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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use [what does this mean?]
Generic drug name: ketorolac (kee TOE role ak)
Brand name(s): SPRIX
GENERIC: available FAMILY: Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by searching at DailyMed.

Alternative Treatment [top]

See Narcotics.

Safety Warnings For This Drug [top]

FDA BLACK-BOX WARNING

Ketorolac tromethamine tablets, a non-steroidal anti-inflammatory drug (NSAID), are indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following injected dosing of ketorolac tromethamine, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine should not exceed 5 days.

Ketorolac tromethamine tablets are not indicated for use in pediatric patients and they are NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine tablets beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events.

GASTROINTESTINAL RISK

  • Ketorolac tromethamine, including ketorolac tromethamine tablets can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events.

CARDIOVASCULAR RISK

  • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • Ketorolac tromethamine is CONTRAINDICATED for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

RENAL RISK

  • Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.

RISK OF BLEEDING

  • Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding .

Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery.

RISK DURING LABOR AND DELIVERY

  • The use of ketorolac tromethamine in labor and delivery is contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions.

CONCOMITANT USE WITH NSAIDs

  • Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving aspirin or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.

SPECIAL POPULATIONS

  • Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight and for patients with moderately elevated serum creatinine (a blood test used to measure kidney function).

Facts About This Drug [top]

Do Not Use: This drug is no more effective than related drugs and causes a higher rate of ulcers.

The following is an excerpt from the black-box warning required on the label for this drug.[1]

Ketorolac is approved only for short-term use, five days or less, in the treatment of acute pain. This drug is available in both oral and injectable forms.

The label for ketorolac warns about the risks of gastrointestinal bleeding and kidney and liver damage. It also warns against the use of...

Do Not Use: This drug is no more effective than related drugs and causes a higher rate of ulcers.

The following is an excerpt from the black-box warning required on the label for this drug.[1]

Ketorolac is approved only for short-term use, five days or less, in the treatment of acute pain. This drug is available in both oral and injectable forms.

The label for ketorolac warns about the risks of gastrointestinal bleeding and kidney and liver damage. It also warns against the use of the drug in labor and delivery, in nursing mothers and in patients before or during surgery. The label cautions that very young or older adults should use the lowest possible dose. Ketorolac remains on a well-recognized list of drugs that are inappropriate for use in older adults.[2]

Adverse effects

The British Medical Journal (BMJ) published a meta-analysis (a study that combines data from many other studies) examining the use of NSAIDs and cardiovascular safety. The authors of the article stated that there is a risk of cardiovascular adverse effects associated with these drugs, and this risk must be considered when treating patients.[3]

Information from another article in the BMJ found that the use of NSAIDs was associated with the occurrence of abnormal heart rhythms called atrial fibrillation or flutter.[4]

Interactions

Studies suggest a possible harmful interaction between NSAIDs and a class of osteoporosis drugs called bisphosphonates. Patients need to be alert to the fact that the combination can result in an increased risk of ulcers and other gastrointestinal adverse effects. Read more in the July 2010 issue of Worst Pills, Best Pills News.

Combining NSAIDs with anticoagulants (blood thinners for preventing blood clots) increases the risk of serious bleeding complications.[5]

When not to use NSAIDS

In patients with advanced kidney disease, treatment with NSAIDs is not recommended. However, if NSAID therapy must be initiated, close monitoring of the patient’s kidney function is advisable.

NSAIDs are also contraindicated in patients in whom aspirin or other nonsteroidal anti-inflammatory/analgesic drugs induce asthma, rhinitis and nasal polyps. These reactions have the potential to be fatal. Therefore, careful questioning of patients for asthma, nasal polyps, urticaria (hives) and low blood pressure associated with NSAIDs before starting therapy is important. In addition, if such symptoms occur during therapy, treatment should be discontinued.

Better options available

Among the NSAIDs, evidence shows that ibuprofen (ADVIL, MEDIPREN, MOTRIN, NUPRIN) is less toxic than other drugs in this family to the gastrointestinal tract, which is one of the main safety concerns with NSAIDs.[6],[7],[8],[9],[10]

Aspirin (EASPRIN, ECOTRIN, EMPIRIN, GENUINE BAYER ASPIRIN) is just as effective as and less costly than other NSAIDs and is the drug of choice for treating pain, fever and inflammation in people who do not have ulcers, gastritis (inflammation of the stomach) or an allergy to aspirin. Some rheumatologists prefer aspirin to other NSAIDs for treating rheumatoid arthritis.[11]

Regulatory actions surrounding ketorolac

2005: The Food and Drug Administration (FDA) requested that manufacturers of NSAIDS, both prescription and over-the-counter, revise the drugs’ labels to include the potentially increased risks of cardiovascular events (read the information noted with COX-2 inhibitors) and gastrointestinal bleeding (see “Warnings” box at top of page). The FDA also required a Medication Guide be provided to patients with each dispensed prescription.

2015: The FDA announced that the agency is strengthening the existing warning for all non-aspirin NSAIDs concerning an increased risk of heart attack and stroke.[12]

2020: The FDA and Health Canada (an agency in Canada similar to the FDA) warned that use of NSAIDs at about 20 weeks or later in pregnancy rarely causes serious kidney problems in an unborn baby.[13],[14] These kidney problems can lead to oligohydramnios, a condition in which there are low levels of amniotic fluid surrounding the baby. Amniotic fluid normally provides a protective cushion and plays an important role in the development of a baby’s lungs, digestive system and muscles. Oligohydramnios in turn can lead to decreased range of motion in a baby’s arms and legs and delayed lung maturation.

last reviewed February 28, 2021