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Ketotifen (Ophthalmic)

Medically reviewed by Last updated on Oct 30, 2020.


(kee toe TYE fen)

Index Terms

  • Ketotifen Fumarate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

Alaway: 0.025% (10 mL) [contains benzalkonium chloride]

Alaway Childrens Allergy: 0.025% (5 mL) [contains benzalkonium chloride]

Claritin Eye: 0.025% (5 mL) [contains benzalkonium chloride]

Eye Itch Relief: 0.025% (5 mL) [contains benzalkonium chloride]

GoodSense Itchy Eye: 0.025% (5 mL) [contains benzalkonium chloride]

TheraTears Allergy: 0.025% (10 mL) [contains benzalkonium chloride]

Zaditor: 0.025% (5 mL) [contains benzalkonium chloride]

Generic: 0.025% (5 mL)

Brand Names: U.S.

  • Alaway Childrens Allergy [OTC]
  • Alaway [OTC]
  • Claritin Eye [OTC]
  • Eye Itch Relief [OTC]
  • GoodSense Itchy Eye [OTC]
  • TheraTears Allergy [OTC]
  • Zaditor [OTC]

Pharmacologic Category

  • Histamine H1 Antagonist
  • Histamine H1 Antagonist, Second Generation
  • Mast Cell Stabilizer
  • Piperidine Derivative


Exhibits noncompetitive H1-receptor antagonist and mast cell stabilizer properties. Efficacy in conjunctivitis likely results from a combination of anti-inflammatory and antihistaminergic actions including interference with chemokine-induced migration of eosinophils into inflamed conjunctiva.


Minimally systemic (Zaditor US prescribing information, 2002)

Onset of Action

Within minutes (Zaditor Canadian product monograph, 2012)

Duration of Action

Up to 12 hours (Zaditor Canadian product monograph, 2012)

Use: Labeled Indications

Allergic conjunctivitis: Temporary relief of eye itching due to allergic conjunctivitis


Hypersensitivity to ketotifen or any component of the formulation

Dosing: Adult

Allergic conjunctivitis: OTC labeling: Ophthalmic: Instill 1 drop into the affected eye(s) twice daily every 8 to 12 hours (maximum: do not exceed 2 applications/day).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Allergic conjunctivitis: Children ≥3 years and Adolescents: Ophthalmic: Instill 1 drop into lower conjunctival sac of affected eye(s) twice daily (spaced 8 to 12 hours apart). Note: Do not exceed 2 applications per day.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.


Ophthalmic: For use in eyes only. Wash hands before use. Do not let tip of applicator touch eye; do not contaminate tip of applicator. Remove soft contact lenses prior to administration. Wait 10 minutes before reinserting lenses if using products containing benzalkonium chloride. Do not wear contact lenses if eyes are red. Allow at least 5 minutes between applications of other eye drops.


Store at 4°C to 25°C (39°F to 77°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Reactions are generally mild, transient, and local as systemic exposure following topical ocular administration is minimal.


Central nervous system: Headache (≤10% to ≤25%)

Ophthalmic: Conjunctival injection (≤10% to ≤25%)

Respiratory: Rhinitis (≤10% to ≤25%)

1% to 10%:

Hypersensitivity: Hypersensitivity reaction (ophthalmic; <5%)

Ophthalmic: Circumocular rash (<5%), conjunctivitis (<5%), disease of the lacrimal apparatus (<5%), eye pain (<5%), keratitis (<5%), mydriasis (<5%), photophobia (<5%), burning sensation of eyes (<3%), eye discharge (<3%), eyelid disease (<3%), eye pruritus (<3%), stinging of eyes (<3%), xerophthalmia (<3%)

Respiratory: Flu-like symptoms (<5%), pharyngitis (<5%)


Special populations:

• Contact lens wearers: Not to treat contact lens-related irritation. Solution contains benzalkonium chloride; soft contact lens wearers should remove them prior to administration and wait at least 10 minutes after administration before reinserting them. Do not wear contact lenses if eyes are red. Do not contaminate dropper tip or solution when placing drops in eyes.

• Self-medication (OTC use): When used for self-medication (OTC), notify healthcare provider if symptoms worsen or do not improve within 3 days. Contact healthcare provider if change in vision, eye pain, or redness occur. Do not use if solution is cloudy or changes color.

Pregnancy Considerations

Topical ocular administration has not been studied.

Patient Education

What is this drug used for?

• It is used to treat eye irritation.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Vision changes

• Eye pain

• Severe eye irritation

• Eye redness

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.