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.
Applies to rivaroxaban: oral tablet
Oral route (Tablet)
Premature discontinuation of any oral anticoagulant, including rivaroxaban, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if rivaroxaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy. Epidural or spinal hematomas, which may result in long-term or permanent paralysis, have occurred in patients treated with rivaroxaban who are receiving neuraxial anesthesia or undergoing spinal puncture. Optimal timing between the administration of rivaroxaban and neuraxial procedures is not known. Factors that can increase the risk of developing hematomas include: use of indwelling epidural catheters; concomitant use of drugs affecting hemostasis, such as NSAIDs, platelet inhibitors, or other anticoagulants; or a history of traumatic or repeated epidural or spinal punctures, spinal deformity, or spinal surgery. Monitor patients frequently for neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider risks/benefits before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.
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:
Incidence not known
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:
Applies to rivaroxaban: oral kit, oral tablet
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.
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
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
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
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.
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)
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
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
Postmarketing reports: Anaphylactic reaction, anaphylactic shock, hypersensitivity
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
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
Uncommon (0.1% to 1%): Hyperglycemia, increased amylase, increased LDH, increased lipase
Rare (less than 0.1%): Localized edema
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
Common (1% to 10%): Eye hemorrhage (including conjunctival hemorrhage)
Uncommon (0.1% to 1%): Vitreous hemorrhage
Rare (less than 0.1%): Intraocular bleeding
Common (1% to 10%): Anxiety reaction, sleep disorders
Common (1% to 10%): Dyspnea, epistaxis, hemoptysis, oropharyngeal pain, sinusitis
Frequency not reported: Pulmonary hemorrhage and pulmonary hemorrhage with bronchiectasis
Common (1% to 10%): Decreased general strength and energy (including fatigue and asthenia), fever
Uncommon (0.1% to 1%): Feeling unwell (including malaise)
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Xarelto