Restasis is a brand-name eye drop that’s prescribed for chronic (long-lasting) dry eye. Restasis contains the active drug cyclosporine and belongs to the calcineurin inhibitor immunosuppressants drug class.
Restasis is approved by the Food and Drug Administration (FDA) to treat chronic dry eye in people ages 16 years and older.
Drug details
You’ll find key information about Restasis below.
- Drug forms: Restasis is a liquid emulsion (an oily liquid mixture) that’s used as eye drops. It comes as the following two products:
- Single-use vials: These vials of Restasis can be used for one dose of the drug.
- Restasis MultiDose: These bottles of Restasis can be used for multiple doses of the drug.
- Generic available? yes
- Prescription required? yes
- Controlled substance? no
- Year of FDA approval: 1983
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. 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.
Chronic dry eye results in your body not being able to make enough of your own tears. There are several factors that may contribute to dry eye symptoms, such as:
- being an older age
- environmental conditions, such as smoke, wind, and dry climate
- other medical conditions you may have, such as Sjogren’s syndrome
Restasis contains the active drug 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.
For more information about this condition, visit our eye health hub.
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.
Guidelines published by the American Academy of Ophthalmology (AAO) state that cyclosporine (the active drug in Restasis) eye drops are effective for treating dry eye. They also state that for some people, the drug can work well enough that symptoms of dry eye go away for long periods of time.
Restasis and children
Restasis is FDA-approved for use in children ages 16 years and older. However, it’s not approved for use in children younger than 16 years of age. The safety and effectiveness of Restasis hasn’t been found in this age group.
Restasis is a brand-name drug that contains the active drug cyclosporine. This active drug is also available as a generic medication called cyclosporine ophthalmic emulsion. A generic drug is an exact copy of the active drug in a brand-name medication.
The generic is considered to be as safe and effective as the original drug. Generics 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.
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 deal with any side effects that may be bothersome.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Restasis, you can do so through MedWatch.
Mild side effects
The more common side effects of Restasis can include:
- burning sensation in your eye*
- increased redness in your eye
- discharge from your eye
- pain in your eye
- itching in your eye
- stinging in your eye
- blurry vision
- feeling like there’s something in your eye
- watery eyes
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. (This 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
- trouble seeing
- having blood in the clear layer that overlays your eye
- Eye infection. (This 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
Another serious side effect, severe allergic reaction, is explained in more detail below in “Side effect details.”
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 being any different than those seen in adults.
Side effect details
You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may or may not cause.
Allergic reaction
As with most drugs, some people can have an allergic reaction after taking Restasis. But it’s not known how many people using the drug may have had an allergic reaction to it.
Symptoms of a mild allergic reaction can include:
- eye swelling
- eye itchiness
- skin itchiness
- flushing
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your tongue, mouth, or throat
- trouble breathing
Call your doctor right away if you have a severe allergic reaction to Restasis. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.
Burning eyes
You may have some temporary burning or stinging in your eyes when you’re using Restasis. To find out how often this side effect occurred in clinical studies, see the drug’s prescribing information.
If you have burning or stinging in your eyes that’s bothersome or lasts longer than 15 minutes after using Restasis, call your eye doctor right away. They can determine what’s causing your symptoms and may be able to recommend ways to help relieve your discomfort.
If you have other questions or concerns about this potential side effect, talk with your doctor or pharmacist.
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.
For more information about the drug’s dosage, see this comprehensive article.
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. These vials of Restasis can be used for one dose of the drug. Each vial contains 0.4 mL of Restasis.
- Restasis MultiDose. These 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 of your eyes twice daily. You should use the medication about every 12 hours.
Note: If you use other eye drops in addition to Restasis, you can probably still use those drops while you’re using Restasis. But make sure to check with your doctor about which eye drops are safe to use with Restasis. In any case, just make sure to wait at least 15 minutes between using Restasis and any other eye drops.
