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📰Read the full Hawthorn evidence review on GMJ News →Complete clinical article, references and updates on news.gmj.ge. This page is the structured safety summary.⚠ Patient replacing ACE inhibitor or beta-blocker with hawthorn — hawthorn is adjunctive ONLY [1] [2]
⚠ Patient on digoxin adding hawthorn — pharmacodynamic interaction risk (both inotropic) [1]
⚠ Patient using hawthorn berry tea expecting HF benefit — sub-therapeutic; needs standardized extract [1]
⚠ Patient with NYHA III–IV HF taking hawthorn alone — evidence supports only mild HF; needs specialist care [2]
🥗 Food first — build your daily Typical 160–900 mg
Check the foods you regularly eat — the bar fills toward your daily target.
Hawthorn berries (fresh, 100 g)200 mg total flavonoids + OPCs (approximate)
Hawthorn berry tea (1 cup)30 mg total flavonoids + OPCs (approximate)
Hawthorn berry jam/syrup50 mg total flavonoids + OPCs (approximate)
Check your regular foods above
🔬 Lab interpreter
Recommended test
BNP/NT-proBNP (if HF)
BNP/NT-proBNP (if HF)
Reference range / target
Per HF management goals
Per HF management goals
Use for objective HF assessment rather than relying on subjective improvement [2].
Full lab monitoring ↓⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
Hawthorn is the most-studied botanical for heart failure — the SPICE trial (n=2,681) confirmed excellent safety but missed the cardiac mortality endpoint. Cochrane evidence supports functional improvement in mild HF. Commission E-approved for NYHA II in Germany. Key teaching: hawthorn is an ADJUNCT — never replace guideline-directed HF therapy. WS 1442 900 mg/day is the evidence-based formulation [1] [2].
1 How much do I need?
👤 Adults: Specific dosage data under clinical review
👴 Elderly: Specific dosage data under clinical review
🤰 Pregnancy: See guidance
Insufficient data. Uterotonic effects in animal studies. Avoid concentrated extracts in pregnancy [1].
👦 Pediatric: See guidance
Not studied in children. No established pediatric indications [1].
🏃 Athletes: Standard dose
⚖️ Obesity: Standard dose
Fat-soluble compounds may require dose adjustment in obesity.
🩺 Renal: Consult specialist
Dose adjustment may be needed in renal impairment.
🌱 Vegan: Standard dose
How to take
🍽 Timing: Twice daily (BID) with meals [1].
💊 With food: Take with food to improve tolerability [1].
🚫 Avoid: Using as sole HF treatment. Combining with digoxin without medical supervision. Non-standardized products [1].
2 Which form?
| Form | Bioavailability | Vegan | Cost |
|---|---|---|---|
| ['WS 1442 (standardized extract)', 'preferred', '900 mg/day, standardized to 18.75% OPCs. Used in SPICE and most major RCTs [1].'] | Standard | Check label | |
| ['LI 132 (standardized extract)', 'alternative', 'Standardized to 2.2% flavonoids. Used in several European RCTs [1].'] | Standard | Check label | |
| ['Hawthorn berry capsules (non-standardized)', 'common', 'Variable OPC content. Not equivalent to WS 1442 [1].'] | Standard | Check label | |
| ['Hawthorn tea (berry or leaf+flower)', 'traditional', "Mild effect. Traditional use for 'heart tonic.' Sub-therapeutic for HF [1]."] | Standard | Check label |
3 Common questions
Can hawthorn replace my heart medication? ▼
Absolutely not. The SPICE trial showed hawthorn did NOT reduce cardiac mortality as add-on therapy. It is studied as an adjunct, never a replacement for guideline-directed HF therapy (ACE inhibitors, beta-blockers, diuretics). German Commission E approves it only for NYHA Class II (mild HF), not for advanced disease [1] [2].
Why is hawthorn still recommended if the SPICE trial was negative? ▼
The SPICE trial missed its primary endpoint but confirmed excellent safety in 2,681 patients. Subgroup analysis suggested benefit in patients with LVEF 25–35% (39% reduction in sudden cardiac death). Earlier, smaller RCTs in mild HF showed functional improvements. The evidence supports hawthorn as a safe adjunct for mild HF, not as a primary treatment [1] [2].
How long before hawthorn works? ▼
Most trials show improvement in exercise tolerance and symptoms within 6–8 weeks. Unlike pharmaceutical inotropes, hawthorn has a slow onset [1].
Is hawthorn berry tea enough? ▼
Probably not. Tea provides modest flavonoid intake but far below the 900 mg/day WS 1442 (18.75% OPCs) used in clinical trials. For therapeutic intent, standardized extracts are necessary [1].
