Ketorolac / Phenylephrine
Ketorolac/phenylephrine is a combination used during cataract surgery or intraocular lens replacement to keep the pupil open and reduce postoperative eye pain.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Ketorolac / Phenylephrine: Patient Information Guide
A plain-language walkthrough of Ketorolac / Phenylephrine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Ketorolac/phenylephrine (brand name Omidria) is a combination drug used exclusively in the surgical setting during eye procedures.
- Omidria intraocular injection is added to irrigating solution during cataract surgery to prevent the pupil from constricting (getting smaller) during the operation
- Omidria intraocular injection is used during intraocular lens replacement to maintain pupil size throughout the procedure
- Omidria also helps reduce eye pain that occurs after cataract surgery or lens replacement
⚙️How it works▾
Omidria contains two medicines that complement each other. Phenylephrine works by activating alpha-1 receptors in the iris — the colored part of your eye — causing the muscle that widens the pupil to contract and stay open. Ketorolac is an NSAID that blocks COX-1 and COX-2 enzymes, reducing prostaglandins (inflammation-triggering chemicals) released during surgical trauma; this both eases post-surgical pain and prevents the pupil from shrinking in response to surgical stimulation.
💊How it's taken▾
Omidria is prepared and administered entirely by your surgical team — you will not handle or dose it yourself. It comes as a concentrated solution that must be diluted into 500 mL of ocular irrigating solution before use. The diluted solution is used as needed to irrigate the eye throughout cataract surgery or lens replacement for a single patient.
- The diluted solution must be used within 4 hours at room temperature or within 24 hours if kept refrigerated
- It should be discarded if it appears cloudy or contains visible particles
🤒Side effects — in detail▾
The most commonly reported side effects of Omidria (affecting 2% or more of patients) include:
- Eye irritation
- Increased pressure inside the eye (intraocular pressure)
- Inflammation in the front chamber of the eye (anterior chamber inflammation)
- Clouding behind the lens implant (posterior capsule opacification)
- Sensation of a foreign body in the eye
More serious reactions — including a significant rise in blood pressure from phenylephrine or breathing difficulty (bronchospasm) in people sensitive to NSAIDs — should be reported to your care team immediately.
⚠️Warnings & precautions▾
- Blood pressure increase: Phenylephrine can enter the bloodstream and raise blood pressure, even when used as an eye irrigation solution. Your surgical team will watch for this.
- Aspirin/NSAID sensitivity and asthma: Ketorolac can cause cross-reactions in people sensitive to aspirin or NSAIDs, including sudden airway tightening (bronchospasm) in people with asthma. Alert your team before surgery if this applies to you.
- Pregnancy — especially third trimester: NSAIDs used late in pregnancy can cause premature closure of the ductus arteriosus, an important blood vessel in the developing baby. Use of Omidria during late pregnancy should be avoided.
- Allergic reaction: Omidria is contraindicated (must not be used) in anyone with a known allergy to any of its ingredients.
🔀What it interacts with▾
The FDA label for Omidria does not list specific drug-drug interactions, but notes two important sensitivities to be aware of:
- Aspirin and other NSAIDs: People who are sensitive to these drugs may have a cross-sensitivity reaction to ketorolac in Omidria, including breathing problems
- Asthma medications/conditions: Patients with asthma are at higher risk for bronchospasm with NSAID use and should make sure their surgical team is aware
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Tell your surgical team about any known allergy to Omidria's ingredients, aspirin, or other NSAIDs — use is contraindicated if you have such an allergy
- Mention any history of asthma, as this raises the risk of breathing-related side effects
- If you are pregnant — particularly in the third trimester — discuss the risks with your doctor before proceeding; late-pregnancy use should be avoided
- If you are breastfeeding, discuss with your provider; systemic absorption of Omidria appears low, but the decision should be made weighing the benefits of breastfeeding against any potential risk
- Omidria has been studied and approved for use in children from newborns through adolescents (under 17 years), with no overall safety differences compared to adults
- Older adults have not shown differences in safety or effectiveness compared to younger adults
🚑If you take too much▾
If too much phenylephrine is absorbed systemically, it can cause a significant rise in blood pressure, as well as headache, anxiety, nausea, vomiting, and serious heart rhythm problems (ventricular arrhythmias). Supportive medical care is recommended and your surgical team is equipped to manage this.
