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

Get emergency medical help if you have any of these signs of an allergic reaction while taking rivaroxaban (the active ingredient contained in Xarelto) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using rivaroxaban and call your doctor at once if you have a serious side effect such as:

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;

• heavy menstrual periods;

• headache, dizziness, weakness, feeling like you might pass out;

• red or pink urine;

• black or bloody stools, coughing up blood or vomit that looks like coffee grounds;

• numbness, tingling, or muscle weakness (especially in your legs and feet); or

• loss of movement in any part of your body.

Less serious side effects of rivaroxaban may include:

• muscle pain;

• itching; or

• pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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

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