Urinorm

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Urinorm

Method of action: Hypouricemic, Uricosuric

Treatment option: Gout

Medically reviewed

Rosario Oropesa

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 Urinorm

Urinorm is a synthetic pharmaceutical product primarily marketed as an oral tablet containing the single active substance, Benzbromarone.

Property Description
Active ingredient Benzbromarone
Form Film-coated tablet (Oral)
Pharmacological class Uricosuric agent
General purpose Lowering high serum urate levels
Origin Synthetic

Urinorm: Identity and Composition Differentiation

Urinorm is a synthetic pharmaceutical preparation administered orally, containing the active substance, Benzbromarone. This compound is chemically defined as a potent halogenated benzofuran derivative. The preparation is manufactured as a film-coated tablet, designed for systemic delivery. Benzbromarone is clinically recognized as one of the most effective uricosuric agents available. The drug’s single-component composition ensures a focused action essential for the chronic management of hyperuricemia. While Urinorm is a common trade name, the INN Benzbromarone is also marketed under similar brands in various global regions, affirming its established presence in international pharmacology.


Pharmacological Classification and Purpose

Urinorm is classified as a uricosuric agent, placing it within the broader pharmacological group of Antigout preparations. This classification means the medicine functions by actively promoting the elimination of uric acid from the body. Unlike other drug types that inhibit the production of uric acid, Urinorm works directly in the kidneys to increase the rate at which the compound is excreted, thereby addressing high circulating levels of serum urate. Benzbromarone's potent activity is based on its ability to inhibit the reabsorption of uric acid in the renal tubules. This activity has a significant impact on maintaining healthier levels of uric acid in the bloodstream, a critical step in managing conditions related to hyperuricemia.

What side effects are possible with Urinorm?

Possible Side Effects and Safety Information

The safety profile for Urinorm is based on data from official government regulatory documents, including a focus on serious and common adverse reactions observed during clinical use and post-marketing surveillance.

Serious Safety Risks

Official regulatory documents contain a Boxed Warning regarding the potential for serious outcomes. A post-marketing clinical trial observed an increased risk of cardiovascular death and death from all causes compared to a related gout medicine in patients with pre-existing cardiovascular disease.

Additional serious, clinically significant adverse reactions include post-marketing reports of severe hepatic failure (some cases resulting in death) and serious, potentially life-threatening skin and hypersensitivity reactions, such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

Common Adverse Reactions

The most frequently reported side effects in clinical trials (occurring in 1% or more of patients) were:

  • Liver function abnormalities
  • Nausea
  • Arthralgia (joint pain)
  • Rash

Transient exposure-related safety pattern: An increase in gout flares is frequently observed upon starting treatment with Urinorm.

Population-Specific Considerations and Limitations

Urinorm is not recommended for use in patients with secondary hyperuricemia (e.g., those being treated for malignant disease or who are organ transplant recipients). Studies assessing safety and effectiveness have not been conducted in these specific populations. Immediate discontinuation of treatment is required if a serious skin reaction or hepatic failure is suspected.

Overdose and Emergency Response

Overdose and When to Seek Help

Urinorm (containing febuxostat) is a prescription medication, and its use should strictly adhere to the dosing instructions provided by a healthcare professional. Taking more than the prescribed dose can lead to potential health risks and may cause severe side effects.

Overdose Presentations and Emergency Action

Specific symptoms or clinical manifestations resulting from an acute, high-dose overdose of Urinorm have not been clearly defined in the available official regulatory documentation or clinical studies. In healthy volunteers, doses significantly exceeding the recommended daily amount did not show dose-limiting toxicities. However, given that Urinorm's active ingredient, febuxostat, is metabolized by the liver, an overdose may theoretically increase the risk of serious adverse events such as serious liver damage.

When to Seek Immediate Medical Attention

If you suspect you have taken an overdose of Urinorm, or if you or someone else has accidentally taken more than the amount prescribed, you must consult a doctor immediately or go to the nearest emergency department.

Management of an overdose is primarily symptomatic and supportive, as there is currently no known antidote for Urinorm overdose. Stopping the medication abruptly should not be done without a doctor's instruction, but an overdose situation requires urgent medical guidance to monitor vital signs and manage any developing complications.

Therapeutic Uses of Urinorm

What Urinorm Treats: Main Uses and Benefits

Urinorm is applied in addressing symptoms related to physical discomfort. It is commonly used to help with certain distressing symptoms that interfere with functional stability.

Support for Acute Symptomatic Discomfort

This domain covers situations involving symptoms related to heightened physiological activity that create noticeable physiological strain. Urinorm is applied across domains where additional symptomatic support is needed, contributes to easing the overall symptom load during phases of increased distress or discomfort. Common indications include helping address pain, burning, urgency, and frequency linked to these episodes.

Quick Fact: Relief for Heightened Physiological Activity

Assistance in Managing Fluctuating Symptom Patterns

Urinorm is considered relevant for conditions characterized by periods of heightened symptoms or episodic manifestations. It may assist with addressing symptom clusters that may appear suddenly or fluctuate in intensity, supporting patients during episodes of heightened discomfort and helping them cope more steadily with symptom fluctuations.

Contribution to Enhanced Patient Stability and Ease

This focuses on general patient support during difficult episodes. Urinorm is relevant when short-term symptomatic assistance is needed; it may assist with supportive relief when symptoms interfere with routine activities. It assists with maintaining functional stability and supports general well-being during phases when symptoms become more noticeable. One patient-oriented benefit is that the medication supports the patient during difficult episodes by easing distress.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Urinorm?

Urinorm (Benzbromarone) is restricted to specific patient populations as defined by official regulatory documentation. The medicine is primarily intended for adults and adolescents aged 14 years and older. Its use is not established for children under 14 due to a lack of sufficient clinical data.


Absolute Contraindications

Urinorm is subject to several absolute contraindications and must not be used in the following populations:

  • Patients with known hypersensitivity to the active substance or excipients.
  • Individuals with a preexisting liver disorder or corresponding symptoms.
  • Patients with impaired renal function or a high tendency to form kidney stones (diathesis).

Reproductive and Conditional Eligibility

Use is strictly contraindicated during pregnancy and is not recommended for women who are breastfeeding. Furthermore, use is conditional: treatment requires a commitment to regular monitoring of liver enzyme levels both before and periodically throughout the entire course of therapy. Patients must also maintain appropriate fluid intake and manage their urine pH to prevent stone formation.

What should I know about interactions with other medicines?

Urinorm Interactions with other medicines and products

When taking Urinorm, it is important to be aware of potential interactions with other products, as these combinations may alter the effects of the medication. This drug, which contains the active ingredient Febuxostat, acts by reducing the body’s production of uric acid.

Authoritative regulatory documents advise that patients must inform their healthcare providers about all other medicines and products they are using. This comprehensive disclosure should include:

  • Prescription medicines
  • Over-the-counter (OTC) medicines
  • Dietary supplements, including vitamins and herbal products

The primary concern is that some products may interact with Urinorm to either enhance or diminish its intended medicinal effects. This general caution is given due to the broad potential for drug-drug interactions, even when specific combination mechanisms are not detailed in the official patient information.

No explicit list of specific, named medicinal products that must be avoided is provided, nor are there explicit rules for timing or spacing doses due to interactions. The overall interaction profile is framed as a use-with-caution scenario, emphasizing the need for professional oversight to manage potential additive or opposing effects.

Mechanism of Action

Urinorm (Febuxostat) acts by engaging a targeted enzyme system to modulate systemic uric acid concentration, a mechanism achieved primarily through enzymatic blockade rather than renal transport.

Blocking Uric Acid Production

This action involves the drug functioning as a selective inhibitor of the Xanthine Oxidoreductase (XOR) enzyme. By binding tightly to the enzyme's active site, the drug prevents the catalysis of precursor molecules into uric acid. This blockade suppresses the formation of uric acid throughout the body.

️ Modulation of Systemic Uric Acid Concentration

The inhibition of uric acid synthesis leads to a sustained reduction in the concentration of serum uric acid. This mechanism modulates systemic urate concentration, causing the circulating fluid to become undersaturated with uric acid. This physiological adjustment generates a concentration gradient that drives the dissolution of solid urate crystal deposits.

Mechanism for Crystal Deposit Dissolution

The sustained low concentration of uric acid establishes a passive mechanism influencing the state of urate deposits. The concentration gradient facilitates the dissolution of crystallized uric acid deposits in tissues, resulting in a reduction in solid urate mass.

Dosage and Administration Information

How to Use Urinorm

Urinorm, which contains the active substance Benzbromarone, is used according to specific instructions. The general principle of its use is to provide a long-term, continuous oral regimen for managing high urate levels.


Administration and Dosage Regimens

Urinorm is administered exclusively by the oral route as a film-coated tablet in available strengths of 25 mg and 50 mg.

The treatment typically involves dose titration:

  • Initial Dosage: The regimen begins with a low dose, generally 25 mg to 50 mg once daily.
  • Maintenance Dosage: Following initiation, the dose is adjusted upward to a continuous maintenance range, typically falling between 50 mg and 150 mg total daily dose, which may be administered once daily or in divided doses.

Administration Conditions

To ensure proper use, the administration protocol includes specific procedural requirements:

Procedural Requirement General Instruction
Timing The tablet is taken with or immediately after a meal.
Fluid Intake Patients are instructed to maintain a high intake of fluids (e.g., 1.5 to 3 litres of water daily).
Urine Management Urine alkalization may be required as an essential co-administration step to prevent the formation of uric acid stones.

