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Lesinurad Side Effects

In Summary

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

For the Consumer

Applies to lesinurad: oral tablet

Along with its needed effects, lesinurad may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lesinurad:

Incidence Not Known

  • Agitation
  • chest pain or discomfort
  • confusion
  • decreased urine output
  • depression
  • difficulty with speaking
  • dizziness
  • double vision
  • headache
  • hostility
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • irritability
  • lethargy
  • muscle twitching
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • rapid weight gain
  • seizures
  • shortness of breath
  • slow speech
  • sweating
  • swelling of the face, ankles, or hands
  • unusual tiredness or weakness
  • vomiting

Some side effects of lesinurad may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Chills
  • cough
  • diarrhea
  • fever
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • runny nose
  • shivering
  • sore throat
  • trouble sleeping

Less Common

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.

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.

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