Tabulated list of adverse reactions

The frequencies of adverse reactions reported with Xarelto are summarised in table 2 below by system organ class (in MedDRA) and by frequency.

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)

very rare (< 1/10,000)

not known (cannot be estimated from the available data)

Table 2: All treatment-emergent adverse reactions reported in patients in phase III studies

Common

 Uncommon

 Rare

 Not known

 
Blood and lymphatic system disorders
 
Anaemia (incl. respective laboratory parameters)
 Thrombocythemia (incl. platelet count increased)A
 
 
 
Immune system disorders
 

 Allergic reaction, dermatitis allergic
 
 
 
Nervous system disorders
 
Dizziness, headache
 Cerebral and intracranial haemorrhage, syncope
 
 
 
Eye disorders
 
Eye haemorrhage (incl. conjunctival haemorrhage)
 
 
 
 
Cardiac disorders
 

 Tachycardia
 
 
 
Vascular disorders
 
Hypotension, haematoma
 
 
 
 
Respiratory, thoracic and mediastinal disorders
 
Epistaxis, haemoptysis
 
 
 
 
Gastrointestinal disorders
 
Gingival bleeding, gastrointestinal tract haemorrhage (incl. rectal haemorrhage), gastrointestinal and abdominal pains, dyspepsia, nausea, constipationA, diarrhoea, vomitingA
 Dry mouth
 
 
 
Hepatobiliary disorders
 

 Hepatic function abnormal
 Jaundice
 
 
Skin and subcutaneous tissue disorders
 
Pruritus (incl. uncommon cases of generalised pruritus), rash, ecchymosis, cutaneous and subcutaneous haemorrhage
 Urticaria
 
 
 
Musculoskeletal and connective tissue disorders
 
Pain in extremityA
 Haemarthrosis
 Muscle haemorrhage
 Compartment syndrome secondary to a bleeding

 
Renal and urinary disorders
 
Urogenital tract haemorrhage (incl. haematuria and menorrhagiaB), renal impairment (incl. blood creatinine increased, blood urea increased)A
 
 
 Renal failure/acute renal failure secondary to a bleeding sufficient to cause hypoperfusion
 
General disorders and administration site conditions
 
FeverA, peripheral oedema, decreased general strength and energy (incl. fatigue and asthenia)

 Feeling unwell (incl. malaise)
 Localised oedemaA
 
 
Investigations
 
Increase in transaminases
 Increased bilirubin, increased blood alkaline phosphataseA, increased LDHA, increased lipaseA, increased amylaseA, increased GGTA
 Bilirubin conjugated incr