Devarol S

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Devarol S

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 Devarol S

Quick Facts

Property Description
Active Ingredient Colecalciferol (Vitamin D₃)
Form Oral solution (drops), soft capsules, tablets
Pharmacological Class Fat-soluble Vitamin, Calcium Regulator
Common Use Supporting bone health and mineral balance
Origin Semi-synthetic (chemically identical to endogenous Vitamin D₃)

What Pharmacological Class Does Devarol S Belong To?

Devarol S is a pharmaceutical preparation whose active substance is Colecalciferol, which functions as an essential calcium regulator and a fat-soluble vitamin. This compound is broadly clinically recognized for its systemic role in mineral homeostasis. It is classified as an Anti-Rachitic Agent due to its critical role in maintaining skeletal integrity. Colecalciferol is accurately described as a prohormone, meaning the body must metabolically convert it into the active hormonal form, Calcitriol, to initiate its full physiological effects. This classification highlights its importance beyond that of a simple nutrient.

Composition, Form, and Origin of Colecalciferol

The active ingredient, Colecalciferol (Cholecalciferol), is chemically identical to the Vitamin D₃ naturally synthesized in human skin. The product is manufactured as a semi-synthetic compound, providing a standardized and reliable source of the nutrient. Because Colecalciferol is a fat-soluble vitamin, Devarol S is typically administered via the oral route in dosage forms optimized for absorption, such as an oral solution in an oily base or encapsulated within soft capsules.

General Purpose and Benefit of Devarol S

The fundamental purpose of administering Devarol S is to support and regulate the body’s control over essential minerals. The active metabolite of Colecalciferol significantly promotes the intestinal absorption of calcium and phosphate from consumed food. This regulatory action is essential for facilitating proper bone mineralization and growth. The product serves as a crucial nutritional supplement intended to maintain long-term bone health and structural stability.

Regulatory References

  1. MedlinePlus Drug Information: Cholecalciferol (Vitamin D3)

What side effects are possible with Devarol S?

Possible Side Effects and Safety Information for Devarol S

This section summarizes the officially documented adverse effects and safety characteristics for Devarol S (Colecalciferol) based strictly on government regulatory documents.

Adverse Reaction Frequency

Side effects are classified according to frequency in regulatory labeling:

Classification Examples of Documented Adverse Effects
Common Stomach pain, nausea, headache.
Uncommon Hypercalciuria (excess calcium in the urine).
Rare Rash, Urticaria (hives), Pruritus (itching).

Serious Adverse Reactions

The most significant safety concern documented in official labeling relates to the risk of Hypercalcaemia (high calcium levels in the blood), which is primarily associated with overdose or long-term exposure to excessive amounts. Persistent hypercalcaemia may lead to severe complications, including Nephrolithiasis (kidney stones) and potentially irreversible kidney damage (Nephrocalcinosis). Rare, but serious, Hypersensitivity Reactions, such as anaphylaxis, are also documented.

Safety Restrictions and Limitations

Regulatory documents define specific contraindications where the medication should not be used:

  • Contraindications: Individuals with pre-existing Hypercalcaemia, Hypercalciuria, Severe Renal Insufficiency, existing Kidney Stones, or Hypervitaminosis D.
  • Caution: Use requires specific caution and monitoring in patients with conditions like Sarcoidosis or in patients with Osteoporosis who are immobilized. Furthermore, an overdose must be strictly avoided during pregnancy due to the risk of harmful effects on the developing fetus.

Overdose and Emergency Response

Overdose and when to seek help

Overdose of the active ingredient, Colecalciferol (Vitamin D₃), is officially documented in regulatory labeling as causing Hypervitaminosis D, a condition primarily characterized by abnormally high blood calcium levels (Hypercalcemia).

Documented Manifestations and Severe Outcomes

Symptoms reported in regulatory documents include gastrointestinal disturbances like anorexia, nausea, and vomiting, alongside renal effects such as polyuria (frequent urination) and the potential formation of kidney stones.

Overdose is considered a severe scenario that may lead to life-threatening outcomes. Documented complications include irreversible renal insufficiency and cardiac arrhythmias due to widespread soft tissue calcification, as stated in official labeling. Toxicity is noted to be more pronounced in infants and children.

Required Emergency Actions

Regulatory authorities mandate that if an overdose is suspected, the product (Devarol S) and any concurrent calcium intake must be immediately discontinued.

Immediate medical attention must be sought if symptoms of hypercalcemia—such as persistent vomiting, confusion, or cardiac symptoms—are observed, as the condition requires urgent clinical management. No specific antidote is known; treatment is symptomatic and supportive, focusing on reducing serum calcium levels through measures like vigorous hydration, as described in official prescribing information.

