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
Warning
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.
Side effects requiring immediate medical attention
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
Side effects not requiring immediate medical attention
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. "UK Summary of Product Characteristics." O 0
3. Cerner Multum, Inc. "Australian Product Information." 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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