Note: This document contains side effect information about ketorolac. Some dosage forms listed on this page may not apply to the brand name Sprix.
Applies to ketorolac: solution, tablet. Other dosage forms:
- nasal spray
Warning
Oral route (Tablet)
Ketorolac tromethamine oral tablets are indicated for short term use only (up to 5 days total duration, including IV/IM and oral therapy in adults) for the management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine if necessary. Not for use in pediatric patients and not indicated for minor or chronic pain. Daily doses beyond label recommendations increase the risk for serious adverse events and do not improve efficacy. The risk for serious and potentially fatal cardiovascular thrombotic events may increase with use, duration of use, and in patients with cardiovascular disease, or risk factors for cardiovascular disease. Contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. May cause peptic ulcers, gastrointestinal bleeding, or potentially fatal stomach or intestinal perforation. Contraindicated in active or history of peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of gastrointestinal bleeding. Contraindicated in patients with: advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high-risk of bleeding. Contraindicated in patients receiving concomitant aspirin or NSAIDs, or as prophylactic analgesic before any major surgery. Contraindicated in labor and delivery and in nursing mothers. Use caution in elderly patients due to high risk of gastrointestinal adverse events and in patients with cardiovascular disease or risk factors. Adjust dosages for elderly patients, patients under 50 kg, and patients with moderately elevated serum creatinine.
Injection route (Solution)
Ketorolac tromethamine is indicated for short term use only (up to 5 days total duration, including IV/IM and oral therapy in adults) for the management of moderately severe acute pain that requires analgesia at the opioid level. Ketorolac tromethamine oral tablets are indicated only as continuation treatment following IV or IM dosing of ketorolac tromethamine if necessary. Not for use in pediatric patients and not indicated for minor or chronic pain. Oral daily doses beyond label recommendations increase the risk for serious adverse events and do not improve efficacy. The risk for serious and potentially fatal cardiovascular thrombotic events may increase with use, duration of use, and in patients with cardiovascular disease, or risk factors for cardiovascular disease. Contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. May cause peptic ulcers, gastrointestinal bleeding, or potentially fatal stomach or intestinal perforation. Contraindicated in active or history of peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of gastrointestinal bleeding. Contraindicated in patients with: advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high-risk of bleeding. Contraindicated in patients receiving concomitant aspirin or NSAIDs, or as prophylactic analgesic before any major surgery. Contraindicated in labor and delivery and in nursing mothers. Use caution in elderly patients due to high risk of gastrointestinal adverse events and in patients with cardiovascular disease or risk factors. Adjust dosages for elderly patients, patients under 50 kg, and patients with moderately elevated serum creatinine. Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred. Contraindicated in patients who previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other NSAIDs. Contraindicated for intrathecal or epidural administration. Use caution in elderly patients due to high risk of gastrointestinal adverse events. Adjust dosages for elderly patients, patients under 50 kg, and patients with moderately elevated serum creatinine. Doses of ketorolac tromethamine injection should not exceed 60 mg/day in these patients.
Serious side effects of Sprix
Along with its needed effects, ketorolac (the active ingredient contained in Sprix) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ketorolac:
More common
- Swelling of face, fingers, lower legs, ankles, and/or feet
- weight gain (unusual)
Less common
- Bruising (not at place of injection)
- high blood pressure
- skin rash or itching
- small, red spots on skin
- sores, ulcers, or white spots on lips or in mouth
Rare
- Abdominal or stomach pain, cramping, or burning that is severe
- bleeding from the rectum or bloody or black, tarry stools
- bloody or cloudy urine
- blue lips and fingernails
- blurred vision of other vision change
- burning, red, tender, thick, scaly, or peeling skin
- chest pain
- convulsions
- cough or hoarseness
- dark urine
- decrease in amount of urine that is sudden
- fainting
- fast, irregular, noisy, or troubled breathing
- fever with severe headache, drowsiness, confusion, and stiff neck or back
- fever with or without chills or sore throat
- hallucinations (seeing, hearing, or feeling things that are not there)
- hearing loss
- hives
- increase in amount of urine or urinating often
- light-colored stools
- loss of appetite
- low blood pressure
- mood changes or unusual behavior
- muscle cramps or pain
- nausea, heartburn, or indigestion that is severe and continues
- nosebleeds
- pain in lower back and/or side
- pain, tenderness, or swelling in the upper stomach area
- painful or difficult urination
- pale skin
- puffiness or swelling of the eyelids or eyes
- ringing or buzzing in ears
- runny nose
- severe restlessness
- shortness of breath
- swollen or painful glands
- swollen tongue
- thirst that continues
- tightness in the chest with or without wheezing
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
Other side effects of Sprix
Some side effects of ketorolac may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Abdominal or stomach pain (mild or moderate)
- bruising at place of injection
- diarrhea
- dizziness
- drowsiness
- headache
- indigestion
- nausea
Less common or rare
- Bloating or gas
- burning or pain at place of injection
- constipation
- feeling of fullness in abdominal or stomach area
- increased sweating
- vomiting
For Healthcare Professionals
Applies to ketorolac: injectable solution, intramuscular solution, nasal spray, oral tablet.
General
The most common adverse reactions among patients treated with ketorolac (the active ingredient contained in Sprix) 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]
Gastrointestinal
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]
Hematologic
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 (the active ingredient contained in Sprix) 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%): 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]
Cardiovascular
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%): 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]
Dermatologic
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]
Hypersensitivity
Frequency not reported: Anaphylactoid reactions
Postmarketing reports: Laryngeal edema, tongue edema[Ref]
Renal
Common (1% to 10%): Abnormal renal function, oliguria
Postmarketing reports: Acute renal failure, nephrotic syndrome[Ref]
Hepatic
Common (1% to 10%): Elevated liver enzymes
Frequency not reported: Hepatitis, jaundice, liver failure[Ref]
Metabolic
Frequency not reported: Weight change
Postmarketing reports: Hyperglycemia, hyperkalemia, hyponatremia[Ref]
Respiratory
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]
Nervous system
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]
Local
Common (1% to 10%): Injection site pain[Ref]
Ocular
Common (1% to 10%): Lacrimation increased (nasal spray)
Postmarketing reports: Conjunctivitis, optic neuritis, visual disturbances, abnormal vision[Ref]
Psychiatric
Frequency not reported: Anxiety, depression, euphoria, hallucinations, abnormal dreams, abnormal thinking
Postmarketing reports: Psychosis[Ref]
Other
Common (1% to 10%): Tinnitus
Frequency not reported: Fever, asthenia, malaise, vertigo, hearing loss[Ref]
Endocrine
Frequency not reported: Female infertility[Ref]
Genitourinary
Postmarketing reports: Flank pain with or without hematuria and/or azotemia, hemolytic uremia syndrome, increased urinary frequency, oliguria, interstitial nephritis, urinary retention[Ref]
Immunologic
Frequency not reported: Infections, sepsis[Ref]
Musculoskeletal
Postmarketing reports: Myalgia[Ref]
