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Systane Side Effects

Common Systane Side Effects


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

Eye Irritation (23)
Vision Blurred (15)
Ocular Hyperaemia (9)
Visual Acuity Reduced (8)
Eye Pain (8)
Photophobia (6)
Lacrimation Increased (5)
Eye Infection (4)
Corneal Abrasion (4)
Eye Pruritus (4)
Erythema Of Eyelid (3)
Corneal Erosion (3)
Chest Discomfort (3)
Abnormal Sensation In Eye (3)
Eye Infection Fungal (3)
Eye Injury (3)
Product Packaging Issue (3)
Hallucination (3)
Foreign Body Sensation In Eyes (3)
Eyelid Oedema (3)

➢ 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.

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.

Systane Side Effects Reported to FDA

The following Systane 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.


The appearance of Systane 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.
Eye Irritation, Vision Blurred
This is a report of a 44-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: dry eye,blepharitis, who was treated with Systane Ultra (dosage: 1-2 Drops As Needed Into The Eye, start time: Feb 24, 2014), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Eye Irritation
  • Vision Blurred
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Systane Ultra treatment in male patients, resulting in eye irritation side effect.

Deafness
This report suggests a potential Systane-balance Deafness side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dry eye and used Systane-balance (dosage: One Or Two Drops Each Eye At Bedtime) starting Aug 22, 2013. Soon after starting Systane-balance the patient began experiencing various side effects, including:
  • Deafness
Drugs used concurrently:
  • Ambien
  • Atavan
  • Aspirin
  • Centrum Silver Men Over Fifty
Although Systane-balance demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as deafness, may still occur.

Vision Blurred, Metamorphopsia, Foreign Body Sensation In Eyes, Lacrimation Increased, Visual Impairment, Ocular Hyperaemia, Eye Inflammation
This Vision Blurred, Metamorphopsia, Foreign Body Sensation In Eyes, Lacrimation Increased, Visual Impairment, Ocular Hyperaemia, Eye Inflammation problem was reported by a physician from US. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: retinitis histoplasma. On Oct 18, 2013 this consumer started treatment with Systane Ultra High Performance (dosage: Unk). The following drugs were being taken at the same time:
  • Systane Liquid Gel Drops (2 Gtt, Q4h)
When commencing Systane Ultra High Performance, the patient experienced the following unwanted symptoms/side effects:
  • Vision Blurred
  • Metamorphopsia
  • Foreign Body Sensation In Eyes
  • Lacrimation Increased
  • Visual Impairment
  • Ocular Hyperaemia
  • Eye Inflammation
Although 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.

Eye Irritation, Ocular Discomfort, Ocular Hyperaemia
This is a report of a 59-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: asthenopia and was treated with Systane Balance (dosage: NA) starting Nov 19, 2013. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Eye Irritation
  • Ocular Discomfort
  • Ocular Hyperaemia
This opens a possibility that Systane Balance treatment could cause the above reactions, including eye irritation, and some female subjects may be more susceptible.


Blood Pressure Increased
A 80-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Systane treatment (dosage: Unk) on Oct 20, 2013. Soon after starting Systane treatment, the subject experienced various side effects, including:
  • Blood Pressure Increased
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Systane.

Depression
A 44-year-old male patient from CA (weight: NA) experienced symptoms, such as: keratitis,pain and was treated with Systane Vitamin Omega-3 Supplement(dosage: 1 Df, Bid). The treatment was initiated on Oct 02, 2013. After that a consumer reported the following side effect(s):
  • Depression
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Systane Vitamin Omega-3 Supplement efficacy:
  • Pain Reliever (1 Df, Prn)


Optic Neuritis, Visual Acuity Reduced, Vision Blurred, Ocular Hyperaemia
In this report, Systane Balance Restorative Formula was administered for the following condition: dry eye.A 42-year-old female consumer from US (weight: NA) started Systane Balance Restorative Formula treatment (dosage: Unk) on Jul 13, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Optic Neuritis
  • Visual Acuity Reduced
  • Vision Blurred
  • Ocular Hyperaemia
A possible interaction with other drugs could have contributed to this reaction:
  • Ambien (Unk)
  • Aricept (Unk)
  • Effexor (Unk)
  • Gabapentin (Unk)
  • Lortab (Unk)
  • Pilocarpine (Unk)
  • Plaquenil (Unk)
  • Promethazine (Unk)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Systane Balance Restorative Formula treatment could be related to the listed above side effect(s).

Joint Injury, Visual Acuity Reduced, Lacrimation Increased, Vision Blurred, Eye Irritation, Fall
This is a report of the following Systane side effect(s):
  • Joint Injury
  • Visual Acuity Reduced
  • Lacrimation Increased
  • Vision Blurred
  • Eye Irritation
  • Fall
A 92-year-old female patient from US (weight: NA) presented with the following condition: NA and received a treatment with Systane (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions:
  • Zebeta
  • Crestor
  • Ecotrin
  • Norvasc
  • Plavix
  • Vitamin B
  • Ascorvic Aciid (vitamin C)
  • Vitamin D
This report suggests that a Systane treatment could be associated with the listed above side effect(s).

