This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Uloric (Febuxostat) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (71)
Death (6)
Life Threatening Events (8)
Reports by Reaction Type
Gout (11),
Renal Failure Acute (9),
Rash (7),
Condition Aggravated (6),
Diarrhoea (5),
Oedema Peripheral (4),
Nausea (4),
Jaundice (3),
Erythema (3),
Dizziness (3),
Stevens-Johnson Syndrome (3),
Dyspnoea (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Uloric (Febuxostat). For a complete list or a specific selection of reports, please use the links above.
Possible Uloric side effects in female
Reported by a physician on 2012-08-22
Patient: female, weighing 49.9 kg (109.8 pounds)
Reactions: Drug Eruption
Drug(s) suspected as cause:
Uloric
Possible Uloric side effects in 42 year old male
Reported by a physician from United States on 2012-08-21
Patient: 42 year old male
Reactions: Fatigue, Rash, Asthenia, Fluid Retention
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Start date: 2012-01-26
Uloric
Administration route: Oral
Indication: Gout
Start date: 2011-07-25
End date: 2012-01-25
Possible Uloric side effects in female
Reported by a physician from India on 2012-08-15
Patient: female
Reactions: Pancytopenia, Febrile Neutropenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cellcept
Dosage: restarted
Indication: Renal Transplant
Start date: 2012-07-31
Cyclosporine
Administration route: Oral
Indication: Renal Transplant
Start date: 2007-05-26
Prednisolone
Indication: Renal Transplant
Uloric
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Pantoprazole Sodium; Folvite
Possible Uloric side effects in 52 year old male
Reported by a consumer/non-health professional from United States on 2012-08-09
Patient: 52 year old male, weighing 95.3 kg (209.6 pounds)
Reactions: Gout, Anaemia, Oedema Peripheral
Drug(s) suspected as cause:
Uloric
Other drugs received by patient: Iron Supplement (Iron); Atenolol; Gemfibrozil; Sucralfate
Possible Uloric side effects in 72 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-03
Patient: 72 year old male
Reactions: Vasculitis, Purpura, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cordarone
Administration route: Oral
Start date: 2012-02-02
End date: 2012-04-27
Lasix
Administration route: Oral
End date: 2012-07-01
Lasix
Administration route: Oral
Start date: 2012-07-01
Lasix
Administration route: Oral
Start date: 2012-02-02
End date: 2012-04-27
Uloric
Administration route: Oral
Start date: 2012-02-27
End date: 2012-04-27
Other drugs received by patient: Nexium; Lantus; Levothyroxine Sodium; Plavix; Novorapid; Rosuvastatin
Possible Uloric side effects in male
Reported by a physician from United States on 2012-07-30
Patient: male
Reactions: Tubulointerstitial Nephritis, Nephritis Allergic, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Uloric
Other drugs received by patient: Colchicine; Solu-Medrol
Possible Uloric side effects in male
Reported by a physician from United States on 2012-07-26
Patient: male
Reactions: Myalgia, Nausea, Headache, Decreased Appetite
Drug(s) suspected as cause:
Colcrys
Indication: Gout
Simvastatin
Indication: Dyslipidaemia
Uloric
Indication: Gout
Possible Uloric side effects in 71 year old female
Reported by a individual with unspecified qualification from United States on 2012-07-26
Patient: 71 year old female
Reactions: Diverticulum, Diarrhoea, Blood Creatinine Increased
Drug(s) suspected as cause:
Colcrys
Administration route: Oral
Indication: Gout
Start date: 2011-01-01
Uloric
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-04-10
Possible Uloric side effects in male
Reported by a physician from United States on 2012-07-26
Patient: male
Reactions: Rash
Drug(s) suspected as cause:
Colcrys
Indication: Gout
Uloric
Indication: Gout
Possible Uloric side effects in
Reported by a individual with unspecified qualification from United States on 2012-07-26
Patient:
Reactions: Diarrhoea
Drug(s) suspected as cause:
Colchicine
Administration route: Oral
Indication: Gouty Arthritis
Uloric
Indication: Gout
Uloric
Administration route: Oral
Indication: Hyperuricaemia
End date: 2012-01-01
Possible Uloric side effects in 79 year old female
Reported by a physician from France on 2012-07-25
Patient: 79 year old female
Reactions: Vomiting, Diarrhoea, Nausea, Dehydration, Renal Failure Acute, Shock
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Irbesartan
Administration route: Oral
Start date: 2009-01-01
End date: 2012-06-14
Uloric
Administration route: Oral
Indication: Gout
Start date: 2011-10-01
End date: 2012-06-14
Other drugs received by patient: Bisoprolol Fumarate; Simvastatin
Possible Uloric side effects in 70 year old male
Reported by a physician from United States on 2012-07-18
Patient: 70 year old male
Reactions: Jaundice, Acute Myocardial Infarction
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Uloric
Possible Uloric side effects in 64 year old male
Reported by a physician from United States on 2012-07-18
Patient: 64 year old male, weighing 84.4 kg (185.6 pounds)
Reactions: Nausea, Hepatic Failure, Rash Pruritic
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Uloric
Other drugs received by patient: Atenolol; Fosinopril Sodium
Possible Uloric side effects in 79 year old male
Reported by a physician from United States on 2012-07-13
Patient: 79 year old male
Reactions: Blood Alkaline Phosphatase Increased, Jaundice
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Uloric
Other drugs received by patient: Prontonix (Pantoprazole)
Possible Uloric side effects in 62 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-12
Patient: 62 year old male, weighing 145.2 kg (319.3 pounds)
Reactions: Pneumonia, Sepsis, Liver Function Test Abnormal, Pulmonary Embolism, Acute Respiratory Distress Syndrome, Thrombocytopenia
Adverse event resulted in: death
Drug(s) suspected as cause:
Uloric
Possible Uloric side effects in male
Reported by a individual with unspecified qualification from United States on 2012-07-12
Patient: male, weighing 93.1 kg (204.8 pounds)
Reactions: Drug Hypersensitivity, Urticaria, Rash, Oedema Peripheral, Alopecia, Dizziness, Platelet Count Decreased, Splenectomy
Drug(s) suspected as cause:
Allopurinol
Administration route: Oral
End date: 2011-12-01
Allopurinol
Administration route: Oral
Start date: 2011-11-01
Allopurinol
Administration route: Oral
Indication: Gout
Start date: 2011-10-01
End date: 2011-11-01
Allopurinol
Administration route: Oral
Indication: Gout
End date: 2011-12-01
Colchicine
Indication: Gout
Start date: 2001-01-01
End date: 2011-01-01
Colcrys
Administration route: Oral
Indication: Gout
Start date: 2011-10-01
End date: 2012-01-26
Colcrys
Administration route: Oral
Start date: 2012-02-01
End date: 2012-05-20
Uloric
Administration route: Oral
Indication: Gout
Start date: 2012-03-19
End date: 2012-04-03
Possible Uloric side effects in 35 year old female
Reported by a physician from United States on 2012-07-11
Patient: 35 year old female
Reactions: Hepatic Failure, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Uloric
Other drugs received by patient: Unknown Diabetes Medications (Drug Used IN Diabetes)
Possible Uloric side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: female
Reactions: Stomatitis, Nasal Discomfort
Drug(s) suspected as cause:
Uloric
Possible Uloric side effects in 66 year old male
Reported by a pharmacist from United States on 2012-06-26
Patient: 66 year old male, weighing 115.5 kg (254.1 pounds)
Reactions: Product Quality Issue, Urticaria, Rash, Erythema
Drug(s) suspected as cause:
Uloric
Possible Uloric side effects in 68 year old male
Reported by a consumer/non-health professional from United States on 2012-06-25
Patient: 68 year old male, weighing 103.4 kg (227.5 pounds)
Reactions: Dyspnoea
Drug(s) suspected as cause:
Uloric
Possible Uloric side effects in 85 year old female
Reported by a physician from France on 2012-06-22
Patient: 85 year old female
Reactions: Acute Generalised Exanthematous Pustulosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Chloroquine Phosphate
Administration route: Oral
End date: 2011-11-23
Colchicine
Administration route: Oral
Indication: Gout
Start date: 2011-11-13
End date: 2011-11-17
Irbesartan and Hydrochlorothiazide
Administration route: Oral
Indication: Hypertension
End date: 2011-11-23
Tramadol HCL
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-10-01
End date: 2011-11-23
Uloric
Administration route: Oral
Indication: Gout
Start date: 2011-11-13
End date: 2011-11-17
Other drugs received by patient: Ibuprofen; Metformin HCL; Miconazole; Amycor; Timolol Maleate; Lantus; Amlodipine; Acetaminophen
Possible Uloric side effects in male
