MedPath

Ketorolac

Generic Name
Ketorolac
Brand Names
Acular, Acuvail, Omidria, Readysharp Anesthetics Plus Ketorolac, Sprix, Toradol, Toronova Suik
Drug Type
Small Molecule
Chemical Formula
C15H13NO3
CAS Number
74103-06-3
Unique Ingredient Identifier
YZI5105V0L

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.

Background

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

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
Ketorolac Tromethamine Capsules
国药准字H20052633
化学药品
胶囊剂
5/9/2020
Ketorolac Trometamol Injection
国药准字H20249823
化学药品
注射剂
12/25/2024
Ketorolac Trometamol Injection
国药准字H20249765
化学药品
注射剂
12/25/2024
Ketorolac Trometamol Injection
国药准字H20253273
化学药品
注射剂
1/24/2025
Ketorolac Trometamol Injection
国药准字H20233312
化学药品
注射剂
10/13/2023
Ketorolac Trometamol Injection
国药准字H20253957
化学药品
注射剂
4/22/2025
Ketorolac Trometamol Injection
国药准字H20253956
化学药品
注射剂
4/22/2025
Ketorolac Trometamol Injection
国药准字H20090110
化学药品
注射剂
10/7/2023
Ketorolac Trometamol Injection
国药准字H20234457
化学药品
注射剂
12/29/2023
Ketorolac Trometamol Injection
国药准字H20203090
化学药品
注射剂
3/11/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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