Lesinurad Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 25, 2024.

Applies to lesinurad: oral tablet.

Important warnings This medicine can cause some serious health issues

You should not use this medicine if you have severe kidney problems, or if you are on dialysis or have received a kidney transplant.

Lesinurad can cause kidney failure, especially if you take it without your other prescribed medications. Call your doctor right away if you urinate less than usual or not at all, or if you have swelling in your feet or ankles, or shortness of breath.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• gout flare-up symptoms--joint pain, stiffness, redness, or swelling (especially at night);

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• heart problems--chest pain or pressure, pain spreading to your jaw or shoulder; or

• signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common side effects may include:

• abnormal kidney function tests;

• heartburn;

• headache; or

• flu-like symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to lesinurad: oral tablet.

General adverse events

The more common side effects include increased serum creatinine, headache, influenza, and gastroesophageal reflux disease.^[Ref]

Renal

• Common (1% to 10%): Increased serum creatinine, renal failure
• Uncommon (0.1% to 1%): Nephrolithiasis^[Ref]

When used at labeled doses in combination with a xanthine oxidase inhibitor (XOI), serum creatinine increases of 1.5 to less than 2 times or 2 times or greater from baseline occurred in 3.9% (n=20/511) and 1.8% (n=9/511) of patients, respectively. Increased serum creatinine levels resolved in most patients (up to 90%) without treatment interruption. Based on baseline renal function, serum creatinine increases occurred in 3%, 3.8%, and 6.9% of patients with normal (CrCl greater than 90 mL/min), mild (CrCl 60 to less than 90 mL/min), or moderate (CrCl greater than 30 to less than 60 mL/min) renal impairment.

Use at higher than approved doses with or without an XOI resulted in increased serum creatinine levels. Consistently, patients receiving 400 mg daily as monotherapy experienced a higher incidence of renal failure. Nephrolithiasis occurred more frequently in patients receiving 400 mg daily in combination with an XOI (2.5%) compared to labeled doses in combination with an XOI (0.6%).^[Ref]

Nervous system

• Common (1% to 10%): Headache^[Ref]

Immunologic

• Common (1% to 10%): Influenza^[Ref]

Gastrointestinal

• Common (1% to 10%): Gastroesophageal reflux disease^[Ref]

Cardiovascular

• Frequency not reported: Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke^[Ref]

Incidence rate ratios for major adverse cardiac events compared to placebo were 1.36 (95% CI: 0.23, 9.25) in 200 mg and 2.71 (95% CI: 0.66, 16) in 400 mg.^[Ref]

Further information

Lesinurad side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer