Ketorolac Tromethamine: uses, dosing, side effects & brands
Ketorolac Tromethamine is a nonsteroidal anti-inflammatory drug sold in the U.S. under 6 brand and generic names, for allergic conjunctivitis, inflammation and pain. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Nonsteroidal Anti-Inflammatory Drug
- Treats (across its forms)
- Allergic Conjunctivitis, Inflammation and Pain
- Available as
- Drops · Injectable · Solution · Tablet · Spray/Inhaler, metered
- Sold as
- 6 products — Acular, Acular Ls and Acular Preservative Free, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 5 to 6 hours
- Boxed warning
- Boxed warning
How Sprix is dosed
From the FDA label for Sprix (application NDA022382). Other ketorolac tromethamine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. ( 2.1 ) SPRIX is not an inhaled product. For adult patients < 65 years of age: 31.5 mg (one 15.75 mg spray in each nostril) every 6 to 8 hours. The maximum daily dose is 126 mg. ( 2.2 , 2.3 ) For patients ≥ 65 years of age, renally impaired patients, and patients less than 50 kg (110 lbs): 15.75 mg (one 15.75 mg spray in only one nostril) every 6 to 8 hours. The maximum daily dose is 63 mg. ( 2.4 ) SPRIX nasal spray should be discarded within 24 hours of taking the first dose, even if the bottle still contains some medication. ( 2.5 ) 2.1 General Dosing Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. The total duration of use of SPRIX alone or sequentially with other formulations of ketorolac (IM/IV or oral) must not exceed 5 days because of the potential for increasing the frequency and severity of adverse reactions associated with the recommended doses [ see Warnings and Precautions ( 5.15 ) ]. Do not use SPRIX concomitantly with other formulations of ketorolac or other NSAIDs [ see Warnings and Precautions ( 5.15 ) ]. 2.2 Administration SPRIX is not an inhaled product. Do not inhale when administering this product. Instruct patients to administer as follows:…
Everything below is the FDA label for Sprix (spray/inhaler, metered). Ketorolac Tromethamine is also sold as drops, injectable, solution and tablet, and those are different medicines to take — follow the label for the one you were prescribed.
Sprix side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] Hypertension [ see Warnings and Precautions ( 5.4 ) ] Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] Hematologic Toxicity [ see Warnings and Precautions ( 5.12 ) ] Most common adverse reactions (incidence ≥2%) in patients treated with SPRIX and occurring at a rate at least twice that of placebo are nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash, bradycardia, decreased urine output, increased ALT and/or AST, hypertension, and rhinitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zyla Life Sciences US Inc. at 1-800-518-1084 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another…
Who shouldn’t take Sprix
SPRIX is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ketorolac or any components of the drug product [ see Warnings and Precautions ( 5.7 , 5.9 ) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7 , 5.8 ) ] In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1 ) ] Use in patients with active peptic ulcer disease and in patients with recent gastrointestinal bleeding or perforation [ see Warnings and Precautions ( 5.2 ) ] Use as a prophylactic analgesic before any major surgery [ see Warnings and Precautions ( 5.11 ) ] Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion [ see Warnings and Precautions ( 5.6 ) ] Use in labor and delivery. Through its prostaglandin synthesis inhibitory effect, ketorolac may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage [ see Use in Specific Populations ( 8.1 ) ] Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical [ see Warnings and Precautions ( 5.11 ), Drug Interactions ( 7 ) ] Concomitant use with probenecid [ see Drug Interactions ( 7 ) ] Concomitant use with pentoxifylline [ see Drug Interactions ( 7 ) ] Known hypersensitivity to ketorolac or any components of the drug product ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) In the setting of CABG surgery ( 4 ) Use in patients with active peptic ulcer disease or with recent GI bleeding or perforation ( 4 ) Use as a prophylactic analgesic before any major surgery ( 4 ) Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion ( 4 ) Use in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding ( 4 ) Use in labor and delivery ( 4 )
Sprix drug interactions
See Table 2 for clinically significant drug interactions with ketorolac. Table 2: Clinically Significant Drug Interactions with Ketorolac Drugs that Interfere with Hemostasis Clinical Impact: Ketorolac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of ketorolac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone [ see Clinical Pharmacology ( 12.3 ) ]. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. When ketorolac is administered concurrently with pentoxifylline, there is an increased risk of bleeding. Intervention: Monitor patients with concomitant use of SPRIX with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [ see Warnings and Precautions ( 5.12 ) ]. Concomitant use of SPRIX and pentoxifylline is contraindicated [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.12 ) ]. Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [ see Warnings and Precautions ( 5.2 ) ]. Intervention: Concomitant use of SPRIX and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ see Warnings and Precautions ( 5.12 ) ]. SPRIX is not a substitute for low dose aspirin for cardiovascular protection. 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). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. 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. During concomitant use of SPRIX and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [ see Warnings and Precautions ( 5.6 ) ]. When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. 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. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis 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 Precautions ( 5.6 ) ]. Digoxin 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. Lithium 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%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of SPRIX and lithium, monitor patients for signs of lithium toxicity. Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Intervention: During concomitant use of SPRIX and methotrexate, monitor patients for methotrexate toxicity. Cyclosporine 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 Clinical Impact: Concomitant use of ketorolac with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [ see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 ) ]. Intervention: The concomitant use of ketorolac with other NSAIDs or salicylates is not recommended. Pemetrexed Clinical Impact: Concomitant use of SPRIX and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). 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. 