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Beta-carotene

Provitamin A (plant precursor of retinol)

ATC code: A11CA02

Brand names: Beta-carotene, Lumitene

Updated · Methodology

Indications

A

Vitamin A deficiency

First line

Beta-carotene is used as a safe retinol alternative for vitamin A deficiency in pregnant women (high-dose retinol is teratogenic), patients with severe malabsorption (coeliac, cystic fibrosis, Crohn, post-bariatric) and people on diets low in animal products. 2011 recommends retinol as first choice in severe paediatric deficiency in developing countries; beta-carotene is an additional option in pregnancy and individual retinol intolerance.

Sources

  1. WHO: Guideline: Vitamin A supplementation in infants and children 6-59 months of age (2011)
  2. AEMPS: Ficha técnica de Carotaben (betacaroteno) (2022)

ICD-10: E50 · ICD-11: 5B55

B

Xerophthalmia (vitamin A deficiency with eye involvement)

Adjunct

Beta-carotene is a provitamin-A source, a supportive option for mild dietary vitamin A deficiency and for recovery after the acute phase, but not first-line for xerophthalmia. In Spain xerophthalmia occurs in patients with severe malabsorption; AEMPS registers Carotaben (50 mg capsules) mainly for erythropoietic protoporphyria, and it is used off-label in vitamin A deficiency. First-line for acute xerophthalmia is retinol, parenterally or orally (200 000 IU, 2011), repeated at day 1 and week 2; beta-carotene is unsuitable for the acute stage due to slow conversion. Maintenance beta-carotene after the acute phase is 15–30 mg/day.

Sources

  1. J Nutr: Provitamin A Carotenoid-Biofortified Maize Consumption Increases Pupillary Responsiveness among Zambian Children in a Randomized Controlled Trial. (2016)
  2. WHO: Guideline: Vitamin A supplementation in infants and children 6-59 months of age (2011)
  3. Adv Nutr: Effects of Food-Based Approaches on Vitamin A Status of Women and Children: A Systematic Review. (2023)

ICD-10: E50.7 · ICD-11: 5B55

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

Cancer prevention through supplements

Not recommended

Beta-carotene was marketed for decades as a «natural antioxidant» for cancer prevention. The ATBC trial (Finland, 1994, NEJM) in 29 133 smokers: beta-carotene 20 mg/day raised lung cancer incidence by 18% vs placebo. The CARET trial (USA, 1996, NEJM) in 18 314 smokers and asbestos workers was stopped early due to 28% higher lung cancer incidence and 17% higher all-cause mortality. Cochrane 2012 on antioxidants confirmed: beta-carotene increases all-cause mortality in non-deficient people. 2021 and SEA do not recommend antioxidant complexes for prevention. In smokers and former smokers beta-carotene >5 mg/day is contraindicated. If beta-carotene was recommended «for cancer prevention», consider seeking a second opinion.

Sources

  1. NEJM (ATBC Study Group): The effect of vitamin E and beta carotene on the incidence of lung cancer (1994)
  2. NEJM (CARET investigators): Effects of a combination of beta carotene and vitamin A on lung cancer (1996)
  3. Cochrane: Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases (2012)
  4. ESC: ESC Guidelines on cardiovascular disease prevention in clinical practice (2021)
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

Beta-carotene is the most studied carotenoid. In the small intestine β,β-carotene-15,15-monooxygenase cleaves each molecule into 2 retinol molecules. Conversion is feedback-regulated: with sufficient vitamin A stores, the body reduces conversion, so hypervitaminosis A from beta-carotene is essentially absent. In high doses beta-carotene itself shows pro-oxidant activity in oxygen-rich environments (smoker lung), explaining increased lung cancer risk in CARET and ATBC.

Safety

Contraindications

  • Current smoking or smoking within the last 10 years (lung cancer risk)
  • Occupational asbestos exposure
  • Hypersensitivity to beta-carotene

Serious adverse effects

  • Increased lung cancer risk in smokers and asbestos workers at doses >20 mg/day (CARET, ATBC)
  • Increased all-cause mortality in non-deficient people (Cochrane 2012)

Common adverse effects

  • Carotenodermia – yellow-orange discolouration of palms, soles and nasolabial folds (reversible, distinguishable from jaundice – sclerae stay white)
  • Yellowish tint of colostrum and breast milk
  • Loose stools

Pregnancy: can you take Beta-carotene?

Advantage over retinol: beta-carotene does not cause hypervitaminosis A and is not teratogenic, so it is the form used in pregnancy when needed. High doses (>30 mg/day) in pregnancy are not studied and not recommended.

Breastfeeding: can you take Beta-carotene?

Compatible (Hale L1). Beta-carotene enters milk and gives colostrum its yellowish tint – this is normal. Daily intake during lactation 1300 μg RAE (about 8 mg beta-carotene).

Calculate RID

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

Label mentions1 mention

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

From other drugs’ labels

  • Orlistat
    «DRUG INTERACTIONS: Fat-soluble Vitamin Supplements and Analogues: All patients should take a daily multivitamin that contains vitamins A, D, E, K, and beta-carotene. ( 7.2 )»

    FDA, section 7 · Open on DailyMed

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Frequently asked

What is Beta-carotene used for?

Beta-carotene is evaluated for the following indications with varying evidence strength: Vitamin A deficiency (evidence tier A), Xerophthalmia (vitamin A deficiency with eye involvement) (evidence tier B), Cancer prevention through supplements (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Beta-carotene?

Common side effects of Beta-carotene (≥ 1 in 100): Carotenodermia – yellow-orange discolouration of palms, soles and nasolabial folds (reversible, distinguishable from jaundice – sclerae stay white), Yellowish tint of colostrum and breast milk, Loose stools. See the Safety section for uncommon and serious reactions.

Is Beta-carotene safe during pregnancy?

Advantage over retinol: beta-carotene does not cause hypervitaminosis A and is not teratogenic, so it is the form used in pregnancy when needed. High doses (>30 mg/day) in pregnancy are not studied and not recommended.

Is Beta-carotene compatible with breastfeeding?

Compatible (Hale L1). Beta-carotene enters milk and gives colostrum its yellowish tint – this is normal. Daily intake during lactation 1300 μg RAE (about 8 mg beta-carotene).

Who should not take Beta-carotene?

Beta-carotene is contraindicated in: Current smoking or smoking within the last 10 years (lung cancer risk); Occupational asbestos exposure; Hypersensitivity to beta-carotene. Full list in the Safety section.

Other drugs in this group

Beta-1,3/1,6-D-glucan (yeast or oat), Bilberry (Vaccinium myrtillus fruit extract), Biotin, L-threonine + pyridoxine (Biotredin), Diindolylmethane (DIM), Myo-inositol, Pyridoxine (vitamin B6), Tocotrienols