Xarelto side effects and drug information

Xarelto is a brand name for Rivaroxaban, and it works by impeding the activity of specific clotting components found in the blood. It is utilized to cure or prevent a particular kind of blood clot known as deep vein thrombosis or DVT that usually results in blood clotting in the lungs, a condition called pulmonary embolism or PE. Typically, DVT can develop among patients who went through a hip or knee replacement operations. It can also occur during or after the hospital stay, especially if the patient is unable to move around like he/she usually does. 

ChemSpider ID 8051086
Trade name Xarelto
ChEMBL Id 198362
ChemSpider ID 8051086
Molar mass 435.882 g/mol
CAS ID 366789-02-8
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Drug Description

At times, Xarelto is utilized to decrease the risk of PE and DVT from recurring right after the patient has been given treatment and medication for blood clots for about six months. Rivaroxaban is also used to treat patients that develop atrial fibrillation – a certain heart rhythm complication – to decrease the possibility of stroke due to a blood clot.

Additionally, Rivaroxaban is utilized to prevent blood cloths among specific groups of people that are hospitalized due to an acute disorder and are at risk of acquiring blood clots but don’t have a greater risk of bleeding. It is also prescribed alongside aspirin as a way to decrease the risk of having a heart attack, heart valve problems, stroke, and many other severe heart complications among those that have underlying coronary heart disease – lowered blood flow towards the heart – or peripheral artery disease – decreased blood flow towards the legs.

If you are planning to take or stop consuming Rivaroxaban, make sure you contact your doctor or physician first.

Side effects

Together with its essential effects, Rivaroxaban – which is the crucial ingredient in Xarelto – might cause several side effects.

Though not all of these side effects might happen, in case they do, patients need to seek immediate medical attention.

Consult with your doctor right away if you experience any of these rivaroxaban side effects while consuming the medication:

More common side effects

  • bleeding gums
  • back pain
  • bladder or bowel dysfunction
  • bloody stools
  • coughing up blood
  • dizziness
  • vaginal bleeding or increased menstrual flow
  • nosebleeds
  • muscle paralysis
  • prolonged bleeding from cuts
  • burning, itching, crawling, muscle numbness, prickling, tingling feelings, or “pins and needles.”
  • difficulty with swallowing or breathing
  • headache
  • leg weakness
  • muscle numbness
  • black or red tarry stools
  • dark brown or red urine
  • vomiting of blood or substance that somehow looks like coffee grounds

Less common side effects

  • pain in the legs or arms
  • fainting
  • wound secretion
  • muscle spams
  • blisters
  • mild allergic reactions

Rare side effects

  • painful or hard urination
  • burning sensation while urinating

Side effects not known

  • blurred vision
  • clay-colored stools
  • dark urine
  • irregular or fast heartbeat
  • itchinghives, or skin rash
  • allergic reactions
  • joint or muscle pain
  • nausea
  • red, irritated eyes
  • sore throat
  • Blistering, peeling, or loosening of the skin
  • chills
  • loss of appetite
  • cough
  • diarrhea
  • fever with or without chills
  • the general feeling of tiredness or weakness
  • hoarseness
  • lower back or side pain
  • swelling or puffiness of the eyelids or around the face, lips, eyes, or tongue
  • red skin lesions, usually with a purple center
  • extreme headache
  • ulcers, sores, white spots in the mouth or on the lips
  • unusual weakness or tiredness
  • unpleasant breath odor
  • stomach pain or swelling
  • unusual bleeding or bruising
  • vomiting
  • tightness in the chest
  • yellow eyes or skin

There are several Xarelto side effects that don’t need medical attention when they occur. These are the side effects that will subside during the treatment since your body adapts to the medication.

Moreover, your health care provider will give you advise diagnoses or treatment for a few of these side effects. Consult your physician or doctor if any of these side effects get worse or continue and if you have any inquiries about them.

Indication And Dosage

  • Rivaroxaban is indicated to prevent venous thromboembolism or VTE and deaths caused by VTE during pre and post-hospitalization discharge among adult patients hospitalized for a severe medical disorder, who have increased risk of suffering from thromboembolic because of moderate to restricted severe mobility and many other risk factors associated to VTE but don’t have a greater risk of bleeding.
  • Rivaroxaban is indicated to lower the risk of systematic embolism or stroke among patients with existing nonvalvular atrial fibrillation or AF. There are small data gathered that relates to the effectiveness of warfarin and Rivaroxaban in lowering the risk of systematic embolism and stroke if warfarin therapy is adequately controlled.
  • Rivaroxaban is indicated to treat deep vein thrombosis or DVT and pulmonary embolism or PE. It is also shown to reduce the risk of PE and DVT from occurring again among patients that have a greater of recurrent PE or DVT right after finishing the initial treatment that lasts for about six months.
  • Rivaroxaban is indicated to prevent DVT that can potentially result in PE among patients going through a hip or knee replacement procedure.
  • Rivaroxaban is indicated together with aspirin to lower the risk of severe cardiovascular complications (myocardial infarction [MI], cardiovascular [CV] death, and stroke) among patients with underlying peripheral artery disease (PAD) or chronic coronary artery disease (CAD).

