Calodis

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Calodis

What is Calodis? - Overview

Property Description
Active ingredient Calcifediol (INN)
Form Extended-release oral capsule
Pharmacological class Vitamin D Analog
Common purpose Supports mineral balance (calcium/phosphate)
Origin Synthetic metabolite form
Status Prescription-only (Rx)

Calodis: Defining Its Core Identity

Calodis is a prescription medicine containing the active ingredient Calcifediol. It is classified pharmacologically as a Vitamin D Analog, a drug class clinically recognized for its essential role in calcium and phosphate homeostasis. Calcifediol is chemically a synthetic form of 25-hydroxyvitamin D3, which is the principal circulating metabolite of Vitamin D found in the body. This unique metabolite structure means it bypasses the body's initial activation step, which is an important feature, especially for patients requiring a more reliable method of raising Vitamin D levels.

Form and General Purpose

Calodis is supplied as an extended-release oral capsule, designed for systemic administration by mouth. The controlled-release design is intended to provide a stable, consistent concentration of Calcifediol in the blood over 24 hours. The medicine is a single-ingredient product, and its primary purpose is to help the body maintain healthy, stable levels of calcium and phosphate. By reliably regulating the body's mineral status, Calodis plays a fundamental role in supporting bone health and ensuring the proper function of the nervous and muscular systems.

What side effects are possible with Calodis?

Possible Side Effects and Safety Information

The official safety information for Calodis (Calcifediol) is focused on the drug's impact on mineral regulation, as defined by government regulatory documents. The primary and most significant safety concern is the risk of hypercalcemia (elevated blood calcium levels) and related electrolyte disturbances, which underlies many documented adverse reactions.


Adverse Reaction Classification

Side effects are categorized based on frequency and the physiological systems affected, known as System-Organ Classes (SOCs):

Category Examples (as listed in regulatory documents)
Common Anemia, Nasopharyngitis, Constipation, Increased Blood Creatinine, Congestive Heart Failure, Cough
SOC Categories Metabolism and Nutrition Disorders (e.g., Hypercalcemia), Gastrointestinal Disorders, Cardiac Disorders, Renal and Urinary Disorders, Blood and Lymphatic System Disorders

Clinically Significant Safety Information

Specific serious adverse reactions are documented, including Severe Hypercalcemia and the risk of Adynamic Bone Disease (a bone disorder caused by excessive suppression of parathyroid hormone) in Chronic Kidney Disease patients. Hypercalcemia of any degree can also potentiate the risk of Digitalis Toxicity in patients taking cardiac glycosides.

The use of Calodis is formally contraindicated in individuals with pre-existing Hypercalcemia, Hypervitaminosis D, or a known history of Calcium Lithiasis (calcium stones). Regulatory agencies note that hypercalcemia may occur at any stage of treatment.

Safety notes for specific populations emphasize the need for caution during pregnancy to strictly avoid overdose, as prolonged high calcium levels are associated with developmental complications. These classifications structure the understanding of the drug’s risk profile, highlighting that consequences are linked directly to its core function in regulating mineral levels.

Overdose and Emergency Response

The official overdose profile for Calcifediol (Calodis) is strictly defined by the development of hypercalcemia, or abnormally high blood calcium levels. Documented clinical manifestations of overdose reflect the systemic effects of this condition.

Overdose presentations typically include a cluster of gastrointestinal, systemic, and neuropsychiatric signs. Patients may experience symptoms such as persistent nausea, vomiting, anorexia (loss of appetite), muscle weakness, and severe fatigue. Central nervous system involvement can manifest as confusion, headache, and drowsiness. Elevated serum calcium levels are the primary laboratory finding.

Overdose carries the potential for severe and life-threatening outcomes, including cardiac arrhythmias, seizures, and the risk of permanent kidney damage (renal failure). Regulatory authorities mandate that patients seek immediate medical attention or call emergency services if severe symptoms are present, such as collapse or inability to be awakened.

Management is strictly supportive. The initial action is the immediate withdrawal of Calodis and all calcium-containing supplements. No specific antidote is known for Calcifediol toxicity. Officially described supportive procedures include aggressive fluid administration and pharmacologic intervention with agents such as bisphosphonates to safely reduce serum calcium levels.

