Last updated on RxList: 12/21/2020
Retisert Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Retisert?

Retisert (fluocinolone acetonide intravitreal implant) is a corticosteroid used to treat inflammation within the eye that may be caused by a variety of diseases or infections. The Retisert implant slowly releases the drug into the eye over a period of approximately 30 months. Retisert will not treat an eye infection.

What Are Side Effects of Retisert?

Common side effects of Retisert include:

Dosage for Retisert

The Retisert implant contains one tablet of 0.59 mg of fluocinolone acetonide. Retisert is designed to release fluocinolone acetonide at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3-0.4 μg/day over approximately 30 months.

What Drugs, Substances, or Supplements Interact with Retisert?

Retisert may interact with oral, nasal, or inhaled steroids. Tell your doctor all medications and supplements you use.

Retisert During Pregnancy and Breastfeeding

It is unknown if Retisert ophthalmic implant is harmful to a fetus if you receive the implant while you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during the 30 months after you receive the implant. It is unknown if the drug from the ophthalmic implant passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Retisert (fluocinolone acetonide intravitreal implant) 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.


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Retisert Consumer Information

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

Call your doctor at once if you have:

  • blurred vision, tunnel vision, problems with peripheral (side) vision;
  • eye redness, eye pain or swelling, seeing halos around lights;
  • bleeding, oozing, or crusting of your eyes;
  • flashes of light or "floaters" in your vision; or
  • cloudiness in your pupil or iris (colored part of your eyes).

Common side effects may include:

  • mild eye redness or pain;
  • feeling like something is in your eye;
  • headache; or
  • your eyes may be more sensitive to light.

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 Retisert (Fluocinolone Acetonide Intravitreal Implant)


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Retisert Professional Information


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, macular 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.

Read the entire FDA prescribing information for Retisert (Fluocinolone Acetonide Intravitreal Implant)

© Retisert Patient Information is supplied by Cerner Multum, Inc. and Retisert Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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