Toradol, Omidria(ketorolac)
Acular, Acuvail, 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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Commercial
Trade Name
FDA
EMA
Acular, Acuvail, Sprix (generic drugs available since 1997-05-16, discontinued: Toradol)
CombinationsOmidria (generic drugs available since 1997-05-16)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ketorolac tromethamine
Ketorolac tromethamine
+
Phenylephrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OMIDRIA | Rayner Surgical | N-205388 RX | 2014-05-30 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acular | New Drug Application | 2012-06-01 |
| acuvail | New Drug Application | 2019-02-21 |
| ketorolac tromethamine | ANDA | 2023-06-19 |
| omidria | New Drug Application | 2017-12-11 |
| sprix | New Drug Application | 2020-03-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pain | EFO_0003843 | D010146 | R52 |
Agency Specific
FDA
EMA
No data
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
373 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 | 6 | 10 | 15 | 18 | 9 | 57 | |
| Pain | D010146 | EFO_0003843 | R52 | 2 | 6 | 6 | 17 | 5 | 35 |
| Cataract | D002386 | EFO_0001059 | H26.9 | — | 1 | 3 | 12 | 3 | 19 |
| Macular edema | D008269 | — | 3 | 1 | 4 | 4 | 12 | ||
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | 2 | 3 | 5 | 1 | 11 |
| Replacement arthroplasty knee | D019645 | — | — | 3 | 6 | 1 | 10 | ||
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | — | 6 | 2 | 9 |
| Acute pain | D059787 | R52 | — | 2 | 3 | 3 | 1 | 8 | |
| Renal colic | D056844 | EFO_1001412 | N23 | 1 | 1 | 2 | 3 | 2 | 8 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 2 | 4 | 1 | 7 |
Show 83 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Appendicitis | D001064 | EFO_0007149 | K37 | — | — | 2 | — | 1 | 3 |
| Abdominal pain | D015746 | R10.9 | — | — | 3 | — | — | 3 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | 3 | — | — | 3 |
| Anterior cruciate ligament injuries | D000070598 | — | 1 | 2 | — | — | 2 | ||
| Chronic pain | D059350 | HP_0012532 | — | — | 1 | — | 1 | 2 | |
| Deglutition disorders | D003680 | HP_0002015 | R13.1 | — | — | 1 | — | — | 1 |
| Dysphonia | D055154 | R49.0 | — | — | 1 | — | — | 1 | |
| Local anesthesia | D000772 | — | — | 1 | — | — | 1 | ||
| Spinal fusion | D013123 | — | — | 1 | — | — | 1 | ||
| Tennis elbow | D013716 | EFO_1001896 | M77.1 | — | — | 1 | — | — | 1 |
Show 21 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 8 | 1 | — | — | — | 9 | ||
| Pulpitis | D011671 | EFO_1001139 | K04.0 | — | 4 | — | — | 3 | 7 |
| 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 |
| Diabetic retinopathy | D003930 | EFO_0003770 | 1 | 1 | — | — | — | 2 | |
| Shoulder impingement syndrome | D019534 | EFO_1001178 | M75.4 | — | 1 | — | — | 1 | 2 |
| Scoliosis | D012600 | EFO_0004273 | M41 | — | 1 | — | — | — | 1 |
| Miosis | D015877 | HP_0000616 | H57.03 | — | 1 | — | — | — | 1 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | 1 | — | — | — | 1 |
Show 9 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | 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 |
| Cerebral arterial diseases | D002539 | EFO_1000859 | 1 | — | — | — | — | 1 | |
| Urologic diseases | D014570 | N39.9 | 1 | — | — | — | — | 1 | |
| Allergic rhinitis | D065631 | J30.9 | 1 | — | — | — | — | 1 | |
| Non-small-cell lung carcinoma | D002289 | 1 | — | — | — | — | 1 | ||
| Mammaplasty | D016462 | 1 | — | — | — | — | 1 |
Show 8 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bunion | D000071378 | M21.61 | — | — | — | — | 2 | 2 | |
| Pathologic dilatation | D004108 | — | — | — | — | 2 | 2 | ||
| Keratoconus | D007640 | EFO_0004223 | H18.6 | — | — | — | — | 2 | 2 |
| Regeneration | D012038 | — | — | — | — | 2 | 2 | ||
| Open-angle glaucoma | D005902 | EFO_0004190 | H40.1 | — | — | — | — | 2 | 2 |
| Retinal vein occlusion | D012170 | EFO_1001157 | H34.81 | — | — | — | — | 1 | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | — | — | — | 1 | 1 |
| Head and neck neoplasms | D006258 | — | — | — | — | 1 | 1 | ||
| Laparoscopic cholecystectomy | D017081 | — | — | — | — | 1 | 1 | ||
| Inguinal hernia | D006552 | HP_0000023 | K40 | — | — | — | — | 1 | 1 |
Show 19 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 |
Target
Agency Approved
PTGS1
PTGS1
PTGS2
PTGS2
Organism
Homo sapiens
Gene name
PTGS1
Gene synonyms
COX1
NCBI Gene ID
Protein name
prostaglandin G/H synthase 1
Protein synonyms
COX-1, Cyclooxygenase-1, PGH synthase 1, PGHS-1, PHS 1, Prostaglandin H2 synthase 1, Prostaglandin-endoperoxide synthase 1, prostaglandin-endoperoxide synthase 1 (prostaglandin G/H synthase and cyclooxygenase)
Uniprot ID
Mouse ortholog
Ptgs1 (19224)
prostaglandin G/H synthase 1 (P22437)
Alternate
No data
Variants
Clinical Variant
No data
Financial
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Sprix - Zyla Life Sciences
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Tabular view
Trends
PubMed Central
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Additional graphs summarizing 9,424 documents
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Safety
Black-box Warning
Black-box warning for: Ketorolac tromethamine, Sprix
Adverse Events
Top Adverse Reactions
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4,533 adverse events reported
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