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Retinol

AEMPS

Fat-soluble vitamin A

ATC code: A11CA01

Brand names: Aquasol A

Updated · Methodology

Indications

A

Vitamin A deficiency

First line

First-line treatment for confirmed vitamin A deficiency. recommends oral 100 000 IU in infants aged 6–11 months and 200 000 IU in children over one year every 4–6 months in regions endemic for hypovitaminosis A, which lowers mortality from measles and diarrhoea. In adults with malabsorption (cystic fibrosis, coeliac disease, biliary obstruction, short bowel syndrome) AEMPS allows maintenance doses under serum retinol and liver function monitoring.

Sources

  1. AEMPS: Ficha tecnica de Auxina A Masiva (retinol) (2023)
  2. WHO: Guideline: Vitamin A supplementation in infants and children 6-59 months of age (2011)

ICD-10: E50 · ICD-11: 5B55

B

Mild acne

Second line

For mild acne, prescription retinoids (tretinoin, adapalene) remain the first choice of topical therapy ( 2024, ). Retinol is a weaker over-the-counter alternative: skin converts it to retinoic acid, but more slowly and less potently than prescription forms, and direct trials of retinol itself in acne are scarce, with evidence largely extrapolated from the retinoid class. Reasonable as an alternative for mild acne or poor tolerance of prescription forms. Dryness and flaking early on are an expected, manageable effect.

Sources

  1. Cochrane: Topical retinoids for acne vulgaris (2012)

ICD-10: L70.0 · ICD-11: ED80.0

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Anti-aging and longevity

Not recommended

Retinol capsules are sold as a skin rejuvenation or anti-aging tool. Oral retinol does not act on skin: tissue concentrations do not reach a level at which retinoic acid activates the renewal programme. That effect comes only from topical retinoids (tretinoin, retinol in cream form) used for many months. Oral high-dose retinol does not rejuvenate – it causes dry skin and hair loss and accumulates in the liver. If retinol capsules were recommended for rejuvenation, consider seeking a second opinion.

Sources

  1. AEMPS: Ficha tecnica de Auxina A Masiva (retinol) (2023)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Retinol is absorbed in the small intestine together with fats and bile acids and stored in hepatic stellate cells as retinyl palmitate. In tissues it is oxidised to retinal and retinoic acid, the active form. Retinoic acid binds nuclear RAR and RXR receptors and regulates transcription of more than 500 genes covering epithelial proliferation and differentiation, spermatogenesis, embryonic development, immune response and phototransduction (via 11-cis-retinal in rhodopsin).

Safety

Contraindications

  • Hypersensitivity to retinol
  • Pregnancy and preconception at doses above 3000 mcg RE/day
  • Hypervitaminosis A
  • Liver cirrhosis of any cause
  • Chronic kidney failure

Serious adverse effects

  • Hepatotoxicity with chronic high-dose intake
  • Idiopathic intracranial hypertension
  • Osteoporosis and fractures in older adults on long-term therapy
  • Teratogenicity in pregnancy
  • Acute vitamin A toxicity after a single dose above 500 000 IU

Common adverse effects

  • Dry skin and flaking
  • Hair loss
  • Cheilitis and angular fissures
  • Headache
  • Nausea

Pregnancy: can you take Retinol?

AEMPS summary of product characteristics (section 4.6): human experience shows that vitamin A causes congenital malformations when given during pregnancy, and the safety of doses above 6,000 IU a day in pregnancy has not been established. Doses above the recommended daily intake (2,500 IU a day in the USA) should be avoided in women who are pregnant or may become pregnant. Animal studies have shown reproductive toxicity; isolated reports describe teratogenic effects with doses above 25,000 IU a day in the first trimester, and the risk of miscarriage or congenital malformations may reach 100% in women taking therapeutic doses in the second month of pregnancy. Vitamin A 50,000 IU capsules are contraindicated during pregnancy and in women planning a pregnancy.

Breastfeeding: can you take Retinol?

Compatible at physiological doses (up to 3000 mcg RE/day). Hale L3 above the dietary reference intake. Retinol accumulates in breast milk. AEMPS advises not to exceed 3000 mcg/day in nursing women to avoid infant accumulation. Doses for confirmed deficiency are set by a clinician.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions5 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • MajorIsotretinoin
    «- Medicamentos análogos a vitamina A comoretinoides, tales como isotretinoína, tretinoína, bexaroteno, acitretina, etretinato, etc. : posible aumento de riesgo de toxicidad por vitamina A; se debe…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateanticoagulantesclass named in the label
    «- Anticoagulantes orales, como warfarina, acenocumarol o dicumarol: con la vitamina A, probable aumento del efecto anticoagulantey riesgo de hemorragia; se debe monitorizar por posibles signos.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateOrlistat
    «- Colestiramina, colestipol , orlistat ,a ceite mineral : posible reducción de la absorción de las vitaminas liposolubles como la A, con reducción de su eficacia; en su caso, se debe separar lo más…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateWarfarin
    «- Anticoagulantes orales, como warfarina, acenocumarol o dicumarol: con la vitamina A, probable aumento del efecto anticoagulantey riesgo de hemorragia; se debe monitorizar por posibles signos.»

    AEMPS, section 4.5 · Open on CIMA

  • Clopidogrel
    «- Antiagregantes plaquetarios , como: clopidogrel, eptifibatida, tirofiban: la administración concomitante con vitamina A puede causar un aumento del efecto anticoagulante, con incremento del riesgo…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Retinol used for?

Retinol is evaluated for the following indications with varying evidence strength: Vitamin A deficiency (evidence tier A), Mild acne (evidence tier B), Anti-aging and longevity (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Retinol?

Common side effects of Retinol (≥ 1 in 100): Dry skin and flaking, Hair loss, Cheilitis and angular fissures, Headache, Nausea. See the Safety section for uncommon and serious reactions.

Is Retinol safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): human experience shows that vitamin A causes congenital malformations when given during pregnancy, and the safety of doses above 6,000 IU a day in pregnancy has not been established. Doses above the recommended daily intake (2,500 IU a day in the USA) should be avoided in women who are pregnant or may become pregnant. Animal studies have shown reproductive toxicity; isolated reports describe teratogenic effects with doses above 25,000 IU a day in the first trimester, and the risk of miscarriage or congenital malformations may reach 100% in women taking therapeutic doses in the second month of pregnancy. Vitamin A 50,000 IU capsules are contraindicated during pregnancy and in women planning a pregnancy.

Is Retinol compatible with breastfeeding?

Compatible at physiological doses (up to 3000 mcg RE/day). Hale L3 above the dietary reference intake. Retinol accumulates in breast milk. AEMPS advises not to exceed 3000 mcg/day in nursing women to avoid infant accumulation. Doses for confirmed deficiency are set by a clinician.

Who should not take Retinol?

Retinol is contraindicated in: Hypersensitivity to retinol; Pregnancy and preconception at doses above 3000 mcg RE/day; Hypervitaminosis A; Liver cirrhosis of any cause; Chronic kidney failure. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

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