Patient Medication Information: uses, side effects, how to take - AG-Rivaroxaban
What AG-Rivaroxaban is used for:
AG-Rivaroxaban 10 mg, 15 mg and 20 mg tablets are used in adults to:
- prevent blood clots after major hip or knee surgery
- treat and prevent blood clots in the veins of the legs, arms or lungs
- prevent blood clots in the brain (stroke) and other blood vessels in the body of patients who have atrial fibrillation (irregular heart rhythm)
AG-Rivaroxaban 2.5 mg tablets are used in combination with acetylsalicylic acid (ASA) in adults to:
- prevent stroke, heart attack or severe leg or arm pain in patients with peripheral artery disease who are at high risk. This is a condition where the blood vessels that carry blood away from the heart to other parts of the body (arteries) are narrowing due to plaque buildup.
- prevent stroke, heart attack, severe leg or arm pain, or death in patients with coronary heart disease. This is a condition where the blood vessels supplying blood to the heart (coronary arteries) become narrow or blocked due to plaque buildup. This causes a lack of oxygen in the heart. These patients may also have peripheral artery disease.
How AG-Rivaroxaban works:
AG-Rivaroxaban belongs to a group of medicines called anticoagulants (blood thinners). It helps prevent blood clots from forming by directly blocking the activity of a clotting factor called Factor-Xa.
The ingredients in AG-Rivaroxaban are:
Medicinal ingredient: Rivaroxaban
Non-medicinal ingredients: Cellulose microcrystalline, croscarmellose sodium, hypromellose, iron oxide red in the 10 mg, 15 mg and 20 mg tablets (i.e., not in the
2.5 mg tablets), iron oxide yellow (2.5 mg tablets only), lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate and titanium dioxide.
AG-Rivaroxaban comes in the following dosage forms:
- Tablets: 2.5 mg, 10 mg, 15 mg and 20 mg
Do not use AG-Rivaroxaban if you:
- are allergic to rivaroxaban or to any other ingredients in AG-Rivaroxaban. AG-Rivaroxaban contains lactose
- are actively bleeding, especially if you are excessively bleeding
have any injuries or conditions that may increase your risk of bleeding. This includes:
- active or recent bleeding in the brain
- active or recent bleeding in the stomach or gut
- have difficulties to stop bleeding (bleeding disorder)
- take medicines to treat HIV / AIDS, such as cobicistat and ritonavir
- take medicines to treat fungal infections, such as ketoconazole, itraconazole and posaconazole
- take dronedarone, a medicine used to control an abnormal heart rhythm called atrial fibrillation
take any other medicines used to prevent or treat blood clots. This includes:
- warfarin, dabigatran, apixaban, edoxaban, heparin
- low molecular weight heparin (LMWH), such as enoxaparin and dalteparin
- heparin derivatives, such as fondaparinux
- have severe liver disease, which can lead to an increased risk of bleeding
- are pregnant, think you might be pregnant or plan on becoming pregnant
- are breastfeeding
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG-Rivaroxaban. Talk about any health conditions or problems you may have, including if you:
have an increased risk of bleeding. This includes if you:
- have severe kidney problems or reduced kidney function
- are taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which are used to relieve pain and reduce inflammation, such as ibuprofen, naproxen and celecoxib
- are taking acetylsalicylic acid (ASA, or ASPIRIN) or any other medicines used to prevent stroke or heart disease, such as clopidogrel, prasugrel and ticagrelor
- are taking medicines to treat depression or other psychological conditions
- have low levels of platelets in the blood or your platelets do not work properly
- have very high blood pressure, not controlled by medical treatment
- have or have had an ulcer in the stomach or bowel
- have a problem with the blood vessels in the back of the eyes (retinopathy)
- have problems with the blood vessels in the brain or spinal column
- had surgery on the brain, spinal column or eyes
- have bronchiectasis, which is a chronic disease where the bronchial tubes of the lungs become damaged, widened, and thickened
- have a history of bleeding into the lungs
- are older than 75 years of age
- have been diagnosed with cancer, had a relapse of cancer or have been treated for cancer in the last 6 months
- have liver problems
- are having surgery for any reason, including an operation that involves a catheter or injection into the spinal column (e.g., for epidural or spinal anesthesia or pain reduction)
- have damaged heart valves or heart valve disease
- have a prosthetic heart valve
- have antiphospholipid syndrome, also known as Hughes syndrome. This is a disorder of the immune system that causes an increased risk of blood clots.
