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Febuxostat Side Effects

The most commonly reported side effects of febuxostat include acute kidney injury, diarrhoea, and nausea, based on 16,281 FDA adverse event reports from 2009 to 2025. 4.1% of reports found the drug to be ineffective.

Febuxostat side effects

Percentages show how often each reaction appears relative to total reports for febuxostat.

1
Acute Kidney Injury5.2%842
2
Diarrhoea5.1%831
3
Nausea5.0%821
4
Rash4.7%771
5
Off Label Use4.4%717
6
Drug Ineffective4.1%675
7
Gout4.0%651
8
Dyspnoea3.7%609
9
Fatigue3.6%579
10
Headache3.5%567
11
Anaemia3.5%565
12
Pneumonia3.2%525
13
Pyrexia3.2%519
14
Death3.1%505
15
Renal Impairment3.0%489

These are voluntary reports and do not establish that febuxostat caused these reactions.

Report severity

75.5%Serious12,298 reports
42.9%Hospitalizations6,984 reports
13.1%Fatal2,138 reports

Seriousness is determined by the reporter, not by OpenClaim.

Febuxostat drug interactions

Other drugs that appear in adverse event reports alongside febuxostat. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Rituximab3.5%575
2
Adalimumab2.8%461
3
Venetoclax2.7%433
4
Omeprazole2.4%397
5
Furosemide2.4%396
6
Lenalidomide2.4%386
7
Valsartan2.2%355
8
Pantoprazole-sodium2.1%349
9
Etanercept2.1%348
10
Cyclosporine2.0%327
11
Esomeprazole2.0%319
12
Apremilast1.9%307
13
Ruxolitinib1.9%304
14
Rivaroxaban1.9%303
15
Ibuprofen1.8%296

Taken alongside

1
Furosemide19.4%3,166
2
Amlodipine15.0%2,443
3
Aspirin14.9%2,423
4
Atorvastatin-calcium11.7%1,910
5
Acetaminophen11.3%1,839
6
Levothyroxine-sodium10.8%1,758
7
Prednisone9.0%1,468
8
Colchicine8.9%1,442
9
Metoprolol8.4%1,374
10
Ergocalciferol8.2%1,333
11
Insulin8.1%1,321
12
Omeprazole8.0%1,305
13
Bisoprolol-fumarate7.8%1,272
14
Pantoprazole-sodium7.3%1,183
15
Carvedilol7.0%1,136

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports febuxostat side effects

28.7% of febuxostat adverse event reports involve female patients and 59.4% involve male patients. The largest age group is elderly at 63%. These figures reflect who reports side effects, not underlying risk.

Sex

Female28.7%
Male59.4%
Unknown11.9%

Age group

< 2<0.1%
2–110.2%
12–17<0.1%
18–6436.9%
65+62.7%

What is febuxostat used for

Conditions and purposes for which patients were taking febuxostat when the adverse event was reported.

Accidental Exposure To Product By ChildAcid Base BalanceAcute Kidney InjuryAdenine Phosphoribosyl Transferase DeficiencyAllergy ProphylaxisAnkylosing SpondylitisAntacid TherapyArthralgiaArthritisAutoimmune DisorderAbdominal PainAcute Kidney InjuryAdenine Phosphoribosyl Transferase DeficiencyAdverse EventAlcoholic Liver Disease

Showing 15 of 221 indications

Febuxostat brand names and reporting trend

Febuxostat is sold under the brand name Uloric.

Brand names

Uloric10,670

Quarterly reports (20092025)

200920122016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking febuxostat with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.