Briclot Adverse Reactions


Dexa Medica
Full Prescribing Info
Adverse Reactions
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.
Other: 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.
Minor bleeding: Requires medical intervention to stop or treat bleeding (e.g., epistaxis requiring visit to medical facility for packing).
Minimal bleeding: All others (e.g., bruising, bleeding gums, oozing from injection sites, etc.) not requiring intervention or treatment.
Dyspnea: 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.
Psychiatric disorders: Uncommon: confusion.
Nervous system disorders: Common: dizziness, syncope, headache.
Uncommon: intracranial hemorrhage.
Eye disorders: Uncommon: eye hemorrhage (e.g., conjunctival, retinal, intraocular bleeding).
Ear and labyrinth disorders: Common: vertigo.
Uncommon: ear hemorrhage. Vascular disorders Common: hypotension.
Respiratory, thoracic, and mediastinal disorders: Very common: dyspnea.
Common: respiratory system bleedings (e.g., epistaxis, hemoptysis).
Gastrointestinal disorders: 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).
Investigations: 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).
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