Drug information for KRYSTEXXA
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
INJECTABLE; INJECTION
8MG
Prescription
(Reference Drug)
PEGLOTICASE
polyethylene glycol-uricase
SAVIENT PHARMS
125293
2012-04-18 Letter
2012-04-18 Letter
2012-04-16 Label
2012-04-16 Label
2011-02-17 Summary Review
2010-11-12 Review
2010-10-26 Letter
2010-10-19 Other
2010-10-01 Other
2010-09-30 Medication Guide
2010-09-20 Letter
2010-09-20 Label
Drug Adverse Effects information for KRYSTEXXA
Role code
Indications
Reaction
# Reports
PS
GOUT
ANAPHYLACTIC REACTION
3
PS
GOUT
ANAPHYLACTOID REACTION
1
PS
GOUT
ARTHRALGIA
1
PS
GOUT
ASTHENIA
1
PS
GOUT
BACK PAIN
1
PS
GOUT
BLOOD URIC ACID INCREASED
1
PS
GOUT
CARDIAC ARREST
1
PS
GOUT
CEREBROVASCULAR ACCIDENT
2
PS
GOUT
CHEST PAIN
1
PS
GOUT
CONDITION AGGRAVATED
1
PS
GOUT
DIZZINESS
2
PS
GOUT
FATIGUE
1
PS
GOUT
GOUT
4
PS
GOUT
HAEMODIALYSIS
1
PS
GOUT
HEPATIC FAILURE
1
PS
GOUT
HYPERSENSITIVITY
1
PS
GOUT
ILEUS
1
PS
GOUT
INFUSION RELATED REACTION
12
PS
GOUT
METHAEMOGLOBINAEMIA
2
PS
GOUT
MUSCLE SPASMS
1
PS
GOUT
NASAL DISCOMFORT
1
PS
GOUT
NAUSEA
1
PS
GOUT
RASH
1
PS
GOUT
RENAL FAILURE ACUTE
1
PS
GOUT
THERAPEUTIC RESPONSE DECREASED
5
PS
GOUT
TREATMENT NONCOMPLIANCE
1
PS
GOUT
URTICARIA
1
PS
GOUTY TOPHUS
ACUTE PRERENAL FAILURE
1
PS
GOUTY TOPHUS
ANAPHYLACTIC REACTION
2
PS
GOUTY TOPHUS
ARTHRALGIA
2
PS
GOUTY TOPHUS
BACK PAIN
1
PS
GOUTY TOPHUS
BLOOD PRESSURE DECREASED
1
PS
GOUTY TOPHUS
BLOOD PRESSURE INCREASED
1
PS
GOUTY TOPHUS
BRUXISM
2
PS
GOUTY TOPHUS
BURNING SENSATION
2
PS
GOUTY TOPHUS
CARDIAC ARREST
1
PS
GOUTY TOPHUS
CEREBRAL INFARCTION
1
PS
GOUTY TOPHUS
CHOKING SENSATION
2
PS
GOUTY TOPHUS
CORONARY ARTERY DISEASE
1
PS
GOUTY TOPHUS
COUGH
1
PS
GOUTY TOPHUS
CYANOSIS
2
PS
GOUTY TOPHUS
DRUG DOSE OMISSION
1
PS
GOUTY TOPHUS
DRUG INEFFECTIVE
1
PS
GOUTY TOPHUS
DYSPEPSIA
1
PS
GOUTY TOPHUS
EMBOLIC STROKE
1
PS
GOUTY TOPHUS
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
GOUTY TOPHUS
HEPATIC FUNCTION ABNORMAL
1
PS
GOUTY TOPHUS
HYPERGLYCAEMIA
1
PS
GOUTY TOPHUS
INFUSION RELATED REACTION
1
PS
GOUTY TOPHUS
ISCHAEMIC HEPATITIS
1
PS
GOUTY TOPHUS
LOSS OF CONSCIOUSNESS
2
PS
GOUTY TOPHUS
NAUSEA
2
PS
GOUTY TOPHUS
PRURITUS
2
PS
GOUTY TOPHUS
PULSELESS ELECTRICAL ACTIVITY
1
PS
GOUTY TOPHUS
PYREXIA
2
PS
GOUTY TOPHUS
RASH
1
PS
GOUTY TOPHUS
RESPIRATORY RATE DECREASED
1
PS
GOUTY TOPHUS
THERAPEUTIC RESPONSE DECREASED
3
PS
GOUTY TOPHUS
TONIC CONVULSION
1
PS
GOUTY TOPHUS
URINARY INCONTINENCE
2
PS
GOUTY TOPHUS
VOMITING
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
ANAPHYLACTIC REACTION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
DYSPNOEA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INCORRECT DOSE ADMINISTERED
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
PYREXIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
THERAPEUTIC RESPONSE DECREASED
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
WRONG TECHNIQUE IN DRUG USAGE PROCESS
1
SS
GOUT
BLOOD URIC ACID INCREASED
1
SS
GOUT
DIABETES MELLITUS
1
SS
GOUT
HYPOTHYROIDISM
1
C
GOUT
CEREBROVASCULAR ACCIDENT
1
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