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Allopurinol / lesinurad Side Effects

For the Consumer

Applies to allopurinol / lesinurad: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Upset stomach or throwing up.
  • Lower back or side pain.
  • Pain when passing urine.
  • Swollen gland.
  • Joint pain.
  • Seizures.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Flu-like signs.
  • Heartburn.
  • Loose stools (diarrhea).
  • Upset stomach.
  • Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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.

Some side effects of allopurinol / lesinurad may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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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