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.

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.

Major Side Effects

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

• 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

• Fainting
• pain in the arms or legs
• wound secretion

• Burning while urinating
• difficult or painful urination

• 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, or skin rash
• 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
• 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

Minor Side Effects

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:

• 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]

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.

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