KETOTIFEN: 5,209 Adverse Event Reports & Safety Profile

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5,209

Total FAERS Reports

9 (0.2%)

Deaths Reported

Hospitalizations

5,209

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Dec 1, 2006

FDA Approved

CVS Pharmacy

Manufacturer

Discontinued

Status

Yes

Generic Available

Active Ingredient: KETOTIFEN FUMARATE · Drug Class: Histamine H1 Receptor Antagonists [MoA] · Route: OPHTHALMIC · Manufacturer: CVS Pharmacy · FDA Application: 021066 · HUMAN OTC DRUG · FDA Label: Available

Patent Expires: Mar 27, 2028 · First Report: 20011223 · Latest Report: 20250910

What Are the Most Common KETOTIFEN Side Effects?

#1 Most Reported

Treatment failure

3,038 reports (58.3%)

#2 Most Reported

Drug ineffective

798 reports (15.3%)

#3 Most Reported

Eye irritation

455 reports (8.7%)

All KETOTIFEN Side Effects by Frequency

Side Effect	Reports	% of Total	Deaths	Hosp.
Treatment failure	3,038	58.3%	0	1
Drug ineffective	798	15.3%	1	9
Eye irritation	455	8.7%	0	0
Eye pain	208	4.0%	0	0
Ocular hyperaemia	166	3.2%	0	0
Eye pruritus	164	3.2%	1	0
Hypersensitivity	102	2.0%	0	3
Vision blurred	87	1.7%	0	0
Condition aggravated	83	1.6%	1	10
Eye swelling	72	1.4%	0	0
Product quality issue	55	1.1%	0	0
Dizziness	52	1.0%	0	2
Dry eye	51	1.0%	0	2
Pruritus	47	0.9%	0	2
Lacrimation increased	43	0.8%	0	0
Off label use	43	0.8%	0	7
Expired product administered	39	0.8%	0	0
Product use in unapproved indication	38	0.7%	0	8
Instillation site pain	36	0.7%	0	0
Burning sensation	35	0.7%	0	2

Who Reports KETOTIFEN Side Effects? Age & Gender Data

Gender: 73.1% female, 26.9% male. Average age: 57.8 years. Most reports from: US. View detailed demographics →

Is KETOTIFEN Getting Safer? Reports by Year

Year	Reports	Deaths	Hosp.
2001	4	0	4
2002	3	0	2
2006	1	0	0
2007	1	0	0
2009	1	0	0
2010	1	0	0
2013	4	0	0
2014	46	1	3
2015	116	0	1
2016	132	0	4
2017	126	0	16
2018	72	0	1
2019	89	0	8
2020	81	0	7
2021	62	0	11
2022	44	0	0
2023	55	1	4
2024	38	0	0
2025	17	0	1

View full timeline →

What Is KETOTIFEN Used For?

Indication	Reports
Product used for unknown indication	4,052
Eye pruritus	291
Eye allergy	210
Hypersensitivity	179
Dry eye	80
Mast cell activation syndrome	47
Eye irritation	44
Ocular hyperaemia	39
Seasonal allergy	32
Lacrimation increased	30

KETOTIFEN vs Alternatives: Which Is Safer?

KETOTIFEN vs KLONOPIN KETOTIFEN vs L-ASPARAGINASE KETOTIFEN vs LABETALOL KETOTIFEN vs LABETALOL\LABETALOL KETOTIFEN vs LACIDIPINE KETOTIFEN vs LACOSAMIDE KETOTIFEN vs LACTOBACILLUS ACIDOPHILUS KETOTIFEN vs LACTOBACILLUS RHAMNOSUS KETOTIFEN vs LACTOSE KETOTIFEN vs LACTULOSE

Other Drugs in Same Class: Histamine H1 Receptor Antagonists [MoA]

CETIRIZINE (47,655) DIPHENHYDRAMINE (25,827) FEXOFENADINE (21,453) LEVOCETIRIZINE (10,782) OLOPATADINE (8,787) AZELASTINE (5,896) DESLORATADINE (3,141) DIMENHYDRINATE (1,934) View all → Class side effects → Compare in class →

Official FDA Label for KETOTIFEN

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Dosage & Administration

Directions

adults and children 3 years and older:
put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day
if using other ophthalmic products while using this product, wait at least 5 minutes between each product
children under 3 years of age: consult a doctor Other information store at 4-25 °C (39-77 °F)

Warnings

Warnings For external use only Do not use

if you are sensitive to any ingredient in this product
if solution changes color or becomes cloudy
to treat contact lens related irritation When using this product
remove contact lenses before use
wait at least 10 minutes before re-inserting contact lenses after use
do not touch tip of container to any surface to avoid contamination
replace cap after each use Stop use and ask doctor if you experience any of the following:
eye pain
changes in vision
redness of the eyes
itching that worsens or lasts more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient

Active ingredient Purpose Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Antihistamine

Inactive Ingredients

Inactive ingredients benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection Questions or comments? [phone icon]Call: 1-800-632-6900 DISTRIBUTED BY: THE KROGER CO., CINCINNATI, OHIO 45202 PRODUCT OF ITALY *Systane® and Zaditor® are registered trademarks of Alcon, Inc., Fribourg, Switzerland CH-1701. Alcon, Inc. is not affiliated with The Kroger Co. or this product. QUALITY GUARANTEE 1-800-632-6900 www.kroger.com 9767401 MK60107