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Restasis

Last reviewed on RxList: 5/1/2019
Restasis Side Effects Center

Last reviewed on RxList 5/1/2019

Restasis (cyclosporine ophthalmic emulsion) is an immunosuppressive agent used to treat chronic dry eye that may be caused by inflammation. Common side effects of Restasis include:

  • eye burning,
  • redness,
  • tearing,
  • discharge,
  • pain,
  • itching,
  • stinging,
  • visual blurring, or
  • feeling as if something is in the eye.

Serious side effects are not expected to occur during treatment with Restasis.

Restasis is an eye drop dosed in single-use vials used twice/day or as directed. Do not use other eye drops or medications during treatment with Restasis unless otherwise directed by your doctor. Do not use Restasis while wearing contact lenses. It is not known whether Restasis will be harmful to a fetus. Talk to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Restasis passes into breast milk. Talk to your doctor if you are breastfeeding or plan to breastfeed.

Our Restasis 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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Restasis Consumer Information

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

Stop using cyclosporine ophthalmic and call your doctor at once if you have:

  • severe eye pain, burning, or stinging after putting in the drops;
  • swollen eyelids; or
  • signs of eye infection--swelling, redness, severe discomfort, crusting or drainage.

Common side effects may include:

  • mild eye pain, redness, or other irritation;
  • watery eyes;
  • blurred vision; or
  • feeling like something is in your eye.

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 Restasis (Cyclosporine)

QUESTION

What causes dry eyes? See Answer
Restasis Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

  • Potential for Eye Injury and Contamination [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, the most common adverse reaction following the use of RESTASIS®was ocular burning (17%).

Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).

Post-marketing Experience

The following adverse reactions have been identified during post approval use of RESTASIS®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the vial tip touching the eye during administration).

Read the entire FDA prescribing information for Restasis (Cyclosporine)

Related Resources for Restasis

Read the Restasis User Reviews »

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

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