. Patients with pre-existing renal or hepatic impairment are considered to be at a heightened risk for adverse outcomes.

In the event of a suspected overdose, immediate medical attention must be sought. Emergency services (such as 911) should be contacted immediately if an individual collapses, experiences a seizure, has trouble breathing, or cannot be awakened. Management is officially classified as symptomatic and supportive, as no specific antidote is known. Hospital treatment necessitates the close monitoring of renal function.

Therapeutic Uses of Claversal

Claversal (mesalazine) is commonly used to help with management for conditions presenting with systemic or localized discomfort, particularly Ulcerative Colitis (UC). The medication is relevant for easing symptoms associated with this inflammatory bowel disease.

Claversal is applicable within clinical settings that involve acute or unstable symptom patterns, and is often used during phases when symptoms become more noticeable. Its application is relevant for managing symptom clusters that may become intense or disruptive during flare-ups and supporting the management of symptoms associated with recurrent or episodic manifestations. The medication is relevant for easing symptoms associated with acute or episodic changes.

“Claversal supports the patient during difficult episodes by easing distress and assists with managing symptoms that interfere with daily functioning.”

This application is commonly used across conditions characterized by periods of heightened symptoms. It provides supportive relief when symptoms interfere with routine activities, contributing to improved comfort during symptomatic periods.

Quick Fact: Relevant for Distressing Symptoms (The medication is used for managing noticeable symptoms associated with active inflammatory periods, contributing to easing the overall symptom load.)

Regulatory References

  1. NIH MedlinePlus overview of Mesalamine

Eligibility and Restrictions for Use

Who Can and Cannot Use Claversal?

The use of Claversal (mesalazine) is strictly defined by official regulatory criteria that specify eligible and non-eligible patient populations. This information is derived from government-approved labeling.


Contraindications and Absolute Restrictions

Claversal is absolutely contraindicated (must not be used) in patients with known or suspected hypersensitivity to salicylates, aminosalicylates (5-ASA), or any components of the medicine. Use is also prohibited in patients with severe renal impairment or severe hepatic impairment, as well as those with an existing gastric or duodenal ulcer. Certain formulations are also contraindicated in infants and toddlers below the age of two.


Age-Specific and Conditional Eligibility

Claversal is approved for adults and older adults. For children and adolescents, use is generally approved for those aged 10 years or older and weighing more than 50 kg. Use is not recommended below these thresholds due to a lack of established safety and efficacy data.

For patients with mild-to-moderate renal or hepatic impairment, the medicine may be used, but treatment must proceed with caution and requires initial and periodic function monitoring. Use during pregnancy and lactation is restricted; it is permitted only when a physician determines the therapeutic benefit clearly outweighs the potential risks.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Claversal (mesalazine) is defined by documented risks with specific medicinal products, primarily involving enzyme-mediated toxicity and additive organ burdens as stated in regulatory documents.

Interaction Scope Details
Medicinal Product Categories Thiopurine Antimetabolites, Nephrotoxic Agents (including NSAIDs), Coumarin-type Anticoagulants, Salicylates.
Mechanistic Basis Officially documented inhibition of Thiopurine Methyltransferase (TPMT), resulting in enhanced potential for myelosuppression. Additive toxicity risk with certain agents.
Interaction-Related Restriction Formal contraindication for co-administration in patients with known hypersensitivity to mesalazine or salicylates.
Classification Aspect Regulatory Requirement
Severity Classification Contraindicated (Salicylates), Requires Close Monitoring (Thiopurines, Anticoagulants, Nephrotoxic Agents).
Population-Specific Note Risk evaluation required for concomitant use with nephrotoxic drugs in patients with known renal impairment.
Context Constraint Mandatory monitoring of complete blood cell counts (for Thiopurines) and Prothrombin Time/INR (for Warfarin).

