Cholecalciferol

ATC code

A11CC05

Therapeutic class

Vitamin D and analogues · Vitamin D and analogues

Forms

oral solution, oral drops, oral softgel, oral tablet, oral ampoule

Brand names

Colecalciferol Normon (ES) · Cholecalciferol Viatris (FR) · D3 Nature Made (US) · PNV-DHA (US)

Overall confidence

high

Regulatory sources consulted

ANSM RCP: CIS 69973217
AEMPS Ficha Técnica: 89368
openfda-label-57496cd3-7dc0-9f97-e063-6294a90ae2ef
PubMed PMID:38828931 ↗
PubMed PMID:38676447 ↗
PubMed PMID:34658250 ↗
PubMed PMID:40429738 ↗
OpenFDA · A11CC05
AEMPS CIMA · nº registro 89368 ↗
ANSM BDPM · CIS 69973217 ↗
RxNorm rxcui 2418 ↗

Approved indications

Treatment and/or prophylaxis of vitamin D deficiency.
Improving the nutritional status of women throughout pregnancy and in the postnatal period (as part of a multivitamin supplement).

Contraindications

Absolute

Hypersensitivity to cholecalciferol or any of the excipients.
Hypercalcaemia, hypercalciuria.
Calcium lithiasis (calcium kidney stones), nephrocalcinosis.
Hypervitaminosis D.

Clinical warnings

To avoid overdose, consider total vitamin D intake from all sources. At high doses, monitor serum calcium and calciuria. — ANSM
Use with caution in patients with sarcoidosis due to the risk of increased metabolism of vitamin D to its active form. — ANSM

Drug interactions

ModerateThiazide diureticsC03AA
Mechanism: Reduce urinary calcium excretion, increasing the risk of hypercalcaemia.
Recommendation: Monitor serum calcium levels regularly.
ANSM SPC
ModerateEnzyme-inducing anticonvulsantsN03A
Mechanism: Increase the metabolism of vitamin D, reducing its concentrations and effectiveness.
Recommendation: An increased dose of vitamin D may be necessary. Monitor 25(OH)D levels.
ANSM SPC
ModerateOrlistatA08AB01
Mechanism: Reduces the intestinal absorption of fat-soluble vitamins, including vitamin D.
Recommendation: Administer vitamin D at least 2 hours before or after Orlistat.
ANSM SPC

Adverse events

Common (≥1%)

hypercalcaemia · hypercalciuria

Rare but serious

nephrocalcinosis · renal failure · cardiac arrhythmia (from severe hypercalcaemia)

Pregnancy and lactation

Vitamin D overdose must be avoided during pregnancy. Supplementation is necessary, but high-dose formulations are not recommended. Cholecalciferol and its metabolites are excreted in breast milk.

Recent literature (PubMed)

Vitamin D for the Prevention of Disease: An Endocrine Society Clinical Practice Guideline.
Demay MB, et al. · J Clin Endocrinol Metab · 2024 · Relevance 5/5
Guía de práctica clínica de la Endocrine Society sobre el uso de vitamina D para reducir el riesgo de enfermedad en individuos sin indicaciones establecidas. Evalúa la evidencia de ensayos aleatorizados sobre la suplementación empírica.
Consensus Statement on Vitamin D Status Assessment and Supplementation: Whys, Whens, and Hows.
Giustina A, et al. · Endocr Rev · 2024 · Relevance 5/5
Declaración de consenso de la 6ª Conferencia Internacional sobre Controversias en Vitamina D. Discute el metabolismo, evaluación, acciones y suplementación, incluyendo los efectos extraesqueléticos y el debate sobre los niveles óptimos de 25(OH)D.
Sources of vitamin D for humans.
Benedik E · Int J Vitam Nutr Res · 2022 · Relevance 4/5
Revisión sobre las fuentes de vitamina D, incluyendo la síntesis endógena, fuentes dietéticas (animales, vegetales, alimentos fortificados) y suplementos. Destaca que es difícil alcanzar la ingesta adecuada solo con la dieta.
Type 1 Diabetes Mellitus and Vitamin D.
Durá-Travé T, et al. · Int J Mol Sci · 2025 · Relevance 3/5
Revisión narrativa sobre la asociación entre el estado de la vitamina D y la patogénesis de la diabetes tipo 1. Concluye que, aunque la deficiencia es prevalente en el debut de la DM1, el papel de la suplementación como terapia adyuvante muestra, como mucho, un efecto positivo a corto plazo.