Therapeutic Uses of Devarol S

Devarol S is a combination medication that is generally used in clinical settings that involve acute or unstable symptom patterns, which may be associated with various inflammatory and allergic conditions.

What Devarol S Treats: Main Uses and Benefits

Devarol S is applied in addressing symptom clusters that may become intense or disruptive due to an immune-mediated or irritative state. The combination generally helps address symptoms related to heightened physiological activity and provides supportive relief by targeting manifestations of discomfort and allergic distress.

Dexamethasone is commonly used across conditions presenting with acute episodes involving inflammatory or irritative states, and Chlorphenamine is considered relevant for easing symptoms that may intensify temporarily due to allergic manifestations.

This combination may assist with maintaining functional stability in conditions characterized by periods of heightened symptoms involving inflammatory or irritative states. Common clinical contexts include scenarios where additional management of discomfort is required for conditions such as allergic rhinitis, some forms of dermatitis, and other situations involving temporary physiological imbalance. It is commonly used to help with symptoms related to heightened physiological activity and generally supports the patient during difficult episodes by easing distress. The product helps improve day-to-day comfort during symptomatic periods.

Quick Fact: Relevant for Symptoms related to heightened physiological activity

This contributes to easing the overall symptom load and helps improve day-to-day comfort during symptomatic periods. The medication supports general well-being during symptomatic phases and is applicable within clinical settings that involve acute or disruptive symptom patterns.

Regulatory References

  1. TGA Safety Alert on Dexamethasone and Chlorphenamine

Eligibility and Restrictions for Use

Devarol S (Colecalciferol) is officially approved for use in adults, older adults, and children for the prevention and treatment of Vitamin D deficiency, subject to specific regulatory restrictions based on mineral balance and underlying health conditions.

Contraindicated Populations (Absolute Non-Eligibility)

Use of Devarol S is contraindicated and must not be used in patients with conditions that pose a primary risk of Vitamin D toxicity or calcium imbalance, including:

  • Hypervitaminosis D (toxic levels of Vitamin D).
  • Hypercalcemia (abnormally high blood calcium) and Hypercalciuria (high calcium in urine).
  • Severe Renal Impairment or active Nephrolithiasis (kidney stones).
  • Known hypersensitivity to Colecalciferol or any excipients.

Condition-Based and Age-Related Restrictions

Restricted/Conditional Use Group Regulatory Status
Sarcoidosis or Granulomatous Conditions Requires special caution and close monitoring of calcium levels due to altered metabolism.
Impaired Renal Function (non-severe) Requires caution; the effects on calcium and phosphate levels must be monitored.
Pediatric Use (High-Dose) High-strength formulations are not recommended or contraindicated for children below certain minimum age thresholds.
Pregnancy and Lactation Permitted for the prevention and treatment of deficiency under medical supervision.

These official regulatory domains define the precise conditions under which the product is considered eligible for use, focusing strictly on absolute prohibitions and necessary population-specific caution.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines documented interactions for Devarol S (Colecalciferol) based on official regulatory labeling, focusing on pharmacokinetic and pharmacodynamic constraints when co-administering certain substances.

Pharmacokinetic Interactions (Exposure Modification)

Mechanism Interacting Substances/Classes Practical Implication
Decreased Absorption Bile Acid Sequestrants (e.g., cholestyramine), Mineral Oil Requires separation of doses to ensure adequate uptake.
Increased Catabolism Anticonvulsants (e.g., phenytoin, phenobarbital), Corticosteroids May lower Colecalciferol blood levels, potentially reducing effectiveness.

Pharmacodynamic Interactions (Additive Effects)

Mechanism Interacting Substances/Classes Clinical Constraint
Increased Calcium Load Thiazide Diuretics Increased risk of hypercalcemia due to enhanced calcium reabsorption.
Potentiation of Toxicity Cardiac Glycosides (e.g., digoxin) Hypercalcemia can increase the risk and severity of digitalis toxicity.

Other Interactions

Concurrent use of other Vitamin D or calcium/phosphate supplements may lead to excessive levels of these substances. Patients with renal impairment or those taking medications affecting metabolism require close monitoring of serum calcium and phosphate levels when using Colecalciferol. The effects of certain antifungal agents may also modulate Vitamin D metabolism.

