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Ketotifen Fumarate

Ketotifen Fumarate

What Is Ketotifen Ophthalmic?

Ketotifen is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Ketotifen ophthalmic (for use in the eyes) is used to treat itching of the eyes caused by allergy to dust, pollen, animals, or other allergens.

Ketotifen ophthalmic may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Why is this medication prescribed?

Ophthalmic ketotifen is used to relieve the itching of allergic pinkeye. Ketotifen is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.

Before taking this medicine

You should not use ketotifen ophthalmic if you are allergic to it, or if you have:

an untreated eye infection; or

eye irritation caused by wearing contact lenses.

Ketotifen ophthalmic is not approved for use by anyone younger than 3 years old.

What side effects can this medication cause?

Ketotifen eye drops may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • runny nose
  • burning or stinging of the eye
  • eye discharge
  • dry eyes
  • eye pain
  • eyelid problems
  • itching
  • problem with tear production
  • blurred vision
  • sensitivity to light
  • rash
  • flu-like symptoms
  • sore throat


Children, infants, neonates

Safe and effective use of ocular ketotifen in neonates, infants, and children below the age of 3 years has not been established. Oral ketotifen has been given to children as young as 6 months at dosages one-half the usual adult dose.

Contact lenses

The preservative benzalkonium chloride may be absorbed by soft contact lenses. Contact lens wearers should wait at least 10 minutes after using ketotifen before inserting their lenses. Do not use ketotifen to treat contact lens related ocular irritation.


Ocular ketotifen is considered a FDA pregnancy category C agent. Animal data reveal no harmful effects of ketotifen during pregnancy.No adequate and well-controlled studies of ketotifen in pregnant women have been performed. Ketotifen has been shown to have little systemic exposure following ocular administration, even with repeat dosing. Thus, harmful effects during pregnancy would not be expected. It is recommended that pregnant women check with their qualified health care professional prior to self-treatment with any medicine, including this non-prescription antihistamine eye drop.


Caution should be exercised when systemically administered ketotifen is administered to a women who is breast-feeding. Ketotifen has been identified in breast milk in animals following oral administration. Ketotifen ophthalmic solution has been shown to have little systemic exposure following ocular administration, even with repeat dosing ; thus ocular administration is not likely to produce detectable quantities in breast milk.