Devisol

Quick links to important sections

Devisol

Medically reviewed

Rosario Oropesa

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 Devisol

Property Description
Active ingredient Calcifediol (25-hydroxyvitamin D3)
Form Oral tablets, oral solution, extended-release capsules
Pharmacological class Vitamin D analogue, Prohormone
General purpose Support mineral homeostasis and bone health
Origin Derived metabolite / synthetic

Devisol is a pharmaceutical preparation, commonly distributed by Orion Pharma, classified as a Vitamin D analogue and a prohormone, intended to supplement the body's essential reserves of Vitamin D. Its active compound is Calcifediol, which is chemically known as 25-hydroxyvitamin D3 or Calcidiol. This product is positioned primarily for addressing Vitamin D deficiency and insufficiency, a scenario recognized worldwide, and is formally situated within the therapeutic group of Vitamins, carrying the official WHO anatomical therapeutic chemical classification code A11CC06.


Composition and Available Forms of Devisol

The medication is manufactured as a single active ingredient product designed exclusively for oral intake. The core component is Calcifediol, which is formulated either as tablets using inert excipients, or contained within a suitable carrier such as an oil or aqueous base when supplied as an oral solution—a form often favored for ease of use in diverse patient groups. Calcifediol is a derived metabolite, meaning it is chemically synthesized or sourced as the direct product of the first metabolic activation step that standard Vitamin D undergoes in the body. The substance is integral to managing the body’s Vitamin D needs.


General Purpose: How Calcifediol Supports the Body

The overarching general purpose of the medication is to reliably support the body's mineral homeostasis and promote bone health. Calcifediol functions as the direct precursor (or prohormone) that the kidneys utilize to create the final, fully active Vitamin D hormone, Calcitriol. By supplying this advanced compound, the medicine rapidly replenishes the body's primary circulating reservoir, ensuring a consistent supply of material needed for essential biological regulation. This approach is distinct from the way standard Vitamin D3 (Cholecalciferol) works, as it bypasses the liver's initial activation requirement, leading to a more direct physiological availability. Calcifediol plays a critical role in the regulation of serum calcium and phosphate concentrations. This regulatory function is fundamental for patients requiring reliable management of these essential mineral levels.

What side effects are possible with Devisol?

Possible Side Effects and Safety Information

The safety profile of calcifediol, the active ingredient in Devisol, is primarily characterized by the potential for metabolic disturbances related to its effect on calcium and phosphate levels, as documented in official regulatory labeling. The principal safety concern is the development of hypercalcemia (elevated serum calcium) and hypercalciuria (elevated urinary calcium).

Manifestations of elevated calcium levels officially listed in regulatory documents may include feeling tired, loss of appetite, nausea, vomiting, constipation, increased thirst, and weight loss.


Officially Classified Adverse Reactions

Adverse reactions that have been classified as common (occurring in 1% to 10% of patients in trials or similar frequency in regulatory reports) are reported across several system-organ classes. These include, but are not limited to, Anemia, Nasopharyngitis, Dyspnea (shortness of breath), Cough, Congestive cardiac failure, Constipation, and Increased blood creatinine levels. These reactions are grouped under categories such as Metabolic/Nutritional, Respiratory, and Cardiac disorders.


Serious Adverse Reactions and Safety Constraints

Serious adverse reactions documented in regulatory information include severe hypercalcemia, which carries a risk of precipitating cardiac arrhythmias or seizures. Another documented concern is the potential for adynamic bone disease, associated with the over-suppression of parathyroid hormone.

The medicine is restricted from use in individuals with pre-existing conditions such as Hypercalcemia, Hypercalciuria, Calcium lithiasis (kidney stones), or Hypervitaminosis D.


Population-Specific Safety Notes

Official prescribing information includes specific safety notes for certain contexts. Caution is required when the medicine is used in patients with renal impairment. Furthermore, specific monitoring of serum calcium is mandated for patients concurrently receiving cardiac glycosides (e.g., digitalis) due to the enhanced risk of toxicity if hypercalcemia occurs. The avoidance of overdose during pregnancy is critical due to the documented risk of severe fetal complications from prolonged hypercalcaemia.

Overdose and Emergency Response

Overdose and when to seek help

Overdosage of Devisol, containing Calcifediol, is officially documented to cause Hypervitaminosis D, which results in elevated blood calcium levels (Hypercalcemia) and elevated urinary calcium (Hypercalciuria).

Documented Overdose Manifestations

Classification Manifestation
Early Symptoms Fatigue, muscle weakness, headache, vomiting, loss of appetite (anorexia), dry mouth, and polydipsia (increased thirst) [HPRA SmPC].
Severe Outcomes Risk of irreversible renal impairment, soft tissue calcification, and cardiac arrhythmias (especially in patients taking digitalis) [FDA Label; Geneesmiddeleninformatiebank SmPC].
Population-Specific Overdose during pregnancy is associated with fetal risks, including physical and mental retardation in the child [HPRA SmPC].