Therapeutic Uses of Calodis

Calodis (Calcifediol) is commonly used to help manage specific metabolic complications that may arise in adults with chronic kidney disease (CKD), particularly in stages 3 or 4. Its primary purpose is to provide supportive assistance for systemic balance in patients experiencing these conditions. It is used to address secondary hyperparathyroidism in certain adults with CKD.


The medication is generally applied in clinical settings marked by systemic or localized discomfort related to the condition. It assists with managing conditions involving the overproduction of Parathyroid Hormone (PTH) and addressing Vitamin D insufficiency. The medication contributes to supporting skeletal health. It is relevant for easing challenging manifestations related to mineral dysregulation. The supportive management of PTH and mineral levels may assist with reducing the risk of progressive bone disorders, such as renal osteodystrophy, in the context of chronic kidney impairment.


Quick Fact: Support for Skeletal Health The medication may assist with maintaining functional stability during symptomatic phases of chronic kidney disease and is relevant for easing challenging manifestations related to mineral dysregulation.

Regulatory References

  1. MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Calodis?

Calodis (Calcifediol) eligibility is strictly defined by official regulatory documents, limiting use to specific adult populations and medical criteria. The medicine is indicated solely for adult patients (ge 18 years) diagnosed with Stage 3 or 4 Chronic Kidney Disease (CKD) who also have serum total 25-hydroxyvitamin D levels below 30 ng/mL.

Eligibility Group Regulatory Status
Eligible Adults Adults (ge 18 years) with Stage 3 or 4 CKD and Vitamin D levels below 30 ng/mL.
Contraindicated Prohibited in patients with hypercalcemia, Hypervitaminosis D, or known hypersensitivity to the medicine.
Not Indicated Use is not indicated for patients with Stage 5 CKD or End-Stage Renal Disease receiving dialysis.

Special Population Eligibility Status
Pediatric Use Safety and efficacy have not been established in children and adolescents (under 18 years).
Pregnancy/Lactation Not recommended during pregnancy; use during breastfeeding requires caution due to potential risks.
Geriatric Use Permitted, as studies have not demonstrated geriatric-specific limitations.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section details only the officially documented interaction patterns of Calcifediol (Calodis) as described in government-approved regulatory documents.


Documented Interaction Restrictions

Classification Interacting Substance/Class Official Interaction Outcome
Contraindicated Other Vitamin D Analogues (e.g., Alfacalcidol, Calcitriol) Formally prohibited due to additive hypercalcemic effects (Pharmacodynamic interaction).
Increased Exposure Risk Thiazide Diuretics (e.g., Hydrochlorothiazide) Increases the risk of hypercalcemia through an additive effect on calcium retention.
Exposure Reduction Hepatic Enzyme Inducers (e.g., Phenobarbital, Phenytoin) Causes reduced plasma concentrations and a shorter half-life due to accelerated hepatic metabolism (Pharmacokinetic interaction).
Potentiation Risk Cardiac Glycosides (e.g., Digoxin) Hypercalcemia caused by Calcifediol can enhance the arrhythmogenic/toxic effects of these agents.

Timing-Based Administration Rules

Substance Class Mandatory Timing Constraint
Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol) Doses must be spaced at least 2 hours apart from Calcifediol to mitigate impaired absorption.
Aluminum-containing Antacids Must be administered two hours before, or four hours after Calcifediol to manage increased aluminum absorption.

The regulatory profile also cautions against the uncontrolled intake of calcium supplements and Vitamin D-fortified foods due to the potential for an additive hypercalcemic load.

Mechanism of Action

Targeting the Vitamin D Receptor and Gene Modulation

Calodis initiates its action by operating as an agonist for the Vitamin D Receptor (VDR), a nuclear receptor expressed in tissues including the intestine, kidney, and parathyroid glands. Upon binding, Calodis forms a complex that translocates to the cell nucleus and directly regulates the transcription of genes responsible for mineral transport. This specific, genomic signaling pathway operates by adjusting gene expression and protein synthesis, contrasting with rapid, non-genomic cellular responses.

️ Modulating Calcium and Phosphate Homeostasis

The resulting gene modulation increases the synthesis of proteins necessary for the enhanced absorption of dietary calcium and phosphate from the gastrointestinal tract and their reabsorption in the renal tubules. This system-wide mineral homeostatic pathway influences systemic concentrations of these elements and their distribution across the body.

Endocrine Feedback and PTH Regulation

Calodis engages the endocrine feedback axis through two mechanisms: direct VDR binding to parathyroid cells and the indirect physiological consequence of increased serum calcium. Both actions facilitate the downregulation of Parathyroid Hormone (PTH) secretion. This modulation contributes to the overall physiological effect profile.

Dosage and Administration Information

How to Use Calodis

The administration of Calodis (Calcifediol extended-release capsules) follows a strict, laboratory-guided protocol. This medicine is for oral administration only and is prescribed for adults with Chronic Kidney Disease (CKD) Stage 3 or 4. The safety and effectiveness of Calodis have not been established in patients with End-Stage Renal Disease (ESRD) or in the pediatric population.


Official Administration Guidelines

Instruction Entity Official Guideline
Administration Route Oral, by mouth.
Dosing Schedule Initial dose is 30 mcg once daily. The maximum recommended dose is 60 mcg once daily.
Timing and Handling The capsule must be swallowed whole; it should not be chewed, crushed, broken, or opened.

Procedural Use and Timing

Calodis is taken once daily at bedtime (qHS). The dose should be taken at least 2 hours after any meal.

Treatment initiation is conditional; the patient's serum calcium level must be below 9.8 mg/dL before the first dose is administered. Dosing is a chronic process, with adjustments evaluated after approximately 3 months of therapy. If a dose is missed, it must be skipped entirely, and the regular schedule must be resumed the following day; an extra dose must not be taken.

This regimen dictates that the administration must follow a specific daily timing and strict capsule-handling rules to maintain the intended extended-release function.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Calodis (Calcifediol)

Evidence for Use in Secondary Hyperparathyroidism (SHPT) in CKD

The body of research for extended-release calcifediol (Calodis) primarily examined the compound in adults who have Chronic Kidney Disease (CKD) in stages 3 or 4 and concurrent Vitamin D insufficiency. The main research has involved Randomized Controlled Trials (RCTs), where participants were randomly assigned to receive either Calodis, a placebo, or sometimes another form of Vitamin D therapy. These trials were typically short- to intermediate-term, lasting between a few weeks up to six months.

The primary focus of these studies was to monitor certain biomarkers in the blood, specifically Parathyroid Hormone (iPTH) levels and the active Vitamin D metabolite, 25-hydroxyvitamin D (25( OH) D). These measurements serve as the biomarkers monitored regarding the body’s mineral balance in the studies. Findings describe patterns where a greater number of participants in the Calodis groups met the predefined measurement goal for 25( OH) D compared to the placebo groups. Reports have also monitored the change in iPTH levels over the evaluation period in the studied groups. Research indicates that the study design included protocols for close monitoring and adjustment of mineral levels during the trials.

What Remains Uncertain: Research Gaps and Limitations

A key limitation is that the primary regulatory research used biochemical endpoints (iPTH and 25( OH) D levels) as the main indicators of response, rather than hard, long-term clinical outcomes. Therefore, the evidence provides context but not individual predictions about whether using Calodis is associated with changes in the long-term risk of fractures or other serious events like cardiovascular events.

The principal research data for Calodis is derived primarily from studies in adults who are in CKD Stages 3 or 4. Limited trial data is available for children (pediatric patients) or patients with End-Stage Renal Disease requiring dialysis. Data regarding the durability of the observed iPTH changes beyond the one-year mark are still emerging.

Frequently Asked Questions (FAQ)

Common questions about Calodis (FAQ)


Q: How quickly does Calodis usually start to work?

A: Studies and official product information indicate that steady-state concentrations of the active vitamin D metabolite are typically reached after approximately three months of consistent daily administration. This means the therapeutic levels are achieved over a chronic period of therapy.


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

A: Official product information does not contain a specific warning against driving. However, because adverse reactions like dizziness or headache have been reported, if these effects occur, it is necessary to avoid driving or operating heavy machinery until you are sure you can do so safely. These symptoms could potentially impair motor function.


Q: Can Calodis be taken with standard pain relievers like ibuprofen or paracetamol?

A: The official interaction lists do not specifically name common pain relievers like ibuprofen or paracetamol (acetaminophen) as having documented interactions with Calodis. To maintain compliance with safety standards, regulatory bodies generally advise that all concomitant products, including pain relievers, should be reviewed by a healthcare professional.


Q: What should I do if a side effect of Calodis seems severe?

A: Regulatory documents instruct patients to contact their doctor immediately if they experience symptoms suggesting a severe side effect, such as signs of very high calcium levels (hypercalcemia). Prompt contact enables a healthcare professional to determine if a change to your regimen is appropriate.


