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Click on icon to see table/diagram/imageDue to the pharmacological mode of action, Xarelto may be associated with an increased risk of occult or overt bleeding from any tissue and organ which may result in post hemorrhagic anemia. The risk of bleedings may be increased in certain patient groups e.g. patients with uncontrolled severe arterial hypertension and/or on concomitant medication affecting hemostasis (see 'Precautions').
The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anemia (see 'Management of Bleeding under Overdosage').
Hemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnea, and unexplained shock. In some cases as a consequence of anemia, symptoms of cardiac ischemia like chest pain or angina pectoris have been observed.
Known complications secondary to severe bleeding such as compartment syndrome and renal failure due to hypoperfusion have been reported for Xarelto. Therefore, the possibility of a hemorrhage should be considered in evaluating the condition in any anticoagulated patient.
Tabulated list of adverse reactions: The frequencies of ADRs reported with Xarelto are summarized in the table as follows. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000). (See Table 9.)
Click on icon to see table/diagram/imagePost marketing observations: The following adverse reactions have been reported post-marketing in temporal association with the use of Xarelto: Immune system disorders: Angioedema and allergic oedema.
Hepatobiliary disorders: Cholestasis, Hepatitis (incl. hepatocellular injury).
Blood and lymphatic system disorders: Thrombocytopenia.
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