Uriflex

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Uriflex

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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 Uriflex

Quick Facts

Property Description
Active ingredient Citric Acid and Citrate salts
Form Oral solution or Crystals for reconstitution
Pharmacological class Urinary Alkalinizing Agent
Common use Management of urine pH and reduction of stone-forming salts
Origin Derived (Organic acid)

What Type of Medicine is Uriflex?

Uriflex is formally classified as a Urinary Alkalinizing Agent, which is a combination medication designed to modulate the chemical environment of the urinary tract. This class of drug is used for conditions linked to overly acidic urine. Its function is chemical and physiological, setting it apart from antimicrobials, as its mechanism revolves around acid-base balance and mineral management. The efficacy of Citrate salts in raising urinary pH is a recognized principle in nephrology.

Composition and Form of Uriflex

The core components of Uriflex are Citric Acid and specific Citrate salts, frequently paired with Potassium Citrate and/or Sodium Citrate to optimize the systemic buffering capacity. The medication is intended for Oral administration and is typically presented as a liquid, such as an Oral solution, or as Crystals requiring reconstitution. Certain formulations are designed for patients requiring careful dietary monitoring. The Citrate ion is an inhibitor of kidney stone formation.

General Purpose and Action of Citric Acid in Uriflex

The primary general purpose of Uriflex is to stabilize the urine pH, ensuring that the urinary environment is less acidic. This is achieved because the Citrate ion is metabolized, which helps increase urinary pH. The Citrate ion acts as a chelating agent by binding with metal ions like Calcium in the urine, a process that inhibits the crystallization of certain salts. This chemical change assists in the management of specific urinary tract disorders and reduces the concentration of substances like Uric Acid, such as in the management of acid-dependent deposits like uric acid calculi.

What side effects are possible with Uriflex?

Possible Side Effects and Safety Information

Uriflex (febuxostat) carries a Boxed Warning required by the U.S. Food and Drug Administration (FDA) due to an increased risk of heart-related death and death from all causes when compared to allopurinol in a postmarketing safety study. Because of this serious risk, Uriflex is generally reserved for use only in patients who have failed to respond to or cannot tolerate allopurinol.

Serious Adverse Reactions and Warnings

Patients with a history of heart problems or stroke should be informed of the risks. Clinically significant adverse reactions include:

  • Cardiovascular Thromboembolic Events: Increased risk of cardiovascular death, non-fatal myocardial infarction (heart attack), and non-fatal stroke, requiring prompt monitoring for related symptoms.
  • Hepatic Effects: Reports of fatal and non-fatal hepatic failure, necessitating regular liver function monitoring. Treatment must be interrupted if signs of liver injury or severely abnormal liver tests are detected.
  • Severe Skin Reactions: Rare reports of serious skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

Common Adverse Reactions

The most commonly reported side effects, observed at a rate of at least 0.5% greater than placebo in clinical trials, include:

  • Liver function abnormalities
  • Nausea
  • Arthralgia (joint pain)
  • Rash
  • Gout Flares: An increase in gout flares is frequently observed upon initiation of treatment due to the change in serum uric acid levels.

Safety Restrictions

Uriflex is contraindicated (should not be used) in individuals being treated concurrently with azathioprine or mercaptopurine.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose of Uriflex, particularly due to abuse or prolonged use at higher than recommended doses, can lead to severe and potentially fatal clinical outcomes. The overdose profile is defined by organ-specific toxicity and systemic metabolic disturbances, reflecting the effects of both components.

Documented Overdose Risks and Symptoms

System Affected Clinical Manifestations (As per Regulatory Sources)
Renal/Metabolic Severe hypokalaemia (very low potassium), renal tubular acidosis, metabolic acidosis, and acute renal failure.
Hepatic Liver damage.
Central Nervous System Reduced level of consciousness and generalized weakness.
Hematological Prolonged prothrombin time/INR (clotting time).
Respiratory Exacerbation of asthma in susceptible patients.

