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Macugen

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Macugen

Macugen Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Macugen (pegaptanib sodium) Injection decreases the level of a protein that affects the cells of the eye and is used to treat age-related macular degeneration. Common side effects include cough, diarrhea, nausea, vomiting, upset stomach, headache, dizziness, joint pain, or painful or burning urination.

A dose of Macugen 0.3 mg should be administered once every six weeks by intravitreous injection into the eye to be treated. Macugen may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Macugen. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Macugen (pegaptanib sodium) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Macugen in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • eye pain or redness, swelling around your eyes;
  • sudden vision problems;
  • seeing flashes of light or "floaters" in your vision;
  • eyes being more sensitive to light;
  • sudden numbness or weakness, especially on one side of the body; or
  • sudden severe headache, confusion, problems with speech or balance.

Less serious side effects may include:

  • watery eyes;
  • blurred vision;
  • swelling of the eyelids; or
  • mild eye pain or discomfort after the injection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Macugen (Pegaptanib Sodium) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Macugen FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Injection Procedure

Serious adverse events related to the injection procedure occurring in < 1% of intravitreous injections included endophthalmitis [see WARNINGS AND PRECAUTIONS], 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 and DOSAGE AND ADMINISTRATION].

Read the entire FDA prescribing information for Macugen (Pegaptanib Sodium) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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