Uricam

Quick links to important sections

Uricam

Method of action: Hypouricemic, Uricosuric

Treatment option: Gout

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 Uricam

Quick Facts

Property Description
Active ingredient Benzbromarone
Form Tablet (Oral preparation)
Pharmacological class Uricosuric agent
General purpose Lowering high uric acid levels
Origin Synthetic compound

What is Uricam and What is its Classification?

Uricam is a prescription-only medication whose active component is the generic drug Benzbromarone. This substance is formally classified as a uricosuric agent, meaning it is a specialized type of urate-lowering drug (ULD). Benzbromarone belongs to the pharmacological group of agents that increase the renal excretion of uric acid, which defines its primary mechanism. Benzbromarone is recognized for its potency compared to older agents in the uricosuric class, making it a tool for cases where standard therapies may be insufficient.

Composition, Origin, and Dosage Form

The core active ingredient, Benzbromarone, is a synthetic compound that is chemically identified as a benzofuran derivative. Uricam is provided as an oral preparation in a tablet form, making it convenient for systemic absorption throughout the body. The composition is centered on the active Benzbromarone substance, which is combined with solid excipients necessary to form the tablet structure. The drug acts as a uricosuric agent, differentiating its action from other common gout medications. The medication is typically positioned for adult patients requiring maintenance therapy for chronic hyperuricemia.

General Purpose of Uricam Therapy

The general purpose of Uricam therapy is to support the body’s ability to eliminate excess uric acid, thereby lowering the overall concentration in the bloodstream. The medication’s function primarily involves promoting uricosuria, which is the technical term for increasing the excretion of uric acid via the kidneys. This enhanced elimination is the key mechanism by which the drug maintains low, stable uric acid levels, serving as the goal for long-term maintenance therapy. A common use scenario involves using the medication to achieve a target serum urate level deemed appropriate by healthcare providers.

Regulatory References

  1. Netherlands Public Assessment Report (Benzbromarone)

What side effects are possible with Uricam?

Possible Side Effects and Safety Information

The safety profile for Uricam (phenazopyridine hydrochloride) is officially documented by government regulatory bodies and outlines known adverse reactions and critical restrictions for use.

Adverse Reactions Scope

Adverse reactions are classified by the body system affected and the frequency of occurrence, as established in clinical trials and post-marketing reports.

  • Common Reactions (System-Organ Class): Reactions such as headache, rash, itching, and occasional gastrointestinal disturbances (including nausea, vomiting, and upset stomach) have been reported.
  • Serious Adverse Reactions: Severe effects reported, typically associated with overdose or pre-existing conditions, include methemoglobinemia, hemolytic anemia, renal toxicity (including transient acute renal failure), and hepatic toxicity. Anaphylactoid-like reactions have also been described.

Safety-Related Restrictions and Limitations

Certain conditions restrict the use of Uricam due to increased safety risks. The drug is contraindicated in patients with known hypersensitivity to the drug or its components, as well as in patients with renal impairment (CrCl <50 mL/min) and severe hepatic impairment.

Population-Specific and Exposure Risks:

  • G6PD Deficiency: Patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency are at heightened risk of hemolytic anemia, even at normal doses.
  • Drug Accumulation: Yellowish discoloration of the skin or the sclera of the eyes is a sign of drug accumulation, often due to decreased renal function, and requires the medicine to be discontinued immediately.
  • Duration of Use: Regulatory documents emphasize that use should not exceed 2 days when taken with an antibacterial agent for urinary tract infections, unless specified by a healthcare provider.

High-Level Safety Notes:

The substance is an azo dye that imparts a harmless reddish-orange color to urine and feces, which may stain clothing or contact lenses. Uricam may also interfere with certain laboratory tests that rely on colorimetric methods.

