Patient Medication Information: uses, side effects, how to take - Toradol
Serious Warnings and Precautions
Heart and blood vessel problems:
Stomach and intestine (gastrointestinal) problems:
Talk to your healthcare professional about any medical conditions you have and medicines you are taking. Pregnancy:
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What is TORADOL used for?
TORADOL is used in adults for the short-term relief of moderate to moderately severe pain. It is usually used:
- after surgery (including dental procedures) or giving birth. The maximum duration of treatment is 5 days.
- for an injury causing muscle or joint pain. The maximum duration of treatment is 7 days.
How does TORADOL work?
- TORADOL belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It can reduce the chemicals produced by your body which cause pain and swelling.
- TORADOL only treats the symptoms and relieves pain and inflammation as long as you take it. TORADOL does not cure the illness or stop it from getting worse.
What are the ingredients in TORADOL?
Medicinal ingredient: ketorolac tromethamine.
Non-medicinal ingredients: carnauba wax, croscarmellose sodium, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.
TORADOL comes in the following dosage forms:
Tablets: 10 mg of ketorolac tromethamine.
Do not use TORADOL if:
- you have heart bypass surgery (planning to have or recently had).
- you have severe, uncontrolled heart failure.
- you have bleeding in the brain or other bleeding disorders.
- you are pregnant and in a later stage of pregnancy (28 weeks or later).
- you are currently breastfeeding (or planning to breastfeed).
- you are allergic to ketorolac tromethamine or any other ingredients in TORADOL or the container.
- you have a history of asthma, hives, growths in your nose, sinus swelling or symptoms of an allergic reaction after taking acetylsalicylic acid (ASA) or other NSAIDs.
- you have active stomach or intestinal ulcers.
- you have active bleeding from the stomach or gut.
- you have inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis).
- you have liver disease (active or severe).
- you have kidney disease (moderate, severe or worsening).
- you are in labour or giving birth.
- you have high potassium in the blood.
- you are going to have any major surgery.
you are taking:
- other NSAIDs, used to treat pain, fever and inflammation.
- probenecid, used to treat gout.
- pentoxifylline (also known as oxpentifylline), used to improve blood circulation.
- you are under 18 years of age.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TORADOL. Talk about any health conditions or problems you may have, including if you:
- have a condition that makes you frail or weak.
- have high cholesterol.
- have or had heart attacks, chest pain, heart disease, stroke or heart failure.
- have poor blood flow to your extremities (like your hands and feet).
- smoke or used to smoke.
- have liver or kidney problems, urine problems or are dehydrated.
- are on a low-salt diet.
- have a history of ulcer or bleeding from the stomach or gut (small or large intestines).
- drink a lot of alcohol.
- have a stomach infection.
- have recently had, or are going to have, surgery of the stomach or intestinal tract. TORADOL may worsen wound healing in your gut after surgery.
- have other bleeding or blood problems.
- have immune system problems.
- have asthma.
- are pregnant, planning on becoming or become pregnant while taking TORADOL.
- are taking any other medicines.
Other warnings you should know about:
TORADOL may cause serious side effects, including:
Blood and bleeding problems:
- TORADOL can cause blood problems, bleeding and prolonged bleeding.
Taking TORADOL with the following medicines can increase the risk of bleeding:
- anticoagulants (prevents blood clots), corticosteroids (anti-inflammatory), or antidepressants like selective serotonin reuptake inhibitors (SSRIs).
- Aseptic meningitis (inflammation of the protective lining of the brain that is not caused by an infection): Patients with autoimmune disorders are at a higher risk.
- Serious skin reactions: In rare cases, serious, life-threatening allergic and skin reactions have been reported with some NSAIDs, such as TORADOL. These skin problems most often happen during the first month of treatment. Tell your healthcare professional immediately if you notice any changes in your skin both during and after treatment. TORADOL might cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discolouration, or vision changes. If you have a reaction from the sun, talk to your healthcare professional.
See the Serious side effects and what to do about them table for more information on these and other serious side effects.