Required Emergency Actions

The regulatory guidance mandates that severe hypercalcemia due to substantial overdosage may require emergency attention [FDA Label, Reference ID: 3947343]. Official instructions specify that immediate action involves the discontinuation of Calcifediol and the initiation of symptomatic and supportive treatment, including rehydration and adjunct pharmacological measures like bisphosphonates [Geneesmiddeleninformatiebank SmPC]. Continued monitoring of serum electrolytes, renal function, and ECG may be necessary in the overdose setting.

Therapeutic Uses of Devisol

What Devisol Treats: Main Uses and Benefits

Devisol is commonly used in areas where short-term symptom management is appropriate, often when symptoms intensify and supportive relief is needed. The therapeutic domain is considered relevant in contexts involving heightened systemic burden. It helps address symptom clusters that may become intense or disruptive, supporting patients during difficult episodes by easing distress and contributing to easing the overall symptom load.

The medicine is applicable across conditions presenting with episodic or fluctuating manifestations and conditions characterized by periods of heightened symptoms. It may assist in clinical scenarios involving temporary functional strain or discomfort.

“It supports patients during difficult episodes by easing distress.”

Quick Fact: Support for Functional Strain

It assists with maintaining functional stability when symptoms become momentarily overwhelming.

Eligibility and Restrictions for Use

The eligibility profile for Devisol (Calcifediol) is strictly defined by official regulatory documentation based on a patient’s physiological status and specific comorbidities. Use is established for adult patients but is subject to several absolute prohibitions and conditional restrictions.


Eligibility Scope

The medicine is contraindicated and must not be used by individuals diagnosed with elevated mineral levels, including hypercalcemia (high blood calcium), hypercalciuria (high urine calcium), calcium lithiasis, or pre-existing hypervitaminosis D. Use is also prohibited in patients with a known hypersensitivity to calcifediol or any non-medicinal ingredients.

Population Restrictions

Safety and efficacy have not been established in the pediatric population (children and adolescents), leading to a regulatory status of not recommended for this age group. Similarly, use is not recommended during pregnancy and breastfeeding and is only permitted under strict clinical oversight.

Special caution and close monitoring are required for eligible adults with underlying conditions such as Chronic Kidney Disease (CKD), severe renal impairment, or sarcoidosis, as these states alter the drug’s processing and risk profile.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation classifies the interactions of Devisol (Calcifediol) into both pharmacokinetic and pharmacodynamic categories.

Interaction Restrictions

Co-administration with other Vitamin D analogs is formally restricted in prescribing information due to the risk of additive effects leading to hypercalcemia and hypercalciuria.

Pharmacodynamic Effects

  • Concomitant use with Thiazide Diuretics is documented to increase the risk of hypercalcemia.
  • Calcifediol-induced hypercalcemia potentiates the effects of Cardiac Glycosides (e.g., Digoxin), increasing the documented risk of cardiac arrhythmias.
  • Corticosteroids are noted to counteract the effects of Calcifediol, which may decrease its therapeutic efficacy.

Exposure-Altering Agents

  • Microsomal Hydroxylation Inducers (e.g., certain anticonvulsants) are documented to reduce the plasma concentrations of Calcifediol by decreasing its half-life.
  • Conversely, strong CYP Inhibitors (e.g., Ketoconazole) may alter serum levels by affecting metabolic enzymes.
  • Agents that impair intestinal absorption, such as Bile Acid Sequestrants (e.g., Cholestyramine) and Orlistat, require a timing separation of at least two hours during administration to mitigate the reduction in exposure.

Mechanism of Action

Enzymatic Bioactivation and Hormonal Precursor Function

The active component, Calcifediol (25-hydroxyvitamin D3), functions as a prohormone and substrate, directly bypassing the initial hepatic activation step required by cholecalciferol. It is transported to the kidney and other tissues where it is utilized by the enzyme 25(OH)D-1alpha-hydroxylase (CYP27B1). This enzyme performs the final conversion to Calcitriol (1,25-dihydroxyvitamin D3), providing a direct supply of the mineral-regulating hormone.

Nuclear Receptor-Mediated Mineral Homeostasis

The resulting Calcitriol functions as an agonist for the Vitamin D Receptor (VDR), a nuclear receptor. VDR activation leads to transcriptional modulation of genes, enhancing the synthesis of transport proteins required for the intestinal absorption and renal reabsorption of calcium (Ca²⁺) and phosphate (PO₄³⁻).

Endocrine Regulation and Systemic Mineral Balance

By engaging the VDR, the mechanism contributes to the suppression of Parathyroid Hormone (PTH) synthesis and secretion, a crucial step in reducing mineral mobilization from bone. This coordinated action stabilizes circulating Ca²⁺ and PO₄³⁻ levels, providing the necessary physiological environment for skeletal tissue.