Pediatric dosage
The typical dosage of Restasis in children ages 16 years and older is the same as it is for adults: one drop into each of your eyes twice daily.
Restasis isn’t approved for use in children less than 16 years of age.
What if I miss a dose?
If you miss a dose of Restasis, just take it as soon as you remember, unless it is almost time for your next dose. If that’s the case, just skip the missed dose and take your next dose as scheduled. Don’t take more than one dose of Restasis at a time.
To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.
Will I need to use this drug long term?
Restasis is meant to be used as 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 is approved to treat chronic dry eye. It comes as a liquid emulsion (an oily liquid mixture) that’s used as eye drops.
Restasis is available as the following two products:
- Restasis single-use vials. These vials of Restasis can be used for one dose of the drug. Each vial contains 0.4 milliliters (mL) of Restasis. The vials are available in packs of either 30 or 60 vials.
- Restasis MultiDose. These bottles of Restasis can be used for multiple doses of the drug. Each bottle contains 5.5 mL of Restasis.
Restasis single-use vials and Restasis MultiDose each contain the same active drug: cyclosporine. And they’re both used by placing one drop into each of your eyes twice daily.
If you have questions about using Restasis single-dose vials or Restasis MultiDose, talk with your doctor. They can recommend which option is right for you.
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 below are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.
Examples of drugs other than Restasis that may be used to treat chronic dry eye include:
- lifitegrast (Xiidra)
- loteprednol etabonate (Lotemax)
- cyclosporine 0.09% (Cequa)
- lubricating eye drops, such as:
- dextran/hypromellose (Bion Tears)
- polyethylene glycol/propylene glycol (Systane)
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 lubrications stay on your eyes. This helps to keep your eyes moist.
You may wonder how Restasis compares with other medications that are prescribed for similar uses. Here we look at how Restasis and Xiidra are alike and different.
Ingredients
Restasis contains the active drug cyclosporine. It belongs to a class of drugs called calcineurin inhibitor immunosuppressants.
Xiidra contains the active drug 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 your 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 prescribed for people ages 17 years and older.
Drug forms and administration
Restasis comes as a liquid emulsion (an oily liquid mixture) that’s used as eye drops. It’s available in the following two products:
- Single-use vials. These vials of Restasis can each be used for one dose of the drug.
- Restasis MultiDose. These bottles of Restasis can be used for multiple doses of the drug.
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. Below are examples of these side effects.
Mild side effects
These lists contain examples of mild side effects that can occur with Restasis, with Xiidra, or with both drugs (when taken individually).
- Can occur with Restasis:
- 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
- Can occur with Xiidra:
- irritation of your eye
- change in the taste of certain foods
- reduced ability to clearly see
- headaches
- swollen sinuses
- Can occur with both Restasis and Xiidra:
- blurry vision
- discharge from your eye
- watery eyes
- eye itching
- mild eye discomfort
Serious side effects
These lists contain examples of serious side effects that can occur with Restasis, with Xiidra, or with both drugs (when taken individually).
- Can occur with Restasis:
- eye injury
- eye infection
- Can occur with Xiidra:
- no unique serious side effects
- Can occur with both Restasis and Xiidra:
- severe allergic reaction
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 drops 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 treatment can help to 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 drug 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 it take to work?
Depending on how severe your dry eye is, Restasis may take 4–6 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 section “Restasis use with other therapies” above.
You should use Restasis according to your doctor’s or healthcare professional’s instructions. Restasis comes as a liquid emulsion (an oily liquid mixture) that’s used as eye drops.
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. And if you wear contact lenses, wait at least 15 minutes after using Restasis to put the lenses back in your eyes.
When to use
You should use Restasis eye drops twice each day. You can use the drops any time of day, but try to keep your doses about 12 hours apart.
To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.
When you get Restasis from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.
The expiration date helps guarantee that the medication is effective during this time. The
Storage
How long a medication remains good can depend on many factors, including how and where you store the medication.
