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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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:
Seek medical attention right away if any of these SEVERE side effects occur 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.
TopSevere 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.
Retisert Side Effects - for the Professional
Retisert
- Ocular adverse events included procedural complications, and eye pain (> 50%). Thirty-five to forty percent of patients reported ocular/conjunctival hyperemia, reduced visual acuity, and conjunctival hemorrhage. (6.1)
- The most common non-ocular event reported was headache (≥ 33%). (6.2)
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb at 1-800-323-0000 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION
Revised: 08/2008
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4.1 Viral, Bacterial, Mycobacterial and Fungal Diseases of Ocular Structures 5.2 Endophthalmitis and Surgical Complications 5.3 Increase in Intraocular Pressure 5.4 Separation of Implant Components 5.5 Other Corticosteroid Induced Adverse Reactions 6.1 Clinical Trials Experience - Ocular Events 6.2 Clinical Trials Experience - Non-Ocular Events 13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility 16 HOW SUPPLIED/STORAGE AND HANDLING |
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FULL PRESCRIBING INFORMATION Top
Side Effects by Body System
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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