OZURDEX

Ozurdex Adverse Events Reported to the FDA Over Time

How are Ozurdex adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Ozurdex, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Ozurdex is flagged as the suspect drug causing the adverse event.

Most Common Ozurdex Adverse Events Reported to the FDA

What are the most common Ozurdex adverse events reported to the FDA?

Endophthalmitis	87 (13.47%)
Device Dislocation	74 (11.46%)
Visual Acuity Reduced	44 (6.81%)
Corneal Oedema	40 (6.19%)
Intraocular Pressure Increased	30 (4.64%)
Ocular Hypertension	19 (2.94%)
Complication Of Device Insertion	18 (2.79%)
Retinal Detachment	17 (2.63%)
Visual Impairment	16 (2.48%)
Vitreous Haemorrhage	14 (2.17%)
Eye Pain	13 (2.01%)
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Glaucoma	13 (2.01%)
Blindness	12 (1.86%)
Corneal Disorder	12 (1.86%)
Drug Ineffective	9 (1.39%)
Hypopyon	9 (1.39%)
Blindness Unilateral	7 (1.08%)
Corneal Decompensation	6 (.93%)
Hyphaema	6 (.93%)
Intraocular Pressure Decreased	6 (.93%)
Iritis	6 (.93%)
Ocular Hyperaemia	6 (.93%)
Retinal Tear	6 (.93%)
Hypotony Of Eye	5 (.77%)
Cataract	4 (.62%)
Cataract Cortical	4 (.62%)
Conjunctival Haemorrhage	4 (.62%)
Eye Haemorrhage	4 (.62%)
Iris Disorder	4 (.62%)
Medical Device Complication	4 (.62%)
Optic Nerve Injury	4 (.62%)
Posterior Capsule Rupture	4 (.62%)
Procedural Pain	4 (.62%)
Retinal Disorder	4 (.62%)
Anterior Chamber Disorder	3 (.46%)
Bradycardia	3 (.46%)
Completed Suicide	3 (.46%)
Hypotension	3 (.46%)
Incorrect Drug Administration Durat...	3 (.46%)
Malaise	3 (.46%)
Pulse Pressure Decreased	3 (.46%)
Tachycardia	3 (.46%)
Ulcerative Keratitis	3 (.46%)
Vertigo	3 (.46%)
Vision Blurred	3 (.46%)
Vitreous Disorder	3 (.46%)
Vitreous Loss	3 (.46%)
Vomiting	3 (.46%)
Anterior Chamber Inflammation	2 (.31%)
Cerebral Haemorrhage	2 (.31%)
Cerebrovascular Accident	2 (.31%)
Circulatory Collapse	2 (.31%)
Conjunctival Oedema	2 (.31%)
Cough	2 (.31%)
Eye Infection Toxoplasmal	2 (.31%)
Eye Inflammation	2 (.31%)
Eye Swelling	2 (.31%)
Fistula	2 (.31%)
Hypertension	2 (.31%)
Iridocyclitis	2 (.31%)
Ischaemia	2 (.31%)
Lenticular Opacities	2 (.31%)
Macular Hole	2 (.31%)
Myopia	2 (.31%)
Pneumonia	2 (.31%)
Retinal Artery Occlusion	2 (.31%)
Retinal Ischaemia	2 (.31%)
Retinal Vascular Disorder	2 (.31%)
Retinal Vein Occlusion	2 (.31%)
Rib Fracture	2 (.31%)
Sudden Visual Loss	2 (.31%)
Adverse Event	1 (.15%)
Angina Pectoris	1 (.15%)
Atrophy Of Globe	1 (.15%)
Cardiac Arrest	1 (.15%)
Chest Pain	1 (.15%)
Cholelithiasis	1 (.15%)
Choroidal Effusion	1 (.15%)
Ciliary Zonular Dehiscence	1 (.15%)
Corneal Deposits	1 (.15%)
Death	1 (.15%)
Depression	1 (.15%)
Eye Disorder	1 (.15%)
Eye Infection	1 (.15%)
Eye Injury	1 (.15%)
Eye Irritation	1 (.15%)
Eye Operation Complication	1 (.15%)
Eyelid Ptosis	1 (.15%)
Hypotonia	1 (.15%)
Impaired Work Ability	1 (.15%)
Injection Site Reaction	1 (.15%)
Instillation Site Erythema	1 (.15%)
Joint Swelling	1 (.15%)
Macular Oedema	1 (.15%)
Maculopathy	1 (.15%)
Myocardial Infarction	1 (.15%)
Ocular Discomfort	1 (.15%)
Ocular Fistula	1 (.15%)
Ocular Vascular Disorder	1 (.15%)
Oedema Peripheral	1 (.15%)
Optic Atrophy	1 (.15%)

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This graph shows the top adverse events submitted to the FDA for Ozurdex, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Ozurdex is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Ozurdex

What are the most common Ozurdex adverse events reported to the FDA?

Procedural And Device Related Injur...	102 (15.79%)
Infections - Pathogen Unspecified	100 (15.48%)
Vision	86 (13.31%)
Ocular Infections, Irritations And ...	66 (10.22%)
Eye	47 (7.28%)
Neurological, Special Senses And Ps...	37 (5.73%)
Ocular Structural Change, Deposit A...	33 (5.11%)
Glaucoma And Ocular Hypertension	32 (4.95%)
Anterior Eye Structural Change, Dep...	24 (3.72%)
Retina, Choroid And Vitreous Hemorr...	23 (3.56%)
Ocular Hemorrhages And Vascular	15 (2.32%)
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Therapeutic And Nontherapeutic Effe...	10 (1.55%)
Cardiac Arrhythmias	7 (1.08%)
Decreased And Nonspecific Blood Pre...	5 (.77%)
Injuries	5 (.77%)
Central Nervous System Vascular	4 (.62%)
Respiratory	4 (.62%)
Cardiac And Vascular Investigations	3 (.46%)
Gastrointestinal Signs	3 (.46%)
Inner Ear And Viiith Cranial Nerve	3 (.46%)
Medication Errors	3 (.46%)
Suicidal And Self-injurious Behavio...	3 (.46%)
Administration Site Reactions	2 (.31%)
Arteriosclerosis, Stenosis, Vascula...	2 (.31%)
Bone And Joint Injuries	2 (.31%)
Coronary Artery	2 (.31%)
Musculoskeletal And Connective Tiss...	2 (.31%)
Neurological	2 (.31%)
Protozoal Infectious	2 (.31%)
Vascular Hypertensive	2 (.31%)
Body Temperature Conditions	1 (.15%)
Cornification And Dystrophic Skin	1 (.15%)
Depressed Mood Disorders	1 (.15%)
Fatal Outcomes	1 (.15%)
Gallbladder	1 (.15%)
Joint	1 (.15%)
Lifestyle Issues	1 (.15%)
Neuromuscular	1 (.15%)
Ocular Neuromuscular	1 (.15%)
Renal Disorders	1 (.15%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Ozurdex, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Ozurdex is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.