Drug information for DUREZOL

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
EMULSION; OPHTHALMIC	0.05%	Prescription	(Reference Drug)	DIFLUPREDNATE	difluprednate	ALCON PHARMS LTD	22212 2009-03-25 Letter 2008-07-25 Review 2008-07-25 Summary Review 2008-06-24 Label 2008-06-24 Letter

Drug Adverse Effects information for DUREZOL

Role code	Indications	Reaction	# Reports
PS	IRITIS	GLARE	1
PS	IRITIS	INTRAOCULAR PRESSURE INCREASED	1
PS	IRITIS	VISION BLURRED	1
PS	OCULAR HYPERAEMIA	CEREBROVASCULAR ACCIDENT	3
PS	OCULAR HYPERAEMIA	CONFUSIONAL STATE	1
SS	CATARACT OPERATION	AMNIOTIC MEMBRANE GRAFT	2
SS	CATARACT OPERATION	CORNEAL DISORDER	2
SS	CATARACT OPERATION	ENDOPHTHALMITIS	6
SS	CATARACT OPERATION	GRAFT COMPLICATION	2
SS	CATARACT OPERATION	TOXIC ANTERIOR SEGMENT SYNDROME	16
SS	CATARACT OPERATION	ULCERATIVE KERATITIS	2
SS	INTRAOCULAR PRESSURE INCREASED	CARDIAC FIBRILLATION	1
SS	INTRAOCULAR PRESSURE INCREASED	PALPITATIONS	1
SS	POSTOPERATIVE CARE	CARDIAC FIBRILLATION	1
SS	POSTOPERATIVE CARE	PALPITATIONS	1
C	ANKYLOSING SPONDYLITIS	ABNORMAL SENSATION IN EYE	4
C	ANKYLOSING SPONDYLITIS	BLINDNESS TRANSIENT	4
C	ANKYLOSING SPONDYLITIS	BLINDNESS UNILATERAL	4
C	ANKYLOSING SPONDYLITIS	EYE INFLAMMATION	4
C	ANKYLOSING SPONDYLITIS	EYE PAIN	4
C	ANKYLOSING SPONDYLITIS	OCULAR HYPERAEMIA	4
C	ANKYLOSING SPONDYLITIS	UVEITIS	4
C	ANXIETY	CONVULSION	1
C	ARTHRITIS	ABNORMAL SENSATION IN EYE	4
C	ARTHRITIS	BLINDNESS TRANSIENT	4
C	ARTHRITIS	BLINDNESS UNILATERAL	4
C	ARTHRITIS	DEATH	1
C	ARTHRITIS	EYE INFLAMMATION	4
C	ARTHRITIS	EYE PAIN	4
C	ARTHRITIS	OCULAR HYPERAEMIA	4
C	ARTHRITIS	UVEITIS	4
C	BACK PAIN	DEATH	1
C	BLOOD CHOLESTEROL INCREASED	CONVULSION	1
C	BLOOD GLUCOSE ABNORMAL	ABNORMAL SENSATION IN EYE	12
C	BLOOD GLUCOSE ABNORMAL	BLINDNESS TRANSIENT	12
C	BLOOD GLUCOSE ABNORMAL	BLINDNESS UNILATERAL	12
C	BLOOD GLUCOSE ABNORMAL	EYE INFLAMMATION	12
C	BLOOD GLUCOSE ABNORMAL	EYE PAIN	12
C	BLOOD GLUCOSE ABNORMAL	OCULAR HYPERAEMIA	12
C	BLOOD GLUCOSE ABNORMAL	UVEITIS	12
C	BLOOD GLUCOSE INCREASED	DEATH	1
C	BLOOD PRESSURE	ABNORMAL SENSATION IN EYE	8
C	BLOOD PRESSURE	BLINDNESS TRANSIENT	8
C	BLOOD PRESSURE	BLINDNESS UNILATERAL	8
C	BLOOD PRESSURE	EYE INFLAMMATION	8
C	BLOOD PRESSURE	EYE PAIN	8
C	BLOOD PRESSURE	OCULAR HYPERAEMIA	8
C	BLOOD PRESSURE	UVEITIS	8
C	CYSTITIS	ABNORMAL SENSATION IN EYE	4
C	CYSTITIS	BLINDNESS TRANSIENT	4
C	CYSTITIS	BLINDNESS UNILATERAL	4
C	CYSTITIS	EYE INFLAMMATION	4
C	CYSTITIS	EYE PAIN	4