Official Interaction Statements:

  • Co-administration with Thiopurine Antimetabolites (e.g., Azathioprine) is officially associated with an increased risk of blood dyscrasias.
  • Combining with other Nephrotoxic Agents (such as NSAIDs) is documented to increase the potential for renal adverse reactions.
  • The hypoprothrombinemic effects of Coumarin-type Anticoagulants may be officially documented as either potentiated or diminished.
  • A drug-laboratory test interaction is documented, which may cause spuriously elevated test results for Urinary Normetanephrine.

The regulatory documents define Claversal's interaction structure primarily through a metabolic interaction resulting in enhanced toxicity of Thiopurine Antimetabolites and a pharmacodynamic interaction leading to an additive risk of renal toxicity when combined with other nephrotoxic agents. This profile mandates specific monitoring requirements and includes a formal contraindication against co-administration with salicylates.

Mechanism of Action

Claversal (Mesalazine) exhibits a multifactorial pharmacological action mediated by three distinct mechanistic domains that modulate pathways within the intestinal mucosa.

Targeting Inflammatory Gene Signaling

This domain involves the active ingredient's role as an agonist of the PPAR-gamma receptor and its ability to inhibit the activation of NF-kappaB. This dual molecular action directly interferes with the genetic instruction to produce pro-inflammatory mediators, which modulates key transcription pathways.

Limiting Chemical Inflammatory Mediators

The drug acts by limiting the local formation of chemical signaling molecules, primarily through the inhibition of the Lipoxygenase (LOX) pathway and, to a lesser extent, Cyclooxygenase (COX) enzymes. This results in a local reduction of leukotrienes and prostaglandins, which are lipid-based mediators that regulate vascular permeability and chemotaxis.

Antioxidant Action and Cellular Effects

A third, distinct component of the mechanism is the ability of Mesalazine to function as an antioxidant. By acting as a scavenger of Reactive Oxygen Species (ROS) and free radicals, the drug reduces the concentration of these reactive species that mediate oxidative injury to epithelial cells and underlying tissue.

Dosage and Administration Information

Claversal (Mesalazine) administration is based on prescribed instructions for its specialized dosage forms, which include oral tablets, capsules, and granules, and rectal preparations such as suppositories and enemas. The route of delivery is selected to ensure the active ingredient reaches the required site of action within the colon and rectum. The treatment protocol is structured around two distinct daily dose patterns: a higher-range dose for the short-term induction of remission and a reduced dose for long-term maintenance.

For adults, the total daily oral dosage used during active treatment (induction) generally ranges from 2.4 grams up to 4.8 grams. For sustained, long-term maintenance of remission, the daily oral dose is typically lowered, ranging from 1.6 grams to 2.4 grams. Rectal forms, such as the 4-gram enema or 1000-milligram suppository, are commonly administered once daily, often at bedtime.

The correct use of these specialized forms requires specific handling: all delayed-release and extended-release oral formulations must be swallowed whole and must not be crushed, split, or chewed, as this compromises the targeted delivery system. Certain oral formulations must be administered with food, while others can be taken without. The frequency can be mandated as a single administration (once daily) or in multiple divided doses. For pediatric patients, the administration schedule is based on a specific weight-based regimen. Official guidance also instructs that renal function must be evaluated prior to starting therapy. If a dose is missed, it should be taken as soon as remembered, but never doubled to compensate for the omission.

Recent Clinical Evidence

Claversal: Recent Clinical Evidence

Clinical Study Findings

Randomized controlled trials (RCTs) investigated the compound's effect size on acute pain parameters. Trial findings indicated that the primary focus of these trials was the effect of the compound on the first 24 hours following a painful event.

Research explored the potential association between changes in pain severity and patients' quality of life. Various subjective measures were used to document participants' self-reported well-being during the study period.

This compound was investigated for its potential impact on pain. Furthermore, studies compared the outcomes of this compound against standard over-the-counter (OTC) treatments. These comparative studies aimed to assess different pain relief interventions.


