Overview
Ketorolac is a Non-steroidal anti-inflammatory drug (NSAID) and is commercially available as an oral tablet, injectable, nasal spray and as an ophthalmic solution. It's analgesic properties make it a useful pain management tool across many settings including postoperative pain, rheumatoid arthritis, osteoarthritis, menstrual disorders, headaches, spinal and soft tissue pain, and ankylosing spondylitis. Impressively, ketorolac has a similar efficacy to standard doses of morphine and meperidine making it a useful opioid sparing agent.
Indication
Ketorolac is a Non-steroidal anti-inflammatory drug (NSAID) and has antipyretic, analgesic and anti-inflammatory properties. It is indicated for short term management of acute pain that requires the calibre of pain management offered by opioids. Clinicians may choose to initiate ketorolac to manage post-operative pain, spinal and soft tissue pain, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, menstrual disorders and headaches among other ailments. Regardless of the etiology of pain, patients should use the lowest possible dose, and avoid using ketorolac for an extended period of time (ideally ≤ 5 days). A benefit of choosing ketorolac over other analgesics with similar potency is that that there does not appear to be a risk of dependence or tolerance with ketorolac use.
Associated Conditions
- Acute Migraine
- Eye Pain
- Inflammation
- Macular Edema, Cystoid
- Ocular Itching
- Pericarditis Acute
- Pseudophakic Cystoid Macular Oedema
- Severe Acute Pain
- Acute, moderate Pain
- Chronic aphakic cystoid macular edema
- Intraoperative miosis
- Postoperative ocular pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/26 | Phase 4 | Recruiting | |||
2025/05/29 | Phase 3 | Not yet recruiting | |||
2025/05/15 | Phase 3 | Recruiting | |||
2025/05/13 | Phase 3 | Not yet recruiting | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
2025/02/28 | Phase 2 | ENROLLING_BY_INVITATION | |||
2025/02/11 | Phase 3 | Not yet recruiting | |||
2024/12/11 | Phase 1 | Not yet recruiting | |||
2024/11/08 | Phase 1 | Recruiting | Inder Paul Singh, M.D. | ||
2024/10/22 | Phase 1 | Recruiting | |||
2024/09/04 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Asclemed USA, Inc. | 76420-184 | INTRAMUSCULAR | 60 mg in 2 mL | 10/12/2022 | |
| Preferred Pharmaceuticals Inc. | 68788-8504 | ORAL | 10 mg in 1 1 | 8/10/2023 | |
| Steriscience Specialties Private Limited | 82449-217 | INTRAMUSCULAR | 60 mg in 2 mL | 7/5/2023 | |
| American Health Packaging | 60687-104 | ORAL | 10 mg in 1 1 | 9/13/2022 | |
| Imprimis NJOF, LLC | 71384-513 | OPHTHALMIC | 0.4 mg in 1 mL | 2/10/2020 | |
| Hospira, Inc. | 0409-3793 | INTRAMUSCULAR, INTRAVENOUS | 15 mg in 1 mL | 1/4/2023 | |
| Caplin Steriles Limited | 65145-139 | OPHTHALMIC | 5 mg in 1 mL | 3/30/2024 | |
| Athenex Pharmaceutical Division, LLC. | 70860-700 | INTRAVENOUS, INTRAMUSCULAR | 15 mg in 1 mL | 3/4/2024 | |
| Henry Schein, Inc. | 0404-9996 | INTRAMUSCULAR, INTRAVENOUS | 30 mg in 1 mL | 8/29/2023 | |
| Henry Schein, Inc. | 0404-9952 | INTRAVENOUS, INTRAMUSCULAR | 15 mg in 1 mL | 9/20/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/28/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| XEVOLAC SOLUTION FOR INJECTION 30 MG/ML | SIN16401P | INJECTION, SOLUTION | 30 mg/ml | 12/14/2021 | |
| ACULAR OPHTHALMIC SOLUTION 0.5% | SIN11189P | SOLUTION | 0.5% w/v | 10/11/1999 | |
| KETO FILM COATED TABLET 10 mg | SIN10330P | TABLET, FILM COATED | 10 mg | 10/28/1998 | |
| KETOROLAC TROMETHAMINE INJECTION 30 mg/ml | SIN11340P | INJECTION | 30 mg/ml | 6/16/2000 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| KETOROLAC-BAXTER ketorolac trometamol 30 mg/1 mL solution for injection ampoule | 218877 | Medicine | A | 12/19/2014 | |
| KETOROLAC MEDSURGE ketorolac trometamol 30 mg/1 mL solution for injection ampoule | 370164 | Medicine | A | 6/8/2022 | |
| KETOROLAC MEDSURGE ketorolac trometamol 10 mg/1 mL solution for injection ampoule | 370166 | Medicine | A | 6/8/2022 | |
| KETOVINZ ketorolac trometamol 5 mg/mL eye drop bottle | 396656 | Medicine | A | 7/18/2023 | |
| ACULAR ketorolac trometamol 5mg/mL eye drop bottle | 63539 | Medicine | A | 6/23/1998 | |
| KETOROLAC KABI ketorolac trometamol 30 mg/1 mL solution for injection, vial | 275273 | Medicine | A | 4/28/2017 | |
| KETOROLAC MEDSURGE ketorolac trometamol 5 mg/mL eye drop bottle | 396650 | Medicine | A | 7/18/2023 | |
| APO-KETOROLAC ketorolac trometamol 10 mg/1 mL solution for injection ampoule | 217078 | Medicine | A | 10/27/2014 | |
| KETOROLAC JUNO ketorolac trometamol 30 mg/1 mL solution for injection ampoule | 211626 | Medicine | A | 8/20/2014 | |
| KETOMOL ketorolac trometamol 5 mg/mL eye drop bottle | 396653 | Medicine | A | 7/18/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE INJECTION, USP | auro pharma inc | 02521601 | Solution - Intramuscular | 30 MG / ML | N/A |
| TORADOL IM 30MG/ML | Hoffmann-La Roche Limited | 02162652 | Liquid - Intramuscular | 30 MG / ML | 12/31/1996 |
| ACULAR | 01968300 | Solution - Ophthalmic | 0.5 % / W/V | 12/31/1992 | |
| KETOROLAC TROMETHAMINE INJECTION, USP | omega laboratories limited | 02539357 | Solution - Intramuscular | 30 MG / ML | N/A |
| KETOROLAC TROMETHAMINE INJECTION USP | 02390582 | Solution - Intramuscular | 30 MG / ML | 5/29/2014 | |
| TORADOL TAB 10MG | syntex inc. | 00864048 | Tablet - Oral | 10 MG / TAB | 12/31/1991 |
| KETOROLAC TROMETHAMINE INJECTION USP | Sterimax Inc | 02461129 | Solution - Intramuscular | 30 MG / ML | N/A |
| ACUVAIL | 02369362 | Solution - Ophthalmic | 0.45 % / W/V | 1/10/2012 | |
| RIVA-KETOROLAC 10 MG | laboratoire riva inc. | 02242189 | Tablet - Oral | 10 MG / TAB | N/A |
| NU-KETOROLAC OPHTHALMIC SOLUTION | nu-pharm inc | 02336693 | Solution - Ophthalmic | 0.5 % | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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