Monograph: Tribulus - Tribulus terrestris

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. Notes: (i) Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. (ii) The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant. (iii) A claim for traditional use must include the term "Traditional Chinese Medicine", "Ayurveda", or "Ayurvedic medicine".
Date: 2019-02-25

NHPID name

Tribulus terrestris ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Tribulus terrestris ( USDA 2011 , PPRC 2010 , API 2001 , McGuffin et al. 2000 )

Common name(s)

Source material

Route Of administration


Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:




1 Day per day

Duration of use

Mutrala (diuretic): For occasional use only.  (APhA 2002, CPhA 2002)

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): Contraindication(s): TCM rubella symptoms; TCM to calm liver and anchor yang; TCM to dispel wind; TCM to dispel wind-heat; TCM to dredge liver qi; TCM to pacify liver: Do not use this product if you have hypotension or liver deficiency.  (Chen and Chen 2004) Known Adverse Reaction(s):

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.


References cited

References reviewed