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Uloric (Febuxostat) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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 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 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 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 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 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 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 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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