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What is the safe therapeutic dose range of saffron for adults and signs of toxicity?
Executive summary
Clinical trials and reviews report typical therapeutic saffron doses for adults in the range of about 20–400 mg/day, with many clinical studies and product guides centering on 30–100 mg/day and common effective trial doses of 30–50 mg/day [1] [2] [3]. Toxicity is reported at much higher intakes: adverse effects begin around grams per day (1.2–5 g) and death has been associated with very large doses (≈20 g/day) in older reviews [4] [5] [6].
1. What researchers actually tested: the trial dose window
Randomized and clinical trials of saffron most often used very small extract doses — many trials used single-digit to low-hundreds of milligrams per day. Reported trial ranges include about 20–400 mg/day, and meta-analyses often highlight 30 mg/day as a commonly studied antidepressant dose; several reviews summarize typical effective trial doses at roughly 30–50 mg/day [1] [2] [3]. Nutrition and supplement guides echo that clinical work has concentrated on the 30–100 mg/day range for mood and eye‑health outcomes [7] [8].
2. What safety summaries and health sites say about “safe” daily use
Authoritative consumer-facing sources mark saffron as “possibly safe” when taken as medicine up to about 100 mg daily for limited durations (for example, up to 26 weeks cited by WebMD) and note that clinical work has used doses up to several hundred milligrams [6] [1]. Several product and review sites extend the upper “considered safe” boundary to 1.5 g/day based on toxicology summaries, but they also caution that most benefits were shown at far lower doses [1] [9] [3].
3. When toxicity shows up: the gram‑level problem
Toxic effects are reported only at much higher intakes than trial doses. Multiple reviews and toxicology papers report gastrointestinal upset (nausea, vomiting, diarrhea), bleeding, uterine stimulation/abortifacient effects, dizziness and, in extreme cases, death at gram‑level intakes. Human reports cite nausea, vomiting, diarrhea and bleeding with doses between about 1.2 and 2 g, while several reviews flag toxic effects around ≥5 g/day and possible lethality at very large doses (≈20 g/day) [4] [5] [10].
4. Specific laboratory and clinical signals of harm to watch for
Subacute and repeated higher doses in humans and animals have been linked to changes in blood counts and some biochemical markers: declines in red blood cell/hemoglobin/hematocrit and platelets were noted in subacute studies, and high experimental doses produced organ‑level effects in animals. Reviews advise particular caution in pregnancy because high doses can stimulate uterine contractions and increase miscarriage risk [11] [4] [5] [3].
5. Practical guidance and common product claims — where sources diverge
Commercial guides and blogs commonly recommend a practical daily supplement range of roughly 30–100 mg, sometimes promoting 80–100 mg as “ideal,” while other consumer sites emphasize that benefits are seen from as little as 30 mg and that higher doses (100–400 mg) have been trialed for other conditions [8] [7] [9]. Toxicology reviews and clinical safety summaries, however, stress that therapeutic doses are far below toxic thresholds and that reported toxicities occur at gram‑level exposures — a point commercial marketers sometimes downplay [5] [6].
6. Who should be especially cautious or avoid saffron
Reviews warn pregnant people to avoid medicinal/therapeutic doses because of uterine stimulation risk; people with bleeding disorders or on anticoagulants should be cautious because high saffron doses can affect bleeding/platelet counts; and those with certain psychiatric conditions or on interacting antidepressants should consult clinicians as clinical overlaps have been discussed in the literature [5] [4] [1].
7. Limitations, uncertainties and what reporting does not say
Available sources differ on upper “safe” limits (100 mg vs 1.5 g/day) and on whether higher therapeutic doses (up to 400 mg) are routinely safe; long‑term safety beyond common trial durations remains under‑studied [6] [1] [7]. Available sources do not mention standardized, universally accepted regulatory daily limits for saffron supplements from agencies like the FDA; they instead rely on clinical trials and toxicology literature (not found in current reporting).
Bottom line: clinical evidence supports therapeutic saffron use at tens to a few hundred milligrams per day (commonly 30–100 mg/day), while toxicity has been documented only at gram‑level intakes (starting around ~1–5 g/day, with severe/lethal outcomes reported at much higher doses) — but pregnant people and those with bleeding or complex medical regimens should avoid medicinal doses without medical supervision [1] [6] [4] [5].