Rivaxored Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions in patients receiving Rivaroxaban were bleedings (see Precautions and 'Description of selected adverse reactions' as follows). The most commonly reported bleedings were epistaxis and gastrointestinal tract haemorrhage.
Tabulated list of adverse reactions: The frequencies of adverse reactions reported with Rivaroxaban are summarised in Table 2 as follows by system organ class (in MedDRA) and by frequency.
Frequencies are defined as very common, common, uncommon, rare, very rare or not known. (See Table 2.)

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Description of selected adverse reactions: Due to the pharmacological mode of action, the use of Rivaxored may be associated with an increased risk of occult or overt bleeding from any tissue or organ which may result in post haemorrhagic anaemia. The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia (see Management of bleeding under Overdosage). Mucosal bleedings (i.e. epistaxis, gingival, gastrointestinal, genito urinary including abnormal vaginal or increased menstrual bleeding) and anaemia were seen more frequently during long term Rivaroxaban treatment compared with VKA treatment. Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit could be of value to detect occult bleeding and quantify the clinical relevance of overt bleeding, as judged to be appropriate. The risk of bleedings may be increased in certain patient groups, e.g. those patients with uncontrolled severe arterial hypertension and/or on concomitant treatment affecting haemostasis (see Haemorrhagic risk under Precautions). Menstrual bleeding may be intensified and/or prolonged. Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea and unexplained shock. In some cases as a consequence of anaemia, symptoms of cardiac ischaemia 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 Rivaxored. Therefore, the possibility of haemorrhage is to be considered in evaluating the condition in any anticoagulated patient.