Prescription medicine
Ketorolac Brand names: Acular, Sprix, Acuvail; first approved as Toradol
Ketorolac (Toradol) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 60 generic labelers, and pharmacies paid $1.02 per mL (Ketorolac 30 mg/mL vial) in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
- Boxed warning
Check it at the source: the ketorolac FDA label on DailyMed (effective August 31, 2023, Fresenius Kabi USA, LLC); the NDA 19698 record on Drugs@FDA; every ketorolac label on DailyMed.
Highlights of the record
FDA label of August 31, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. Oral ketorolac tromethamine is indicated only as continuation treatment following intravenous or intramuscular dosing of ketorolac tromethamine, if necessary. The total combined duration of use of oral ketorolac tromethamine and ketorolac tromethamine injection should not exceed 5 days. Ketorolac tromethamine is not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine beyond the label recommendations will not provide better efficacy but will increase the risk of developing serious adverse events. GASTROINTESTINAL RISK Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS ). […]
Used for
From the label: indications and usageCarefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac.
Forms and strengths
- 10 mg
- 15.75 mg
- 4 mg/ml
- 4.5 mg/ml
- 5 mg/ml
- 15 mg/ml
- 30 mg/ml
- 60 mg/2ml
Injection (solution); film-coated tablet; injection; solution/ drops; solution.
On the market
- Earliest approval on file
- November 30, 1989 Toradol, Roche Palo; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 57 first May 16, 1997; 29 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 63 of which 60 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- August 15, 2029 Acuvail solution/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.02 per mL Ketorolac 30 mg/mL vial
- Shortage (FDA)
- 13 of 26 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 24 since 2012 3 Class I among all firms' recalls; latest October 1, 2025; 2 more by firms not listed as its makers
- FAERS reports
- 5,597 through July 30, 2026
What is ketorolac used for?
From the label: indications and usageCarefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Acute Pain in Adult Patients Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. […]
Conditions named in the indications of ketorolac's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cyclooxygenase Inhibitor and Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Ketorolac Tromethamine), Fresenius Kabi USA, LLC, effective August 31, 2023 (SPL set 3d88cbe6-5230-47aa-80af-0c41283d1f00), via openFDA; the full label on DailyMed
What does the patient leaflet for ketorolac say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with the use of NSAIDs taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed
Source: FDA drug label (Ketorolac Tromethamine), Fresenius Kabi USA, LLC, effective August 31, 2023 (SPL set 3d88cbe6-5230-47aa-80af-0c41283d1f00), via openFDA; the full label on DailyMed
Is there a generic for ketorolac (Toradol)?
The FDA approved the first generic ketorolac on May 16, 1997. 57 generic applications are approved; 29 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ketorolac from 60 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Toradol injection; a patent listed only for Acuvail solution/drops runs to August 15, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1989 earliest approval on file
- 1997 first generic approved
- 2029 last listed patent
- 2018 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ketorolac (Toradol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.02 per mL (Ketorolac 30 mg/mL vial), down 6% from $1.08 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ketorolac 30 mg/mL vial (generic)
- Acular ls 0.4% eye solution (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ketorolac 0.4% eye solution | Generic | $12.67 per mL | n/a | +6% |
| Ketorolac 0.5% eye solution | Generic | $1.39 per mL | n/a | -9% |
| Ketorolac 10 mg tablet | Generic | $0.164 per tablet | $4.93 | -34% |
| Ketorolac 30 mg/mL vial | Generic | $1.02 per mL | n/a | -6% |
| Ketorolac 60 mg/2 mL vial | Generic | $0.552 per mL | $1.10 per vial | -4% |
| Acular ls 0.4% eye solution | Brand | $54.45 per mL | n/a | -0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is ketorolac in shortage?
The FDA Drug Shortage Database lists 13 of 26 ketorolac presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on March 23, 2018. 12 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 0338-0069-10) | Baxter Healthcare | Current | October 2, 2026 |
| Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 0409-3793-01) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 0641-6041-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 25021-700-01) | Sagent Pharmaceuticals | Current | September 18, 2026 |
| Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 25021-700-01) | Gland Pharma Limited | Current | July 22, 2026 |
| Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 62332-599-25) | Alembic Pharmaceuticals | Current | May 15, 2026 |
| Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 63323-161-01) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 76045-107-10) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has ketorolac been recalled?
The FDA's Enforcement Report lists 26 recalls naming ketorolac since 2012: 3 Class I (the most serious), 23 Class II, 0 Class III; 7 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of ketorolac and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 1, 2025 | Class II | Aspiro Pharma Limited | Presence of Particulate Matter: Particulate matter identified as glass |
| September 5, 2025 | Class II | Apotex Corp. | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns |
| May 28, 2025 | Class II | Apotex Corp. | Lack of Assurance of Sterility |
| April 26, 2023 | Class II | Akorn, Inc. | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| October 13, 2022 | Class II | Akorn, Inc. | CGMP Deviations: |
| August 10, 2022 | Class II | Nephron Sc Inc | cGMP Deviations: deviations leading to potential cross-contamination. |
| December 23, 2020 | Class I | Fresenius Kabi USA, LLC | Presence of Particulate Matter - found in reserve sample vials at the firm. |
| December 17, 2020 | Class II | Fresenius Kabi USA, LLC | Presence of Particulate Matter - found in reserve sample vials at the firm. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ketorolac label say about other medicines?