Infection: TORADOL may mask signs of an infection such as fever or muscle aches. If you notice other symptoms of infection (e.g., painful or frequent urination, sore throat, cough), tell your healthcare professional.
Surgery: Tell all your doctors, dentists, pharmacists and/or healthcare professionals that you are taking this medicine. This is especially important if you are planning to have heart surgery.
Fertility in women: TORADOL may affect your fertility. This means that it may be difficult for you to have a child. If you have trouble having a child, you might need to stop taking TORADOL. Talk to your healthcare professional if you have any questions about this.
Patients 65 years or older: Side effects like gastrointestinal problems may happen more often. Your healthcare professional might have you start with a lower dose of TORADOL. They will monitor your health during and after treatment.
Driving and using machinery: TORADOL may cause eye or nervous system problems. This includes tiredness, trouble sleeping, blurred vision, spinning or dizziness (vertigo), hearing problems or depression. Be careful about driving or doing activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking TORADOL, do NOT drive or operate machinery.
Check-ups and testing: You will have regular visits with your healthcare professional during treatment with TORADOL to monitor your health. They will:
- Check your blood pressure.
- Check your eyes. TORADOL can cause blurred or reduced vision.
- Do blood and urine tests to check your liver, kidney and blood health.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions
Do not take TORADOL with:
The following may also interact with TORADOL:
- antacids, used to treat symptoms of excess stomach acid.
- medicines used to treat depression (antidepressants), like citalopram, fluoxetine, paroxetine, sertraline, and lithium.
- medicines used to treat high blood pressure, like enalapril, lisinopril, perindopril, ramipril, candesartan, irbesartan, losartan, and valsartan.
- medicines used to lower extra fluid levels (diuretics), like furosemide, and hydrochlorothiazide.
- medicines used as blood thinners or to prevent blood clots, like warfarin, clopidogrel, heparin, and dextrans.
- medicines used to treat seizures or epilepsy (antiepileptics), like carbamazepine and phenytoin.
- cyclosporin and tacrolimus, used to lower the risk of organ transplant rejection.
- methotrexate and pemetrexed, used to treat different cancers.
- digoxin, used to treat heart disorders.
- corticosteroids, used to treat inflammation, like glucocorticoids such as prednisone.
- mifepristone, used for abortions. TORADOL should not be taken for 8 to 12 days after taking mifepristone.
- medicines used to treat bacterial infections (antibiotics), like aminoglycosides and quinolone antibiotics.
- opioids, used to relive pain.
- thiothixene, used to treat schizophrenia.
- alprazolam, used to manage symptoms of anxiety.
- zidovudine, used to prevent and treat human immunodeficiency virus HIV.
- medicines used to treat muscle spasms and back pain (muscle relaxants).
- alcohol.
How to take TORADOL:
- Take exactly as your healthcare professional has told you. They should recommend the lowest dose possible for your treatment for the shortest time needed.
Taking TORADOL with these medicines may cause serious drug interactions. Ask your healthcare professional if you are unsure you are taking these medicines. |
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- Your healthcare professional will check if TORADOL is working for you and if it is causing you any unwanted effects. They may change your dose depending on how you respond to TORADOL.
To lessen stomach upset, take this medicine immediately after a meal (with food or milk). However, taking TORADOL with food may delay the onset of pain relief. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhea) occurs and continues, contact your healthcare professional.
- You should remain standing or sitting upright for about 15 to 30 minutes after taking this medicine. This helps to prevent irritation that may lead to trouble swallowing.
- This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.
Usual dose:
For pain relief after surgery (including dental procedures) or giving birth:
- The usual dose is 10 mg every 4 to 6 hours as needed.
- Maximum duration of treatment: 5 days.
For pain relief for an injury causing muscle or joint pain:
- The usual dose is 10 mg every 4 to 6 hours as needed.
- Maximum duration of treatment: 7 days.
Overdose:
Signs of an overdose with TORADOL may include:
- nausea or vomiting;
- abnormally fast, slow or deep breathing;
- abdominal pain, ulcer or bleeding from the stomach or gut;
- kidney problems;
- high blood pressure;
- coma.
| If you think you, or a person you are caring for, have taken too much TORADOL, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you miss a dose, take it as soon as you remember. Take your next dose at the usual time. Do not take two doses at the same time to make up for a forgotten dose.
