The following adverse reactions are also discussed elsewhere in the monograph: Bleeding (see Precautions): Major bleeding
: Fatal/life-threatening: Any one of the following: fatal; intracranial; intrapericardial bleed with cardiac tamponade; hypovolemic shock or severe hypotension due to bleeding and requiring pressors or surgery; clinically overt or apparent bleeding associated with a decrease in hemoglobin (Hb) of more than 5 g/dl; transfusion of 4 or more units (whole blood or packed red blood cells (PRBCs)) for bleeding.
Any one of the following: significantly disabling (e.g., intraocular with permanent vision loss); clinically overt or apparent bleeding associated with a decrease in Hb of 3 g/dl; transfusion of 2-3 units (whole blood or PRBCs) for bleeding.
Requires medical intervention to stop or treat bleeding (e.g., epistaxis requiring visit to medical facility for packing).
All others (e.g., bruising, bleeding gums, oozing from injection sites, etc.) not requiring intervention or treatment.
Includes dyspnea exertional, dyspnea at rest, nocturnal dyspnea, dyspnea paroxysmal nocturnal (see Precautions).
The other common adverse reactions: Headache; Cough; Dizziness; Nausea; Atrial fibrillation; Hypertension; Non-cardiac chest pain; Diarrhea; Back pain; Hypotension; Fatigue; Chest pain; Bradycardia; Immune system disorders: hypersensitivity reactions including angioedema (see Contraindications); Skin and subcutaneous tissue disorders: rash; Gynecomastia and other sex-hormonal adverse reactions, including sex organ malignancies; Laboratory abnormalities: serum uric acid and serum creatinine levels increased.
Adverse reactions by frequency and system organ class: Neoplasm benign, malignant, and unspecified (including cyst and polyps):
Uncommon: tumor bleedings (e.g., bleeding from bladder cancer, gastric cancer, colon cancer).
Blood and lymphatic system disorders:
Very common: blood disorder bleedings (e.g., increased tendency to bruise, spontaneous hematoma, hemorrhagic diathesis).
Immune system disorders:
Uncommon: hypersensitivity including angioedema.
Metabolism and nutrition disorders:
Very common: hyperuricemia (uric acid increases to >upper limit of normal from baseline below or within reference range).
Common: gout/gouty arthritis.
Nervous system disorders:
Common: dizziness, syncope, headache.
Uncommon: intracranial hemorrhage.
Uncommon: eye hemorrhage (e.g., conjunctival, retinal, intraocular bleeding).
Ear and labyrinth disorders:
Uncommon: ear hemorrhage. Vascular disorders Common: hypotension.
Respiratory, thoracic, and mediastinal disorders:
Very common: dyspnea.
Common: respiratory system bleedings (e.g., epistaxis, hemoptysis).
Common: gastrointestinal hemorrhage (e.g., gingival bleeding, rectal hemorrhage, gastric ulcer hemorrhage), diarrhea, nausea, dyspepsia, constipation.
Uncommon: retroperitoneal hemorrhage.
Skin and subcutaneous tissue disorders:
Common: subcutaneous or dermal bleeding (e.g., ecchymosis, skin hemorrhage, petechiae), rash, pruritus.
Musculoskeletal connective tissue and bone:
Uncommon: muscular bleedings (e.g., hemarthrosis, muscle hemorrhage).
Renal and urinary disorders:
Common: urinary tract bleeding (e.g., hematuria, cystitis hemorrhagic).
Reproductive system and breast disorders:
Uncommon: reproductive system bleedings (e.g., vaginal hemorrhage, hematospermia, postmenopausal hemorrhage).
Common: blood creatinine increased (creatinine increases of >50% from baseline).
Injury, poisoning, and procedural complications:
Common: postprocedural hemorrhage, traumatic bleedings (e.g., confusion, traumatic hematoma, traumatic hemorrhage).