Mechanism of Action

Prohormone Activation and VDR Gene Regulation

The active component, Colecalciferol, is a prohormone that must first be metabolized in the liver and then in the kidneys (via the enzyme CYP27B1) to yield the biologically active hormone, Calcitriol. Calcitriol acts as a natural agonist for the Vitamin D Receptor (VDR), a nuclear receptor that directly regulates gene transcription when activated. This mechanism influences the synthesis rate of key proteins responsible for mineral homeostasis throughout the body.

Endocrine Control of Mineral Homeostasis

VDR activation is central to the calcium and phosphate homeostasis pathway. This involves the active hormone enhancing the synthesis of transport proteins (e.g., Calbindin-D9k) in the small intestine, leading to increased absorption of dietary minerals. Concurrently, it participates in a critical negative feedback loop by directly suppressing the gene for Parathyroid Hormone (PTH) in the parathyroid glands.

Causal Cascade to Skeletal Physiology

The resulting cascade—efficient intestinal absorption, reduced mineral loss via renal reabsorption, and hormonal suppression of PTH—results in a sustained concentration of calcium and phosphate in the circulation. This provision of building blocks facilitates the process of bone mineralization, which is the physiological core effect that influences the physical characteristics of the skeletal matrix.

Dosage and Administration Information

Official Administration Guidelines (Oral Route)

Devarol S is an oral combination product that must be administered according to specific principles governing its two components (a corticosteroid and an antihistamine).

Administration Scope Official Instruction
Route of Administration The approved and standard route is Oral (by mouth).
Dosing Schedule Dosage must be individualized based on the patient's acute needs, and is determined by a healthcare provider. The typical adult antihistamine component is often dosed in 4 mg units.
Frequency and Timing The medication is often taken in divided doses every 4 to 6 hours during acute symptomatic periods. If administered once daily, it is recommended to take the dose in the morning with breakfast to align with the body’s natural rhythm.
Administration Conditions The medication must be taken with or immediately after food to help minimize potential gastric irritation associated with the corticosteroid component.
Preparation If using the oral solution, the dose must be measured precisely using a calibrated measuring device (spoon or syringe); household spoons must not be used.
Population Rules Older adults may require a lower daily dose or less frequent administration (e.g., every 6 to 8 hours).
Course Duration & Tapering Use is generally restricted to short-term courses for acute management. If the medication is taken for more than a few days, the dose must be withdrawn gradually (tapered) upon discontinuation to allow the body to adjust.

These official instructions define the required steps for the use of the medicine, emphasizing accurate measurement and a necessary gradual dose reduction upon ending therapy for courses exceeding a few days.

Recent Clinical Evidence

Research evidence / Overview of studies for Devarol S

Evidence for Deficiency Diseases (Rickets and Osteomalacia)

This section summarizes the research where Devarol S was evaluated in research exploring its role in anti-rachitic activity, detailing the Randomized Controlled Trials (RCTs) and meta-analyses that examined its use in individuals with confirmed vitamin D deficiency. The focus will be on the study designs, the biomarkers measured (like 25-hydroxyvitamin D [25(OH)D]), and the clinical endpoints evaluated in children and adults.

Studies were conducted in infants, children, and adolescents with conditions such as rickets, and in adults with conditions such as osteomalacia (bone demineralization). Findings describe patterns observed where administration of the medicine was associated with shifts in the monitored biomarkers. Research indicated that the use of Colecalciferol was studied for its role in the resolution of clinical signs linked to rickets or osteomalacia in the observed groups.

Evidence for Skeletal Integrity and Fall Prevention

This part of the overview will outline the research landscape where the medicine was evaluated in research examining bone mineral density and functional outcomes like the incidence of falls in older adults. It details the specific study types, such as large-scale RCTs, that assessed fracture rates and measures of muscle strength.

Research exploring outcomes related to daily functioning and activity level was primarily conducted using Randomized Controlled Trials and subsequent Meta-analyses focused on older adults. The evidence describes patterns observed where measuring changes in muscle function and fall incidence appears to be highly dependent on the participants' baseline vitamin D status. The body of research on this indication contains mixed findings across different systematic reviews regarding fall and fracture prevention.

What is Still Uncertain About the Research

This concluding section provides a neutral summary of the identified evidence gaps and areas of inconsistent findings documented in systematic reviews. Research highlights what is known and what is still uncertain regarding the research landscape. The body of evidence contains mixed findings and inconsistent results when assessing outcomes like BMD in individuals who were not already deficient. Furthermore, specific findings in some studies were only observed when calcium was co-administered, suggesting that the research often explored this combination.