Dosage and Administration Information

Official Administration of Devisol (Calcifediol)

Calcifediol is strictly administered through the oral route, with official dosage forms including extended-release capsules (e.g., 30 micrograms and 60 micrograms) and soft capsules or oral solutions (e.g., 0.266 mg). The prescribed dosing schedule depends on the formulation and the specific regulatory regimen.

Usage patterns are defined by two primary frequencies: The extended-release capsule is taken once daily, typically at bedtime, while certain soft capsule formulations are administered once per month. For daily use, the capsule must be swallowed whole and patients are explicitly instructed not to crush, chew, break, or open it. The timing of administration is constrained by the relationship to food; the dose should be taken at a consistent time and often separated from meals to regulate drug exposure.

Administration for specific populations must adhere to labeling, which notes that no dose adjustment is typically required for older adults. Treatment initiation is procedural, often requiring verification that specific serum calcium levels have been met. For regimens involving dose titration, an adjustment is not made immediately but follows a strict monitoring period of approximately three months. If a scheduled dose is missed, the official instruction is to skip the missed dose entirely and resume the next regularly scheduled dose; an extra dose must not be taken.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Devisol

Evidence for use in Vitamin D Deficiency and Insufficiency

Studies for Devisol (cholecalciferol) have been primarily conducted as randomized controlled trials (RCTs). These trials were designed to examine outcomes related to systemic imbalance, specifically measuring changes in serum 25(OH)D levels in the blood. Research highlights changes measured during the study period, with data showing patterns related to modifications in circulating vitamin D levels when participants received the intervention. However, evidence quality varies across studies, and findings describe group patterns, not personal outcomes.

Evidence for use in Bone Health Support (Osteoporosis and Osteomalacia)

Devisol was evaluated in research contexts involving conditions where symptoms may vary in intensity, such as osteoporosis and osteomalacia. Studies explored whether the use of Devisol was associated with changes in measured bone mineral density and bone turnover markers. Findings were mixed; while some research reported measured differences, others reported patterns comparable to control groups. The evidence contributes to the broader research landscape, but certainty remains low.

Long-term Studies and Follow-up

Research focusing on extended use has explored short-term symptom changes, but long-term evidence is not fully established. Studies monitored responses over defined time intervals, usually lasting less than one year. The available research provides insight into short-term changes, but follow-up durations were limited, making it difficult to assess the sustainability of observed measurements over a period of several years.

What is Still Uncertain About Devisol

Critical gaps remain in the available evidence. Comparative evidence is lacking, and data for certain groups, such as individuals with complex, comorbid conditions, remains insufficient. Research provides context but does not determine whether an individual will respond similarly, and long-term changes and patterns are not fully characterized.

Key Studies & References

  1. Calcium plus vitamin D supplementation and risk of fractures: an updated meta-analysis from the National Osteoporosis Foundation
  2. Vitamin D and Bone Health: - Society for Endocrinology (Clinical Guideline)
  3. Effect of Vitamin D Supplementation on Risk of Fractures and Falls According to Dosage and Interval: A Meta-Analysis - Endocrinology and Metabolism
  4. Cholecalciferol (vitamin D3): efficacy, safety, and implications in public health - Frontiers (Systematic Review)

Frequently Asked Questions (FAQ)

Common questions about Devisol (FAQ)


Q: Is it okay to take Devisol with common antacids?

Official information indicates that taking the medicine with high doses of calcium-containing preparations may increase the risk of high blood calcium, known as hypercalcemia. Additionally, caution is advised with magnesium-containing products, especially for patients with kidney problems, due to the potential for elevated magnesium levels. Regulatory warnings typically highlight the need to consider the calcium and magnesium content in any concurrent over-the-counter medications.


Q: Does Devisol interact with common herbal supplements like St. John's Wort?

Regulatory product information notes caution with drugs that stimulate microsomal hydroxylation, as these are enzyme-inducing agents that can potentially reduce the level of Devisol (calcifediol) in the blood. This general caution extends to certain herbal supplements. Official documentation often includes a general caution that all concurrent medications, vitamins, and herbs should be reviewed by a prescribing healthcare professional, as they may alter the drug's metabolic pathway.


Q: Can taking Devisol affect my ability to drive or operate machinery?

Official product documentation typically includes information on the potential effects on ability to drive and use machines. Potential side effects associated with high calcium levels, such as extreme fatigue or dizziness, are noted in regulatory information. These effects have the potential to impair one's ability to focus or react, and official documents include warnings about their impact on driving and using machines.


Q: Can Devisol be used by people who have a diagnosed lactose intolerance?

