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Toradol IM Side Effects

Generic Name: ketorolac

Note: This document contains side effect information about ketorolac. Some of the dosage forms listed on this page may not apply to the brand name Toradol IM.

For the Consumer

Applies to ketorolac: injectable, solution, tablet

Other dosage forms:

Along with its needed effects, ketorolac (the active ingredient contained in Toradol IM) 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

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 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

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

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. "Product Information. Toradol (ketorolac)." Roche Laboratories, Nutley, NJ.

2. "Product Information. Sprix (ketorolac)." American Regent Laboratories Inc, Shirley, NY.

3. "Product Information. Ketorolac Tromethamine (ketorolac)." Hospira Inc, Lake Forest, IL.

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

5. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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.

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