Evigrade

Black seed (Nigella sativa)

Botanical supplement, black seed oil (Nigella sativa, thymoquinone); no EMA HMPC monograph

ATC code: A11JA-NIGELLA(Black seed / nigella (Nigella sativa seed oil, thymoquinone))

Brand names – supplements: Amazing Herbs Black Seed Oil, Heritage Store Black Seed Oil, NOW Black Seed Oil Supplements are not tested in clinical trials and are not registered as medications.

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

Dyslipidemia

Not recommended

The Razmpoosh meta-analysis (Phytother Res 2019) pooled 17 RCTs with 1098 participants: at 1–3 g/day of oil or powder for 6–12 weeks in patients with dyslipidaemia, black seed reduced total cholesterol by a mean 0.4 mmol/L, by 0.3 mmol/L and triglycerides by 0.2 mmol/L versus placebo. The effect is smaller than with statins, methodology heterogeneous and risk of bias high. 2019 and Spanish SEA 2022 recommend statins as first line in confirmed cardiovascular risk. Black seed is not in international guidelines. If the oil was bought instead of a prescribed statin, discuss with a cardiologist; substitution in proven coronary disease raises the recurrent-infarct risk.

ICD-10: E78 · ICD-11: 5C80

D

Allergic rhinitis

Not recommended

Black seed is an over-the-counter supplement. In the Nikakhlagh RCT (Am J Otolaryngol 2011) in 66 patients with seasonal allergic rhinitis, black seed oil 0.5 mL/day for 6 weeks moderately reduced nasal congestion, itching and sneezing versus placebo. The effect was smaller than with intranasal steroids and antihistamines, the sample was small and methodology weak. No positive systematic review exists. ARIA 2020 and the Spanish SEAIC 2022 consensus recommend intranasal glucocorticoids (mometasone, fluticasone) and second-generation antihistamines (cetirizine, desloratadine) as first line in allergic rhinitis, plus allergen-contact control and immunotherapy when indicated. Black seed is not in international guidelines. If black seed oil was bought instead of the prescribed intranasal steroid, discuss with an allergist; the substitution is not justified.

ICD-10: J30.9 · ICD-11: CA08.0

D

Immune support and respiratory infection care

Not recommended

Black seed is marketed as an «immune booster», especially in halal and ayurvedic shops, and intensively after the COVID-19 pandemic as «natural protection against viruses». The evidence base is weak. Reviews by Tavakkoli 2017 and later summaries describe thymoquinone effects in vitro and in animal models of influenza, asthma, and COVID-19, but few high-quality human RCTs with hard endpoints (lab-confirmed infection rates, hospitalisation, symptom duration) exist, and those are methodologically weak: small samples, varied source material, open-label designs. Cochrane has not published a systematic review on Nigella sativa for cold or flu prevention or treatment. The Living Guidelines for COVID-19 (2023) and the Spanish SEIMC do not recommend black seed. Evidence-based seasonal measures are influenza and COVID-19 vaccination, hand hygiene, masking at peaks, sleep, and adequate dietary protein. If the product was bought «for immunity», consider seeking a second opinion – frequent infections, night sweats, or weight loss warrant assessment for haematological disease, HIV, or immunodeficiency rather than seed oil.

D

Superfoods and adaptogens (marketing category)

Not recommended

Black seed and black seed oil (Nigella sativa) are sold as a superfood and adaptogen, with promises of stronger immunity, more energy and overall wellbeing. There is no convincing evidence that it delivers these benefits in a healthy person: good-quality studies on this use have not been done. Sleep, regular movement and a varied diet support energy and resilience far more reliably than any single supplement. The seed itself, in culinary amounts, is safe.

D

Type 2 diabetes mellitus

Not recommended

Black seed is actively marketed as a «natural insulin alternative» and a remedy «instead of metformin». The Hadi 2021 meta-analysis (Pharmacol Res) of 16 RCTs in type 2 diabetes reported fasting glucose reductions of about 17 mg/dL and reductions of about 0.5%. The effect resembles a weak metformin dose, but methodology limits the conclusion: trials are short (8–12 weeks), populations are heterogeneous, doses ranged from 1 to 3 g/day, and most studies kept metformin and insulin in place – so the black-seed effect is additive. RCTs with hard endpoints (micro- and macrovascular complications, mortality) have not been performed. Standards of Care 2024 recommend metformin as first-line in most patients with type 2 diabetes, adding an SGLT2 inhibitor (empagliflozin, dapagliflozin) or GLP-1 receptor agonist (semaglutide, dulaglutide, liraglutide) in heart failure, chronic kidney disease, or atherosclerotic cardiovascular disease, and basal insulin at HbA1c above 10%. The Spanish redGDPS holds the same approach. Replacing metformin or insulin with black seed in type 2 diabetes worsens glycaemia and risks retinopathy, nephropathy, neuropathy, and cardiovascular events. If black seed was recommended as a substitute, consider seeking a second opinion – glycaemic targets in type 2 diabetes are reached with proven drugs.

ICD-10: E11 · ICD-11: 5A11

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 seed is an annual plant of the Ranunculaceae family cultivated in the Mediterranean, North Africa and the Middle East. Cold-pressed seed oil contains thymoquinone (0.5–2%) – the main active component with antioxidant and anti-inflammatory effects in vitro and in animal models. Small human RCTs show modest reductions in lipids, blood pressure and seasonal rhinitis symptoms, but methodology is weak, samples small and heterogeneity high. No HMPC monograph exists; in 2011 rejected all black seed health claims for insufficient cause-and-effect substantiation. AESAN classifies it as a complemento alimenticio without therapeutic indication. Traditional Arabic medicine describes it as a «cure for everything» («al-habba al-sawda» in Sahih al-Bukhari) – this is a religious and cultural text, not an evidence base.

Safety

Contraindications

  • Known hypersensitivity to black seed or Ranunculaceae
  • Use of warfarin, DOACs or antiplatelet drugs – thymoquinone moderately enhances anticoagulation
  • Severe hypotension
  • Diabetes on insulin or sulfonylurea – hypoglycaemia risk in combination

Serious adverse effects

  • Bleeding amplification when combined with anticoagulants and antiplatelet drugs
  • Severe hypoglycaemia when combined with insulin and sulfonylureas
  • Severe allergic reactions in sensitised users (rare)

Common adverse effects

  • Gastrointestinal discomfort, nausea and heartburn when taking oil on an empty stomach
  • Contact dermatitis with topical use
  • Blood-pressure reduction when combined with antihypertensives

Pregnancy: can you take Black seed (Nigella sativa)?

Black seed safety in human pregnancy has not been studied in RCTs. Traditional Arabic medicine uses food doses, but concentrated oil supplements may show uterotonic effects in animal experiments. EFSA has set no safe dose for pregnant women. AEMPS and AESAN advise against supplements without therapeutic indication during pregnancy.

Breastfeeding: can you take Black seed (Nigella sativa)?

Lactation safety has not been studied in RCTs. Black seed oil supplements are not justified 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 Black seed (Nigella sativa) used for?

Black seed (Nigella sativa) is evaluated for the following indications with varying evidence strength: Dyslipidemia (evidence tier C), Superfoods and adaptogens (marketing category) (evidence tier D), Allergic rhinitis (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Black seed (Nigella sativa)?

Common side effects of Black seed (Nigella sativa) (≥ 1 in 100): Gastrointestinal discomfort, nausea and heartburn when taking oil on an empty stomach, Contact dermatitis with topical use, Blood-pressure reduction when combined with antihypertensives. See the Safety section for uncommon and serious reactions.

Is Black seed (Nigella sativa) safe during pregnancy?

Black seed safety in human pregnancy has not been studied in RCTs. Traditional Arabic medicine uses food doses, but concentrated oil supplements may show uterotonic effects in animal experiments. EFSA has set no safe dose for pregnant women. AEMPS and AESAN advise against supplements without therapeutic indication during pregnancy.

Is Black seed (Nigella sativa) compatible with breastfeeding?

Lactation safety has not been studied in RCTs. Black seed oil supplements are not justified during lactation.

Who should not take Black seed (Nigella sativa)?

Black seed (Nigella sativa) is contraindicated in: Known hypersensitivity to black seed or Ranunculaceae; Use of warfarin, DOACs or antiplatelet drugs – thymoquinone moderately enhances anticoagulation; Severe hypotension; Diabetes on insulin or sulfonylurea – hypoglycaemia risk in combination. Full list in the Safety section.

Other drugs in this group

Nicotinamide mononucleotide (NMN), Olive leaf extract (Olea europaea, oleuropein), Omega-6 polyunsaturated fatty acids (linoleic acid and GLA), Omega-9 monounsaturated fatty acid (oleic acid), Resveratrol, Turkey tail (Trametes versicolor, Coriolus versicolor), Bilberry (Vaccinium myrtillus fruit extract), Eleutherococcus senticosus («Siberian ginseng»)