Retisert Side Effects

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

Retisert Implant

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 Retisert Implant:

Abnormal sensation in the eye; back or limb pain; blurred vision; cough; dizziness; drooping eyelids; dry eye; eye irritation, itching, or redness; eye pain; fever; flu-like symptoms; headache; increased tearing; joint pain; nausea; nose and throat irritation; reduced vision; sinus inflammation; swelling of the eye or eyelid; upper respiratory tract infection; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding of the eye; eye discharge; eye infection; eye pain; implant problems; vision changes.

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.

Retisert Side Effects - for the Professional

Retisert

Clinical Trials Experience - Ocular Events

The available safety data includes exposure to Retisert in patients with chronic non-infectious uveitis affecting the posterior segment in two multicenter controlled clinical trials. Patients were randomized to dosage regimens of 0.59 mg or 2.1 mg implants.

The most frequently reported ocular adverse events were cataract, increased intraocular pressure, procedural complication, and eye pain. These events occurred in approximately 50 - 90% of patients. Cataract includes aggravated cataract, and posterior capsular opacification. Procedural complications includes post-op complication, post-op wound complication, post-op wound site erythema, and wound dehiscense.

Based on clinical trials with Retisert, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery. IOP lowering medications to lower intraocular pressure were required in approximately 77% of patients; filtering surgeries were required to control intraocular pressure in 37% of patients.

Ocular adverse events occurring in approximately 10 - 40% of patients in decreasing order of incidence were ocular/conjunctival hyperemia, reduced visual acuity, glaucoma, conjunctival hemorrhage, blurred vision, abnormal sensation in the eye, eye irritation, maculopathy, vitreous floaters, hypotony, pruritus, ptosis, increased tearing, vitreous hemorrhage, dry eye, eyelid edema, macula edema and visual disturbance.

Ocular adverse events occurring in approximately 5 - 9% of patients in decreasing order of incidence were eye discharge, photophobia, blepharitis, corneal edema, iris adhesions, choroidal detachment, diplopia, eye swelling, retinal detachment, photopsia, retinal hemorrhage and hyphema.

Clinical Trials Experience - Non-Ocular Events

The most frequently reported non-ocular adverse event was headache (33%). Other non-ocular adverse events occurring in approximately 5-20% of patients in decreasing order of incidence were nasopharyngitis, arthralgia, sinusitis, dizziness, pyrexia, upper respiratory tract infection, influenza, vomiting, nausea, cough, back pain, limb pain, and rash.

Side Effects by Body System - for Healthcare Professionals

Ocular

Clinical trials have reported nearly all phakic eyes may develop cataracts and require cataract surgery within an average of 2 years following intravitreal implantation of fluocinolone.

Based on clinical trials, the manufacturer reports within 3 years post implantation, approximately 77% of patients will require IOP lowering medications to control intraocular pressure and 37% of patients will require filtering procedures to control intraocular pressure.

Ocular side effects associated with fluocinolone intravitreal implant have frequently included cataract, increased intraocular pressure, procedural complication, and eye pain reported in 50% to 90% of patients. Procedural complications have included cataract fragments in the eye postoperatively, implant expulsion, injury, mechanical complication of implant, migration of implant, postoperative complications, postoperative wound complications, and wound dehiscence. Reduced visual acuity, conjunctival hemorrhage, conjunctival hyperemia, glaucoma, blurred vision, abnormal sensation in the eye, eye irritation, hypotony, pruritus, vitreous floaters, maculopathy, vitreous hemorrhage, ptosis, eye inflammation, eyelid edema, increased tearing, and dry eye have been reported in 10% to 35% of patients. Macular edema, visual disturbance, eye discharge, conjunctival edema/chemosis, photophobia, blepharitis, corneal edema, photopsia, retinal hemorrhage, choroidal detachment, vitreous opacities, and eye swelling have been reported in 5% to 9% of patients.

Ocular side effects associated with ophthalmic administration of corticosteroids have included elevated intraocular pressure, glaucoma, optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing, ocular infection, and perforation of the globe (around area of thinning sclera).

Prolonged use of corticosteroids may result in elevated IOP and/or glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.

Other

Other side effects have included headache in 31% of patients. Influenza, limb pain, back pain, and pain have also been reported.

Respiratory

Respiratory side effects have included nasopharyngitis, sinusitis, cough, and upper respiratory tract infection.

Musculoskeletal

Musculoskeletal side effects have included arthralgia.

Nervous system

Nervous system side effects have included dizziness.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.

Dermatologic

Dermatologic side effects have included rash.

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