Hidroferol

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Hidroferol

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Hidroferol

Quick Facts
Active Ingredient Calcifediol (25-hydroxycholecalciferol)
Form Oral solution, soft gelatine capsule
Pharmacological Class Vitamin D analogue / derivative
Common Use Restoring Vitamin D status and calcium balance
Origin Synthetic metabolite

What Type of Medicine is Hidroferol?

Hidroferol is a medicinal product whose active ingredient is Calcifediol (also known as 25-hydroxycholecalciferol), which is classified as a Vitamin D analogue or derivative. It is a single-ingredient product designed to stabilize the metabolism of Vitamin D and calcium in the body. The drug's classification recognizes its unique role as a key chemical entity that the body uses to maintain calcium homeostasis, a function clinically recognized across global health organizations.


Composition and Origin: Is Calcifediol a Natural Vitamin?

Calcifediol is not a natural vitamin itself but a synthetic derivative—specifically a metabolite of Vitamin D3 (Cholecalciferol)—meaning it has already undergone the initial activation step required in the liver. Calcifediol is the main circulating form of Vitamin D. Consequently, the medicine provides the central form used for assessment and regulation in the bloodstream.

The product is provided in specific, standardized dosage forms, which typically include an oral solution or a soft gelatine capsule. In both forms, the active component, Calcifediol, is dissolved in a pharmaceutically inert oil-based vehicle, such as medium-chain triglycerides, ensuring controlled delivery and systemic absorption of the compound.


General Purpose and Benefit

The general purpose of Hidroferol is to rapidly and reliably restore the essential status of the Vitamin D metabolite in the body, serving as a powerful precursor to the final, active hormone, Calcitriol. Calcifediol offers a more predictable correction of Vitamin D deficiency than Cholecalciferol, especially in individuals with certain absorption challenges. By efficiently providing this necessary compound, the medicine supports the integrity of the skeletal system and promotes the optimal function of the organs responsible for regulating calcium and phosphate. Ultimately, its primary benefit is addressing foundational needs related to Vitamin D availability and overall mineral balance required for healthy bone maintenance.

What side effects are possible with Hidroferol?

Possible Side Effects and Safety Information

The safety profile of Hidroferol (Calcifediol) is primarily defined by the risk of hypercalcemia (high calcium levels in the blood) and hyperphosphatemia, which are consequences of excessive Vitamin D activity.


Adverse Reactions by Frequency

Frequency Category Examples of Documented Side Effects
Uncommon (Up to 1 in 100 people) Nausea, vomiting, dry mouth, constipation, abdominal cramps, taste alterations, anorexia.
Rare (Up to 1 in 1,000 people) Photophobia, conjunctivitis with corneal calcifications.
Not Known Weakness, fatigue, headache, muscle pain, itching, decreased libido.

Serious Adverse Reactions and Toxicity

The most clinically significant adverse reactions are linked to prolonged or excessive use and may include the risk of nephrocalcinosis (calcium deposits in the kidneys), impaired renal function (potentially leading to kidney failure), and cardiac arrhythmia (irregular heart rhythm), particularly in patients with existing heart conditions or those taking digitalis.

Safety-Related Restrictions and Limitations

Hidroferol is contraindicated and must not be used in the following conditions, as stated in regulatory labeling:

  • Pre-existing Hypercalcemia (blood calcium level greater than 10.5 mg/dL).
  • Hypercalciuria (high calcium level in the urine) or established calcium stone formations.
  • Hypervitaminosis D (excess Vitamin D).
  • Pregnancy and Lactation (Breastfeeding).

Mandatory Monitoring: Due to the risk of hypercalcemia, periodic monitoring of serum calcium, urinary calcium, and phosphorus levels is required throughout treatment as specified in official documents. Caution is also required for patients with severe renal impairment or granulomatous diseases.

Overdose and Emergency Response

Overdose and when to seek help


The most significant adverse effects of Hidroferol (calcifediol) are associated with excessive intake of vitamin D, which may lead to hypercalcemia (abnormally high calcium levels in the blood) and potentially poisoning. This is an overdose risk tied to taking a dose higher than prescribed or for too long.

Documented Overdose Presentations

The primary clinical manifestation is hypercalcemia, which can cause symptoms such as weakness, fatigue, headache, dry mouth, nausea, vomiting, constipation, increased thirst (polydipsia), and increased urination (polyuria). More severe intoxication can affect multiple systems, potentially causing arrhythmia (heart rhythm disorders), nephrocalcinosis (calcium deposits in the kidneys), and in the most severe cases, kidney or heart failure.