- have a stent, which is a small metal coil inserted into a blocked blood vessel to restore blood flow by keeping it open
- have a history of stroke, with or without bleeding in the brain
- are taking rifampicin, a medicine used to treat bacterial infections, including tuberculosis
- are taking medicines used to prevent epilepsy or seizures, such as phenytoin, carbamazepine and phenobarbital
- are lactose intolerant. AG-Rivaroxaban contains lactose.
Other warnings you should know about:
Do not stop taking AG-Rivaroxaban without first talking to your healthcare professional. If you stop taking AG-Rivaroxaban, blood clots may form and cause a stroke, heart attack, or other serious complications. This can lead to severe disability or even death.
Risk of Bleeding: As with other blood thinners, taking AG-Rivaroxaban may increase the risk of bleeding from any part of the body, including internal organs. It may be serious or even life-threatening. Tell your healthcare professional right away if you have any unusual bleeding or bruising. For examples of bleeding, see the Serious side effects and what to do about them table below.
Spinal or epidural blood clots (hematoma): People who take AG-Rivaroxaban and have medicine injected into their spinal or epidural area, or have a spinal puncture, have a risk of forming a spinal or epidural blood clot. This can cause long-term or permanent loss of the ability to move (paralysis). The risk of developing a spinal or epidural blood clot is higher if:
A thin tube called an epidural catheter is placed in your back to give certain
medicines
- You take NSAIDs or a medicine to prevent blood from clotting
- You have a history of difficult or repeated epidural or spinal punctures
- You have a history of problems with the spinal column or have had surgery on the spinal column
If you take AG-Rivaroxaban and receive spinal anesthesia or have a spinal puncture, your healthcare professional will watch you closely for symptoms of spinal or epidural blood clots.
Tell your healthcare professional right away if you develop the following symptoms after an epidural or a spinal procedure:
- back pain
- tingling
- numbness
- muscle weakness (especially in your legs and feet)
- or loss of control of the bowels or bladder (incontinence)
Surgery:
- Tell your healthcare professional if you are going to have any surgeries, including dental procedures, while taking AG-Rivaroxaban. There is an increased risk of bleeding if you take AG-Rivaroxaban during these procedures. It can be life-threatening.
- Your healthcare professional may ask you to stop taking AG-Rivaroxaban before the surgery, and to resume taking AG-Rivaroxaban after the procedure. It is important that you take AG-Rivaroxaban before and after the procedure exactly at the times the healthcare professional has instructed.
Anticoagulant-Related Nephropathy (ARN):
Some cases were reported in patients taking rivaroxaban. It is a type of serious kidney damage caused by anticoagulant medicines. ARN causes bleeding in the kidneys, sometimes with the presence of blood in the urine. This leads to the kidneys being unable to function properly. Your healthcare professional may monitor the health of your kidneys during your treatment with AG-Rivaroxaban. If you are experiencing symptoms of ARN during your treatment, tell your healthcare professional right away.
Children and adolescents:
- AG-Rivaroxaban is not indicated in children less than 18 years of age.
Pregnancy:
- AG-Rivaroxaban should not be used during pregnancy. Taking it during pregnancy may harm an unborn baby.
- Your healthcare professional may ask you to use a highly effective birth control method while taking AG-Rivaroxaban.
- If you discover that you are pregnant while taking AG-Rivaroxaban, contact your healthcare professional as soon as possible.
Breastfeeding: AG-Rivaroxaban should not be used while breastfeeding. It may pass into breast milk and harm a breastfed baby. AG-Rivaroxaban will only be given to you once you have stopped breastfeeding.
Check-ups and testing: Your healthcare professional may:
- evaluate your risk of bleeding before starting AG-Rivaroxaban and regularly during treatment. This includes performing blood tests to check the amount of red blood cells in the blood, and monitoring blood pressure.
- do blood tests before you start taking AG-Rivaroxaban and during treatment to check if your kidneys are working properly.
