Lysine (L-Lysine)
Pronunciation: LY-seen.
- Generic name
- L-lysine; lysine
- Drug class
- Not applicable -- L-lysine is an essential amino acid sold as a dietary/food supplement, not a regulated drug class, in the United States, United Kingdom, European Union, and New Zealand. In Canada it is a licensed Natural Health Product ingredient; in Australia it is an active ingredient in TGA-Listed (AUST L) complementary medicines.
- Form
- Capsule, tablet, or powder; commonly 500 mg to 1,000 mg per unit, varies by product since there is no single regulator-set standard dose
- Route
- Oral (capsule, tablet, or powder)
- Legal status
- Regulated as a food/dietary supplement in the United States, United Kingdom, European Union, and New Zealand -- not a prescription or pharmacy-only medicine in any of these four. Canada is a genuine exception: L-lysine products can be licensed as Natural Health Products with a Health Canada Natural Product Number (NPN). Australia is a genuine exception: L-lysine is an active ingredient in multiple TGA ARTG-Listed (AUST L) complementary medicines, including a product specifically marketed for cold sore prevention.
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Ethical Nutrients Lysine Cold Sore Defence (Metagenics (Aust) Pty Ltd, ARTG 353838); EZZ L-Lysine Growth Capsule (EZZ Life Science Holdings Ltd, ARTG 413522/476307) (4) · Full directory
What L-lysine; lysine is and how it works
L-lysine is an essential amino acid -- one the body needs but cannot make on its own, so it must come from food (meat, fish, dairy, eggs, legumes) or supplementation. It is genuinely NOT a regulated prescription or over-the-counter medicine in the United States, United Kingdom, European Union, or New Zealand -- it is sold and regulated as a food or dietary supplement in these markets. Canada is a real exception where L-lysine products can be licensed by Health Canada as Natural Health Products, and Australia is a real exception where L-lysine is an active ingredient in TGA-Listed complementary medicines. (1)
People most commonly take L-lysine supplements hoping to reduce cold sore (herpes labialis) outbreaks. Because it is 'just an amino acid', it is easy to assume it is automatically safe at any dose -- but the evidence for cold-sore prevention is genuinely mixed and depends heavily on dose, and there are real, documented safety cautions for people with certain heart, gallbladder, kidney, or liver conditions.
Mechanism of action: how L-lysine; lysine works
L-lysine is an essential proteinogenic amino acid required for protein synthesis, collagen formation, and calcium absorption, among other roles. Its proposed mechanism for reducing herpes simplex recurrence is competitive inhibition of arginine, an amino acid the herpes simplex virus uses for replication -- a plausible biological mechanism, though the clinical evidence for a meaningful antiviral effect at commonly used doses remains limited per the systematic review reviewed for this dossier. (1)
What L-lysine; lysine is used for
Cold sore (herpes labialis) prevention -- preliminary/mixed evidence, dose-dependent
The most common reason people take L-lysine supplements. A systematic review of the evidence found that doses below 1 g/day appear ineffective for prophylaxis or treatment of herpes simplex lesions unless combined with a low-arginine diet, while doses above 3 g/day showed more promise for reducing recurrence and improving subjective symptoms in at least one trial -- but the overall evidence base is weak (only 8 of 12 reviewed trials were placebo-controlled, sample sizes were small, and the one randomised trial reviewed by the Cochrane Skin Group was rated 'very low' quality evidence). This is preliminary, mixed evidence, not established clinical proof. (1)
Dietary supplementation (general essential-amino-acid intake)
As an essential amino acid, lysine is also used more generally as a dietary supplement to help meet overall protein/amino-acid intake needs, marketed this way across all 6 markets reviewed. (2)
Before taking L-lysine; lysine
Do not take / not appropriate for
- There is no absolute contraindication described in the sources reviewed for this dossier, but caution is advised (see tell_your_clinician below) before starting supplementation if you have certain heart, gallbladder, kidney, or liver conditions. (all countries) (1)
Tell your clinician about
- If you have cardiovascular disease -- caution is advised with lysine supplementation.