Corneal Abrasion, Eye Injury, Product Packaging Issue
This Systane Eye Drops report was submitted by a 55-year-old female consumer from US (weight: NA). The patient was diagnosed with: dry eye and Systane Eye Drops was administered (dosage: (as Needed Ophthalmic)) starting: 2012. The consumer developed a set of symptoms:
  • Corneal Abrasion
  • Eye Injury
  • Product Packaging Issue
Other drugs used simultaneously:
  • Nexium
  • Synthroid
  • Lotrel
  • Lexapro
Those unexpected symptoms could be linked to a Systane Eye Drops treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Vision Blurred
This is a report of a possible correlation between Systane use and the following symptoms/side effect(s):
  • Vision Blurred
which could contribute to an assessment of Systane risk profile.A 62-year-old male consumer from US (weight: NA) was suffering from asthenopia and was treated with Systane (dosage: 2 Drops, 1 Time) starting Apr 04, 2013.Other concurrent medications: NA.

Corneal Abrasion, Eye Injury, Product Packaging Issue
A 55-year-old female patient from US (weight: NA) presented with the following symptoms: NA and after a treatment with Systane Eye Drops (dosage: NA) experienced the following side effect(s):
  • Corneal Abrasion
  • Eye Injury
  • Product Packaging Issue
The treatment was started on 2012. Systane Eye Drops was used in combination with the following drugs: NA.This report could alert potential Systane Eye Drops consumers.

Ulcerative Keratitis
In this report, a 58-year-old female patient from US (weight: NA) was affected by a possible Systane side effect.The patient was diagnosed with dry eye,foreign body sensation in eyes. After a treatment with Systane (dosage: 2 Gtt Ou Ophthalmic, start date: Jan 08, 2013), the patient experienced the following side effect(s):
  • Ulcerative Keratitis
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Systane treatment.

Asthma, Rash Pruritic, Lip Swelling, Swollen Tongue, Pharyngeal Oedema, Urticaria, Chest Discomfort, Dyspnoea
This is a report of a 27-year-old female patient from US (weight: NA), who used Systane Eyedrops (dosage: NA) for a treatment of postoperative care. After starting a treatment on Oct 18, 2012, the patient experienced the following side effect(s):
  • Asthma
  • Rash Pruritic
  • Lip Swelling
  • Swollen Tongue
  • Pharyngeal Oedema
  • Urticaria
  • Chest Discomfort
  • Dyspnoea
The following drugs could possibly have interacted with the Systane Eyedrops treatment NA.Taken together, these observations suggest that a Systane Eyedrops treatment could be related to side effect(s), such as Asthma, Rash Pruritic, Lip Swelling, Swollen Tongue, Pharyngeal Oedema, Urticaria, Chest Discomfort, Dyspnoea.

Dizziness, Pallor, Gait Disturbance, Fall, Skin Discolouration
This dizziness side effect was reported by a consumer or non-health professional from US. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Systane Eyedrops (dosage: 1 Df Qid Ou Ophthalmic), which was started on Sep 04, 2012. Concurrently used drugs:
  • Simvastatin
  • Lisinopril
  • Atenolol
  • Vitamin D Nos
  • Multivitamin
  • Aspirin
When starting to take Systane Eyedrops the consumer reported the following symptoms:
  • Dizziness
  • Pallor
  • Gait Disturbance
  • Fall
  • Skin Discolouration
These side effects may potentially be related to Systane Eyedrops.

Eye Irritation
This is a Systane Liquid Gel side effect report of a 81-year-old male patient (weight:NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Systane Liquid Gel (dosage:Unk, start time: Sep 01, 2011), combined with:
  • Restasis (2 Gtt, Bid)
  • Hypotears Ddpf
, and developed a serious reaction and a eye irritation side effect. The patient presented with:
  • Eye Irritation
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Systane Liquid Gel treatment in male patients suffering from NA, resulting in eye irritation.

Eye Irritation
This report suggests a potential Systane eye irritation side effect(s) that can have serious consequences. A 46-year-old female patient from UNITED STATES (weight:NA) was diagnosed with the following health condition(s): dry eye and used Systane (dosage: 2 Gtt, Qid) starting Oct 14, 2011. Soon after starting Systane the patient began experiencing various side effects, including:
  • Eye Irritation
Drugs used concurrently:
  • Restasis (2 Gtt, Bid)
Although Systane demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as eye irritation, may still occur.

Eye Irritation, Eye Pruritus, Vision Blurred
This eye irritation problem was reported by a consumer or non-health professional from UNITED STATES. A 65-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Oct 05, 2011 a consumer started treatment with Systane (dosage: NA). The following drugs/medications were being taken at the same time:
  • Refresh Pm
  • Restasis (1 Gtt, Bid)
When commencing Systane, the patient experienced the following unwanted symptoms /side effects:
  • Eye Irritation
  • Eye Pruritus
  • Vision Blurred
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as eye irritation, may become evident only after a product is in use by the general population.

