Drug information for OZURDEX
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
IMPLANT; INTRAVITREAL
0.7MG
Prescription
(Reference Drug)
DEXAMETHASONE
Dexamethasone
ALLERGAN
22315
2012-02-29 Letter
2012-02-28 Label
2010-09-29 Letter
2010-09-29 Label
2010-09-07 Letter
2009-10-29 Review
2009-10-29 Summary Review
2009-06-23 Letter
2009-06-22 Label
Drug Adverse Effects information for OZURDEX
Role code
Indications
Reaction
# Reports
PS
CYSTOID MACULAR OEDEMA
CORNEAL DISORDER
1
PS
CYSTOID MACULAR OEDEMA
CORNEAL OEDEMA
1
PS
CYSTOID MACULAR OEDEMA
DEVICE DISLOCATION
2
PS
CYSTOID MACULAR OEDEMA
IRIS DISORDER
1
PS
EYE INFLAMMATION
CORNEAL OEDEMA
1
PS
EYE INFLAMMATION
DEVICE DISLOCATION
1
PS
EYE INFLAMMATION
INTRAOCULAR PRESSURE INCREASED
1
PS
INTERMEDIATE UVEITIS
CORNEAL DECOMPENSATION
2
PS
INTERMEDIATE UVEITIS
DEVICE DISLOCATION
2
PS
MACULAR OEDEMA
BLINDNESS UNILATERAL
2
PS
MACULAR OEDEMA
CORNEAL DISORDER
1
PS
MACULAR OEDEMA
CORNEAL OEDEMA
4
PS
MACULAR OEDEMA
DEVICE DISLOCATION
4
PS
MACULAR OEDEMA
DRUG INEFFECTIVE
1
PS
MACULAR OEDEMA
ENDOPHTHALMITIS
4
PS
MACULAR OEDEMA
EYE PAIN
2
PS
MACULAR OEDEMA
GLAUCOMA
1
PS
MACULAR OEDEMA
INTRAOCULAR PRESSURE INCREASED
1
PS
MACULAR OEDEMA
OCULAR HYPERAEMIA
2
PS
MACULAR OEDEMA
VISUAL IMPAIRMENT
2
PS
MACULAR OEDEMA
VITREOUS HAEMORRHAGE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
COMPLICATION OF DEVICE INSERTION
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
CORNEAL DISORDER
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
CORNEAL OEDEMA
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
DEVICE DISLOCATION
6
PS
PRODUCT USED FOR UNKNOWN INDICATION
ENDOPHTHALMITIS
3
PS
PRODUCT USED FOR UNKNOWN INDICATION
INTRAOCULAR PRESSURE INCREASED
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
LENTICULAR OPACITIES
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
MACULAR OEDEMA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
OCULAR VASCULAR DISORDER
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
RETINAL VASCULAR DISORDER
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
ULCERATIVE KERATITIS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
VISUAL ACUITY REDUCED
1
PS
RETINAL VEIN OCCLUSION
CATARACT
1
PS
RETINAL VEIN OCCLUSION
ENDOPHTHALMITIS
4
PS
RETINAL VEIN OCCLUSION
INCORRECT DRUG ADMINISTRATION DURATION
1
PS
RETINAL VEIN OCCLUSION
INJECTION SITE REACTION
1
PS
RETINAL VEIN OCCLUSION
INTRAOCULAR PRESSURE DECREASED
1
PS
RETINAL VEIN OCCLUSION
RETINAL DETACHMENT
4
PS
RETINAL VEIN OCCLUSION
VISUAL IMPAIRMENT
1
PS
UVEITIS
DEVICE DISLOCATION
2
PS
UVEITIS
IRIS DISORDER
2
SS
CYSTOID MACULAR OEDEMA
DEVICE DISLOCATION
1
SS
CYSTOID MACULAR OEDEMA
IRIS DISORDER
1
SS
MACULAR OEDEMA
INTRAOCULAR PRESSURE INCREASED
1
SS
MACULAR OEDEMA
VITREOUS HAEMORRHAGE
1
SS
UVEITIS
DEVICE DISLOCATION
2
SS
UVEITIS
IRIS DISORDER
2
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