Xarelto Side Effects

Generic Name: rivaroxaban

Note: This page contains side effects data for the generic drug rivaroxaban. It is possible that some of the dosage forms included below may not apply to the brand name Xarelto.

It is possible that some side effects of Xarelto may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to rivaroxaban: oral tablet

As well as its needed effects, rivaroxaban (the active ingredient contained in Xarelto) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking rivaroxaban, check with your doctor immediately:

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
  • 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 rivaroxaban side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Blisters
  • muscle spasm

For Healthcare Professionals

Applies to rivaroxaban: oral tablet


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]


Very common (10% or more): Any bleeding
Common (1% to 10%): Anemia (including postoperative anemia)
Uncommon (0.1% to 1%): Non-fatal non-critical organ bleeding, bleeding into a critical organ, fatal bleeding, decreased hemoglobin, decrease in hemoglobin by 2 g/dL (20 g/L) or more, transfusion of 2 or more units of whole blood or packed red blood cells (including extra-surgical site bleeding), bleeding that required reoperation, thrombocythemia, occult blood positive
Postmarketing reports: Agranulocytosis[Ref]


Common (1% to 10%): Gastrointestinal bleeding, gastrointestinal hemorrhage (including rectal hemorrhage), upper abdominal pain, dyspepsia, toothache, gingival bleeding, nausea, constipation, diarrhea, vomiting
Uncommon (0.1% to 1%): Dry mouth, hematochezia, hemorrhoidal hemorrhage, melena, lip hemorrhage, mouth hemorrhage, tongue hemorrhage, gastric ulcer hemorrhage, hemorrhagic gastritis, lower abdominal pain
Rare (less than 0.1%): Retroperitoneal bleeding[Ref]

Nervous system

Common (1% to 10%): Syncope, dizziness, headache, sleep disorders
Uncommon (0.1% to 1%): Cerebral and intracranial hemorrhage
Rare (0.01% to 0.1%): Fatal intracranial bleeding, cerebellar hemorrhage, hemorrhagic transformation stroke
Frequency not reported: Spinal/epidural hematoma, intraspinal bleeding
Postmarketing reports: Subdural hematoma, hemiparesis[Ref]


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%): Hypotension (include procedural hypotension), hypertension, hematoma, tachycardia, deep vein thrombosis, peripheral edema
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]


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%): Jaundice, increased conjugated bilirubin (with or without concomitant ALT increase)
Postmarketing reports: Cholestasis, cytolytic hepatitis[Ref]


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]


Postmarketing reports: Hypersensitivity, anaphylactic reaction, anaphylactic shock, angioedema[Ref]


Common (1% to 10%): Wound secretion, pruritus (including uncommon cases of generalized pruritus), blister, rash, ecchymosis, wound hemorrhage, cutaneous and subcutaneous hemorrhage, contusion
Uncommon (0.1% to 1%): Allergic dermatitis, urticaria
Postmarketing reports: Stevens-Johnson syndrome[Ref]


Common (1% to 10%): Urogenital tract hemorrhage (including hematuria and menorrhagia), vaginal hemorrhage, urinary retention
Uncommon (0.1% to 1%): Urinary tract infection
Rare (0.01% to 0.1%): Menometrorrhagia, metrorrhagia[Ref]


Uncommon (0.1% to 1%): Increased LDH, increased lipase, increased amylase, hyperglycemia
Rare (less than 0.1%): Localized edema[Ref]


Common (1% to 10%): Back pain, osteoarthritis, pain in extremity, muscle spasm, arthralgia, increased muscle tone and cramping
Uncommon (0.1% to 1%): Hemarthrosis
Rare (less than 0.1%): Muscle hemorrhage
Frequency not reported: Intramuscular bleeding with compartment syndrome[Ref]


Common (1% to 10%): Eye hemorrhage (including conjunctival hemorrhage)
Uncommon (0.1% to 1%): Vitreous hemorrhage
Rare (less than 0.1%): Intraocular bleeding[Ref]


Common (1% to 10%): Anxiety reaction[Ref]


Common (1% to 10%): Sinusitis, oropharyngeal pain, epistaxis, hemoptysis, dyspnea
Frequency not reported: Pulmonary hemorrhage and pulmonary hemorrhage with bronchiectasis[Ref]


Common (1% to 10%): Fever, decreased general strength and energy (including fatigue and asthenia)
Uncommon (0.1% to 1%): Feeling unwell (including malaise)[Ref]


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

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