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Rohto Side Effects

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Common Rohto Side Effects


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

Conjunctivitis (1)
Corneal Abrasion (1)
Corneal Disorder (1)
Chemical Burns Of Eye (1)
Burning Sensation (1)
Vision Blurred (1)
Application Site Erythema (1)
Application Site Pain (1)
Corneal Scar (1)
Corneal Transplant (1)
Optic Nerve Disorder (1)
Poisoning (1)
Pruritus (1)
Iris Hyperpigmentation (1)
Feeling Abnormal (1)
Dry Eye (1)
Erythema (1)
Eye Irritation (1)
Alcohol Poisoning (1)


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.

Rohto Side Effects Reported to FDA



Rohto Side Effect Report#9959106
Corneal Disorder, Optic Nerve Disorder
This is a report of a 24-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: ocular hyperaemia, who was treated with Rohto Cool (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Corneal Disorder, Optic Nerve Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rohto Cool treatment in female patients, resulting in Corneal Disorder side effect.
Rohto Side Effect Report#9916152
Burning Sensation, Pruritus, Erythema
This report suggests a potential Rohto Cool Burning Sensation side effect(s) that can have serious consequences. A 39-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: asthenopia and used Rohto Cool (dosage: NA) starting NS. After starting Rohto Cool the patient began experiencing various side effects, including: Burning Sensation, Pruritus, ErythemaAdditional drugs used concurrently: NA. Although Rohto Cool demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Burning Sensation, may still occur.
Rohto Side Effect Report#9844443
Eye Irritation
This Eye Irritation problem was reported by a consumer or non-health professional from US. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: eye disorder. On
Dec 15, 2013 this consumer started treatment with Rohto Hdra (dosage: NA). The following drugs were being taken at the same time: NA. When using Rohto Hdra, 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.
Rohto Side Effect Report#9413532
Feeling Abnormal
This Feeling Abnormal side effect was reported by a consumer or non-health professional from US. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Rohto Hydra (drug dosage: NA), which was initiated on
Apr 08, 2013. Concurrently used drugs:
  • Clonazepam
  • Sertraline
  • Hydrochlorot
  • Amlodipine
  • Levothyroxine
  • Omeprazol
  • Famotidin
  • Singulair
.After starting to take Rohto Hydra the consumer reported adverse symptoms, such as: Feeling AbnormalThese side effects may potentially be related to Rohto Hydra.
Rohto Side Effect Report#7984812-3
Iris Hyperpigmentation
This is a report of a 36-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: ocular hyperaemia,growth of eyelashes, who was treated with Rohto (dosage: Unk, start time:
Apr 01, 2011), combined with:
  • Latisse (1 Gtt, Prn)
and developed a serious reaction and side effect(s): Iris Hyperpigmentation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rohto treatment in female patients, resulting in Iris Hyperpigmentation side effect.
Rohto Side Effect Report#7091951-0
Application Site Erythema, Application Site Pain, Vision Blurred
This report suggests a potential Rohto Arctic Redness Reliever Application Site Erythema side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: erythema,eye irritation and used Rohto Arctic Redness Reliever (dosage: Several Drops In Rt. Eye) starting
Sep 21, 2010. After starting Rohto Arctic Redness Reliever the patient began experiencing various side effects, including: Application Site Erythema, Application Site Pain, Vision BlurredAdditional drugs used concurrently: NA. Although Rohto Arctic Redness Reliever demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Application Site Erythema, may still occur.
Rohto Side Effect Report#6146271-5
Alcohol Poisoning, Chemical Burns Of Eye, Corneal Abrasion, Corneal Scar, Corneal Transplant, Poisoning
This Alcohol Poisoning problem was reported by a consumer or non-health professional from United States. A 27-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 28, 2007 this consumer started treatment with Rohto V. Ice Eye Drops (see Label) (dosage: NA). The following drugs were being taken at the same time: NA. When using Rohto V. Ice Eye Drops (see Label), the patient experienced the following unwanted symptoms/side effects: Alcohol Poisoning, Chemical Burns Of Eye, Corneal Abrasion, Corneal Scar, Corneal Transplant, PoisoningAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Alcohol Poisoning, may become evident only after a product is in use by the general population.
Rohto Side Effect Report#10072499
Conjunctivitis, Dry Eye
This Conjunctivitis side effect was reported by a consumer or non-health professional from US. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: erythema,dry eye.The patient was prescribed Rohto Cool (drug dosage: 2-3x/day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Rohto Cool the consumer reported adverse symptoms, such as: Conjunctivitis, Dry EyeThese side effects may potentially be related to Rohto Cool.



The appearance of Rohto 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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What are common Rohto Side Effects for Men?

Men Side EffectsReports
Conjunctivitis 1
Dry Eye 1

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.

    Rohto 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 Rohto Side Effects

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    Rohto Safety Alerts, Active Ingredients, Usage Information

    NDC10742-8142
    TypeHUMAN OTC DRUG
    Proprietary NameRohto Cool
    NameNaphazoline hydrochloride, Polysorbate 80
    Dosage FormLIQUID
    RouteOPHTHALMIC
    On market since20010821
    LabelerThe Mentholatum Company
    Active Ingredient(s)NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80
    Strength(s).12; 2
    Unit(s)mg/mL; mg/mL
    Pharma Class

    More About Rohto

    Side Effects reported to FDA: 8

    Rohto safety alerts: 2013

    Latest Rohto clinical trials