Toradol Side Effects

Generic Name: ketorolac

Note: This page contains side effects data for the generic drug ketorolac. It is possible that some of the dosage forms included below may not apply to the brand name Toradol.

It is possible that some side effects of Toradol may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to ketorolac: injectable, solution, tablet

Other dosage forms:

As well as its needed effects, ketorolac (the active ingredient contained in Toradol) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking ketorolac, check with your doctor immediately:

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 ketorolac side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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, nasal spray, oral tablet

General

The most common adverse reactions among patients treated with ketorolac (the active ingredient contained in Toradol) 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. 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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