Drug information for ZADITOR

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SOLUTION/DROPS; OPHTHALMIC EQ 0.025% BASE Over The Counter  (Reference Drug) KETOTIFEN FUMARATE ketotifen fumarate ophthalmic solution ALCON PHARMA 21066
2012-05-08 Letter

2011-12-16 Review

2008-07-14 Letter

2006-10-23 Label

2006-10-23 Letter

2001-07-20 Label

1999-07-02 Review

1999-07-02 Letter

1999-07-02 Label

Drug Adverse Effects information for ZADITOR

Role code Indications Reaction # Reports
SS DRY EYE FOREIGN BODY SENSATION IN EYES 2
SS DRY EYE OCULAR HYPERAEMIA 2
SS DRY EYE THYROID DISORDER 2
SS DRY EYE VISION BLURRED 2
C ATRIAL FIBRILLATION ATRIAL FIBRILLATION 1
C ATRIAL FIBRILLATION DIZZINESS 1
C ATRIAL FIBRILLATION NAUSEA 1
C ATRIAL FIBRILLATION PRODUCT QUALITY ISSUE 1
C ATRIAL FIBRILLATION VOMITING 1
C BLOOD CHOLESTEROL INCREASED BLADDER OPERATION 1
C BLOOD CHOLESTEROL INCREASED BLOOD CHOLESTEROL INCREASED 1
C BLOOD CHOLESTEROL INCREASED INCISIONAL HERNIA 1
C DYSPEPSIA BLADDER OPERATION 1
C DYSPEPSIA BLOOD CHOLESTEROL INCREASED 1
C DYSPEPSIA INCISIONAL HERNIA 1
C GLUCOSE TOLERANCE IMPAIRED BLADDER OPERATION 1
C GLUCOSE TOLERANCE IMPAIRED BLOOD CHOLESTEROL INCREASED 1
C GLUCOSE TOLERANCE IMPAIRED INCISIONAL HERNIA 1
C HYPERTENSION BLADDER OPERATION 1
C HYPERTENSION BLOOD CHOLESTEROL INCREASED 1
C HYPERTENSION INCISIONAL HERNIA 1
C MULTIPLE SCLEROSIS BLADDER OPERATION 1
C MULTIPLE SCLEROSIS BLOOD CHOLESTEROL INCREASED 1
C MULTIPLE SCLEROSIS INCISIONAL HERNIA 1
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