Lesinurad
Lesinurad is a medication used to treat high uric acid levels in the blood (hyperuricemia) associated with gout. It works by helping the kidneys remove more uric acid from the body. This medication is typically prescribed together with other gout medications, not alone.
Lesinurad is a urate transporter inhibitor used to lower uric acid levels in patients with gout when combined with other urate-lowering therapies.
Key facts at a glance
- ATC
- M04AB05
- RxNorm
- 1731031
- Generic
- Lesinurad
- Class
- atc-m04
- Brands
- —
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
12 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
N/Aavoid
discontinue breastfeeding or discontinue drug
monitor infant for adverse effects
pediatric_age
age 12 to 17not recommended
safety and efficacy not established in patients under 18 years
N/A
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 to 74no specific adjustment
use with caution due to potential decreased renal function
monitor renal function regularly
Use with caution and monitor for adverse effects.
geriatric
elderly 75 and olderno specific adjustment
use with caution due to potentially decreased renal function
monitor renal function regularly
Use with caution and monitor for adverse effects.
renal_impairment
moderateuse with caution
not recommended in patients with eGFR below 45 mL/min/1.73 m²
monitor renal function regularly
Use with caution and monitor for adverse effects.
renal_impairment
severecontraindicated
not recommended in patients with eGFR below 30 mL/min/1.73 m²
monitor renal function
Use of this medication in this population requires careful consideration of risks and benefits.
hepatic_impairment
mildno adjustment needed
no dose adjustment required for mild hepatic impairment
standard monitoring
hepatic_impairment
moderateno specific adjustment
use with caution in moderate hepatic impairment
monitor liver function
Use with caution and monitor for adverse effects.
hepatic_impairment
severeuse with caution
not studied in severe hepatic impairment - use only if benefits outweigh risks
monitor liver function closely
Statistics and clinical data
FDA approval year
Initial FDA approval date for Lesinurad
Drug class
Urate transporter inhibitor for gout treatment
Primary indication
Therapeutic indication for Lesinurad
Market status
Lesinurad was withdrawn from the US market in 2019 due to safety concerns
Lesinurad is indicated for the treatment of hyperuricemia associated with gout. It is specifically approved for use in combination with a xanthine oxidase inhibitor (such as allopurinol or febuxostat) for patients who have not achieved target serum uric acid levels with the xanthine oxidase inhibitor alone.
Lesinurad is a selective uric acid reabsorption inhibitor (SURI) that works by inhibiting the URAT1 transporter in the proximal tubule of the kidney. By blocking URAT1, it reduces the reabsorption of uric acid back into the bloodstream, thereby increasing uric acid excretion through the urine.
Lesinurad carries a boxed warning for kidney-related risks, including acute kidney injury. It should not be used as monotherapy. Patients should stay well hydrated to reduce the risk of kidney stones. Liver function should be monitored during treatment. Common side effects may include headache, influenza, elevated blood creatinine, and gastrointestinal symptoms.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 24, 2026. · Read our editorial policy