Key takeaways
- The Food and Drug Administration (FDA) has approved Restasis for treating chronic dry eye in adults and children ages 16 years and older. It’s available in single-use vials and a multiuse bottle.
- Restasis contains cyclosporine as an active ingredient. Cyclosporine is an immunosuppressant that reduces inflammation and improves tear production in the eyes.
- Common side effects of Restasis include a burning sensation in the eye, redness, and blurry vision, but serious side effects like eye injury or infection are rare.
Drug details
You’ll find key information about Restasis here:
- Drug class: calcineurin inhibitor immunosuppressant
- Drug forms: liquid emulsion (an oily liquid mixture) that comes as two types of eye drops:
- Restasis single-use vials, which can be used for one dose of the drug
- Restasis MultiDose, which can be used for multiple doses
- Generic available? yes
- Prescription required? yes
- Controlled substance? no
Restasis is a brand-name drug that contains the active ingredient cyclosporine. This active ingredient is also available as a generic medication called cyclosporine ophthalmic emulsion. A generic drug is an exact copy of the active ingredient in a brand-name medication.
The generic is considered to be as safe and effective as the original drug. And they tend to cost less than brand-name drugs.
If you’re interested in using the generic form of Restasis, talk with your doctor. They can tell you whether it comes in forms and strengths that can be used for your condition.
The following section describes typical dosages of Restasis that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
Drug forms and strengths
Restasis is a liquid emulsion (an oily liquid mixture) that’s used as eye drops. It’s available in one strength: 0.5 milligrams (mg) per milliliter (mL).
Restasis comes as the following two products:
- Single-use vials: The vials of Restasis can be used for one dose of the drug. Each vial contains 0.4 mL of Restasis.
- Restasis MultiDose: The bottles of Restasis can be used for multiple doses of the drug. Each bottle contains 5.5 mL of Restasis.
Dosage for chronic dry eye
The typical dosage of Restasis for chronic dry eye is one drop into each eye twice daily. You should use the medication about every 12 hours.
Note: If you use other eye drops in addition to Restasis, check with your doctor whether they’re safe to use with Restasis. If they’re safe to use, wait at least 15 minutes between using Restasis and the other eye drop.
Restasis dosage for children
The typical dosage of Restasis in children ages 16 years and older is the same as it is for adults: one drop into each eye twice daily.
Restasis isn’t approved for use in children younger than 16 years of age.
How to use Restasis
You should use Restasis according to your doctor’s instructions.
Before you put Restasis drops into your eyes, you should wash your hands. And be sure to remove contact lenses if you’re wearing them.
After you’ve placed Restasis drops in your eyes, wait at least 15 minutes before putting any other drops into your eyes. If you wear contact lenses, wait at least 15 minutes after using Restasis before putting the lenses back in your eyes.
About using Restasis
You’ll find information about key dosage issues here:
- When to use: You should use Restasis eye drops twice daily. You can use the drops any time of day, but try to keep your doses about 12 hours apart.
- If you miss a dose: If you miss a dose of Restasis, take it as soon as you remember, unless it is almost time for your next dose. If that’s the case, skip the missed dose and take your next dose as scheduled. Do not take more than one dose of Restasis at a time.
- Length of use: Restasis is meant to be a long-term treatment. If you and your doctor determine that Restasis is safe and effective for you, you’ll likely take it long term.
Restasis can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Restasis. These lists do not include all possible side effects.
For more information on the possible side effects of Restasis, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be bothersome.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while taking Restasis and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.
Mild side effects
The more common side effects of Restasis can include:
- burning sensation in your eye
- increased redness in your eye
- eye discharge or watery eyes
- pain, itching, or stinging in your eye
- blurry vision
- feeling like there’s something in your eye
Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.
Serious side effects
Serious side effects from Restasis aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- Eye injury, which may happen if you touch your eye forcefully with the tip of the Restasis vial or bottle. Symptoms can include:
- redness in your eye
- irritation in your eye
- difficulty seeing
- having blood in the clear layer that overlays your eye
- Eye infection, which may happen if the tip of the Restasis vial or bottle gets contaminated and passes an infection to your eye. Symptoms can include:
- redness in your eye
- thick discharge from your eye
- feeling like there’s something in your eye
Allergic reaction
For some people, Restasis can cause an allergic reaction. This was reported after Restasis and Restasis MultiDose became available for use.
In general, symptoms of an allergic reaction can be mild or serious. They can include:
- swelling of the eye
- hives
- swelling of the throat, tongue, or face
- shortness of breath
- severe angioedema, in rare cases
Ways to manage
For mild allergic reaction symptoms, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Restasis, your doctor may recommend a different medication instead.
Side effects in children
Restasis is approved for use in children ages 16 years and older. The side effects of Restasis in these children haven’t been reported as different than those seen in adults.
