Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the following. Their frequency is defined using the following conventions: Common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000). Within each system organ class, adverse drug reactions are presented in order of decreasing seriousness.
Blood and the lymphatic system disorders:
Uncommon: Thrombocytopenia, leucopenia and eosinophilia.
Rare: Neutropenia, including severe neutropenia.
Very rare: Thrombotic thrombocytopenic purpura (TTP), aplastic anaemia, pancytopoenia, agranulocytosis, severe thrombocytopoenia, granulocytopoenia and anaemia.
Immune system disorders:
Very rare: Serum sickness and anaphylactoid reactions.
Very rare: Hallucinations and confusion.
Nervous system disorders:
Uncommon: Intracranial bleeding (some cases were reported with fatal outcome), headache, paraesthesia and dizziness.
Very rare: Taste disturbances.
Uncommon: Eye bleeding (conjunctival, ocular and retinal).
Ear and labyrinth disorders:
Very rare: Serious haemorrhage, haemorrhage of operative wound, vasculitis and hypotension.
Respiratory, thoracic and mediastinal disorders: Common: Epistaxis.
Very rare: Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm and interstitial pneumonitis.
Common: Gastrointestinal haemorrhage, diarrhoea, abdominal pain and dyspepsia.
Uncommon: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation and flatulence.
Rare: Retroperitoneal haemorrhage.
Very rare: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis) and stomatitis.
Very rare: Acute liver failure, hepatitis and abnormal liver function test.
Skin and subcutaneous tissue disorders:
Uncommon: Rash, pruritus and skin bleeding (purpura).
Very rare: Bullous dermatitis (toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme), angioedema, erythematous rash, urticaria, eczema and lichen planus.
Musculoskeletal, connective tissue and bone disorders:
Very rare: Musculoskeletal bleeding (haemarthrosis), arthritis, arthralgia and myalgia.
Renal and urinary disorders:
Very rare: Glomerulonephritis and increased blood creatinine.
General disorders and administration site conditions:
Common: Bleeding at puncture site.
Very rare: Fever.
Uncommon: Prolonged bleeding time, decreased neutrophil count and decreased platelet count.