Torapix 2.5/Torapix 5 Adverse Reactions

*Treatment-emergent adverse reactions in NVAF patients: Immune System Disorders: Uncommon: Hypersensitivity (including drug hypersensitivity such as rash and anaphylactic reaction such as allergic edema).
Nervous System Disorders: Uncommon: Brain hemorrhage, other intracranial or intraspinal hemorrhage (including subdural hematoma, subarachnoid hemorrhage, and spinal hematoma).
Eye Disorders: Common: Eye hemorrhage (including conjunctival hemorrhage).
Vascular Disorders: Common: Other hemorrhage, hematoma.
Uncommon: Intra-abdominal hemorrhage.
Respiratory, Thoracic and Mediastinal Disorders: Common: Epistaxis.
Uncommon: Hemoptysis.
Rare: Respiratory tract hemorrhage (including pulmonary alveolar hemorrhage, laryngeal hemorrhage, and pharyngeal hemorrhage).
Gastrointestinal Disorders: Common: Gastrointestinal hemorrhage (including hematemesis and melena), rectal hemorrhage, gingival bleeding.
Uncommon: Hemorrhoidal hemorrhage, hematochezia, mouth hemorrhage.
Rare: Retroperitoneal hemorrhage.
Renal and Urinary Disorders: Common: Hematuria.
Reproductive System and Breast Disorders: Uncommon: Abnormal vaginal hemorrhage, urogenital hemorrhage.
General Disorders and Administration Site Condition: Uncommon: Application site bleeding.
Investigations: Uncommon: Occult blood positive.
Injury, Poisoning and Procedural Complications: Common: Confusion.
Uncommon: Traumatic hemorrhage, post procedural hemorrhage, incision site hemorrhage.
*Treatment-emergent adverse reactions in VTE patients: Blood and Lymphatic System Disorders: Rare: Hemorrhagic anemia, hemorrhagic diathesis, spontaneous hematoma.
Nervous System Disorders: Rare: Cerebral hemorrhage, hemorrhagic stroke.
Eye Disorders: Uncommon: Conjunctival hemorrhage.
Rare: Eye hemorrhage, retinal hemorrhage, scleral hemorrhage, vitreous hemorrhage.
Ear and Labyrinth Disorders: Rare: Ear hemorrhage.
Cardiac Disorders: Rare: Pericardial hemorrhage.
Vascular Disorders: Common: Hematoma.
Rare: Hemorrhage, intra-abdominal hematoma, hemorrhagic shock.
Respiratory, Thoracic, and Mediastinal Disorders: Common: Epistaxis.
Uncommon: Hemoptysis.
Rare: Pulmonary alveolar hemorrhage.
Gastrointestinal Disorders: Common: Gingival bleeding.
Uncommon: Rectal hemorrhage, hematochezia, hemorrhoidal hemorrhage, gastrointestinal hemorrhage, hematemesis.
Rare: Melena, anal hemorrhage, gastric ulcer hemorrhage, mouth hemorrhage, abdominal wall hematoma, Mallory-Weiss syndrome, gastric hemorrhage, peptic ulcer hemorrhage, small intestine hemorrhage.
Skin and Subcutaneous Tissue Disorders: Uncommon: Ecchymosis, skin hemorrhage.
Rare: Petechiae, purpura, increased tendency to bleed, blood blister, skin ulcer hemorrhage.
Musculoskeletal and Connective Tissue Disorders: Rare: Muscle hemorrhage.
Renal and Urinary Disorders: Common: Hematuria.
Rare: Urinary tract hemorrhage.
Reproductive System and Breast Disorders: Common: Menorrhagia.
Uncommon: Vaginal hemorrhage, metrorrhagia.
Rare: Menometrorrhagia, uterine hemorrhage, genital hemorrhage, breast hematoma, hematospermia, postmenopausal hemorrhage.
General Disorders and Administration Site Conditions: Uncommon: Injection site hematoma, vessel puncture site hematoma.
Rare: Injection site hemorrhage, infusion site hematoma.
Investigations: Uncommon: Blood urine present, occult blood positive.
Rare: Occult blood, red blood cells urine positive.
Injury, Poisoning, and Procedural Complications: Common: Confusion.
Uncommon: Wound hemorrhage, post procedural hemorrhage, traumatic hematoma.
Rare: Periorbital hematoma, vascular pseudoaneurysm, subcutaneous hematoma, procedural hematoma, post procedural hematoma, post procedural hematuria, extradural hematoma, renal hematoma, subdural hemorrhage.