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Restasis

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Restasis

Restasis Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Restasis (cyclosporine ophthalmic emulsion) is used to treat chronic dry eye that may be caused by inflammation. It is an immunosuppressive agent. Common side effects include eye burning, redness, tearing, discharge, pain, itching, stinging, or visual blurring.

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 breast-feeding or plan to breast-feed.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Restasis in Detail - Patient Information: Side Effects

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

Eye burning, redness, tearing, discharge, pain, itching, stinging, or visual blurring may occur.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Restasis Overview - Patient Information: Side Effects

SIDE EFFECTS: Burning, stinging, redness, pain, or itching of the eye may occur. Blurred vision, feeling as if something is in the eye, or eye discharge may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, severe itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Restasis (Cyclosporine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Restasis FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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) »

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Restasis - User Reviews

Restasis User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Restasis sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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