The ketorolac label names 23 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name ketorolac. 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 |
|---|---|---|
| Alprazolam | drug interactions | Clinical Impact: Hallucinations have been reported when ketorolac was used in patients taking psychoactive drugs (…). Intervention: During concomitant use of SPRIX and psychoactive drugs, monitor patients for hallucinations. |
| Aspirin | boxed warning | Ketorolac tromethamine is CONTRAINDICATED in patients with previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). |
| Carbamazepine | drug interactions | Clinical Impact: Sporadic cases of seizures have been reported during concomitant use of ketorolac and antiepileptic drugs (phenytoin, carbamazepine). Intervention: During concomitant use of SPRIX and antiepileptic drugs, monitor patients for seizures. |
| Cyclosporine | drug interactions | Clinical Impact: Concomitant use of SPRIX and cyclosporine may increase cyclosporine’s nephrotoxicity. Intervention: During concomitant use of SPRIX and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates |
| Diclofenac | drug interactions | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Diflunisal | drug interactions | NSAIDs and Salicylates Clinical Impact: Concomitant use of ketorolac with other NSAIDs or salicylates (…) increases the risk of GI toxicity, with little or no increase in efficacy [ see Warnings and Precautions () and Clinical Pharmacology () ]. Intervention: The concomitant use of ketorolac with other NSAIDs or salicylates is not recommended. |
| Digoxin | drug interactions | Clinical Impact: The concomitant use of ketorolac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of SPRIX and digoxin, monitor serum digoxin levels. |
| Fluoxetine | drug interactions | Clinical Impact: Hallucinations have been reported when ketorolac was used in patients taking psychoactive drugs (…). Intervention: During concomitant use of SPRIX and psychoactive drugs, monitor patients for hallucinations. |
| Furosemide | drug interactions | Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. … Intervention: During concomitant use of SPRIX with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [ see Warnings and … |
| Heparin | warnings | Patients on therapeutic doses of anticoagulants (e.g., heparin or dicumarol derivatives) have an increased risk of bleeding complications if given ketorolac tromethamine concurrently; therefore, physicians should administer such concomitant therapy only extremely cautiously. |
| Indomethacin | drug interactions | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Lithium | drug interactions | Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. … Intervention: During concomitant use of SPRIX and lithium, monitor patients for signs of lithium toxicity. |
| Meloxicam | drug interactions | Pemetrexed Clinical Impact: Concomitant use of SPRIX and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days … |
| Methotrexate | drug interactions | Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (…). Intervention: During concomitant use of SPRIX and methotrexate, monitor patients for methotrexate toxicity. |
Every other medicine the ketorolac label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nabumetone | drug interactions | Pemetrexed Clinical Impact: Concomitant use of SPRIX and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following … |
| Pemetrexed | drug interactions | Pemetrexed Clinical Impact: Concomitant use of SPRIX and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). Intervention: During concomitant use of SPRIX and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. … |
| Pentoxifylline | contraindications | The concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated. |
| Phenytoin | drug interactions | Clinical Impact: Sporadic cases of seizures have been reported during concomitant use of ketorolac and antiepileptic drugs (phenytoin, carbamazepine). Intervention: During concomitant use of SPRIX and antiepileptic drugs, monitor patients for seizures. |
| Probenecid | contraindications | The concomitant use of ketorolac tromethamine and probenecid is contraindicated. |
| Propranolol | drug interactions | ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). … Intervention: During concomitant use of SPRIX and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. … |
| Thiothixene | drug interactions | Clinical Impact: Hallucinations have been reported when ketorolac was used in patients taking psychoactive drugs (…). Intervention: During concomitant use of SPRIX and psychoactive drugs, monitor patients for hallucinations. |
| Tromethamine | boxed warning | WARNING Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires … |
| Warfarin | warnings | The concurrent use of ketorolac tromethamine and therapy that affects hemostasis, including prophylactic low-dose heparin (2500-5000 units q12h), warfarin and dextrans have not been studied … |
Source: FDA drug label (Ketorolac Tromethamine), Fresenius Kabi USA, LLC, effective August 31, 2023 (SPL set 3d88cbe6-5230-47aa-80af-0c41283d1f00), via openFDA; the full label on DailyMed
What do FAERS reports show for ketorolac?
The FDA Adverse Event Reporting System holds 5,597 reports that list ketorolac among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 306 are coded as a death and 1,451 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does ketorolac compare with medicines for the same use?
14 side-by-side pages set ketorolac beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ketorolac
- medicines labeled for the same conditions
- Other cyclooxygenase inhibitors
- the pharmacologic class, with prices and generics
- Ketorolac side effects
- the label's list beside FAERS reports
- Ketorolac shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other