This official information serves to define the known risk profile of the medicine, strictly based on regulatory findings.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Uricam (Benzbromarone) is dominated by the risk of severe, life-threatening hepatic disorder, which dictates the required emergency response. Documented clinical manifestations of severe toxicity align with acute liver injury, including jaundice (yellowing of the skin or eyes), dark urine, general malaise, and gastrointestinal distress such as anorexia or abdominal pain. These presentations are often accompanied by critically elevated liver enzymes in laboratory testing and represent the essential trigger for seeking immediate help. This critical risk is officially noted to occur predominantly within the first six months of administration.

Severe or overwhelming toxicity has been associated in regulatory documentation with fulminant hepatitis and acute liver failure, outcomes which may escalate to severe coagulation dysfunction, hepatic encephalopathy, and may potentially lead to death or necessitate emergency liver transplantation. Official guidance strictly requires the user to immediately stop taking the drug upon the onset of any symptoms suggestive of liver injury. Urgent medical help must be sought because there is no specific antidote known for Uricam toxicity. Management is strictly symptomatic and supportive, requiring close observation, monitoring, and appropriate measures to address the life-threatening physiological consequences.

Therapeutic Uses of Uricam

What Uricam Treats: Main Uses and Benefits

Uricam (Benzbromarone) is a prescription medication commonly used in the long-term management of high uric acid levels in the blood, a condition known as chronic hyperuricemia. Its primary therapeutic benefit is sustained control over serum urate concentrations, which is considered a key strategy for preventing the painful, debilitating recurrence of acute gout flares. The medication is indicated for use in chronic hyperuricemia and disorders caused by an increased uric acid concentration when diet alone is insufficient.

This therapy is relevant for conditions presenting with symptoms related to recurrent joint inflammation and urate crystal accumulation, including tophaceous gout and refractory gout that has not responded adequately to other treatments. The medication may assist with reducing the size of existing tophi, providing support that helps ease the overall symptom burden. A common patient goal is: “Sustained reduction in uric acid levels supports long-term joint health and assists with managing the occurrence of flares.”

Quick Fact: Therapeutic Benefits
Primary Therapeutic Domain Chronic Hyperuricemia and Gout
Main Use Context Long-term maintenance therapy
Symptom Cluster Focus Recurrent Joint Inflammation
Specific Benefit Reduction of Urate Crystal Load (Tophi)

Regulatory References

  1. French National Agency for the Safety of Medicines and Health Products (ANSM) Public Assessment Report

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

Uricam (Benzbromarone) is defined by official regulatory documents as a second-line urate-lowering therapy for chronic hyperuricemia and gout. This means its use is restricted to adults and adolescents aged 14 years and older only when treatment with first-line agents, such as allopurinol, is not possible due to intolerance or contraindications.


Absolute Contraindications

Regulatory documents explicitly prohibit the use of Uricam in several specific populations and conditions:

  • Impaired Organ Function: Contraindicated in patients with impaired renal function or a preexisting liver disorder.
  • Urological Conditions: Contraindicated in individuals with kidney stone diathesis (a tendency to form kidney stones).
  • Acute Flare: Contraindicated for initiation during an acute gout attack.
  • Life Stage: Use is contraindicated during pregnancy and is generally not recommended while breastfeeding.
  • Hypersensitivity: Contraindicated in patients with a known allergy to the active substance or excipients.

What should I know about interactions with other medicines?

Uricam's official interaction profile is defined by pharmacokinetic changes and potential efficacy impairment when co-administered with specific medicinal products. Regulatory documents state that Benzbromarone is an inhibitor of the CYP2C9 enzyme, a documented pharmacokinetic interaction that increases the plasma exposure of co-administered drugs metabolized by this pathway. This effect is clinically significant with the anticoagulant Warfarin, where altered metabolism can officially elevate the risk of bleeding.

Conversely, the therapeutic uricosuric action of Uricam is officially documented to be decreased when co-administered with Acetylsalicylic acid (Aspirin) or certain Thiazide Diuretics.

A separate, pharmacodynamic interaction involves additive effects when co-administered with other uricosuric agents (e.g., Probenecid), which may increase the documented risk of forming uric acid kidney stones.

