Macugen Side Effects

Please note - some side effects for Macugen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Macugen - for the Consumer

Macugen

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Macugen:

Diarrhea; dizziness; headache; minor eye irritation; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding; blurred vision or other unusual changes in vision; chest pain; eye discharge; floaters, sparks, or lights in your vision; hearing loss; hoarseness; pain, redness, or swelling of your eye or eyelid; sensitivity to light.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Macugen Side Effects - for the Professional

Macugen

Injection Procedure

Serious adverse events related to the injection procedure occurring in < 1% of intravitreous injections included endophthalmitis [see Warnings and Precautions (5.1)], retinal detachment, and iatrogenic traumatic cataract.

Clinical Studies Experience

The most frequently reported adverse events in patients treated with Macugen 0.3 mg for up to two years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased intraocular pressure (IOP), ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These events occurred in approximately 10-40% of patients.

The following events were reported in 6-10% of patients receiving Macugen 0.3 mg therapy:

Ocular: blepharitis, conjunctivitis, photopsia, vitreous disorder.
Non-Ocular: bronchitis, diarrhea, dizziness, headache, nausea, urinary tract infection.

The following events were reported in 1-5% of patients receiving Macugen 0.3 mg therapy:

Ocular: allergic conjunctivitis, conjunctival edema, corneal abrasion, corneal deposits, corneal epithelium disorder, endophthalmitis, eye inflammation, eye swelling, eyelid irritation, meibomianitis, mydriasis, periorbital hematoma, retinal edema, vitreous hemorrhage.
Non-Ocular: arthritis, bone spur, carotid artery occlusion, cerebrovascular accident, chest pain, contact dermatitis, contusion, diabetes mellitus, dyspepsia, hearing loss, pleural effusion, transient ischemic attack, urinary retention, vertigo, vomiting.

Postmarketing Experience

Anaphylaxis/anaphylactoid reactions, including angioedema, have been identified during postapproval use of Macugen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure [see Warnings and Precautions (5.3) and Dosage and Administration (2.4)].

Side Effects by Body System - for Healthcare Professionals

Ocular

Ocular side effects classified as serious have included endophthalmitis, retinal detachment, and iatrogenic traumatic cataract in <1% of patients. Anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased intraocular pressure, ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities have been reported in 10% to 40% of patients. Blepharitis, conjunctivitis, photopsia, and vitreous disorder have been reported in 6% to 10% of patients. Allergic conjunctivitis, conjunctival edema, corneal abrasion, corneal deposits, corneal epithelium disorder, eye inflammation, eye swelling, eyelid irritation, meibomianitis, mydriasis, periorbital hematoma, retinal edema, and vitreous hemorrhage have been reported in 1% to 5% of patients.

Respiratory

Respiratory side effects have included bronchitis (6% to 10%) and pleural effusion (1% to 5%) of patients.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (6% to 10%), nausea (6% to 10%), vomiting (1% to 5%), and dyspepsia (1% to 5%).

Nervous system

Nervous system side effects have included dizziness (6% to 10%), headache (6% to 10%), and hearing loss (1% to 5%).

Musculoskeletal

Musculoskeletal side effects have included arthritis, bone spur, and contusion in 1% to 5% of patients.

Cardiovascular

Cardiovascular side effects have included carotid artery occlusion, cerebrovascular accident, chest pain, and transient ischemic attack in 1% to 5% of patients.

Dermatologic

Dermatologic side effects have included contact dermatitis in 1% to 5% of patients.

Genitourinary

Genitourinary side effects have included urinary tract infection (6% to 10%) and urinary retention (1% to 5%).

Metabolic

Metabolic side effects have included diabetes mellitus in 1% to 5% of patients.

Hypersensitivity

Hypersensitivity side effects have rarely included anaphylaxis and/or anaphylactoid reactions, including angioedema. However, causality has not been established.

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