When to Seek Immediate Medical Help

If you take more of this medicine than the dose prescribed by your doctor (overdose) and experience any symptoms of toxicity, especially severe or worsening symptoms, you should seek immediate medical attention. While overdose symptoms often improve after discontinuing treatment, severe intoxication can lead to serious complications like kidney or heart failure. The risk of overdose is also higher in patients with prolonged immobility, who may require a dose reduction to avoid hypercalcemia.

Required Emergency Actions

The symptoms of overdose usually improve or disappear when the treatment is stopped. However, patients must be aware that if intoxication is severe, specialized clinical treatment for high calcium levels is required to prevent organ damage.

Therapeutic Uses of Hidroferol

What Hidroferol Treats: Main Uses and Benefits

The therapeutic actions of Hidroferol are commonly applied across contexts where additional symptomatic support for certain systemic imbalances is needed. Clinical application is generally focused on addressing vitamin D deficiency and related conditions that may lead to significant symptomatic burden. The medicine is commonly used to help manage symptomatic relief in conditions such as osteomalacia, nutritional rickets, and renal osteodystrophy.


Supporting Comfort During Symptomatic Periods

It is often relevant for assisting with the management of symptoms that interfere with daily functioning and supports the patient during difficult episodes. Hidroferol is applied when symptomatic support for conditions characterized by periods of heightened symptoms is appropriate. It offers supportive relief that contributes to improved comfort during periods of heightened symptoms.

“Supports the patient in maintaining a sense of stability when symptoms are more noticeable.”

This is particularly helpful in scenarios where symptoms create noticeable physiological strain. It is relevant in clinical settings that involve symptoms related to physical discomfort that may appear suddenly or intensify over time.


Quick Fact Block

Quick Fact:
Helps manage symptoms related to Physical Discomfort
Is relevant for easing symptoms that interfere with daily functioning

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Hidroferol — Official Regulatory Information

The eligibility profile for Hidroferol (Calcifediol) is strictly determined by official government regulatory labels, defining specific populations who must avoid the medicine and others who require special caution.


Eligibility Scope

Category Official Regulatory Statements
Populations for whom use is contraindicated Patients with Hypercalcaemia (high blood calcium), Hypercalciuria (high urine calcium), Hypervitaminosis D, a history of calcium stone formations, or Hypersensitivity to the drug or excipients.
Age-related eligibility rules Adults are the primary established patient population. Use is not recommended in children and adolescents due to insufficient data on safety and efficacy.
Condition-specific eligibility rules Requires special caution in patients with Sarcoidosis, Tuberculosis, other granulomatous diseases, or Heart failure. Caution is also advised in cases of Severe Renal Impairment.
Pregnancy and lactation eligibility status Not recommended for use during pregnancy and should not be used while breastfeeding, as stated in the product information.

Eligibility Classifications (High-Level)

Classification Official Regulatory Wording
Eligibility severity classification Contraindicated (Hypercalcaemia, Hypersensitivity). Not Recommended (Pregnancy, Lactation, Children). Use with Special Caution (Sarcoidosis, Severe Renal Impairment).

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Calcifediol (Hidroferol) is formally documented in regulatory sources and defines necessary restrictions related to its role as a Vitamin D analogue.


Official Interaction Restrictions

Co-administration with other Vitamin D analogues or derivatives (such as Calcitriol or Alfacalcidol) is strictly contraindicated. This restriction is due to the significant and additive risk of developing hypercalcemia (excess calcium in the blood) and Vitamin D intoxication.

Documented Exposure and Effect Alterations

Interactions that affect the systemic exposure or pharmacodynamic activity of Calcifediol are classified into three main areas:

  • Metabolic Interactions: Certain enzyme inducers, including anticonvulsants like Phenytoin and Phenobarbital, can stimulate the breakdown of Calcifediol. This action reduces its plasma concentration and half-life, which may necessitate monitoring of serum levels.
  • Absorption Interference: Substances that bind to or inhibit the absorption of fats may reduce the uptake of Calcifediol. Bile acid sequestrants (e.g., Cholestyramine) and Mineral oil are documented to impair intestinal absorption. Administration of these agents must be separated by several hours from Hidroferol to minimize this effect.
  • Pharmacodynamic Interactions: Combining Hidroferol with Thiazide diuretics or cardiac glycosides requires caution. Thiazide diuretics may cause hypercalcemia due to an additive effect on calcium excretion, while hypercalcemia, if present, can potentiate the cardiotoxicity of glycosides.