C	CYSTITIS	OCULAR HYPERAEMIA	4
C	CYSTITIS	UVEITIS	4
C	CYSTITIS INTERSTITIAL	ABNORMAL SENSATION IN EYE	4
C	CYSTITIS INTERSTITIAL	BLINDNESS TRANSIENT	4
C	CYSTITIS INTERSTITIAL	BLINDNESS UNILATERAL	4
C	CYSTITIS INTERSTITIAL	EYE INFLAMMATION	4
C	CYSTITIS INTERSTITIAL	EYE PAIN	4
C	CYSTITIS INTERSTITIAL	OCULAR HYPERAEMIA	4
C	CYSTITIS INTERSTITIAL	UVEITIS	4
C	CYSTOID MACULAR OEDEMA	DEVICE DISLOCATION	1
C	CYSTOID MACULAR OEDEMA	IRIS DISORDER	1
C	DEPRESSED MOOD	CONVULSION	1
C	DEPRESSION	ABNORMAL SENSATION IN EYE	4
C	DEPRESSION	BLINDNESS TRANSIENT	4
C	DEPRESSION	BLINDNESS UNILATERAL	4
C	DEPRESSION	CONVULSION	1
C	DEPRESSION	EYE INFLAMMATION	4
C	DEPRESSION	EYE PAIN	4
C	DEPRESSION	OCULAR HYPERAEMIA	4
C	DEPRESSION	UVEITIS	4
C	FLUID RETENTION	DEATH	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	DEATH	1
C	HYPERCALCAEMIA	ABSCESS LIMB	3
C	HYPERCALCAEMIA	ACQUIRED DIAPHRAGMATIC EVENTRATION	3
C	HYPERCALCAEMIA	ANAEMIA	3
C	HYPERCALCAEMIA	ANGIOPATHY	1
C	HYPERCALCAEMIA	ANXIETY	3
C	HYPERCALCAEMIA	AORTIC DISORDER	3
C	HYPERCALCAEMIA	ARTERIOSCLEROSIS	1
C	HYPERCALCAEMIA	ATELECTASIS	3
C	HYPERCALCAEMIA	ATRIAL FIBRILLATION	3
C	HYPERCALCAEMIA	ATROPHY	3
C	HYPERCALCAEMIA	BACK PAIN	3
C	HYPERCALCAEMIA	BLINDNESS	3
C	HYPERCALCAEMIA	BLOOD CREATININE INCREASED	3
C	HYPERCALCAEMIA	BUNDLE BRANCH BLOCK RIGHT	3
C	HYPERCALCAEMIA	BURSITIS	3
C	HYPERCALCAEMIA	CARBUNCLE	3
C	HYPERCALCAEMIA	CARDIAC FAILURE	3
C	HYPERCALCAEMIA	CARDIOMEGALY	3
C	HYPERCALCAEMIA	CELLULITIS	3
C	HYPERCALCAEMIA	CEREBROVASCULAR ACCIDENT	3
C	HYPERCALCAEMIA	CHEST PAIN	3
C	HYPERCALCAEMIA	COMPRESSION FRACTURE	3
C	HYPERCALCAEMIA	CONSTIPATION	3
C	HYPERCALCAEMIA	DEEP VEIN THROMBOSIS	3
C	HYPERCALCAEMIA	DEFORMITY	3
C	HYPERCALCAEMIA	DIARRHOEA	3
C	HYPERCALCAEMIA	DIZZINESS	3
C	HYPERCALCAEMIA	DYSPLASTIC NAEVUS	3
C	HYPERCALCAEMIA	DYSPNOEA	3
C	HYPERCALCAEMIA	EAR DISORDER	2
C	HYPERCALCAEMIA	EMOTIONAL DISTRESS	3
C	HYPERCALCAEMIA	ERYTHEMA	3
C	HYPERCALCAEMIA	FATIGUE	3
C	HYPERCALCAEMIA	FINGER AMPUTATION	1
C	HYPERCALCAEMIA	FURUNCLE	3
C	HYPERCALCAEMIA	GANGRENE	3
C	HYPERCALCAEMIA	GOUT	3
C	HYPERCALCAEMIA	HAEMOPTYSIS	3
C	HYPERCALCAEMIA	HAND FRACTURE	3
C	HYPERCALCAEMIA	HYPERCALCAEMIA	3
C	HYPERCALCAEMIA	HYPOAESTHESIA	3
C	HYPERCALCAEMIA	HYPOXIA	3
C	HYPERCALCAEMIA	INFECTION	3
C	HYPERCALCAEMIA	INJURY	3
C	HYPERCALCAEMIA	INTERVERTEBRAL DISC DEGENERATION	3
C	HYPERCALCAEMIA	INTERVERTEBRAL DISC PROTRUSION	3
C	HYPERCALCAEMIA	ISCHAEMIC CARDIOMYOPATHY	3
C	HYPERCALCAEMIA	JOINT SWELLING	3
