Drug information for ULORIC

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 40MG Prescription   FEBUXOSTAT febuxostat TAKEDA PHARMS 21856
2011-02-04 Label

2011-02-03 Letter

2009-04-07 Review

2009-04-07 Summary Review

2009-02-20 Label

2009-02-18 Letter
TABLET; ORAL 80MG Prescription  (Reference Drug) FEBUXOSTAT febuxostat TAKEDA PHARMS   "

Drug Adverse Effects information for ULORIC

Role code Indications Reaction # Reports
PS BLOOD URIC ACID INCREASED ERYTHEMA 1
PS BLOOD URIC ACID INCREASED INFLAMMATION 1
PS BLOOD URIC ACID INCREASED SWELLING 1
PS GOUT ANAPHYLACTIC REACTION 2
PS GOUT ANXIETY 1
PS GOUT ARTHRALGIA 1
PS GOUT BODY TEMPERATURE INCREASED 1
PS GOUT CHILLS 1
PS GOUT CONDITION AGGRAVATED 1
PS GOUT DEFORMITY 1
PS GOUT DEPRESSION 1
PS GOUT DYSPNOEA 2
PS GOUT DYSURIA 1
PS GOUT ERYTHEMA 2
PS GOUT GOUT 1
PS GOUT HEART RATE INCREASED 1
PS GOUT INFLAMMATION 1
PS GOUT INSOMNIA 1
PS GOUT JOINT SWELLING 1
PS GOUT MYOCARDIAL INFARCTION 1
PS GOUT OEDEMA PERIPHERAL 2
PS GOUT PANIC ATTACK 1
PS GOUT RASH 1
PS GOUT STEVENS-JOHNSON SYNDROME 2
PS GOUT SWELLING 1
PS GOUT SWOLLEN TONGUE 2
PS GOUT TACHYPHRENIA 1
PS GOUT TENDERNESS 1
PS GOUTY ARTHRITIS DUODENAL ULCER 1
SS BLOOD CHOLESTEROL INCREASED DIARRHOEA 1
SS BLOOD URIC ACID RENAL FAILURE ACUTE 3
SS BLOOD URIC ACID RESPIRATORY FAILURE 3
SS BLOOD URIC ACID TOXIC EPIDERMAL NECROLYSIS 3
SS GOUT DIARRHOEA 3
SS GOUT RENAL FAILURE ACUTE 3
SS GOUT RESPIRATORY FAILURE 3
SS GOUT TOXIC EPIDERMAL NECROLYSIS 3
SS GOUTY TOPHUS HEPATIC ENZYME INCREASED 1
SS HYPERTENSION DIARRHOEA 2
SS IMMUNOSUPPRESSION RENAL FAILURE ACUTE 1
SS ISCHAEMIC HEART DISEASE PROPHYLAXIS DIARRHOEA 1
SS PRODUCT USED FOR UNKNOWN INDICATION GINGIVAL BLEEDING 2
SS PRODUCT USED FOR UNKNOWN INDICATION GINGIVAL PAIN 2
SS PROSTATOMEGALY DIARRHOEA 1
SS TYPE 2 DIABETES MELLITUS DIARRHOEA 2
C ANXIETY VIITH NERVE PARALYSIS 1
C ARTHRITIS VIITH NERVE PARALYSIS 2
C ATRIAL FIBRILLATION ACQUIRED OESOPHAGEAL WEB 1
C ATRIAL FIBRILLATION DRUG WITHDRAWAL SYNDROME 1
C ATRIAL FIBRILLATION DYSPNOEA 1
C ATRIAL FIBRILLATION ESCHERICHIA INFECTION 1
C ATRIAL FIBRILLATION FEELING ABNORMAL 1
C ATRIAL FIBRILLATION GAIT DISTURBANCE 1
C ATRIAL FIBRILLATION GASTROINTESTINAL HAEMORRHAGE 1
C ATRIAL FIBRILLATION GROIN ABSCESS 1
C ATRIAL FIBRILLATION HAEMORRHAGE INTRACRANIAL 1
C ATRIAL FIBRILLATION HIATUS HERNIA 1
