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Ketorolac

Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) used for short-term relief of moderate to moderately severe pain (injection, tablets, nasal spray) and for eye itching and inflammation or pain after eye surgery (eye drops).

Brand names ToradolSprixAcuvailAcularAcular Ls +6 more
Drug classes Cyclooxygenase Inhibitor
Rx Forms 5
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 67 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 →

How we combine label and product data →
Other forms & routes:
Injection Nasal Ophthalmic
Ketorolac at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Ketorolac (Toradol) is a strong NSAID that blocks the COX-1 and COX-2 enzymes making prostaglandins, the chemicals behind pain and inflammation; a hospital standby since about 1989 and available generically, it treats a few days of moderately severe pain, usually after surgery, and as eye drops, eye itching, inflammation and post-surgery eye pain. For a few days most people tolerate it well, and Sprix nasal spray commonly irritates the nose and throat and waters the eyes. The boxed warning caps all forms at 5 days total because stomach bleeding, heart attack, stroke and kidney damage risks climb with dose and time; never stretch it or add aspirin or other NSAIDs.

Clinical pearls

  • Ketorolac tablets only continue treatment after a shot or IV (into a vein) dose, and those injection days count toward the limit.
  • Warfarin and antidepressants such as SSRIs or SNRIs raise its bleeding risk, so list every medicine and condition before the first dose.
  • Ketorolac must not be used when you are dehydrated, so mention vomiting, diarrhea or poor drinking before taking it.
  • It can raise lithium, methotrexate and digoxin levels and blunt blood pressure medicines, so those prescribers need to know.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Ketorolac is for short-term use only, no more than 5 days in total across all forms, and only for moderately severe acute pain. It is not for minor or chronic pain or for children. Taking more than the daily maximum does not give better relief but raises the risk of serious harm.

  • Stomach and intestines: ulcers, bleeding and tears can be fatal and can occur without warning. Older adults are at higher risk.
  • Heart and brain: raises the risk of heart attack and stroke, which may occur early in treatment. It must not be used around CABG surgery.
  • Kidneys: not for people with advanced kidney disease or dehydration.
  • Bleeding: ketorolac affects platelets, so it must not be used in people at high risk of bleeding or before major surgery.
  • Labor and delivery: must not be used, as it can affect the baby's circulation and slow contractions.
  • Aspirin or other NSAIDs: must not be combined with ketorolac.
  • Dosing: doses are adjusted for people 65 or older, under 50 kg, or with raised creatinine.
Read the full warning on DailyMed →
How you get itPrescription only
Comes asInjection, Tablet, Eye drops +2
Earliest FDA record1989
Companies listing it with the FDA106
FDA label last updatedFeb 2, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide — a plain-language walkthrough of Ketorolac, written from its FDA label.

What Ketorolac is used for

▾

Ketorolac is an NSAID used for pain and eye conditions, depending on the product.

  • Ketorolac Tromethamine injection: short-term (5 days or less) management of moderately severe acute pain in adults, usually after surgery.
  • Ketorolac Tromethamine tablets: continuation after injection for the same type of pain.
  • Sprix nasal spray: short-term (up to 5 days) management of moderate to moderately severe pain in adults.
  • Acular and Ketorolac Tromethamine eye drops: temporary relief of eye itching from seasonal allergic conjunctivitis, and inflammation after cataract surgery.
  • Acular Ls eye drops: eye pain and burning/stinging after corneal refractive surgery.
  • Acuvail eye drops: pain and inflammation after cataract surgery.

How Ketorolac works

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Ketorolac blocks COX-1 and COX-2 enzymes, which cuts the body's production of prostaglandins. Prostaglandins make nerves more sensitive to pain and drive inflammation. Lowering them eases pain and inflammation.

The label notes the exact mechanism is not completely understood.

Ketorolac dosage

▾

How ketorolac is taken depends on the product. Follow your prescriber and the label.

  • Injection: given into a muscle or vein by a healthcare professional. Treatment for pain starts this way.
  • Tablets: only a follow-on after injection, never the first dose.
  • Sprix nasal spray: used about every 6 to 8 hours, and discarded within 24 hours of the first dose.
  • Eye drops: used in the eye as directed.
  • All forms of ketorolac for pain combined should not exceed 5 days.