Mechanism of Action

How Hidroferol Works

The mechanism of Hidroferol (Calcifediol) is centered on its function as a pro-hormone that influences the body's primary endocrine system for mineral homeostasis. Its action is purely pharmacodynamic, focusing on regulating core biological pathways.


Activating the Key Enzymatic Cascade

Calcifediol must first be transformed into its potent, final active form, Calcitriol, a process primarily occurring in the kidneys and regulated by the enzyme 25(OH)D-1alpha-hydroxylase (CYP27B1). Calcifediol serves as the direct substrate for this rate-limiting conversion, contributing to the available pool of the final hormonal signal. This step is critical because the full physiological action depends on this enzyme's ability to complete the activation process.


️ Modulating Mineral Transport through Gene Expression

The resulting Calcitriol exerts its effect by binding to the Nuclear Vitamin D Receptor (VDR), a transcription factor found in target cells, particularly those lining the intestines. This binding modulates gene expression, upregulating proteins essential for the transport and absorption of calcium and phosphate. This results in increased intestinal absorption and the adjustment of circulating mineral levels, a prerequisite physiological state for bone mineralization processes.


Regulating Parathyroid Endocrine Feedback

The systemic increase in the activated hormone (Calcitriol) simultaneously engages a negative feedback loop that acts directly on the parathyroid glands. This interaction suppresses the secretion of Parathyroid Hormone (PTH), a key regulator of calcium. By modulating this major endocrine pathway, the mechanism influences the systemic retention of calcium and phosphate, resulting in the adjustment of mineral balance.

Dosage and Administration Information

How Hidroferol is Used: Official Administration Guidelines

Hidroferol (Calcifediol) is a medicine strictly for oral administration, provided as a soft gelatine capsule or oral solution. Its use is based on distinct schedules, dependent on the patient's condition and the specific formulation.


Usage Feature Official Instructions
Route of Administration Oral only (swallowing the capsule or solution).
Standard Dosing Regimen Typically, one 0.266 mg capsule is taken once a month for a defined course (e.g., 2–4 months).
Specific Daily Dosing For certain chronic conditions (e.g., secondary hyperparathyroidism using a prolonged-release capsule), the initial dose is 30 micrograms administered once daily.
Timing & Preparation Capsules must be swallowed whole and should not be chewed or crushed. For the prolonged-release capsule, administration is specifically at bedtime and must be taken at least two hours after any meal.
Treatment Duration The course is generally time-limited (e.g., 3 to 4 months), followed by reassessment. The regimen is either spaced out or discontinued once target levels are reached.

Procedural Rules and Monitoring

Adherence to the prescribed frequency is essential, and the maximum frequency for the high-dose capsule should not exceed once per week in high-risk scenarios. If a dose is missed, patients are instructed to skip the missed dose and take the medicine at the next regularly scheduled time; a double dose must never be taken.

Administration is guided by laboratory controls. Patients must undergo periodic blood monitoring of 25(OH)D and calcium levels, especially before starting therapy, after three to four months, and during maintenance, to guide the continuation or adjustment of the prescribed frequency. The 0.266 mg formulation is not recommended for children and adolescents.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Trial Data: Profile of Findings and Tolerability

Studies investigated the compound's effect profile in relation to factors implicated in bone metabolism and vitamin D deficiency. Research protocols evaluated changes in serum 25-hydroxyvitamin D [25(OH)D] status in various patient populations, including postmenopausal women and individuals with chronic kidney disease.

Primary Outcomes Assessed

  • Vitamin D Status Correction: Research, including randomized trials, has reported that calcifediol administration was associated with achieving serum 25( OH) D levels above 30 ng/mL in a higher percentage of patients, and in less time, compared to standard vitamin D3 (cholecalciferol) supplementation.
  • Secondary Effects: Trials examined reported changes in markers of bone turnover, such as parathyroid hormone ( PTH) levels, which have been observed to decrease following treatment in specific patient groups, including those undergoing hemodialysis.

