Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: 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) and not known – cannot be estimated from the available data.


System organ class               Frequency                  Adverse Reaction 
Infections and infestations      Not known                  Fever
Immune system disorders          Not known                  Hypersensitivity Nervous system disorders         Not known                  Cerebral haemorrhage; Cerebral subdural haematoma
Vascular disorders               Not known                  Haemorrhage Respiratory, thoracic and        Not known
Haemothorax, epistaxis mediastinal disorders
Gastrointestinal disorders       Not known                  Gastroinestinal haemorrhage, rectal haemorrhage,
haematemesis; pancreatitis;
diarrhoea; nausea; vomiting;
melaena
Hepatobiliary disorders          Not known                  Jaundice; hepatic dysfunction Skin and subcutaneous            Not known                  Rash; alopecia; purpura; disorders                                                   'purple toes' syndrome; erythematous swollen skin patches leading to ecchymosis, infarction and skin necrosis; calciphylaxis
Renal and urinary disorders       Not known                   Anticoagulant-related nephropathy, haematuria
Investigations                    Not known                   Unexplained drop in haematocrit; haemoglobin decreased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il