Fraxiparine Adverse Reactions





Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Adverse reactions are listed as follows by system organ class and frequency.
The following convention has been used for the classification of adverse reactions in terms of frequency: Very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥1/1000 to <1/100, rare ≥1/10,000 to <1/1000, very rare <1/10,000.
Blood and lymphatic system disorders: Very common: Haemorrhagic manifestations at various sites, more frequent in patients with other risk factors (see Contraindications and Interactions).
Rare: Thrombocytopenia, (including heparin-induced thrombocytopenia) (see Precautions), thrombocytosis.
Very rare: Eosinophilia, reversible following treatment discontinuation.
Immune system disorders: Very rare: Hypersensitivity reactions (including angioedema and cutaneous reactions), anaphylactoid reaction.
Very rare: Reversible hyperkalaemia related to heparin-induced aldosterone suppression, particularly in patients at risk (see Precautions).
Reproductive system and breast disorders: Very rare: Priapism.
Skin and subcutaneous tissue disorders: Rare: Rash, urticaria, erythema, pruritus.
Investigations: Common: Transaminases increased, usually transient.
General disorders and administration site conditions: Very common: Injection site haematoma.
In some cases, the emergence of firm nodules, which do not indicate an encystment of the heparin may be noted. These nodules usually disappear after a few days.
Common: Injection site reaction.
Rare: Injection site calcification. Calcification is more frequent in patients with abnormal calcium phosphate product, such as in some cases of chronic renal failure.
Very rare: Injection site necrosis (see Precautions).
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