Toradol IV/IM

Name: Toradol IV/IM

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Commonly used brand name(s)

In the U.S.

  • Toradol
  • Toradol IV/IM

Available Dosage Forms:

  • Tablet
  • Solution
  • Injectable

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For Toradol IV/IM

Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedure. It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac is not a narcotic and is not habit-forming. It will not cause physical or mental dependence, as narcotics can. However, ketorolac is sometimes used together with a narcotic to provide better pain relief than either medicine used alone.

Ketorolac has side effects that can be very dangerous. The risk of having a serious side effect increases with the dose of ketorolac and with the length of treatment. Therefore, ketorolac should not be used for more than 5 days. Before using this medicine, you should discuss with your doctor the good that this medicine can do as well as the risks of using it.

Ketorolac is available only with your doctor's prescription.

Before Using Toradol IV/IM

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ketorolac in children up to 16 years of age with use in other age groups.

Geriatric

Stomach or intestinal problems, swelling of the face, feet, or lower legs, or sudden decrease in the amount of urine may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of ketorolac. Also, elderly people are more likely than younger adults to get very sick if the medicine causes stomach problems. Studies in older adults have shown that ketorolac stays in the body longer than it does in younger people. Your doctor will consider this when deciding on how much ketorolac should be given for each dose and how often it should be given.

Pregnancy

Pregnancy Category Explanation
1st Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Aceclofenac
  • Acemetacin
  • Amtolmetin Guacil
  • Aspirin
  • Bromfenac
  • Bufexamac
  • Celecoxib
  • Choline Salicylate
  • Clonixin
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Droxicam
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Ibuprofen
  • Indomethacin
  • Ketoprofen
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Pentoxifylline
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Probenecid
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sulfasalazine
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Valdecoxib

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Acenocoumarol
  • Amiloride
  • Amineptine
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Anagrelide
  • Apixaban
  • Ardeparin
  • Argatroban
  • Bemiparin
  • Bendroflumethiazide
  • Benzthiazide
  • Betamethasone
  • Betrixaban
  • Bivalirudin
  • Budesonide
  • Bumetanide
  • Cangrelor
  • Certoparin
  • Chlorothiazide
  • Chlorthalidone
  • Cilostazol
  • Citalopram
  • Clomipramine
  • Clopamide
  • Clopidogrel
  • Cortisone
  • Cyclopenthiazide
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Deflazacort
  • Desipramine
  • Desirudin
  • Desmopressin
  • Desvenlafaxine
  • Dexamethasone
  • Diazoxide
  • Dibenzepin
  • Digoxin
  • Dipyridamole
  • Dothiepin
  • Doxepin
  • Duloxetine
  • Edoxaban
  • Enoxaparin
  • Eplerenone
  • Epoprostenol
  • Eptifibatide
  • Escitalopram
  • Ethacrynic Acid
  • Feverfew
  • Fluocortolone
  • Fluoxetine
  • Fluvoxamine
  • Fondaparinux
  • Furosemide
  • Ginkgo
  • Gossypol
  • Heparin
  • Hydrochlorothiazide
  • Hydrocortisone
  • Hydroflumethiazide
  • Iloprost
  • Imipramine
  • Indapamide
  • Lepirudin
  • Levomilnacipran
  • Lithium
  • Lofepramine
  • Meadowsweet
  • Melitracen
  • Methotrexate
  • Methyclothiazide
  • Methylprednisolone
  • Metolazone
  • Milnacipran
  • Nadroparin
  • Nefazodone
  • Nortriptyline
  • Opipramol
  • Paramethasone
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentosan Polysulfate Sodium
  • Phenindione
  • Phenprocoumon
  • Polythiazide
  • Pralatrexate
  • Prasugrel
  • Prednisolone
  • Prednisone
  • Protein C
  • Protriptyline
  • Reboxetine
  • Reviparin
  • Rivaroxaban
  • Sertraline
  • Sibutramine
  • Spironolactone
  • Tacrolimus
  • Tianeptine
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Torsemide
  • Treprostinil
  • Triamterene
  • Trichlormethiazide
  • Trimipramine
  • Venlafaxine
  • Vilazodone
  • Vorapaxar
  • Vortioxetine
  • Warfarin
  • Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Alacepril
  • Atenolol
  • Azilsartan
  • Azilsartan Medoxomil
  • Benazepril
  • Betaxolol
  • Bisoprolol
  • Candesartan
  • Captopril
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Cilazapril
  • Delapril
  • Enalapril
  • Enalaprilat
  • Eprosartan
  • Esmolol
  • Fosinopril
  • Imidapril
  • Irbesartan
  • Labetalol
  • Levobunolol
  • Lisinopril
  • Losartan
  • Metipranolol
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Olmesartan
  • Oxprenolol
  • Penbutolol
  • Pentopril
  • Perindopril
  • Pindolol
  • Practolol
  • Propranolol
  • Quinapril
  • Ramipril
  • Sotalol
  • Spirapril
  • Telmisartan
  • Temocapril
  • Timolol
  • Trandolapril
  • Valsartan
  • Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse or
  • Diabetes mellitus (sugar diabetes) or
  • Edema (swelling of face, fingers, feet or lower legs caused by too much fluid in the body) or
  • Kidney disease or
  • Liver disease (severe) or
  • Systemic lupus erythematosus (SLE)—The chance of serious side effects may be increased
  • Asthma or
  • Heart disease or
  • High blood pressure—Ketorolac may make your condition worse.
  • Bleeding in the brain (history of) or
  • Hemophilia or other bleeding problems—Ketorolac may increase the chance of serious bleeding
  • Bleeding from the stomach or intestines (history of) or
  • Colitis, stomach ulcer, or other stomach or intestinal problems (or history of)—Ketorolac may make stomach or intestinal problems worse. Also, bleeding from the stomach or intestines is more likely to occur during ketorolac treatment in people with these conditions

