Sandimmun Neoral Adverse Reactions

Many side effects associated with ciclosporin therapy are dose-dependent and responsive to dose reduction. In the various indications, the overall spectrum of side effects is essentially the same; there are, however, differences in incidence and severity. As a consequence of the higher initial doses and longer maintenance therapy required after transplantation, side effects are more frequent and usually more severe in transplant patients than in patients treated for other indications.
Frequency Estimate: Very Common: ≥10%. Common: ≥1% to <10%. Uncommon: ≥0.1% to <1%. Rare: ≥0.01% to <0.1%. Very Rare: <0.01%.
Renal: Very common: Renal dysfunction (see Precautions).
Cardiovascular: Very common: Hypertension.
Nervous System: Very common: Tremor, headache. Common: Paraesthesia. Uncommon: Signs of encephalopathy eg, convulsions, confusion, disorientation, decreased responsiveness, agitation, insomnia, visual disturbances, cortical blindness, coma, paresis, cerebellar ataxia. Rare: Motor polyneuropathy. Very rare: Optic disc oedema including papilloedema, with possible visual impairment secondary to benign intracranial hypertension.
Gastrointestinal Tract and Liver: Common: Anorexia, nausea, vomiting, abdominal pain, diarrhoea, gingival hyperplasia, hepatic dysfunction. Rare: Pancreatitis.
Metabolic: Very common: Hyperlipidaemia. Common: Hyperuricaemia, hyperkalaemia, hypomagnesaemia. Rare: Hyperglycaemia.
Musculoskeletal: Common: Muscle cramps, myalgia. Rare: Muscle weakness, myopathy.
Haemopoietic: Uncommon: Anaemia, thrombocytopenia. Rare: Microangiopathic haemolytic anaemia, haemolytic uraemic syndrome.
Skin and Appendages: Common: Hypertrichosis. Uncommon: Allergic rashes.
Body as a Whole: Common: Fatigue. Uncommon: Oedema, increased weight.
Endocrine: Rare: Menstrual disturbances, gynecomastia.