Use the lowest effective dose for the shortest time.

Dosing details from the FDA-approved label

From the Ketorolac prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Ketorolac tromethamine tablets (continuation therapy to ketorolac injection)
    • Indicated only as continuation therapy to ketorolac tromethamine injection
    • Oral formulation should not be given as an initial dose
    • Use minimum effective dose for the individual patient
    • Maximum: maximum 40 mg total daily dose; combined duration of injection and tablets not to exceed 5 days
  • Ketorolac tromethamine injection (single or multiple dose, moderately severe acute pain requiring analgesia at the opioid level)
    • May be used as a single or multiple dose on a regular or "as needed" schedule
    • Intravenous bolus must be given over no less than 15 seconds
    • Intramuscular administration should be given slowly and deeply into the muscle
    • Maximum: maximum 120 mg total daily dose; therapy not to exceed 5 days
    • Hypovolemia should be corrected prior to administration
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to intravenous or intramuscular dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from intravenous or intramuscular dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine. Note: Oral formulation should not be given as an initial dose. Use minimum effective dose for the individual patient. Total duration of treatment in adult patients: the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. KETOROLAC TROMETHAMINE INJECTION Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or "as needed" schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS – Renal Effects ). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. When administering ketorolac tromethamine injection, the intravenous bolus must be given over no less than 15 seconds. The intramuscular administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing intravenous or intramuscular. Duration of analgesic effect is usually 4 to 6 hours. Single-Dose Treatment: The following regimen should be limited to single administration use only Intramuscular Dosing • Patients <65 years of age: One dose of 60 mg. • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg. Intravenous Dosing • Patients <65 years of age: One dose of 30 mg.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Ketorolac side effects

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Common side effects

  • Nasal discomfort or irritation (Sprix)
  • Nasal pain (rhinalgia) (Sprix)
  • Watery eyes (Sprix)
  • Throat irritation (Sprix)
  • Rash
  • Slow heart rate (Sprix)
  • Decreased urine output (Sprix)
  • Raised liver blood tests (Sprix)

When to get medical help

  • Black or bloody stools, vomiting blood, or severe stomach pain, which can signal a stomach or intestinal bleed, ulcer or tear. These can happen without warning.
  • Chest pain, shortness of breath, weakness on one side, or slurred speech, which can signal a heart attack or stroke. Get emergency help.
  • Swelling of the face or throat, trouble breathing, or wheezing, which can signal a severe allergic reaction. Get emergency help.
  • Skin rash, blisters, mucosal sores or other signs of allergy. Stop the drug and call your doctor.
  • Fever, rash, swollen glands or facial swelling, which can signal a reaction called DRESS.
  • Nausea, fatigue, yellow skin or eyes, itching, or upper right belly tenderness, which can signal liver problems.
  • Little urine, swelling, or fluid retention, which can signal kidney problems or worsening heart failure.
  • Unusual bleeding or bruising.

The most common side effects reported with Sprix include:

  • Nasal discomfort and nasal pain
  • Watery eyes
  • Throat irritation
  • Runny nose
  • Rash
  • Slow heart rate
  • Decreased urine output
  • Raised liver tests
  • High blood pressure

Seek help for signs of bleeding, heart attack or stroke, allergic reaction, severe skin reaction, liver or kidney problems.

Ketorolac warnings and precautions

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  • GI bleeding, ulcers and perforation: can be fatal and happen without warning. Risk is higher with age, alcohol, smoking, steroids, anticoagulants and a history of ulcers.
  • Heart attack and stroke: risk may start early and rises with longer use.
  • Kidney injury: especially with dehydration, heart failure, liver problems, or when taking water pills, ACE inhibitors or ARBs.
  • Bleeding: ketorolac affects platelets.
  • Blood pressure, fluid retention and heart failure: may worsen.
  • Liver, skin and allergic reactions: including DRESS, can be serious.
  • Never exceed 5 days of total use for pain.

Ketorolac interactions

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Ketorolac can interact with many medicines.

