Is Ketorolac Available Over the Counter?
No, ketorolac is NOT available over the counter (OTC) in the United States—it requires a prescription for all formulations.
Prescription Status
Ketorolac is available only by prescription in the following forms 1:
- Oral tablets (10 mg)
- Intramuscular injection (15-30 mg)
- Intravenous injection (15-30 mg)
- Ophthalmic solution (Acular - for eye use only)
The FDA-approved drug labeling explicitly indicates ketorolac tromethamine tablets must be "dispensed in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required)" 1, which is standard language for prescription medications requiring pharmacy dispensing.
Why Ketorolac Requires a Prescription
Unlike OTC NSAIDs (ibuprofen, naproxen), ketorolac requires prescription status due to:
Significant safety concerns:
- Gastrointestinal bleeding risk - particularly in elderly patients (≥65 years), those with peptic ulcer disease, or high-dose/prolonged use 1
- Renal toxicity - especially in patients with compromised fluid status, interstitial nephritis, or receiving nephrotoxic drugs 2
- Bleeding complications - through reversible platelet inhibition 1
- Cardiovascular risks - in patients with or at risk for cardiovascular disease 2
Strict dosing limitations:
- Maximum 5 days of parenteral use 3, 1
- Reduced doses required for elderly patients 1
- Not approved for pediatric use under 17 years for oral formulation 1
OTC Alternatives
While ketorolac itself is prescription-only, other NSAIDs ARE available OTC for pain relief 4:
- Ibuprofen (Motrin, Advil)
- Naproxen sodium (Aleve)
- Aspirin
These OTC NSAIDs have established safety profiles at lower doses for self-directed use, whereas ketorolac's potency (described as "the most potent NSAID known" 5) necessitates medical supervision.
Clinical Context
The guideline evidence confirms that while vasoconstrictors and some antihistamines are available OTC for ocular symptoms 4, ketorolac (Acular) for ophthalmic use is listed separately as an NSAID requiring prescription. Similarly, in pain management guidelines, ketorolac is consistently discussed in the context of physician-directed therapy with specific monitoring requirements 2, 3, 6.
Bottom line: Patients seeking ketorolac must obtain a prescription from a healthcare provider. For self-treatment of mild to moderate pain, OTC alternatives like ibuprofen or naproxen are appropriate first-line options.