Immediate Medical Attention Required

Any sign of severe hypokalaemia or renal tubular acidosis constitutes a very serious condition that will require immediate treatment. The most serious harms—particularly those affecting the kidneys and gut—have been reported in association with prolonged, high-dose use linked to dependence. Because overdose can result in life-threatening conditions, including acute organ failure, urgent medical assistance must be sought at the first suspicion of ingestion beyond the prescribed amount or if any severe symptoms, such as reduced consciousness or difficulty breathing, occur.

Therapeutic Uses of Uriflex

What Uriflex Treats: Main Uses and Benefits

Uriflex (a combination of Citrate salts) is commonly used for managing the risk of recurrent stone manifestation in long-term preventative care. This includes conditions characterized by periods of heightened symptoms such as uric acid stones and calcium oxalate stones linked to Hypocitraturia (low urinary citrate). The medication is applied in addressing these conditions and contributes to easing the overall symptom load by supporting the management of recurrent stone episodes.

The medication is relevant for easing symptoms related to physical discomfort such as urinary irritation and burning sensation (dysuria) that stem from acidic urine. It is also relevant in managing chronic metabolic conditions that present with systemic imbalance, such as Renal Tubular Acidosis (RTA). For these patient groups, the medication may assist with maintaining functional stability and may help patients cope more steadily with symptom fluctuations.


Quick Fact: Relief for Chronic Stone-Forming Tendency

Category Therapeutic Scope
Primary Use Supports the management of recurrent uric acid and calcium oxalate stone manifestation.
Symptom Management Easing acid-related urinary irritation and burning discomfort.
Clinical Context Management of hypocitraturia and metabolic acidosis.

Regulatory References

  1. DailyMed overview of Potassium Citrate

Eligibility and Restrictions for Use

Who Can and Cannot Use Uriflex?

Eligibility for Uriflex (Citrate salts) is strictly determined by official regulatory documents, primarily focusing on a patient's renal function and systemic electrolyte balance.

Contraindicated Populations

Uriflex is contraindicated and must not be used in patients presenting with several high-risk conditions, including:

  • Severe renal impairment, specifically conditions like oliguria, azotemia, or anuria.
  • Hyperkalemia (high blood potassium) or conditions predisposing to it, such as untreated Addison's disease or severe myocardial damage.
  • Acute dehydration or heat cramp.
  • Conditions that cause gastrointestinal obstruction or delayed passage (for solid forms).

Age and Life Stage Restrictions

Population Group Official Eligibility Status
Adults Established use for indicated conditions.
Pediatric Use Safety and effectiveness are not established for certain formulations; use in children under two years must be determined by a physician.
Pregnancy/Lactation Use is only recommended if clearly needed (FDA Category C).

Conditional Use and Caution

Use requires caution and close monitoring in patients with impaired renal function (if not severe enough to be a contraindication) and those with cardiac failure or hypertension.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Uriflex (Citrate salts) interactions are primarily based on its potassium content and its official function as a urinary alkalinizing agent. The regulatory prescribing information details several mandatory restrictions and significant interaction outcomes.

Interaction Category Interacting Agents Official Outcome or Restriction
Contraindicated Combinations Potassium-sparing diuretics (e.g., Triamterene, Spironolactone) Prohibited due to documented risk of severe hyperkalemia.
Gastrointestinal Risk Drugs that slow gastrointestinal transit (e.g., Anticholinergics) Restriction against co-administration (for solid forms) to mitigate potential for GI lesions.

Pharmacodynamic and Exposure Interactions

Co-administration with other agents that elevate potassium levels can enhance this effect; this includes ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), and Nonsteroidal Anti-inflammatory Drugs (NSAIDs). For patients with renal impairment, this pharmacodynamic interaction results in a substantially increased risk of severe hyperkalemia.