Proper Use of ketorolac

This section provides information on the proper use of a number of products that contain ketorolac. It may not be specific to Toradol IV/IM. Please read with care.

For patients taking ketorolac tablets:

  • To lessen stomach upset, ketorolac tablets should be taken with food (a meal or a snack) or with an antacid.
  • Take this medicine with a full glass of water. Also, do not lie down for about 15 to 30 minutes after taking it. This helps to prevent irritation that may lead to trouble in swallowing.

For patients using ketorolac injection:

  • Medicines given by injection are sometimes used at home. If you will be using ketorolac at home, your health care professional will teach you how the injections are to be given. You will also have a chance to practice giving injections. Be certain that you understand exactly how the medicine is to be injected.

For safe and effective use of this medicine, do not use more of it, do not use it more often, and do not use it for more than 5 days. Using too much of this medicine increases the chance of unwanted effects, especially in elderly patients.

Ketorolac should be used only when it is ordered by your doctor for treating certain kinds of pain. Because of the risk of serious side effects, do not save any leftover ketorolac for use in the future, and do not share it with other people.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For pain:
      • Adults (patients 16 years of age and older)—One 10-milligram (mg) tablet four times a day, four to six hours apart. Some people may be directed to take two tablets for the first dose only.
      • Children up to 16 years of age—Use and dose must be determined by your doctor.
  • For injection dosage form:
    • For pain:
      • Adults (patients 16 years of age and older)—15 or 30 mg, injected into a muscle or a vein four times a day, at least 6 hours apart. This amount of medicine may be contained in 1 mL or in one-half (0.5) mL of the injection, depending on the strength. Some people who do not need more than one injection may receive one dose of 60 mg, injected into a muscle.
      • Children up to 16 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Toradol IV/IM

Taking certain other medicines together with ketorolac may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. Therefore, do not take acetaminophen (e.g., Tylenol) together with ketorolac for more than a few days, unless otherwise directed by your medical doctor or dentist. Also, do not take any of the following medicines together with ketorolac, unless your medical doctor or dentist has directed you to do so and is following your progress:

  • Aspirin or other salicylates
  • Diclofenac (e.g., Voltaren®)
  • Diflunisal (e.g., Dolobid®)
  • Etodolac (e.g., Lodine®)
  • Fenoprofen (e.g., Nalfon®)
  • Floctafenine (e.g., Idarac®)
  • Flurbiprofen (e.g., Ansaid®)
  • Ibuprofen (e.g., Motrin®)
  • Indomethacin (e.g., Indocin®)
  • Ketoprofen (e.g., Orudis®)
  • Meclofenamate (e.g., Meclomen®)
  • Mefenamic acid (e.g., Ponstel®)
  • Nabumetone (e.g., Relafen®)
  • Naproxen (e.g., Naprosyn®)
  • Oxaprozin (e.g., Daypro®)
  • Phenylbutazone (e.g., Butazolidin®)
  • Piroxicam (e.g., Feldene®)
  • Sulindac (e.g., Clinoril®)
  • Tenoxicam (e.g., Mobiflex®)
  • Tiaprofenic acid (e.g., Surgam®)
  • Tolmetin (e.g., Tolectin®)
  • Zomepirac (e.g., Zomax®)

Ketorolac may cause some people to become dizzy or drowsy. If either of these side effects occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert.

Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

For the Consumer

Applies to ketorolac: injectable, solution, tablet

Other dosage forms:

  • nasal spray

Along with its needed effects, ketorolac (the active ingredient contained in Toradol IV / 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, nasal spray, oral tablet

General

The most common adverse reactions among patients treated with ketorolac (the active ingredient contained in Toradol IV / 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]

Some side effects of Toradol IV / IM may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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