Common Restasis Side Effects


The most commonly reported Restasis side effects (click to view or check a box to report):

Eye Irritation (753)
Eye Pain (347)
Vision Blurred (342)
Ocular Hyperaemia (278)
Lacrimation Increased (174)
Foreign Body Sensation In Eyes (173)
Eye Pruritus (165)
Eye Discharge (127)
Dry Eye (103)
Instillation Site Pain (92)
Scleral Hyperaemia (89)
Headache (79)
Eye Swelling (78)
Eyelid Oedema (64)
Dizziness (58)
Erythema Of Eyelid (56)
Incorrect Dose Administered (53)
Photophobia (53)
Rash (53)
Abnormal Sensation In Eye (52)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Restasis Side Effects Reported to FDA



Restasis Side Effect Report#9971343
Ocular Hyperaemia, Vitreous Floaters, Growth Of Eyelashes
This is a report of a 60-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dry eye, who was treated with Restasis (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Ocular Hyperaemia, Vitreous Floaters, Growth Of Eyelashes after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Restasis treatment in female patients, resulting in Ocular Hyperaemia side effect.
Restasis Side Effect Report#9969819
Pain
This report suggests a potential Restasis Pain side effect(s) that can have serious consequences. A 69-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dry eye and used Restasis (dosage: 1 Drop Into The Eye) starting
Feb 11, 2014. After starting Restasis the patient began experiencing various side effects, including: PainAdditional drugs used concurrently: NA. Although Restasis demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain, may still occur.
Restasis Side Effect Report#9961558
Hip Fracture, Fall
This Hip Fracture problem was reported by a consumer or non-health professional from US. A 90-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Restasis (dosage: NA). The following drugs were being taken at the same time: NA. When using Restasis, the patient experienced the following unwanted symptoms/side effects: Hip Fracture, FallAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hip Fracture, may become evident only after a product is in use by the general population.
Restasis Side Effect Report#9866390
Eye Pain, Eye Pain
This Eye Pain side effect was reported by a consumer or non-health professional from US. A 79-year-old female patient (weight:NA) experienced the following symptoms/conditions: dry eye.The patient was prescribed Restasis (drug dosage: 2 Gtt, Bid), which was initiated on 201311. Concurrently used drugs: NA..After starting to take Restasis the consumer reported adverse symptoms, such as: Eye Pain, Eye PainThese side effects may potentially be related to Restasis.
Restasis Side Effect Report#9866389
Muscle Twitching
This is a report of a 55-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dry eye, who was treated with Restasis (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Muscle Twitching after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Restasis treatment in female patients, resulting in Muscle Twitching side effect.
Restasis Side Effect Report#9866381
Abnormal Sensation In Eye, Therapeutic Response Unexpected, Vision Blurred, Eye Discharge
This report suggests a potential Restasis Abnormal Sensation In Eye side effect(s) that can have serious consequences. A 90-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dry eye and used Restasis (dosage: 2 Gtt, Bid) starting NS. After starting Restasis the patient began experiencing various side effects, including: Abnormal Sensation In Eye, Therapeutic Response Unexpected, Vision Blurred, Eye DischargeAdditional drugs used concurrently:
  • Revive /01220707/
Although Restasis demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abnormal Sensation In Eye, may still occur.
Restasis Side Effect Report#9866374
Eye Inflammation, Eye Swelling, Eye Pain, Dry Eye, Eye Pruritus, Vision Blurred
This Eye Inflammation problem was reported by a consumer or non-health professional from US. A 65-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dry eye. On 201310 this consumer started treatment with Restasis (dosage: 2 Gtt, Bid). The following drugs were being taken at the same time: NA. When using Restasis, the patient experienced the following unwanted symptoms/side effects: Eye Inflammation, Eye Swelling, Eye Pain, Dry Eye, Eye Pruritus, Vision BlurredAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Eye Inflammation, may become evident only after a product is in use by the general population.
Restasis Side Effect Report#9866364
Vision Blurred, Eye Pain
This Vision Blurred side effect was reported by a consumer or non-health professional from US. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: dry eye.The patient was prescribed Restasis (drug dosage: 2 Gtt, Bid), which was initiated on 201212. Concurrently used drugs: NA..After starting to take Restasis the consumer reported adverse symptoms, such as: Vision Blurred, Eye PainThese side effects may potentially be related to Restasis.
Restasis Side Effect Report#9866363
Eye Irritation, Dry Eye
This is a report of a 84-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: lacrimation increased, who was treated with Restasis (dosage: 2 Gtt, Bid, start time: 201306), combined with: NA. and developed a serious reaction and side effect(s): Eye Irritation, Dry Eye after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Restasis treatment in female patients, resulting in Eye Irritation side effect.
Restasis Side Effect Report#9866353
Dry Mouth, Nervousness, Blood Pressure Increased, Heart Rate Increased, Flushing, Off Label Use
This report suggests a potential Restasis Dry Mouth side effect(s) that can have serious consequences. A 63-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dry eye,corneal abrasion and used Restasis (dosage: 2 Gtt, Unk) starting
Dec 17, 2013. After starting Restasis the patient began experiencing various side effects, including: Dry Mouth, Nervousness, Blood Pressure Increased, Heart Rate Increased, Flushing, Off Label UseAdditional drugs used concurrently: NA. Although Restasis demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dry Mouth, may still occur.
Restasis Side Effect Report#9866352
Instillation Site Pain, Foreign Body Sensation In Eyes
This Instillation Site Pain problem was reported by a consumer or non-health professional from US. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dry eye. On 201309 this consumer started treatment with Restasis (dosage: 2 Gtt, Bid). The following drugs were being taken at the same time:
  • Theratears
When using Restasis, the patient experienced the following unwanted symptoms/side effects: Instillation Site Pain, Foreign Body Sensation In EyesAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Instillation Site Pain, may become evident only after a product is in use by the general population.
Restasis Side Effect Report#9866347
Abnormal Sensation In Eye, Incorrect Dose Administered, Scleral Hyperaemia
This Abnormal Sensation In Eye side effect was reported by a consumer or non-health professional from US. A 72-year-old male patient (weight:NA) experienced the following symptoms/conditions: dry eye.The patient was prescribed Restasis (drug dosage: 2 Gtt, Bid), which was initiated on NS. Concurrently used drugs:
  • Systane (Unk)
  • Blood Pressure Medicine Nos (Unk)
  • Medicine For Emotions Nos (Unk)
.After starting to take Restasis the consumer reported adverse symptoms, such as: Abnormal Sensation In Eye, Incorrect Dose Administered, Scleral HyperaemiaThese side effects may potentially be related to Restasis.
Restasis Side Effect Report#9866344
Swelling Face, Scleral Hyperaemia, Eye Irritation