  • Aspirin and other NSAIDs: more GI toxicity and bleeding, with no added benefit.
  • Probenecid and pentoxifylline: should not be combined.
  • Warfarin, other blood thinners, SSRIs and SNRIs: higher bleeding risk.
  • ACE inhibitors, ARBs, beta-blockers and diuretics: weaker blood pressure effects and possible kidney harm.
  • Digoxin, lithium, methotrexate, cyclosporine, pemetrexed: may increase levels or toxicity.
  • Seizure drugs, psychoactive drugs and muscle relaxants: seizures, hallucinations or apnea reported.

Interactions listed in the FDA-approved label

From the Ketorolac prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Anticoagulants such as warfarin, antiplatelet agents, SSRIs, SNRIs: Ketorolac and anticoagulants have a synergistic effect on bleeding, and concomitant use increases the risk of serious bleeding compared with either drug alone. Monitor patients for signs of bleeding.
  • Pentoxifylline: Concomitant use increases the risk of bleeding. Concomitant use is contraindicated.
  • Aspirin: Concomitant use with analgesic doses of aspirin produces no greater therapeutic effect and was associated with a significantly increased incidence of GI adverse reactions. Concomitant use with analgesic doses of aspirin is not generally recommended because of increased risk of bleeding.
  • ACE inhibitors, ARBs, beta-blockers: NSAIDs may diminish the antihypertensive effect; in elderly, volume-depleted or renally impaired patients, co-administration with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. Monitor blood pressure and renal function; patients should be adequately hydrated.
  • Diuretics (loop, e.g. furosemide, and thiazide): NSAIDs reduced the natriuretic effect of loop and thiazide diuretics in some patients. Observe for signs of worsening renal function and assure diuretic efficacy including antihypertensive effects.
  • Digoxin: Concomitant use has been reported to increase the serum concentration and prolong the half-life of digoxin. Monitor serum digoxin levels.
  • Lithium: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. Monitor patients for signs of lithium toxicity.
  • Methotrexate: Concomitant use may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Monitor patients for methotrexate toxicity.
  • Probenecid: Concomitant administration of oral ketorolac and probenecid results in increased half-life and systemic exposure. Concomitant use is contraindicated.
  • Other NSAIDs or salicylates: Concomitant use increases the risk of GI toxicity, with little or no increase in efficacy. Concomitant use is not recommended.
Read the label’s full interactions text

Drug Interactions Ketorolac is highly bound to human plasma protein (mean 99.2%). There is no evidence in animal or human studies that ketorolac tromethamine induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs. Warfarin, Digoxin, Salicylate, and Heparin The in vitro binding of warfarin to plasma proteins is only slightly reduced by ketorolac tromethamine (99.5% control vs 99.3%) when ketorolac plasma concentrations reach 5 to 10 mcg/mL. Ketorolac does not alter digoxin protein binding. In vitro studies indicate that, at therapeutic concentrations of salicylate (300 mcg/mL), the binding of ketorolac was reduced from approximately 99.2% to 97.5%, representing a potential two-fold increase in unbound ketorolac plasma levels. Therapeutic concentrations of digoxin, warfarin, ibuprofen, naproxen, piroxicam, acetaminophen, phenytoin and tolbutamide did not alter ketorolac tromethamine protein binding. In a study involving 12 adult volunteers, oral ketorolac tromethamine was coadministered with a single dose of 25 mg warfarin , causing no significant changes in pharmacokinetics or pharmacodynamics of warfarin. In another study, ketorolac tromethamine dosed intravenous or intramuscular was given with two doses of 5000 U of heparin to 11 healthy volunteers, resulting in a mean template bleeding time of 6 minutes (3.2 to 11.4 min) compared to a mean of 6.0 minutes (3.4 to 7.5 min) for heparin alone and 5.1 minutes (3.5 to 8.5 min) for placebo. Although these results do not indicate a significant interaction between ketorolac tromethamine and warfarin or heparin, the administration of ketorolac tromethamine to patients taking anticoagulants should be done extremely cautiously and patients should be closely monitored (see WARNINGS and PRECAUTIONS – Hematologic Effects ).