Comparative Studies

Research protocols included comparative arms to assess outcomes against existing therapies. Studies reported findings related to calcifediol's effect in rapidly raising 25( OH) D levels when evaluated in individuals with deficiency or insufficiency.

Patient Populations and Study Exclusions

Study protocols specified inclusion and exclusion criteria based on existing health conditions of participants, such as renal status and pre-existing hypercalcemia, for whom the compound was evaluated. The research data is limited to the specific dosage and treatment durations examined in the study protocols.

Full details regarding participant safety monitoring and reported side effects are documented in the respective clinical trial reports, with hypercalcemia being a monitored adverse event in several trials.

Key Studies & References

  1. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) / Patient Information Leaflet (PIL) for Hidroferol (Calcifediol)
  2. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD)

Frequently Asked Questions (FAQ)

Common questions about Hidroferol (FAQ)


Q: Is Hidroferol the same as regular vitamin D?

No, Hidroferol is not the same as standard vitamin D3 (cholecalciferol) supplements. Hidroferol contains calcifediol, which is a metabolite (or precursor) of vitamin D. Regulatory documents describe calcifediol as the main circulating form of vitamin D used for assessment and regulation in the bloodstream, having already undergone the initial activation step in the liver.


Q: How long does Hidroferol stay in the body after the dose?

The active substance in Hidroferol, calcifediol, has a relatively long presence in the body. Official pharmacokinetics data reports an elimination half-life of approximately 15 to 30 days. This long half-life is the basis for the spaced-out dosing schedules often described in product information.


Q: Can Hidroferol cause trouble sleeping?

Official safety documents have reported general central nervous system (CNS) effects, such as drowsiness and headache, in the 'not known' or 'uncommon' frequency categories. These potential effects, along with others, are typically monitored by a healthcare professional as part of ongoing treatment assessment.


Q: Does taking Hidroferol make you feel tired or energized?

Official documentation has listed side effects like weakness and fatigue under the 'not known' frequency category, meaning they are observed but their frequency is not precisely established. The symptoms of weakness and fatigue are listed in the safety documentation, and any concerning symptoms are typically monitored during treatment.


Q: Can people who have had bariatric surgery use Hidroferol?

Research cited in official documents indicates that calcifediol may offer a more predictable correction of vitamin D status compared to standard supplements. The drug's profile, as described in research, is relevant for individuals with various forms of absorption challenges, which may be why calcifediol is used instead of standard vitamin D in certain cases.


Q: Is there a known link between Hidroferol and headaches?

Headache is listed as an adverse reaction in the official product information, often classified under the 'not known' frequency category. Headache is one of the possible effects listed in the safety documentation, and all patients are advised to undergo mandatory monitoring of calcium levels throughout treatment.


Q: Can I take other vitamin supplements while using Hidroferol?

Co-administration with other vitamin D analogues or derivatives is strictly contraindicated due to the additive risk of developing hypercalcemia. Official documentation notes that non-prescription products containing vitamin D, calcium, or magnesium should be assessed by a healthcare professional prior to use.


Q: Are there any warnings regarding alcohol consumption and Hidroferol?

Regulatory documents do not provide specific warnings about the interaction between the active ingredient and general alcohol consumption. However, it is noted that some oral solution formulations of the medicine are described as containing a small amount of ethanol (alcohol) as an inactive ingredient.


Q: Does Hidroferol need to be taken with food for better absorption?

Regulatory documents state that one specific prolonged-release formulation must be taken at least two hours after any meal (on an empty stomach). For other formulations, there are no specific restrictions, though administration alongside a high-fat meal can be associated with increased absorption of the medicine.


Q: Are there any research studies looking at Hidroferol's use in pregnant individuals?

Official product information states that Hidroferol is not recommended for use during pregnancy and should not be used while breastfeeding. The drug is officially not recommended for use during pregnancy, and safety data for this population is insufficient or restricted.


Q: How quickly should I expect to see an effect after starting Hidroferol?

Official research summaries have reported that calcifediol is associated with a faster onset of action in achieving target 25(OH)D levels compared to standard cholecalciferol supplementation. The full therapeutic effect is measured by mandatory periodic blood monitoring of vitamin D levels and is determined by the patient's specific health goals.


Q: Is it true that Hidroferol interacts with certain seizure medications?

Yes, official regulatory documents explicitly list anticonvulsants such as phenytoin and phenobarbital. These agents are described as enzyme inducers that can reduce the concentration of calcifediol in the blood. This reduction may necessitate therapeutic monitoring of vitamin D levels.