The regulatory information includes population-specific constraints: administration is formally contraindicated in patients with severe hepatic disorder due to the documented amplification of hepatotoxicity risk related to the drug's metabolic pathway. Furthermore, the official profile notes that alcohol consumption may counteract the urate-lowering goal of therapy by increasing serum uric acid levels.

Mechanism of Action

Uricam's mechanism, driven by the active ingredient Benzbromarone, acts on the physiological process of urate elimination.

Selective Blockade of Renal Urate Reabsorption

Uricam acts as an inhibitor of the Urate Transporter 1 (URAT1), a protein located on the surface of kidney tubule cells. This molecular target is responsible for reabsorbing approximately 90% of filtered uric acid back into the bloodstream. By blocking URAT1, the drug ensures that uric acid remains in the kidney filtrate instead of being recycled back into circulation. The mechanistic cascade is direct: transporter blockade ightarrow failure of reabsorption ightarrow increased uricosuria (excretion of uric acid in the urine).

Modulating Systemic Urate Homeostasis

The increased elimination caused by the URAT1 blockade alters the body’s overall urate balance. This prolonged action is supported by the formation of an active metabolite (6-hydroxybenzbromarone) which sustains the inhibitory effect on the transporter, extending the duration of urate clearance. This mechanism results in a reduction in the concentration of uric acid in the systemic bloodstream. The effectiveness of this process is intrinsically limited by the underlying function of the kidneys, as adequate filtration is necessary to deliver uric acid to the blocked transporters.

Dosage and Administration Information

Uricam (Benzbromarone) is used exclusively via the oral route as a tablet, intended for long-term maintenance therapy for chronic hyperuricemia. The drug is taken whole and must always be administered with a sufficient amount of water, typically one glass, as maintaining adequate fluid intake and high urinary output is an established procedural condition throughout treatment.

The dosing schedule follows a clear titration structure for adults. Therapy is initiated with a low starting dose of 25 mg or 50 mg, taken once daily. Based on clinical requirements, the dose is adjusted to a maintenance regimen that typically falls within 50 mg to 100 mg per day. The dose may be taken once daily or divided for administration up to three times a day, as part of the established therapeutic approach. The maximal approved daily dose is documented as 200 mg.

The timing of intake specifies that the tablet should be taken with or after food to aid administration. The overall dosage is flexible and subject to adjustment according to the patient's age and condition, but its use is restricted by a specific constraint: the drug is contraindicated in cases of severe renal impairment, specifically when the creatinine clearance is less than 20 mL/min. If a dose is missed, standard practice involves taking it when remembered unless it is near the next scheduled time, and explicitly prohibits doubling the dose.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Uricam

Evidence for Use in Chronic Hyperuricemia and Gout

Research examined Uricam in contexts involving conditions characterized by fluctuating or episodic manifestations, such as chronic hyperuricemia and gout. Studies focused on how serum urate (sUA) levels change over defined time intervals. The research includes short-term randomized controlled trials (RCTs) and long-term observational cohort studies.

The findings describe patterns observed in the studies, primarily reporting measurements of changes in the serum urate biomarker levels. Trials explored outcomes describing episodic or acute changes related to gout flare frequency. Research describes patterns of sUA measurements over longer observation periods in patients followed in observational settings.

What remains uncertain is the long-term characterization of durability regarding functional status and joint health. Comparative evidence is lacking against other urate-lowering drugs in large, dedicated clinical trials. Additionally, research is ongoing to clarify the optimal study criteria for evaluating treatment for newly diagnosed chronic hyperuricemia.

Evidence in Specific, Difficult-to-Treat Patient Groups

Research explored the use of Uricam in patient groups categorized as refractory, meaning patients had an insufficient response to previous standard therapies. These studies focused on short-term symptom changes, examining whether patients achieved sUA target levels. Data show patterns related to patient persistence with therapy.

Research Focus: Long-Term Outcomes and Cardiovascular Risk

Research examined the relationship between Uricam use and outcomes monitoring physiological strain or stress, particularly Major Adverse Cardiovascular Events (MACE). This relies heavily on large-scale, long-term retrospective cohort analyses and systematic reviews.

