Side effects typical of systemically acting glucocorticoids (cushingoid features) may occur occasionally. These side effects are dependent on the dose, the treatment period, a simultaneous or previous therapy with other glucocorticoids and the individual sensitivity.
Clinical studies have shown that during administration of Budenofalk, the frequency of glucocorticoid-related side effects is lower (approximately halved) than during oral administration of equivalent doses of prednisolone. However, the occurrence of side effects typical of glucocorticoids cannot be excluded.
Skin: Exanthema due to hypersensitivity reactions (allergic exanthema), striae and bleeding of the skin, acne, delayed wound healing, contact eczema.
Muscle and Skeleton: Myopathy, bone fragility, osteochondroses (aseptic osteonecroses).
Eyes: Glaucoma, cataract.
Central Nervous System: Psyche: Depression, nervousness, euphoria.
Gastrointestinal Tract: Gastric complaints, gastric ulcer, pancreatitis.
Metabolism: Cushing's syndrome: Moon face, stern obesity, diabetes, increased blood sugar, edema, increased potassium excretion, inactivity of the adrenal cortex or adrenocortical atrophy, retardation of growth in children, disturbance of excretion of sex hormones (eg, amenorrhea, hirsutism, disturbance of potency).
Vascular System: Increased risk of thrombosis, vascular diseases (withdrawal syndrome following long-term therapy.
Immunologic System: Decrease of natural body defense (eg, increased risk of infection). For juveniles, papilledema and/or pseudotumor cerebri in single cases.
When changing from systemically-acting glucocorticoids to the topically acting budesonide, an increase of recurrence of disease symptoms may occur which appear outside the intestine, especially at skin and joints (extraintestinal manifestations).