C ATRIAL FIBRILLATION INFLAMMATION 1
C ATRIAL FIBRILLATION JOINT SWELLING 1
C ATRIAL FIBRILLATION PAIN 1
C ATRIAL FIBRILLATION PERINEAL PAIN 1
C ATRIAL FIBRILLATION PSORIASIS 1
C ATRIAL FIBRILLATION RENAL IMPAIRMENT 1
C ATRIAL FIBRILLATION RHEUMATOID ARTHRITIS 1
C ATRIAL FIBRILLATION STAPHYLOCOCCAL ABSCESS 1
C ATRIAL FIBRILLATION TREMOR 1
C ATRIAL FIBRILLATION URINARY INCONTINENCE 1
C BACK PAIN AMNESIA 2
C BLOOD CHOLESTEROL AMNESIA 1
C BLOOD CHOLESTEROL INCREASED CARDIAC FAILURE CONGESTIVE 1
C BLOOD CHOLESTEROL INCREASED DRUG CHEMICAL INCOMPATIBILITY 1
C BLOOD CHOLESTEROL INCREASED HALLUCINATION 1
C BLOOD CHOLESTEROL INCREASED HEADACHE 1
C BLOOD CHOLESTEROL INCREASED INSOMNIA 1
C BLOOD CHOLESTEROL INCREASED MUSCULOSKELETAL STIFFNESS 1
C BLOOD CHOLESTEROL INCREASED PARALYSIS 1
C CARDIOVASCULAR EVENT PROPHYLAXIS VIITH NERVE PARALYSIS 1
C CORONARY ARTERIAL STENT INSERTION CARDIAC FAILURE CONGESTIVE 1
C CORONARY ARTERIAL STENT INSERTION HYPOTENSION 1
C CORONARY ARTERIAL STENT INSERTION LOWER GASTROINTESTINAL HAEMORRHAGE 1
C CORONARY ARTERIAL STENT INSERTION RENAL FAILURE 1
C GASTROOESOPHAGEAL REFLUX DISEASE CARDIAC FAILURE CONGESTIVE 1
C GASTROOESOPHAGEAL REFLUX DISEASE DRUG CHEMICAL INCOMPATIBILITY 1
C GASTROOESOPHAGEAL REFLUX DISEASE HALLUCINATION 1
C GASTROOESOPHAGEAL REFLUX DISEASE INSOMNIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE PARALYSIS 1
C GOUT ACUTE RESPIRATORY DISTRESS SYNDROME 1
C GOUT AMNESIA 2
C GOUT BACK PAIN 1
C GOUT CARDIAC FAILURE CONGESTIVE 1
C GOUT CEREBROVASCULAR ACCIDENT 3
C GOUT CHOLELITHIASIS 1
C GOUT COLOSTOMY 1
C GOUT COMA 1
C GOUT DEATH 1
C GOUT DIALYSIS 1
C GOUT DRUG CHEMICAL INCOMPATIBILITY 1
C GOUT DRUG WITHDRAWAL SYNDROME 2
C GOUT ESCHERICHIA INFECTION 2
C GOUT FEELING ABNORMAL 2
C GOUT GAIT DISTURBANCE 2
C GOUT GASTROINTESTINAL HAEMORRHAGE 1
C GOUT GROIN ABSCESS 2
C GOUT HALLUCINATION 1
C GOUT HYPOAESTHESIA 3
C GOUT INFLAMMATION 2
C GOUT INFUSION RELATED REACTION 4
C GOUT INSOMNIA 1
C GOUT INTESTINAL OBSTRUCTION 1
C GOUT JOINT SWELLING 2
C GOUT LYMPHOMA 3
C GOUT METHAEMOGLOBINAEMIA 1
C GOUT MULTI-ORGAN FAILURE 1
C GOUT OFF LABEL USE 1
C GOUT PAIN 2
C GOUT PANCREATITIS NECROTISING 1
C GOUT PARALYSIS 1
C GOUT PERINEAL PAIN 2
C GOUT PSORIASIS 2
C GOUT RENAL FAILURE 1
C GOUT RHEUMATOID ARTHRITIS 2
C GOUT SEPSIS 1
C GOUT STAPHYLOCOCCAL ABSCESS 2
