Ketorolac: Side Effects, Uses, Dosage, Interactions, Warnings (2024)

• Uses
  • What Is Ketorolac and How Does It Work?
• Dosage
  • What Are Dosages of Ketorolac?
• Side Effects
  • What Are Side Effects Associated with Using Ketorolac?
• Drug Interactions
  • What Other Drugs Interact with Ketorolac?
• Warnings and Precautions
  • What Are Warnings and Precautions for Ketorolac?

What Is Ketorolac and How Does It Work?

Ketorolac is used for the short-term treatment of moderate to severe pain. It is usually used before or after medical procedures or after surgery. Reducing pain helps you recover more comfortably so that you can return to your normal daily activities. This medication is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

Ketorolac should not be used for mild or long-term painful conditions (such as arthritis).

Ketorolac is available under the following different brand names: Toradol.

What Are Dosages of Ketorolac?

Dosages of Ketorolac:

Adult and Pediatric Dosage Forms and Strengths

Tablet

• 10 mg

Injectable solution

• 15 mg/mL
• 30 mg/mL

Prefilled syringe

• 15 mg/mL
• 30 mg/mL
• 60 mg/mL

Dosage Considerations – Should be Given as Follows:

Moderately Severe Acute Pain

• Short-term (up to 5 days) management of moderately severe acute pain that requires analgesia at opioid level; not indicated for minor or chronic painful conditions

Adult

• Intravenous (IV): 30 mg as a single dose or 30 mg every 6 hours; not to exceed 120 mg/day
• Intramuscular (IM): 60 mg as a single dose or 30 mg every 6 hours; not to exceed 120 mg/day
• Oral: 20 mg once after IV or IM therapy, THEN 10 mg every 4-6 hours; not to exceed 40 mg/day

Geriatric

• Intravenous (IV): 15 mg as a single dose or 15 mg every 6 hours; not to exceed 60 mg/day
• Intramuscular (IM): 30 mg as a single dose or 15 mg every 6 hours; not to exceed 60 mg/day
• Oral: 10 mg once after IV or IM therapy, THEN 10 mg every 4-6 hours; not to exceed 40 mg/day

Pediatric (Off-label):

Children under 2 years

• Safety and efficacy not established

Children 2-16 years

• Single-dose: 0.5 mg/kg IV/IM once; not to exceed 15 mg
• Multiple-dose: 0.5 mg/kg IV/IM every 6 hours; not to exceed 5 days

Children over 16 years, less than 50 kg

• Intravenous (IV): 15 mg as a single dose or 15 mg every 6 hours; not to exceed 60 mg/day
• Intramuscular (IM): 30 mg as a single dose or 15 mg every 6 hours; not to exceed 60 mg/day
• Oral: 10 mg once after IV/IM therapy, THEN 10 mg every 4-6 hours; not to exceed 40 mg/day

Children over 16 years, greater than 50 kg

• Intravenous (IV): 30 mg as a single dose or 30 mg every 6 hours; not to exceed 120 mg/day
• Intramuscular (IM): 60 mg as a single dose or 30 mg every 6 hours; not to exceed 120 mg/day
• Oral: 20 mg once after IV/IM therapy, THEN 10 mg every 4-6 hours; not to exceed 40 mg/day

Dosing Considerations

• Always begin with parenteral therapy; oral administration indicated only as a continuation of intravenous/intramuscular (IV/IM) dosing, if necessary
• Duration of therapy should not exceed 5 days
• Dosage beyond maximum or labeled doses will not provide better efficacy but will increase the risk of serious adverse events
• Decrease daily dose in patients over 65 years, less than 50 kg, or with moderately elevated serum creatinine
• Not approved for use in pediatric patients
• Geriatric: Long-term use should be avoided because of asymptomatic, pathologic gastrointestinal (GI) conditions; duration of therapy should not exceed 5 days
• Dosage adjustment required for patients over 65 years or less than 50 kg

Dosing Modifications

Renal impairment

• Severe: Contraindicated
• Moderate (moderately elevated serum creatinine): Use 50% of recommended dosage; not to exceed 60 mg/day intramuscular/intravenous (IM/IV)

Hepatic impairment

• Not studied; use caution; discontinue if symptoms of liver toxicity develop

What Are Side Effects Associated with Using Ketorolac?

Side effects of ketorolac include:

• Headache
• Drowsiness
• Indigestion
• Stomach or abdominal pain
• Nausea
• Diarrhea
• Dizziness
• Itching
• Swelling (edema)
• Increased blood urea nitrogen (BUN)
• Constipation
• Purpura
• Increased serum creatinine
• Drowsiness
• High blood pressure (hypertension)

Less common side effects of ketorolac include:

• Abnormal thinking
• Black, “tarry” stool
• Blurred vision
• Bronchospasm
• Changes in taste
• Cholestatic jaundice
• Depression
• Difficulty in concentration
• Euphoria
• Hemolytic-uremic syndrome
• Hepatitis
• High blood potassium
• Increased liver function test values
• Insomnia
• Liver failure
• Low blood pressure (hypotension)
• Low blood sodium
• Nervousness
• Pale skin (pallor)
• Peptic ulcer
• Rash
• Rectal bleeding
• Severe allergic reaction (anaphylaxis)
• Swelling and sores inside the mouth
• Throat/tongue swelling
• Urinary frequency
• Urinary retention
• Urinating less than usual
• Vasodilation

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

What Other Drugs Interact with Ketorolac?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Severe interactions of ketorolac include:

• None

Ketorolac has serious interactions with at least 47 different drugs.