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 Deficiency - Management guidelines for adults and children (Clinical Practice Guideline)
  3. Vitamin D: supplement use in specific population groups (NICE Public Health Guideline PH56)

Frequently Asked Questions (FAQ)

Common questions about Devarol S (FAQ)


Q: How quickly does Devarol S usually start working?

A: The active ingredient in Devarol S is a prohormone, meaning the body must first metabolize it into the active form. Official studies primarily track changes in blood levels of 25- hydroxyvitamin D—the vitamin D storage form. Achieving a measurable increase in these levels typically takes several weeks to a few months after starting treatment.

Q: How long can a person typically take Devarol S?

A: Official guidance indicates that treatment duration is highly individualized and subject to continuous medical monitoring. While high doses are generally intended for the initial correction of a deficiency, continued use, if necessary, transitions to lower maintenance doses. This approach is intended to manage potential toxicity risks associated with prolonged use.

Q: What foods or drinks should people know about when using Devarol S?

A: Official administration guidelines state the medicine is taken with food, which may assist with absorption. Specific warnings in regulatory documents advise that certain food components, such as grapefruit and grapefruit juice, may potentially affect how the medicine works. The intake of other supplements containing calcium, phosphate, and Vitamin D should be discussed with a healthcare provider due to the need for monitoring.

Q: Is Devarol S safe to use for older adults?

A: Devarol S is included in official therapeutic uses for older adults in the context of preventing and treating vitamin D deficiency. However, official administration guidelines mention that in some cases, older adults may require a lower or less frequent dose. This reflects specific bone health intake recommendations defined for this age group.

Q: Can people with kidney problems use Devarol S?

A: Official information clearly states that Devarol S is contraindicated (must not be used) in people with severe renal impairment or pre-existing kidney stones. Use in these cases is accompanied by a requirement for close medical monitoring of blood calcium and phosphate levels.

Q: Does Devarol S interact with common over-the-counter supplements?

A: Interactions are possible. Regulatory labels warn against the concurrent use of other calcium or phosphate supplements or certain antacids, as this may increase the overall mineral load. Official documents indicate that the co-administration of certain over-the-counter drugs may potentially modify the metabolism of the active ingredient.

Q: Is it okay to drive or operate machinery while using Devarol S?

A: The active ingredient in Devarol S is not typically associated with drowsiness or other central nervous system effects. Safety information states that users should monitor their individual response to the medicine before deciding to drive or operate machinery.

Q: Are there any known long-term side effects associated with Devarol S?

A: The most significant safety concern documented in official labeling relates to the risk of Hypercalcaemia (high calcium levels in the blood), which is associated with prolonged exposure. Persistent hypercalcaemia, the most significant risk, is linked in official documents to potential severe complications like kidney stone formation and kidney damage.

Q: What does the research say about stopping Devarol S suddenly?

A: If the medicine has been taken for more than a few days, regulatory guidelines specify that the dose must be withdrawn gradually (tapered). To ensure the body's systems adjust appropriately, regulatory information indicates that gradual withdrawal is necessary when stopping a course lasting more than a few days.

Q: Can Devarol S affect sleep?

A: The official documentation does not commonly list sleep disturbance as an adverse reaction. Research overviews have explored the potential link between correcting a deficiency and its influence on overall sleep parameters, but this is not listed as a common adverse reaction.

Q: Is there a generic version of Devarol S available?

A: The active compound, Colecalciferol (Vitamin D₃), is widely available in generic formulations and as an over-the-counter supplement. The availability of a specific generic equivalent to the branded product depends on individual market approvals.

Q: How does Devarol S affect blood sugar levels?

A: Blood sugar changes are not listed as a common or required monitoring point in regulatory safety labels. Some research overviews have observed minor, non-significant effects on fasting blood glucose levels, reflecting the systemic role of Vitamin D in glucose metabolism.

Q: Is Devarol S used to prevent a condition, or only to treat it?

A: Official uses cover both the prevention and the treatment of Vitamin D deficiency. The specific therapeutic application is determined based on a patient's clinical situation.

Q: Can Devarol S be used by people who are vegetarian or vegan?

A: The active ingredient, Colecalciferol, can be sourced from lanolin (animal-derived) or from non-animal sources. Therefore, the suitability of the specific product for vegetarian or vegan diets depends entirely on the excipients and the source listed in the official composition documents.

Q: Are there different strengths of Devarol S?

A: Yes. Official drug labels and prescribing information indicate that the active ingredient is available in multiple unit strengths across its various dosage forms. The availability of multiple strengths reflects the necessary individualization of dosage for patients.

Q: Does Devarol S interact with caffeine?

