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Nonsteroidal anti-inflammatory agents
Ketorolac spray is only intended for short-term (up to 5 days) treatment of moderate to moderately severe pain. It should not be used to treat minor or long-term pain. Do not use more of ketorolac spray than prescribed. Do not use ketorolac spray to treat children.
Ketorolac spray is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious, and sometimes fatal, heart and blood vessel problems (eg, a heart attack, a stroke). The risk may be greater if you already have heart problems or if you take ketorolac spray for a long time. Do not use ketorolac spray right before or after coronary artery bypass graft (CABG) surgery.
Ketorolac spray may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.
Do not use ketorolac spray if:
Do not use ketorolac spray to prevent pain before any major surgery.
The short-term (up to 5 days) treatment of moderate to moderately severe pain.
Ketorolac spray is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes these symptoms.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with ketorolac spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with ketorolac spray. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if ketorolac spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use ketorolac spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use ketorolac spray.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; increased tearing; mild nasal discomfort, irritation, or pain; mild stomach pain or upset; nausea; throat irritation; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue, unusual hoarseness); bloody or black, tarry stools; bloody or cloudy urine; change in the amount of urine produced or trouble urinating; chest, jaw, or left arm pain; confusion; dark urine; depression; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of appetite; mental or mood changes; mouth sores; numbness of an arm or leg; one-sided weakness; pale stools; persistent flu-like symptoms; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting or diarrhea; shortness of breath; sudden or unexplained weight gain; swelling of the arms, hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of ketorolac spray:
Store unopened bottles of ketorolac spray in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store opened bottles of ketorolac spray at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container out of direct sunlight. Store upright, away from heat, moisture, and light. Discard opened bottles of ketorolac spray within 24 hours of opening. Do not store in the bathroom. Keep ketorolac spray out of the reach of children and away from pets.
This information should not be used to decide whether or not to take ketorolac spray or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ketorolac spray. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ketorolac spray. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using ketorolac spray.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
Not all side effects for ketorolac may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
Applies to ketorolac: injectable, solution, tablet
Other dosage forms:
In addition to its needed effects, some unwanted effects may be caused by ketorolac. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking ketorolac:More common
Some of the side effects that can occur with ketorolac may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
Applies to ketorolac: injectable solution, nasal spray, oral tablet
The most common adverse reactions among patients treated with ketorolac include abdominal pain, nausea, dyspepsia, and headaches. For patients receiving the nasal spray, nasal discomfort, rhinalgia, increased lacrimation, throat irritation, and rhinitis were reported.[Ref]
A large postmarketing observational study (n=10,000) revealed the incidence of clinically serious gastrointestinal (GI) bleeding was dose dependent and more than double in patients 65 years or older. The incidence of clinically serious GI bleeding after up to 5 days of treatment with doses of 60 mg or less, greater than 60 to 90 mg, greater than 90 to 120 mg, or greater than 120 mg, respectively was 0.4%, 0.4%, 0.9%, and 4.6% in those less than 65 years compared with 1.2%, 2.8%, 2.2%, and 7.7% in those 65 years or older. Among patients with a history of GI perforation, ulcer, or bleeding, these numbers were 2.1%, 4.6%, 7.8%, and 15.4% compared with 4.7%, 3.7%, 2.8%, and 25%, in younger and older patients, respectively.[Ref]
Very common (10% or more): Abdominal pain, dyspepsia, nausea
Common (1% to 10%): Constipation, diarrhea, flatulence, gastrointestinal (GI) fullness, GI ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, stomatitis, vomiting, throat irritation (nasal spray)
Frequency not reported: Anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, melena, rectal bleeding, increased appetite, peptic ulcers, ulcers, hematemesis, gastritis
Postmarketing reports: Acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease), eructation[Ref]
Common (1% to 10%): Anemia, increased bleeding time
Frequency not reported: Bleeding, hematoma, postoperative wound hemorrhage
Postmarketing reports: Agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, thrombocytopenia purpura, thrombocytopenia, neutropenia, postoperative wound hemorrhage (rarely requiring blood transfusion)[Ref]
Serious events of bleeding (n=4) or hematoma (n=3) at the operative site were reported in controlled clinical trials in patients (n=455) undergoing major surgeries (primarily knee and hip replacements, and abdominal hysterectomies) receiving ketorolac nasal spray compared with 1 patient in the placebo group (hematoma).