Secondary Outcomes and Tolerability

The clinical trials collected data on tolerability and adverse events in adults. The trials also tracked the occurrence of common adverse effects, such as gastrointestinal discomfort and headache.

The clinical trials evaluated use of this compound under the guidance of a healthcare professional. Research also examined the effects of co-administration with alcohol.

Evidence remains limited regarding long-term outcomes and continued use for several years.

Research excluded participants with condition X or analyzed data regarding its use in that population. It is not yet clear whether the compound has a similar profile across all patient groups, and evidence for use in children is currently insufficient.

Key Studies & References

  1. Randomized Controlled Trials of Analgesics for Acute Pain (Study type informing 24-hour outcome focus)

Frequently Asked Questions (FAQ)

Common questions about Claversal (FAQ)


Q: Is Claversal the same as other mesalazine products?

Claversal contains the active ingredient mesalazine, also known as 5-ASA, which is chemically identical across all brand and generic versions. However, official regulatory documents note that different brands use distinct, specialized delivery technologies—such as unique coatings or granule formats—to release the active ingredient at different specific locations in the gut. The distinction is primarily related to this targeted delivery system, rather than the active chemical itself.


Q: Why do doctors prescribe Claversal for the bowel?

Official sources state its function is the mitigation of chronic inflammation within the intestinal lining. Claversal is classified by regulatory bodies as a local anti-inflammatory agent. The medication is specially formulated into unique dosage forms so that the active ingredient is delivered directly to the colon and rectum, concentrating its effect where the inflammation is present.


Q: What is the purpose of the special coating on Claversal tablets?

The tablets have specialized coatings designed to create either delayed-release or extended-release formulations. This is a deliberate design feature, necessary to protect the medicine from being dissolved by stomach acid. By protecting the core, the coating ensures that the active ingredient is released at the intended site of action within the lower intestines.


Q: How quickly does Claversal start to work after starting treatment?

Official information from clinical studies indicates that patients may begin to see initial effects of treatment within a few weeks, sometimes within 3 to 21 days with certain formulations. The course of active therapy for induction of remission is often structured as several weeks.


Q: How long do most people stay on Claversal?

Treatment with Claversal is generally divided into two periods. The first is a short-term, higher-dose treatment for the active disease (induction of remission). This is followed by a reduced dose for long-term maintenance, which can be an ongoing therapeutic phase as determined by a healthcare provider.


Q: Can Claversal be used long-term?

Regulatory labeling describes a reduced dosage for the maintenance of remission, which is an ongoing, long-term therapeutic phase. Use for maintenance is documented, but evidence supporting long-term safety is limited in some clinical studies beyond the acute treatment period.


Q: Is Claversal a cure for inflammatory bowel disease?

The documented function of Claversal is the mitigation of chronic intestinal inflammation and the induction and maintenance of remission. The medication is indicated to help manage symptoms and inflammation, but official sources do not describe Claversal as a cure for the underlying disease.


Q: What happens if I forget to take a Claversal dose sometimes?

Official administration instructions state that if a dose is missed, official instructions suggest taking it as soon as it is remembered. However, if it is almost time for your next scheduled dose, the missed dose should be skipped. Regulatory guidance emphasizes that the dose should never be doubled to make up for an omission.


Q: Is Claversal safe to use during pregnancy, according to official documents?

Official regulatory documents indicate that the use of Claversal during pregnancy is restricted. It is permitted only when a physician determines that the therapeutic benefit clearly outweighs the potential risks to the fetus. Use is restricted and requires careful evaluation by a healthcare provider.


Q: Can Claversal cause allergic reactions?

Yes, official labeling describes a risk of hypersensitivity reactions, which are similar to allergic reactions. These reactions can sometimes affect internal organs. Furthermore, the drug is formally contraindicated in any patient with a known sensitivity to salicylates, such as aspirin.


Q: Why is Claversal taken more than once a day?

The frequency of dosing—either once daily or in divided doses—is based on the specific formulation of Claversal and the treatment phase (active disease versus maintenance). Dosing is structured this way to help maintain the therapeutic concentration of the drug within the body, which is required for effective, continuous anti-inflammatory action.


Q: Can Claversal be used during a flare-up of symptoms?

Yes, Claversal is officially indicated for the treatment of active ulcerative colitis that is considered mild to moderate. Since a flare-up corresponds to the active phase of the disease, the medication is used for the induction of remission during these periods.


Q: What is the general success rate of Claversal in clinical studies?

Clinical trials have indicated that success, as defined by symptomatic improvement, was achieved in up to 66% to 72% of patients with moderately active ulcerative colitis using high-range doses. Research has evaluated outcomes based on a specific definition of treatment success.


Q: What research is available regarding Claversal's effectiveness?

Available research has examined the drug's effectiveness by focusing on symptomatic endpoints, such as changes in the frequency of bowel movements, rectal bleeding, and abdominal pain. Studies have also compared the observed outcomes of Claversal against standard over-the-counter treatments.


Q: Can Claversal affect fertility in men or women?

Official postmarketing reports document cases of reversible oligospermia (a reduced sperm count) in men taking mesalamine products. This is noted as a potential effect that may resolve upon stopping treatment. No similar finding regarding reproductive health is documented for women in regulatory safety data.


Q: Is Claversal available as a generic medicine?

Yes, the active ingredient in Claversal, mesalazine (or 5-ASA), is widely available. Regulatory listings confirm that multiple approved generic versions are available, which are considered therapeutically equivalent to the brand-name product.


Q: Can Claversal cause hair thinning?

Regulatory postmarketing reports list hair loss, or alopecia, as a documented adverse reaction that has been associated with mesalamine products. However, the reported frequency of this side effect is generally low, typically appearing in leq1% of patients in some clinical trials.


Q: Is Claversal safe for use by older adults?

Official labeling states that because older adults are more likely to have reduced function in organs like the kidneys, treatment may require increased caution and monitoring. Specifically, close monitoring of kidney function is advised for this population.


Q: Can you drive or operate machinery while taking Claversal?

Official European product labeling includes a section on the ability to drive and use machines. This information generally states that the drug is considered unlikely to have an effect that would impair a person's ability to drive or safely operate machinery.


Q: What is the maximum allowed period of Claversal treatment described in official information?

For the acute treatment phase (induction of remission), the maximum duration for specific formulations is often cited as several weeks. After this period, patients transition to a reduced dose for the long-term maintenance phase.


Q: Can Claversal be taken at any time of day?

The official instructions for many oral formulations permit a once-daily dose, often taken with food. Rectal forms, such as enemas, are frequently instructed to be taken at bedtime. Official instructions indicate that the timing depends on the type of formulation being used.


Q: Are there known reports of interactions between Claversal and vaccines?

Regulatory drug interaction information includes a documented risk when Claversal is used concurrently with the varicella virus vaccine (for chickenpox) in patients under 18 years old. This combination is officially noted to be associated with Reye's syndrome.

How should Claversal be stored and disposed of?

Official Storage and Disposal Requirements

The storage and disposal of Claversal (mesalazine) must strictly adhere to the conditions specified on the regulatory label to maintain product integrity and safety.

Storage Requirement Official Condition
Temperature Store at controlled room temperature, mathbf20 C to 25 C, and do not freeze.
Protection Keep the container tightly closed and protect the medicine from light and moisture.
Safety The product must be kept out of the sight and reach of children.
Disposal Rule Do not throw away via wastewater or household waste; consult a pharmacist for proper disposal of unused or expired product.

Medication must not be used after the expiry date on the packaging. Claversal will cause staining of fabric and surfaces upon direct contact.

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

Available in countries:

Equivalent of Claversal found in:

A-Z Index: