ℹ️ Compiled from public regulatory records · Last regulator revision: May 28, 2026🚩 Report this page
Vitamin D3
Active ingredient
Sold asD-TABS · LUXA-D · VIDEXTRA · AG-VITAMINE D · JAMP-VITAMIN D
CA Health CanadaGB MHRA
Drug class
-
Availability
See label
Routes
Oral
Markets covered
2
Products on record
26
Overview
Vitamin D3 is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised September 8, 2025[1]
• Treatment and prevention of vitamin D deficiency; • Management and prevention of primary and corticosteroid-induced osteoporosis, in conjunction with calcium; • Treatment of refractory rickets (vitamin D resistant rickets); • Treatment of familial hypophosphatemia; • Treatment of hypoparathyroidism.
CONTRAINDICATIONS • Hypersensitivity to vitamin D, any of its analogues and derivatives or to any ingredient in the formulation component of the container (see Dosage Form, Composition, and Packaging). • Hypercalcemia and/or hypercalciuria • Nephrolithiasis (renal calculi) • Severe renal impairment • Malabsorption syndrome • Abnormal sensitivity to the toxic effects of Vitamin D • Sarcoidosis • Hypervitaminosis D.
WARNINGS AND PRECAUTIONS General Chronic or acute administration of excessive doses of cholecalciferol may lead to hypervitaminosis D, manifested by hypercalcemia and its sequelae. The therapeutic index of Vitamin D analogues is narrow and there is great interindividual variation in the dose that will lead to chronic toxicity.
GBUnited Kingdom· MHRA
6 products
Uses
GBOfficial regulatory label· revised September 6, 2024[2]
Treatment of Vitamin D deficiency. Prevention of Vitamin D deficiency in high-risk patients. As an adjunct to specific therapy for osteoporosis in patients with Vitamin D deficiency or at risk of Vitamin D insufficiency. Vitamin D3 800 IU Capsules are indicated in adults, the elderly and adolescents.
How to take
Sources & citations
[1]Health Canada (DPD) · 02442256 · revised September 8, 2025
[2]MHRA (UK) · PL303220022 · revised September 6, 2024
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
5 mg) in adults and 1000 IU (25 mcg) in children may result in hypervitaminosis. Other Vitamin D analogues with shorter duration of action may have a lower propensity to accumulate and to cause hypercalcemia. Cardiovascular Caution is required for patients receiving treatment for cardiovascular disease.
(See DRUG INTERACTIONS) Immune LUXA D should not be prescribed in patients with sarcoidosis, as there is increased conversion of vitamin D to its active metabolite. (See CONTRAINDICATIONS). High doses of Vitamin D can induce hypercalcemia and hypercalcuria.
Serum and urinary calcium levels sh ould be monitored. 4 Renal LUXA D should not be used in patients with severe renal impairment and should be used with caution in patients with mild and moderate impairment of renal function. (See CONTRAINDICATIONS).
The effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. There is no clear evidence for causation between vitamin D supplementation and renal stones, but the risk is plausible, especially in the context of concomitant calcium supplementation.
The need for additional calcium supplementation should be considered f or individual patients. Calcium supplements should be given under close medical supervision. During treatment, the serum and urinary calcium levels should be monitored and the kidney function checked by measurement of serum creatinine.
These checks are particularly important in concomitant treatment with diuretics. In the case of hypercalcaemia or signs of impaired kidney function, the dose must be reduced or treatment interrupted. 5 mmol/24 hours (300 mg/24 hours).
Vitamin D must be used with particular caution in patients with disturbed urinary excretion of calcium and phosphate, in treatment with benzothiadiazine derivatives. Plasma and urinary calcium levels should be monitored in these patients.
Endocrine and Metabolism Hypercalcemia Early symptoms of hypercalcemia may include weakness, fatigue, somnolence, headache, anorexia, dry mouth, metallic taste, nausea, vomiting, vertigo, tinnitus, ataxia and hypotonia. Later and possibly more serious manifestation include nephrocalcinosis, ren al dysfunction, osteoporosis in adults, impaired growth in children, anemia, metastatic calcification, pancreatitis, generalized vascular calcification and seizures.
Extreme hypercalcaemia may result in coma and death. Special Populations Pregnant Women The recommended daily dose of Vitamin D in pregnant women in Canada is 600 IU (15 mcg) daily. Studies have shown safe use of Vitamin D at doses up to 4000 IU (100 mcg) daily during pregnancy although studies in animals have shown reproductive toxicity.
Avoid the use of vitamin D in excess of the recommended dietary allowance during pregnancy unless potential benefits outweigh the possible adverse effects. Hypercalcemia during pregnancy may also lead to suppression of parathyroid hormone release in the neonate, resulting in hypocalcemia, tetany and seizures.
Severe deficiency of vitamin D during pregnancy can result in maternal osteomalacia and lead to significant morbidity in both mother and fetus. Breast-feeding The recommended daily dose of Vitamin D in nursing women is 600 IU (15 mcg).
Vitamin D and its metabolites are excreted in breast milk. However, Vitamin D may be deficient in maternal milk; therefore, breastfed infants may require supplementation. Use of excessive amounts of Vitamin D in nursing mothers may result in hypercalcemia in infants.
A daily dose of 4,000 IU (100 mcg) should not be exceeded. When prescribing additional vitamin D to a breast-fed child the practitioner should consider the dose of any additional vitamin D given to the mother. 5 Monitoring and Laboratory Tests: Periodic monitoring of serum calcium, phosphate, magnesium, and alkaline phosphatase is recommended for patients taking Vitamin D3.
75 mmol/L. The best indicator of vitamin D status is 25-hydroxyvitamin D or 25(OH)D serum concentration, as this level reflects total vitamin D exposure (from skin synthesis, food and supplements). However, there is no clinical benefit in monitoring vitamin D levels unless a clinical condition, such as malabsorption syndromes, chronic renal or liver failure, unexplained bone pain, unusual fractures, and other evidence of metabolic bone disorders, predisposes the patient to vitamin D deficiency.
Other clinical situations where vitamin D testing is indicated include hypo- or hypercalcemia/hyperphosphatemia, hypo-or hyperparathyroidism, unexplained increases in serum alkaline phosphatase or patients with symptoms suggesting hypervitaminosis D.
Posology Adults Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation. Vitamin D3 800 IU and 1,000 IU capsules are suitable for daily vitamin D supplementation. Dosage should be established by a physician.
Osteoporosis:
For the adjunct therapy of osteoporosis a daily dose of 800-1,000 IU. A daily doses equivalent of 2,000 IU vitamin D should be considered in fragile elderly patients who are at particular risk of falls and fractures. Patients should receive supplemental calcium if intake from diet is inadequate.
Vitamin D deficiency (serum levels < 25 nmol/l or < 10 ng/ml) in adults and the elderly: 800 IU-4,000 IU daily for up to 12 weeks depending upon the severity of the disease and the patient`s response to treatment. Vitamin D insufficiency (serum levels 25-50 nmol/l or 10-20 ng/ml) in adults and the elderly: AND Long term maintenance therapy following treatment of deficiency in adults and the elderly: AND Prevention of vitamin D deficiency: 800-1600 IU daily.
Vitamin D deficiency or insufficiency in adolescents 12-18 years: 800 IU daily depending on the severity of the disease and the patient`s response to treatment. Should only be given under medical supervision. Hepatic impairment: no dose adjustment is necessary for patients with hepatic impairment.
During vitamin D therapy, calcium and phosphor intake has fundamental significance with respect to the success of the treatment. Before starting the vitamin D therapy, the patient’s dietary habits should be carefully evaluated by the doctor and artificially added vitamin D content of certain food types should be taken into consideration.
, anticonvulsant medications, glucocorticoids) - Patients with malabsorption, including inflammatory bowel disease and coeliac disease - Those recently treated for vitamin D deficiency, and requiring maintenance therapy. 4). Paediatric population Vitamin D3 Capsules should not be used in children under 12 years.
Method of administration Oral The capsules should be swallowed whole (not chewed) with water.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised September 6, 2024[2]
The frequency of possible side effects listed below are defined as:
Very common (≥ 1/10) Common (≥ 1/100 to <1/10) Uncommon (≥ 1/1,000 to <1/100) Rare (≥ 1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Immune system disorders: Not known (cannot be estimated from the available data): Hypersensitivity reactions such as angio-oedema or laryngeal oedema.
Metabolism and nutrition disorders:
Uncommon: hypercalcaemia and hypercalciuria.
Skin and subcutaneous disorders:
Rare: Pruritus, rash and urticaria. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised September 6, 2024[2]
In the case of therapeutic treatment the dose should be established on an individual basis for the patients by regular checking of plasma calcium levels. During long-term treatment, serum calcium level, urinary calcium excretion and renal function should be monitored by measuring the serum creatinine level.
5), and in the case of hyperphosphataemia, as well as for patients with an increased risk of lithiasis. 5 mmol)/24 hours) or signs of impaired renal function the dose should be reduced or the treatment discontinued. Vitamin D should be used with caution in patients with impaired renal function.
In this case monitoring of calcium and phosphate levels is necessary, and the risk of soft tissue calcification should be taken into consideration. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D should be used.
Similar monitoring is necessary for children whose mother receive treatment with vitamin D in pharmacological amounts. Some children may react with increased sensitivity to the effect of vitamin D. Vitamin D3 Capsules should not be taken if pseudohypoparathyroidism is present (the need for vitamin D may be reduced by the sometimes normal sensitivity to vitamin D, with a risk of long-term overdose).
In such cases, more manageable vitamin D derivatives are available. Vitamin D3 Capsules should be used with caution in patients with sarcoidosis because of the risk of vitamin D’s increased transformation to its active form. Blood and urine calcium levels should be regularly monitored in these patients.
In the case of concomitant use with other medicinal product containing vitamin D, its vitamin D content should be taken into consideration. The concomitant use of multivitamin products and dietary supplements containing vitamin D should be avoided.
Medicinal products having effect through the inhibition of bone resorption decrease the calcium amounts derived from bone. In order to avoid this, as well as concomitantly to treatment with medicines enhancing bone development, it is necessary to take vitamin D and ensure proper calcium levels.
Paediatric population Vitamin D3 Capsules are not indicated for use in children under 12 years. This product contains sorbitol liquid partially dehydrated. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised September 6, 2024[2]
1. - Diseases/conditions associated hypercalcaemia and / or hypercalciuria. - Calcium nephrolithiasis, nephrocalcinosis, D- hypervitaminosis - Severe renal impairment.
This is not medical advice. Consult a qualified healthcare professional.