In pediatric patients, an increased risk of bleeding was observed following tonsillectomy. In a retrospective analysis, risk of bleeding following a tonsillectomy with or without adenoidectomy was 10.1% in patients receiving this drug compared with 2.2% in those receiving opioids. The postoperative hemorrhage rate in patients 12 years and younger was 6.5% with ketorolac treatment versus 3.3% without. In a prospective study in patients 3 to 9 years undergoing tonsillectomy with or without adenoidectomy, the overall incidence of bleeding in patients receiving this drug was 16.3% compared with 17% in children receiving morphine. However, during the first 24 hours after surgery, bleeding was observed in 14.3% of the ketorolac group versus 4.2% of the morphine group.[Ref]
Common (1% to 10%): Edema, hypertension, bradycardia
Frequency not reported: Congestive heart failure, palpitations, pallor, tachycardia, syncope, cardiac failure
Postmarketing reports: Arrhythmia, chest pain, flushing, hypotension, myocardial infarction, vasculitis[Ref]
Clinical trials of several cyclooxygenase (COX)-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs appear to have a similar risk. There is no consistent evidence that concurrent use of aspirin mitigates this increased risk and may be associated with an increased risk of serious gastrointestinal events.[Ref]
Common (1% to 10%): Rash, pruritus, purpura, sweating
Very rare (less than 0.01%):
Frequency not reported: Alopecia, photosensitivity, urticaria
Postmarketing reports: Angioedema, exfoliative dermatitis, erythema multiforme, Lyell's syndrome, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis[Ref]
Frequency not reported: Anaphylactoid reactions
Postmarketing reports: Laryngeal edema, tongue edema[Ref]
Common (1% to 10%): Abnormal renal function, oliguria
Postmarketing reports: Acute renal failure, nephrotic syndrome[Ref]
Common (1% to 10%): Elevated liver enzymes
Frequency not reported: Hepatitis, jaundice, liver failure[Ref]
Frequency not reported: Weight change
Postmarketing reports: Hyperglycemia, hyperkalemia, hyponatremia[Ref]
Very common (10% or more): Nasal discomfort (15%, nasal spray), rhinalgia (13%, nasal spray)
Common (1% to 10%): Rhinitis (nasal spray)
Frequency not reported: Epistaxis, pulmonary edema, asthma
Postmarketing reports: Bronchospasm, respiratory depression, pneumonia[Ref]
Very common (10% or more): Headaches
Common (1% to 10%): Drowsiness, dizziness
Frequency not reported: Extrapyramidal symptoms, hyperkinesis, inability to concentrate, insomnia, paresthesia, somnolence, stupor, tremors
Postmarketing reports: Aseptic meningitis, convulsions, coma, taste abnormality[Ref]
Common (1% to 10%): Injection site pain[Ref]
Common (1% to 10%): Lacrimation increased (nasal spray)
Postmarketing reports: Conjunctivitis, optic neuritis, visual disturbances, abnormal vision[Ref]
Frequency not reported: Anxiety, depression, euphoria, hallucinations, abnormal dreams, abnormal thinking
Postmarketing reports: Psychosis[Ref]
Common (1% to 10%): Tinnitus
Frequency not reported: Fever, asthenia, malaise, vertigo, hearing loss[Ref]
Frequency not reported: Female infertility[Ref]
Postmarketing reports: Flank pain with or without hematuria and/or azotemia, hemolytic uremia syndrome, increased urinary frequency, oliguria, interstitial nephritis, urinary retention[Ref]
Frequency not reported: Infections, sepsis[Ref]
Postmarketing reports: Myalgia[Ref]
1. "Product Information. Toradol (ketorolac)." Roche Laboratories, Nutley, NJ.
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
4. "Product Information. Sprix (ketorolac)." American Regent Laboratories Inc, Shirley, NY.
5. "Product Information. Ketorolac Tromethamine (ketorolac)." Hospira Inc, Lake Forest, IL.
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