Prescription medicine
Ketorolac and phenylephrine Brand names: Omidria
Ketorolac and phenylephrine (Omidria) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ketorolac and phenylephrine FDA label on DailyMed (effective July 7, 2023, Rayner Surgical Inc.); the NDA 205388 record on Drugs@FDA; every ketorolac and phenylephrine label on DailyMed.
Highlights of the record
FDA label of July 7, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageOmidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain.
Forms and strengths
- 10.16 mg/ml / 2.88 mg/ml
Injection (solution) (concentrate).
On the market
- Earliest approval on file
- May 30, 2014 Omidria, Rayner Surgical; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first July 1, 2019; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- April 23, 2034 Omidria solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 82 through July 30, 2026
What is ketorolac and phenylephrine used for?
From the label: indications and usageOmidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for: Maintaining pupil size by preventing intraoperative miosis ( 1 ) Reducing postoperative pain ( 1 ) OMIDRIA is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement.
Conditions named in the indications of ketorolac and phenylephrine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cyclooxygenase Inhibitor, Nonsteroidal Anti-inflammatory Drug and alpha-1 Adrenergic Agonist.
Source: FDA drug label (Omidria), Rayner Surgical Inc., effective July 7, 2023 (SPL set f25d7a42-da2a-7310-e053-2995a90a590f), via openFDA; the full label on DailyMed
Is there a generic for ketorolac and phenylephrine (Omidria)?
The FDA approved the first generic ketorolac and phenylephrine on July 1, 2019. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 3 patents for Omidria solution, the last expiring on April 23, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2019 first generic approved
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ketorolac and phenylephrine label say about other medicines?
The ketorolac and phenylephrine label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | warnings and precautions | There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac in patien ts who either have a known hypersensitivity to aspirin/NSAIDs or a past medical history of asthma. |
Source: FDA drug label (Omidria), Rayner Surgical Inc., effective July 7, 2023 (SPL set f25d7a42-da2a-7310-e053-2995a90a590f), via openFDA; the full label on DailyMed
What do FAERS reports show for ketorolac and phenylephrine?
The FDA Adverse Event Reporting System holds 82 reports that list ketorolac and phenylephrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 2 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cyclooxygenase inhibitors
- the pharmacologic class, with prices and generics
- Ketorolac and phenylephrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other