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Zurampic Side Effects

Generic name: lesinurad

Medically reviewed by Drugs.com. Last updated on Dec 4, 2022.

Note: This document contains side effect information about lesinurad. Some dosage forms listed on this page may not apply to the brand name Zurampic.

Applies to lesinurad: oral tablet.

Warning

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:

Common side effects may include:

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

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

Renal

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]

Common (1% to 10%): Increased serum creatinine, renal failure

Uncommon (0.1% to 1%): Nephrolithiasis[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]

Frequently asked questions

References

1. Product Information. Zurampic (lesinurad). Astra-Zeneca Pharmaceuticals. 2015.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.