4 Clinical evidence
Strong
Heart failure (safety): the SPICE trial (n=2,681, 24 months, WS 1442 900 mg/day vs placebo in NYHA II–III HF patients on optimal medical therapy) demonstrated excellent safety — no increase in adverse events vs placebo. The primary endpoint (cardiac mortality reduction) was not met (p=0.209) [2]. HIGH
Moderate
Heart failure (functional): a Cochrane review (14 RCTs, n=855) found hawthorn extract significantly improved maximal workload (6-minute walk, bicycle ergometry) and reduced exercise-induced dyspnea and fatigue in mild HF patients [1]. Hypertension: WS 1442 reduced diastolic BP by ~2.6 mmHg vs placebo in a 16-week RCT of T2DM patients (n=79) [1]. LVEF 25–35% subgroup: SPICE post-hoc analysis showed a significant 39% reduction in sudden cardiac death in this subgroup (hypothesis-generating) [2]. MODERATE
Insufficient
5 Safety, toxicity & adverse events
Relative
⚠ Concurrent digoxin — additive cardiac effect (important)
⚠ Antihypertensives, nitrates, beta-blockers — additive cardiovascular effects
⚠ Heart failure — use only alongside, not instead of, prescribed therapy and with clinician oversight
🚩 Red flags
● Patient on digoxin adding hawthorn — both positive inotropes; monitor [1]
● Patient with advanced HF (NYHA III–IV) relying on hawthorn — needs specialist management [2]
● Patient replacing prescribed HF medications with hawthorn — life-threatening decision [1] [2]
6 Interactions
Drug interactions
Digoxin Major
Mechanism: Both hawthorn and digoxin are positive inotropes through different mechanisms (hawthorn: cAMP increase; digoxin: Na/K ATPase inhibition) [1].
Effect: Potential additive inotropic effect. No pharmacokinetic interaction but pharmacodynamic overlap [1].
Action: Monitor digoxin levels and cardiac function. Cardiologist oversight required [1].
ACE inhibitors / ARBs Moderate
Mechanism: Hawthorn has mild ACE-inhibitory activity [1].
Effect: Additive BP reduction. Usually beneficial in mild HF [1].
Action: Monitor BP. May be synergistic (beneficial) in mild HF [1].
Supplement synergies
Coenzyme Q10 · 100–300 mg CoQ10 + 900 mg hawthorn extract
CoQ10 supports mitochondrial energy production in cardiomyocytes; hawthorn improves cardiac function. Complementary cardiovascular support [1].
CoQ10 supports mitochondrial energy production in cardiomyocytes; hawthorn improves cardiac function. Complementary cardiovascular support [1].
Magnesium · 200–400 mg elemental Mg
Magnesium supports cardiac rhythm and vascular tone; deficiency worsens HF [1].
Magnesium supports cardiac rhythm and vascular tone; deficiency worsens HF [1].
7 Regulatory
Germany (Commission E): Approved for NYHA Class II heart failure (decreasing cardiac output). One of few botanicals with formal cardiac indication in a major regulatory system [1].
European Union (EMA): Traditional herbal medicinal product status for temporary relief of nervous cardiac complaints. Well-established use status for NYHA II HF [1].
United States (FDA): Available as dietary supplement. No FDA-approved health claims [1].
8 US supplement products
230
on-market products containing Hawthorn (NIH DSLD)
Brands carrying Hawthorn (115)
Click a brand to see its Hawthorn products.
9 Frequently paired with
10 Cite this page
Vancouver: Pkhakadze G. Hawthorn — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Aug 15]. Available from: https://supplement.ge/ingredients/hawthorn/
APA 7th: Pkhakadze, G. (2026). Hawthorn — Safety profile. Public Health Institute of Georgia. https://supplement.ge/ingredients/hawthorn/
📋 Editorial information
Author: Prof. G. Pkhakadze, MD, MPH, PhD
Institution: Public Health Institute of Georgia (PHIG)
Affiliation: David Tvildiani Medical University (DTMU)
First published: January 2026
Last reviewed: 2026-05-29
Next review: February 2027
References: 4 cited sources
COI: SupplementIndex receives no funding from supplement manufacturers. All content independently authored by PHIG.
Process: Systematic literature review
📄 License & reuse
Published under Creative Commons Attribution 4.0 International (CC BY 4.0). You may share and adapt for any purpose with attribution.
Pkhakadze G. "Hawthorn — Safety Profile." SupplementIndex, PHIG, 2026. https://supplement.ge/ingredients/hawthorn/ CC BY 4.0.
GP
Prof. G. Pkhakadze, MD, MPH, PhD
Professor of Public Health · Head of Department, DTMU
Editor-in-Chief, Georgian Medical Journal (ISSN 3088-4322)
Chair, Public Health Institute of Georgia · UEMS Public Health Section
Educational and public health purposes. CC BY 4.0. Consult your healthcare provider before starting any supplement. Corrections: info@accreditation.ge. Publisher: PHIG