DRUGS AND SUPPLEMENTS

Nicotinamide

March 22, 2017

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Nicotinamide

Natural Standard Bottom Line Monograph, Copyright © 2013 (www.naturalstandard.com). Commercial distribution prohibited. This monograph is intended for informational purposes only, and should not be interpreted as specific medical advice. You should consult with a qualified healthcare provider before making decisions about therapies and/or health conditions.

While some complementary and alternative techniques have been studied scientifically, high-quality data regarding safety, effectiveness, and mechanism of action are limited or controversial for most therapies. Whenever possible, it is recommended that practitioners be licensed by a recognized professional organization that adheres to clearly published standards. In addition, before starting a new technique or engaging a practitioner, it is recommended that patients speak with their primary healthcare provider(s). Potential benefits, risks (including financial costs), and alternatives should be carefully considered. The below monograph is designed to provide historical background and an overview of clinically-oriented research, and neither advocates for or against the use of a particular therapy.

Related Terms

  • 3-Carbamoylpyridine, 3-pyridinecarboxamide, 3-pyridinecarboxylic acid amide, amid kyseliny nikotinove (Czech), amide PP, aminonicotin, amixicotyn, amnicotin, austrovit PP, Benicot, beta-pyridinecarboxamide, delonin amide, dipegyl, endobion, factor PP, hansamid, inovitan PP, m-(aminocarbonyl)pyridine, mediatric, NAD, NADH, NADP, NADPH, NAM, niacinamide, niamide, niavit PP, nicamide, nicamina, nicamindon, nicasir, Nicobion®, nicofort, nicogen, nicomidol, nicosan 2, nicosylamide, nicota, nicotamide, nicotilamide, nicotililamido, nicotinamida (Spanish), nicotinamidum (Latin), nicotine acid amide, nicotine amide, nicotinic acid amide, nicotinic amide, Nicotinsäureamid (German), nicotol, nicotylamide, nicotylamidum, nicovel, nicovit, nicovitina, nicovitol, nicozymin, niko-tamin, nikotinamid, Nikotinsäureamid (German), Nikotin(säure)amid (German), niocinamide, nizymin, papulex, pelmin, pelmine, pelonin amide, PP-faktor, pyridine-3-carboxylic acid amide, savacotyl, vi-nicotyl, vitamin B, vitamin B3, vitamin PP, witamina PP (Polish).

Background

  • Nicotinamide (also known as niacinamide) is chemically similar to niacin and, like niacin, is a form of vitamin B3. Nicotinamide and niacin are found in many foods, including vegetables, fruits, grains, meats, milk, and eggs.

  • Nicotinamide is approved by the U.S. Food and Drug Administration (FDA) for the prevention and treatment of pellagra, a vitamin B3 deficiency disease characterized by diarrhea, dermatitis, neurodegeneration, and dementia.

  • Nicotinamide has been investigated for the prevention of type 1 diabetes. It is included in skin care products for the treatment of acne and UV-induced immune suppression, and in products intended to enhance appearance.

Scientific Evidence

Uses

These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.

Grade*

Pellagra (niacin)

Nicotinamide is approved by the U.S. Food and Drug Administration (FDA) for use in the prevention and treatment of pellagra, a vitamin B3 deficiency disease.

A

Hyperpigmentation

In preliminary research, nicotinamide decreased hyperpigmentation (darkening of patches of skin). Well-designed clinical trials are needed before a conclusion can be made.

B

Type 1 Diabetes mellitus: preservation of beta-islet cell function

Preliminary data suggest that nicotinamide may prevent the onset of type 1 diabetes and prevent damage to the insulin-producing cells of the pancreas. Additional clinical research is needed before firmer conclusions can be made.

B

Acne

Preliminary research suggests that nicotinamide, applied to the affected area, may help treat acne, with an effect similar to that of the antibiotic clindamycin. Additional research is needed before a conclusion can be made.

C

Autoimmune disorders

Limited research suggests that mild pemphigus foliaceus, an autoimmune skin disorder, may respond to treatment with a combination niacinamide and the antibiotic tetracycline. Further research on the effect of niacinamide alone is needed before a conclusion can be made.

C

Cancer

Results of human studies on the effectiveness of niacin in aiding cancer treatment are mixed. Additional research is needed before a conclusion can be made.