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿35 supplements and herbs with documented Ketorolac interactions, ranked by severity Check Ketorolac against a supplement or herb →

Before taking Ketorolac

▾
  • Do not use with active or past stomach ulcer or GI bleeding.
  • Do not use with allergy to ketorolac, or asthma, hives or allergic reactions after aspirin or NSAIDs.
  • Do not use around CABG surgery, before major surgery, or in labor and delivery.
  • Do not use with advanced kidney disease, dehydration, or bleeding disorders or brain bleeding.
  • Tell your doctor about heart disease, high blood pressure, heart failure, liver disease or inflammatory bowel disease.
  • Pregnancy: avoid at about 30 weeks and later; limit use from about 20 weeks.
  • Breastfeeding: ketorolac passes into breast milk; discuss with your doctor.
  • Women trying to conceive: NSAIDs may cause reversible infertility.
  • Older adults need caution and lower dosing.
  • Children: not for pediatric use with injection or tablets; Sprix not for under 2.

Ketorolac overdose

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Overdose symptoms are usually tiredness, drowsiness, nausea, vomiting and upper stomach pain. GI bleeding can occur, and high blood pressure, kidney failure, breathing problems and coma are rare. There is no specific antidote, so treatment is supportive care. Get emergency help right away.

What Ketorolac does in the body

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Ketorolac is an NSAID with pain-relieving activity. Its effect is tied to its S-form. It has no sedative or anti-anxiety effects. Peak pain relief occurs within 2 to 3 hours. Dose size mainly changes how long relief lasts, not how strong it is.

How your body processes Ketorolac

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Oral ketorolac is fully absorbed. A high-fat meal lowers the peak level and delays it by about 1 hour, while antacids do not affect absorption. It is heavily bound to proteins in the blood and is mostly broken down in the liver. About 92% leaves in the urine and about 6% in stool.

The half-life is about 5 to 6 hours and is longer in older adults (about 7 hours). Reduced kidney function slows clearance.

How to store Ketorolac

▾

Store at 20° to 25°C (68° to 77°F). Protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

35

Supplements & herbs that interact with Ketorolac

35 supplements and herbal products have documented interactions with Ketorolac in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 18
  • Minor · 12
ACTIVATED CHARCOAL Major ASARABACCA Major BEER Major SIBERIAN COCKLEBUR Major WINE Major AFRICAN WILD POTATO Moderate ARISTOLOCHIA Moderate Banderol Moderate +27 more
Every supplement checked against Ketorolac — ranked by severity The full interaction hub: 5 major · 18 moderate · 12 minor · every one linked to its full report. Check Ketorolac against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Ketorolac has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

FOLIC ACID Insufficient Evidence
See the full Ketorolac nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Ketorolac: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Ketorolac — the kind of thing our pharmacy team would talk through with you at the counter.

What is ketorolac used for?

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It depends on the form. The injection, tablets and Sprix nasal spray are for short-term relief of moderate to moderately severe pain in adults. The eye drops treat eye itching from seasonal allergies, or inflammation and pain after eye surgery, depending on the brand.

How long can I take it?

▾
For pain, no more than 5 days total, counting injection, tablets and spray together. Taking it longer or at higher doses raises the risk of serious side effects without better relief. Switch to another pain reliever as your doctor directs.

Can I take it with ibuprofen or aspirin?

▾
No. Ketorolac should not be combined with aspirin or other NSAIDs because the risk of stomach bleeding and other serious effects goes up with no extra benefit. Always check with me before adding any pain reliever.

What side effects should I expect, and when should I call?

▾
With Sprix, nasal irritation, nasal pain and watery eyes are most common. Call your doctor right away for black or bloody stools, vomiting blood, chest pain, trouble breathing, swelling of the face, a skin rash, yellowing skin or eyes, or very little urine.

Is ketorolac safe in pregnancy?

▾
NSAIDs can cause fetal heart and kidney problems. They should be avoided at about 30 weeks and later, and limited between about 20 and 30 weeks. It must not be used during labor and delivery. Talk to your doctor if you are pregnant or trying to become pregnant.

Who shouldn't take it?

▾
People with a history of stomach ulcers or GI bleeding, advanced kidney disease, bleeding problems, or allergy to aspirin or NSAIDs should not take it. It is also off-limits around CABG surgery. Tell me about your medical history and medicines first.

Is Ketorolac available over the counter?

▾
No. Ketorolac is a prescription medicine: every Ketorolac product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Ketorolac first available?

