Note: This document contains side effect information about pegaptanib ophthalmic. Some dosage forms listed on this page may not apply to the brand name Macugen.

Applies to pegaptanib ophthalmic: intraocular solution.

Serious side effects of Macugen

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad headache.
• Change in eyesight, eye pain, or very bad eye irritation.
• Trouble passing urine.
• Pain when passing urine.
• Eyelid swelling.
• Eye redness.
• Eye discharge.
• Bleeding in the eye.
• Eye is bothered by bright light.

Other side effects of Macugen

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Eye irritation.
• Seeing floaters.
• Dizziness.
• Diarrhea.
• Headache.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to pegaptanib ophthalmic: intravitreal solution.

Ocular

Very common (10% to 40%): Anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, increased intraocular pressure, ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, vitreous opacities

Common (1% to 10%): Blepharitis, conjunctivitis, photopsia, vitreous disorder, 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

Uncommon (0.1% to 1%): Retinal detachment, iatrogenic traumatic cataract, other adverse events related to the injection procedure^[Ref]

Cardiovascular

Very common (10% to 40%): Hypertension

Common (1% to 10%): Chest pain^[Ref]

Dermatologic

Common (1% to 10%): Contact dermatitis, contusion^[Ref]

Endocrine

Common (1% to 10%): Diabetes mellitus^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, dyspepsia, vomiting^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, urinary retention^[Ref]

Musculoskeletal

Common (1% to 10%): Arthritis, bone spur^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, carotid artery occlusion, cerebrovascular accident, vertigo, transient ischemic attack^[Ref]

Other

Common (1% to 10%): Hearing loss^[Ref]

Respiratory

Common (1% to 10%): Bronchitis, pleural effusion^[Ref]

Hypersensitivity

Postmarketing reports: Angioedema and other anaphylaxis/anaphylactoid^[Ref]