Ketorolac has moderate interactions with at least 228 different drugs.

Ketorolac has mild interactions with at least 78 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

What Are Warnings and Precautions for Ketorolac?

Warnings

Cardiovascular risk:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
• The risk may increase with duration of use
• Patients with existing cardiovascular disease or risk factors for such disease may be at greater risk
• NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery
• Patients treated with NSAIDs following heart attack reported to be more likely to die in the first year of heart attack compared to patients not treated with NSAIDs after a first heart attack

Gastrointestinal risk:

• NSAIDs increase the risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
• GI adverse events may occur at any time during use and without warning symptoms
• Elderly patients are at greater risk for serious GI events

Additional Warnings:

• Major surgery: Contraindicated for prophylactic analgesic
• Coronary artery bypass graft (CABG): Contraindicated for treatment of perioperative pain in the setting of CABG surgery
• Labor and delivery: Contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions
• Breastfeeding women: Contraindicated because of potential adverse effects of prostaglandin-inhibiting drugs on neonates
• Use with other nonsteroidal anti-inflammatory drugs (NSAIDs): Contraindicated in patients currently receiving aspirin or other NSAIDs, because of cumulative risk of inducing serious NSAID-related adverse effects
• Renal risk: Contraindicated with advanced renal impairment and in patients at risk for renal failure due to volume depletion
• Gastrointestinal: Contraindicated with active peptic ulcer disease, recent GI bleeding or perforation, or history of peptic ulcer disease or GI bleeding
• Bleeding risk: Inhibits platelet function; contraindicated with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, and high risk of bleeding
• Demonstrated hypersensitivity: Contraindicated with previously demonstrated hypersensitivity to ketorolac or allergic manifestations to aspirin or other NSAIDs
• Injectable: Contraindicated for intrathecal or epidural administration, due to its alcohol content.
• Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred, and appropriate counteractive measures must be available when administering the first dose of ketorolac injection

This medication contains ketorolac. Do not take Toradol if you are allergic to ketorolac or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Duration of therapy greater than 5 days
• Not for chronic or minor pain
• Demonstrated hypersensitivity to ketorolac or allergic manifestations to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs); appropriate counteractive measures must be available when first ketorolac injection is given
• Major surgery: Contraindicated for prophylactic analgesia; contraindicated for the treatment of perioperative pain in the setting of CABG surgery
• OB/GYN: Contraindicated during labor and delivery because it may adversely affect fetal circulation and inhibit uterine contractions; contraindicated in breastfeeding women because of potential adverse effects of prostaglandin-inhibiting drugs on neonates
• Renal: Contraindicated with advanced renal impairment and in patients at risk for renal failure due to volume depletion
• GI: Contraindicated with previous or currently active peptic ulcer disease, previous or current GI bleeding, or perforation
• Bleeding risk: Because of inhibition of platelet function; contraindicated with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, and high risk of bleeding
• Use with other NSAIDs: Contraindicated in patients currently receiving aspirin or other NSAIDs, because of cumulative risk of inducing serious NSAID-related adverse effects
• Contraindicated for intrathecal or epidural administration because of alcohol content

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Ketorolac?"

Long-Term Effects

• Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals; those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion; and those taking diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers.
• See "What Are Side Effects Associated with Using Ketorolac?"

Cautions

• Use with caution in perioperative setting, tonsillectomy in children (may interfere with hemostasis), gastric perforation, hepatic/renal impairment, history of hepatic/renal disease, concomitant anticoagulant therapy, hypertension (may cause new onset of hypertension or worsening of existing hypertension).
• Oral therapy should be used only as continuation after initial parenteral therapy.
• Limited data supporting safe use of multiple-dose parenteral treatment in children.
• The potential risk of cardiovascular damage.
• Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals; those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion; and those taking diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers.
• Risk of severe skin reactions.
• May cause drowsiness, blurred vision, and dizziness; may impair the ability to operate heavy machinery.
• May increase risk of hyperkalemia, especially in renal disease, patients with diabetes, the elderly, and when used concomitantly with other agents capable of inducing hyperkalemia.
• Not for use in patients with aspirin-sensitive asthma (severe bronchospasm may occur).
• Heart Failure (HF) risk:
  • NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
  • NSAIDS should be avoided or withdrawn whenever possible
  • AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134

Pregnancy and Lactation

• Use ketorolac with caution during the first and second trimesters of pregnancy if benefits outweigh risks.
• Animal studies show risk and human studies are not available, or neither animal nor human studies were done.
• Use ketorolac only in LIFE-THREATENING emergencies during the third trimester of pregnancy when no safer drug is available.
• There is positive evidence of human fetal risk (may cause premature closure of ductus arteriosus).
• Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to non-aspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and approximately 2.6% of controls
• Ketorolac is excreted in breast milk with multiple doses; its use is contraindicated if breastfeeding.