ADVERSE REACTIONS
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Clinical Studies Experience
The most frequent adverse reactions reported with the use of ketorolac tromethamine ophthalmic solutions have been transient stinging and burning on instillation. These reactions were reported by up to 40% of patients participating in clinical trials.
Other adverse reactions occurring approximately 1 to 10% of the time during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis, and superficial ocular infections.
Other adverse reactions reported rarely with the use of ketorolac tromethamine ophthalmic solutions included: corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision).
Postmarketing Experience
The following adverse reactions have been identified during post-marketing use of ketorolac tromethamine ophthalmic solution 0.5% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical ketorolac tromethamine ophthalmic solution 0.5% or a combination of these factors, include bronchospasm or exacerbation of asthma, corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown [see Warnings and Precautions (5.2, 5.4)].
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REPORTS OF SUSPECTED ACULAR SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Acular. The information is not vetted and should not be considered as verified clinical evidence.
Possible Acular side effects / adverse reactions in 49 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-20
Patient: 49 year old female
Reactions: Dermatitis Contact
Suspect drug(s):
Acular
Indication: Product Used FOR Unknown Indication
Fluorescite
Indication: Product Used FOR Unknown Indication
Restasis
Indication: Product Used FOR Unknown Indication
Xalatan
Indication: Glaucoma
Possible Acular side effects / adverse reactions in 65 year old female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-24
Patient: 65 year old female weighing 48.0 kg (105.6 pounds)
Reactions: Lacrimation Increased, Eye Pain
Suspect drug(s):
Acular
Other drugs received by patient: Oftaquix; Maxidex
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