This is a report of a 54-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dry eye,blood cholesterol increased, who was treated with Restasis (dosage: 2 Gtt, Bid, start time: 201310), combined with:
  • Lipitor (10 Mg, Unk)
  • Krill Oil
  • Vagifem
and developed a serious reaction and side effect(s): Swelling Face, Scleral Hyperaemia, Eye Irritation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Restasis treatment in female patients, resulting in Swelling Face side effect.
Restasis Side Effect Report#9866340
Visual Impairment, Headache, Vision Blurred
This report suggests a potential Restasis Visual Impairment side effect(s) that can have serious consequences. A 78-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dry eye and used Restasis (dosage: 2 Gtt, Qd) starting 201310. After starting Restasis the patient began experiencing various side effects, including: Visual Impairment, Headache, Vision BlurredAdditional drugs used concurrently: NA. Although Restasis demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Visual Impairment, may still occur.
Restasis Side Effect Report#9866339
Madarosis, Eye Irritation, Eye Irritation, Vision Blurred, Foreign Body Sensation In Eyes
This Madarosis problem was reported by a consumer or non-health professional from US. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dry eye. On NS this consumer started treatment with Restasis (dosage: 2 Gtt, Bid). The following drugs were being taken at the same time: NA. When using Restasis, the patient experienced the following unwanted symptoms/side effects: Madarosis, Eye Irritation, Eye Irritation, Vision Blurred, Foreign Body Sensation In EyesAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Madarosis, may become evident only after a product is in use by the general population.
Restasis Side Effect Report#9866337
Off Label Use, Superficial Injury Of Eye
This Off Label Use side effect was reported by a physician from US. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: dacryostenosis acquired.The patient was prescribed Restasis (drug dosage: 2 Gtt, Bid), which was initiated on NS. Concurrently used drugs: NA..After starting to take Restasis the consumer reported adverse symptoms, such as: Off Label Use, Superficial Injury Of EyeThese side effects may potentially be related to Restasis.
Restasis Side Effect Report#9866334
Eye Pain
This is a report of a 83-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dry eye,hypertension, who was treated with Restasis (dosage: 2 Gtt, Bid, start time: 201311), combined with:
  • Amlodipine (5 Mg, Qd)
and developed a serious reaction and side effect(s): Eye Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Restasis treatment in female patients, resulting in Eye Pain side effect.
Restasis Side Effect Report#9866331
Eyelid Disorder, Swelling Face, Eyelid Irritation, Skin Irritation, Eye Irritation, Scleral Hyperaemia, Scleral Hyperaemia, Erythema Of Eyelid
This report suggests a potential Restasis Eyelid Disorder side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dry eye and used Restasis (dosage: 2 Gtt, Bid) starting 201308. After starting Restasis the patient began experiencing various side effects, including: Eyelid Disorder, Swelling Face, Eyelid Irritation, Skin Irritation, Eye Irritation, Scleral Hyperaemia, Scleral Hyperaemia, Erythema Of EyelidAdditional drugs used concurrently: NA. Although Restasis demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Eyelid Disorder, may still occur.
Restasis Side Effect Report#9866329
Ocular Hyperaemia, Eye Irritation
This Ocular Hyperaemia problem was reported by a consumer or non-health professional from US. A 59-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dry eye. On 2008 this consumer started treatment with Restasis (dosage: Unk). The following drugs were being taken at the same time: NA. When using Restasis, the patient experienced the following unwanted symptoms/side effects: Ocular Hyperaemia, Eye IrritationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ocular Hyperaemia, may become evident only after a product is in use by the general population.
Restasis Side Effect Report#9866328
Therapeutic Response Decreased
This Therapeutic Response Decreased side effect was reported by a physician from US. A female patient (weight:NA) experienced the following symptoms/conditions: dry eye,hypersensitivity.The patient was prescribed Restasis (drug dosage: 2 Gtt, Bid), which was initiated on NS. Concurrently used drugs:
  • Zyrtec (10 Mg, Unk)
  • Diazide /00007602/ (25 Mg, Unk)
  • Atenolol (25 Mg, Unk)
  • Vasotec /00574902/ (20 Mg, Unk)
.After starting to take Restasis the consumer reported adverse symptoms, such as: Therapeutic Response DecreasedThese side effects may potentially be related to Restasis.
Restasis Side Effect Report#9866324
Eye Irritation, Ocular Hyperaemia, Dry Eye
This is a report of a 54-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dry eye,hypersensitivity, who was treated with Restasis (dosage: 2 Gtt, Bid, start time: NS), combined with:
  • Claritin /00413701/ (Unk Unk, Prn)
  • Sudafed /00076302/ (Unk Unk, Prn)
and developed a serious reaction and side effect(s): Eye Irritation, Ocular Hyperaemia, Dry Eye after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Restasis treatment in female patients, resulting in Eye Irritation side effect.
Restasis Side Effect Report#9866321
Eye Irritation, Eye Pain
This report suggests a potential Restasis Eye Irritation side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dry eye and used Restasis (dosage: 2 Gtt, Unk) starting 201307. After starting Restasis the patient began experiencing various side effects, including: Eye Irritation, Eye PainAdditional drugs used concurrently: NA. Although Restasis demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Eye Irritation, may still occur.
Restasis Side Effect Report#9866319
Vision Blurred, Dry Eye
This Vision Blurred problem was reported by a physician from US. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dry eye. On
Nov 13, 2013 this consumer started treatment with Restasis (dosage: 2 Gtt, Qam). The following drugs were being taken at the same time: NA. When using Restasis, the patient experienced the following unwanted symptoms/side effects: Vision Blurred, Dry EyeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Vision Blurred, may become evident only after a product is in use by the general population.
Restasis Side Effect Report#9866318
Incorrect Dose Administered, Eye Irritation, Eye Pruritus
This Incorrect Dose Administered side effect was reported by a consumer or non-health professional from US. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: dry eye.The patient was prescribed Restasis (drug dosage: Unk), which was initiated on 201306. Concurrently used drugs:
  • Refresh Optive (2 Gtt, Unk)
  • Blood Pressure Medicine (Unk)
  • Cholesterol Medicine (Unk)
  • Osteoporosis Medicine
.After starting to take Restasis the consumer reported adverse symptoms, such as: Incorrect Dose Administered, Eye Irritation, Eye PruritusThese side effects may potentially be related to Restasis.
Restasis Side Effect Report#9866315
Instillation Site Pain, Photophobia
This is a report of a 69-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dry eye, who was treated with Restasis (dosage: 2 Gtt, Bid, start time: 201312), combined with:
  • Natural Tears (Every 20 Minutes)
  • Synthroid
  • Symbicort
and developed a serious reaction and side effect(s): Instillation Site Pain, Photophobia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Restasis treatment in female patients, resulting in Instillation Site Pain side effect.


