Evigrade

Hawthorn (Crataegus monogyna / laevigata)

Medicinal plant; EMA HMPC well-established use for mild nervous tension and traditional use in mild chronic heart failure; standardised WS 1442 extract (Crataegutt)

ATC code: C01EB-HAWTHORN(Hawthorn (Crataegus monogyna, C. laevigata))

Brand names: HeartCare (Nature's Way, standardised WS 1442), Crataegus Comp. (Weleda), Hawthorn Berry (Gaia Herbs)

Updated · 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.

C

Symptoms of mild heart failure (NYHA II)

Not recommended

Hawthorn is a herbal product with HMPC traditional use for mild chronic heart failure symptoms (NYHA I–II) in patients in whom severe pathology has been excluded. The Cochrane 2008 review reported moderate improvement in exercise tolerance and dyspnoea. The large SPICE trial (Holubarsch 2008, n = 2681, NYHA II–III) gave the headline result: WS 1442 does not reduce cardiovascular mortality on top of standard therapy. The HF 2021 guideline does not include hawthorn in the chronic heart failure treatment algorithm. Hawthorn does not replace ACE inhibitors, beta-blockers, mineralocorticoid antagonists or SGLT2 inhibitors. If hawthorn was offered as a substitute for standard therapy, consider seeking a second opinion from a cardiologist.

ICD-10: I50.9 · ICD-11: BD1Z

D

Mild arterial hypertension

Not recommended

Hawthorn is popular in Spain and Russia as a «mild remedy for blood pressure». The small Walker 2006 trial in patients with type 2 diabetes and hypertension reported a minor diastolic BP reduction of about 3 mmHg with 1000 mg/day extract over 16 weeks – clinically marginal. No systematic review confirms an antihypertensive effect. 2024 and SEH-LELHA 2022 guidelines do not include hawthorn in initial or maintenance hypertension therapy. Substituting hawthorn for ACE inhibitors, ARBs, thiazide diuretics or calcium channel blockers is not justified. If BP remains uncontrolled, discuss standard pharmacotherapy with a general practitioner or cardiologist.

ICD-10: I10 · ICD-11: BA00.Z

D

Stress and anxiety

Not recommended

Hawthorn tincture sits under HMPC as traditional use for mild nervous tension and sleep disturbances, usually in combinations with valerian, passionflower and lemon balm. No quality RCTs of hawthorn alone in anxiety disorders exist; the perceived effect mostly reflects the ritual of taking the product and the herbal combination. AEMPS registers these combinations as traditional herbal medicines – a status, not evidence of efficacy by modern standards. For pronounced or persistent anxiety, the evidence supports psychotherapy and, when indicated, physician-prescribed SSRIs or SNRIs. If hawthorn was offered as a substitute for anxiety treatment, consider seeking a second opinion from a psychiatrist or psychotherapist.

ICD-10: F41.9 · ICD-11: 6B0Z

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

The standardised hawthorn leaf and flower extract (WS 1442) contains oligomeric procyanidins and flavonoids (hyperoside, vitexin, rutin). Preclinical work shows mild phosphodiesterase III inhibition, increased myocardial Ca2+ sensitivity and a longer refractory period, producing weak inotropic and antiarrhythmic effects in experimental models. NO-dependent vasodilation of coronary arteries and antioxidant activity have also been described. Clinical effects are modest: WS 1442 yields a small improvement in exercise tolerance in mild CHF but does not affect cardiovascular mortality.

Safety

Contraindications

  • Severe chronic heart failure (NYHA III–IV) – requires standard therapy, not hawthorn
  • Pregnancy and lactation
  • Age under 12 years
  • Hypersensitivity to hawthorn or other Rosaceae plants

Serious adverse effects

  • Potentiation of digoxin and cardiac glycosides with risk of arrhythmia
  • Potentiation of beta-blockers and calcium channel blockers with bradycardia and hypotension
  • Heart failure decompensation when standard therapy is replaced with hawthorn

Common adverse effects

  • Nausea, epigastric discomfort
  • Dizziness
  • Allergic skin reactions

Pregnancy: can you take Hawthorn (Crataegus monogyna / laevigata)?

Adequate safety data in pregnancy are lacking. EMA HMPC and AEMPS do not recommend hawthorn extracts during gestation due to insufficient data.

Breastfeeding: can you take Hawthorn (Crataegus monogyna / laevigata)?

No milk transfer data are available. EMA HMPC and AEMPS do not recommend use during lactation.

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 Hawthorn (Crataegus monogyna / laevigata) used for?

Hawthorn (Crataegus monogyna / laevigata) is evaluated for the following indications with varying evidence strength: Symptoms of mild heart failure (NYHA II) (evidence tier C), Mild arterial hypertension (evidence tier D), Stress and anxiety (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Hawthorn (Crataegus monogyna / laevigata)?

Common side effects of Hawthorn (Crataegus monogyna / laevigata) (≥ 1 in 100): Nausea, epigastric discomfort, Dizziness, Allergic skin reactions. See the Safety section for uncommon and serious reactions.

Is Hawthorn (Crataegus monogyna / laevigata) safe during pregnancy?

Adequate safety data in pregnancy are lacking. EMA HMPC and AEMPS do not recommend hawthorn extracts during gestation due to insufficient data.

Is Hawthorn (Crataegus monogyna / laevigata) compatible with breastfeeding?

No milk transfer data are available. EMA HMPC and AEMPS do not recommend use during lactation.

Who should not take Hawthorn (Crataegus monogyna / laevigata)?

Hawthorn (Crataegus monogyna / laevigata) is contraindicated in: Severe chronic heart failure (NYHA III–IV) – requires standard therapy, not hawthorn; Pregnancy and lactation; Age under 12 years; Hypersensitivity to hawthorn or other Rosaceae plants. Full list in the Safety section.

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