FEBUXOSTAT

N/A

Manufactured by Takeda Pharmaceuticals America, Inc.

31,059 FDA adverse event reports analyzed

Last updated: 2026-04-14

About FEBUXOSTAT

FEBUXOSTAT is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. The most commonly reported adverse reactions for FEBUXOSTAT include DIARRHOEA, NAUSEA, ACUTE KIDNEY INJURY, RASH, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FEBUXOSTAT.

Top Adverse Reactions

DIARRHOEA850 reports
NAUSEA841 reports
ACUTE KIDNEY INJURY837 reports
RASH783 reports
OFF LABEL USE715 reports
GOUT686 reports
DRUG INEFFECTIVE676 reports
DYSPNOEA620 reports
FATIGUE598 reports
ANAEMIA568 reports
HEADACHE567 reports
PNEUMONIA532 reports
PYREXIA526 reports
DEATH515 reports
RENAL IMPAIRMENT493 reports
CHRONIC KIDNEY DISEASE467 reports
RENAL FAILURE457 reports
ARTHRALGIA449 reports
DECREASED APPETITE449 reports
PAIN418 reports
CARDIAC FAILURE402 reports
MALAISE394 reports
BLOOD CREATININE INCREASED393 reports
CONDITION AGGRAVATED375 reports
DIZZINESS369 reports
ASPARTATE AMINOTRANSFERASE INCREASED361 reports
FALL354 reports
ALANINE AMINOTRANSFERASE INCREASED349 reports
DRUG HYPERSENSITIVITY344 reports
OEDEMA PERIPHERAL331 reports
ERYTHEMA330 reports
PERIPHERAL SWELLING326 reports
ASTHENIA324 reports
GENERAL PHYSICAL HEALTH DETERIORATION322 reports
VOMITING319 reports
CONSTIPATION318 reports
HYPERTENSION313 reports
PLATELET COUNT DECREASED301 reports
PRURITUS288 reports
HYPOTENSION278 reports
DRUG INTOLERANCE271 reports
INFUSION RELATED REACTION267 reports
PAIN IN EXTREMITY259 reports
C REACTIVE PROTEIN INCREASED257 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES255 reports
DRUG INTERACTION252 reports
TENOSYNOVITIS248 reports
ENTHESOPATHY246 reports
SYNOVITIS240 reports
C REACTIVE PROTEIN ABNORMAL238 reports
COUGH231 reports
PSORIATIC ARTHROPATHY231 reports
TONGUE DISORDER228 reports
ABDOMINAL DISCOMFORT227 reports
INSOMNIA226 reports
PRODUCT USE ISSUE226 reports
DEHYDRATION223 reports
WHITE BLOOD CELL COUNT DECREASED222 reports
RASH PRURITIC221 reports
FEBRILE NEUTROPENIA220 reports
ABDOMINAL PAIN219 reports
TENDONITIS219 reports
WEIGHT DECREASED217 reports
ATRIAL FIBRILLATION213 reports
CARDIAC FAILURE CONGESTIVE213 reports
CONTRAINDICATED PRODUCT ADMINISTERED212 reports
RHEUMATOID ARTHRITIS212 reports
HYPERKALAEMIA210 reports
DRUG ERUPTION209 reports
INFLAMMATION209 reports
HYPERSENSITIVITY208 reports
HAEMOGLOBIN DECREASED206 reports
HYPERCALCAEMIA198 reports
SKIN ULCER197 reports
COVID 19195 reports
URINARY TRACT INFECTION195 reports
BLOOD PRESSURE INCREASED188 reports
TREATMENT FAILURE188 reports
BACK PAIN187 reports
JOINT SWELLING186 reports
SEPSIS184 reports
MYOCARDIAL INFARCTION176 reports
PLEURAL EFFUSION175 reports
ULCER172 reports
BASAL CELL CARCINOMA171 reports
SKIN NECROSIS171 reports
NEUTROPHIL COUNT DECREASED170 reports
END STAGE RENAL DISEASE169 reports
HYPOKALAEMIA169 reports
URTICARIA169 reports
CHEST PAIN168 reports
INFECTION167 reports
PANNICULITIS164 reports
THROMBOCYTOPENIA164 reports
RHEUMATOID NODULE163 reports
BLOOD PARATHYROID HORMONE DECREASED162 reports
WEIGHT INCREASED161 reports
INTERSTITIAL LUNG DISEASE160 reports
NEUTROPENIA160 reports
HEPATIC FUNCTION ABNORMAL157 reports

Report Outcomes

Out of 16,003 classified reports for FEBUXOSTAT:

Serious 75.3%Non-Serious 24.7%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male9,494 (66.8%)
Female4,582 (32.3%)
Unknown126 (0.9%)

Reports by Age

Age 77380 reports
Age 71371 reports
Age 70368 reports
Age 74368 reports
Age 78351 reports
Age 76345 reports
Age 72337 reports
Age 68336 reports
Age 75326 reports
Age 69324 reports
Age 79318 reports
Age 80302 reports
Age 73299 reports
Age 65274 reports
Age 63264 reports
Age 60255 reports
Age 67252 reports
Age 81249 reports
Age 82246 reports
Age 64231 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with FEBUXOSTAT?

This profile reflects 31,059 FDA FAERS reports that mention FEBUXOSTAT. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FEBUXOSTAT?

Frequently reported terms in FAERS include DIARRHOEA, NAUSEA, ACUTE KIDNEY INJURY, RASH, OFF LABEL USE, GOUT. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FEBUXOSTAT?

Labeling and FAERS entries often list Takeda Pharmaceuticals America, Inc. in connection with FEBUXOSTAT. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.