As a urinary alkalinizing agent, Uriflex alters the excretion of certain other medicinal products. It is officially documented to decrease the renal excretion of basic drugs (e.g., Amphetamines), leading to an increase in their systemic exposure. Conversely, it may increase the renal clearance of acidic drugs (e.g., Salicylates), resulting in lower plasma concentrations. The medication must be administered with or immediately following food, which is a mandatory timing rule to reduce the potential for documented gastrointestinal irritation.

Mechanism of Action

Inhibiting Uric Acid Synthesis via Xanthine Oxidase

Uriflex works at the molecular level by selectively targeting the xanthine oxidase (XO) enzyme within the purine catabolism pathway. By acting as an inhibitor, Uriflex prevents the enzyme from catalyzing the final steps of uric acid production, specifically the conversion of hypoxanthine and xanthine into uric acid. This action directly leads to a significant reduction in the overall formation rate of uric acid in the body.


Modulating Systemic Uric Acid Homeostasis

The core mechanism of enzyme inhibition results in the physiological effect of lowering the serum uric acid concentration. This systematic reduction in circulating uric acid influences uric acid homeostasis by reducing the saturation level in the blood. This physiological adjustment lessens the potential for solid uric acid crystals to form.

Dosage and Administration Information

How Uriflex is Used

The usage of Uriflex, a Urinary Alkalinizing Agent based on citrate salts, is structured around achieving a precise biochemical change in the urine rather than managing acute symptoms. Administration is strictly through the oral route.


Administration and Dosage Rules

Uriflex is typically administered as a long-term maintenance therapy to sustain the intended effects on urinary chemistry. Dosing is standardized in milliequivalents (mEq), and the daily amount is almost always taken in divided doses (two or three times daily) to maintain continuous alkalinity. The initial adult dosage often begins at 30 mEq or 60 mEq per day, depending on the patient's existing urinary citrate levels, with a maximum recognized daily dosage not exceeding 100 mEq.


Contextual Use Requirements

Proper use requires specific timing related to food intake. The medication must be taken with meals or within 30 minutes after consuming food or a snack, which is intended to minimize the potential for gastrointestinal irritation.

Dosage Form Administration Instruction
Extended-Release Tablets Must be swallowed whole and should not be crushed, chewed, or sucked. The inert wax matrix may appear in the stool.
Oral Solution / Crystals Must be adequately diluted in water or juice prior to ingestion.

Dosage Adjustment and Monitoring

The administration is highly procedural and depends on the patient's biochemical response. The dosage is titrated (adjusted) to meet two specific therapeutic targets: raising the urinary pH to a range of 6.0 to 7.0 and achieving a urinary citrate level greater than 320 mg/day. The adequacy of any dose change is verified by monitoring 24-hour urinary pH and citrate measurements, typically over time. The therapy also includes the procedural requirement of maintaining a high daily fluid intake.

Recent Clinical Evidence

Research evidence / Overview of Studies for Uriflex (Citrate Salts)


Evidence for the Prevention of Recurrent Uric Acid Stones

Research exploring citrate salts was studied for managing stone formation, and included both Randomized Controlled Trials (RCTs) and extensive, long-term Observational Studies. These studies focused on populations of adults who had experienced uric acid kidney stones or who had consistently acidic urine. Studies consistently reported measurements indicating that the introduction of citrate salts was associated with a rise in urinary pH, moving it toward a less acidic range. This shift in chemistry was reported to increase the solubility of uric acid, which research describes as a crucial factor for preventing crystallization and supporting stone management. Observational data spanning multiple years described patterns of stone recurrence in populations studied over defined time intervals. Evidence relying on multi-year, large-scale placebo-controlled RCTs specifically for long-term stone recurrence remains limited.


