Lesinurad Side Effects

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

Applies to lesinurad: oral tablet.

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]

See also:

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