Handling and Duration

Urinorm is intended for chronic, long-term administration. In the event of a missed dose, the missed dose should be taken when remembered, unless it is close to the next scheduled dose, in which case it is skipped. Patients must never take two doses at once to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Urinorm


Evidence for Use in Chronic Hyperuricemia and Gout

Research exploring Urinorm (Benzbromarone) was studied for patients with high levels of uric acid in the bloodstream (chronic hyperuricemia) and the related condition, gout. Studies used in research exploring how symptoms change over time include both short-term Randomized Controlled Trials (RCTs) and various long-term observational studies. RCTs compare Urinorm against other standard treatments, such as Allopurinol, or against inactive comparisons (placebo) to monitor changes under controlled conditions.

These trials were used in research examining outcomes related to physical discomfort. Researchers primarily monitored changes in a key biomarker measure: the achievement of a defined target level for serum urate (SU). Studies also explored outcomes describing episodic or acute changes by monitoring how often patients experienced gout flares and monitoring patterns in visible urate deposits known as tophi. Data show patterns related to the maintenance of SU levels over the initial weeks of treatment. Reported outcomes were short-term and often based on small populations.


Outcomes Studied in Clinical Research

Research has examined several outcomes reflecting daily functioning or activity level in patients with gout. The most consistent focus has been on measuring the association between Urinorm use and the achievement and maintenance of lower serum urate levels, as studies monitored outcomes related to uric acid excretion. Studies monitored how symptoms evolved in the observed populations. Findings describe patterns observed in the studies where serum urate measurements consistently decreased across treatment groups, which research provides context related to the study of the condition.

Beyond biomarker changes, studies also explored outcomes reflecting daily functioning or activity level by monitoring observed patterns in the size and volume of tophi in specific patient cohorts. Additionally, researchers monitored outcomes related to physical discomfort by collecting patient reports on the frequency and duration of acute gout attacks.


Research in Specific Patient Groups and Remaining Uncertainty

Research examined Urinorm's use in specific patient groups, including adults with mild-to-moderate chronic kidney disease (CKD). This research explores potential use in patients who may have limitations with other urate-lowering agents due to kidney function. Studies documented patterns in the maintenance of SU targets in patients with mild kidney impairment; research examined this specific subgroup.

Uncertainty remains in several areas. Comparative results varied when examining Urinorm directly against newer urate-lowering agents, as comparative evidence is limited. Follow-up durations were limited in many of the key efficacy trials, contributing to uncertainty about long-term clinical outcomes such as patterns in gout flare frequency and tophi size over many years. Furthermore, evidence quality varies across studies, with data for certain groups remaining insufficient.

Key Studies & References

  1. Comparison of Benzbromarone and Allopurinol on Primary Prevention of the First Gout Flare in Asymptomatic Hyperuricemia - MDPI
  2. Lessons to be learned from real life data based on 98 gout patients using benzbromarone
  3. Benzbromarone in the treatment of gout - SciELO (Review covering efficacy and safety, including CKD patients and market withdrawal context)
  4. NCL Joint Formulary Committee (JFC) Meeting (Reference to quality of evidence, comparative trials, and use in refractory gout)

Frequently Asked Questions (FAQ)

Common questions about Urinorm (FAQ)


Q: How is Urinorm different from other common medications for similar conditions?

A: Official documents describe Urinorm as a uricosuric agent. This means its primary action is to increase the amount of uric acid the kidneys remove from the body, promoting excretion. This mechanism is one way it is distinguished from other medications for similar conditions, which often work by reducing the production of uric acid in the body instead.

Q: How quickly should I expect Urinorm to start working after I begin taking it?

A: Studies and official information indicate that a reduction in serum urate levels (the main goal of the treatment) can often be observed as early as the first two weeks after starting the medicine. Healthcare providers generally monitor the full effect and stabilization of these levels over the subsequent weeks. The stabilization of these levels is typically part of the overall management strategy described in official documents.

Q: Are there any common over-the-counter medicines or supplements that interact with Urinorm?

A: Official documents advise that the intended effect of Urinorm can be reduced by products containing salicylates, such as high-dose aspirin. The effect can also be influenced by certain over-the-counter products, like fluconazole. Official precautions note the need to inform your healthcare provider about all medicines, including OTCs and supplements, before starting treatment.

Q: Are there any known food restrictions or dietary rules when using Urinorm?

A: Regulatory information advises that patients avoid alcohol, especially beer, and minimize consumption of purine-rich foods like organ meats, as these can increase uric acid levels. Furthermore, official administration conditions indicate the tablet is to be taken with or immediately following a meal.

Q: Can consuming alcohol affect the way Urinorm works in the body?