Depending on the test results, your healthcare professional may discontinue your treatment with AG-Rivaroxaban.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious drug interactions:
Serious drug interactions with AG-Rivaroxaban include:
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The following may interact with AG-Rivaroxaban:
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which are used to relieve pain and reduce inflammation, such as ibuprofen, naproxen and celecoxib
- Acetylsalicylic acid (ASA, or ASPIRIN), used to relieve fever and pain
- Medicines used to prevent stroke or heart disease, such as clopidogrel, prasugrel and ticagrelor
- Dronedarone, a medicine used to control an abnormal heart rhythm called atrial fibrillation
- Medicines used to treat bacterial infections, such as clarithromycin and rifampicin
- Medicines used to control epilepsy or seizures, such as phenytoin, carbamazepine and phenobarbital
- Medicines used to treat depression or other psychological conditions, such as Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)
- St. John’s Wort (also known as Hypericum perforatum), a herbal remedy used to treat depression
AG-Rivaroxaban 2.5 mg tablets are prescribed with acetylsalicylic acid (ASA). Ask your healthcare professional first before taking any other NSAIDs. They will determine if it is beneficial for you to take it during your treatment with AG-Rivaroxaban and ASA.
How to take AG-Rivaroxaban:
Take:
- AG-Rivaroxaban tablets exactly as your healthcare professional tells you
AG-Rivaroxaban tablets at the same time every day to help you remember it - AG-Rivaroxaban 2.5 mg and 10 mg tablets with or without food
- AG-Rivaroxaban 15 mg and 20 mg tablets with food
- Swallow tablet whole, preferably with water. Do not split tablets.
- AG-Rivaroxaban tablets may be crushed and mixed with applesauce. Take the applesauce mixture right away after you have mixed it. A crushed 2.5 mg or 10 mg tablet can be taken with or without food. Eat food right after taking a crushed 15 mg or 20 mg tablet. The healthcare professional may give you the crushed AG-Rivaroxaban tablet also via a tube.
- It is not recommended to crush and mix a 2.5 mg AG-Rivaroxaban tablet and an acetylsalicylic acid (ASA, or ASPIRIN) tablet together with applesauce.
- Do not stop taking AG-Rivaroxaban without talking to the healthcare professional first.
Usual dose:
Prevention of blood clots after major hip or knee surgery
Usual adult dose: Take one 10 mg tablet once a day with or without food.
Take the first tablet 6 to 10 hours after your operation. Then take a tablet every day until your healthcare professional tells you to stop.
If you have had a major hip operation, you will usually take AG-Rivaroxaban for 35 days.
If you have had a major knee operation, you will usually take AG-Rivaroxaban for 14 days.
Treatment and prevention of blood clots in the veins of the legs or arms, or blood vessels of the lungs
Adults:
- Day 1 to 21: Take one 15 mg tablet TWICE a day (in the morning and evening) with food.
- Day 22 and onwards: Take one 20 mg tablet ONCE a day with food.
After at least 6 months treatment, your healthcare professional may decide to continue treatment with either one 20 mg tablet once a day or one 10 mg tablet once a day.
The 10 mg tablet may be taken with or without food.
This is a long-term treatment and you should continue to take AG-Rivaroxaban until your healthcare professional says otherwise.
Prevention of blood clots in your brain (stroke) and in other blood vessels of your body if you have atrial fibrillation
Usual adult dose: Take one 20 mg tablet once a day with food.
If your kidneys are not working properly, your healthcare professional may prescribe 15 mg once a day with food.
This is a long-term treatment and you should continue to take AG-Rivaroxaban until your healthcare professional says otherwise.
The recommended maximum daily dose is 20 mg.
Prevention of stroke, heart attack, severe leg or arm pain, or death if you have coronary artery disease and / or peripheral artery disease
Usual adult dose: Take one 2.5 mg tablet twice a day with or without food. Take AG-Rivaroxaban around the same time every day (for example, one tablet in the morning and one in the evening).
Also take 1 tablet of 75 mg-100 mg of acetylsalicylic acid (ASA, or ASPIRIN) once a day. Take the ASA tablet at the same time as one of your AG-Rivaroxaban doses.
This is a long-term treatment and you should continue to take your treatment until your healthcare professional says otherwise.
Overdose:
Taking too much AG-Rivaroxaban may cause excessive bleeding.
| If you think you, or a person you are caring for, have taken too much AG-Rivaroxaban, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no symptoms. |
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Missed dose:
- If you take AG-Rivaroxaban 2.5 mg tablets twice a day and miss a dose, skip the missed dose and take the next dose as usual.
- If you take AG-Rivaroxaban 15 mg tablets twice a day and miss a dose, take the missed dose as soon as you remember. If you forget to take a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in one day. Do not take more than two 15 mg tablets in one day. The next day, take AG-Rivaroxaban as usual.
- If you take AG-Rivaroxaban 10 mg, 15 mg or 20 mg tablets once a day and miss a dose, take the missed dose as soon as you remember on the same day. If this is not possible, you should skip the missed dose and take the next dose on the following day as usual. Do not take a double dose to make up for the one that was missed.