Q: Why is the dosing schedule for Hidroferol sometimes weekly or monthly?

The active substance, calcifediol, has a naturally long half-life (up to 30 days) in the bloodstream. The spaced-out dosing schedules (such as weekly or monthly) are described for vitamin D deficiency where a dose is administered to achieve target vitamin D levels, minimizing the frequency of administration.


Q: What happens if a person takes a typical daily vitamin D supplement while on Hidroferol?

Official product information strictly contraindicates the co-administration of Hidroferol with any other Vitamin D analogues or derivatives. This is noted due to the risk of hypercalcemia (excess calcium in the blood) and Vitamin D intoxication, as co-administration can lead to an additive effect on vitamin D activity.


Q: Can Hidroferol affect blood pressure measurements?

The drug's interaction profile notes that combining it with Thiazide diuretics, which are often used for high blood pressure, may lead to a higher risk of hypercalcemia. Additionally, high calcium levels can increase the risk of toxicity from certain cardiac medications ( cardiac glycosides). The official interaction profile focuses on documented interactions with Thiazide diuretics and cardiac glycosides.


Q: Is it normal to feel a metallic taste after taking Hidroferol?

Taste alterations are listed as an uncommon side effect in official safety documents. A specific metallic taste is documented in the safety information as a possible side effect, and all patients are required to undergo periodic calcium level monitoring.


Q: What happens when treatment with Hidroferol is stopped?

Treatment with Hidroferol is typically a time-limited course (e.g., 3-4 months) designed to correct a deficiency. Once target vitamin D levels are reached, the regimen is either spaced out or discontinued based on reassessment and the periodic blood monitoring of vitamin D levels.


Q: Are there specific times of the day that Hidroferol is typically used?

For one specific formulation (the prolonged-release capsule), official prescribing information directs administration to be at bedtime. For the standard high-dose monthly capsule, the timing is generally based on the prescribed frequency, without a mandatory time of day.


Q: Is Hidroferol considered a long-term treatment option?

While the initial treatment is often a time-limited course (e.g., 3-4 months), regulatory documents and research evidence suggest the drug can be effective for both the correction and maintenance of vitamin D levels. The necessity for continued management beyond the initial correction phase is based on the results of the periodic blood monitoring.


Q: Can Hidroferol affect the results of certain lab tests?

Use of Hidroferol requires mandatory periodic monitoring of specific blood and urine tests, including 25(OH)D and calcium levels, to ensure safety and effectiveness. The requirement for mandatory periodic blood monitoring is for 25(OH)D and calcium levels, as these are the markers most directly influenced by the drug's activity.


Q: Is there research comparing the effectiveness of different vitamin D metabolites?

Official research summaries often compare calcifediol's effect profile to cholecalciferol ( Vitamin D3). Comparisons with other metabolites, such as calcitriol and alfacalcidol, are detailed in authoritative medical reviews, particularly in the context of use for patients with renal impairment.


Q: Can Hidroferol interact with herbal supplements like St. John's Wort?

Official drug labels state that interactions with herbal products have not been formally studied. However, the medicine is known to interact with enzyme-inducing substances (like phenytoin), which can potentially reduce the amount of calcifediol in the blood. Official drug labels state that interactions with herbal products have not been formally studied, but note that the medicine is known to interact with other enzyme-inducing substances.


Q: Does Hidroferol interact with any common foods or drinks?

Regulatory information advises on the timing of administration relative to meals for one specific formulation. While no specific food is listed as being strictly prohibited, administration alongside a high-fat meal can significantly increase the absorption of the medicine, potentially affecting total exposure.

How should Hidroferol be stored and disposed of?

How to Store and Dispose of Hidroferol?

The storage and disposal of Hidroferol (calcifediol) must strictly follow the official instructions provided on the regulatory label.


Storage Requirements

Hidroferol must be stored at room temperature and the maximum temperature must not exceed 30 C (86 F). The product must be protected from both light and moisture. For stability, keep the medicine in its original container until administration. The medicine must be stored out of the sight and reach of children to prevent accidental ingestion.


Disposal Instructions

Do not use the medicine after the printed expiry date. Disposal of any unused or expired product must be carried out in accordance with local regulatory requirements. It is officially prohibited to dispose of Hidroferol via wastewater or with regular household waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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