July 30, 2016
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Omidria

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Omidria

Side Effects
Interactions

SIDE EFFECTS

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
(N=462)
n (%)
Omidria
(N=459)
n (%)
Ocular Events
  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

DRUG INTERACTIONS

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

Side Effects
Interactions

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.


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