Europe — EMA
Hidroferol (Calcifediol Monohydrate)
Hidroferol (calcifediol monohydrate) is an oral vitamin D supplement for deficiency, bone health, and secondary hyperparathyroidism.
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What is Calcifediol Monohydrate?
Hidroferol is an oral vitamin D analogue containing the active ingredient calcifediol monohydrate. The product is marketed in the European Union as an over‑the‑counter supplement, with the specific strength and dosage form not disclosed in the available data. Calcifediol is a pre‑hormone of vitamin D that helps maintain normal calcium and phosphate levels in the body.
What is Calcifediol Monohydrate used for?
Hidroferol is used to address conditions related to insufficient vitamin D activity. It is commonly recommended in the following situations:
- Vitamin D deficiency confirmed by laboratory testing - Secondary hyperparathyroidism associated with chronic kidney disease - Support of bone health in adults at risk of osteopenia - Adjunct therapy for patients with malabsorption syndromes affecting vitamin D - Prevention of hypocalcemia in individuals with limited sun exposure
What are the side effects of Calcifediol Monohydrate?
Adverse reactions to Hidroferol are generally uncommon but can occur. They are categorized by frequency and severity.
Common: - Mild gastrointestinal discomfort (nausea, abdominal pain) - Transient headache - Slight increase in serum calcium levels without symptoms - Fatigue or drowsiness - Skin rash or mild itching
Serious: - Hypercalcemia presenting with nausea, vomiting, polyuria, or cardiac arrhythmia - Severe allergic reaction (anaphylaxis, angioedema) - Persistent elevated serum phosphate levels - Renal impairment due to calcium deposition
What precautions apply to Calcifediol Monohydrate?
Before using Hidroferol, consider the following safety points:
- Assess baseline serum calcium, phosphate, and vitamin D levels to avoid overtreatment. - Use caution in patients with a history of hypercalcemia, kidney stones, or renal disease. - Monitor calcium and phosphate periodically during long‑term therapy. - Pregnant or breastfeeding individuals should consult a healthcare professional, as safety data are limited. - Individuals taking thiazide diuretics may be at increased risk of hypercalcemia. - Discontinue use and seek medical advice if symptoms of hypercalcemia develop.
What does Calcifediol Monohydrate interact with?
Hidroferol may interact with other medicines, affecting calcium balance or vitamin D metabolism.
Avoid: - High‑dose calcium supplements taken concurrently without monitoring. - Vitamin D analogues (e.g., calcitriol) that could lead to excess active vitamin D. - Certain anticonvulsants (e.g., phenobarbital, phenytoin) that increase vitamin D catabolism.
Use with caution: - Thiazide diuretics, which reduce urinary calcium excretion. - Corticosteroids, which may impair vitamin D activation. - Bisphosphonates, as combined effects on bone metabolism require monitoring. - Mineral oil or cholestyramine, which can reduce absorption of fat‑soluble vitamins.



