Most Common Restasis Side Effects

Restasis is a popular prescription eye drop used to treat chronic dry eye by increasing the production of natural tears. Understanding the possible Restasis side effects is important in order to make an informed decision about its use.

Most Common Restasis Side Effects Optometrist
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Mild Side Effects of Restasis

The side effects of Restasis can range from mild to severe, with the most common side effects being relatively mild in nature. According to clinical studies, approximately 17% of patients using Restasis may experience eye burning or stinging, one of the frequently reported Restasis side effects. This sensation typically occurs upon application and can last for a few minutes. However, the severity and duration of the burning or stinging sensation may decrease over time as the body becomes accustomed to the medication. It is important to note that if this side effect persists or worsens, patients should consult our optometrist for further evaluation.

Another common side effect of Restasis is eye redness, which occurs in roughly 15% of patients. This redness may be accompanied by itching, which can be a sign of an allergic reaction. If a patient experiences severe itching or if the redness worsens, they should consult our optometrist to determine if an alternative treatment might be more suitable. In some cases, patients may also develop eye discharge or watery eyes. Although this is a less common side effect, affecting approximately 5% of patients, it is essential to monitor the condition and consult a healthcare professional if the discharge becomes persistent or changes in color or consistency.

Common Side Effects of Restasis

Common Side Effects of Restasis

In clinical trials, the most frequently reported side effect of Restasis was a temporary burning or stinging sensation in the eyes upon instilling the drops. In fact, about 17% of patients experienced ocular burning in studies (similarly, a recent analysis found ~14.7% incidence of burning with Restasis vs ~6.5% with placebo). This burning/stinging is usually mild and brief, occurring right after the drop is applied, and tends to subside within minutes. Importantly, most people do not find it severe enough to stop using Restasis, and this sensation often improves with continued use over time, one long-term study noted patients reported less burning after 3 years of use compared to 1 year. Below is a list of common Restasis side effects:

  • Eye burning or stinging: A transient burning or tingling feeling is the most common side effect. It typically happens immediately after putting in the eye drops and then fades. For most patients, this irritation is mild and becomes less pronounced as treatment continues.
    • Tip:Storing the single-use vial in the refrigerator for a few minutes just before use (while keeping long-term storage at room temperature) can help lessen the burning or stinging on instillation. Do not actually freeze or permanently store the medication in the fridge, just a short chill before dosing can make it more comfortable.
  • Eye redness (conjunctival hyperemia): Some users experience redness of the eyes while on Restasis. This redness is usually mild and even part of dry eye symptoms itself. As Restasis improves the dry eye condition over time, the redness typically diminishes. If one eye becomes markedly red while the other does not, or if redness is accompanied by severe pain, it could indicate an issue like infection, in that case, seek medical advice.
  • Watery eyes or discharge: Paradoxically, excess tearing (watering eyes) can occur with Restasis use. This is often a reflex response to the drop or the sensation of dryness, the eyes may water to try to flush out what they perceive as foreign. Some people also notice a bit of mucous discharge (e.g. “eye boogers”) after starting Restasis. These effects are generally mild. In fact, a little extra tearing can be a sign the medication is beginning to help your tear production. Gently blot away any excess tears or discharge with a clean tissue (avoid rubbing the eyes). If you experience heavy mucus or yellow/green discharge, or crusting, that’s not a typical side effect, it may signal an eye infection, which should be evaluated by a doctor.
  • Foreign body sensation: Restasis can make it feel like “something is in your eye” (a gritty or sandy feeling). This foreign body sensation is common in dry eye disease itself and can be temporarily heightened when starting the drops. It often improves as the medication hydrates the eye surface and the dry eye symptoms resolve. The feeling may also occur momentarily as the drop spreads across the eye, but should disappear as the drop is absorbed. Try not to rub your eyes if you feel this, rubbing can worsen irritation.
  • Itchy eyes: Mild itching of the eyes is another common side effect reported by Restasis users. Like burning, this eye itchiness usually happens right after the drops are applied and tends to be transient. Over time, as inflammation is reduced and the ocular surface heals, itchiness often decreases. If itching is severe or persistent, inform your eye care provider (to ensure it’s not an allergic reaction or another issue).
  • Blurred vision: You may notice brief blurry vision immediately after putting in Restasis. Any eye drop can blur vision for a few minutes simply because the liquid coats the surface of the eye. With Restasis, this blurriness should be temporary, as the emulsion spreads and gets absorbed, clear vision returns. It’s wise to wait a few minutes after dosing before driving or operating machinery, until your vision clears. Blurred vision is also a common symptom of dry eye itself, so ongoing blurriness (at other times of day) is likely due to the underlying dry eye and should improve as treatment takes effect.
  • Eye pain or irritation: A small percentage of patients report eye pain or a sense of irritation when using Restasis. This often overlaps with the burning/stinging sensation and is typically described as a mild aching or discomfort in the eye. Again, this side effect is usually short-lived and happens just after instillation. If you have significant pain that lasts more than a few minutes after the drop, or pain that worsens over time, let your doctor know. Moderate discomfort can be normal, but sharp or prolonged pain is not and could signal another problem.

