ALLERGY EYE (KETOTIFEN) (ketotifen fumarate)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

There are 10 severe adverse reactions.

More Frequent	Less Frequent
Ocular inflammation Ocular redness	Conjunctivitis Keratitis Ocular discharge Ocular itching Ocular pain Pruritus of skin Skin rash Urticaria

Rare/Very Rare
None.

There are 8 less severe adverse reactions.

More Frequent	Less Frequent
Headache disorder Rhinitis	Conjunctivitis Keratitis Ocular discharge Ocular itching Ocular pain Pruritus of skin Skin rash Urticaria

Rare/Very Rare
None.

Category C. (See Users Guide.)

Drug/Drug Class	Severity	Precaution Description	Pregnancy Category Description
Ketotifen	2	Insuff human data avail; consider maternal benefit vs neonatal risk	No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information.

Ketotifen is distributed into milk in rats following oral administration. It is not known if topical ocular administration could result in sufficient systemic absorption to produce detectable distribution in breast milk; therefore, caution should be exercised when ocular ketotifen is administered to a nursing woman.

Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.

Drug Name	Excretion Potential	Effect on Infant	Notes
Ketotifen	Unknown. It is unknown whether the drug is excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Insufficient human data available

No enhanced Geriatric Use information available for this drug.