The Food and Drug Administration (FDA) approves prescription drugs such as Restasis to treat certain conditions. Restasis may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.
Restasis for chronic dry eye
Restasis is FDA approved to treat chronic dry eye. With this condition, you have inflammation or irritation in your eyes that causes dryness. Your body also doesn’t make enough tears. This often results in stinging, burning, redness, or itching around your eyes. It can also cause difficulty with wearing contact lenses. The condition is called “chronic” because it’s long lasting.
There are several factors that may contribute to dry eye symptoms, such as:
- older age
- environmental conditions, such as smoke, wind, and dry climate
- other medical conditions you may have, such as Sjögren disease
Restasis contains the active ingredient cyclosporine. It’s thought to work by calming down the inflammation in your eyes and tear ducts. This action helps to improve your body’s natural ability to make tears, which moistens your eyes and reduces dry eye symptoms.
Effectiveness for chronic dry eye
Restasis has been found to be effective for treating chronic dry eye. For information on how Restasis performed in clinical studies, see the drug’s prescribing information.
Cyclosporine (the active ingredient in Restasis) eye drops are effective for treating dry eye. For some people, the drug can work well enough that symptoms of dry eye go away for long periods of time.
Restasis is not known to interact with other medications, herbs, supplements, foods, or alcohol. The manufacturer did not list any interactions in the drug’s prescribing information.
However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Restasis.
Before starting Restasis treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.
Restasis and other eye drops
Even though Restasis doesn’t have any known drug interactions, it’s still important to wait at least 15 minutes after using Restasis before putting any other drops into your eyes. Doing this helps minimize your risk of eye irritation. It also helps to make sure that your eyes are absorbing all of the medication after you’ve applied Restasis drops.
Restasis is not expected to affect pregnancy. This is because the drug is used as eye drops, which aren’t usually absorbed into the body. So it’s unlikely that a fetus would be exposed to the drug.
It isn’t known whether Restasis eye drops pass into breast milk. Restasis also isn’t found in the bloodstream. However, you and your doctor can discuss the risks and benefits of using this drug if you’re breastfeeding or planning to.
If you have questions about the safety of using Restasis during pregnancy or breastfeeding, talk with your doctor.
Other drugs are available that can treat chronic dry eye. Some may be a better fit for you than others. If you’re interested in finding an alternative to Restasis, talk with your doctor. They can tell you about other medications that may work well for you.
Note: Some of the drugs listed here are used off-label to treat these specific conditions. With off-label use, your doctor prescribes a drug for a purpose that isn’t approved by the Food and Drug Administration (FDA).
Examples of drugs other than Restasis that may be used to treat chronic dry eye include:
Other remedies for chronic dry eye include:
- using homeopathic alternatives
- cleansing your eye area with diluted baby shampoo
Another alternative treatment for chronic dry eye is punctal plugs. With punctal plugs, tiny tubes are placed into your tear ducts. The tubes form a barrier to help natural tears and lubricants stay on your eyes. This helps to keep your eyes moist.
You may wonder how Restasis compares with other medications prescribed for similar uses. Here we look at how Restasis and Xiidra are alike and different.
Ingredients
Restasis contains the active ingredient cyclosporine. It belongs to a class of drugs called calcineurin inhibitor immunosuppressants.
Xiidra contains the active ingredient lifitegrast. It belongs to a class of drugs called lymphocyte function-associated antigen-1 antagonists.
Uses
Both Restasis and Xiidra are approved to treat chronic dry eye by increasing the eyes’ natural ability to make tears. This helps to moisten your eyes and reduce symptoms of chronic dry eye.
Restasis can be prescribed for people ages 16 years and older. Xiidra can be prescribed for people ages 17 years and older.
Drug forms and administration
Restasis comes as a liquid emulsion (an oily liquid mixture) used as eye drops. It’s available in single-use vials or multidose bottles. Whether you’re using Restasis single-use vials or Restasis MultiDose, you’ll use the drug twice each day by placing drops of the medication into your eyes.
Xiidra comes as a liquid solution inside single-dose vials. It’s also used as eye drops that are placed twice each day.
Side effects and risks
Restasis and Xiidra both contain drugs that are placed into your eye. Therefore, these medications can cause very similar side effects. The table shows examples of these side effects.
Mild side effects
The table contains examples of mild side effects that can occur with Restasis, with Xiidra, or with both drugs (when used individually).
| Can occur with both Restasis and Xiidra | Can occur with Restasis | Can occur with Xiidra | |
|---|---|---|---|
| Mild side effects | • eye irritation • blurry vision • discharge from your eye • watery eyes • eye itching • mild eye discomfort • mild allergic reaction | • burning sensation in your eye • redness in your eye • pain in your eye • stinging in your eye • feeling like there’s something in your eye | • change in the taste of certain foods • reduced ability to clearly see • headaches • swollen sinuses |
| Serious side effects | • severe allergic reaction | • eye injury • eye infection | • no unique serious side effects |
Effectiveness
Restasis and Xiidra are both used to treat chronic dry eye.
