Lycopene

Tetraterpene carotenoid; pigment of tomatoes, rosehip, watermelon and grapefruit; sold as a supplement and as the food colorant E160d; not registered as a medicine by AEMPS

ATC code: A11JA-LYCOPENE

Brand names: Lyc-O-Mato (LycoRed), NOW Lycopene, Nature's Way Lycopene

Updated 1 Jun 2026 · Methodology

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.

“Cardiovascular wellness” (marketing claim)

Not recommended

Lycopene is sold as a «vascular health support» on the back of observational data linking the Mediterranean diet with lower cardiovascular risk. Randomised controlled trials of isolated lycopene do not show a significant reduction in cardiovascular events. 2011 rejected health claims for lycopene and protection of from oxidation – the evidence base did not meet the regulatory threshold. 2021 builds primary prevention on , BP, lipid and glucose control and Mediterranean diet; in that framework tomatoes appear as ordinary food, not as a supplement. Regular consumption of tomatoes and tomato paste with olive oil is useful and safe; high-dose lycopene capsules are marketing.

Sources

“Prostate cancer prevention” (marketing claim)

Not recommended

Lycopene is the flagship supplement in the «tomatoes protect against prostate cancer» narrative. Observational studies in Mediterranean populations did link high tomato intake to lower prostate cancer rates. Randomised controlled trials did not confirm the signal: the systematic review by Kavanaugh 2007 found «very limited evidence», and the Cochrane review by Ilic 2011 did not confirm a risk reduction with lycopene supplements. rejected all lycopene health claims in 2011 and 2014, including «prostate protection». SEOM 2024 and AUA 2023 do not include lycopene in primary prostate cancer prevention. For men over 50, shared decision-making about PSA screening with a urologist, smoking cessation and obesity control are the relevant actions – not a lycopene supplement.

Sources

Benign prostatic hyperplasia

Not recommended

Lycopene is heavily marketed as a «prostate health support» for benign prostatic hyperplasia. No quality RCTs with urological endpoints (IPSS, post-void residual volume, flow rate) exist – only small trials with conflicting results. 2011 rejected health claims linking lycopene to prostate function. EAU 2024 and AEU 2023 do not include lycopene in BPH algorithms: the first line consists of alpha-blockers (tamsulosin, silodosin), 5-alpha-reductase inhibitors (finasteride, dutasteride) and, when indicated, PDE-5 inhibitors (tadalafil). Lower urinary tract symptoms require in-person urology assessment with PSA and ultrasound, not self-prescribed lycopene from iHerb.

Sources

ICD-10: N40 · ICD-11: GA90

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

Lycopene is an acyclic carotenoid with 11 conjugated double bonds. A strong antioxidant that scavenges singlet oxygen and peroxyl radicals. Among carotenoids lycopene is poorly absorbed from raw tomatoes and better absorbed from heat-processed products with fat (tomato paste, sauce with olive oil). It accumulates in the prostate, liver and skin. Putative cardioprotective mechanisms include antioxidant activity, inflammation modulation and a small reduction in oxidised . Clinically these mechanisms do not translate into meaningful reductions of cardiovascular events or prostate cancer.

Safety

Contraindications

Hypersensitivity to lycopene or tomatoes
Active gastrointestinal bleeding (potential mild antiplatelet effect at high doses)

Serious adverse effects

Allergic reactions in tomato-allergic individuals
Potentiation of anticoagulants at high doses (theoretical, isolated case reports)

Common adverse effects

Orange palms and soles (lycopenodermia) with prolonged high-dose use
Epigastric discomfort, heartburn
Flatulence, loose stools

Pregnancy: can you take Lycopene?

Safe in usual dietary amounts. AESAN does not recommend high-dose lycopene supplements in gestation – safety data are insufficient.

Breastfeeding: can you take Lycopene?

Compatible in usual dietary amounts. AESAN does not recommend high-dose supplements during lactation.

Calculate RID

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

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Frequently asked

What is Lycopene used for?

Lycopene is evaluated for the following indications with varying evidence strength: “Prostate cancer prevention” (marketing claim) (evidence tier D), Benign prostatic hyperplasia (evidence tier D), “Cardiovascular wellness” (marketing claim) (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Lycopene?

Common side effects of Lycopene (≥ 1 in 100): Orange palms and soles (lycopenodermia) with prolonged high-dose use, Epigastric discomfort, heartburn, Flatulence, loose stools. See the Safety section for uncommon and serious reactions.

Is Lycopene safe during pregnancy?

Safe in usual dietary amounts. AESAN does not recommend high-dose lycopene supplements in gestation – safety data are insufficient.

Is Lycopene compatible with breastfeeding?

Compatible in usual dietary amounts. AESAN does not recommend high-dose supplements during lactation.

Who should not take Lycopene?

Lycopene is contraindicated in: Hypersensitivity to lycopene or tomatoes; Active gastrointestinal bleeding (potential mild antiplatelet effect at high doses). Full list in the Safety section.

Other drugs in this group

Maca, Mixed tocopherols, Monolaurin (glycerol monolaurate), Mucuna pruriens (velvet bean), Pyrroloquinoline quinone (PQQ), Silicon (organic silicon, silica from horsetail or bamboo), Andrographis paniculata, Cordyceps (Cordyceps sinensis, Cordyceps militaris)