C	HYPERCALCAEMIA	LACERATION	3
C	HYPERCALCAEMIA	LEUKAEMIA	1
C	HYPERCALCAEMIA	LEUKOCYTOSIS	3
C	HYPERCALCAEMIA	LUMBAR SPINAL STENOSIS	3
C	HYPERCALCAEMIA	LUNG INFILTRATION	3
C	HYPERCALCAEMIA	LYMPHADENOPATHY	3
C	HYPERCALCAEMIA	MALAISE	3
C	HYPERCALCAEMIA	MONOCLONAL IMMUNOGLOBULIN PRESENT	3
C	HYPERCALCAEMIA	MUSCULOSKELETAL PAIN	3
C	HYPERCALCAEMIA	NEOPLASM MALIGNANT	2
C	HYPERCALCAEMIA	NEURALGIA	3
C	HYPERCALCAEMIA	NEUROPATHY PERIPHERAL	3
C	HYPERCALCAEMIA	NEUTROPENIA	3
C	HYPERCALCAEMIA	OEDEMA PERIPHERAL	1
C	HYPERCALCAEMIA	OSTEOARTHRITIS	3
C	HYPERCALCAEMIA	OSTEONECROSIS	3
C	HYPERCALCAEMIA	OSTEONECROSIS OF JAW	3
C	HYPERCALCAEMIA	OSTEOPENIA	3
C	HYPERCALCAEMIA	OSTEOSCLEROSIS	3
C	HYPERCALCAEMIA	PAIN	3
C	HYPERCALCAEMIA	PAIN IN EXTREMITY	1
C	HYPERCALCAEMIA	PANCYTOPENIA	3
C	HYPERCALCAEMIA	PARAESTHESIA	3
C	HYPERCALCAEMIA	PLEURAL EFFUSION	3
C	HYPERCALCAEMIA	PNEUMONIA	3
C	HYPERCALCAEMIA	PULMONARY EMBOLISM	3
C	HYPERCALCAEMIA	PYREXIA	3
C	HYPERCALCAEMIA	RADIAL NERVE PALSY	3
C	HYPERCALCAEMIA	RENAL FAILURE	3
C	HYPERCALCAEMIA	RIB FRACTURE	3
C	HYPERCALCAEMIA	ROTATOR CUFF SYNDROME	3
C	HYPERCALCAEMIA	SCOLIOSIS	3
C	HYPERCALCAEMIA	SEPSIS	3
C	HYPERCALCAEMIA	SPINAL OSTEOARTHRITIS	3
C	HYPERCALCAEMIA	SPONDYLOLISTHESIS	3
C	HYPERCALCAEMIA	TENDERNESS	3
C	HYPERCALCAEMIA	TOE AMPUTATION	1
C	HYPERCALCAEMIA	VASCULAR CALCIFICATION	3
C	HYPERSENSITIVITY	DEATH	1
C	HYPERTENSION	CONVULSION	1
C	INSOMNIA	ABNORMAL SENSATION IN EYE	4
C	INSOMNIA	BLINDNESS TRANSIENT	4
C	INSOMNIA	BLINDNESS UNILATERAL	4
C	INSOMNIA	CONVULSION	1
C	INSOMNIA	DEATH	1
C	INSOMNIA	EYE INFLAMMATION	4
C	INSOMNIA	EYE PAIN	4
C	INSOMNIA	OCULAR HYPERAEMIA	4
C	INSOMNIA	UVEITIS	4
C	MOOD SWINGS	CONVULSION	1
C	NEUROPATHY PERIPHERAL	DEATH	1
C	PRODUCT USED FOR UNKNOWN INDICATION	ABNORMAL SENSATION IN EYE	8
C	PRODUCT USED FOR UNKNOWN INDICATION	BLINDNESS TRANSIENT	8
C	PRODUCT USED FOR UNKNOWN INDICATION	BLINDNESS UNILATERAL	8
C	PRODUCT USED FOR UNKNOWN INDICATION	EYE INFLAMMATION	8
C	PRODUCT USED FOR UNKNOWN INDICATION	EYE PAIN	8
C	PRODUCT USED FOR UNKNOWN INDICATION	OCULAR HYPERAEMIA	8
C	PRODUCT USED FOR UNKNOWN INDICATION	PRURITUS GENERALISED	1
C	PRODUCT USED FOR UNKNOWN INDICATION	URTICARIA	1
C	PRODUCT USED FOR UNKNOWN INDICATION	UVEITIS	8
C	PROPHYLAXIS	CONVULSION	1
C	PROPHYLAXIS	DEATH	1
C	PRURITUS	DEATH	3
C	PULMONARY HYPERTENSION	DEATH	1
C	UVEITIS	CONVULSION	3
C	UVEITIS	DEVICE DISLOCATION	2
C	UVEITIS	IRIS DISORDER	2

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