Restasis eye drops should be stored in the original container you received from your pharmacy. If you’re using the single-use vials, you’ll get a box of vials. If you’re using Restasis MultiDose, you’ll get a bottle of the medication.
Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms.
Does Restasis need to be refrigerated?
No, in fact, Restasis shouldn’t be refrigerated. You should keep Restasis stored at room temperature (59–77°F/15–25°C) in its original container.
Disposal
If you no longer need to take Restasis and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.
The
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. 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.
Using more than the recommended dosage of Restasis can lead to serious side effects. Be sure to never use more Restasis eye drops than your doctor recommends.
Overdose symptoms
Symptoms of a Restasis overdose can include:
- increased eye irritation
- burning in your eyes
- redness in your eyes
What to do if you think you’ve overdosed
If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.
It’s not known whether Restasis interacts with alcohol. But because Restasis works only in your eyes, it’s unlikely that the drug would interact with alcohol.
If you drink and have questions about how much alcohol is safe for you to consume while you’re using Restasis, talk with your doctor.
Restasis hasn’t been shown to interact with other medications. However, it’s still important to talk with your doctor or pharmacist about any prescription medications, vitamins, supplements, and over-the-counter medications you take before starting Restasis.
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 to minimize your risk of eye irritation. It also helps to make sure that your eyes are absorbing all of the medication after you’ve placed Restasis drops.
There isn’t enough information available to know whether Restasis is safe to use during pregnancy. It’s important to know that when you use Restasis as prescribed (by placing the drops into your eyes), Restasis isn’t found in your bloodstream. This means it’s very unlikely that a developing fetus would be exposed to the drug.
Restasis contains the active drug cyclosporine, which also comes in a pill form that’s taken by mouth and used to treat other conditions. Some animal studies have shown that females who were given cyclosporine by mouth had fetuses with reduced fetal birth weights and slowed skeletal growth.
But keep in mind that Restasis is not taken by mouth. It’s used as eye drops. And animal studies don’t always predict what will happen in people.
If you have questions about the safety of using Restasis during pregnancy, talk with your doctor.
It’s not known whether Restasis is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Restasis.
It’s not known whether Restasis passes into human breast milk. It’s important to note that when you use Restasis as prescribed (by placing the drops into your eyes), the drug isn’t found in your bloodstream. This means it’s very unlikely that a child who’s breastfed would be exposed to the drug through breast milk.
Restasis contains the active drug cyclosporine, which also comes in a pill form that’s taken by mouth and used to treat other conditions. Cyclosporine has been shown to pass into the breast milk of females* who’ve taken the drug by mouth. But keep in mind that Restasis is not taken by mouth. It’s used as eye drops.
If you have questions about the safety of using Restasis while breastfeeding, talk with your doctor. They can recommend safe and healthy ways to feed your child.
* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.
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.
It’s important to note that you’ll have to get Restasis at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.
Your insurance plan may require you to get prior authorization before approving coverage for Restasis. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Restasis.
If you’re not sure if you’ll need to get prior authorization for Restasis, contact your insurance company. And to learn more about the cost of Restasis, see this article.
Financial and insurance assistance
If you need financial support to pay for Restasis, or if you need help understanding your insurance coverage, help is available.
Allergan, Inc., the manufacturer of Restasis, offers a savings card that may help lower the cost of your prescription. For more information and to find out if you’re eligible for support, call 844-4MY-TEARS (844-469-8327) or visit the program website.
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. There’s not enough information to know whether it’s safe to use Restasis during pregnancy. For more information, please see the “Restasis and pregnancy” section above.
- Breastfeeding. It’s not known whether Restasis can pass into human breast milk. For more information, please see the “Restasis and breastfeeding” section above.
- Allergy to Restasis. Restasis is contraindicated (should not be used in any circumstance) if you have a history of allergic reaction to Restasis or any of its ingredients. If you’re unsure about your medication allergies, talk with your doctor.
Note: For more information about the potential negative effects of Restasis, see the “Restasis side effects” section above.
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.
