Toradol IM Side Effects
Generic name: ketorolac
Medically reviewed by Drugs.com. Last updated on Jun 13, 2024.
Note: This document provides detailed information about Toradol IM.
For healthcare professionals
Applies to ketorolac: injectable solution, intramuscular solution, nasal spray, oral tablet Side Effects associated with ketorolac. Some dosage forms listed on this page may not apply specifically to the brand name Toradol IM.
For healthcare professionals
Applies to ketorolac: injectable solution, intramuscular solution, nasal spray, oral tablet.
General adverse events
The most common adverse reactions among patients treated with ketorolac (the active ingredient contained in Toradol IM) 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
- 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]
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]
Hematologic
- 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]
Cardiovascular
- 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]
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]
References
1. (2002) "Product Information. Toradol (ketorolac)." Roche Laboratories
2. (2004) "Product Information. Ketorolac Tromethamine (ketorolac)." Hospira Inc
3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
4. Cerner Multum, Inc. "Australian Product Information."
5. (2014) "Product Information. Sprix (ketorolac)." American Regent Laboratories Inc
Frequently asked questions
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- Drug class: Nonsteroidal anti-inflammatory drugs
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Further information
Toradol IM side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.