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.
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:…
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…
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? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Drops | — | — | View → | |
| 2 | 70/100 | Prescription | Drops | — | — |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 93;314 | 10 mg | white | round | — |
| KT | 10 mg | white | round | — |
| M;134 | 10 mg | white | round | — |
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.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
R.E.C.K. (Ropivacaine HCl
Presence of Particulate Matter
QuVa Pharma, Inc. · Oct 10, 2025
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
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.
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…
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…
| 3 | 70/100 | Prescription | Drops | — | — | View → |
| 4 | Not yet rated | Prescription | Injectable | — | — | View → |
| 5 | Not yet rated | Prescription | Spray/Inhaler | — | — | View → |
| 6 | Not yet rated | Prescription | Injectable | — | — | View → |