MACUGEN

Macugen Adverse Events Reported to the FDA Over Time

How are Macugen adverse event reports trending over time?

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

Most Common Macugen Adverse Events Reported to the FDA

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

Visual Acuity Reduced	70 (4.84%)
Endophthalmitis	42 (2.91%)
Intraocular Pressure Increased	39 (2.7%)
Retinal Haemorrhage	35 (2.42%)
Eye Pain	34 (2.35%)
Cerebrovascular Accident	20 (1.38%)
Eye Haemorrhage	20 (1.38%)
Injection Site Pain	18 (1.25%)
Blindness Transient	17 (1.18%)
Nausea	17 (1.18%)
Drug Ineffective	16 (1.11%)
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Hypersensitivity	16 (1.11%)
Chest Pain	14 (.97%)
Drug Hypersensitivity	14 (.97%)
Myocardial Infarction	13 (.9%)
Condition Aggravated	12 (.83%)
Macular Degeneration	12 (.83%)
Retinal Detachment	12 (.83%)
Vitreous Haemorrhage	12 (.83%)
Blindness Unilateral	11 (.76%)
Death	11 (.76%)
Detachment Of Retinal Pigment Epith...	11 (.76%)
Eye Irritation	11 (.76%)
Ocular Hyperaemia	11 (.76%)
Vision Blurred	11 (.76%)
Blood Pressure Increased	10 (.69%)
Cerebral Infarction	10 (.69%)
Choroidal Haemorrhage	10 (.69%)
Discomfort	10 (.69%)
Cataract	9 (.62%)
Dyspnoea	9 (.62%)
Eye Swelling	9 (.62%)
Hypertension	9 (.62%)
Macular Oedema	9 (.62%)
Post Procedural Complication	9 (.62%)
Rash	9 (.62%)
Sudden Death	9 (.62%)
Blindness	8 (.55%)
Dysphagia	8 (.55%)
Fall	8 (.55%)
Anaphylactic Shock	7 (.48%)
Choroidal Neovascularisation	7 (.48%)
Disease Progression	7 (.48%)
Lacrimation Increased	7 (.48%)
Pain	7 (.48%)
Retinal Artery Occlusion	7 (.48%)
Retinal Tear	7 (.48%)
Vitritis	7 (.48%)
Blood Pressure Systolic Increased	6 (.42%)
Dehydration	6 (.42%)
Eye Discharge	6 (.42%)
Injection Site Reaction	6 (.42%)
Malaise	6 (.42%)
Ocular Hypertension	6 (.42%)
Palpitations	6 (.42%)
Procedural Complication	6 (.42%)
Tachycardia	6 (.42%)
Abdominal Pain Upper	5 (.35%)
Balance Disorder	5 (.35%)
Bradycardia	5 (.35%)
Cardiac Failure	5 (.35%)
Corneal Oedema	5 (.35%)
Feeling Abnormal	5 (.35%)
Glaucoma	5 (.35%)
Headache	5 (.35%)
Hyphaema	5 (.35%)
Hyponatraemia	5 (.35%)
International Normalised Ratio Incr...	5 (.35%)
Loss Of Consciousness	5 (.35%)
Optic Ischaemic Neuropathy	5 (.35%)
Pneumonia	5 (.35%)
Renal Failure	5 (.35%)
Retinal Disorder	5 (.35%)
Stevens-johnson Syndrome	5 (.35%)
Uveitis	5 (.35%)
Visual Impairment	5 (.35%)
Vitreous Detachment	5 (.35%)
Abscess Limb	4 (.28%)
Acute Respiratory Failure	4 (.28%)
Alveolitis Allergic	4 (.28%)
Apnoea	4 (.28%)
Atrial Fibrillation	4 (.28%)
Blood Pressure Decreased	4 (.28%)
Cellulitis	4 (.28%)
Chills	4 (.28%)
Constipation	4 (.28%)
Diabetic Ketoacidosis	4 (.28%)
Diarrhoea	4 (.28%)
Eye Disorder	4 (.28%)
Eye Operation Complication	4 (.28%)
Hyperaemia	4 (.28%)
Hyperhidrosis	4 (.28%)
Necrotising Fasciitis	4 (.28%)
Nervousness	4 (.28%)
Oedema	4 (.28%)
Pruritus	4 (.28%)
Pyrexia	4 (.28%)
Renal Failure Acute	4 (.28%)
Scar	4 (.28%)
Sinus Disorder	4 (.28%)
Urinary Tract Infection	4 (.28%)

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This graph shows the top adverse events submitted to the FDA for Macugen, 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 Macugen 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 Macugen

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

Vision	136 (9.41%)
Ocular Infections, Irritations And ...	81 (5.61%)
Retina, Choroid And Vitreous Hemorr...	78 (5.4%)
Infections - Pathogen Unspecified	71 (4.91%)
Eye	69 (4.78%)
Ocular Structural Change, Deposit A...	63 (4.36%)
Neurological, Special Senses And Ps...	43 (2.98%)
Central Nervous System Vascular	41 (2.84%)
Allergic Conditions	40 (2.77%)
Epidermal And Dermal Conditions	37 (2.56%)
Respiratory	37 (2.56%)
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Gastrointestinal Signs	36 (2.49%)
Neurological	33 (2.28%)
Ocular Hemorrhages And Vascular	31 (2.15%)
Administration Site Reactions	29 (2.01%)
Injuries	27 (1.87%)
Procedural And Device Related Injur...	27 (1.87%)
Cardiac And Vascular Investigations	24 (1.66%)
Coronary Artery	23 (1.59%)
Cardiac Arrhythmias	21 (1.45%)
Fatal Outcomes	20 (1.38%)
Therapeutic And Nontherapeutic Effe...	20 (1.38%)
Anterior Eye Structural Change, Dep...	17 (1.18%)
Hematology Investigations	17 (1.18%)
Glaucoma And Ocular Hypertension	13 (.9%)
Electrolyte And Fluid Balance Condi...	11 (.76%)
Gastrointestinal Motility And Defec...	11 (.76%)
Medication Errors	11 (.76%)
Bacterial Infectious	9 (.62%)
Renal Disorders	9 (.62%)
Vascular Hypertensive	9 (.62%)
Cardiac Disorder Signs	7 (.48%)
Heart Failures	7 (.48%)
Hepatobiliary	7 (.48%)
Upper Respiratory Tract Disorders	7 (.48%)
Anxiety Disorders	6 (.42%)
Bone And Joint Injuries	6 (.42%)
Headaches	6 (.42%)
Lower Respiratory Tract Disorders	6 (.42%)
Ocular Sensory Symptoms	6 (.42%)
Oral Soft Tissue Conditions	6 (.42%)
Vascular	6 (.42%)
Angiedema And Urticaria	5 (.35%)
Disturbances In Thinking	5 (.35%)
Embolism And Thrombosis	5 (.35%)
Joint	5 (.35%)
Movement Disorders	5 (.35%)
Muscle	5 (.35%)
Schizophrenia And Other Psychotic	5 (.35%)
Tissue	5 (.35%)
Arteriosclerosis, Stenosis, Vascula...	4 (.28%)
Body Temperature Conditions	4 (.28%)
Bronchial Disorders	4 (.28%)
Decreased And Nonspecific Blood Pre...	4 (.28%)
Diabetic Complications	4 (.28%)
Gastrointestinal Inflammatory Condi...	4 (.28%)
Inner Ear And Viiith Cranial Nerve	4 (.28%)
Renal And Urinary Tract Investigati...	4 (.28%)
Skin Appendage Conditions	4 (.28%)
Skin Vascular Abnormalities	4 (.28%)
Vascular Inflammations	4 (.28%)
Abdominal Hernias And Other Abdomin...	3 (.21%)
Gastrointestinal Neoplasms Malignan...	3 (.21%)
Hearing	3 (.21%)
Immunology And Allergy	3 (.21%)
Lifestyle Issues	3 (.21%)
Mood Disorders	3 (.21%)
Peripheral Neuropathies	3 (.21%)
Physical Examination Topics	3 (.21%)
Platelet	3 (.21%)
Pleural	3 (.21%)
Viral Infectious	3 (.21%)
Anemias Nonhemolytic And Marrow Dep...	2 (.14%)
Aneurysms And Artery Dissections	2 (.14%)
Cardiac Therapeutic Procedures	2 (.14%)
Enzyme	2 (.14%)
Fractures	2 (.14%)
Gastrointestinal Conditions	2 (.14%)
Gastrointestinal Hemorrhages	2 (.14%)
Gastrointestinal Ulceration And Per...	2 (.14%)
Glucose Metabolism Disorders	2 (.14%)
Malabsorption Conditions	2 (.14%)
Mental Impairment	2 (.14%)
Musculoskeletal And Connective Tiss...	2 (.14%)
Myocardial	2 (.14%)
Ocular Neuromuscular	2 (.14%)
Respiratory And Mediastinal Neoplas...	2 (.14%)
Therapeutic Procedures And Supporti...	2 (.14%)
Vascular Hemorrhagic	2 (.14%)
Age Related Factors	1 (.07%)
Benign Neoplasms Gastrointestinal	1 (.07%)
Bone And Joint Therapeutic Procedur...	1 (.07%)
Bone Disorders	1 (.07%)
Cardiac Valve	1 (.07%)
Chemical Injury And Poisoning	1 (.07%)
Cranial Nerve Disorders	1 (.07%)
Deliria	1 (.07%)
Depressed Mood Disorders	1 (.07%)
Gastrointestinal Tract Disorders Co...	1 (.07%)
Head And Neck Therapeutic Procedure...	1 (.07%)
Investigations, Imaging And Histopa...	1 (.07%)

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This graph shows the top categories of adverse events submitted to the FDA for Macugen, 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 Macugen 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.