Human medicines European public assessment report (EPAR): Evrenzo, roxadustat, Anemia;Kidney Failure, Chronic, Date of authorisation: 18/08/2021, Revision: 3, Status: Authorised
The most common side effects with Evrenzo (which may affect more than 1 in 10 people) are hypertension (high blood pressure), vascular access thrombosis (formation of blood clots in the blood vessels associated with dialysis), diarrhoea, peripheral oedema (swelling especially of the ankles and feet), hyperkalaemia (high blood potassium levels) and nausea (feeling sick).
The most common serious side effects (which may affect up to 1 in 10 people) are sepsis (blood poisoning), hyperkalaemia, hypertension and deep vein thrombosis (blood clot in a deep vein, usually in the leg).
Evrenzo must not be used in people who are allergic to peanuts, soya, or the active substance or any other ingredients of Evrenzo. It must also not be used in women who are breastfeeding or during the third trimester of pregnancy.
For the full list of side effects and restrictions, see the package leaflet.
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