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Lesinurad Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 18, 2020.

In Summary

Commonly reported side effects of lesinurad include: increased serum creatinine. Other side effects include: acute kidney injury. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to lesinurad: oral tablets

Warning

  • Acute renal failure reported; more common when lesinurad administered as monotherapy.1 Use lesinurad in combination with a xanthine oxidase inhibitor (e.g., allopurinol, febuxostat).1 (See Renal Effects under Cautions.)

Side effects include:

Headache, influenza, increased Scr, GERD.

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]

References

1. "Product Information. Zurampic (lesinurad)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

More about lesinurad

Consumer resources

Other brands
Zurampic

Professional resources

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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.