C

Dry skin

Preliminary research suggests that nicotinamide may have beneficial effects on atopic dry skin. Additional research is needed before a conclusion can be made.

C

Hyperphosphatemia

Preliminary research suggests that nicotinamide may reduce blood phosphorus levels in hemodialysis patients with hyperphosphatemia (high blood phosphorus level). Additional research is needed before a conclusion can be made.

C

Macular degeneration

Preliminary research suggests that nicotinamide, in combination with antioxidants, improves macular function in people with macular disease (eye disease). Further research on the effect of nicotinamide alone is needed before a conclusion can be made.

C

Osteoarthritis

Early research suggests that niacinamide may be useful to treat osteoarthritis. Further research is needed before a conclusion can be made.

C

*Key to grades:A: Strong scientific evidence for this use; B: Good scientific evidence for this use; C: Unclear scientific evidence for this use; D: Fair scientific evidence against this use (it may not work); F: Strong scientific evidence against this use (it likely does not work).

Tradition/Theory

The below uses are based on tradition or scientific theories. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious and should be evaluated by a qualified health care professional.

  • AIDS, antimicrobial, brain injury, dermatitis herpetiformis (an intensely itchy rash of bumps and blisters), granuloma annulare (rash with red bumps arranged in a ring), MELAS syndrome, psoriasis, schizophrenia, skin disorders (erythema diutinum, erythema induratum, erythema multiforme, necrobiosis lipoidica, polymorphic light eruption), stroke, tuberculosis.

Dosing

The below doses are based on scientific research, publications, traditional use, or expert opinion. Many herbs and supplements have not been thoroughly tested, and safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients, even within the same brand. The below doses may not apply to all products. You should read product labels, and discuss doses with a qualified healthcare provider before starting therapy.

Adults (18 years and older)

  • In the United States, the recommended dietary allowance (RDA) of nicotinamide for individuals over 14 years of age is 16 milligrams daily for males and 14 milligrams daily for females. The RDA for women who are pregnant or breastfeeding is 17-18 milligrams daily. Infants require five milligrams daily. Nicotinamide is present in many vitamin preparations.

  • For acne, 4% nicotinamide gel has been applied to the affected area twice daily for eight weeks.

  • For dry skin, 2% nicotinamide cream has been applied to the affected area twice daily for eight weeks.

  • For hyperphosphatemia (high blood phosphorus, during hemodialysis), doses in the range of 500 milligrams to six grams have been taken by mouth daily for 12 weeks.

  • For hyperpigmentation (darkening of patches of skin), 5% niacinamide has been applied to the affected area twice daily for up to 12 weeks.

  • For osteoarthritis, 500 milligrams has been taken by mouth six times daily for 12 weeks.

  • For pellagra, 300-500 milligrams has been taken by mouth daily in divided doses.

Children (under 18 years old)

  • For pellagra, 100-300 milligrams has been taken by mouth in divided doses daily.

  • For type 1 diabetes mellitus (preservation of beta-islet cell function), 3-60 milligrams per kilogram of body weight has been taken by mouth daily for 6-36 months.

Safety

The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.

Allergies

  • Nicotinamide is an essential vitamin and therefore hypersensitivity is unlikely.

Side Effects and Warnings

  • Nicotinamide is likely safe when consumed in amounts normally found in the diet. Nicotinamide is an essential vitamin and therefore hypersensitivity is unlikely.

  • Nicotinamide may cause antianxiety effects, diarrhea, dry hair, fatigue, flushing, gastrointestinal disturbances, headache, nausea, rashes, thrombocytopenia (low platelet count), and vomiting.

  • Nicotinamide may lower blood sugar levels. Caution is advised in people with diabetes or hypoglycemia and in those taking drugs, herbs, or supplements that affect blood sugar. Blood glucose levels may need to be monitored by a qualified healthcare professional, including a pharmacist. Medication adjustments may be necessary.

  • Nicotinamide may increase the risk of bleeding by lowering platelet count, particularly in hemodialysis patients. Caution is advised in hemodialysis patients, people with bleeding disorders, or those taking drugs, herbs, or supplements that may increase the risk of bleeding. Dosing adjustments may be necessary.

  • Use cautiously in people using CNS depressants, as nicotinamide has CNS depressive effects and may increase the risk of drowsiness or sedation. Use caution if driving or operating heavy machinery.

  • Nicotinamide may decrease blood pressure. Caution is advised in people taking drugs, herbs, or supplements that lower blood pressure.

  • Nicotinamide may interfere with the way the body processes certain drugs, herbs, or supplements using the liver's cytochrome P450 enzyme system. As a result, the levels of these agents may change in the blood and may cause increased or decreased effects or potentially serious adverse reactions. People taking any medications should check the package insert and speak with a qualified healthcare professional, including a pharmacist, about possible interactions.

  • Use cautiously in people with immune disorders or those using agents that suppress the immune system, as nicotinamide may have immune system effects.

  • Use cautiously in people with gastrointestinal disorders or in those taking agents for such conditions, as gastrointestinal disturbances, including nausea, vomiting, and diarrhea, have been reported.

  • Use cautiously in people with liver damage or those taking agents that may damage the liver, as high doses of nicotinamide may cause liver damage or increase the risk of liver toxicity.

  • Avoid in large doses (3-12 grams daily or higher), due to the incidence of gastrointestinal upset, headache, fatigue, and rashes, and the risk of liver damage.

Pregnancy and Breastfeeding

  • Scientific information is lacking on the use of nicotinamide at levels greater than the recommended dietary allowance (RDA) of 17-18 milligrams in pregnant or breastfeeding women.

Interactions

Most herbs and supplements have not been thoroughly tested for interactions with other herbs, supplements, drugs, or foods. The interactions listed below are based on reports in scientific publications, laboratory experiments, or traditional use. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy.

Interactions with Drugs

  • Nicotinamide may lower blood sugar levels. Caution is advised when using medications that may also lower blood sugar. People taking insulin or drugs for diabetes by mouth should be monitored closely by a qualified healthcare professional, including a pharmacist. Medication adjustments may be necessary.

  • Nicotinamide may increase the risk of bleeding, particularly in hemodialysis patients, when taken with drugs that increase the risk of bleeding. Some examples include aspirin, anticoagulants (blood thinners) such as warfarin (Coumadin®) or heparin, antiplatelet drugs such as clopidogrel (Plavix®), and nonsteroidal anti-inflammatory drugs such as ibuprofen (Motrin®, Advil®) or naproxen (Naprosyn®, Aleve®).

  • Nicotinamide may increase the amount of drowsiness caused by some drugs, such as CNS depressants, benzodiazepines such as lorazepam (Ativan®) or diazepam (Valium®), barbiturates such as phenobarbital, narcotics such as codeine, some antidepressants, and alcohol. Caution is advised while driving or operating machinery.

  • Nicotinamide may lower blood pressure. Caution is advised in people taking drugs that lower blood pressure.

  • Nicotinamide may interfere with the way the body processes certain drugs using the liver's cytochrome P450 enzyme system. As a result, the levels of these drugs may change in the blood and may cause increased or decreased effects or potentially serious adverse reactions. People taking any medication should check the package insert and speak with a qualified healthcare professional, including a pharmacist, about possible interactions.

  • Nicotinamide may also interact with agents that may damage the liver, agents that affect the immune system, antianxiety drugs, anti-inflammatory agents, domperidone, or gastrointestinal agents.

Interactions with Herbs and Dietary Supplements

  • Nicotinamide may lower blood sugar levels. Caution is advised when using herbs or supplements that may also lower blood sugar. Blood glucose levels may require monitoring, and doses may need adjustment.

  • Nicotinamide may increase the risk of bleeding, particularly in hemodialysis patients, when taken with herbs and supplements that are believed to increase the risk of bleeding. Multiple cases of bleeding have been reported with the use of Ginkgo biloba, and fewer cases with garlic and saw palmetto. Numerous other agents may theoretically increase the risk of bleeding, although this has not been proven in most cases.

  • Nicotinamide may increase the amount of drowsiness caused by some herbs or supplements, such as sedatives. Caution is advised if driving or operating heavy machinery.

  • Nicotinamide may lower blood pressure. Caution is advised in people taking herbs or supplements that lower blood pressure.

  • Nicotinamide may interfere with the way the body processes certain herbs or supplements using the liver's cytochrome P450 enzyme system. As a result, the levels of other herbs or supplements may change in the blood. It may also alter the effects that other herbs or supplements potentially may have on the P450 system.

  • Nicotinamide may also interact with antianxiety herbs and supplements, anti-inflammatory herbs and supplements, gastrointestinal herbs and supplements, herbs and supplements that may damage the liver, herbs and supplements that affect the immune system, or phosphorus.

Author Information

  • This information is based on a systematic review of scientific literature edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).

References

Natural Standard developed the above evidence-based information based on a thorough systematic review of the available scientific articles. For comprehensive information about alternative and complementary therapies on the professional level, go to www.naturalstandard.com. Selected references are listed below.

  1. Cabrera-Rode E, Molina G, Arranz C, et al. Effect of standard nicotinamide in the prevention of type 1 diabetes in first degree relatives of persons with type 1 diabetes. Autoimmunity 2006;39(4):333-340. View Abstract

  2. Chaplin DJ, Horsman MR, Aoki DS. Nicotinamide, Fluosol DA and Carbogen: a strategy to reoxygenate acutely and chronically hypoxic cells in vivo. Br J Cancer 1991;63(1):109-113. View Abstract

  3. Chen S, Lu X, Zhou G. Mild pemphigus foliaceus responding to combination therapy with niacinamide and tetracycline. Int J Dermatol 2003;42(12):981-982. View Abstract

  4. Crino A, Schiaffini R, Ciampalini P, et al. A two year observational study of nicotinamide and intensive insulin therapy in patients with recent onset type 1 diabetes mellitus. J Pediatr Endocrinol Metab 2005;18(8):749-754. View Abstract

  5. Crino A, Schiaffini R, Manfrini S, et al. A randomized trial of nicotinamide and vitamin E in children with recent onset type 1 diabetes (IMDIAB IX). Eur J Endocrinol 2004;150(5):719-724. View Abstract

  6. Damian DL, Patterson CR, Stapelberg M, et al. UV radiation-induced immunosuppression is greater in men and prevented by topical nicotinamide. J Invest Dermatol 2008;128(2):447-454. View Abstract

  7. Elliott RB, Pilcher CC, Fergusson DM, et al. A population based strategy to prevent insulin-dependent diabetes using nicotinamide. J Pediatr Endocrinol Metab 1996;9(5):501-509. View Abstract

  8. Falsini B, Piccardi M, Iarossi G, et al. Influence of short-term antioxidant supplementation on macular function in age-related maculopathy: a pilot study including electrophysiologic assessment. Ophthalmology 2003;110(1):51-60. View Abstract

  9. Hakozaki T, Takiwaki H, Miyamoto K, et al. Ultrasound enhanced skin-lightening effect of vitamin C and niacinamide. Skin Res Technol 2006;12(2):105-113. View Abstract

  10. Hoskin PJ, Rojas AM, Phillips H, et al. Acute and late morbidity in the treatment of advanced bladder carcinoma with accelerated radiotherapy, carbogen, and nicotinamide. Cancer 2005;103(11):2287-2297. View Abstract

  11. Kamal M, Abbasy AJ, Muslemani AA. Effect of nicotinamide on newly diagnosed type 1 diabetic children. Acta Pharmacol Sin 2006;27(6):724-727. View Abstract

  12. Kjellen E, Joiner MC, Collier JM, et al. A therapeutic benefit from combining normobaric carbogen or oxygen with nicotinamide in fractionated X-ray treatments. Radiother Oncol 1991;22(2):81-91. View Abstract

  13. Niren NM, Torok HM. The Nicomide Improvement in Clinical Outcomes Study (NICOS): results of an 8-week trial. Cutis 2006;77(1 Suppl):17-28. View Abstract

  14. Powell ME, Hill SA, Saunders MI, et al. Human tumor blood flow is enhanced by nicotinamide and carbogen breathing. Cancer Res 1997;57(23):5261-5264. View Abstract

  15. Smid L, Lesnicar H, Zakotnik B, et al. Radiotherapy, combined with simultaneous chemotherapy with mitomycin C and bleomycin for inoperable head and neck cancer--preliminary report. Int J Radiat Oncol Biol Phys 1995;32(3):769-775. View Abstract

Copyright © 2013 Natural Standard (www.naturalstandard.com)

The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.

Updated:  

March 22, 2017