Side Effects of Restasis (cyclosporine ophthalmic emulsion)

Restasis (cyclosporine ophthalmic emulsion) is an immunosuppressive drug that helps patients increase their eyes' natural ability to produce tears and is used to treat a type of chronic dry eye condition caused by inflammation. 

Cyclosporine, the medicine in Restasis, is also available in oral and injectable forms that are used to treat various conditions including treatment or prevention of rejection of transplanted organs, psoriasis, and rheumatoid arthritis. 

Following oral administration or injection, cyclosporine is absorbed in the bloodstream and works systemically to suppress the body's immune system. However, cyclosporine eye drop emulsion is thought to work differently. 

Restasis is believed to work locally in the eye as a partial modulator of the immune system. Tear production is thought to be decreased when lymphocytes, a type of white blood cell of the immune system, die and accumulate in the tear glands. 

Restasis reverses this condition, increasing tear production. Restasis does not produce its effect immediately. An increase in tear production may not be noticed until 3 to 6 months after starting treatment.

Common side effects of Restasis include

• temporary burning sensation in the eye,
• eye redness,
• discharge,
• watery eyes,
• eye pain,
• foreign body sensation,
• itching,
• stinging, and
• blurred vision.

Serious side effects of Restasis include

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

Drug interactions of Restasis include other eye drops. 

Due to the lack of conclusive safety data, Restasis should be used in pregnancy only if clearly needed. It is unknown if Restasis is excreted into breast milk following administration into the eye. 

Although blood levels were undetectable following ophthalmic administration, Restasis should be used cautiously while breastfeeding.

The most common side effect of cyclosporine ophthalmic emulsion is a temporary burning sensation in the eye. Other side effects include:

• eye redness,
• discharge,
• watery eyes,
• eye pain,
• foreign body sensation,
• itching,
• stinging, and
• blurred vision.

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

• Potential for Eye Injury and Contamination 

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).

No information provided.