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Toradol

Last reviewed on RxList: 1/11/2017
Please Note: This Brand Name drug is no longer available in the US. (Generic versions may still be available.)
Toradol Side Effects Center

Last reviewed on RxList 8/31/2016

Toradol (ketorolac tromethamine) is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat moderately severe pain and inflammation, usually after surgery. Toradol works by blocking the production of prostaglandins, compounds that cause pain, fever, and inflammation. The brand name Toradol is no longer available in the U.S. Generic versions may be available. Common side effects of Toradol include:

Toradol is available as a 10 mg tablet and a solution (30 mg per ml) for intravenous (IV) or intramuscular (IM) administration. Toradol solution is administered as a single 15- to 60-mg dose once every 6 hours not to exceed 60 or 120 mg a day. The recommended oral dose is one to two Toradol tablets initially followed by one tablet every 4-6 hours, not to exceed 40 mg daily. Toradol should not be used for more than 5 days. Drug interactions may occur with lithium, ACE inhibitors, warfarin, and medications used to treat high uric acid levels. Warnings may apply to individuals who have ulcers, cardiovascular disease, kidney disease, and bleeding disorders. People who are taking aspirin or NSAIDs should not take Toradol because of the cumulative risk of inducing serious NSAID-related side effects. Toradol is generally avoided during pregnancy. Pregnant women may take Toradol only if it is clearly needed and the potential benefit justifies the potential risk to the fetus. Nursing mothers should not take Toradol, because it is excreted in breast milk. Toradol solution may be used as a single dose in children in certain instances, but safety and effectiveness in the pediatric population is not established.

Our Toradol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Toradol Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ketorolac and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any mouth sores or skin rash, no matter how mild;
  • pale skin, easy bruising, severe tingling, numbness, pain, muscle weakness; or
  • fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects may include:

  • upset stomach, mild nausea or vomiting, diarrhea, constipation;
  • mild heartburn, stomach pain, bloating, gas;
  • dizziness, headache, drowsiness;
  • sweating; or
  • ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Toradol (Ketorolac Tromethamine)

Toradol Professional Information

SIDE EFFECTS

Adverse reaction rates increase with higher doses of TORADOL (ketorolac tromethamine) . Practitioners should be alert for the severe complications of treatment with TORADOL (ketorolac tromethamine) , such as GI ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see BOXED WARNING, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION). These NSAID-related complications can be serious in certain patients for whom TORADOL (ketorolac tromethamine) is indicated, especially when the drug is used inappropriately.

In patients taking TORADOL (ketorolac tromethamine) or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:

Gastrointestinal (GI) experiences including:
abdominal pain* constipation/diarrhea dyspepsia*
flatulence GI fullness GI ulcers (gastric/duodenal)
gross bleeding/perforation Heartburn nausea*
stomatitis Vomiting  
Other experiences:
abnormal renal function Anemia dizziness
drowsiness Edema elevated liver enzymes
headaches* Hypertension increased bleeding time
injection site pain Pruritus purpura
rashes Tinnitus sweating
*Incidence greater than 10%

Additional adverse experiences reported occasionally ( < 1% in patients taking TORADOL (ketorolac tromethamine) or other NSAIDs in clinical trials) include:

Body as a Whole: fever, infections, sepsis

Cardiovascular: congestive heart failure, palpitation, pallor, tachycardia, syncope

Dermatologic: alopecia, photosensitivity, urticaria

Gastrointestinal: anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, hepatitis, increased appetite, jaundice, melena, rectal bleeding

Hemic and Lymphatic: ecchymosis, eosinophilia, epistaxis, leukopenia, thrombocytopenia

Metabolic and Nutritional: weight change

Nervous System: abnormal dreams, abnormal thinking, anxiety, asthenia, confusion, depression, euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaise

Reproductive, female: infertility

Respiratory: asthma, cough, dyspnea, pulmonary edema, rhinitis

Special Senses: abnormal taste, abnormal vision, blurred vision, hearing loss

Urogenital: cystitis, dysuria, hematuria, increased urinary frequency, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, urinary retention

Other rarely observed reactions (reported from postmarketing experience in patients taking TORADOL (ketorolac tromethamine) or other NSAIDs) are:

Body as a Whole: angioedema, death, hypersensitivity reactions such as anaphylaxis, anaphylactoid reaction, laryngeal edema, tongue edema (see WARNINGS), myalgia

Cardiovascular: arrhythmia, bradycardia, chest pain, flushing, hypotension, myocardial infarction, vasculitis

Dermatologic: exfoliative dermatitis, erythema multiforme, Lyell's syndrome, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis

Gastrointestinal: acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease)

Hemic and Lymphatic: agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, postoperative wound hemorrhage (rarely requiring blood transfusion - see BOXED WARNING, WARNINGS, and PRECAUTIONS)

Metabolic and Nutritional: hyperglycemia, hyperkalemia, hyponatremia

Nervous System: aseptic meningitis, convulsions, coma, psychosis

Respiratory: bronchospasm, respiratory depression, pneumonia

Special Senses: conjunctivitis

Urogenital: flank pain with or without hematuria and/or azotemia, hemolytic uremic syndrome

Postmarketing Surveillance Study

A large postmarketing observational, nonrandomized study, involving approximately 10,000 patients receiving ketorolac tromethamineIV/IM, demonstrated that the risk of clinically serious gastrointestinal (GI) bleeding was dose-dependent (see Tables 3A and 3B). This was particularly true in elderly patients who received an average daily dose greater than 60 mg/day of ketorolac tromethamineIV/IM (see Table 3A).

Table 3 Incidence of Clinically Serious GI Bleeding as Related to Age, Total Daily Dose, and History of GI Perforation, Ulcer, Bleeding (PUB) After up to 5 Days of Treatment With Ketorolac TromethamineIV/IMA.

A. Adult Patients Without History of PUB
Age of Patients Total Daily Dose of Ketorolac TromethamineIV/IM
  ≤ 60 mg > 60 to 90 mg > 90 to 120 mg > 120 mg
< 65 years of age 0.4% 0.4% 0.9% 4.6%
≥ 65 years of age 1.2% 2.8% 2.2% 7.7%
B. Adult Patients With History of PUB
Age of Patients Total Daily Dose of Ketorolac TromethamineIV/IM
  ≤ 60 mg > 60 to 90 mg > 90 to 120 mg > 120 mg
< 65 years of age 2.1% 4.6% 7.8% 15.4%
≥ 65 years of age 4.7% 3.7% 2.8% 25.0%

Read the entire FDA prescribing information for Toradol (Ketorolac Tromethamine)

Related Resources for Toradol

Read the Toradol User Reviews »

© Toradol Patient Information is supplied by Cerner Multum, Inc. and Toradol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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