Reported by a individual with unspecified qualification from United States on 2012-06-21
Patient: male, weighing 77.2 kg (169.8 pounds)
Reactions: Prostatic Specific Antigen Increased, Prostate Cancer, Drug Ineffective, Insomnia
Drug(s) suspected as cause:
Colcrys
Administration route: Oral
Indication: Gout
Start date: 2012-03-01
End date: 2012-04-01
Colcrys
Administration route: Oral
Start date: 2012-04-01
Uloric
Administration route: Oral
Indication: Gout
Start date: 2012-03-01
Other drugs received by patient: Prednisone TAB; Famotidine; Allopurinol
Possible Uloric side effects in 71 year old male
Reported by a consumer/non-health professional from United States on 2012-06-21
Patient: 71 year old male, weighing 77.1 kg (169.6 pounds)
Reactions: Gout, Prostate Cancer, Insomnia, Pain, Condition Aggravated
Drug(s) suspected as cause:
Colcrys
Dosage: 0.6 mg, 1 in 1 d, per oral, 0.6 mg, 2 in 1 d, per oral
Administration route: Oral
Indication: Gout
End date: 2012-05-03
Colcrys
Dosage: 0.6 mg, 1 in 1 d, per oral, 0.6 mg, 2 in 1 d, per oral
Administration route: Oral
Indication: Gout
Start date: 2012-05-04
Uloric
Dosage: 80 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Gout
Start date: 2012-03-01
Other drugs received by patient: Allopurinol; Prednisone TAB; Famotidine
Possible Uloric side effects in 81 year old female
Reported by a physician from United States on 2012-06-20
Patient: 81 year old female, weighing 83.9 kg (184.6 pounds)
Reactions: Jaundice, Urinary Tract Infection, Pyrexia, Faeces Discoloured, Eating Disorder, Malaise, Drug-Induced Liver Injury, Fluid Intake Reduced, Asthenia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Uloric
Other drugs received by patient: Norco 10 / 325 (Paracetamol, Hydrocodone Bitartrate); Bumex; Avapro; Levothyroxine Sodium
Possible Uloric side effects in male
Reported by a individual with unspecified qualification from United States on 2012-06-14
Patient: male, weighing 77.2 kg (169.8 pounds)
Reactions: Prostatic Specific Antigen Increased, Drug Ineffective, Prostate Cancer
Drug(s) suspected as cause:
Colcrys
Administration route: Oral
Start date: 2012-04-01
Colcrys
Administration route: Oral
Indication: Gout
Start date: 2012-03-01
End date: 2012-04-01
Uloric
Administration route: Oral
Indication: Gout
Start date: 2012-03-01
Other drugs received by patient: Allopurinol
Possible Uloric side effects in 70 year old male
Reported by a physician from United States on 2012-06-07
Patient: 70 year old male
Reactions: Stevens-Johnson Syndrome
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Uloric
Other drugs received by patient: Unknown Diabetes Medication (Drug Used IN Diabetes); Unknown Blood Pressure Medication (Antihypertensives); Dexamethasone
Possible Uloric side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: male
Reactions: Heart Rate Decreased, Gout, Therapy Cessation, Diverticulitis, Hernia Repair, Deep Vein Thrombosis, Post Procedural Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metoprolol Tartrate
Uloric
Dosage: 80 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Gout
Start date: 2010-07-01
Other drugs received by patient: Prednisone TAB; Colcrys
Possible Uloric side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: male, weighing 77.1 kg (169.6 pounds)
Reactions: Arthritis
Drug(s) suspected as cause:
Uloric
Possible Uloric side effects in 70 year old male
Reported by a consumer/non-health professional from United States on 2012-05-04
Patient: 70 year old male, weighing 131.1 kg (288.4 pounds)
Reactions: Pruritus, Gout
Drug(s) suspected as cause:
Inositol TAB
Dosage: |dosagetext: 1000 mg||strength: 500 mg||freq: daily||route: oral|
Administration route: Oral
Indication: Cardiac Disorder
Start date: 2009-11-26
End date: 2012-04-20
Uloric
Dosage: |dosagetext: 80 mg||strength: 80 mg||freq: daily||route: oral|
Administration route: Oral
Indication: Blood Uric Acid Increased
Start date: 2012-02-14
End date: 2012-05-03
Possible Uloric side effects in 75 year old male
Reported by a pharmacist from United States on 2012-05-03
Patient: 75 year old male
Reactions: Back Pain, Fall
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Uloric
Other drugs received by patient: Lasix; Hydralazine HCL; Aspirin; Insulin (Insulin); Ismo (Amlodipine); Ismo
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