September 3, 2015
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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.

Last reviewed on RxList: 6/16/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions

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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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