- If you have gallstones, or a personal or family history of gallstones -- high lysine intake has been linked to gallstone formation and elevated cholesterol in animal studies.
- If you have kidney or liver problems -- caution is advised, and safe maximum doses have not been established for people with severe kidney or liver disease.
- If you have asthma or a condition affecting your immune system -- caution is advised.
- If you are pregnant, trying to conceive, or breastfeeding -- safe maximum doses have not been established for these groups.
- If you are considering giving lysine supplements to a young child -- safe maximum doses have not been established for young children.
- All other supplements and medicines you take, particularly other amino acid supplements, since high lysine intake may reduce absorption of arginine, another amino acid important for wound healing and blood vessel function.
How to take L-lysine; lysine
- There is no single regulator-set standard dose, since lysine is not a regulated drug in most markets -- follow the specific product's label directions or a clinician's/pharmacist's advice.
- If using lysine specifically for cold-sore prevention, be aware the evidence reviewed suggests doses below 1 g/day are unlikely to help unless combined with a low-arginine diet, while the higher doses (above 3 g/day) that showed more promise in one trial have not been extensively studied for long-term safety.
- If you are using a TGA-Listed Australian product marketed for cold-sore prevention, follow that specific product's own labelled directions.
- Discuss any planned high-dose or long-term use with a clinician or pharmacist first, particularly if you have any of the conditions listed above.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)
Missed dose
Not applicable in the same way as a prescribed medicine, since lysine is a food/supplement product without a regulator-set dosing schedule in most markets. If you are following a specific product's dosing schedule, simply resume your normal schedule at the next planned dose.
Overdose
This dossier's sources did not describe a specific lysine overdose syndrome or established toxic dose threshold in humans, though animal studies have linked very high doses to kidney injury, elevated cholesterol, and gallstone formation. As with any supplement, taking substantially more than a product's labelled amount is not advised. If a large accidental ingestion occurs, especially in a child, or if any concerning symptoms develop, contact a doctor or poison control centre for guidance. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Abdominal cramps and diarrhoea have been reported with excessive amino acid supplement intake.
What to notice: Abdominal cramps and diarrhoea have been reported with excessive amino acid supplement intake.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Most trials reviewed for cold-sore prevention reported the supplement was generally well tolerated at the doses studied, though the overall safety evidence base for high, sustained doses is limited.
What to notice: Most trials reviewed for cold-sore prevention reported the supplement was generally well tolerated at the doses studied, though the overall safety evidence base for high, sustained doses is limited.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Signs of a gallstone problem or rising cholesterol — moderate caution
Symptoms: Upper abdominal pain, especially after eating fatty food, or a known rise in cholesterol on blood testing.
Action: Tell your clinician if you have gallstones, a personal or family history of gallstones, or high cholesterol before starting lysine supplementation -- animal studies have linked high lysine intake to gallstone formation and elevated cholesterol, and people with these conditions should use caution and have relevant monitoring as advised by their clinician. (1)
Signs of kidney problems — moderate caution
Symptoms: Reduced urination, swelling, or unusual fatigue.
Action: Tell your clinician if you have kidney disease before starting lysine supplementation -- caution is advised, animal research has linked high-dose lysine to kidney injury, and safe maximum doses have not been established for people with severe kidney disease. (1)
Cardiovascular disease caution — moderate caution
Symptoms: Not applicable -- this is a precaution for people with an existing diagnosis, not a symptom to watch for.
Action: Tell your clinician about any cardiovascular disease before starting lysine supplementation, since the systematic review reviewed for this dossier specifically advises caution in this group, partly due to a theoretical risk that high lysine intake may reduce absorption of arginine, an amino acid important for blood vessel function. (1)
Asthma or immune-system conditions — moderate caution
Symptoms: Not applicable -- this is a precaution for people with an existing diagnosis, not a symptom to watch for.
