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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.

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 feeling while urinating
  • difficult or painful urination

Incidence Not Known

  • Blistering, peeling, or loosening of the skin
  • blurred vision
  • chills
  • clay-colored stools
  • cough
  • dark urine
  • diarrhea
  • fast or irregular heartbeat
  • fever with or without chills
  • general feeling of tiredness or weakness
  • hives, itching, or skin rash
  • hoarseness
  • joint or muscle pain
  • loss of appetite
  • lower back or side pain
  • nausea
  • 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
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach pain or swelling
  • tightness in the chest
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • 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 kit, oral tablet

General

The most common adverse reactions were bleeding complications.[Ref]

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

Hematologic

Very common (10% or more): Any bleeding

Common (1% to 10%): Anemia (including postoperative anemia)

Uncommon (0.1% to 1%): Bleeding into a critical organ, bleeding that required reoperation, decreased hemoglobin, decrease in hemoglobin by 2 g/dL (20 g/L) or more, fatal bleeding, non-fatal non-critical organ bleeding, occult blood positive, thrombocythemia, transfusion of 2 or more units of whole blood or packed red blood cells (including extra-surgical site bleeding),

Postmarketing reports: Agranulocytosis[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea, dyspepsia, gastrointestinal bleeding, gastrointestinal hemorrhage (including rectal hemorrhage), gingival bleeding, nausea, toothache, upper abdominal pain, vomiting

Uncommon (0.1% to 1%): Dry mouth, gastric ulcer hemorrhage, hematochezia, hemorrhagic gastritis, hemorrhoidal hemorrhage, lip hemorrhage, lower abdominal pain, melena, mouth hemorrhage, tongue hemorrhage

Rare (less than 0.1%): Retroperitoneal bleeding[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, syncope

Uncommon (0.1% to 1%): Cerebral and intracranial hemorrhage

Rare (0.01% to 0.1%): Cerebellar hemorrhage, fatal intracranial bleeding, hemorrhagic transformation stroke

Frequency not reported: Intraspinal bleeding, spinal/epidural hematoma

Postmarketing reports: Hemiparesis, subdural hematoma[Ref]

Cardiovascular

Following study drug discontinuation in the ROCKET AF trial, cases of stroke were reported in during the transition from rivaroxaban (the active ingredient contained in Xarelto) to warfarin in nonvalvular atrial fibrillation patients.[Ref]

Common (1% to 10%): Deep vein thrombosis, hematoma, hypertension, hypotension (include procedural hypotension), peripheral edema, tachycardia

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)[Ref]

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%): Increased conjugated bilirubin (with or without concomitant ALT increase), jaundice

Postmarketing reports: Cholestasis, cytolytic hepatitis[Ref]

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[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic reaction, anaphylactic shock, hypersensitivity[Ref]

Dermatologic

Common (1% to 10%): Blister, contusion, cutaneous and subcutaneous hemorrhage, ecchymosis, pruritus (including uncommon cases of generalized pruritus), rash, wound hemorrhage, wound secretion

Uncommon (0.1% to 1%): Allergic dermatitis, urticaria

Postmarketing reports: Angioedema, Stevens-Johnson syndrome[Ref]

Genitourinary

Common (1% to 10%): Urinary retention, urogenital tract hemorrhage (including hematuria and menorrhagia), vaginal hemorrhage

Uncommon (0.1% to 1%): Urinary tract infection

Rare (0.01% to 0.1%): Menometrorrhagia, metrorrhagia[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperglycemia, increased amylase, increased LDH, increased lipase

Rare (less than 0.1%): Localized edema[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, increased muscle tone and cramping, muscle spasm, osteoarthritis, pain in extremity

Uncommon (0.1% to 1%): Hemarthrosis

Rare (less than 0.1%): Muscle hemorrhage

Frequency not reported: Intramuscular bleeding with compartment syndrome[Ref]

Ocular

Common (1% to 10%): Eye hemorrhage (including conjunctival hemorrhage)

Uncommon (0.1% to 1%): Vitreous hemorrhage

Rare (less than 0.1%): Intraocular bleeding[Ref]

Psychiatric

Common (1% to 10%): Anxiety reaction, sleep disorders[Ref]

Respiratory

Common (1% to 10%): Dyspnea, epistaxis, hemoptysis, oropharyngeal pain, sinusitis

Frequency not reported: Pulmonary hemorrhage and pulmonary hemorrhage with bronchiectasis[Ref]

Other

Common (1% to 10%): Decreased general strength and energy (including fatigue and asthenia), fever

Uncommon (0.1% to 1%): Feeling unwell (including malaise)[Ref]

References

1. "Product Information. Xarelto (rivaroxaban)." Bayer Inc, Toronto, IA.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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