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Lesinurad Side Effects

For the Consumer

Applies to lesinurad: oral tablet

In addition to its needed effects, some unwanted effects may be caused by lesinurad. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Minor Side Effects

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

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:
  • Heartburn

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.

Not all side effects for lesinurad may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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