FDA label
What is ketorolac used for?
The FDA-approved uses of ketorolac, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for ketorolac tromethamine (injection, solution) lists this use: Acute Pain in Adult Patients.
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Ketorolac Tromethamine, injection, solution
Indications and Usage, quoted from the label by Civica, Inc. (ANDA209900). Cross-references to other label sections are left out.
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).
Acute Pain in Adult Patients
Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS ). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
Source: DailyMed label, set id 1e8ddf13-c513-4e16-a91a-9d55726d9071, version 3, effective November 4, 2024. NDC 72572-354, one of 73 listings for this product.
Ketorolac Tromethamine, tablet, film coated
Indications and Usage, quoted from the label by Injecta Medcial LLC (ANDA216651). Cross-references to other label sections are left out.
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets USP and other treatment options before deciding to use ketorolac tromethamine tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Acute Pain in Adult Patients
Ketorolac tromethamine tablets USP are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets USP are to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine tablets USP and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but Ketorolac Tromethamine Tablet USP therapy is not to exceed 5 days.
Source: DailyMed label, set id 515464a7-16c5-2811-e063-6294a90aa451, version 4, effective June 18, 2026. NDC 87234-7695, one of 53 listings for this product.
Questions
What is ketorolac used for?
The FDA label for ketorolac tromethamine (injection, solution) lists this use: Acute Pain in Adult Patients.
What drug class is ketorolac?
FDA lists ketorolac in the Cyclooxygenase Inhibitor and Nonsteroidal Anti-inflammatory Drug established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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