Immune system disorders: hypersensitivity.
Eye disorders: ocular hemorrhage (including conjunctival hemorrhage).
Vascular disorders: hemorrhage (including hematoma, and vaginal and urethral hemorrhage), hypotension (including procedural hypotension).
Respiratory, thoracic and mediastinal disorders: epistaxis, hemoptysis.
Gastrointestinal disorders: nausea, gastrointestinal hemorrhage (including hematemesis and melaena), haematochezia, rectal hemorrhage, gingival bleeding.
Hepatobiliary disorders: transaminases increased (including alanine aminotransferase increased and alanine aminotransferase abnormal), aspartate aminotransferase increased gammaglutamyltransferase increased, liver function test abnormal, blood alkaline phosphatase increased, blood bilirubin increased.
Musculoskeletal and connective tissue disorders: muscle hemorrhage.
Renal and urinary disorders: hematuria (including respective laboratory parameters).
Injury, poisoning and procedural complications: contusion, post procedural hemorrhage (including post procedural hematoma, wound hemorrhage, vessel puncture site hematoma and catheter site hemorrhage), wound secretion, incision site hemorrhage (including incision site hematoma), operative hemorrhage.
Prevention of stroke and systemic embolism: NVAF: Treatment-emergent adverse reactions in NVAF patients: Immune system disorders: hypersensitivity (including drug hypersensitivity such as skin rash and anaphylactic reaction such as allergic edema).
Nervous system disorders: brain haemorrhage, other intracranial or intraspinal haemorrhage (including subdural haematoma, subarachnoid haemorrhage, and spinal haematoma).
Eye disorders: eye haemorrhage (including conjunctival haemorrhage).
Vascular disorders: other haemorrhage, haematoma, intra-abdominal haemorrhage.
Respiratory, thoracic and mediastinal disorders: epistaxis, haemoptysis, respiratory tract haemorrhage (including pulmonary alveolar haemorrhage, laryngeal haemorrhage, and pharyngeal haemorrhage).
Gastrointestinal disorders: gastrointestinal haemorrhage (including hematemesis and melaena), rectal haemorrhage, gingival bleeding, haemorrhoidal haemorrhage, haematochezia, mouth haemorrhage, retroperitoneal haemorrhage.
Renal and urinary disorders: haematuria.
Reproductive system and breast disorders: abnormal vaginal haemorrhage, urogenital haemorrhage.
General disorders and administration site conditions: application site bleeding.
Investigations: occult blood positive.
Injury, poisoning and procedural complications: contusion, traumatic haemorrhage, post procedural haemorrhage, incision site haemorrhage.
Treatment of VTE: Treatment-emergent adverse reactions in VTEtx patients: Blood and lymphatic system disorders: haemorrhagic anaemia, haemorrhagic diathesis, spontaneous haematoma.
Nervous system disorders: cerebral haemorrhage, haemorrhagic stroke.
Eye disorders: conjunctival haemorrhage, eye haemorrhage, retinal haemorrhage, schlera haemorrhage, vitreous haemorrhage.
Ear and labyrinth disorders: ear haemorrhage.
Cardiac disorders: pericardial haemorrhage.
Vascular disorders: haematoma, haemorrhage, intra-abdominal haematoma, shock haemorrhagic.
Respiratory, thoracic, and mediastinal disorders: epistaxis, haemoptysis, pulmonary alveolar haemorrhage.
Gastrointestinal disorders: gingival bleeding, rectal haemorrhage, haematochezia, haemorrhoidal, haemorrhage, gastrointestinal haemorrhage, haematemesis, melaena, anal haemorrhage, gastric ulcer haemorrhage, mouth haemorrhage, abdominal wall haematoma, Mallory-Weiss syndrome, gastric haemorrhage, peptic ulcer haemorrhage, small intestine haemorrhage.
Skin and subcutaneous tissue disorders: ecchymosis, skin haemorrhage, petechiae purpura, increased tendency to bleed, blood blister, skin ulcer haemorrhage.
Musculoskeletal and connective tissue disorders: muscle haemorrhage.
Renal and urinary disorders: haematuria, haemorrhage urinary tract.
Reproductive system and breast disorders: menorrhagia, vaginal haemorrhage, metrorrhagia, menometrorrhagia, uterine haemorrhage, genital haemorrhage, breast haematoma, haematospermia, postmenopausal haemorrhage.
General disorders and administration site conditions: injection site haematoma, vessel puncture site haematoma, injection site haemorrhage, infusion site haematoma.
Investigations: blood urine present, occult blood positive, occult blood, red blood cells urine positive.
Injury, poisoning, and procedural complications: contusion, wound haemorrhage, post procedural haemorrhage, traumatic haematoma, periorbital haematoma, vascular pseudoaneurysm, subcutaneous haematoma, procedural haematoma, post procedural haematoma, post procedural haematuria, extradural haematoma, renal haematoma, subdural haemorrhage
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