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. In the absence of data regarding 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 following pemetrexed administration. Probenecid Clinical Impact: Concomitant administration of oral ketorolac and probenecid results in increased half-life and systemic exposure. [ see Clinical Pharmacology ( 12.3 ) ]. Intervention: Concomitant use of SPRIX and probenecid is contraindicated. Antiepileptic Drugs 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. Psychoactive Drugs Clinical Impact: Hallucinations have been reported when ketorolac was used in patients taking psychoactive drugs (fluoxetine, thiothixene, alprazolam). Intervention: During concomitant use of SPRIX and psychoactive drugs, monitor patients for hallucinations. Nondepolarizing Muscle Relaxants Clinical Impact: In postmarketing experience there have been reports of a possible interaction between ketorolac and nondepolarizing muscle relaxants that resulted in apnea. The concurrent use of ketorolac with muscle relaxants has not been formally studied. Intervention: During concomitant use of SPRIX and nondepolarizing muscle relaxants, monitor patients for apnea. Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs) : Monitor patients for bleeding who are concomitantly taking SPRIX with drugs that interfere with hemostasis. Concomitant use of SPRIX and analgesic doses of aspirin is not generally recommended. ( 7 ) ACE inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers : Concomitant use with SPRIX may diminish the antihypertensive effect of these drugs. Monitor blood pressure. ( 7 ) ACE Inhibitors and ARBs : Concomitant use with SPRIX in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function. ( 7 ) Diuretics : NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects. ( 7 ) Digoxin : Concomitant use with SPRIX can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels. ( 7 )
Every ketorolac tromethamine product we track (6)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Drops | No data | — | View → | |
| 2 | 72/100 | Prescription | Drops | No data | — | View → | |
| 3 | 72/100 | Prescription | Drops | No data | — | View → | |
| 4 | Not yet rated | Prescription | Injectable | No data | — | View → | |
| 5 | Not yet rated | Prescription | Spray/Inhaler | No data | — | View → | |
| 6 | Not yet rated | Prescription | Injectable | No data | — | View → |
What ketorolac tromethamine pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Combination products containing ketorolac tromethamine
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Ketorolac Tromethamine recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Ketorolac Tromethamine Injection
Presence of Particulate Matter: Particulate matter identified as glass
Aspiro Pharma Limited · Oct 1, 2025
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Apotex Corp. · Sep 5, 2025
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility
Apotex Corp. · May 28, 2025
What people report to the FDA about ketorolac tromethamine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 4,643 reports naming ketorolac tromethamine, and the FDA flagged 57% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- drug hypersensitivity325 reports
- nausea256 reports
- headache248 reports
- fatigue224 reports
- dyspnoea221 reports
- treatment failure205 reports
- vomiting168 reports
- diarrhoea154 reports
Read these as a signal, not a rate. A report does not mean ketorolac tromethamine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
How long ketorolac tromethamine stays in your system
The elimination half-life of ketorolac tromethamine is about 5 to 6 hours. FDA label mean terminal elimination half-life is 5.6 hours (range 4.0-7.9) in healthy young adults (24-35 yrs). It lengthens with age (about 7 hours in the elderly, 65-78 yrs) and, most importantly, with reduced kidney function: in renally impaired patients the mean half-life ranges from 6 to 19 hours depending on severity, since ketorolac is largely eliminated renally. Ketorolac has no long-lasting active metabolite and is not a prodrug. Half-life is not the same as a drug-test detection window — how long it stays measurable can exceed the time the drug is clinically active.
KETOROLAC TROMETHAMINE tablet — FDA label (DailyMed) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is Sprix?
SPRIX (ketorolac tromethamine) Nasal Spray is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs, available as a clear, colorless to yellow solution packaged in a glass vial with a snap on spray pump that delivers 15.75 mg ketorolac tromethamine per spray and is intended for intranasal administration.
What kind of drug is ketorolac tromethamine?
The FDA classifies ketorolac tromethamine as a nonsteroidal anti-inflammatory drug. NSAIDs block cyclooxygenase (COX) enzymes that your body uses to make prostaglandins, the chemicals behind pain, swelling, and fever. Lowering prostaglandins eases pain and inflammation and brings down a high temperature. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does ketorolac tromethamine stay in your system?
The elimination half-life of ketorolac tromethamine is about 5 to 6 hours — that is how long the body takes to clear half of a dose. FDA label mean terminal elimination half-life is 5.6 hours (range 4.0-7.9) in healthy young adults (24-35 yrs). It lengthens with age (about 7 hours in the elderly, 65-78 yrs) and, most importantly, with reduced kidney function: in renally impaired patients the mean half-life ranges from 6 to 19 hours depending on severity, since ketorolac is largely eliminated renally. Ketorolac has no long-lasting active metabolite and is not a prodrug. Half-life is not the same as a drug-test detection window — how long it stays measurable can exceed the time the drug is clinically active. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take ketorolac tromethamine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ketorolac tromethamine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is ketorolac tromethamine sold under?
We track 6 ketorolac tromethamine-containing products in the U.S.: Acular, Acular Ls, Acular Preservative Free, Ketorolac Tromethamine, Sprix and Toradol. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does ketorolac tromethamine come in?
Across the brands we track, ketorolac tromethamine is currently marketed as drops, injectable, solution, tablet and spray/inhaler, metered, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ketorolac tromethamine?
Yes. Our catalog lists 1 generic ketorolac tromethamine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has ketorolac tromethamine been recalled?
The FDA's Enforcement database lists 3 recall records whose product description mentions ketorolac tromethamine. The most recent: Ketorolac Tromethamine Injection (Oct 1, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Ketorolac Tromethamine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ketorolac-tromethamine
- MLA
- “Ketorolac Tromethamine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ketorolac-tromethamine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for ketorolac tromethamine on DailyMed (NIH) ↗ — including its boxed warning in full.