February 14, 2016
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Omidria

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Omidria




Omidria Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/26/2016

Omidria (phenylephrine and ketorolac) Injection is a combination alpha 1-adrenergic receptor agonist and a nonsteroidal anti-inflammatory drug (NSAID) that is added to an ophthalmic irrigation solution used during cataract surgery or intraocular lens replacement and is used for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. Common side effects of Omidria include eye inflammation, increased ocular pressure, eye irritation, the feeling of a foreign body being in the eye, sensitivity of eyes to light, sores in the eye, or allergic reactions such as skin rash, swelling of the face, lips, or tongue.

For administration to patients undergoing cataract surgery or intraocular lens replacement, a dose of 4 mL of Omidria is diluted in 500 mL of ophthalmic irrigation solution. Omidria may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Omidria should only be administered if necessary. Consult your doctor before breastfeeding.

Our Omidria (phenylephrine and ketorolac) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Omidria FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Omidria (Phenylephrine and Ketorolac Injection)

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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