Q: Does Calodis have a warning about dependency or addiction?

A: According to the official safety information provided by regulatory agencies, there are no warnings regarding any potential for physical dependency or addictive behavior associated with the use of this medicine.


Q: Is it normal to feel [general, non-specific symptom, e.g., slightly drowsy] when starting Calodis?

A: Official reports indicate that drowsiness is not listed as a common, general side effect of Calodis. However, it is cited as a possible symptom associated with hypercalcemia (high calcium levels), a potential serious side effect. Unexpected drowsiness or fatigue should be reported to a healthcare professional.


Q: Is there a generic version of Calodis available?

A: Calodis is the extended-release formulation of the active ingredient calcifediol. Availability of generic equivalents is subject to regulatory approval status, which may change over time. Questions about specific product availability should be directed to a pharmacist or healthcare provider.


Q: Is Calodis known to cause weight gain or loss?

A: Official product information does not list weight changes as a common side effect of the medicine. However, regulatory documents state that unexplained weight loss can be a symptom associated with the potentially serious adverse reaction of hypercalcemia (high calcium levels).


Q: Can I take Calodis if I have a history of liver issues?

A: Official documents do not list a history of liver disease as a formal contraindication (a condition prohibiting use). However, because calcifediol is metabolized in the liver, its use in patients with liver issues is often noted as potentially requiring careful monitoring by a healthcare professional.


Q: What happens when I stop taking Calodis?

A: Studies on the drug’s behavior indicate that when treatment is discontinued, blood levels of the active vitamin D metabolite gradually decrease. It may take a period of weeks to months for these levels to return to pre-treatment amounts.


Q: Is Calodis safe for people with high blood pressure?

A: A diagnosis of high blood pressure alone is not listed as a reason to avoid Calodis. Official drug interaction warnings note that certain blood pressure medications, such as thiazide diuretics, can increase the risk of hypercalcemia when used concurrently. Use with these medicines requires close monitoring.


Q: Does Calodis have known interactions with herbal supplements?

A: Official regulatory documents caution against using natural or herbal products that contain nutrients like Vitamin D, calcium, or phosphorus. Combining them with Calodis could potentially lead to an excessive buildup of minerals and heighten the risk of hypercalcemia.


Q: What does the term 'contraindication' mean regarding Calodis?

A: A contraindication is a specific medical condition or circumstance where the use of a medicine is prohibited because the risks clearly outweigh any potential benefits. For Calodis, pre-existing conditions like hypercalcemia (high blood calcium) or hypervitaminosis D are listed as formal contraindications.


Q: Can Calodis interact with common antidepressant medications?

A: Regulatory interaction lists specifically mention the antidepressant medication nefazodone as a substance that may alter the level of calcifediol in the blood. Official information indicates that monitoring of mineral levels is required if Calodis is used alongside nefazodone.


Q: What does official guidance say about using Calodis with alcohol?

A: Official product documents acknowledge that some formulations of the capsule may contain a small amount of alcohol (ethanol) as an inactive ingredient (excipient). This concentration is generally considered negligible and is not expected to have any noticeable clinical effects.


Q: Are headaches a common initial side effect when taking Calodis?

A: Headache is listed in official documents as a reported adverse reaction. It is also noted as a possible symptom associated with hypercalcemia (high calcium levels). Frequent or severe headaches experienced after starting Calodis should be discussed with a healthcare provider.


Q: Do official documents mention any effects of Calodis on sleep?

A: Calodis is officially directed to be taken once daily at bedtime (qHS) to align with certain bodily functions. Despite this timing, official side effect reports do not list insomnia or changes in sleep quality as a commonly reported adverse reaction.

How should Calodis be stored and disposed of?

To ensure the quality and safety of Calodis, store the medication precisely as directed on the original container label, which will specify the required temperature (e.g., room temperature or refrigeration) and protection from light or moisture. Always keep the medication in its original, sealed container and ensure it is stored out of sight and reach of children.

Dispose of any expired or unused Calodis as soon as possible. The preferred method for disposal is through a drug take-back program or a mail-back envelope. If those options are not readily available, check the medication's labeling for any specific instructions. Unless otherwise directed, do not flush the medicine down the toilet. If disposal in household trash is necessary and permitted, mix the drug with an undesirable substance, such as used coffee grounds or cat litter, seal the mixture in a container, and discard it in the trash.

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

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