🔬Pharmacokinetics — how your body processes it▾
Studies show that systemic (whole-body) absorption of both phenylephrine and ketorolac from Omidria is very low — in many patients, blood levels were undetectable. In a study of 14 patients, detectable phenylephrine levels were found in only 1 patient, and those levels could not be clearly separated from pre-surgery eye drops given beforehand. Ketorolac was detected in the blood of 10 out of 14 patients at low levels during the first 8 hours after surgery. This low systemic exposure helps explain why serious whole-body side effects are uncommon with Omidria.
📦How to store it▾
Store at 20˚ to 25˚C (68˚ to 77˚F). Protect from light.
📄 Written from Ketorolac / Phenylephrine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Ketorolac / Phenylephrine — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Omidria and why would I get it during eye surgery? ▾
Will I feel Omidria being given during surgery? ▾
What side effects should I watch for after my surgery? ▾
I have asthma and take aspirin for my heart — is Omidria safe for me? ▾
I'm pregnant — can I still receive Omidria? ▾
Can Omidria be used in children? ▾
Is Ketorolac / Phenylephrine available over the counter? ▾
When was Ketorolac / Phenylephrine first available? ▾
Who makes Ketorolac / Phenylephrine? ▾
💬 Answers drafted from Ketorolac / Phenylephrine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Ketorolac / Phenylephrine comes
Ketorolac / Phenylephrine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Omidria is used to maintain pupil dilation (prevent the pupil from shrinking) during cataract surgery or intraocular lens replacement
- Omidria is used to reduce eye pain after cataract surgery or intraocular lens replacement
- Omidria must be diluted before use — it is added to 500 mL of ocular irrigating solution by healthcare providers
- Omidria is prepared and used for a single patient during a single surgical procedure
- Once diluted, Omidria solution should be used within 4 hours at room temperature or within 24 hours if refrigerated
- Omidria should not be used if the solution appears cloudy or contains particles
📊 Ketorolac / Phenylephrine across the U.S. market
How Ketorolac / Phenylephrine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Ketorolac / Phenylephrine is used
A general measure of how commonly Ketorolac / Phenylephrine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ketorolac / Phenylephrine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ketorolac / Phenylephrine prescribed? Of the 1,596 medications we measure, Ketorolac / Phenylephrine ranks #1,143 by Medicaid prescriptions — more than 28% of them.
Utilization by Ketorolac / Phenylephrine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation Solution
Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1540230
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ketorolac / Phenylephrine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 9 listed Ketorolac / Phenylephrine NDCs with Medicaid activity.
🔍 Compare Ketorolac / Phenylephrine products
A representative set of FDA-listed product records for Ketorolac / Phenylephrine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| PHENYLEPHRINE 10.16 mg/mL; KETOROLAC 2.88 mg/mL | — | Hospira, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| PHENYLEPHRINE 10.16 mg/mL; KETOROLAC 2.88 mg/mL | Intraocular | Omeros Corporation | NDA | View NDC → |
| 2.88; 10.16 mg/mL; mg/mL | Intraocular | Omeros Corporation × 2 listings | NDA | View NDC → |
| PHENYLEPHRINE 10.16 mg/mL; KETOROLAC 2.88 mg/mL | — | Patheon Manufacturing Services LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| PHENYLEPHRINE 10.16 mg/mL; KETOROLAC 2.88 mg/mL | Intraocular | Rayner Surgical Inc. | NDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Ketorolac / Phenylephrine NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ketorolac / Phenylephrine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ketorolac / Phenylephrine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Ketorolac / Phenylephrine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 1540229 1 dose form · 1 strength
-
Dose form (SCDF) Ophthalmic Irrigation Solution RxCUI 1543459No current FDA listingClinical drug / strength (SCD) ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/MLRxCUI 1540230
Look up RxCUI 1540229 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Ketorolac / Phenylephrine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Ketorolac / Phenylephrine belongs to the Nonsteroidal Anti-inflammatory Drug class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Rayner Surgical Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.