All of the above side effects are localized to the eye and are generally mild to moderate in intensity. It’s worth noting that many of these effects, burning, redness, grittiness, blurred vision, are also symptoms of dry eye disease itself. So when you start Restasis, you might already have some of these symptoms from dry eye, and the drop may transiently accentuate them.

With consistent use over weeks to months, as Restasis reduces ocular surface inflammation, dry eye symptoms (and these side effects) tend to improve. In clinical trials, most adverse events were reported as mild, and very few patients (only about 1–2%) discontinued Restasis due to side effects. In other words, most people find the side effects tolerable enough to continue therapy while their eyes gradually get healthier.

Rare but Serious Risks (Uncommon)

Rare but Serious Risks (Uncommon)

Serious adverse reactions to Restasis are very rare. There are a few precautions to be aware of, mostly related to proper use of the eye drops and potential allergies:

Eye infection

Restasis itself does not cause eye infections, but improper handling of the bottle or vials can introduce bacteria to your eye. If the tip of the dropper touches your eye or any surface, it can contaminate the medication. Using a contaminated dropper could lead to bacterial eye infection, such as conjunctivitis (pink eye). Signs of infection include increasing eye redness, thick or yellow discharge, swelling, and eye pain that doesn’t resolve. Prevent this by always washing your hands before use, avoiding touching the dropper tip to anything (including your eye or eyelids), and discarding single-use vials immediately after one use. Restasis is available in preservative-free single-use vials and a multi-dose bottle; if using the multi-dose bottle, keep the tip sterile and the cap on tightly when not in use. Eye infections from Restasis use are rare and generally only happen if there’s contamination, so correct technique is key. If you suspect an infection (e.g. sudden pain, one eye becoming very red and irritated, pus-like discharge), stop using the drops and contact your eye doctor for evaluation.

Eye injury

Similarly, eye injury is not a direct effect of the drug but can occur if the dropper is not used carefully. Accidentally poking or scratching the eye with the vial tip can cause a corneal abrasion or other injury. Always instill the drops cautiously: tilt your head back, hold the dropper above the eye without touching it, and let a drop fall in. If you have unsteady hands or poor dexterity, ask your provider about assistive eye drop devices or have someone help you apply the drops to avoid injury. Severe eye pain or significantly blurred vision after using a drop could indicate an injury, seek medical attention if you suspect you’ve injured your eye.

Allergic reaction

True allergies to Restasis (cyclosporine) are extremely uncommon, but post-marketing reports have noted rare cases of hypersensitivity reactions. This could manifest as swelling of the face, eyelids, or around the eyes, hives, or difficulty breathing in severe cases. If after using Restasis you experience extensive swelling (e.g. your eyelids or lips puff up) or any trouble breathing, it could be a sign of a serious allergic reaction (angioedema), and you should seek emergency medical care. Fortunately, such reactions are very rare. Mild eye-area swelling or redness is more likely due to local irritation than a true allergy, but it’s wise to have any concerning symptoms checked by a physician.

Tips for Patients (Especially Contact Lens Wearers)

Tips for Patients (Especially Contact Lens Wearers)

Because this information is for a contact lens clinic’s patient page, it’s important to discuss how Restasis use intersects with contact lens use:

Remove contact lenses before using Restasis

You should not instill Restasis while wearing contact lenses. The medication contains an emulsifying agent and, while it’s formulated to be gentle on the eye, contact lenses can interfere with the drop’s distribution and may absorb ingredients. Moreover, many dry eye patients probably shouldn’t be wearing contacts until their condition improves. If you do wear contacts, take them out before putting in Restasis, and wait at least 15 minutes after the drop before reinserting your lenses. This waiting period allows the medication to fully absorb into the ocular surface. Following this rule will help avoid any interaction between the drop and your lenses (and also ensures the drop isn’t diluted or removed by the lens).