These drugs haven’t been directly compared in clinical studies. But separate studies have found both Restasis and Xiidra to be effective in increasing your eyes’ natural ability to make tears.
Costs
The exact price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.
Restasis is approved to treat chronic dry eye. But sometimes it’s used in combination with other drugs, depending on how severe your symptoms of chronic dry eye are.
If you’d like to know more about using another type of eye drop with Restasis, talk with your doctor. They can recommend whether you need to use these products with Restasis.
Restasis with lubricating eye drops
Restasis works by helping your body to make natural tears. But because it takes a few weeks to do this, lubricating eye drops can be used with Restasis during the first few months of treatment. Lubricating eye drops can help relieve your dry eye symptoms right away.
Preservative-free lubricating eye drops are often recommended for this purpose. These drops have a lower risk of irritating your eyes than some other formulations of eye drops.
Examples of lubricating eye drops include:
- polyethylene glycol/propylene glycol (Systane)
- carboxymethylcellulose sodium (Refresh)
- glycerin/hypromellose/polyethylene glycol (Visine)
- dextran/hypromellose (Bion Tears)
Restasis with steroid eye drops
For a short period of time, Restasis may be used in combination with steroid eye drops. This combination of treatments can help reduce inflammation, swelling, and redness in your eyes.
But it’s important that you use steroid eye drops for only a short amount of time. Using them over a long period of time can lead to problems in your eyes, such as infections. It may also lead to cataracts (cloudiness in the lens of your eye) or glaucoma (increased pressure in your eye).
Examples of steroid eye drops include:
- loteprednol etabonate (Lotemax)
- prednisolone (OmniPred, Pred Forte)
- difluprednate (Durezol)
Can I use other eye drops with Restasis?
Yes, you can use other eye drops with Restasis, as directed by your doctor. However, you should wait at least 15 minutes after you’ve used Restasis before using any other eye drops.
Restasis is approved to treat chronic dry eye. With this condition, there’s inflammation or irritation in your eye that causes dryness.
Restasis contains the active ingredient cyclosporine. It belongs to a class of drugs called calcineurin inhibitor immunosuppressants. Restasis is thought to work by calming down inflammation in your eyes and tear ducts. This helps to improve your body’s natural ability to make tears, which can relieve symptoms of chronic dry eye.
How long does Restasis take to work?
Depending on how severe your dry eye is, Restasis may take 4 to 6 months to relieve your symptoms. But for some people with mild dry eye, the drug may reduce dry eye symptoms within a month.
Your eye doctor may recommend a lubricating eye drop for you to use when you first start Restasis treatment. Using a lubricating eye drop can help relieve dry eye symptoms right away while you’re waiting for Restasis to start working.
For more information about using lubricating eye drops with Restasis, see the “Restasis use with other therapies” section.
Here are answers to some frequently asked questions about Restasis.
Will I have any withdrawal symptoms or other side effects if I stop using Restasis?
No, you probably won’t have any withdrawal symptoms if you stop using Restasis. However, your chronic dry eye symptoms may return once you stop using the drug.
Does Restasis cause cancer?
No, Restasis isn’t expected to cause cancer. During clinical studies, cancer wasn’t reported as a side effect of Restasis. If you have concerns about developing cancer while using Restasis, talk with your doctor.
Can hair loss occur with Restasis?
No, hair loss wasn’t reported as a side effect of Restasis during clinical studies. If you have concerns about hair loss while you’re using Restasis, talk with your doctor. They can discuss ways to help improve the condition.
Can I wear eye makeup or contact lenses while I’m using Restasis?
Yes, you can wear eye makeup and contact lenses while you’re using Restasis. However, you should wait at least 15 minutes after using Restasis eye drops before putting contact lenses or any other products into your eyes.
As with all medications, the cost of Restasis can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Financial and insurance assistance: If you need financial support to pay for Restasis or help to understand your insurance coverage, help is available. The Restasis Savings Program is available for people with qualifying insurance plans. For more information and to find out if you’re eligible for support, call 844-469-8327 or visit the program website.
Generic version: Restasis is available in a generic form called cyclosporine ophthalmic emulsion. A generic drug is an exact copy of the active ingredient in a brand-name medication. The generic is considered to be as safe and effective as the original drug. And generics tend to cost less than brand-name drugs. To find out how the cost of cyclosporine compares to the cost of Restasis, talk with your doctor or pharmacist.
Before taking Restasis, talk with your doctor about your health history. Restasis may not be right for you if you have certain medical conditions or other factors affecting your health. These include:
- pregnancy
- breastfeeding
- allergic reaction to Restasis or any of its ingredients
Note: For more information about the potential negative effects of Restasis, see the “Restasis side effects” section.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
