Ranibizumab Side Effects

Please note - some side effects for Ranibizumab 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 Ranibizumab - for the Consumer

Ranibizumab

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 Ranibizumab:

Cough; dry eye; eye discomfort; feeling of something in the eye; headache; increased tear production; nausea; nose or throat irritation; seeing floaters or spots.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest, jaw, or arm pain; confusion; decreased vision or other vision changes; eye or eyelid swelling; eye pain, pressure, redness, bleeding, or discharge; fainting; fever, chills, or persistent sore throat; one-sided weakness; sensitivity to light; shortness of breath; slurred speech; sudden, severe nausea or vomiting; unusual sweating or weakness.

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.

Side Effects by Body System - for Healthcare Professionals

Applies to: intraocular solution

Cardiovascular

Cardiovascular side effects including peripheral edema (up to 6%) and atrial fibrillation (up to 5%).

Although a low rate of arterial thromboembolic events were observed in clinical trials, there is a potential risk of ATE's (nonfatal stroke, nonfatal myocardial infarction, or vascular death) following intravitreal use of VEGF inhibitors.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 10%), constipation (up to 8%), and gastroesophageal reflux disease (up to 6%) have been reported.

General

General side effects including wound healing complications (up to 1%) have been reported.

Hematologic

Hematologic side effects including anemia (up to 11%) have been reported.

Immunologic

The pretreatment incidence of immunoreactivity to ranibizumab was 0% to 5% across treatment groups. After monthly dosing with ranibizumab for 6 to 24 months, antibodies to ranibizumab were detected in approximately 1% to 8% of patients. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to ranibizumab in immunoassays and are highly dependent on the sensitivity and specificity of the assay. The clinical significance of immunoreactivity to ranibizumab is unclear at this time, although some patients with the highest levels of immunoreactivity were noted to have iritis or vitritis.

Immunologic side effects including seasonal allergies (up to 8%) and immunogenicity have been reported.

Metabolic

Metabolic side effects include hypercholesterolemia (up to 7%).

Musculoskeletal

Musculoskeletal side effects including arthralgia (up to 11%) have been reported.

Nervous system

Nervous system side effects including headache (up to 12%) and peripheral neuropathy (up to 5%) have been reported.

Ocular

Conjunctival hemorrhage (up to 74%), eye pain (up to 35%), vitreous floaters (up to 27%), increased intraocular pressure (up to 24%), vitreous detachment (up to 21%), intraocular inflammation (up to 18%), cataract (up to 28%), foreign body sensation in the eye (up to 16%), eye irritation (up to 15%), increased lacrimation (up to 14%), blepharitis (up to 12%), dry eye (up to 12%), visual disturbance or blurred vision (up to 18%), eye pruritus (up to 12%), ocular hyperemia (up to 11%), retinal disorder (up to 10%), maculopathy (up to 11%), retinal degeneration (up to 8%), ocular discomfort (up to 7%), conjunctival hyperemia (up to 7%), posterior capsule opacification (up to 7%), and injection site hemorrhage (up to 5%) have also been reported.

Ocular side effects including endophthalmitis, rhegmatogenous retinal detachments, and iatrogenic traumatic cataracts are serious adverse events related to the injection procedure that have occurred in less than 0.1% of intravitreal injections.

Tear of the retinal pigment epithelium among neovascular AMD patients has been identified postmarketing.

Renal

Renal side effects including renal failure (up to 7%) and chronic renal failure (up to 6%) have been reported.

Respiratory

Respiratory side effects including nasopharyngitis (up to 16%), bronchitis (up to 11%), cough (up to 9%), upper respiratory tract infection (up to 9%), sinusitis (up to 8%), influenza (up to 7%), and chronic obstructive pulmonary disease (up to 6%) have been reported.

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