A: There is generally no major direct drug-drug interaction found in regulatory databases between the active ingredient and caffeine. This information is always subject to change; therefore, a complete list of all supplements and dietary factors should be reviewed by a healthcare professional.

Q: How long do the effects of Devarol S last after stopping the medicine?

A: Because the active ingredient is fat-soluble and stored in the body's tissues, its elimination from the body is gradual. Consequently, its effects on vitamin D status may continue for some time after the treatment course is completed.

Q: Is the effectiveness of Devarol S different for men and women?

A: Official product labels do not state differences in effectiveness based on gender. However, some research has explored potential variability in patient response to vitamin D supplementation between men and women.

Q: Can Devarol S affect fertility?

A: Official regulatory documents do not list any effect on fertility as a common or serious adverse reaction. Although the subject has been explored in medical research, a definitive cause-and-effect relationship has not been established.

Q: Is Devarol S commonly used in other countries?

A: Yes, the active ingredient (Colecalciferol/Vitamin D₃) is approved and widely used in many countries worldwide. Its use is standardized and recognized by major global regulatory bodies, including those in Europe, Australia, Canada, and Japan.

Q: Does Devarol S interact with herbal remedies like St. John's wort?

A: Yes, official interaction databases list St. John's wort (Hypericum perforatum) as an interacting substance. This herbal remedy may potentially decrease the overall effect of Devarol S by increasing the rate at which the body breaks down the active ingredient.

Q: Why do some people need a higher dose of Devarol S than others?

A: Official guidelines state that dosage must be individualized based on several patient factors. A person may require a higher dose due to a more severe baseline deficiency, higher body weight, or certain concurrent conditions that reduce absorption, such as malabsorption syndromes or obesity.

Q: Can Devarol S affect laboratory test results?

A: Yes, it can. Since the primary action of the medication is to regulate minerals, official warnings note that if the medicine is administered in excess, it can cause elevated laboratory results for serum calcium and phosphate levels. Official safety information requires the monitoring of these specific levels during treatment.

Q: Is it necessary to finish the entire course of Devarol S?

A: The recommended course duration is specific to a patient's clinical needs and the goal of therapy (correcting or preventing deficiency). Stopping the course before the therapeutic goal is met may result in the condition remaining uncorrected.

Q: Are there any common misconceptions about Devarol S?

A: Educational materials from government bodies often address common misunderstandings regarding vitamin D. These materials clarify that the body utilizes both supplemental and nutritional forms of the vitamin, while also noting the specific risks associated with excessive sun exposure.

Q: How is the safety of Devarol S monitored by health authorities?

A: Health authorities conduct ongoing safety monitoring through strict pharmacovigilance systems and mandatory adverse event reporting. Regulatory documents instruct both patients and healthcare providers to report any suspected side effects, which helps in the continuous evaluation of the product’s safety profile.

Q: Is Devarol S considered a high-risk medication?

A: While the medicine is generally used to correct a deficiency, official regulatory documents emphasize that the risk of toxicity (hypercalcaemia) is significant and severe if the product is taken in excessive amounts or for long periods without medical supervision. Close monitoring is cited in official documents as a necessary safety requirement when using the product.

Q: Does Devarol S have any known effects on vision?

A: Vision issues are not a common side effect of the active ingredient itself. However, post-marketing safety reports for combination treatments involving Colecalciferol have included rare events such as inflammation in the eye (uveitis, scleritis, or episcleritis).

Q: Are there any specific genetic factors that influence how Devarol S works?

A: Research indicates that the active metabolite of the drug binds to the Vitamin D Receptor (VDR), a key regulator of gene activity. Studies have explored the role of genetic variations (polymorphisms) in the VDR gene in certain patient populations, as the VDR is where the active drug metabolite binds.

How should Devarol S be stored and disposed of?

How to Store and Dispose of Devarol S

The storage of Devarol S (Colecalciferol) must adhere strictly to labeled requirements to maintain the product's stability.


Storage Conditions

  • Temperature and Protection: Store the medicine at room temperature and keep from freezing. The product must be protected from excessive heat, moisture, and direct light.
  • Container Integrity: Keep the medicine in the original container and ensure the container is tightly closed.
  • Child Safety: It is mandatory to keep Devarol S out of the sight and reach of children.
  • Shelf-Life: The Oral Solution must be discarded 60 days after first opening. Do not use the medicine after the expiration date on the package.

Disposal Instructions

Do not keep outdated medicine or medicine no longer needed. Any unused product or waste material must be disposed of in accordance with local requirements. Patients should consult a pharmacist or healthcare professional for specific instructions on disposal.

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

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