Bilberry (Vaccinium myrtillus fruit extract)

Herbal preparation, EMA HMPC traditional herbal medicinal product

ATC code: A11JA-BILBERRY (Bilberry (Vaccinium myrtillus, fruit extract))

Brand names – supplements

Bilberry Extract, NOW Bilberry, Mirtoselect, Swanson Bilberry

Supplements are not tested in clinical trials and are not registered as medications.

Mechanism of action

Bilberry fruit contains anthocyanosides – 15 glycosides of cyanidin, delphinidin, malvidin and other anthocyanidins – the active constituents of 25% standardised extracts. Anthocyanosides scavenge free radicals in vitro, stabilise capillary collagen and elastin and reduce vascular permeability in animal experiments. In humans, oral bioavailability of anthocyanosides is low – under 1% – and plasma levels fall within 4–6 hours. HMPC in 2015 classified bilberry fruit extract as a traditional herbal medicinal product based on 30 years of use, not on clinical trial evidence.

Indications

Chronic venous insufficiency

Adjunct

Bilberry fruit extract received HMPC traditional-use status in 2015 for mild symptoms of chronic venous insufficiency – heavy and painful legs, oedema. The decision rests on 30 years of European use, not on large RCTs. The Cochrane review 2018 of herbal extracts in CVI found very low-quality evidence for bilberry anthocyanosides – the effect on symptoms is small and the difference vs placebo is clinically marginal. Spanish AEEV considers compression stockings and micronised diosmin/hesperidin first-line. If a clinician prescribed bilberry extract as monotherapy for CVI, consider seeking a second opinion – the efficacy is weakly supported. Add-on use with compression for mild symptoms is reasonable, but it does not replace compression therapy.

Sources

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.

Night vision improvement

Not recommended

Bilberry fruit extract is promoted to improve night vision and help the eyes adapt to the dark. It has not shown convincing benefit for this use: there is no solid evidence that it actually affects vision in low light. When night vision gets worse, the cause is worth checking with an ophthalmologist, since it may come from vitamin A deficiency, a retinal problem, or other conditions that have proven treatments. Bilberry should not replace a treatment with proven benefit, or you risk losing time on care that works.

Sources

Vision supplements (marketing category)

Not recommended

Bilberry fruit extract is sold as an eye-health supplement and marketed for visual acuity, night vision, and eye fatigue. There is no convincing evidence that it helps for this use. When vision is a concern, an eye exam and treating the actual cause work: correcting refraction with glasses or lenses, managing dry eye, monitoring the retina in diabetes or age-related changes. Do not take bilberry in place of treatment with proven benefit, since that risks leaving a real condition untreated.

Sources

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Safety

Contraindications

Known hypersensitivity to bilberry or other Vaccinium species
Age under 18 (EMA HMPC – no data)
Pregnancy and lactation for concentrated extracts

Serious adverse effects

Theoretical increased bleeding risk with concomitant anticoagulants or antiplatelet drugs – no clinical case reports

Common adverse effects

Mild dyspepsia
Loose stools
Dark discolouration of tongue and stool

PregnancyFDA N

Fresh bilberries in dietary amounts are safe in pregnancy. Concentrated 25% anthocyanoside extracts have not been studied in pregnancy RCTs; EMA HMPC advises avoiding them in pregnancy and lactation due to lack of data. AESAN classifies the preparation as a complemento alimenticio without therapeutic indication. Bilberry products marketed for vision are not justified in pregnancy.

Breastfeeding

Data on transfer of bilberry anthocyanosides into human milk are lacking. EMA HMPC advises avoiding concentrated extracts during lactation.

Calculate RID

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

Frequently asked

What is Bilberry (Vaccinium myrtillus fruit extract) used for?

Bilberry (Vaccinium myrtillus fruit extract) is evaluated for the following indications with varying evidence strength: Chronic venous insufficiency (evidence tier C), Night vision improvement (evidence tier D), Vision supplements (marketing category) (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Bilberry (Vaccinium myrtillus fruit extract)?

Common side effects of Bilberry (Vaccinium myrtillus fruit extract) (≥ 1 in 100): Mild dyspepsia, Loose stools, Dark discolouration of tongue and stool. See the Safety section for uncommon and serious reactions.

Is Bilberry (Vaccinium myrtillus fruit extract) safe during pregnancy?

FDA category N. Fresh bilberries in dietary amounts are safe in pregnancy. Concentrated 25% anthocyanoside extracts have not been studied in pregnancy RCTs; EMA HMPC advises avoiding them in pregnancy and lactation due to lack of data. AESAN classifies the preparation as a complemento alimenticio without therapeutic indication. Bilberry products marketed for vision are not justified in pregnancy.

Is Bilberry (Vaccinium myrtillus fruit extract) compatible with breastfeeding?

Data on transfer of bilberry anthocyanosides into human milk are lacking. EMA HMPC advises avoiding concentrated extracts during lactation.

Who should not take Bilberry (Vaccinium myrtillus fruit extract)?

Bilberry (Vaccinium myrtillus fruit extract) is contraindicated in: Known hypersensitivity to bilberry or other Vaccinium species; Age under 18 (EMA HMPC – no data); Pregnancy and lactation for concentrated extracts. Full list in the Safety section.

Mechanism of action

Indications

Chronic venous insufficiency

Adjunct

Sources

Safety

Contraindications

Known hypersensitivity to bilberry or other Vaccinium species
Age under 18 (EMA HMPC – no data)
Pregnancy and lactation for concentrated extracts

Serious adverse effects

Theoretical increased bleeding risk with concomitant anticoagulants or antiplatelet drugs – no clinical case reports

Common adverse effects

Mild dyspepsia
Loose stools
Dark discolouration of tongue and stool

PregnancyFDA N

Breastfeeding

Data on transfer of bilberry anthocyanosides into human milk are lacking. EMA HMPC advises avoiding concentrated extracts during lactation.

Calculate RID

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

Frequently asked

What is Bilberry (Vaccinium myrtillus fruit extract) used for?

What are the side effects of Bilberry (Vaccinium myrtillus fruit extract)?

Is Bilberry (Vaccinium myrtillus fruit extract) safe during pregnancy?

Is Bilberry (Vaccinium myrtillus fruit extract) compatible with breastfeeding?

Data on transfer of bilberry anthocyanosides into human milk are lacking. EMA HMPC advises avoiding concentrated extracts during lactation.

Who should not take Bilberry (Vaccinium myrtillus fruit extract)?