✓ No active regulatory warningsFDA MedWatch, EMA EudraVigilance, WHO VigiBase, WADA Prohibited List · 2026-05-29
📰Read the full Saffron Extract evidence review on GMJ News →Complete clinical article, references and updates on news.gmj.ge. This page is the structured safety summary.⚠ Meta-analysis: comparable to fluoxetine for mild-moderate depression [1]
⚠ SSRI-induced sexual dysfunction — unique therapeutic niche [2]
⚠ Adulteration is rampant — use certified extracts (Affron, SaffroMood) [1]
⚠ Fewer drug interactions than St. John's Wort (no CYP3A4 induction) [1]
ℹ️ Not obtained from food. Not applicable — this is not obtained from food in meaningful amounts; supplementation is the practical route.
🔬 Lab interpreter
ℹ️ No validated blood test. There is no established laboratory test to assess status or guide dosing for this ingredient. Clinical response and symptoms are the practical guide.
⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
Saffron 30 mg/day is one of the best-evidenced botanical antidepressants — meta-analysis comparable to SSRIs for mild-moderate depression. Also helps SSRI-induced sexual dysfunction (unique niche). ADULTERATION is rampant due to extreme cost — use certified extracts only. Fewer drug interactions than St. John's Wort [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
Culinary safe. Therapeutic doses — avoid (possible uterotonic) [1].
👦 Pediatric: See guidance
Limited data [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: 15 mg BID [1].
💊 With food: With or without food [1].
🚫 Avoid: High doses in pregnancy [1].
2 Which form?
| Form | Bioavailability | Vegan | Cost |
|---|---|---|---|
| ['Standardized saffron extract (Affron, SaffroMood)', 'preferred', 'Standardized to 3.5% lepticrosalides or equivalent. 30 mg/day [1].'] | Standard | Check label | |
| ['Saffron stigma extract', 'common', 'Various standardizations. 15 mg BID [1].'] | Standard | Check label |
3 Common questions
Is saffron really as good as SSRIs for depression? ▼
Multiple RCTs and a meta-analysis show 30 mg/day comparable to fluoxetine and citalopram for MILD-MODERATE depression [1]. NOT for severe depression. It's one of the best-evidenced botanical antidepressants, alongside St. John's Wort (which has more drug interaction concerns).
Adulteration concern? ▼
Saffron is the world's most expensive spice — adulteration is rampant. Cheap products may contain turmeric, safflower, or corn silk instead of actual saffron. Use certified, standardized extracts from reputable brands (Affron, SaffroMood) [1].
Can saffron help SSRI sexual side effects? ▼
Yes — an RCT showed saffron 30 mg/day improved sexual function in men taking fluoxetine [2]. This is a notable finding since SSRI-induced sexual dysfunction is common.
4 Clinical evidence
Strong
Meta-analysis of 5 RCTs: saffron 30 mg/day comparable to fluoxetine and citalopram for mild-moderate depression (HAM-D scores) [1]. Crocin and safranal modulate monoamine neurotransmitters — confirmed pharmacology [1]. HIGH
Moderate
SSRI-induced sexual dysfunction: saffron improved sexual function in men on fluoxetine (RCT) [2]. PMS: reduced PMS symptoms in 2 RCTs [2]. Age-related macular degeneration: 20 mg/day improved visual acuity in small trials [2]. Appetite/snacking: reduced snacking frequency in one RCT [2]. MODERATE
Insufficient
5 Safety, toxicity & adverse events
Absolute contraindications
✕ Pregnancy — high doses are uterine-stimulating and potentially abortifacient
Relative
⚠ Concurrent antidepressants — additive serotonergic effect
⚠ Bipolar disorder — theoretical mania risk
⚠ Doses well above culinary amounts (>5 g) are toxic
⚠ Antihypertensives/antiplatelets — additive effects
🚩 Red flags
● Adulterated product (cheap saffron = likely fake) [1]
● Patient on SSRIs adding saffron — monitor for serotonergic excess [1]
6 Interactions
Drug interactions
SSRIs Moderate
Mechanism: Additive serotonergic activity. [1]
Effect: Theoretical serotonin excess. Some trials combined safely. [1]
Supplement synergies
Omega-3 EPA · 1–2 g EPA
Complementary mechanisms for depression [1].
Complementary mechanisms for depression [1].
Rhodiola · 200–400 mg rhodiola
Different mood-supporting mechanisms [1].
Different mood-supporting mechanisms [1].
7 Regulatory
Iran: World's largest producer (90%+). Traditional medicine [1].
United States: Dietary supplement [1].
Australia: TGA-listed for mood support [1].
8 US supplement products
1
on-market products containing Saffron Extract (NIH DSLD)
Brands carrying Saffron Extract (1)
Click a brand to see its Saffron Extract products.
9 Cite this page
Vancouver: Pkhakadze G. Saffron Extract — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Aug 15]. Available from: https://supplement.ge/ingredients/saffron-extract/
APA 7th: Pkhakadze, G. (2026). Saffron Extract — Safety profile. Public Health Institute of Georgia. https://supplement.ge/ingredients/saffron-extract/
📋 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: 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. "Saffron Extract — Safety Profile." SupplementIndex, PHIG, 2026. https://supplement.ge/ingredients/saffron-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