▾
The earliest FDA record we hold for Ketorolac is from 1989: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Ketorolac was first used.

Who makes Ketorolac?

▾
106 companies list Ketorolac products in the FDA's NDC Directory, including A-S Medication Solutions, Remedyrepack Inc., Medical Purchasing Solutions, LLC. That count includes repackagers and distributors as well as manufacturers, so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Ketorolac on HelloPharmacist

📊Ketorolac supplement interactions35 checked — ranked by severity 🌿Drug & Supplement CheckerKetorolac vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Ketorolac NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Ketorolac Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Ketorolac forms and strengths (how it comes)

Ketorolac is available in 5 forms. 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

Into a muscle · Into a vein
Brands Acunivive 15 Acunivive 30 Acunivive 60 Toronova II SUIK Toronova SUIK
How this form is used
What it may be used for
  • Ketorolac Tromethamine injection: short-term (5 days or less) management of moderately severe acute pain in adults needing opioid-level relief, usually after surgery.
Important instructions
  • Ketorolac Tromethamine injection: treatment starts with injection into a vein or muscle.
  • Ketorolac Tromethamine injection and tablets combined must not exceed 5 days.
  • Ketorolac Tromethamine injection has a higher maximum daily dose than the tablets.
Available strengths 4 strengths
15 mg/2 mL 15 mg/mL 30 mg/mL 60 mg/2 mL
271 FDA-listed product records ⓘ

Tablet

By mouth
How this form is used
What it may be used for
  • Ketorolac Tromethamine tablets: short-term (5 days or less) continuation treatment for moderately severe acute pain in adults, after initial injection dosing.
Important instructions
  • Ketorolac Tromethamine tablets are only for continuing treatment after injection, never for the first dose.
  • Combined use of injection and tablets must not exceed 5 days.
  • Ketorolac Tromethamine tablets have a lower maximum daily dose than the injection.
Available strengths 1 strength
10 mg
126 FDA-listed product records ⓘ

Eye drops

In the eye
Brands Acular Acular Ls Acuvail
How this form is used
What it may be used for
  • Acular and Ketorolac Tromethamine eye drops: temporary relief of eye itching from seasonal allergic conjunctivitis, and treatment of inflammation after cataract surgery.
  • Acular Ls: reduces eye pain and burning/stinging after corneal refractive surgery.
  • Acuvail: treats pain and inflammation after cataract surgery.
Important instructions
  • Ketorolac Tromethamine ophthalmic solution 0.5%: before first use, check that the tamper-evident ring is intact, tear it off, then turn the cap counterclockwise to open. If the ring is broken or missing, contact your pharmacist.
Available strengths 4 strengths
0.5 mg/mL 4 mg/mL 4.5 mg/mL 5 mg/mL
63 FDA-listed product records ⓘ

Nasal spray

In the nose
Brands Sprix
How this form is used
What it may be used for
  • Sprix: short-term (up to 5 days) management of moderate to moderately severe pain in adults needing opioid-level relief.
Important instructions
  • Sprix is not an inhaled product.
  • Sprix is used about every 6 to 8 hours, with one spray in each nostril for adults under 65.
  • Sprix: people 65 or older, under 50 kg or with kidney problems use a lower dose in one nostril only.
  • Sprix: discard the bottle within 24 hours of the first dose, even if medicine remains.
Available strengths 1 strength
15.75 mg
5 FDA-listed product records ⓘ

Spray

By mouth
Available strengths 1 strength
15.75 mg
1 FDA-listed product record ⓘ

Ketorolac on the U.S. market: products, makers and brands

How Ketorolac 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.

106 companies list 482 Ketorolac product records with the FDA, mostly as injection, tablet, eye drops; the earliest marketing or approval year on record is 1989. Brand names on the directory include Toradol, Sprix, Acuvail and 8 more; the rest are generics.

5
Dose forms ⓘ
106
Labelers (makers, repackagers, distributors)
11
Brand names
482
FDA-listed product records ⓘ
1989
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (15) · Kit (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions8%
Remedyrepack Inc.6%
Medical Purchasing Solutions, LLC5%
Fresenius Kabi USA, LLC5%
Cardinal Health 107, LLC5%
Bryant Ranch Prepack4%
Other makers67%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Ketorolac is used (Medicaid data)

A general measure of how commonly Ketorolac 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 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.