Possible side effects from using AG-Rivaroxaban:
These are not all the possible side effects you may have when taking AG-Rivaroxaban. If you experience any side effects not listed here, tell your healthcare professional.
As AG-Rivaroxaban acts on the blood-clotting system, most side effects are related to signs of bruising or bleeding. In some cases, bleeding may not be obvious, such as unexplained swelling.
Patients treated with AG-Rivaroxaban may also experience the following side effects:
Nausea, vomiting, stomach ache, constipation, diarrhea, indigestion, and decreased general strength and energy.
AG-Rivaroxaban can cause abnormal blood test results. The healthcare professional may perform blood tests before you take AG-Rivaroxaban and regularly during treatment. They will tell you if the test results are abnormal and if you need treatment to correct these side effects.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Common | |||
| Anemia (decreased number of red blood cells): pale complexion, weakness, tiredness, dizziness, headache, breathlessness, unusually fast heartbeat, or chest pain | ✓ | ||
| Bleeding from hemorrhoids | ✓ | ||
| Bleeding from a surgical wound, an injury or other medical procedure | ✓ | ||
| Bleeding gums for longer than 5 minutes when you brush your teeth | ✓ | ||
| Bleeding in the eye | ✓ | ||
| Bleeding under the skin | ✓ | ||
| Blood in your urine, (red / pink tinge to urine) | ✓ | ||
| Fever | ✓ | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Gastrointestinal (GI) Bleeding (bleeding anywhere along the GI tract between mouth and anus): blood in vomit, black tarry stool, bright red blood in your stool or coming from rectum, rapid pulse, low blood pressure, low urine flow, confusion, weakness, dizziness | ✓ | ||
| Genital bleeding in postmenopausal women | ✓ | ||
| Hypotension (low blood pressure): dizziness, fainting, lightheadedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | ✓ | ||
| Increased or more frequent menstrual bleeding | ✓ | ||
| Itchy skin or rash | ✓ | ||
| Localized swelling | ✓ | ||
| Nosebleed lasting more than 5 minutes | ✓ | ||
| Pain or swelling in your limbs | ✓ | ||
| Tachycardia (abnormally fast heartbeat) | ✓ | ||
| Unexpected bruising | ✓ | ||
| Uncommon | |||
| Decreased urine output | ✓ | ||
| Hemarthrosis (bleeding into a joint): joint pain, swelling | ✓ | ||
| Hemoptysis: coughing up blood | ✓ | ||
| Intracerebral Hemorrhage (bleeding in the brain): sudden, severe headache; confusion; nausea and vomiting; seizures; loss of consciousness | ✓ | ||
| Oozing from the surgical wound | ✓ | ||
| Seizure (fit) reported in adults: loss of consciousness with uncontrollable shaking | ✓ | ||
| Syncope (fainting): a temporary loss of consciousness due to a sudden drop in | ✓ | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| blood pressure | |||
| Rare | |||
| Allergic Reaction: difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat | ✓ | ||
| Liver Disorder: yellowing of the skin or eyes, dark urine, pale stools, abdominal pain, nausea, vomiting, loss of appetite | ✓ | ||
| Very rare | |||
| Splenic Rupture: left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder | ✓ | ||
| Unknown | |||
| Agranulocytosis (decrease in white blood cells): frequent infection with fever, chills, sore throat | ✓ | ||
| Anticoagulant-Related Nephropathy (ARN) (serious kidney damage caused by anticoagulant medicines): bleeding in the kidney sometimes with presence of blood in urine leading to inability of the kidneys to work properly | ✓ | ||
| Compartment Syndrome: increased pressure within legs or arms after a bleed, with pain, swelling, numbness or paralysis | ✓ | ||
| Eosinophilic Pneumonia (accumulation of a type of white blood cells that cause inflammation in the lung): shortness of breath, cough, wheezing, chest pain, fever, and unintended weight loss | ✓ | ||
| Stevens-Johnson Syndrome (SJS) (severe skin rash): redness, blistering and / or peeling of the skin and / or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | ✓ | ||
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. |
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Storage:
- Keep AG-Rivaroxaban tablets at room temperature (15-30°C).
- Keep out of reach and sight of children.
- Do not use AG-Rivaroxaban after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
If you want more information about AG-Rivaroxaban:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 450-449-9272.
1310 rue Nobel
Boucherville, Québec
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Date of Authorization: 2026-07-29