Section 4.8 — Undesirable effects

Summary of the safety profile The most common adverse reactions (≥10%) were: hyperphosphataemia, fatigue, diarrhoea, nausea, decreased appetite, stomatitis, palmar-plantar erythrodysaesthesia syndrome, alopecia, and dry skin. Tabulated list of adverse reactions Adverse reactions reported in clinical trials with Veraxanib are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100). Metabolism and nutrition disorders: Very common: hyperphosphataemia, decreased appetite. Common: hyponatraemia. General disorders: Very common: fatigue. Common: peripheral oedema, weight decreased. Gastrointestinal disorders: Very common: diarrhoea, nausea, stomatitis. Common: vomiting, constipation, abdominal pain, dysgeusia. Skin and subcutaneous tissue disorders: Very common: palmar-plantar erythrodysaesthesia syndrome, alopecia, dry skin. Common: nail disorder. Investigations: Common: increased ALT, increased AST, increased blood creatinine, increased blood alkaline phosphatase. Eye disorders: Common: retinal pigment epithelial detachment, blurred vision, central serous retinopathy. Description of selected adverse reactions Hyperphosphataemia: Hyperphosphataemia was observed in approximately 85% of patients and was generally manageable with dietary restriction and phosphate binders. Dose reduction was required in 12% of patients.