1,877,272
Medicaid prescriptions filled (Q1–Q4 2025)
$41.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ketorolac prescribed? Of the 1,601 medications we measure, Ketorolac ranks #117 by Medicaid prescriptions — more than 93% of them.

Where Ketorolac ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #117 of 1,601
#112 Potassium 1,949,817 Rx #113 Nicotine 1,920,723 Rx #114 Dulaglutide Injection 1,895,289 Rx #115 Valacyclovir 1,885,604 Rx #116 Dexmethylphenidate 1,880,821 Rx #117 Ketorolac 1,877,272 Rx #118 Fluticasone Oral Inhal... 1,858,417 Rx #119 Potassium Chloride 1,842,382 Rx #120 Fluticasone and Salmet... 1,781,081 Rx #121 Fluticasone / Salmeter... 1,781,081 Rx #122 Citalopram 1,776,268 Rx

Utilization by Ketorolac 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.

The 1 mL / 30 mg/mL injection is the most-dispensed Ketorolac product — about 35% of these Medicaid prescriptions.

1 ML ketorolac tromethamine 30 MG/ML Injection Most dispensed

650,252 Medicaid prescriptions (Q1–Q4 2025) 35% of Ketorolac prescriptions shown $14.4M gross reimbursement (before rebates) ≈ $22 per prescription (gross)

Summed across the 15 of 76 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1665461

ketorolac tromethamine 10 MG Oral Tablet

469,808 Medicaid prescriptions (Q1–Q4 2025) 25% of Ketorolac prescriptions shown $5.7M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 9 of 250 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 834022

1 ML ketorolac tromethamine 15 MG/ML Injection

333,542 Medicaid prescriptions (Q1–Q4 2025) 18% of Ketorolac prescriptions shown $13.8M gross reimbursement (before rebates) ≈ $41 per prescription (gross)

Summed across the 18 of 56 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860092

2 ML ketorolac tromethamine 30 MG/ML Injection

267,195 Medicaid prescriptions (Q1–Q4 2025) 14% of Ketorolac prescriptions shown $3.7M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 14 of 69 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1665459

ketorolac tromethamine 5 MG/ML Ophthalmic Solution

136,236 Medicaid prescriptions (Q1–Q4 2025) 7% of Ketorolac prescriptions shown $2.4M gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 12 of 51 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860107

ketorolac tromethamine 4 MG/ML Ophthalmic Solution

11,828 Medicaid prescriptions (Q1–Q4 2025) <1% of Ketorolac prescriptions shown $1M gross reimbursement (before rebates) ≈ $88 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860103

1 ML ketorolac tromethamine 30 MG/ML Prefilled Syringe

2,525 Medicaid prescriptions (Q1–Q4 2025) <1% of Ketorolac prescriptions shown $112,702 gross reimbursement (before rebates) ≈ $45 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860114

2 ML ketorolac tromethamine 30 MG/ML Prefilled Syringe

1,417 Medicaid prescriptions (Q1–Q4 2025) <1% of Ketorolac prescriptions shown $3,576 gross reimbursement (before rebates) ≈ $2.52 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860115

ketorolac tromethamine 4.5 MG/ML Ophthalmic Solution

112 Medicaid prescriptions (Q1–Q4 2025) <1% of Ketorolac prescriptions shown $34,284 gross reimbursement (before rebates) ≈ $306 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 858364

Other Ketorolac products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

4,357 Medicaid prescriptions (Q1–Q4 2025) <1% of Ketorolac prescriptions shown $346,223 gross reimbursement (before rebates) ≈ $79 per prescription (gross)

Summed across the 1 of 75 listed NDC products with Medicaid activity.

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, 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 75 of 591 listed Ketorolac NDCs with Medicaid activity.

Compare Ketorolac products

A representative set of FDA-listed product records for Ketorolac — 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.)

Showing 200 of 482 products — FDA National Drug Code Directory. See every product, package size and price: browse all 482 Ketorolac NDCs →

Ketorolac 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.