Rash
This is a Systane side effect report of a 44-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Systane (dosage: NA) starting Oct 05, 2011. Concurrently used drugs:
  • Restasis (1 Gtt, Bid)
Soon after that, the consumer experienced the following of symptoms:
  • Rash
This opens a possibility that Systane could cause rash and that some female patients may be more susceptible.

Vision Blurred
A 88-year-old male patient (weight: NA) from UNITED STATES with the following symptoms: NA started Systane treatment (dosage: NA) on Jun 01, 2011. Soon after starting Systane treatment, the consumer experienced several side effects, including:
  • Vision Blurred
. Concurrently used drugs:
  • Restasis (2 Gtt, Bid)
  • Blink
  • Refresh Plus
This finding indicates that some patients can be more vulnerable to developing Systane side effects, such as vision blurred.

Eyelid Irritation
This eyelid irritation side effect was reported by a consumer or non-health professional from UNITED STATES. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: dry eye.The patient was prescribed Systane (dosage: 1 Gtt, Prn), which was started on Sep 23, 2011. Concurrently used drugs:
  • Restasis (1 Gtt, Bid)
.When starting to take Systane the consumer reported symptoms, such as:
  • Eyelid Irritation
These side effects may potentially be related to Systane.

Eye Irritation, Eye Pain, Foreign Body Sensation In Eyes, Cataract
This is a report of a 65-year-old female patient (weight: NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Systane (dosage: NA, start time: Jan 01, 2007), combined with:
  • Restasis (1 Gtt, Bid)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Eye Irritation
  • Eye Pain
  • Foreign Body Sensation In Eyes
  • Cataract
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Systane treatment in female patients, resulting in eye irritation side effect.

Eye Irritation, Photophobia
This report suggests a potential Systane Eye Irritation, Photophobia side effect(s) that can have serious consequences. A 60-year-old male patient (weight: NA) from UNITED STATES was diagnosed with the following symptoms/conditions: dry eye and used Systane (dosage: Unk) starting Sep 10, 2011. Soon after starting Systane the patient began experiencing various side effects, including:
  • Eye Irritation
  • Photophobia
Drugs used concurrently:
  • Restasis (1 Gtt, Bid)
Although Systane demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as eye irritation, may still occur.

Asthenopia, Eye Irritation, Abnormal Sensation In Eye, Ocular Hyperaemia
This Asthenopia, Eye Irritation, Abnormal Sensation In Eye, Ocular Hyperaemia problem was reported by a consumer or non-health professional from UNITED STATES. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dry eye. On Mar 01, 2011 this consumer started treatment with Systane Liquigel (dosage: Unk). The following drugs were being taken at the same time:
  • Restasis (1 Gtt, Bid)
When commencing Systane Liquigel, the patient experienced the following unwanted symptoms/side effects:
  • Asthenopia
  • Eye Irritation
  • Abnormal Sensation In Eye
  • Ocular Hyperaemia
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as asthenopia, may become evident only after a product is in use by the general population.

Abnormal Sensation In Eye, Eye Irritation, Asthenopia
This is a report of a 56-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: dry eye and was treated with Systane Lubricating Drop (dosage: Unk) starting Jun 27, 2011. Concurrently used drugs:
  • Restasis (1 Gtt, Bid)
Soon after that, the consumer experienced the following side effects:
  • Abnormal Sensation In Eye
  • Eye Irritation
  • Asthenopia
This opens a possibility that Systane Lubricating Drop treatment could cause the above reactions, including abnormal sensation in eye, and some female subjects may be more susceptible.

Vision Blurred, Eye Irritation, Eye Pruritus
A 74-year-old male patient (weight: NA) from UNITED STATES with the following symptoms/conditions: dry eye started Systane Ultra treatment (dosage: Unk) on NS. Soon after starting Systane Ultra treatment, the subject experienced various side effects, including:
  • Vision Blurred
  • Eye Irritation
  • Eye Pruritus
Concurrently used drugs:
  • Restasis (1 Gtt, Bid)
  • Alrex /00595201/ (Unk)
This finding indicates that some male patients could be more vulnerable to Systane Ultra.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


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    Systane Safety Alerts, Active Ingredients, Usage Information

    NDC0065-0429
    TypeHUMAN OTC DRUG
    Proprietary NameSystane Lubricant
    Namepolyethylene glycol 400 and Propylene Glycol
    Dosage FormSOLUTION/ DROPS
    RouteOPHTHALMIC
    On market since20030301
    LabelerAlcon Laboratories, Inc.
    Active Ingredient(s)POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
    Strength(s)4; 3
    Unit(s)mg/mL; mg/mL
    Pharma Class

    More About Systane

    Side Effects reported to FDA: 83

    Systane safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 3

    Latest Systane clinical trials