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 reaction greater than 5 % was bleeding.

Hematologic

Very common (10% or more): Clinically relevant non-major bleeding
Common (1% to 10%): Major bleeding, bleeding into critical organ (intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome or retroperitoneal), bleeding resulting in transfusion of greater than and equal to 2 units of whole blood or packed red blood cells
Uncommon (0.1% to 1%): Fatal bleeding (up to 0.4%), fatal intracranial bleeding, non-fatal critical organ bleeding (intracranial, retroperitoneal, intraocular, intra-articular), non-fatal non-critical organ bleeding, decrease in Hb greater than or equal to 2 g/dL, transfusion of greater than or equal to 2 units of whole blood or packed red blood cells, bleeding that required re-operation extra-surgical site, bleeding requiring transfusion of greater than 2 units of whole blood or packed cells
Rare (less than 0.1%): Bleeding into a critical organ
Frequency not reported: Pulmonary hemorrhage, pulmonary hemorrhage with bronchiectasis
Postmarketing reports: Agranulocytosis

Nervous system

Uncommon (0.1% to 1%): Syncope
Postmarketing reports: Cerebral hemorrhage, subdural hematoma, epidural hematoma, hemiparesis

Hypersensitivity

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

Dermatologic

Common (1% to 10%): Wound secretion, pruritus, blister
Postmarketing reports: Stevens-Johnson syndrome

Gastrointestinal

Common (1% to 10%): Gastrointestinal bleeding (up to 3.1%), upper abdominal pain, dyspepsia, toothache

Hepatic

Postmarketing reports: Jaundice, cholestasis, cytolytic hepatitis

Musculoskeletal

Common (1% to 10%): Back pain, osteoarthritis, pain in extremity, muscle spasm

Genitourinary

Uncommon (0.1% to 1%): Menorrhagia, urinary tract infection
Postmarketing reports: Retroperitoneal hemorrhage

Other

Common (1% to 10%): Fatigue

Respiratory

Common (1% to 10%): Sinusitis, oropharyngeal pain

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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