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Toradol

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Toradol

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Toradol Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Toradol (ketorolac tromethamine) is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat moderately severe pain and inflammation, usually after surgery. Toradol is available as a generic drug called ketorolac. Toradol works by blocking the production of prostaglandins, compounds that cause pain, fever, and inflammation. Some common side effects of Toradol include headache, heartburn, dizziness, and constipation.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Toradol in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Toradol Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Upset stomach, nausea, vomiting, constipation, diarrhea, gas, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast/pounding heartbeat, hearing changes (such as ringing in the ears), mental/mood changes (such as confusion, depression), persistent/severe headache, stomach pain, sudden/unexplained weight gain, swelling of the hands or feet, vision changes (such as blurred vision), unusual tiredness.

Tell your doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, change in amount of urine, signs of infection (such as fever, chills, persistent sore throat), symptoms of meningitis (such as unexplained stiff neck, fever).

This drug may rarely cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any symptoms of liver damage, including: dark urine, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Toradol (Ketorolac Tromethamine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Toradol FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

A A A

Toradol - User Reviews

Toradol User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Toradol sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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