Xarelto Side Effects
Generic name: rivaroxaban
Note: This document contains side effect information about rivaroxaban. Some dosage forms listed on this page may not apply to the brand name Xarelto.
Applies to rivaroxaban: oral powder for suspension, 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.
Serious side effects of Xarelto
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:
- 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
- increased menstrual flow or vaginal bleeding
- leg weakness
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- vomiting of blood or material that looks like coffee grounds
- pain in the arms or legs
- wound secretion
- Burning feeling while urinating
- difficult or painful urination
Incidence not known
- Blistering, peeling, or loosening of the skin
- blurred vision
- chest tightness
- clay-colored stools
- dark urine
- fast or irregular heartbeat
- fever with or without chills
- general feeling of tiredness or weakness
- hives, itching, skin rash
- joint or muscle pain
- loss of appetite
- lower back or side pain
- 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
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
Other side effects of Xarelto
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:
- muscle spasm
For Healthcare Professionals
Applies to rivaroxaban: oral granule for reconstitution, oral kit, oral tablet.
The most common adverse reactions were bleedings/bleeding complications/bleeding events.[Ref]
Uncommon (0.1% to 1%): Traumatic hematoma
Rare (0.01% to 0.1%): Vascular pseudoaneurysm
Common (1% to 10%): Pruritus, rash, ecchymosis, cutaneous hemorrhage, subcutaneous hemorrhage, blister, unspecific blistering, subcutaneous hematoma
Very rare (less than 0.01%): Toxic epidermal necrolysis
Frequency not reported: Generalized urticaria, maculopapular rash, viral rash
Very common (10% or more): Nausea (up to 11.1%)
Common (1% to 10%): Gingival bleeding, gastrointestinal (GI) tract hemorrhage, rectal hemorrhage, GI pain, abdominal pain, dyspepsia, constipation, diarrhea, vomiting, upper abdominal pain, major GI bleeding, GI bleeding events (included upper GI bleeding, lower GI bleeding, rectal bleeding), GI hemorrhage
Uncommon (0.1% to 1%): Dry mouth, increased lipase, increased amylase, anal hemorrhage, hematemesis, hematochezia, hemorrhoidal hemorrhage, lower GI hemorrhage, melena, lip hemorrhage, mouth hemorrhage, tongue hemorrhage, abdominal discomfort, lower abdominal pain, occult blood positive, upper GI hemorrhage, gastric ulcer hemorrhage, hemorrhagic gastritis, gastric hemorrhage
Rare (0.01% to 0.1%): Nonfatal retroperitoneal bleeding
Uncommon (0.1% to 1%): Metrorrhagia, blood urine present
Rare (0.01% to 0.1%): Menometrorrhagia
Frequency not reported: Abnormal vaginal/increased menstrual bleeding[Ref]
Major bleeding was defined as clinically overt bleeding associated with a decrease in Hb of at least 2 g/dL, a transfusion of at least 2 units of packed RBCs/whole blood, bleeding at a critical site, or with a fatal outcome.
Clinically relevant nonmajor bleeding was bleeding that was clinically overt, did not meet the criteria for major bleeding, but was associated with medical intervention, unscheduled contact with physician, temporary cessation of therapy, discomfort for patient, or impairment of daily life activities.
Modified ISTH major bleeding was defined as fatal bleeding; symptomatic bleeding in a critical area or organ (e.g., intraarticular, IM with compartment syndrome, intraspinal, intracranial, intraocular, respiratory, pericardial, liver, pancreas, retroperitoneal, adrenal gland, kidney); bleeding into the surgical site requiring reoperation; or bleeding leading to hospitalization.
Nonfatal noncritical organ bleeding was major bleeding that was not fatal or in a critical organ, but resulted in a decrease in Hb of at least 2 g/dL and/or transfusion of at least 2 units of packed RBCs/whole blood.