The FDA’s enforcement reports list 4 Ketorolac recalls since July 2021. Three of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Oct 1, 2025 · Aspiro Pharma Limited
Presence of Particulate Matter: Particulate matter identified as glass
  • Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO… Lots: Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027. FDA record D-0036-2026 →
Ongoing Class II Sep 5, 2025 · Apotex Corp.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
  • Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC… Lots: Batch # VA0444, exp. date 01/2026 Batch # VA4608, exp. date 01/2026 Batch # TZ7016, exp. date 12/2025 UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316 FDA record D-0677-2025 →
Ongoing Class II May 28, 2025 · Apotex Corp.
Lack of Assurance of Sterility
  • Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2 Lots: Batch TZ1236, Exp Date: 11/30/2025 FDA record D-0494-2025 →
Class II Aug 10, 2022 · Terminated · Nephron Sc Inc
cGMP Deviations: deviations leading to potential cross-contamination.
  • Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 04… Lots: Lot#: 023011 Exp 8/31/2022 FDA record D-1354-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ketorolac RxCUI 35827 7 dose forms · 15 strengths
  1. Dose form (SCDF) Cartridge RxCUI 1665674 No current FDA listing
    Clinical drug / strength (SCD) 1 ML ketorolac tromethamine 15 MG/ML RxCUI 1665675 1 ML ketorolac tromethamine 30 MG/ML RxCUI 1665679
  2. Dose form (SCDF) Injectable Solution RxCUI 372545 In current FDA listings
    Clinical drug / strength (SCD) tromethamine 10 MG/ML RxCUI 861846 tromethamine 30 MG/ML RxCUI 860096
  4. Dose form (SCDF) Metered Dose Nasal Spray RxCUI 1797854 In current FDA listings
    Clinical drug / strength (SCD) tromethamine 15.8 MG/ACTUAT RxCUI 1797855
  6. Dose form (SCDF) Oral Tablet RxCUI 372547 In current FDA listings
    Clinical drug / strength (SCD) tromethamine 10 MG RxCUI 834022

Look up RxCUI 35827 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.

Ketorolac brand names

Ketorolac is sold under 11 brand names in the FDA directory — Toradol, Sprix, Acuvail, Acular and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Toradol Sprix Acuvail Acular Acular Ls Toronova II SUIK Toronova SUIK Acunivive 15 Acunivive 30 Acunivive 60 Acunivive 90

Who makes Ketorolac: manufacturers and labelers

40 companies list Ketorolac products with the FDA. By number of product records, the largest are A-S Medication Solutions, Remedyrepack Inc., Medical Purchasing Solutions, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

A-S Medication Solutions 30 Remedyrepack Inc. 22 Medical Purchasing Solutions, LLC 19 Fresenius Kabi USA, LLC 18 Cardinal Health 107, LLC 17 Bryant Ranch Prepack 15 NuCare Pharmaceuticals,Inc. 14 Hospira, Inc. 12 Gland Pharma Limited 11 Baxter Healthcare Corporation 11 Henry Schein, Inc. 11 Preferred Pharmaceuticals Inc. 9 Hikma Pharmaceuticals USA Inc. 9 HF Acquisition Co LLC, DBA HealthFirst 9 Asclemed USA, Inc. 9 Allergan, Inc. 9 Alembic Pharmaceuticals Inc. 9 Sun Pharmaceutical Industries, Inc. 9 Fosun Pharma USA Inc 8 Proficient Rx LP 8 Caplin Steriles Limited 8 NuCare Pharmaceuticals, Inc. 7 Eugia US LLC 6 Civica, Inc. 6

…and 16 more on the FDA NDC directory.

Ketorolac drug class (RxNorm)

Ketorolac belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase Inhibitor
Drug family (ATC) Sympathomimetics excl. antiglaucoma preparations, Acetic acid derivatives and related substances, Antiinflammatory agents, non-steroids
How it works Cyclooxygenase Inhibitors

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.

Sources for this Ketorolac page

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 2, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ketorolac.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ketorolac after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
67
NDC products indexed
482
Distinct labelers/manufacturers represented
106
Linked representative label ⓘ
Civica, Inc.
Linked label effective
Feb 2, 2026
Composite sections available
22
Linked SPL Set ID
32198544-4a46-495c-ab65-0836dcbc2c49
Linked SPL Document ID
cc594527-566a-4fd8-944a-41e39918cbc3
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Civica, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →