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Restasis

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Restasis

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)

CLINICAL PHARMACOLOGY

Mechanism of Action

Cyclosporine is an immunosuppressive agent when administered systemically.

In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.

Pharmacokinetics

Blood cyclosporine A concentrations were measured using a specific high pressure liquid chromatography-mass spectrometry assay. Blood concentrations of cyclosporine, in all the samples collected, after topical administration of RESTASIS® 0.05%, twice daily, in humans for up to 12 months, were below the quantitation limit of 0.1 ng/mL. There was no detectable drug accumulation in blood during 12 months of treatment with RESTASIS® ophthalmic emulsion.

Clinical Studies

Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1,200 patients with moderate to severe keratoconjunctivitis sicca. RESTASIS® demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed due to ocular inflammation. This effect was seen in approximately 15% of RESTASIS® ophthalmic emulsion-treated patients versus approximately 5% of vehicle-treated patients. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

No increase in bacterial or fungal ocular infections was reported following administration of RESTASIS® .

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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