Gokshura Fruit Extract

About

What it is and where it shows up.

Gokshura fruit extract is derived from the dried fruits of Tribulus terrestris L. (family Zygophyllaceae), an annual herb used for centuries in Ayurvedic, Traditional Chinese, and folk medicine systems. It is employed primarily as a botanical dietary supplement and nutraceutical ingredient for its purported diuretic, aphrodisiac, and genitourinary-supportive properties, with key bioactive constituents including steroidal saponins (protodioscin, diosgenin), flavonoids, alkaloids, and tannins.

Safety summary

The regulatory and scientific consensus.

At typical supplemental doses (250–750 mg/day), the extract is generally well tolerated in healthy adults, with mild gastrointestinal effects (nausea, gastric irritation) being the most commonly reported adverse events. EFSA has flagged the whole plant in its compendium of botanicals of possible concern due to the presence of β-carboline alkaloids and lithogenic steroidal saponins, and the NIH LiverTox database notes a theoretical risk of liver or kidney injury at high doses or in persons with pre-existing hepatic disease. No formal Acceptable Daily Intake (ADI) has been established by any major regulatory body for the fruit extract specifically.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
Health Canada (Canada)	Approved	Fruits and roots of Tribulus terrestris are listed among Natural Health Products in Health Canada's Natural Health Products Ingredients Database (2019), permitting regulated sale as a licensed natural health product.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Tribulus terrestris is recognised in the Ayurvedic Pharmacopoeia of India and listed in FSSAI's approved novel food/ingredient applications (application 51/Std/PA/FSSAI/2018 references Tribulus terrestris among approved ingredients). Permitted for use in Ayurvedic formulations and dietary supplements under FSSAI regulations.source
FDA (Food and Drug Administration) (United States)	Approved	Not subject to a formal FDA pre-market approval; sold as a botanical dietary supplement under DSHEA (21 U.S.C. §343). No GRAS notice filed or granted specifically for gokshura/Tribulus terrestris fruit extract as a conventional food ingredient. Typical commercial dose is 250–750 mg/day in capsule or tablet form.source
EFSA (European Food Safety Authority) (European Union)	Under_review	Tribulus terrestris (whole plant) is listed in the EFSA Compendium of Botanicals reported to contain naturally occurring substances of possible concern for human health when used in food and food supplements, citing β-carboline alkaloids (40–80 mg/kg dry matter), lithogenic steroidal saponins (e.g., protodioscin), mycotoxin sporidesmin, CNS effects in sheep, and hepatotoxicity in male rats. EMA has published a final assessment report for the herb but no EU-wide food ingredient approval has been granted; use in food supplements varies by member state.

Who should approach with care

Whose guidance would steer them away.

Pregnancy — Steroidal saponins and alkaloids in T. terrestris fruit extract may exert hormonal effects; no safety data in pregnancy, and traditional Ayurvedic guidance contraindicates use during gestation.

Lactation — No safety data exist for transfer of steroidal saponins or β-carboline alkaloids into breast milk; use is not established as safe during lactation.

Infants — No safety or dosing data for infants; steroidal saponins may exert hormonal activity inappropriate for this population.

Children — Potential hormonal (testosterone-modulating) effects from steroidal saponins are inappropriate for pre-pubertal children; no paediatric safety data available.

Liver Disease — NIH LiverTox rates T. terrestris as a possible rare cause of clinically apparent liver injury at high doses or in persons with pre-existing liver disease or cirrhosis.

Research citations

The sources behind this verdict.

1EFSA. Assessment report on Tribulus terrestris L., herba – European Medicines Agency (EMA). ema.europa.eu
2PubMed. Promising phytopharmacology, nutritional potential, health benefits, and traditional usage of Tribulus terrestris L. herb, 2024. pmc.ncbi.nlm.nih.gov
3PubMed. Rhabdomyolysis Risk: The Dangers of Tribulus terrestris, an Over-the-Counter Supplement, 2024. pmc.ncbi.nlm.nih.gov
4PubMed. A comparative diuretic evaluation of fruit and root of Gokshura (Tribulus terrestris Linn.) in albino rats, 2023. pmc.ncbi.nlm.nih.gov
5other. Tribulus – LiverTox: Clinical and Research Information on Drug-Induced Liver Injury, 2022. ncbi.nlm.nih.gov
6PubMed. A Comprehensive Review of the Phytochemical, Pharmacological, and Toxicological Properties of Tribulus terrestris L., 2020. pmc.ncbi.nlm.nih.gov

Independently researched7 citations