The dosage of Xarelto given by your doctor depends on the advice diagnosis or treatment you need plus a few key factors, including:

  • the kind of condition you are treating using Xarelto
  • your age
  • other medical disorders and illness that you have, like kidney damage

Here are the most common FDA approved dosages for Xarelto to treat specific medical complications

Nonvalvular atrial fibrillation

  • Typical dosage – 20 mg once a day after eating the evening meal
  • For patients with severe kidney problems – 15 mg once a day after eating the evening meal
  • For patients with severe kidney problems – this prescription drug is not recommended

Treatment of DVTs or PEs

  • Typical dosage – 15 mg twice a day taken with food for 21 days and another 20 mg once a day made with food for the rest of the treatment
  • For patients with severe kidney problems – this prescription drug is not recommended

Prevention of DVTs or PEs among patients who recently underwent hip or knee replacement surgery:

  • After a hip replacement surgery – 10 mg once a day with or without food for a time of 35 days
  • After a knee replacement surgery – 12 mg once a day with or without food for a period of 35 days
  • For patients with severe kidney problems – this prescription drug is not recommended

Lowering the risk of severe heart complications among patients with existing peripheral artery disease (PAD) or chronic coronary artery disease (CAD):

  • Typical dosage – 2.5 mg twice a day, together with 75-100 mg of aspirin once a day. Consume with or without food.

Drug Interaction

There are plenty of drugs that alter the way Rivaroxaban operates. In the same way, Rivaroxaban can also react with other medications that you are consuming.

It’s essential that you update your healthcare provider, may it be your physician or doctor about everything that you consume, including over-the-counter medications, nutritional and dietary supplements, recreational or illegal drugs, and herbal or herbs preparations.

Kinds of medicine that have the ability to react with Rivaroxaban include:

  • Certain types of blood thinner
  • Certain heart medications
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Antibiotics
  • Medications used to cure HIV
  • Medicines utilized to cure blood or circulation problems
  • Anti-seizure drugs, like carbamazepine (Tegretol)
  • Antifungal medications
  • St. John’s wort

Examples of blood thinners and medications used to cure circulation complications include:

  • Dipyridamole (Persantine)
  • Warfarin (Coumadin, Jantoven)
  • Anagrelide (Agrylin)
  • Clopidogrel (Plavix)
  • Cilostazol (Pletal)

Rivaroxaban might also react with certain NSAIDs like:

  • Ibuprofen (Motrin, Advil, and other brands)
  • Naproxen (Aleve, Naprelan, Anaprox and other brands)
  • Aspirin
  • Indomethacin (Indocin)

Examples of medications for heart problems that might react to Rivaroxaban include:

  • Tirofiban (Aggrastat)
  • Amiodarone (Cordarone)
  • Diltiazem (Dilacor, Cardizem, Tiazac)

Examples of anti-seizure medications that might react with Rivaroxaban include:

  • Phenytoin (Phenytek, Dilantin)
  • Carbamazepine (Epitol, Teril, Carbatrol, Tegretol, Equetro, Tegretol-XR)
  • Phenobarbital (Solfoton, Luminal)

Antifungals and antibiotics that might react with Xarelto include:

  • Clarithromycin (Biaxin, in Prevpac)
  • Rifampin or medications containing rifampin (Rifadin, Rifater, Rifamate, Rimactane)
  • Erythromycin (E-Mycin, E.E.S., Erythrocin)
  • Itraconazole (Sporanox, Onmel)
  • Fluconazole (Diflucan)
  • Ketoconazole (Nizoral)

HIV prescription drugs that might interact with Rivaroxaban include:

  • Ritonavir (Norvir)
  • Indinavir (Crixivan)
  • Lopinavir (in Kaletra)

Warnings and Precautions

Rivaroxaban has black box warnings. Generally, these are the most crucial warnings given by the Food and Drug Administration or FDA. The role of these black box warnings is to alert both the patients and doctors regarding the effects of the meds that might be hazardous.

