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Allopurinol / lesinurad Side Effects

For the Consumer

Applies to allopurinol / lesinurad: oral tablet

Along with its needed effects, allopurinol/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 allopurinol / lesinurad:

More common
  • Rash
  • rash with flat lesions or small raised lesions on the skin
Less common
  • Chest pain or discomfort
  • confusion
  • difficulty in speaking
  • double vision
  • headache
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • slow speech
  • sweating
  • vomiting
Rare
  • Anxiety
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloating
  • blood in the urine or stools
  • bloody nose
  • blue or pale skin
  • bruising
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • chills
  • clay-colored stools
  • constipation
  • cough
  • dark urine
  • depression
  • diarrhea
  • difficulty breathing
  • difficulty in moving
  • dizziness
  • dry mouth
  • eye pain
  • fast heartbeat
  • fever
  • general feeling of illness
  • general tiredness and weakness
  • incoherent speech
  • increased urination
  • indigestion
  • joint or muscle pain
  • large, flat, blue or purplish patches on the skin
  • lightheadedness, dizziness, or fainting
  • loss of appetite
  • metallic taste
  • muscle pain, stiffness, tenderness, wasting, or weakness
  • noisy breathing
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on the skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • right upper abdominal pain and fullness
  • slow or irregular heartbeat
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach pain
  • swelling of the feet or lower legs
  • swollen glands
  • thirst
  • tightness in the chest
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal pain
  • vomiting of blood
  • weight loss
  • yellow eyes or skin

Some side effects of allopurinol / 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:

Less common
  • Runny nose
  • shivering
  • trouble sleeping
Rare
  • Belching
  • blurred vision
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in vision
  • decreased appetite
  • heartburn
  • impaired vision
  • increased sweating
  • indigestion
  • loss of taste
  • redness, soreness, or itching of the skin
  • sleepiness or unusual drowsiness
  • sores, welts, or blisters
  • stomach discomfort, upset, or pain
  • swelling of the breasts or breast soreness in both females and males
  • tenderness in the stomach area
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet

For Healthcare Professionals

Applies to allopurinol / lesinurad: oral tablet

General

The most commonly reported side effects included increased blood/serum creatinine, influenza, and headache.[Ref]

Renal

Very common (10% or more): Blood creatinine increased (up to 11.4%), serum creatinine elevation 1.5 to less than 2 times baseline (up to 11%)
Common (1% to 10%): nephrolithiasis, renal failure, serum creatinine elevation greater than or equal to 2 times baseline
Frequency not reported: Acute prerenal/renal failure, acute uric acid nephropathy, chronic renal failure, renal events, renal impairment

Allopurinol:
Postmarketing reports: Azotemia, nephritis, renal failure

Lesinurad:
Frequency not reported: Kidney stones, renal-related adverse reactions, transient serum creatinine increases[Ref]

Renal failure and blood creatinine increased more commonly occurred in patients with reduced kidney function (e.g., CrCl 30 to 60 mL/min).[Ref]

Nervous system

Common (1% to 10%): Headache
Frequency not reported: Drowsiness, non-fatal stroke

Allopurinol:
Postmarketing reports: Ageusia/taste loss, amnesia, dizziness, headache, neuritis, paresthesia, peripheral neuropathy, peroneal nerve palsy, somnolence, vertigo[Ref]

Gastrointestinal

Common (1% to 10%): Gastroesophageal reflux disease

Allopurinol:
Postmarketing reports: Abdominal pain, dyspepsia, gastritis, gastrointestinal hemorrhage, hemorrhagic pancreatitis, salivary gland enlargement, stomatitis, tongue edema, vomiting[Ref]

Immunologic

Common (1% to 10%): Influenza[Ref]

Cardiovascular

There were 1.85 major adverse cardiovascular events (MACE) per 100 patient-years of exposure for the combination drug, while there were 0.61 events for lesinurad and 0.6 events for placebo.[Ref]

Frequency not reported: Cardiovascular death, cardiovascular events/major adverse cardiovascular events (MACE), non-fatal myocardial infarction

Allopurinol:
Postmarketing reports: Bradycardia, necrotizing vasculitis, pericarditis, peripheral vascular disorder, thrombophlebitis, vasculitis, vasodilation

Lesinurad:
Frequency not reported: Cardiovascular death, MACE, non-fatal myocardial infarction[Ref]

Dermatologic

Frequency not reported: Skin rash

Allopurinol:
Postmarketing reports: Alopecia, bullous dermatitis, ecchymosis, eczema, erythema multiforme, exfoliative dermatitis, face edema, furuncle, hyperhidrosis, leukocytoclastic vasculitis, lichen planus, onycholysis, pruritus, skin edema, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria[Ref]

Hematologic

Frequency not reported: Bone marrow depression

Allopurinol:
Postmarketing reports: Agranulocytosis, anemia, aplastic anemia, eosinophilia, hemolytic anemia, leukocytosis, leukopenia, lymphadenopathy, lymphocytosis, pancytopenia, prothrombin level decreased, purpura, reticulocytosis, thrombocytopenia[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity[Ref]

Ocular

Allopurinol:
Postmarketing reports: Amblyopia, cataract, conjunctivitis, iritis, optic neuritis, retinitis[Ref]

Psychiatric

Allopurinol:
Postmarketing reports: Confusional state, depression, insomnia, libido decreased[Ref]

Other

Allopurinol:
Postmarketing reports: Asthenia, malaise, pyrexia, tinnitus[Ref]

Genitourinary

Allopurinol:
Postmarketing reports: Albuminuria, erectile dysfunction, hematuria, infertility male[Ref]

Metabolic

Allopurinol:
Postmarketing reports: Decreased appetite, hypercalcemia, hyperlipidemia[Ref]

Respiratory

Allopurinol:
Postmarketing reports: Asthma, bronchospasm, epistaxis, pharyngitis, rhinitis[Ref]

Musculoskeletal

Allopurinol:
Postmarketing reports: Arthralgia, myalgia[Ref]

Endocrine

Allopurinol:
Postmarketing reports: Gynecomastia[Ref]

Hepatic

Frequency not reported: Hepatotoxicity

Allopurinol:
Postmarketing reports: Cholestatic jaundice, granulomatous hepatitis, hepatic necrosis, hepatitis, hepatomegaly, hyperbilirubinemia[Ref]

References

1. "Product Information. Duzallo (allopurinol-lesinurad)." Ironwood Pharmaceuticals, Inc, Cambridge, MA.

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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