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Systane Side Effects

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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.

Systane Side Effects Reported to FDA



Systane Side Effect Report#9925012
Eye Irritation, Vision Blurred
This is a report of a 44-year-old male patient (weight: NA) from US, suffering from the following health 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): Eye Irritation, Vision Blurred 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.
Systane Side Effect Report#9778330
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. After starting Systane-balance the patient began experiencing various side effects, including: DeafnessAdditional 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.
Systane Side Effect Report#9761266
Vision Blurred, Metamorphopsia, Foreign Body Sensation In Eyes, Lacrimation Increased, Visual Impairment, Ocular Hyperaemia, Eye Inflammation
This Vision Blurred 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 using 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 InflammationAlthough 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.
Systane Side Effect Report#9723051
Eye Irritation, Ocular Discomfort, Ocular Hyperaemia
This Eye Irritation side effect was reported by a consumer or non-health professional from US. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: asthenopia.The patient was prescribed Systane Balance (drug dosage: NA), which was initiated on
Nov 19, 2013. Concurrently used drugs: NA..After starting to take Systane Balance the consumer reported adverse symptoms, such as: Eye Irritation, Ocular Discomfort, Ocular HyperaemiaThese side effects may potentially be related to Systane Balance.
Systane Side Effect Report#9658074
Blood Pressure Increased
This is a report of a 80-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Systane (dosage: Unk, start time:
Oct 20, 2013), combined with: NA. and developed a serious reaction and side effect(s): Blood Pressure Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Systane treatment in female patients, resulting in Blood Pressure Increased side effect.
Systane Side Effect Report#9646190
Depression
This report suggests a potential Systane Vitamin Omega-3 Supplement Depression side effect(s) that can have serious consequences. A 44-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: keratitis,pain and used Systane Vitamin Omega-3 Supplement (dosage: 1 Df, Bid) starting
Oct 02, 2013. After starting Systane Vitamin Omega-3 Supplement the patient began experiencing various side effects, including: DepressionAdditional drugs used concurrently:
  • Pain Reliever (1 Df, Prn)
Although Systane Vitamin Omega-3 Supplement demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Depression, may still occur.
Systane Side Effect Report#9435943
Optic Neuritis, Visual Acuity Reduced, Vision Blurred, Ocular Hyperaemia
This Optic Neuritis problem was reported by a consumer or non-health professional from US. A 42-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dry eye. On
Jul 13, 2013 this consumer started treatment with Systane Balance Restorative Formula (dosage: Unk). The following drugs were being taken at the same time:
  • Ambien (Unk)
  • Aricept (Unk)
  • Effexor (Unk)
  • Gabapentin (Unk)
  • Lortab (Unk)
  • Pilocarpine (Unk)
  • Plaquenil (Unk)
  • Promethazine (Unk)
When using Systane Balance Restorative Formula, the patient experienced the following unwanted symptoms/side effects: Optic Neuritis, Visual Acuity Reduced, Vision Blurred, Ocular HyperaemiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Optic Neuritis, may become evident only after a product is in use by the general population.
Systane Side Effect Report#9349834
Joint Injury, Visual Acuity Reduced, Lacrimation Increased, Vision Blurred, Eye Irritation, Fall
This Joint Injury side effect was reported by a consumer or non-health professional from US. A 92-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Systane (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Zebeta
  • Crestor
  • Ecotrin
  • Norvasc
  • Plavix
  • Vitamin B
  • Ascorvic Aciid (vitamin C)
  • Vitamin D
.After starting to take Systane the consumer reported adverse symptoms, such as: Joint Injury, Visual Acuity Reduced, Lacrimation Increased, Vision Blurred, Eye Irritation, FallThese side effects may potentially be related to Systane.
Systane Side Effect Report#9305918
Corneal Abrasion, Eye Injury, Product Packaging Issue
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 Systane Eye Drops (dosage: (as Needed Ophthalmic), start time: 2012), combined with:
  • Nexium
  • Synthroid
  • Lotrel
  • Lexapro
and developed a serious reaction and side effect(s): Corneal Abrasion, Eye Injury, Product Packaging Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Systane Eye Drops treatment in female patients, resulting in Corneal Abrasion side effect.
Systane Side Effect Report#9221534
Vision Blurred
This report suggests a potential Systane Vision Blurred side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: asthenopia and used Systane (dosage: 2 Drops, 1 Time) starting
Apr 04, 2013. After starting Systane the patient began experiencing various side effects, including: Vision BlurredAdditional drugs used concurrently: NA. Although Systane demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vision Blurred, may still occur.
Systane Side Effect Report#9095426
Corneal Abrasion, Eye Injury, Product Packaging Issue
This Corneal Abrasion problem was reported by a consumer or non-health professional from US. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 2012 this consumer started treatment with Systane Eye Drops (dosage: NA). The following drugs were being taken at the same time: NA. When using Systane Eye Drops, the patient experienced the following unwanted symptoms/side effects: Corneal Abrasion, Eye Injury, Product Packaging IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Corneal Abrasion, may become evident only after a product is in use by the general population.
Systane Side Effect Report#9037052
Ulcerative Keratitis
This Ulcerative Keratitis side effect was reported by a consumer or non-health professional from US. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: dry eye,foreign body sensation in eyes.The patient was prescribed Systane (drug dosage: 2 Gtt Ou Ophthalmic), which was initiated on
Jan 08, 2013. Concurrently used drugs: NA..After starting to take Systane the consumer reported adverse symptoms, such as: Ulcerative KeratitisThese side effects may potentially be related to Systane.
Systane Side Effect Report#8969514
Asthma, Rash Pruritic, Lip Swelling, Swollen Tongue, Pharyngeal Oedema, Urticaria, Chest Discomfort, Dyspnoea, Rash Pruritic
This is a report of a 27-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: postoperative care, who was treated with Systane Eyedrops (dosage: NA, start time:
Oct 18, 2012), combined with: NA. and developed a serious reaction and side effect(s): Asthma, Rash Pruritic, Lip Swelling, Swollen Tongue, Pharyngeal Oedema, Urticaria, Chest Discomfort, Dyspnoea, Rash Pruritic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Systane Eyedrops treatment in female patients, resulting in Asthma side effect.
Systane Side Effect Report#8811538
Dizziness, Pallor, Gait Disturbance, Fall, Skin Discolouration
This report suggests a potential Systane Eyedrops Dizziness 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: NA and used Systane Eyedrops (dosage: 1 Df Qid Ou Ophthalmic) starting
Sep 04, 2012. After starting Systane Eyedrops the patient began experiencing various side effects, including: Dizziness, Pallor, Gait Disturbance, Fall, Skin DiscolourationAdditional drugs used concurrently:
  • Simvastatin
  • Lisinopril
  • Atenolol
  • Vitamin D Nos
  • Multivitamin
  • Aspirin
Although Systane Eyedrops demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dizziness, may still occur.
Systane Side Effect Report#8061466-1
Eye Irritation
This Eye Irritation problem was reported by a consumer or non-health professional from United States. A 81-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Sep 01, 2011 this consumer started treatment with Systane Liquid Gel (dosage: Unk). The following drugs were being taken at the same time:
  • Restasis (2 Gtt, Bid)
  • Hypotears Ddpf
When using Systane Liquid Gel, the patient experienced the following unwanted symptoms/side effects: Eye IrritationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Eye Irritation, may become evident only after a product is in use by the general population.
Systane Side Effect Report#8061426-0
Eye Irritation
This Eye Irritation side effect was reported by a physician from United States. A 46-year-old female patient (weight:NA) experienced the following symptoms/conditions: dry eye.The patient was prescribed Systane (drug dosage: 2 Gtt, Qid), which was initiated on
Oct 14, 2011. Concurrently used drugs:
  • Restasis (2 Gtt, Bid)
.After starting to take Systane the consumer reported adverse symptoms, such as: Eye IrritationThese side effects may potentially be related to Systane.
Systane Side Effect Report#8061401-6
Eye Irritation, Eye Pruritus, Vision Blurred
This is a report of a 65-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Systane (dosage: NA, start time:
Oct 05, 2011), combined with:
  • Refresh Pm
  • Restasis (1 Gtt, Bid)
and developed a serious reaction and side effect(s): Eye Irritation, Eye Pruritus, Vision Blurred 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.
Systane Side Effect Report#8061394-1
Rash
This report suggests a potential Systane Rash side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Systane (dosage: NA) starting
Oct 05, 2011. After starting Systane the patient began experiencing various side effects, including: RashAdditional drugs used concurrently:
  • Restasis (1 Gtt, Bid)
Although Systane demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash, may still occur.
Systane Side Effect Report#8061360-6
Vision Blurred
This Vision Blurred problem was reported by a consumer or non-health professional from United States. A 88-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 01, 2011 this consumer started treatment with Systane (dosage: NA). The following drugs were being taken at the same time:
  • Restasis (2 Gtt, Bid)
  • Blink
  • Refresh Plus
When using Systane, the patient experienced the following unwanted symptoms/side effects: Vision BlurredAlthough 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.
Systane Side Effect Report#8061352-7
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 (drug dosage: 1 Gtt, Prn), which was initiated on
Sep 23, 2011. Concurrently used drugs:
  • Restasis (1 Gtt, Bid)
.After starting to take Systane the consumer reported adverse symptoms, such as: Eyelid IrritationThese side effects may potentially be related to Systane.
Systane Side Effect Report#8061327-8
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 health 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): Eye Irritation, Eye Pain, Foreign Body Sensation In Eyes, Cataract 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.
Systane Side Effect Report#8061326-6
Eye Irritation, Photophobia
This report suggests a potential Systane Eye Irritation 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. After starting Systane the patient began experiencing various side effects, including: Eye Irritation, PhotophobiaAdditional 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.
Systane Side Effect Report#8061239-X
Asthenopia, Eye Irritation, Abnormal Sensation In Eye, Ocular Hyperaemia
This Asthenopia 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 using Systane Liquigel, the patient experienced the following unwanted symptoms/side effects: Asthenopia, Eye Irritation, Abnormal Sensation In Eye, Ocular HyperaemiaAlthough 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.
Systane Side Effect Report#8061165-6
Abnormal Sensation In Eye, Eye Irritation, Asthenopia
This Abnormal Sensation In Eye side effect was reported by a consumer or non-health professional from United States. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: dry eye.The patient was prescribed Systane Lubricating Drop (drug dosage: Unk), which was initiated on
Jun 27, 2011. Concurrently used drugs:
  • Restasis (1 Gtt, Bid)
.After starting to take Systane Lubricating Drop the consumer reported adverse symptoms, such as: Abnormal Sensation In Eye, Eye Irritation, AsthenopiaThese side effects may potentially be related to Systane Lubricating Drop.
Systane Side Effect Report#8061145-0
Vision Blurred, Eye Irritation, Eye Pruritus
This is a report of a 74-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: dry eye, who was treated with Systane Ultra (dosage: Unk, start time: NS), combined with:
  • Restasis (1 Gtt, Bid)
  • Alrex /00595201/ (Unk)
and developed a serious reaction and side effect(s): Vision Blurred, Eye Irritation, Eye Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Systane Ultra treatment in male patients, resulting in Vision Blurred side effect.


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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.

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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.

    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.

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    Discuss Systane Side Effects

    Did You Have a Systane Side Effect?

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    How Effective is Systane for You?

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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