Xarelto Side Effects

Generic Name: rivaroxaban

Note: This document contains side effect information about rivaroxaban. Some of the dosage forms listed on this page may not apply to the brand name Xarelto.

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

For the Consumer

Applies to rivaroxaban: oral tablet

Along with its needed effects, rivaroxaban (the active ingredient contained in Xarelto) 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 rivaroxaban:

More common
  • Back pain
  • bleeding gums
  • bloody stools
  • bowel or bladder dysfunction
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • coughing up blood
  • difficulty with breathing or swallowing
  • dizziness
  • headache
  • increased menstrual flow or vaginal bleeding
  • leg weakness
  • nosebleeds
  • numbness
  • paralysis
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • vomiting of blood or material that looks like coffee grounds
Less common
  • Fainting
  • pain in the arms or legs
  • wound secretion
Rare
  • Burning while urinating
  • difficult or painful urination
Incidence not known
  • Abdominal or stomach pain or swelling
  • blistering, peeling, or loosening of the skin
  • blurred vision
  • chills
  • clay-colored stools
  • cough or hoarseness
  • dark urine
  • diarrhea
  • fast or irregular heartbeat
  • fever with or without chills
  • general feeling of tiredness or weakness
  • hives
  • itching
  • joint or muscle pain
  • loss of appetite
  • lower back or side pain
  • nausea or vomiting
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • severe headache
  • skin rash
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • tightness in the chest
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin

Some side effects of rivaroxaban 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:

Less common
  • Blisters
  • muscle spasm

For Healthcare Professionals

Applies to rivaroxaban: oral tablet

General

The most common adverse reactions were bleeding complications.

The risk of bleeding may be increased in certain patient groups, including patients with uncontrolled severe arterial hypertension and/or concomitant treatment affecting hemostasis.

Hematologic

Very common (10% or more): Any bleeding
Common (1% to 10%): Anemia (including postoperative anemia)
Uncommon (0.1% to 1%): Non-fatal non-critical organ bleeding, bleeding into a critical organ, fatal bleeding, decreased hemoglobin, decrease in hemoglobin by 2 g/dL (20 g/L) or more, transfusion of 2 or more units of whole blood or packed red blood cells (including extra-surgical site bleeding), bleeding that required reoperation, thrombocythemia, occult blood positive
Postmarketing reports: Agranulocytosis

Gastrointestinal

Common (1% to 10%): Gastrointestinal bleeding, gastrointestinal hemorrhage (including rectal hemorrhage), upper abdominal pain, dyspepsia, toothache, gingival bleeding, nausea, constipation, diarrhea, vomiting
Uncommon (0.1% to 1%): Dry mouth, hematochezia, hemorrhoidal hemorrhage, melena, lip hemorrhage, mouth hemorrhage, tongue hemorrhage, gastric ulcer hemorrhage, hemorrhagic gastritis, lower abdominal pain
Rare (less than 0.1%): Retroperitoneal bleeding

Nervous system

Common (1% to 10%): Syncope, dizziness, headache, sleep disorders
Uncommon (0.1% to 1%): Cerebral and intracranial hemorrhage
Rare (0.01% to 0.1%): Fatal intracranial bleeding, cerebellar hemorrhage, hemorrhagic transformation stroke
Frequency not reported: Spinal/epidural hematoma, intraspinal bleeding
Postmarketing reports: Subdural hematoma, hemiparesis

Cardiovascular

Common (1% to 10%): Hypotension (include procedural hypotension), hypertension, hematoma, tachycardia, deep vein thrombosis, peripheral edema
Rare (less than 0.1%): Vascular pseudoaneurysm
Frequency not reported: Pericardial and intra-articular bleeding, symptoms of cardiac ischemia such as chest pain or angina pectoris (as a consequence of anemia)

Following study drug discontinuation in the ROCKET AF trial, cases of stroke were reported in during the transition from rivaroxaban to warfarin in nonvalvular atrial fibrillation patients.

Hepatic

Common (1% to 10%): Increase in transaminases
Uncommon (0.1% to 1%): Abnormal hepatic function, increased bilirubin, increased blood alkaline phosphatase, increased gamma glutamyltransferase (GGT)
Rare (less than 0.1%): Jaundice, increased conjugated bilirubin (with or without concomitant ALT increase)
Postmarketing reports: Cholestasis, cytolytic hepatitis

Renal

Common (1% to 10%): Renal impairment (including increased blood creatinine and blood urea)
Uncommon (0.1% to 1%): Decreased creatinine renal clearance
Frequency not reported: Renal failure/acute renal failure secondary to a bleeding sufficient to cause hypoperfusion

Hypersensitivity

Postmarketing reports: Hypersensitivity, anaphylactic reaction, anaphylactic shock, angioedema

Dermatologic

Common (1% to 10%): Wound secretion, pruritus (including uncommon cases of generalized pruritus), blister, rash, ecchymosis, wound hemorrhage, cutaneous and subcutaneous hemorrhage, contusion
Uncommon (0.1% to 1%): Allergic dermatitis, urticaria
Postmarketing reports: Stevens-Johnson syndrome

Genitourinary

Common (1% to 10%): Urogenital tract hemorrhage (including hematuria and menorrhagia), vaginal hemorrhage, urinary retention
Uncommon (0.1% to 1%): Urinary tract infection
Rare (0.01% to 0.1%): Menometrorrhagia, metrorrhagia

Metabolic

Uncommon (0.1% to 1%): Increased LDH, increased lipase, increased amylase, hyperglycemia
Rare (less than 0.1%): Localized edema

Musculoskeletal

Common (1% to 10%): Back pain, osteoarthritis, pain in extremity, muscle spasm, arthralgia, increased muscle tone and cramping
Uncommon (0.1% to 1%): Hemarthrosis
Rare (less than 0.1%): Muscle hemorrhage
Frequency not reported: Intramuscular bleeding with compartment syndrome

Ocular

Common (1% to 10%): Eye hemorrhage (including conjunctival hemorrhage)
Uncommon (0.1% to 1%): Vitreous hemorrhage
Rare (less than 0.1%): Intraocular bleeding

Psychiatric

Common (1% to 10%): Anxiety reaction

Respiratory

Common (1% to 10%): Sinusitis, oropharyngeal pain, epistaxis, hemoptysis, dyspnea
Frequency not reported: Pulmonary hemorrhage and pulmonary hemorrhage with bronchiectasis

Other

Common (1% to 10%): Fever, decreased general strength and energy (including fatigue and asthenia)
Uncommon (0.1% to 1%): Feeling unwell (including malaise)

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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