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4.8 Undesirable effects
Adverse events are listed below by system organ class and frequency.
Frequencies are defined as: very common (=1/l0), common (=1/100 to <1/10), uncommon (=1/1000 to <1/100), rare ( =1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Immune system disorders
Very rare: Hypersensitivity reactions including anaphylaxis
Nervous System Disorders
Very rare: convulsions, particularly in case of misuse
Eye disorders
Rare: Colour vision disturbances, retinal vein/artery occlusion
Vascular disorders
Rare: Thromboembolic events
Very rare: Arterial or venous thrombosis at any sites. Malaise with hypotension, with or without loss of consciousness (generally following a too fast intravenous injection, exceptionally after oral administration).
Gastro-intestinal disorders
Very rare: Digestive effects such as nausea, vomiting and diarrhoea.
Skin and subcutaneous tissue disorders
Rare: Allergic skin reactions
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