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Elderberry (Sambucus nigra)

Plant immunomodulator, supplement. In EU – traditional herbal medicinal product (EMA HMPC monograph on flowers, berries classified as food)

ATC code: A11JA-ELDERBERRY

Brand names – supplements: Now Elderberry, Nature's Way Sambucus, Sambucol, Gaia Herbs Black ElderberrySupplements are not tested in clinical trials and are not registered as medications.

Updated · Methodology

Indications

C

Influenza

Adjunct

Black elderberry as Sambucol syrup is positioned for influenza. The original Zakay-Rones 2004 RCT in 60 patients with lab-confirmed influenza A/B showed 4-day symptom duration reduction vs placebo with 15 mL syrup four times daily for 5 days. The Hawkins 2019 meta-analysis included this trial plus 3 more RCTs. Limitations: small samples, single-centre design, potential conflict of interest. 2018 in confirmed influenza in patients with risk factors (age ≥65, pregnancy, immunosuppression, chronic disease) lists oseltamivir within 48 hours of symptom onset first-line; elderberry is in the «complementary, evidence limited» category. In Austria Sambucol was registered in 2024 as an OTC product with «cold and flu» indication. If elderberry was recommended as a substitute for oseltamivir in a high-risk patient, consider seeking a second opinion.

Sources

  1. J Int Med Res: Randomised study of the efficacy and safety of oral elderberry extract in the treatment of influenza A and B virus infections (2004)
  2. Complement Ther Med: Black elderberry (Sambucus nigra) supplementation effectively treats upper respiratory symptoms: meta-analysis of randomised controlled trials (2019)
  3. IDSA: Clinical practice guidelines by the Infectious Diseases Society of America: 2018 update on diagnosis, treatment, chemoprophylaxis and institutional outbreak management of seasonal influenza (2018)
  4. Cochrane: Interventions for treating influenza in adults and children: complementary therapies review (2024)

ICD-10: J10-J11 · ICD-11: 1E32

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.

D

Common cold

Not recommended

Black elderberry is widely sold as a «natural cold remedy» promising to shorten URI duration. The Hawkins 2019 meta-analysis in 180 patients across 4 RCTs showed moderate 2–4 day symptom duration reduction with Sambucol syrup started in the first hours of illness. Evidence quality is limited by small samples, heterogeneous methods and potential conflicts of interest (some trials sponsored by the manufacturer). The updated Cochrane 2024 review on flu and cold rated the data as mixed evidence: small effect, uncertain clinical relevance. AAFP 2019 and SEIMC 2020 for the common cold list paracetamol for fever, fluids, rest, nasal saline irrigation first-line; elderberry is not in international guidelines. If elderberry was recommended as a substitute for symptomatic therapy or for antibiotic in bacterial superinfection, consider seeking a second opinion.

Sources

  1. Complement Ther Med: Black elderberry (Sambucus nigra) supplementation effectively treats upper respiratory symptoms: meta-analysis of randomised controlled trials (2019)
  2. Nutrients: Elderberry supplementation reduces cold duration and symptoms in air-travellers: a randomised, double-blind placebo-controlled trial (2016)
  3. AAFP: Common cold: diagnosis and treatment (2019)
  4. SEIMC: Documento de consenso sobre el manejo del resfriado común (2020)

ICD-10: J00 · ICD-11: CA00

D

Immune support and respiratory infection care

Not recommended

Black elderberry is sold as an «immunity booster» promising URI prophylaxis. The Tiralongo 2016 RCT in 312 air-travellers showed moderate reduction in cold duration and severity with elderberry taken 10 days before and during the flight, but no reduction in incidence. HMPC 2013 recognises elder flowers as a traditional herbal medicinal product, not a prophylactic. approved no «immunity» health claim for elderberry. For influenza prevention CDC and ECDC recommend annual vaccination in all aged ≥6 months; elderberry is not in international prophylaxis guidelines. If elderberry was recommended as a vaccination substitute or in an immunocompromised patient, consider seeking a second opinion.

