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 Black Seed / Nigella evidence review on GMJ News →Complete clinical article, references and updates on news.gmj.ge. This page is the structured safety summary.
2
Conditional
Black Seed / Nigella
Nigella sativa (thymoquinone)
Conditionally SafeModerateBotanicals
RDA
Typical 500–2,000 mg
Target
Improvement from baseline
Upper limit
No UL
Products
Dosage by population group — reference
🔗 Best with: Turmeric / Curcumin, Honey (Manuka), Berberine✅ USP Verified, ConsumerLab Approved, Clean Label Project Certified
⚠ Anticoagulant + antiplatelet interaction [1]
⚠ Diabetes medications + Nigella — additive glucose lowering [2]
⚠ Effects are real but MODEST — manage expectations [2]
⚠ Concentrated extracts in pregnancy — caution (uterotonic) [1]
ℹ️ Not obtained from food. Not applicable — this is not obtained from food in meaningful amounts; supplementation is the practical route.
🔬 Lab interpreter
Recommended test
FBG, HbA1c, lipid panel
Reference range / target
Improvement from baseline
When to test
8–12 weeks [2].
Modest improvements expected [2].
Full lab monitoring ↓
⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
Black seed (Nigella sativa) thymoquinone has the broadest pharmacological profile of any single plant compound. Meta-analyses confirm modest benefits for glucose (FBG −17.8, HbA1c −0.71%), lipids, BP, and weight. Traditional 'cure for everything except death' is overstated but the compound IS remarkably versatile. Effects are MODEST, not miraculous [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
Food spice safe. Concentrated extracts — avoid (possible uterotonic) [1].
👦 Pediatric: See guidance
Traditional food use safe. Supplement data limited [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: With meals [1].
💊 With food: Seeds with food. Oil can be taken alone or with food [1].
🚫 Avoid: Anticoagulants without monitoring. Concentrated extracts in pregnancy [1].
2 Which form?
FormBioavailabilityVeganCost
['Nigella sativa oil (cold-pressed)', 'common', 'Contains 0.5–1.5% TQ. 1–3 mL/day [1].']StandardCheck label
['TQ-standardized extract', 'preferred', 'Higher TQ content. 200–500 mg/day [2].']StandardCheck label
['Whole black seeds', '', 'Traditional. 1–3 g/day. Peppery taste [1].']StandardCheck label
3 Common questions
Is it really 'a cure for everything'?
Thymoquinone has remarkably broad pharmacological activity in preclinical models. Meta-analyses confirm modest human benefits for glucose, lipids, BP, and weight — but effects are MODEST, not miraculous. The traditional reputation exceeds the clinical evidence [1] [2].
Seeds vs oil vs extract?
Seeds: traditional, culinary, lowest TQ. Oil: moderate TQ. Standardized extract: highest TQ, most consistent dosing [1] [2].
4 Clinical evidence

Strong

Thymoquinone pharmacology: NF-κB inhibition, antioxidant (SOD/catalase upregulation), pro-apoptotic in cancer cell lines [1]. HIGH

Moderate

Blood glucose: meta-analysis of 17 RCTs showed FBG −17.8 mg/dL and HbA1c −0.71% [2]. Lipids: meta-analysis showed modest TC, LDL, TG reduction [2]. Blood pressure: ~3 mmHg SBP reduction [2]. Body weight: ~2 kg over 8–12 weeks [2]. Helicobacter pylori: some trials show improved eradication when added to triple therapy [1]. MODERATE

Insufficient

Cancer treatment (human) [1]. Alzheimer's [1]. Asthma [1]. Male fertility [1]. COVID-19 [1]. Despite extensive preclinical promise, human outcome data are limited [2]. LOW
5 Safety, toxicity & adverse events

Relative

⚠ Antidiabetics and antihypertensives — additive lowering
⚠ Anticoagulants/antiplatelets — bleeding risk
⚠ May induce/inhibit CYP enzymes — caution with narrow-window drugs
⚠ Pregnancy — high doses may be uterine-stimulating

🚩 Red flags

Anticoagulant patient [1]
Diabetes medications without glucose monitoring [2]
6 Interactions

Drug interactions

Anticoagulants Moderate
Mechanism: TQ has antiplatelet effects. [1]
Effect: Bleeding risk. [1]
Action: Monitor [1].
Diabetes medications Moderate
Mechanism: Additive glucose lowering. [2]
Effect: Hypoglycemia. [2]
Action: Monitor glucose [2].

Supplement synergies

Honey · 1–2 tsp honey
Traditional Islamic medicine combination (Habbatus Sauda + honey) [1].
7 Regulatory
Islamic world: Traditional medicine (Tibb-un-Nabawi/Prophetic medicine) [1].
India: Unani and Ayurvedic medicine (kalonji) [1].
United States: GRAS (food). Dietary supplement [1].
Black Seed / Nigella vs Turmeric / CurcuminBlack Seed / Nigella vs Honey
8 Cite this page
Vancouver: Pkhakadze G. Black Seed / Nigella — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Aug 19]. Available from: https://supplement.ge/ingredients/black-seed-nigella/
APA 7th: Pkhakadze, G. (2026). Black Seed / Nigella — Safety profile. Public Health Institute of Georgia. https://supplement.ge/ingredients/black-seed-nigella/
📋 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: 2 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. "Black Seed / Nigella — Safety Profile." SupplementIndex, PHIG, 2026. https://supplement.ge/ingredients/black-seed-nigella/ 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