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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