Be patient with the medication

Unlike something that gives immediate relief (like artificial tears), Restasis works by gradually changing the tear production and inflammation in your eyes. It often takes several weeks (up to 3–6 months) to notice substantial improvement in dry eye symptoms. During the early phase of treatment, the common side effects (burning, etc.) might be more noticeable, but don’t give up too soon. Eye doctors note that “Restasis burns… until it doesn’t”, in other words, if you can tolerate the initial discomfort, it usually lessens with time and the benefits for your dry eye can be significant. Only a small fraction of patients end up discontinuing Restasis due to side effects in clinical trials, which suggests that with proper guidance most people can manage the temporary side effects.

Manage side effects with simple strategies

If the drops sting, remember the refrigeration tip mentioned above, a slightly chilled drop can be more soothing on instillation. Using preservative-free artificial tears in between Restasis doses (spaced at least 15 minutes apart from Restasis) may also help keep your eyes comfortable as you adjust. Just be sure to separate any lubricant drops from your Restasis dose by at least 15 minutes (Restasis is typically twice a day, e.g. morning and evening) so that the artificial tear doesn’t wash out the medication. If you experience mild blurred vision after dosing, plan your day so that you’re not immediately driving or doing something visually intensive right after putting in the drops, giving it a few minutes to clear. And as always, regular follow-ups with your eye care provider are important: they can check your progress, ensure you’re using the drops correctly, and address any persisting side effect that concerns you.

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Common Side Effects of Restasis
Rare but Serious Risks (Uncommon)

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Common Questions

In some cases, Restasis may initially cause increased eye irritation, making dry eye symptoms seem worse. However, these symptoms generally subside as the body adjusts to the medication. If the irritation persists or worsens, consult your optometrist to discuss alternative treatment options.
Restasis is generally considered safe for long-term use in the treatment of chronic dry eye. The medication works by increasing the production of natural tears, providing relief for many patients experiencing dry eye symptoms. However, it is crucial to have regular check-ups with our eye care professional to monitor the effectiveness and any potential side effects of Restasis. In some cases, patients may experience side effects such as eye irritation, redness, or discharge, but these symptoms usually subside as the body adjusts to the medication. If you have concerns about the long-term use of Restasis or its potential side effects, it is essential to discuss them with your eye care professional. They can provide personalized guidance and recommend alternative treatment options if needed.
When you stop using Restasis, your dry eye symptoms may gradually return as the medication is no longer stimulating the production of natural tears. This can lead to increased discomfort, redness, or irritation associated with chronic dry eye. Since every patient's situation is unique, it is essential to consult your optometrist before discontinuing Restasis. They can help determine if stopping the medication is appropriate for your individual needs and suggest alternative treatment options if necessary.
Restasis is generally safe when used as directed, but it can cause some side effects that may be considered eye problems. The most common side effects include eye irritation, redness, or discharge. These symptoms typically subside as your body adjusts to the medication, but if they persist or worsen, it's important to consult our eye care professional. Rare but more serious eye problems associated with Restasis include eye infections and vision changes. If you experience increased redness, swelling, pain, or a yellowish discharge from your eye, contact our eye care professional immediately for evaluation and treatment. Similarly, if you notice any vision changes while using Restasis, consult our eye care professional as soon as possible, as this may indicate a more serious underlying issue. If you have concerns about eye problems related to Restasis, consult your eye care professional. They can provide personalized guidance and help determine if Restasis is the right treatment option for your dry eye symptoms.
Restasis is not known to have a direct impact on kidney function. The medication is an eye drop specifically designed to treat chronic dry eye by increasing the production of natural tears. Its primary mode of action is localized to the eye, and it is not typically associated with systemic side effects or adverse effects on organs such as the kidneys. However, if you have pre-existing kidney issues or concerns about potential interactions with other medications you are taking, it is important to discuss them with your optometrist before starting Restasis.
No, Restasis is not an eye steroid. Restasis is a type of medication called a calcineurin inhibitor, which works differently from steroids. Its active ingredient, cyclosporine, helps increase tear production in the eyes by reducing inflammation and promoting the function of tear-producing cells. This provides relief for patients experiencing chronic dry eye symptoms. Steroid eye drops, on the other hand, are typically used to treat inflammation and related conditions in the eye. Although they can be effective in addressing some symptoms of dry eye, long-term use of steroids may cause side effects such as increased eye pressure or cataract formation.
The success rate of Restasis varies among patients, as individual responses to the medication can differ. Restasis has been shown to be effective in increasing tear production and reducing dry eye symptoms in many individuals, but it may not work for everyone. Some patients may experience relief from their dry eye symptoms, while others may not notice significant improvement or may experience side effects.
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