Evidence for Calcium Oxalate Stone Management with Hypocitraturia

Research exploring recurrent calcium oxalate stones in populations with low urinary citrate (Hypocitraturia) includes multiple RCTs that have been synthesized in Systematic Reviews and Meta-Analyses. Clinical trials reported measurements showing a consistent increase in the amount of citrate excreted in the urine, aligning with the research interest in increasing this natural crystallization inhibitor. Systematic reviews described patterns suggesting a reduced rate of new stone formation in populations studied with citrate salts compared to those receiving a placebo or no intervention. However, the quality of evidence varies across different studies, suggesting certainty remains low in some areas.


Evidence Gaps and Areas of Research Uncertainty

The research landscape highlights several areas where further data are sought. Long-term effects for some outcomes are not fully established through continuous, controlled RCTs, with much of the extended data relying on observational findings. Also, evidence for older adults and individuals with specific comorbidities is not always isolated in large-scale dedicated RCTs; therefore, findings often reflect the characteristics of the populations studied in the major trials.

Key Studies & References

  1. DailyMed: Potassium Citrate Extended-Release Tablets (Official FDA Labeling and Monograph)
  2. Effect of potassium citrate therapy on stone recurrence and residuals in calcium oxalate stone formers with hypocitraturia: A randomized controlled trial

Frequently Asked Questions (FAQ)

Common questions about Uriflex (FAQ)


Q: What conditions must a person have to be eligible for Uriflex?

Official product information states that Uriflex is indicated for the long-term maintenance of alkaline urine in patients diagnosed with uric acid and cystine kidney stones. It may also be used as a co-treatment (adjuvant) in gout therapy or to correct certain renal tubular disorders.

Q: Why is Uriflex considered a long-term treatment option?

Uriflex is designed to be a long-term treatment option because its therapeutic goal is continuous maintenance. The medicine works to maintain an alkaline urinary pH and increase citrate levels constantly, which is desirable for the ongoing prevention of chronic kidney stones.

Q: How long can a person usually take Uriflex for?

Uriflex is designed and officially intended for long-term maintenance therapy. Clinical studies have followed the effects of this type of medication for sustained periods, in some cases for up to several years.

Q: Do studies show Uriflex is effective for long-term use?

Research indicates support for the long-term goal of therapy through observational findings, which show sustained changes in important biochemical targets like urinary pH and citrate levels. However, official information notes that evidence from continuous, long-term randomized controlled trials is described as limited.

Q: Do patients typically see a full resolution of symptoms with Uriflex?

The medicine is indicated for the long-term maintenance of an alkaline urinary pH to prevent the recurrence of stones. Its therapeutic goal is continuous maintenance, rather than a full resolution or cure.

Q: Does Uriflex help with [Symptom related to condition] or is it only for the underlying issue?

Uriflex works primarily as a urinary alkalinizing agent, meaning its function is to change the chemical environment of the urine. Its purpose is to prevent the formation of new kidney stones and manage the underlying issue. It is not intended to treat or manage acute symptoms, such as pain.

Q: Are there specific symptoms that mean Uriflex is working correctly?

Verification that the medicine is achieving its goal is determined by monitoring biochemical measurements, not patient-reported symptoms. The key metrics monitored are specific 24-hour urinary pH and citrate levels.

Q: What is the difference between Uriflex and a supplement that claims to treat the same condition?

Uriflex is classified as a prescription-only Human Prescription Drug and a Urinary Alkalinizing Agent. Regulatory labeling confirms it is subject to official standards for manufacturing, efficacy, and safety. Supplements are not held to these same regulatory standards.

Q: Can I take Uriflex if I have a history of kidney problems?

Official information states that Uriflex is contraindicated (must not be used) in patients who have severe renal impairment. Official information advises caution regarding the use of this medicine in individuals with non-severe or impaired renal function because of the documented risk of developing hyperkalemia (high blood potassium).

Q: Why is Uriflex not recommended for people with [Specific common contraindication]?

Uriflex is not recommended for use in patients with severe kidney impairment because it limits the body's ability to excrete potassium. This carries a documented risk of potentially fatal hyperkalemia (dangerously high potassium levels).

