What is Ketorolac and How Does It Work?
Ketorolac, often known by the brand name Toradol, is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the short-term management of moderately severe acute pain that requires analgesia at the opioid level [1.2.4, 1.3.7]. It works by blocking the body's production of prostaglandins, substances that cause pain, fever, and inflammation [1.3.2]. Unlike milder NSAIDs like ibuprofen, ketorolac is significantly more potent and is often initiated via injection (intravenous or intramuscular) in a hospital setting before transitioning to oral tablets [1.2.5, 1.7.5]. Its potency, however, comes with a higher risk of serious side effects, which is why its use is strictly limited.
The 5-Day Rule: The Most Important Guideline
The single most important rule for ketorolac use is the duration limit. The total combined duration of ketorolac therapy—including IV, IM, and oral forms—must not exceed five days [1.2.6]. This FDA-mandated boxed warning is due to a well-documented increase in the frequency and severity of adverse events beyond this period [1.2.3]. Studies have shown that treatment durations greater than five days more than double the rate of clinically significant gastrointestinal (GI) bleeding [1.2.1]. This rule applies to all patients, but especially to those at higher risk, such as the elderly [1.2.3]. If pain persists beyond five days, a healthcare provider must switch the patient to an alternative analgesic [1.2.2].
When to Stop Ketorolac Immediately: Critical Warning Signs
Beyond the five-day limit, certain symptoms indicate that ketorolac should be stopped immediately and medical attention sought. These signs point to potentially life-threatening complications.
Signs Requiring Immediate Discontinuation:
- Gastrointestinal Bleeding: This is the most prominent risk. Symptoms include stomach pain, heartburn, black and tarry stools, or vomiting blood or material that looks like coffee grounds [1.3.2, 1.4.7].
- Cardiovascular Events: NSAIDs, including ketorolac, carry a risk of heart attack or stroke. Seek emergency help for chest pain spreading to the jaw or shoulder, sudden weakness or numbness on one side of the body, slurred speech, or shortness of breath [1.4.6].
- Kidney Injury: Ketorolac is contraindicated in patients with advanced renal disease [1.4.5]. Warning signs include a sudden decrease in urination, swelling in the feet and ankles (edema), unexplained weight gain, and fatigue [1.3.1, 1.4.7].
- Allergic Reactions: Severe reactions can occur. Stop the medication and call your doctor for any skin rash, hives, itching, blisters, or swelling of the face, tongue, or throat [1.5.1, 1.5.6].
- Liver Problems: Though less common, signs of liver toxicity include jaundice (yellowing of the skin or eyes), severe fatigue, dark urine, and pain in the upper right part of the stomach [1.3.4].
Contraindications and High-Risk Populations
Certain individuals should not use ketorolac at all, or only with extreme caution and reduced dosages. Stopping or avoiding the medication is crucial in these scenarios.
- Absolute Contraindications: Ketorolac is contraindicated in patients with active peptic ulcer disease, recent GI bleeding, a history of bleeding disorders, advanced kidney disease, or before any major surgery (especially coronary artery bypass graft, or CABG) [1.4.5, 1.4.6]. It is also contraindicated in patients with a known hypersensitivity to aspirin or other NSAIDs [1.4.3].
- The Elderly (65 and older): Older adults are more sensitive to the adverse effects of ketorolac, particularly GI bleeding and kidney problems. They often have slower drug clearance, leading to higher concentrations in the body [1.6.5]. Extreme caution and reduced dosages are necessary [1.4.3].
- Patients with Kidney or Liver Disease: Since ketorolac is primarily cleared by the kidneys, patients with even mild renal impairment are at a higher risk of drug accumulation and toxicity [1.6.1, 1.6.3]. It should be avoided in those with advanced kidney disease [1.6.2].
- Pregnancy and Breastfeeding: Ketorolac should be avoided during late pregnancy (after 20 weeks) as it can cause harm to the fetus [1.5.1]. It is also not recommended for use during labor, delivery, or while breastfeeding [1.4.1, 1.4.2].
Ketorolac vs. Other Common NSAIDs: A Comparison
To understand why ketorolac has such strict rules, it's helpful to compare it to more common over-the-counter NSAIDs.
| Feature | Ketorolac (Toradol) | Ibuprofen (Advil, Motrin) | Naproxen (Aleve) |
|---|---|---|---|
| Potency | Very High. Considered one of the most potent NSAIDs for pain relief [1.7.4, 1.7.5]. | Moderate. | Moderate. |
| Primary Use | Short-term (≤5 days) for moderate-to-severe acute pain, often post-surgical [1.3.6]. | Mild-to-moderate pain, fever, inflammation. Can be used for chronic conditions [1.7.2]. | Mild-to-moderate pain, fever, inflammation. Longer-acting than ibuprofen. |
| Usage Limit | Strict 5-day maximum for all forms combined [1.2.4]. | OTC use is typically for up to 10 days, but can be used longer under medical supervision [1.2.2, 1.7.3]. | Similar to ibuprofen; longer-term use requires medical guidance. |
| Primary Risks | High risk of severe GI bleeding, kidney toxicity, and cardiovascular events [1.4.1]. | Lower risk of GI and kidney issues compared to ketorolac, but risk increases with dose and duration [1.7.2]. | Similar risk profile to ibuprofen, but may have a slightly better cardiovascular profile than some NSAIDs [1.4.1]. |
| Availability | Prescription only [1.4.2]. | Available over-the-counter and by prescription [1.7.3]. | Available over-the-counter and by prescription. |
Conclusion: Prioritizing Safety with Short-Term Use
The decision of when should ketorolac be stopped is governed by a strict, evidence-based safety protocol. The absolute 5-day limit is the primary rule to prevent severe GI, renal, and cardiovascular complications [1.2.5]. Beyond this time limit, the appearance of any serious side effect—from signs of internal bleeding to allergic reactions—mandates immediate discontinuation and medical consultation. Its high potency makes it an effective tool for severe acute pain, but this efficacy is balanced by significant risks that are managed by adhering to these critical stopping guidelines.
For more information, you can visit the FDA's Medication Guide for Ketorolac.
