Hidroferol Adverse Reactions

Adverse reactions to calcifediol are generally uncommon (≥1/1,000 to <1/100) but sometimes they are moderately significant.
The most significant adverse effects are related to excessive intake of vitamin D, i.e. they are often associated with overdose or prolonged treatment, especially when associated with high doses of calcium. The doses of vitamin D analogues required for hypervitaminosis vary considerably from one subject to another. The most common adverse reactions are due to the hypercalcemia which can occur initially or at a later stage.
Endocrine disorders: Pancreatitis, among the late symptoms of hypercalcemia.
Metabolism and nutrition disorders: Elevation of blood urea nitrogen (BUN), albuminuria, hypercholesterolemia, hypercalcemia.
Nervous system disorders: In case of moderate hypercalcemia the following symptoms may appear: weakness, fatigue, drowsiness, headache, irritability.
Eye disorders: Rarely (≥1/10,000 to <1/1,000), at very high doses photophobia and conjunctivitis with corneal calcifications may occur.
Cardiac disorders: In case of hypercalcemia cardiac arrhythmias may occur.
Gastrointestinal disorders: Nausea, vomiting, dry mouth, constipation, taste disturbances, with a metallic taste, abdominal cramps. If hypercalcemia progresses anorexia may occur.
Hepatobiliary disorders: High calcemia levels can lead to increased transaminase (SGOT and SGPT).
Musculoskeletal and connective tissue disorders: Bone and muscle pain may occur in early stages of hypercalcemia, calcification in soft tissues.
Renal and urinary disorders: Manifestations of hypercalcemia are: nephrocalcinosis and deterioration of kidney function (with polyuria, polydipsia, nocturia and proteinuria).
General disorders and alterations in the place of administration: Later symptoms of hypercalcemia include: rhinorrhea, pruritus, hyperthermia, decreased libido.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.