Skip to main content
Print Save

Restasis Side Effects

Generic name: cyclosporine ophthalmic

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 30, 2023.

Note: This document contains side effect information about cyclosporine ophthalmic. Some dosage forms listed on this page may not apply to the brand name Restasis.

Applies to cyclosporine ophthalmic: ophthalmic emulsion, ophthalmic solution.

Serious side effects of Restasis

Along with its needed effects, cyclosporine ophthalmic (the active ingredient contained in Restasis) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cyclosporine ophthalmic:

Less common

  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chills
  • cough
  • difficult, burning, or painful urination
  • ear congestion
  • fever
  • headache
  • loss of voice
  • lower back or side pain
  • runny or stuffy nose
  • sneezing
  • sore throat
  • trouble breathing
  • unusual tiredness or weakness

Other side effects of Restasis

Some side effects of cyclosporine ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Burning, pain, itching, or other discomfort of the eye
  • pain upon instillation of drops
  • redness of the white part of your eyes or inside of your eyelids

Less common

  • Blurred vision
  • clear or yellow fluid from the eye
  • difficulty with reading
  • eye irritation
  • feeling of having something in the eye
  • halos around lights
  • headache
  • itching skin
  • redness, swelling, or itching of the eyelid
  • sticky or matted eyelashes
  • stinging
  • watery eye

For Healthcare Professionals

Applies to cyclosporine ophthalmic: ophthalmic emulsion, ophthalmic solution.

General

The most commonly reported side effects were ocular burning, eye pain, eye irritation, lacrimation, ocular hyperemia, and eyelid erythema.[Ref]

Ocular

Very common (10% or more): Ocular burning

Common (1% to 10%): Eyelid erythema, increased lacrimation, ocular hyperemia, blurred vision, eyelid edema, conjunctival hyperemia, eye irritation, eye pain

Uncommon (0.1% to 1%): Ocular bacterial keratitis, ocular herpes zoster, conjunctival edema, lacrimal disorder, eye discharge, eye pruritus, conjunctival irritation, conjunctivitis, foreign body sensation in eyes, deposit eye, keratitis, blepharitis, corneal decompensation, chalazion, corneal infiltrates, corneal scar, eyelid pruritus, iridocyclitis, epiphora, stinging[Ref]

Hypersensitivity

Postmarketing side effects include: hypersensitivity (eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema and dyspnea).[Ref]

Local

Very common (10% or more): Instillation site pain

Common (1% to 10%): Instillation site irritation, instillation site erythema

Uncommon (0.1% to 1%): Instillation site reaction, instillation site discomfort[Ref]

Frequently asked questions

References

1. Product Information. Restasis (cycloSPORINE ophthalmic). Allergan Inc. 2022.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer