KETOTIFEN FUMARATE

N/A

Manufactured by Alcon Laboratories, Inc.

11,458 FDA adverse event reports analyzed

Last updated: 2026-04-15

About KETOTIFEN FUMARATE

KETOTIFEN FUMARATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alcon Laboratories, Inc.. The most commonly reported adverse reactions for KETOTIFEN FUMARATE include TREATMENT FAILURE, DRUG INEFFECTIVE, EYE IRRITATION, EYE PAIN, OCULAR HYPERAEMIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for KETOTIFEN FUMARATE.

Top Adverse Reactions

TREATMENT FAILURE2,496 reports
DRUG INEFFECTIVE899 reports
EYE IRRITATION628 reports
EYE PAIN270 reports
OCULAR HYPERAEMIA222 reports
EYE PRURITUS212 reports
PRURITUS210 reports
FATIGUE182 reports
HEADACHE178 reports
HYPERSENSITIVITY171 reports
NAUSEA163 reports
DYSPNOEA162 reports
PAIN149 reports
DIARRHOEA148 reports
VISION BLURRED141 reports
CONDITION AGGRAVATED135 reports
DIZZINESS133 reports
URTICARIA125 reports
RASH124 reports
DRUG HYPERSENSITIVITY119 reports
INSTILLATION SITE PAIN113 reports
VOMITING108 reports
DRY EYE107 reports
ASTHENIA103 reports
EYE SWELLING101 reports
ERYTHEMA98 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION92 reports
BLOOD PRESSURE INCREASED86 reports
OFF LABEL USE86 reports
VISUAL IMPAIRMENT84 reports
LACRIMATION INCREASED82 reports
ASTHMA81 reports
PRODUCT DOSE OMISSION ISSUE81 reports
COUGH80 reports
ABDOMINAL PAIN79 reports
GAIT DISTURBANCE78 reports
ABDOMINAL DISCOMFORT76 reports
WEIGHT DECREASED76 reports
ARTHRALGIA72 reports
BACK PAIN72 reports
FALL71 reports
DYSPHAGIA69 reports
CONSTIPATION67 reports
PRODUCT USE IN UNAPPROVED INDICATION67 reports
ANAPHYLACTIC REACTION65 reports
JOINT SWELLING64 reports
OSTEOARTHRITIS64 reports
PRODUCT QUALITY ISSUE62 reports
PNEUMONIA60 reports
SOMNOLENCE60 reports
MALAISE59 reports
DRY SKIN58 reports
PYREXIA58 reports
WHEEZING56 reports
FEELING ABNORMAL55 reports
HYPOAESTHESIA54 reports
MYALGIA53 reports
RHINORRHOEA53 reports
PHOTOPHOBIA51 reports
ANGIOEDEMA50 reports
CONTUSION50 reports
BLISTER49 reports
CHEST DISCOMFORT49 reports
BURNING SENSATION48 reports
CHILLS48 reports
INSOMNIA48 reports
COVID 1947 reports
HYPERTENSION47 reports
NASOPHARYNGITIS46 reports
MUSCULOSKELETAL STIFFNESS45 reports
PERIPHERAL SWELLING45 reports
ANXIETY44 reports
BLOOD GLUCOSE INCREASED44 reports
EYE DISCHARGE44 reports
ILLNESS44 reports
LOSS OF CONSCIOUSNESS43 reports
SINUSITIS43 reports
URINARY TRACT INFECTION43 reports
EXPIRED PRODUCT ADMINISTERED41 reports
EYE DISORDER41 reports
EYELID OEDEMA40 reports
NECK PAIN40 reports
PAIN IN EXTREMITY40 reports
ARTHRITIS39 reports
DRUG INTOLERANCE38 reports
SKIN REACTION38 reports
SNEEZING38 reports
DYSPHONIA37 reports
HYPOTENSION37 reports
RHEUMATOID ARTHRITIS37 reports
OEDEMA36 reports
EAR PAIN35 reports
EYE INFLAMMATION35 reports
HEART RATE INCREASED35 reports
MIGRAINE35 reports
MUSCLE SPASMS35 reports
MUSCULAR WEAKNESS35 reports
INSTILLATION SITE IRRITATION34 reports
TENDERNESS34 reports
DYSPHORIA33 reports

Report Outcomes

Out of 6,341 classified reports for KETOTIFEN FUMARATE:

Serious 16.1%Non-Serious 83.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female4,391 (73.9%)
Male1,543 (26.0%)
Unknown7 (0.1%)

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with KETOTIFEN FUMARATE?

This profile reflects 11,458 FDA FAERS reports that mention KETOTIFEN FUMARATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for KETOTIFEN FUMARATE?

Frequently reported terms in FAERS include TREATMENT FAILURE, DRUG INEFFECTIVE, EYE IRRITATION, EYE PAIN, OCULAR HYPERAEMIA, EYE PRURITUS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures KETOTIFEN FUMARATE?

Labeling and FAERS entries often list Alcon Laboratories, Inc. in connection with KETOTIFEN FUMARATE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.