Certainty remains low for long-term effects on cardiovascular risk because there is a lack of large, randomized trials specifically designed to assess this outcome. Retrospective data are subject to limitations such as confounding factors that may influence the observed patterns.

Special Populations Studied: Focus on Renal Impairment

Studies monitored Uricam in special populations, particularly those with co-existing moderate Chronic Kidney Disease (CKD). This research tracked renal function markers, such as the estimated Glomerular Filtration Rate (eGFR). Long-term effects on the progression of the underlying kidney condition are not fully established, as follow-up durations were limited in controlled settings.

Examining the Full Research Landscape and Gaps

The studies highlight that evidence quality varies across studies, spanning short-term RCTs and large observational data. Comparative evidence is lacking, and data for certain high-risk groups remain insufficient. Research does not determine whether an individual will respond similarly to the group patterns reported in the literature, as study results reflect the specific conditions under which they were conducted.

Key Studies & References French National Agency for the Safety of Medicines and Health Products (ANSM) Public Assessment Report (Narcaricin/Benzbromarone Summary of Product Characteristics)

Frequently Asked Questions (FAQ)

Common questions about Uricam (FAQ)


Q: If I forget to take a dose, what should I do?

Regulatory instructions specify that if a dose is missed, it should be taken when remembered unless it is near the next scheduled time. The official product information explicitly prohibits taking a double dose to make up for the one that was missed.


Q: How is Uricam related to Warfarin?

Uricam is documented to affect the metabolism of certain other medicines. According to official product information, it acts as an inhibitor of the CYP2C9 enzyme. This action may increase the concentration of medicines like Warfarin in the bloodstream, which is officially documented as elevating the risk of bleeding.


Q: What is the required fluid intake when taking Uricam?

Official administration instructions state the drug must always be administered with a sufficient amount of water, typically one glass. Maintaining adequate fluid intake and high urinary output is a required procedural condition to support the drug's intended effect throughout treatment.


Q: Can children or adolescents take Uricam?

Official regulatory documents define specific age restrictions for Uricam. The use of this drug is restricted to adults and adolescents aged 14 years and older. It is not indicated for use in children who are younger than 14 years of age.


Q: Why does my urine look reddish-orange after taking this drug?

Uricam's substance is an azo dye that is known to impart a reddish-orange color to both the urine and feces. This color change is a known effect documented in the official safety information and is not a sign of a serious issue with the drug.


Q: What is the half-life of Uricam or its active metabolite?

The pharmacokinetic profile of Uricam is defined by its active ingredient, Benzbromarone. According to regulatory data, the parent compound has a relatively short elimination half-life of about 3 hours. However, its active metabolite sustains the effect with a significantly longer half-life of approximately 30 hours.


Q: Does Uricam have a known shelf-life or expiration date from the date of manufacture?

Like all prescription medicines, Uricam carries an expiration date. This date is determined by stability testing performed by the manufacturer and correlates with the specified storage conditions described in the product information.


Q: How do I know if the drug is working to lower my uric acid?

Clinical guidelines indicate how the effectiveness of urate-lowering drugs is monitored. Efficacy is generally tracked by routine measurements of the amount of uric acid in a blood sample (known as a serum urate test) to confirm a therapeutic target level is being maintained.

How should Uricam be stored and disposed of?

Uricam must be stored at room temperature, away from excess heat and moisture, which generally means avoiding storage in a bathroom. It is required to keep the medication in its original container and ensure the lid is tightly closed to maintain product stability.

Child-Safety and Disposal

For safety, always store Uricam out of the sight and reach of children, keeping safety caps locked. When disposing of unused or expired medicine, the preferred option is to utilize a community drug take-back program or a prepaid mail-back envelope. If a take-back option is unavailable and Uricam is not on the FDA's flush list, you must mix it with an unpalatable substance (such as dirt or coffee grounds), place the mixture in a sealed container, and then discard it in the household trash. Do not discard the product in a way that allows easy access or consumption.

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

Available in countries:

Equivalent of Uricam found in:

A-Z Index: