No active regulatory warningsFDA MedWatch, EMA EudraVigilance, WHO VigiBase, WADA Prohibited List · 2026-05-29
Updated: 2026-05-29 · v2.0 · Prof. G. Pkhakadze, MD, MPH, PhDCiteEditorial
📰Read the full Pine Bark Extract evidence review on GMJ News →Complete clinical article, references and updates on news.gmj.ge. This page is the structured safety summary.
1
Safe
Pine Bark Extract
Pinus pinaster (Pycnogenol)
Generally SafeModerateBotanicals
RDA
Typical 50–200 mg
Target
N/A
Upper limit
No UL
Products
3
Dosage by population group — reference
🔗 Best with: Grape Seed Extract, Vitamin C, Horse Chestnut✅ USP Verified, ConsumerLab Approved, Clean Label Project Certified
⚠ Patient buying generic 'pine bark extract' expecting Pycnogenol® results — evidence is brand-specific [1] [2]
⚠ Patient on anticoagulants adding Pycnogenol® — mild antiplatelet activity; monitor [1]
⚠ Patient using Pycnogenol® as sole CVI treatment instead of compression — it is adjunctive [1]
⚠ Patient expecting cognitive enhancement from Pycnogenol® — evidence limited to 1 small RCT [2]
🥗 Food first — build your daily Typical 50–200 mg
Check the foods you regularly eat — the bar fills toward your daily target.
Pine bark tea (traditional)20 mg OPCs (approximate equivalent)
Grape seed extract (similar OPCs)50 mg OPCs (approximate equivalent)
Dark chocolate (procyanidins)30 mg OPCs (approximate equivalent)
Cranberries (proanthocyanidins)25 mg OPCs (approximate equivalent)
0 mg OPCs (approximate equivalent)
Check your regular foods above
🔬 Lab interpreter
Recommended test
No routine monitoring required
Reference range / target
N/A
When to test
N/A
Monitor INR if on anticoagulants [1].
Full lab monitoring ↓
⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
Pine bark extract (Pycnogenol®) has its strongest evidence for CVI — genuine meta-analytic support from 7 RCTs. The critical caveat: nearly all evidence is brand-specific. Generic pine bark products are NOT interchangeable with Pycnogenol® and may have very different OPC profiles. For CVI, 100–360 mg/day for ≥4 weeks. Cost is a barrier ($30–60/month) [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 safety data. No published RCTs in pregnant women. Avoid during pregnancy and lactation [1].
👦 Pediatric: See guidance
Limited data. One ADHD pilot trial in children aged 6–14 used 1 mg/kg/day. Not established for routine pediatric use [2].
🏃 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: Take with or after meals to improve tolerability [1].
💊 With food: No specific requirements. Food reduces GI side effects [1].
🚫 Avoid: Concomitant use with immunosuppressants. High doses before surgery (antiplatelet effect). Pregnancy and lactation [1].
2 Which form?
FormBioavailabilityVeganCost
['Pycnogenol® (branded extract)', 'preferred', 'Standardized to 65–75% procyanidins. Virtually all clinical trial evidence uses this specific extract [1].']StandardCheck label
['Generic pine bark extract', 'common', 'Highly variable procyanidin content. No guarantee of bioequivalence with Pycnogenol®. Lower cost [2].']StandardCheck label
['Pine bark + grape seed combination', 'combination', 'Some products combine OPC sources. No head-to-head trials vs Pycnogenol® alone [2].']StandardCheck label
3 Common questions
Is generic pine bark extract the same as Pycnogenol®?
No. Pycnogenol® is a proprietary extract standardized to 65–75% procyanidins from French maritime pine, with specific manufacturing processes. Generic pine bark extracts may use different pine species, extraction methods, and have variable procyanidin content. Nearly all clinical evidence is specific to Pycnogenol® [1] [2].
How long does Pycnogenol take to work for CVI?
Clinical trials show measurable improvement in leg heaviness, edema, and pain within 4–8 weeks of consistent use at 100–360 mg/day [1].
Can Pycnogenol replace compression stockings for varicose veins?
No. Pycnogenol® is studied as an adjunct. Compression therapy remains first-line for CVI. Pycnogenol® may reduce symptoms but does not replace mechanical compression or address underlying venous reflux [1].
Is pine bark extract safe long-term?
Pycnogenol® has been studied in trials up to 12 months with a good safety profile. GI discomfort and headache are the most common adverse effects. Long-term safety beyond 1 year is not well-characterized [1].
4 Clinical evidence

Strong

Chronic venous insufficiency (CVI): meta-analysis of 7 RCTs (n=592) showed significant improvement in leg heaviness, edema, and pain with 100–360 mg/day Pycnogenol® over 4–12 weeks (WMD for edema: −3.3 cm ankle circumference reduction) [1]. HIGH

Moderate

Asthma (adjunct): 100 mg/day Pycnogenol® reduced rescue inhaler use and improved spirometry in 2 RCTs (n=130) as add-on to standard therapy [1]. Dysmenorrhea: 60 mg/day from ovulation to menses reduced pain scores in 2 RCTs vs placebo [1]. Skin photoprotection: 75–100 mg/day reduced UV-induced erythema (MED increase) in 2 small RCTs [2]. MODERATE

Insufficient

Cognitive enhancement: 1 small RCT in healthy adults showed improved sustained attention; replication needed [2]. ADHD in children: 1 pilot RCT (n=61) suggested benefit; confirmatory trials absent [2]. Erectile dysfunction: 1 RCT of Pycnogenol® + L-arginine showed improvement, but cannot isolate Pycnogenol® effect [2]. LOW
5 Safety, toxicity & adverse events

Relative

⚠ Concurrent anticoagulants — mild antiplatelet activity
⚠ Concurrent immunosuppressants — immunomodulatory effects
⚠ Concurrent antihypertensives — may lower blood pressure additively

🚩 Red flags

Patient on warfarin/antiplatelet drugs adding Pycnogenol® — monitor for bleeding [1]
Patient substituting generic pine bark for Pycnogenol® and expecting equivalent results [2]
Immunosuppressed patient taking Pycnogenol® — immunomodulatory risk [1]
6 Interactions

Drug interactions

Warfarin / Anticoagulants Moderate
Mechanism: OPCs inhibit platelet aggregation; additive anticoagulant effect [1].
Effect: Increased bleeding risk [1].
Action: Monitor INR. Consider avoiding combination at high doses [1].
ACE inhibitors / ARBs Moderate
Mechanism: Pycnogenol® has ACE-inhibitory activity [1].
Effect: Additive blood pressure reduction [1].
Action: Monitor blood pressure. May allow dose reduction of antihypertensive [1].

Supplement synergies

Vitamin C · 500 mg vitamin C with 100 mg Pycnogenol®
Vitamin C regenerates oxidized procyanidins, potentially enhancing antioxidant capacity [2].
L-Arginine · 1.7 g L-arginine + 40 mg Pycnogenol® TID
Pycnogenol® + L-arginine increased NO production and improved erectile function in 1 RCT [2].
7 Regulatory
United States (FDA): Available as dietary supplement. Pycnogenol® has self-affirmed GRAS status for food use. No FDA-approved health claims [1].
European Union (EFSA): Available as food supplement. No authorized health claims. EFSA rejected proposed antioxidant claims for insufficient evidence [1].
France: Pycnogenol® is approved as a pharmaceutical-grade product for CVI in some EU countries [1].
Japan: Available as a functional food ingredient. Popular in the Japanese supplement market [1].
8 US supplement products
3
on-market products containing Pine Bark Extract (NIH DSLD)

Brands carrying Pine Bark Extract (3)

Click a brand to see its Pine Bark Extract products.
Or browse all 3 products in one list →
9 Frequently paired with
Black Cohosh 1 sharedCat's Claw 1 sharedGrape Seed Extract 1 shared
Pine Bark Extract vs Grape Seed ExtractPine Bark Extract vs Vitamin C
10 Cite this page
Vancouver: Pkhakadze G. Pine Bark Extract — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Aug 15]. Available from: https://supplement.ge/ingredients/pine-bark-extract/
APA 7th: Pkhakadze, G. (2026). Pine Bark Extract — Safety profile. Public Health Institute of Georgia. https://supplement.ge/ingredients/pine-bark-extract/
📋 Editorial information
Author: Prof. G. Pkhakadze, MD, MPH, PhD
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. "Pine Bark Extract — Safety Profile." SupplementIndex, PHIG, 2026. https://supplement.ge/ingredients/pine-bark-extract/ 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