Ketorolac
Acular, Acuvail, Ketorolac Tromethamine, Omidria, Sprix (ketorolac) is a small molecule pharmaceutical. Ketorolac was first approved as Toradol on 1989-11-30. It is used to treat pain in the USA. It has been approved in Europe to treat intraocular lens implantation and postoperative pain. The pharmaceutical is active against prostaglandin G/H synthase 1 and prostaglandin G/H synthase 2.
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Drug Products
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Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acular | New Drug Application | 2024-09-25 |
| acular ls | New Drug Application | 2024-06-21 |
| acunistat-30 | ANDA | 2022-02-22 |
| acunistat-60 | ANDA | 2022-02-22 |
| acunivive 15 | ANDA | 2022-02-24 |
| acunivive 30 | ANDA | 2022-02-25 |
| acunivive 60 | ANDA | 2022-02-25 |
| acunivive 90 | ANDA | 2022-02-25 |
| acuvail | New Drug Application | 2024-05-31 |
| chi-myst | unapproved drug other | 2016-08-19 |
Show 22 more
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ketorolac Tromethamine / Phenylephrine Hydrochloride, Omidria, Rayner Surgical | |||
| 9066856 | 2033-10-23 | DP | |
| 9486406 | 2033-10-23 | DP | |
| 9855246 | 2033-10-23 | DP | |
| 8173707 | 2023-07-30 | U-1518 | |
| 8586633 | 2023-07-30 | DP | |
| 9278101 | 2023-07-30 | U-1518 | |
| 9399040 | 2023-07-30 | DP | |
| Ketorolac Tromethamine, Acuvail, Abbvie | |||
| 7842714 | 2029-08-15 | DS, DP | |
| 8512717 | 2028-03-07 | DP | |
| 9192571 | 2028-03-07 | DP | |
| 8992952 | 2024-08-05 | DP | |
| Ketorolac Tromethamine, Acular Ls, Abbvie | |||
| 8008338 | 2027-05-24 | DS, DP | U-1181 |
| 8207215 | 2024-05-28 | U-1251 | |
| 8377982 | 2024-05-28 | U-1363 | |
| 8541463 | 2024-05-28 | U-1441 | |
| 8648107 | 2024-05-28 | DP | |
| 8906950 | 2024-05-28 | U-1626 | |
| 8946281 | 2024-05-28 | U-1662 | |
| 9216167 | 2024-05-28 | U-1800 | |
ATC Codes
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AB: Acetic acid derivatives and related substances
— M01AB15: Ketorolac
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BC: Antiinflammatory agents, non-steroidal, ophthalmologic
— S01BC05: Ketorolac
— S01F: Mydriatics and cycloplegics
— S01FB: Sympathomimetics excl. antiglaucoma preparations
— S01FB51: Phenylephrine and ketorolac
Clinical
Clinical Trials
616 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | 9 | 16 | 19 | 57 | 53 | 151 |
| Pain | D010146 | EFO_0003843 | R52 | 3 | 7 | 9 | 20 | 15 | 52 |
| Cataract | D002386 | HP_0000518 | H26.9 | 2 | 2 | 6 | 21 | 4 | 34 |
| Replacement arthroplasty knee | D019645 | — | — | — | 2 | 5 | 13 | 9 | 28 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 2 | 4 | 11 | 9 | 25 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 3 | 2 | 9 | 7 | 20 |
| Acute pain | D059787 | — | R52 | 2 | 3 | 4 | 8 | 4 | 20 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | 4 | 5 | 7 | 4 | 19 |
| Inflammation | D007249 | MP_0001845 | — | 2 | — | 5 | 8 | 3 | 18 |
| Anesthesia | D000758 | — | — | 1 | — | 1 | 4 | 10 | 16 |
Show 179 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | 3 | — | 5 | 10 |
| Appendicitis | D001064 | EFO_0007149 | K37 | — | 1 | 3 | — | 2 | 6 |
| Anterior cruciate ligament injuries | D000070598 | — | — | — | 1 | 2 | — | 2 | 4 |
| Abdominal pain | D015746 | HP_0002027 | R10.9 | — | — | 4 | — | — | 4 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 1 | 2 | 1 | — | 1 | 4 |
| Conjunctivitis | D003231 | HP_0000509 | H10 | — | 2 | 2 | — | — | 3 |
| Shoulder impingement syndrome | D019534 | EFO_1001178 | M75.4 | — | 1 | 1 | — | 1 | 3 |
| Intraocular lens implantation | D019654 | — | — | — | — | 3 | — | — | 3 |
| Allergic rhinitis | D065631 | — | J30.9 | 1 | — | 1 | — | — | 2 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 1 | — | 1 | — | — | 2 |
Show 35 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | 1 | — | — | — | 10 |
| Pulpitis | D011671 | EFO_1001139 | K04.0 | 1 | 5 | — | — | 4 | 10 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | 2 | 2 | — | — | — | 4 |
| Bunion | D000071378 | — | M21.61 | — | 1 | — | — | 2 | 3 |
