Allopurinol / lesinurad Side Effects
Medically reviewed by Drugs.com. Last updated on Nov 30, 2020.
For the Consumer
Applies to allopurinol/lesinurad: oral tablet
- Kidney problems like kidney failure have happened with this drug. Tell your doctor if you have ever had kidney problems.
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, swallowing, 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.
- 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:
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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to allopurinol / lesinurad: oral tablet
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
Postmarketing reports: Azotemia, nephritis, renal failure
Renal failure and blood creatinine increased more commonly occurred in patients with reduced kidney function (e.g., CrCl 30 to 60 mL/min).[Ref]
Common (1% to 10%): Headache
Frequency not reported: Drowsiness, non-fatal stroke
Common (1% to 10%): Gastroesophageal reflux disease
Common (1% to 10%): Influenza[Ref]
Frequency not reported: Cardiovascular death, cardiovascular events/major adverse cardiovascular events (MACE), non-fatal myocardial infarction
Frequency not reported: Cardiovascular death, MACE, non-fatal myocardial infarction[Ref]
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: Skin rash
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]
Frequency not reported: Bone marrow depression
Postmarketing reports: Agranulocytosis, anemia, aplastic anemia, eosinophilia, hemolytic anemia, leukocytosis, leukopenia, lymphadenopathy, lymphocytosis, pancytopenia, prothrombin level decreased, purpura, reticulocytosis, thrombocytopenia[Ref]
Frequency not reported: Hypersensitivity[Ref]
Postmarketing reports: Arthralgia, myalgia[Ref]
Postmarketing reports: Gynecomastia[Ref]
Frequency not reported: Hepatotoxicity
1. "Product Information. Duzallo (allopurinol-lesinurad)." Ironwood Pharmaceuticals, Inc, Cambridge, MA.
More about allopurinol / lesinurad
- Other brands
Related treatment guides
Some side effects may not be reported. You may report them to the FDA.