Regulatory documents contain a list of excipients (non-medicinal ingredients) present in different formulations. While some Devisol forms may contain other agents like sorbitol, lactose is typically not listed in the available soft capsule versions. It is important that individuals with a diagnosed intolerance obtain and review the specific formulation's excipient list from their healthcare provider or pharmacist.


Q: Is Devisol safe to use if I occasionally consume alcohol?

Official sources note that some soft capsule formulations may contain a small amount of alcohol (ethanol) as a manufacturing component. Official interaction lists typically do not specify a major interaction with occasional consumption of general alcohol. However, the medicine is generally contraindicated (not allowed) for patients who have pre-existing liver disease, as this condition can change how the body processes the drug.


Q: How quickly does Devisol typically leave the body after the last dose is taken?

Official pharmacokinetic studies indicate that the mean half-life of the active ingredient, calcifediol, ranges from approximately 10 to 22 days. The half-life describes the time required for the amount of drug in the body to be reduced by half. This long half-life means that the substance is expected to remain in the circulatory system for a prolonged duration following administration.


Q: What research has been conducted on Devisol use in patients with existing heart conditions?

Official safety warnings highlight the use of the medicine in individuals with heart conditions, particularly when taking certain heart medications called cardiac glycosides. This is because the principal side effect of Devisol, high calcium levels (hypercalcemia), can increase the risk of digitalis toxicity and potential cardiac arrhythmias. Regulatory documents require careful monitoring of calcium levels for these patients.


Q: Can Devisol cause changes in mood, such as increased anxiety or depression?

Official lists of potential side effects have occasionally included reports of effects on mood, such as confusion or depression. However, the incidence of these reactions is not always known or classified among the most common adverse events. If a person experiences changes in mood, it is important for the prescribing healthcare professional to be informed, as even common symptoms like high calcium levels can impact overall well-being.


Q: Is the drug known to be harmful if accidentally taken by a child?

Regulatory documents state that the medicine is not recommended for use in children and adolescents because its safety and effectiveness have not been fully established in that age group. Official safety warnings emphasize that accidental overdose of Vitamin D analogues in children can lead to severe toxicity and high calcium levels, which can cause serious organ dysfunction.


Q: What is the typical long-term timeframe people are instructed to take Devisol?

Official regulatory information does not typically specify a universal maximum duration for treatment. However, clinical studies supporting the drug's use have evaluated its safety and effectiveness over long-term periods, often greater than six months. The total duration of treatment is determined by the prescribing healthcare professional based on ongoing monitoring and individual evaluation.


Q: Does Devisol require a special diet or fluid intake to work correctly?

Official safety information includes a caution against making abrupt changes in dietary calcium intake or using high-dose calcium-containing preparations concurrently. This is because significant dietary changes could exacerbate the risk of developing hypercalcemia (high blood calcium). No specific fluid intake is typically required for the drug to work correctly.


Q: What is the description of the maximum dose of Devisol in official sources?

Regulatory dosing tables list recommended starting and maintenance doses based on a patient’s specific condition. While a specific universal maximum dose may not be listed, regulatory safety guidelines require that the prescribed calcifediol dosing respects a consistent upper limit of safety for total Vitamin D intake. This is essential to prevent the risk of drug-related toxicity.


Q: Are there any known geographical or seasonal factors that might affect Devisol's efficacy?

Official reviews indicate that because the active ingredient, calcifediol, bypasses the initial liver activation step, its effectiveness is more consistent than standard Vitamin D3. Standard Vitamin D3 production in the body is more prone to variation from external factors like season (sun exposure) or body weight.


Q: Is Devisol known to interact with herbal teas or natural beverages?

Official regulatory documents list that certain natural beverages can affect the body's processing of the drug. For example, consuming grapefruit or grapefruit juice may potentially alter the blood concentrations of calcifediol. This is because grapefruit can affect the metabolic enzyme CYP3 A4 involved in the drug's pathway.


Q: Does Devisol carry a risk of photochemical interactions if exposed to sun?

Official patient information does not specify a direct photochemical interaction risk with regular sun exposure. However, regulatory documents note that one of the potential later symptoms of an overdose of the medicine is intolerance to sunlight, which is also called photosensitivity.

How should Devisol be stored and disposed of?

Devisol (Calcifediol) must be stored and disposed of according to official regulatory guidelines to maintain potency and safety.

Storage Conditions

Store the medication at room temperature, typically between 15 C and 30 C (59 F to 86 F). It must be protected from excess heat, moisture, and light, and it should not freeze. Keep the product in its original container, ensuring it is tightly closed.

Safety and Disposal

For child safety, store Devisol out of the sight and reach of children. Unused or expired medicine must not be kept. Disposal must be completed according to local and national regulations; patients should ask a healthcare professional for guidance. The medicine must not be thrown into wastewater or drains.

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

Available in countries:

Equivalent of Devisol found in:

A-Z Index: