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Drugs and Health Products

Black Pepper – Piper nigrum

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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

  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant’s discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

June 11, 2014

Proper name(s)

Piper nigrum L. (Piperaceae) (Duke 2009; USDA 1995)

Common name(s)

  • Black pepper (USDA 1995)
  • White pepper (USDA 1995)

Source material(s)

Fruit (CNF 2009)

Route(s) of administration

Oral

Dosage form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of

Powdered Piper nigrum
  • Traditionally used in Ayurvedic medicine to improve digestion (API 2001).
  • Traditionally used in Ayurvedic medicine as an antiparasitic (API 2001).

Dose(s)

Subpopulation(s)

Adults (≥ 18 years)

Quantity

Powdered Piper nigrum

250-420 mg dried fruit, per day (CNF 2012; API 2001).

Piperine (valid only for Class II and III applications)

Up to 14 mg piperine per day as a pure isolate or as a constituent of standardized Piper nigrum fruit extracts (TGA 2007).

Duration of use

Statement(s) to the effect of

All Products

For use beyond 12 weeks, consult a health care practitioner (Lieberman et al. 2005).

Antiparasitic

For occasional use only

Risk information

Statement(s) to the effect of

Caution(s) and warning(s)

All products

  • If you are pregnant or breasfeeding, consult a healthcare practitioner prior to use.
  • If you are taking any other medications or natural health products, consult a health care practitioner prior to use, as black pepper/piperine may alter their effectiveness (Han 2011; Srinivasan 2007; Khajuria et al. 2002; Bano et al. 1991).

Antiparasitic
If symptoms worsen or if they persist for more than 2 weeks, consult a health care practitioner.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current NNHPD Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

No statement required.

Specifications

References cited

  • API 2001: The Ayurvedic Pharmacopeia of India-part I, Ministry of Health and Family Welfare, Government of India, New Delhi (IN): The Controller of Publications; 2001.
  • Badmaev V, Majeed M, Norkus EP. Piperine, an alkaloid derived from black pepper increases serum response of beta-carotene during 14-days of oral beta-carotene supplementation. Nutrition Research Journal 1999;19(3):381-388.
  • Bano G, Raina RK, Zutshi U, Bedi KL, Johri RK, Sharma SC. Effect of piperine on bioavailability and pharmacokinetics of propranolol and theophylline in healthy volunteers. European Journal of Pharmacology 1991;41(6):615-7.
  • Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications;2001.
  • Brinker F. Next link will take you to another Web site Updates and Additions for HERB CONTRAINDICATIONS AND DRUG INTERACTIONS, 3rd ed. WITH extensive APPENDICES ADDRESSING INFLUENCES ON pHASE i, ii & iii METABOLISM NEW APPENDIX  BENEFITS OF INTEGRATING botanicals WITH conventional therapies [Internet]. 2010 [Accessed 2010 October 29].
  • CNF 2012:Next link will take you to another Web site Canadian Nutrient File, Food and Nutrition, Health Canada [Internet]. [Accessed 2013 August 21]
  • Han HK. The effects of black pepper on the intestinal absorption and hepatic metabolism of drugs. Expert Opinion on Drug Metabolism & Toxicology 2011;7(6):721-729.
  • Khajuria A, Thusu N, Zutshi U. Piperine modulates permeability characteristics of intestine by inducing alterations in membrane dynamics: influence on brush border membrane fluidity, ultrastructure and enzyme kinetics. Phytomedicine 2002;9(3):224-31.
  • Lieberman S, Spahrs R, Stanton A. Martinez L, Grinder M. 2005. Weight loss, body measurements, and compliance: A 12-week total lifestyle intervention pilot study. Alternative & Complementary Therapies 2005(December):307-313.
  • Pattanaik S, Hota D, Prabhakar S, Kharbanda P, Pandhi P. Effect of piperine on the steady-state pharmacokinetics of phenytoin in patients with epilepsy. Phytotherapy Research 2006 Aug;20(8):683-6.
  • Srinivasan K. Black Pepper and its pungent principle-piperine: a review of diverse physiological effects. Critical Reviews in Food Science and Nutrition 2007;47(8):735-748.
  • TGA 2007: Australian Therapeutic Goods Administration.Next link will take you to another Web site CMEC 64: Complementary Medicines Evaluation Committee, Extracted Ratified Minutes Sixty-fourth Meeting, 14 December 2007. Australian Government Department of Health and Aging, Sydney, Australia;2007. [Accessed 2014 April 23].
  • USDA 1995: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program.Next link will take you to another Web site Germplasm Resources Information Network (GRIN). [Internet].  Piper nigrum L. National Germplasm Resources Laboratory, Beltsville (MD). [Last updated 1995 May 26; Accessed 2013 August 27].

References reviewed

  • Duke 2009: Dr. Duke's Phytoschemical and Ethnobotanical Databases.Next link will take you to another Web site Phytochemical databases. Phytochemical databases. [Internet]. [Accessed 2009 November 19]