C GOUT THERAPEUTIC RESPONSE DECREASED 2
C GOUT TREMOR 2
C GOUT VIITH NERVE PARALYSIS 5
C GOUT VISION BLURRED 3
C GOUTY TOPHUS CEREBRAL INFARCTION 1
C GOUTY TOPHUS COUGH 1
C GOUTY TOPHUS EMBOLIC STROKE 1
C HIV INFECTION AMNESIA 1
C HYPERCHOLESTEROLAEMIA ACUTE RESPIRATORY DISTRESS SYNDROME 1
C HYPERCHOLESTEROLAEMIA CHOLELITHIASIS 1
C HYPERCHOLESTEROLAEMIA COLOSTOMY 1
C HYPERCHOLESTEROLAEMIA COMA 1
C HYPERCHOLESTEROLAEMIA DEATH 1
C HYPERCHOLESTEROLAEMIA DIALYSIS 1
C HYPERCHOLESTEROLAEMIA GASTROINTESTINAL HAEMORRHAGE 1
C HYPERCHOLESTEROLAEMIA MULTI-ORGAN FAILURE 1
C HYPERCHOLESTEROLAEMIA OFF LABEL USE 1
C HYPERCHOLESTEROLAEMIA PANCREATITIS NECROTISING 1
C HYPERCHOLESTEROLAEMIA RENAL FAILURE 1
C HYPERCHOLESTEROLAEMIA SEPSIS 1
C HYPERTENSION ACUTE RESPIRATORY DISTRESS SYNDROME 1
C HYPERTENSION AMNESIA 1
C HYPERTENSION BACK PAIN 1
C HYPERTENSION CARDIAC FAILURE CONGESTIVE 1
C HYPERTENSION CHOLELITHIASIS 1
C HYPERTENSION COLOSTOMY 1
C HYPERTENSION COMA 1
C HYPERTENSION DEATH 1
C HYPERTENSION DIALYSIS 1
C HYPERTENSION DRUG CHEMICAL INCOMPATIBILITY 1
C HYPERTENSION DRUG WITHDRAWAL SYNDROME 2
C HYPERTENSION ESCHERICHIA INFECTION 2
C HYPERTENSION FEELING ABNORMAL 2
C HYPERTENSION GAIT DISTURBANCE 2
C HYPERTENSION GASTROINTESTINAL HAEMORRHAGE 1
C HYPERTENSION GOUT 1
C HYPERTENSION GROIN ABSCESS 2
C HYPERTENSION HALLUCINATION 1
C HYPERTENSION HYPERURICAEMIA 1
C HYPERTENSION INFLAMMATION 2
C HYPERTENSION INSOMNIA 1
C HYPERTENSION INTESTINAL OBSTRUCTION 1
C HYPERTENSION JOINT SWELLING 2
C HYPERTENSION MULTI-ORGAN FAILURE 1
C HYPERTENSION OFF LABEL USE 1
C HYPERTENSION PAIN 2
C HYPERTENSION PANCREATITIS NECROTISING 1
C HYPERTENSION PARALYSIS 1
C HYPERTENSION PERINEAL PAIN 2
C HYPERTENSION PSORIASIS 2
C HYPERTENSION RENAL FAILURE 1
C HYPERTENSION RHEUMATOID ARTHRITIS 2
C HYPERTENSION SEPSIS 1
C HYPERTENSION STAPHYLOCOCCAL ABSCESS 2
C HYPERTENSION TREMOR 2
C HYPERTENSION VIITH NERVE PARALYSIS 2
C LEUKAEMIA BLISTER 1
C LEUKAEMIA RASH PRURITIC 1
C LEUKAEMIA SKIN EXFOLIATION 1
C MINERAL SUPPLEMENTATION DRUG WITHDRAWAL SYNDROME 1
C MINERAL SUPPLEMENTATION ESCHERICHIA INFECTION 1
C MINERAL SUPPLEMENTATION FEELING ABNORMAL 1
C MINERAL SUPPLEMENTATION GAIT DISTURBANCE 1
C MINERAL SUPPLEMENTATION GROIN ABSCESS 1
C MINERAL SUPPLEMENTATION INFLAMMATION 1
C MINERAL SUPPLEMENTATION JOINT SWELLING 1
C MINERAL SUPPLEMENTATION PAIN 1
