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Acular (Ketorolac Tromethamine Ophthalmic) - Side Effects and Adverse Reactions

 
 



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)].



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



See index of all Acular side effect reports >>

Drug label data at the top of this Page last updated: 2012-06-18

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