What are possible side effects from using TORADOL?
These are not all the possible side effects you may have when taking TORADOL. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Nausea, vomiting, diarrhea, constipation, stomach upset, heartburn, indigestion, feeling gassy;
- Headache, dizziness, light-headedness;
- Feeling tired, trouble sleeping, abnormal dreams;
- Feeling of burning or prickling of the skin;
- Anxiety, nervousness;
- Thirst, dry mouth, sore throat, changes in tastes;
- Bruises, rash;
- Muscle pain/twitching/weakness;
- Mouth sores;
- Increased sweating;
- Bruising;
- Hair loss;
- Increased sensitivity to light.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Gastrointestinal (GI) problems (bleeding, blockage, holes, ulcers or inflammation in your GI tract): blood in vomit, black tarry or bloody stool, dizziness, stomach pain, bloating, loss of appetite, weight loss, nausea, vomiting, constipation or diarrhea, chills or fever | ✓ | ||
| Hypertension (high blood pressure): fatigue, dizziness or fainting, chest pain | ✓ | ||
| UNCOMMON | |||
| Anaphylaxis/hypersensitivity (severe allergic reactions): | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| sudden wheeziness and chest pain or tightness; or swelling of eyelids, face, lips, tongue or throat, swelling or anaphylactic reaction/shock | |||
| Aseptic meningitis (inflammation of the protective lining of the brain that is not caused by infection): Headaches, stiff neck, nausea and vomiting, fever or clouding of consciousness | ✓ | ||
| Blood problems (low white and/or red blood cell or platelet count): feeling tired or weak, pale skin, bruising or bleeding for longer than usual if you hurt yourself, fever, chills | ✓ | ||
| Congestive heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise | ✓ | ||
| Cystitis (bladder infection): increased need to urinate, pain in the pelvis or lower back, frequent urination during the night, cloudy urine that may contain blood, burning or pain urinating | ✓ | ||
| Depression (sad mood that will not go away): difficulty sleeping or sleeping too much, changes in appetite or weight, reduced | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| sex drive and thoughts of death or suicide. | |||
| Kidney disorder/problems (including kidney failure and renal papillary necrosis): nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, mental status changes (drowsiness, confusion, coma, painful urination, chills, back pain) | ✓ | ||
| Liver problems (including hepatitis, liver failure, cholestasis): yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness | ✓ | ||
| Lung problems (including asthma): increased shortness of breath, wheezing, difficulty breathing, cough, chest tightness, irregular heartbeat, lung infection, chest pain, fever | ✓ | ||
| Myocardial infarction (heart attack): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| indigestion, anxiety, feeling faint and possible irregular heartbeat. | |||
| Stroke (bleeding or blood clot in the brain): sudden numbness, weakness or tingling of the face, arm, or leg, particularly on one side of the body, sudden headache, blurry vision, difficulty swallowing or speaking, or lethargy, dizziness, fainting, vomiting, trouble understanding, trouble with walking and loss of balance | ✓ | ||
| Tinnitus (hearing problems): includes ringing, buzzing, clicking or hissing in ears, loss of hearing | ✓ | ||
| Vertigo (a sense of severe spinning dizziness, light-headedness) | ✓ | ||
| RARE | |||
| Serious skin reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, swelling of face and/or legs, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine or dark urine, red or dry itchy skin, purple or red spots on skin | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Eye problems: blurred vision, | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| loss of part or all of central vision, reduced colour vision, dimness of vision. | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store TORADOL at room temperature (15o C to 30oC) away from light.
- Do NOT keep expired medicine or medicine no longer needed. Return to your healthcare professional.
- Keep out of reach and sight of children.
If you want more information about TORADOL:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://www.aapharma.ca/en/), or by calling 1-877-998-9097.
Last Revised: AUG 09, 2024
TORADOL® is a registered trademark used under license by AA Pharma Inc.
All other trademarks are the property of their respective owners.