Q: Is Uriflex safe for older adults (seniors)?

Official labeling includes guidance on use in the geriatric population. It describes that dosage selection for older adults should be done cautiously, often due to the higher frequency of decreased kidney function in this population.

Q: Do studies indicate a difference in effectiveness based on the severity of the condition?

Official dosage guidance is differentiated based on the severity of the patient's condition before treatment. The specific measure used to guide the dose is the pre-treatment level of urinary citrate (e.g., mild/moderate versus severe hypocitraturia).

Q: What should I do if I miss a dose of Uriflex?

Regulatory information provides directions that if a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped and the regular schedule resumed. The label states that doses should not be doubled.

Q: What happens if I accidentally take two doses of Uriflex?

Taking more than the prescribed amount may lead to symptoms of an overdose. Official documents state that overdose can result in hyperkalemia (high potassium), potentially causing muscle weakness, confusion, or tingling, which requires immediate medical attention.

Q: Can taking Uriflex affect the results of blood tests?

Because Uriflex contains potassium, monitoring specific blood levels is required. Official product information indicates that monitoring of specific blood levels, including the measurement of serum potassium and liver function, is required during therapy.

Q: Are there any common over-the-counter medicines that are known to interact with Uriflex?

The official regulatory information states that certain common over-the-counter medicines may interact with Uriflex. This includes nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin (salicylates). Official information states that these interactions require monitoring by a healthcare provider.

Q: Why is Uriflex sometimes used together with other medicines?

Uriflex is officially documented as a co-treatment (adjuvant) in certain therapies. Due to its alkalinizing effect, it is sometimes administered with uricosuric agents in the treatment for gout.

Q: Does Uriflex have any effect on blood pressure?

Official information indicates that Uriflex formulations that contain sodium salts are used with caution in patients with hypertension (high blood pressure). The potential effect on blood pressure may depend on the specific formulation being used.

Q: Can Uriflex cause fatigue or make me sleepy?

Fatigue or sleepiness are not listed among the common side effects described in official drug information. However, official warnings state that unusual weakness or listlessness may be a sign of a more serious issue, such as hyperkalemia (high potassium).

Q: Is it possible to have an allergic reaction to Uriflex ingredients?

Official warnings describe that an allergic reaction is possible. Signs of this reaction include a rash, itching, hives, or swelling of the face, lips, tongue, or throat. Regulatory warnings indicate that these signs warrant immediate medical attention.

Q: What are the rules regarding driving or operating machinery while on Uriflex?

Official regulatory labeling does not contain specific warnings or advice regarding the operation of machinery or driving while using Uriflex.

Q: What is the risk of dependence or addiction with Uriflex?

The active ingredients in Uriflex are not scheduled by the Drug Enforcement Administration (DEA). Additionally, the medicine has not been associated with a risk of dependence or addiction in the official warnings and precautions.

Q: What are the ingredients in Uriflex besides the active component?

The official prescribing information lists inactive ingredients in addition to the citric acid and citrate salts. These inactive components may include colorants, flavorings, stabilizers, and preservatives.

How should Uriflex be stored and disposed of?

Uriflex (Citric Acid and Citrate Salts) must be stored under specific conditions defined by regulatory labeling to maintain stability.

Storage Requirements

Condition Regulatory Requirement
Temperature Store at Controlled Room Temperature, between 20 C to 25 C (68 F to 77 F).
Protection Protect from freezing, excessive heat, and moisture.
Container Keep in the original container, which must be tightly closed when not in use.

Handling and Disposal

The medication must be stored out of the reach and sight of children. For crystal or powder formulations, any solution prepared that is not used immediately should generally be discarded. Unused or expired Uriflex should be disposed of via drug take-back programs or by mixing the product with an undesirable substance before discarding in the household trash. The medication must not be flushed down a toilet or poured down a drain.

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

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