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Henrik Jess Nielsen
2026-06-01 23:40:55 +02:00
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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) for VTEp, NVAF, and VTEt respectively.
Table 2: Tabulated adverse reactions
| System organ class | Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery (VTEp) | Prevention of stroke and systemic embolism in adult patients with NVAF, with one or more risk factors (NVAF) | Treatment of DVT and PE, and prevention of recurrent DVT and PE (VTEt) |
| ---------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------- |
| Blood and lymphatic system disorders | | | |
| Anaemia | Common | Common | Common |
| Thrombocytopenia | Uncommon | Uncommon | Common |
| Immune system disorders | | | |
| Hypersensitivity, allergic oedema and Anaphylaxis | Rare | Uncommon | Uncommon |
| Pruritus | Uncommon | Uncommon | Uncommon\* |
| Angioedema | Not known | Not known | Not known |
| Nervous system disorders | | | |
| Brain haemorrhage † | Not known | Uncommon | Rare |
| Eye disorders | | | |
| Eye haemorrhage (including conjunctival haemorrhage) | Rare | Common | Uncommon |
| Vascular disorders | | | |
| Haemorrhage, haematoma | Common | Common | Common |
| Hypotension (including procedural hypotension) | Uncommon | Common | Uncommon |
| Intra-abdominal haemorrhage | Not known | Uncommon | Not known |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | | |
| Epistaxis | Uncommon | Common | Common |
| Haemoptysis | Rare | Uncommon | Uncommon |
| Respiratory tract haemorrhage | Not known | Rare | Rare |
| Gastrointestinal disorders | | | |
| Nausea | Common | Common | Common |
| Gastrointestinal haemorrhage | Uncommon | Common | Common |
| Haemorrhoidal haemorrhage | Not known | Uncommon | Uncommon |
| Mouth haemorrhage | Not known | Uncommon | Common |
| Haematochezia | Uncommon | Uncommon | Uncommon |
| Rectal haemorrhage, gingival bleeding | Rare | Common | Common |
| Retroperitoneal haemorrhage | Not known | Rare | Not known |
| Hepatobiliary disorders | | | |
| Liver function test abnormal, asparate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased | Uncommon | Uncommon | Uncommon |
| Gamma-glutamyltransferase increased | Uncommon | Common | Common |
| Alanine aminotransferase increased | Uncommon | Uncommon | Common |
| Skin and subcutaneous tissue disorders | | | |