1 of 81 


The appearance of Restasis on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Restasis Side Effects for Women?

Women Side Effects Reports
Eye Irritation 650
Eye Pain 300
Vision Blurred 281
Ocular Hyperaemia 251
Eye Pruritus 149
Foreign Body Sensation In Eyes 149
Lacrimation Increased 145
Eye Discharge 104
Dry Eye 83
Scleral Hyperaemia 80

What are common Restasis Side Effects for Men?

Men Side Effects Reports
Eye Irritation 102
Vision Blurred 61
Eye Pain 47
Lacrimation Increased 27
Ocular Hyperaemia 25
Foreign Body Sensation In Eyes 24
Eye Discharge 21
Dry Eye 19
Eye Pruritus 16
Instillation Site Pain 13

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Restasis reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Restasis Side Effects

    Did You Have a Restasis Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Restasis for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Restasis Safety Alerts, Active Ingredients, Usage Information

    NDC 0023-9163
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name RESTASIS
    Name cyclosporine
    Dosage Form EMULSION
    Route OPHTHALMIC
    On market since 20030401
    Labeler Allergan, Inc.
    Active Ingredient(s) CYCLOSPORINE
    Strength(s) 0.5
    Unit(s) mg/mL
    Pharma Class Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhib

    Restasis Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2022

    Restasis safety alerts: No

    Reported deaths: 9

    Reported hospitalizations: 48

    Latest Restasis clinical trials

    Popular Pages