C MINERAL SUPPLEMENTATION PERINEAL PAIN 1
C MINERAL SUPPLEMENTATION PSORIASIS 1
C MINERAL SUPPLEMENTATION RHEUMATOID ARTHRITIS 1
C MINERAL SUPPLEMENTATION STAPHYLOCOCCAL ABSCESS 1
C MINERAL SUPPLEMENTATION TREMOR 1
C MULTIPLE MYELOMA MULTIPLE MYELOMA 1
C MUSCLE RELAXANT THERAPY AMNESIA 1
C MUSCLE RELAXANT THERAPY BACK PAIN 1
C MUSCLE RELAXANT THERAPY INTESTINAL OBSTRUCTION 1
C NAUSEA MULTIPLE MYELOMA 1
C OSTEOPOROSIS BRAIN CONTUSION 1
C OSTEOPOROSIS COUGH 1
C OSTEOPOROSIS DIZZINESS 1
C OSTEOPOROSIS HEAD INJURY 1
C OSTEOPOROSIS INCREASED UPPER AIRWAY SECRETION 1
C OSTEOPOROSIS INJECTION SITE HAEMATOMA 1
C OSTEOPOROSIS PNEUMONIA 1
C PAIN MULTIPLE MYELOMA 1
C PAIN IN JAW CARDIAC FAILURE CONGESTIVE 1
C PAIN IN JAW DRUG CHEMICAL INCOMPATIBILITY 1
C PAIN IN JAW HALLUCINATION 1
C PAIN IN JAW INSOMNIA 1
C PAIN IN JAW PARALYSIS 1
C PRODUCT USED FOR UNKNOWN INDICATION BACK PAIN 4
C PRODUCT USED FOR UNKNOWN INDICATION GOUT 1
C PRODUCT USED FOR UNKNOWN INDICATION INTESTINAL OBSTRUCTION 4
C PRODUCT USED FOR UNKNOWN INDICATION VIITH NERVE PARALYSIS 1
C PSORIASIS ALOPECIA 1
C PSORIASIS AMNESIA 1
C PSORIASIS ARTHRALGIA 1
C PSORIASIS BACK PAIN 1
C PSORIASIS BALANCE DISORDER 1
C PSORIASIS CERVICOBRACHIAL SYNDROME 1
C PSORIASIS COUGH 1
C PSORIASIS DIARRHOEA 1
C PSORIASIS DYSPEPSIA 1
C PSORIASIS DYSPNOEA 1
C PSORIASIS FEELING ABNORMAL 1
C PSORIASIS HYPOAESTHESIA 1
C PSORIASIS INJECTION SITE PAIN 1
C PSORIASIS INTERVERTEBRAL DISC DEGENERATION 1
C PSORIASIS JOINT SWELLING 1
C PSORIASIS MUSCLE SPASMS 1
C PSORIASIS MUSCULOSKELETAL PAIN 1
C PSORIASIS MYALGIA 1
C PSORIASIS NAUSEA 1
C PSORIASIS NECK PAIN 1
C PSORIASIS OSTEOARTHRITIS 1
C PSORIASIS PAIN IN EXTREMITY 1
C PSORIASIS PARAESTHESIA 1
C PSORIASIS POLLAKIURIA 1
C PSORIASIS SPINAL OSTEOARTHRITIS 1
C PSORIASIS VISION BLURRED 1
C PSORIASIS WHEEZING 1
C RED BLOOD CELL COUNT DECREASED CEREBROVASCULAR ACCIDENT 3
C RED BLOOD CELL COUNT DECREASED HYPOAESTHESIA 3
C RED BLOOD CELL COUNT DECREASED LYMPHOMA 3
C RED BLOOD CELL COUNT DECREASED VIITH NERVE PARALYSIS 3
C RED BLOOD CELL COUNT DECREASED VISION BLURRED 3
C RENAL FAILURE CARDIAC FAILURE CONGESTIVE 1
C RENAL FAILURE DRUG CHEMICAL INCOMPATIBILITY 1
C RENAL FAILURE HALLUCINATION 1
C RENAL FAILURE INSOMNIA 1
C RENAL FAILURE PARALYSIS 1
C RESPIRATORY TRACT CONGESTION CARDIAC FAILURE CONGESTIVE 1
C RESPIRATORY TRACT CONGESTION DRUG CHEMICAL INCOMPATIBILITY 1