Fatal bleeding was adjudicated death with the primary cause of death from bleeding[Ref]
Very common (10% or more): Any bleeding (up to 28.3%)
Common (1% to 10%): Anemia (including respective laboratory parameters), postprocedural hemorrhage (including postoperative anemia, wound hemorrhage), hemorrhage, thrombocytosis, major bleeding, clinically relevant nonmajor bleeding, modified International Society on Thrombosis and Hemostasis (ISTH) major bleeding, bleeding leading to hospitalization (nonfatal, noncritical organ, not requiring reoperation), Thrombolysis in Myocardial Infarction Bleeding Criteria (TIMI) major bleeding (coronary artery bypass graft [CABG]/non-CABG), clinically overt signs of hemorrhage associated with a drop in hemoglobin (Hb) of at least 5 g/dL or drop in hematocrit of at least 15%
Uncommon (0.1% to 1%): Increased platelet count, operative hemorrhage, traumatic hemorrhage, decreased Hb, decreased hematocrit, bleeding varicose vein, nonfatal symptomatic bleeding in critical organ, decrease in Hb of at least 2 g/dL, nonfatal noncritical organ bleeding, transfusion of at least 2 units of packed RBCs/whole blood, nonfatal critical organ bleeding, bleeding that required reoperation, extra-surgical site bleeding requiring transfusion of more than 2 units of whole blood/packed cells, critical site bleeding, bleeding into a critical organ, fatal bleeding event
Rare (0.01% to 0.1%): Bleeding into the surgical site requiring reoperation (nonfatal noncritical organ), fatal non-intracranial bleeding
Frequency not reported: Trivial bleeding
Common (1% to 10%): Increased transaminases (including increased ALT, increased AST), increased GGT, increased ALT
Uncommon (0.1% to 1%): Hepatic impairment, increased bilirubin, increased AST, abnormal liver function test, increased hepatic enzyme, increased conjugated bilirubin (with or without concomitant increase of ALT), hyperbilirubinemia
Uncommon (0.1% to 1%): Allergic reaction
Common (1% to 10%): Pain in extremity, contusion, back pain, muscle spasm, arthralgia, increased muscle cramping
Uncommon (0.1% to 1%): Hemarthrosis
Rare (0.01% to 0.1%): Muscle hemorrhage
Frequency not reported: Compartment syndrome (secondary to bleeding)[Ref]
Intracranial bleeding events included intraparenchymal, intraventricular, subdural, subarachnoid, and/or epidural hematoma. Hemorrhagic stroke referred to nontraumatic intraparenchymal and/or intraventricular hematoma in patients on therapy plus 2 days.[Ref]
Common (1% to 10%): Dizziness, headache, syncope, increased muscle tone
Uncommon (0.1% to 1%): Cerebral hemorrhage, loss of consciousness, intracranial hemorrhage/bleeding, nonfatal intracranial hemorrhage/bleeding, hemorrhagic stroke (fatal and nonfatal), other intracranial hemorrhage/bleeding (fatal and nonfatal), fatal intracranial hemorrhage/bleeding
Rare (0.01% to 0.1%): Subdural hematoma, cerebellar hemorrhage, hemorrhagic transformation stroke
Postmarketing reports: Hemiparesis[Ref]
Common (1% to 10%): Eye hemorrhage, conjunctival hemorrhage
Uncommon (0.1% to 1%): Vitreous hemorrhage, periorbital hematoma
Rare (0.01% to 0.1%): Nonfatal intraocular bleeding[Ref]
Common (1% to 10%): Pyrexia/fever, peripheral edema, decreased general strength and energy, fatigue, asthenia, wound secretion, unspecific pain, wound healing complications, feeling unwell, wound hemorrhage
Uncommon (0.1% to 1%): Increased blood alkaline phosphatase, malaise, increased lactate dehydrogenase, incision site hemorrhage
Rare (0.01% to 0.1%): Localized edema, feeling abnormal
Frequency not reported: Mucosal bleedings (i.e., epistaxis, gingival, gastrointestinal, genitourinary [including abnormal vaginal/increased menstrual bleeding])[Ref]
Common (1% to 10%): Renal impairment (including increased blood creatinine, increased blood urea)
Uncommon (0.1% to 1%): Decreased renal CrCl, increased blood creatinine, increased blood urea
Frequency not reported: Renal failure/acute renal failure (secondary to bleeding sufficient to cause hypoperfusion)
Postmarketing reports: Anticoagulant-related nephropathy[Ref]
Common (1% to 10%): Epistaxis/nosebleed, hemoptysis, dyspnea
Very rare (less than 0.01%): Eosinophilic pneumonia
Frequency not reported: Pulmonary hemorrhage, pulmonary hemorrhage with bronchiectasis, epistaxis leading to transfusion, cough
Postmarketing reports: Eosinophilic pneumonia[Ref]
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More about Xarelto (rivaroxaban)
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Related treatment guides
1. Product Information. Xarelto (rivaroxaban). Janssen Pharmaceuticals. 2022.
2. Product Information. Xarelto (rivaroxaban). Bayer Australia Ltd. 2020.
3. Product Information. Xarelto (rivaroxaban). Bayer Plc. 2022.
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.