  • Warning for discontinuing the treatment: don’t interrupt the usage of this medicine without consulting your healthcare provider first. If you stop consuming a blood thinner, there is an increased risk that you will suffer from a stroke or have blood pressure.
  • Warning for Epidural or spinal blood clots (hematoma): patients who consume these medications and have another drug that’s injected in specific areas of their spines or have an underlying spinal puncture have a greater of building severe blood clot. This can result in long-term or permanent paralysis. Moreover, the risk is even higher if you are taking nonsteroidal anti-inflammatory drugs (NSAIDs) or other drugs to stop your blood from clotting. If you ever developed spinal or epidural punctures in the past, or have a history of spinal surgery or complications within your spine, your risk is even higher.
  • Warning for bleeding risk: Xarelto raises your risk of suffering from severe bleeding that could be fatal to your health. This is due to the blood-thinning capacity of the drug, which reduces the risk of experience blood clots in the body. Contact your doctor or seek medical attention immediately if you experience symptoms of severe bleeding. Your doctor might facilitate a cure in the form of meds called Andexxa to reverse the blood-thinning impact of Xarelto.
  • Warning for artificial heart valve risk: don’t consume these meds if you have an artificial (prosthetic) heart valve. There are still zero clinical trials regarding the efficacy of these meds with artificial heart valves.
  • Warning for an allergic reaction: Xarelto can cause an allergic reaction with symptoms including breathing problems and swelling of tongue and throat.
  • Warning for pregnant women: Clinical trials and researches in animals have displayed adverse effects on the unborn child if a pregnant mother consumes this regulared drug. But, there are limited studies carried out in humans to fully understand how the drug works on a human fetus. Moreover, Xarelto can also increase the risk of premature delivery and severe bleeding.
  • Warning for lactating mothers: Xarelto can potentially pass through the mother’s breast milk. 
  • Warning for seniors: there’s an increased risk of bleeding and age if the patient is of age. However, the advantages of Xarelto might overlap the risks.
  • Warning for children: there hasn’t been any studies or clinical trials regarding the safety and effectiveness of Xarelto among patients below 18 years old.

Overdose and Contraindications

If you consume too much Xarelto, you could potentially experience haemorrhage or internal bleeding. Symptoms of overdose include:

  • black or blood stools
  • abnormal bruising or bleeding
  • blood in urine
  • vomiting or coughing up blood

If you or anyone you know experiences symptoms of overdosage, contact your healthcare provider immediately or go to the nearest emergency center. In worst cases where someone collapses or doesn’t breathe after taking Xarelto, contact 911 right away.

Furthermore, Xarelto is contraindicated for utilizations by several patients, especially those with severe hypersensitivity to the meds.

  • Epidural anaesthesia, knee replacement, bleeding, spinal anaesthesia, and lumbar puncture – Xarelto should not be used by patients who have current major bleeding in the acute stage. Bleeding can happen at any part during therapy.
  • Anticoagulant therapy – Xarelto needs to be utilized with caution among patients who are under other anticoagulant therapy such as warfarin, platelet inhibitors like ticlopidine and aspiring, NSAIDs, and fibrinolytic because of increased risk of bleeding.
  • Renal impairment, renal failure – don’t use Xarelto if you have renal failure or serious renal impairment. Stop using the drug if a patient acquires acute renal failure. 
  • Sudden discontinuation – don’t suddenly stop using Xarelto without sufficient alternative anticoagulation. Stopping the meds places patients at high risk of suffering from thrombotic circumstances and stroke. 
  • Prosthetic heart valves – there are still no studies and clinical trials regarding the utilization of Xareltoamong patients with prosthetic heart valves.
  • Breast-feeding – Xarelto has been spotted in breastmilk. However, there is still no sufficient evidence that shows the effects of the drug on milk production and breastfed baby.

Clinical Pharmacology

Xarelto is considered as an oral factor inhibitor that specifically impedes the primary site and doesn’t need a cofactor like Anti-thrombin III to carry out the activity. Generally speaking, Rivaroxaban allows free factor Xa, as well as prothrombinase activity. It is discovered that the inhibition lowers the development of thrombin in the body. Besides, Xarelto doesn’t have any direct impact on the aggregation of the platelet. However, it indirectly prevents aggregation of platelet as supported by thrombin.

Medication Guide

Consume Xarelto at the exact time each day. See to it that you follow every direction by your doctor and talk to your healthcare provider if you have questions with parts that you don’t understand.

Consume Xarelto specifically as directed. Never take more or less than your doctor prescribed. Always consult your doctor for advice diagnosis or treatment.