C RESPIRATORY TRACT CONGESTION HALLUCINATION 1
C RESPIRATORY TRACT CONGESTION INSOMNIA 1
C RESPIRATORY TRACT CONGESTION PARALYSIS 1
C RHEUMATOID ARTHRITIS BACK PAIN 1
C RHEUMATOID ARTHRITIS DRUG WITHDRAWAL SYNDROME 1
C RHEUMATOID ARTHRITIS ESCHERICHIA INFECTION 1
C RHEUMATOID ARTHRITIS FEELING ABNORMAL 1
C RHEUMATOID ARTHRITIS GAIT DISTURBANCE 1
C RHEUMATOID ARTHRITIS GROIN ABSCESS 1
C RHEUMATOID ARTHRITIS INFLAMMATION 1
C RHEUMATOID ARTHRITIS INTESTINAL OBSTRUCTION 1
C RHEUMATOID ARTHRITIS JOINT SWELLING 1
C RHEUMATOID ARTHRITIS PAIN 1
C RHEUMATOID ARTHRITIS PERINEAL PAIN 1
C RHEUMATOID ARTHRITIS PSORIASIS 1
C RHEUMATOID ARTHRITIS RHEUMATOID ARTHRITIS 1
C RHEUMATOID ARTHRITIS STAPHYLOCOCCAL ABSCESS 1
C RHEUMATOID ARTHRITIS TREMOR 1
C TRIGEMINAL NEURALGIA CARDIAC FAILURE CONGESTIVE 1
C TRIGEMINAL NEURALGIA DRUG CHEMICAL INCOMPATIBILITY 1
C TRIGEMINAL NEURALGIA HALLUCINATION 1
C TRIGEMINAL NEURALGIA INSOMNIA 1
C TRIGEMINAL NEURALGIA PARALYSIS 1
C TYPE 2 DIABETES MELLITUS ACUTE RESPIRATORY DISTRESS SYNDROME 3
C TYPE 2 DIABETES MELLITUS CHEST PAIN 1
C TYPE 2 DIABETES MELLITUS CHOLECYSTITIS 1
C TYPE 2 DIABETES MELLITUS CHOLELITHIASIS 3
C TYPE 2 DIABETES MELLITUS COLOSTOMY 3
C TYPE 2 DIABETES MELLITUS COMA 3
C TYPE 2 DIABETES MELLITUS DEATH 3
C TYPE 2 DIABETES MELLITUS DIALYSIS 3
C TYPE 2 DIABETES MELLITUS DYSPNOEA 1
C TYPE 2 DIABETES MELLITUS GAIT DISTURBANCE 1
C TYPE 2 DIABETES MELLITUS GASTROINTESTINAL HAEMORRHAGE 3
C TYPE 2 DIABETES MELLITUS MULTI-ORGAN FAILURE 4
C TYPE 2 DIABETES MELLITUS OEDEMA PERIPHERAL 1
C TYPE 2 DIABETES MELLITUS OFF LABEL USE 3
C TYPE 2 DIABETES MELLITUS PANCREATITIS NECROTISING 4
C TYPE 2 DIABETES MELLITUS RENAL FAILURE 3
C TYPE 2 DIABETES MELLITUS SEPSIS 3
C TYPE 2 DIABETES MELLITUS WEIGHT INCREASED 1
C URINARY TRACT INFECTION ABASIA 5
C URINARY TRACT INFECTION ASTHENIA 6
C URINARY TRACT INFECTION COUGH 4
C URINARY TRACT INFECTION DYSPHAGIA 6
C URINARY TRACT INFECTION DYSSTASIA 6
C URINARY TRACT INFECTION HERPES ZOSTER 4
C URINARY TRACT INFECTION MENTAL STATUS CHANGES 4
C URINARY TRACT INFECTION ORAL INFECTION 3
C URINARY TRACT INFECTION PRODUCT QUALITY ISSUE 2
C URINARY TRACT INFECTION RESPIRATORY DISORDER 3
C URINARY TRACT INFECTION SIALOADENITIS 3
C URINARY TRACT INFECTION WHEEZING 4
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