Applies to apixaban: oral tablet.

Serious side effects of Apixaban

Along with its needed effects, apixaban 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 apixaban:

Rare

• Blood in the eyes
• blood in the urine
• bloody or black, tarry stools
• bruising or purple areas on the skin
• confusion
• constipation
• coughing up blood
• decreased alertness
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• headache
• hives, itching, skin rash
• joint pain or swelling
• nausea and vomiting
• nosebleeds
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the eye
• severe stomach pain
• shortness of breath
• tightness in the chest
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds

For Healthcare Professionals

Applies to apixaban: oral tablet.

General

The most common adverse events were related to bleeding. Common adverse reactions were anemia, hemorrhage, and nausea.^[Ref]

Hematologic

Patients with diabetes had more bleeding events than non-diabetic subjects. Hemorrhage includes hematoma, and vaginal and urethral hemorrhage. Postprocedural hemorrhage includes postprocedural hematoma, wound hemorrhage, vessel puncture site hematoma, and catheter site hemorrhage.^[Ref]

Very common (10% or more): Minor bleed (11.7%)

Common (1% to 10%): Anemia postoperative, clinically relevant nonmajor bleed, hemoglobin decreased, anemia, hemorrhage

Uncommon (0.1% to 1%): Postprocedural hemorrhage, hemoglobin decrease of 2 g/dL or more, transfusion of 2 units or more red blood cells, fatal bleed, thrombocytopenia, hemorrhagic anemia

Rare (less than 0.1%): Bleed at critical site^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (14.1%)

Common (1% to 10%): Constipation, vomiting, diarrhea, abdominal pain upper, abdominal pain, dyspepsia, gastritis, gastroenteritis, toothache, gingival bleeding, rectal hemorrhage, dyspepsia, gastrointestinal hemorrhage (including hematemesis and melena),

Uncommon (0.1% to 1%): Major gastrointestinal bleed, hematochezia, hemorrhoidal hemorrhage, hematemesis, melena, anal hemorrhage, occult blood positive, occult blood, intra-abdominal hemorrhage, mouth hemorrhage

Rare (less than 0.1%): Retroperitoneal hemorrhage^[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, peripheral edema, atrial fibrillation, cardiac failure, hypertension, deep vein thrombosis, tachycardia, cardiac failure congestive, palpitations, thrombosis, angina pectoris, bradycardia, blood pressure increased, procedural hypotension, unstable angina, tachycardia^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, fatigue, syncope, ischemic stroke, vertigo

Uncommon (0.1% to 1%): Somnolence, cerebrovascular accident, transient ischemic attack, major intracranial bleed, brain hemorrhage, other intracranial or intraspinal hemorrhage (including subdural hematoma, subarachnoid hemorrhage, and spinal hematoma)

Frequency not reported: Stroke^[Ref]

Local

Common (1% to 10%): Hematoma, wound hemorrhage, wound secretion

Uncommon (0.1% to 1%): Incision-site hemorrhage, operative hemorrhage, traumatic hematoma, injection site hematoma, vessel puncture site hematoma, application site bleeding, traumatic hemorrhage^[Ref]

Ocular

Common (1% to 10%): Cataract, conjunctival hemorrhage, eye hemorrhage

Uncommon (0.1% to 1%): Major intraocular bleed, periorbital hematoma, conjunctival hemorrhage, retinal hemorrhage

Frequency not reported: Ocular hemorrhage^[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, dyspnea, epistaxis, bronchitis, cough, upper respiratory tract infection, influenza, pneumonia, sinusitis, chronic obstructive pulmonary disease, lower respiratory tract infection, hemoptysis, dyspnea exertional, respiratory tract infection

Uncommon (0.1% to 1%): Dyspnea

Rare (less than 0.1%): Pulmonary embolism, respiratory tract hemorrhage (including pulmonary alveolar hemorrhage, laryngeal hemorrhage, and pharyngeal hemorrhage)^[Ref]

Other

Very common (10% or more): Procedural pain (10.3%)

Common (1% to 10%): Pyrexia, chest pain, fall, asthenia, blood creatine phosphokinase increased, pain, body temperature increased, laceration, chest discomfort, tooth extraction

Uncommon (0.1% to 1%): Herpes zoster^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, menorrhagia

Uncommon (0.1% to 1%): vaginal hemorrhage, metrorrhagia, menometrorrhagia, genital hemorrhage, blood urine present, red blood cells urine positive, abnormal vaginal hemorrhage, urogenital hemorrhage^[Ref]

Renal

Common (1% to 10%): Hematuria, blood creatinine increased, renal failure^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, pain in extremity, osteoarthritis, muscle spasms, musculoskeletal pain, myalgia, arthritis

Uncommon (0.1% to 1%): Muscle hemorrhage, joint swelling^[Ref]

Metabolic

Common (1% to 10%): Gout, diabetes mellitus, blood glucose increased, hyperglycemia, hypokalemia, decreased appetite^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity (including drug hypersensitivity such as skin rash and anaphylactic reaction such as allergic edema)^[Ref]

Hepatic

Uncommon (0.1% to 1%): Transaminases increased, AST increased, ALT increased, gamma-glutamyl transferase increased, liver function test abnormal, blood alkaline phosphatase increased, blood bilirubin increased^[Ref]

Psychiatric

Common (1% to 10%): Insomnia, depression

Uncommon (0.1% to 1%): Anxiety^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, contusion, rash, cellulitis, ecchymosis, erythema, blister

Uncommon (0.1% to 1%): Skin hemorrhage, petechiae, skin rash^[Ref]

Oncologic

Uncommon (0.1% to 1%): Basal cell carcinoma^[Ref]