"For adults and children who undergo cataract surgery, implantation of an artificial lens is the standard of care. But a clinical trial suggests that for most infants, surgery followed by the use of contact lenses for several years â€” and an eventu"...
Clinical Studies Experience
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.
Table 1 shows frequently reported ocular adverse reactions with an incidence of ≥ 2% of subjects as seen in the combined clinical trial results from three randomized, placebo-controlled studies.
Table 1: Ocular Adverse Reactions Reported by ≥
2% of Subjects
|MedDRA Preferred Term||Placebo
|Anterior Chamber Inflammation||102 (22%)||111 (24%)|
|Intraocular Pressure Increased||15 (3%)||20 (4%)|
|Posterior Capsule Opacification||16 (4%)||18 (4%)|
|Eye Irritation||6 (1%)||9 (2%)|
|Foreign Body Sensation in Eyes||11 (2%)||8 (2%)|
Read the Omidria (phenylephrine and ketorolac injection) Side Effects Center for a complete guide to possible side effects
No information provided.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/28/2016
Additional Omidria Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.