| Periapical periodontitis | D010485 | EFO_1001391 | K04.5 | 1 | 1 | — | — | 1 | 3 |
| Phimosis | D010688 | EFO_1001104 | N47.1 | 1 | 1 | — | — | — | 2 |
| Paraphimosis | D010263 | EFO_1001086 | N47.2 | 1 | 1 | — | — | — | 2 |
| Balanitis | D001446 | EFO_1000833 | N48.1 | 1 | 1 | — | — | — | 2 |
| Neuralgia | D009437 | EFO_0009430 | — | 1 | 1 | — | — | — | 2 |
| Spondylolisthesis | D013168 | EFO_0007493 | M43.1 | 1 | 1 | — | — | 1 | 2 |
Show 19 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | — | — | — | 3 | 4 |
| Pathologic dilatation | D004108 | — | — | 1 | — | — | — | 3 | 4 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | — | — | — | — | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | 1 | 2 |
| Tibial fractures | D013978 | EFO_0003944 | S82.20 | 1 | — | — | — | 1 | 2 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | 1 | 2 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | 1 | 2 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | — | — | — | 1 | 2 |
| Cluster headache | D003027 | HP_0012199 | G44.00 | 1 | — | — | — | — | 1 |
| Trigeminal neuralgia | D014277 | EFO_1001219 | G50.0 | 1 | — | — | — | — | 1 |
Show 22 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Laparoscopic cholecystectomy | D017081 | — | — | — | — | — | — | 3 | 3 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | — | — | — | 3 | 3 |
| Colorectal neoplasms | D015179 | — | — | — | — | — | — | 3 | 3 |
| Emergence delirium | D000071257 | — | — | — | — | — | — | 3 | 3 |
| Regeneration | D012038 | — | — | — | — | — | — | 3 | 3 |
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | — | — | — | — | 2 | 2 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | — | 2 | 2 |
| Rupture | D012421 | — | — | — | — | — | — | 2 | 2 |
| Inguinal hernia | D006552 | HP_0000023 | K40 | — | — | — | — | 2 | 2 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 2 | 2 |
Show 62 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ketorolac |
| INN | ketorolac |
| Description | Ketorolac is a racemate comprising equimolar amounts of (R)-(+)- and (S)-(-)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid. While only the (S)-(-) enantiomer is a COX1 and COX2 inhibitor, the (R)-(+) enantiomer exhibits potent analgesic activity. A non-steroidal anti-inflammatory drug, ketorolac is mainly used (generally as the tromethamine salt) for its potent analgesic properties in the short-term management of post-operative pain, and in eye drops to relieve the ocular itching associated with seasonal allergic conjunctivitis. It was withdrawn from the market in many countries in 1993 following association with haemorrhage and renal failure. It has a role as a cyclooxygenase 2 inhibitor, a cyclooxygenase 1 inhibitor, a non-steroidal anti-inflammatory drug and an analgesic. It contains a (R)-ketorolac and a (S)-ketorolac. It is a conjugate acid of a ketorolac(1-). |
| Classification | Small molecule |
| Drug class | anti-inflammatory agents (acetic acid derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 74103-06-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL469 |
| ChEBI ID | 76223 |
| PubChem CID | 3826 |
| DrugBank | DB00465 |
| UNII ID | YZI5105V0L (ChemIDplus, GSRS) |
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Sprix – Assertio Therapeutics
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Sprix – Zyla Life Sciences
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Estimated US medical usage
Ketorolac
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Trends
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Safety
Black-box Warning
Black-box warning for: Acunistat-30, Acunistat-60, Acunivive 15, Acunivive 30, Acunivive 60, Acunivive 90, Ketorlac tromethamine, Ketorocaine l kit, Ketorocaine lm kit, Ketorolac, Ketorolac trometham, Ketorolac tromethamine, Ketorolac tromethamine ketorolac tromethamine, Readysharp anesthetics plus ketorolac, Readysharp ketorolac, Sprix, Toradol, Toronova ii suik, Toronova suik
Adverse Events
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7,811 adverse events reported
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