FEBUXOSTAT TABLETS 80 MG

N/A

Manufactured by Macleods Pharmaceuticals Limited

21,060 FDA adverse event reports analyzed

Last updated: 2026-04-14

About FEBUXOSTAT TABLETS 80 MG

FEBUXOSTAT TABLETS 80 MG is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Macleods Pharmaceuticals Limited. The most commonly reported adverse reactions for FEBUXOSTAT TABLETS 80 MG include ACUTE KIDNEY INJURY, OFF LABEL USE, DIARRHOEA, ANAEMIA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FEBUXOSTAT TABLETS 80 MG.

Top Adverse Reactions

ACUTE KIDNEY INJURY594 reports
OFF LABEL USE524 reports
DIARRHOEA509 reports
ANAEMIA482 reports
NAUSEA476 reports
RENAL IMPAIRMENT422 reports
PYREXIA406 reports
DYSPNOEA387 reports
RASH385 reports
CARDIAC FAILURE370 reports
DRUG INEFFECTIVE367 reports
PNEUMONIA357 reports
HEADACHE345 reports
DECREASED APPETITE343 reports
FATIGUE302 reports
ASPARTATE AMINOTRANSFERASE INCREASED285 reports
GENERAL PHYSICAL HEALTH DETERIORATION285 reports
BLOOD CREATININE INCREASED273 reports
ALANINE AMINOTRANSFERASE INCREASED270 reports
DEATH270 reports
ERYTHEMA263 reports
PAIN257 reports
PLATELET COUNT DECREASED255 reports
MALAISE249 reports
C REACTIVE PROTEIN INCREASED225 reports
DRUG HYPERSENSITIVITY222 reports
DRUG INTERACTION222 reports
INFUSION RELATED REACTION220 reports
ARTHRALGIA219 reports
DRUG INTOLERANCE217 reports
CONDITION AGGRAVATED216 reports
FALL214 reports
FEBRILE NEUTROPENIA212 reports
HYPERTENSION208 reports
HYPOTENSION205 reports
CONSTIPATION200 reports
OEDEMA PERIPHERAL200 reports
PERIPHERAL SWELLING197 reports
HYPERKALAEMIA196 reports
VOMITING196 reports
PSORIATIC ARTHROPATHY194 reports
CONTRAINDICATED PRODUCT ADMINISTERED191 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES191 reports
TENDONITIS189 reports
TENOSYNOVITIS187 reports
ENTHESOPATHY186 reports
TONGUE DISORDER186 reports
RENAL FAILURE185 reports
DRUG ERUPTION183 reports
C REACTIVE PROTEIN ABNORMAL182 reports
SYNOVITIS181 reports
WHITE BLOOD CELL COUNT DECREASED176 reports
DIZZINESS172 reports
HYPERCALCAEMIA172 reports
PRODUCT USE ISSUE172 reports
INFLAMMATION167 reports
RASH PRURITIC167 reports
NEUTROPHIL COUNT DECREASED166 reports
SKIN ULCER166 reports
INSOMNIA164 reports
RHEUMATOID ARTHRITIS163 reports
INTERSTITIAL LUNG DISEASE158 reports
DEHYDRATION155 reports
ASTHENIA153 reports
HEPATIC FUNCTION ABNORMAL153 reports
ATRIAL FIBRILLATION152 reports
TREATMENT FAILURE152 reports
COVID 19150 reports
NEUTROPENIA150 reports
ABDOMINAL PAIN147 reports
PRURITUS147 reports
SKIN NECROSIS147 reports
ULCER147 reports
BASAL CELL CARCINOMA145 reports
CHRONIC KIDNEY DISEASE144 reports
PANNICULITIS143 reports
RHEUMATOID NODULE142 reports
BLOOD PARATHYROID HORMONE DECREASED141 reports
URINARY TRACT INFECTION139 reports
SEPSIS138 reports
HAEMOGLOBIN DECREASED137 reports
HYPERSENSITIVITY137 reports
PLEURAL EFFUSION137 reports
HYPOKALAEMIA136 reports
COUGH134 reports
ALANINE AMINOTRANSFERASE ABNORMAL133 reports
THROMBOCYTOPENIA132 reports
TUMOUR LYSIS SYNDROME125 reports
ABDOMINAL DISCOMFORT124 reports
GRANULOMA SKIN124 reports
BACK PAIN120 reports
THERAPY NON RESPONDER119 reports
MUSCULOSKELETAL STIFFNESS118 reports
GOUT115 reports
RED BLOOD CELL SEDIMENTATION RATE115 reports
RED BLOOD CELL SEDIMENTATION RATE INCREASED115 reports
INFECTION113 reports
PANCYTOPENIA113 reports
URTICARIA113 reports
OVERDOSE112 reports

Report Outcomes

Out of 9,499 classified reports for FEBUXOSTAT TABLETS 80 MG:

Serious 94.1%Non-Serious 5.9%

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

Male5,877 (69.0%)
Female2,625 (30.8%)
Unknown21 (0.2%)

Reports by Age

Age 77290 reports
Age 74279 reports
Age 76274 reports
Age 78274 reports
Age 71257 reports
Age 75250 reports
Age 70234 reports
Age 69231 reports
Age 79230 reports
Age 68227 reports
Age 73220 reports
Age 72217 reports
Age 80215 reports
Age 82191 reports
Age 81189 reports
Age 65181 reports
Age 63175 reports
Age 84172 reports
Age 67171 reports
Age 83169 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 TABLETS 80 MG?

This profile reflects 21,060 FDA FAERS reports that mention FEBUXOSTAT TABLETS 80 MG. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FEBUXOSTAT TABLETS 80 MG?

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

Who manufactures FEBUXOSTAT TABLETS 80 MG?

Labeling and FAERS entries often list Macleods Pharmaceuticals Limited in connection with FEBUXOSTAT TABLETS 80 MG. 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.