Sources

  1. EMA HMPC: Community herbal monograph on Sambucus nigra L., flos (2013)
  2. Nutrients: Elderberry supplementation reduces cold duration and symptoms in air-travellers: a randomised, double-blind placebo-controlled trial (2016)
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

Black elderberry berries contain anthocyanins (cyanidin-3-glucoside, cyanidin-3-sambubioside), flavonoids (quercetin, rutin), phenolic acids and vitamin C. In vitro extracts suppress influenza A and B virus haemagglutination, block sialic acid receptor binding and inhibit neuraminidase. In cell models anthocyanins increase pro-inflammatory cytokine synthesis (IL-6, IL-8, TNF-α) in monocytes. The human mechanism in supplement doses (10–15 mL syrup) is not clinically confirmed – anthocyanin pharmacokinetics in humans are limited by low bioavailability (<1%). HMPC 2013 recognised elder flowers as a traditional herbal medicinal product for the common cold based on 30 years of traditional use, without requiring efficacy evidence.

Safety

Contraindications

  • Pregnancy and lactation
  • Children under 12 (EMA HMPC – insufficient data)
  • Active autoimmune disease (theoretical Th1 cytokine activation risk)
  • Immunosuppressant therapy (ciclosporin, tacrolimus, methotrexate, biologics) – theoretical antagonism
  • Allergy to Caprifoliaceae family plants
  • Raw berries, leaves, bark, roots (contain cyanogenic glycosides, poisoning risk)

Serious adverse effects

  • Cyanide poisoning from consumption of raw berries, leaves, bark or roots (nausea, vomiting, weakness, tachycardia, seizures in severe cases)
  • Anaphylactic reactions (rare)
  • Masking of flu symptoms and delayed antiviral therapy in high-risk patients

Common adverse effects

  • Nausea
  • Diarrhoea
  • Abdominal pain
  • Allergic reactions (urticaria, skin rash)

Pregnancy: can you take Elderberry (Sambucus nigra)?

No RCT data in pregnancy. EMA HMPC 2013 lists pregnancy as contraindication for the traditional herbal product due to lack of safety data. Raw berries and leaves contain cyanogenic glycosides (sambunigrin) with intoxication risk – avoid in pregnancy.

Breastfeeding: can you take Elderberry (Sambucus nigra)?

No data on transfer of anthocyanins and other elderberry components into breast milk. EMA HMPC 2013 lists lactation as contraindication. Lactating women should avoid.

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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 Elderberry (Sambucus nigra) used for?

Elderberry (Sambucus nigra) is evaluated for the following indications with varying evidence strength: Influenza (evidence tier C), Immune support and respiratory infection care (evidence tier D), Common cold (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Elderberry (Sambucus nigra)?

Common side effects of Elderberry (Sambucus nigra) (≥ 1 in 100): Nausea, Diarrhoea, Abdominal pain, Allergic reactions (urticaria, skin rash). See the Safety section for uncommon and serious reactions.

Is Elderberry (Sambucus nigra) safe during pregnancy?

No RCT data in pregnancy. EMA HMPC 2013 lists pregnancy as contraindication for the traditional herbal product due to lack of safety data. Raw berries and leaves contain cyanogenic glycosides (sambunigrin) with intoxication risk – avoid in pregnancy.

Is Elderberry (Sambucus nigra) compatible with breastfeeding?

No data on transfer of anthocyanins and other elderberry components into breast milk. EMA HMPC 2013 lists lactation as contraindication. Lactating women should avoid.

Who should not take Elderberry (Sambucus nigra)?

Elderberry (Sambucus nigra) is contraindicated in: Pregnancy and lactation; Children under 12 (EMA HMPC – insufficient data); Active autoimmune disease (theoretical Th1 cytokine activation risk); Immunosuppressant therapy (ciclosporin, tacrolimus, methotrexate, biologics) – theoretical antagonism; Allergy to Caprifoliaceae family plants. Full list in the Safety section.

Other drugs in this group

Eleutherococcus senticosus («Siberian ginseng»), Fisetin (flavonol from strawberries, mangoes and onions), Grape seed extract (Vitis vinifera, oligomeric proanthocyanidins), Horsetail, Nicotinamide, Reishi (Ganoderma lucidum, lingzhi), Tribulus terrestris (puncture vine), Beta-1,3/1,6-D-glucan (yeast or oat)