A: Official documents advise against consuming alcohol, particularly beer, because it can raise the body's uric acid levels, potentially counteracting the medicine’s purpose. Additionally, excessive alcohol intake can increase the chance of serious liver problems, which are a specific safety concern associated with Urinorm.

Q: What are the officially listed major drug classes that should be avoided with Urinorm?

A: Regulatory documents advise against co-administering drugs that are potentially hepatotoxic (meaning toxic to the liver), which includes certain medicines like tuberculostatics. They also note that the effects of certain medicines, specifically coumarin anticoagulants (like warfarin), may be increased when taken with Urinorm. These are the broad classes that are identified for professional consideration in regulatory documents.

Q: Is it okay to take Urinorm with other daily vitamins or minerals?

A: Official precautions require that patients inform their healthcare provider about all substances they are using, which includes over-the-counter medicines and dietary supplements. Vitamins and minerals are included within this category of supplements. This comprehensive disclosure is required to help the provider assess the potential for any unwanted interactions.

Q: What happens if I accidentally take more Urinorm than prescribed?

A: The official prescribing information states that if you accidentally take more than your prescribed dose, you must immediately consult with your doctor or pharmacist. This consultation is the required action specified in the event of taking more than the prescribed amount.

Q: How is Urinorm eliminated from the body?

A: According to official pharmacokinetic information, the active substance is primarily processed, or metabolized, by the liver. The compounds resulting from this metabolism are primarily excreted from the body mainly through the bile and feces.

Q: Are there any specific laboratory tests required before or during Urinorm use?

A: A Liver function test is required to be performed before starting treatment with Urinorm. Because of the risk of liver disorder, these tests are then repeated periodically throughout the course of treatment, particularly for at least the first six months. This regular monitoring is required as a precaution to track the effects of the medicine.

Q: Why is Urinorm sometimes described as a 'prophylactic' treatment?

A: Patient information describes Urinorm as being used to prevent gout. This is achieved by the medicine helping the kidneys to remove uric acid from the bloodstream. The use of the drug is described by patient information as being preventative, which aligns with the general meaning of prophylactic use.

Q: What is the relationship between Urinorm and liver function?

A: There is a critical relationship between Urinorm and the liver: its use is contraindicated (not allowed) in patients who have a pre-existing liver disorder. Official warnings mention that severe hepatic failure (serious liver damage) has been reported as an adverse reaction. For this reason, regular liver function monitoring is required periodically during treatment, particularly in the initial months.

Q: Are there different strengths or formulations of Urinorm available?

A: Urinorm is marketed as an oral film-coated tablet. According to official prescribing information, it is available in specific strengths, typically 25 mg and 50 mg tablets. The available formulations may vary slightly by region.

Q: What should I do if I notice a sudden rash while taking Urinorm?

A: The official prescribing information warns that serious skin and hypersensitivity reactions are a possibility. If a rash or other potential serious skin reaction is suspected, the regulatory guidance is that immediate discontinuation of treatment is required. Official guidance requires that you seek immediate consultation with your healthcare provider if such symptoms occur.

Q: Can Urinorm be crushed or chewed, or must it be swallowed whole?

A: Urinorm is manufactured as a film-coated tablet intended for oral use. While official materials do not explicitly detail whether crushing or chewing is permissible, the film coating usually indicates the tablet should be swallowed whole to ensure proper delivery. It is recommended to consult the product's specific patient leaflet or pharmacist for confirmation on administration, as is standard practice.

Q: Can Urinorm cause a change in urine color or smell?

A: Official warnings associated with the potential for serious liver damage list dark urine as a symptom that requires immediate medical attention. It is important to note any change in urine color or other new symptoms and report them to your healthcare provider promptly.

Q: Does Urinorm interfere with fertility or reproductive health?

A: The Summary of Product Characteristics (SmPC) for Urinorm includes a specific section detailing information on Fertility, alongside guidance on Pregnancy and Lactation. This indicates that official regulatory bodies have examined and provided specific information regarding reproductive health in the prescribing materials.

How should Urinorm be stored and disposed of?

How to Store and Dispose of Urinorm

Urinorm (Benzbromarone) must be stored and handled according to specific regulatory requirements to maintain product stability and ensure safety.


Storage Requirements

Condition Requirement
Temperature Store at or below 30 C (86 °F).
Packaging Keep in the original foil blisters and cardboard carton to protect the tablets from light and moisture.
Child Safety Mandatory requirement to keep the medicine out of the sight and reach of children.
Stability The approved shelf life is 3 years when stored under the specified conditions.

Disposal Instructions

Any unused or expired Urinorm tablets must be disposed of in accordance with local pharmaceutical waste requirements. The product must not be discarded through wastewater (e.g., flushing) or general household waste without following established local regulatory guidelines.

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

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