Action: Tell your clinician about any asthma or condition affecting your immune system before starting lysine supplementation -- caution is specifically advised for these groups in the evidence reviewed. (1)
Interactions
- Other amino acid supplements, particularly arginine: high lysine intake may reduce arginine absorption, since the two amino acids compete for absorption -- tell your clinician about any other amino acid supplements you take. (1)
- Calcium supplements: some study data suggest lysine may increase intestinal calcium absorption in the context of a low-protein diet -- discuss with your clinician if you take calcium supplements and are considering lysine.
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Safe maximum doses have not been established for pregnant women in the sources reviewed for this dossier. Seek advice from a health professional before use if pregnant or trying to conceive. (1) (2) (3) (4) (5)
Breastfeeding
Safe maximum doses have not been established for breastfeeding women in the sources reviewed. Seek advice from a health professional before use if breastfeeding. (1) (2) (3) (4) (5)
Children
Safe maximum doses have not been established for young children in the sources reviewed. Consult a clinician before giving lysine supplements to a child. (1) (2) (3) (4) (5)
Elderly
No specific age-based dose adjustment was described in the sources reviewed for this dossier. (1) (2) (3) (4) (5)
Hepatic_impairment
Safe maximum doses have not been established for people with severe liver disease in the sources reviewed -- caution is advised and clinician guidance should be sought. (1) (2) (3) (4) (5)
Renal_impairment
Safe maximum doses have not been established for people with severe kidney disease in the sources reviewed -- caution is advised and clinician guidance should be sought, particularly given animal-study signals linking high-dose lysine to kidney injury. (1) (2) (3) (4) (5)
Source_ids
US-PMC-LYSINE-HSV-SYSTEMATIC-REVIEW-2018 (1) (2) (3) (4) (5)
Monitoring
Before starting
- Check whether you have cardiovascular disease, gallstones, kidney or liver problems, asthma, or an immune-system condition, given the documented cautions for these groups.
- Check whether you take other amino acid supplements, particularly arginine.
During treatment
- Watch for any signs of gallbladder problems or unexpected changes in cholesterol if using long-term or at high doses.
- Watch for any signs of kidney problems if using long-term or at high doses.
- Discuss with your clinician if using lysine for cold-sore prevention to confirm it is a reasonable complement to, not a replacement for, proven antiviral treatment where needed.
Storage
Store capsules, tablets, or powder as directed on the product label, typically in a cool, dry place. Keep out of reach of children, as with any supplement product.
Professional information
Clinician-facing context only, sourced from a peer-reviewed systematic review of lysine for herpes simplex prophylaxis and each country's general food/supplement/Natural-Health-Product/listed-medicine regulatory framework reviewed for this dossier; verify against current primary literature before recommending.
General (not a regulator-set standard in most markets)
Indication: Cold sore (herpes labialis) prevention -- preliminary/mixed evidence, dose-dependent
Dose summary: Study-specific doses only: 312 mg to 3 g daily across trials reviewed; doses below 1 g/day appeared ineffective without a low-arginine diet, while a 3 g/day dose showed benefit in one trial -- no established clinical standard dose exists.
Renal context: No specific renal dose adjustment described in the sources reviewed; caution advised in people with kidney disease. (1)
Hepatic guidance
No specific hepatic dose-adjustment guidance was described in the sources reviewed; caution is advised for people with severe liver disease.
Overdose note
No specific lysine overdose syndrome or established toxic dose threshold in humans was described in the sources reviewed; animal studies have linked very high doses to kidney injury, elevated cholesterol, and gallstone formation. (1)
Frequently asked questions
Is L-lysine a regulated medicine?
In the United States, United Kingdom, European Union, and New Zealand, L-lysine is genuinely NOT a regulated prescription or over-the-counter medicine -- it is sold and regulated as a food or dietary supplement. Canada is a real exception: L-lysine products can be licensed by Health Canada as Natural Health Products with a Natural Product Number (NPN). Australia is a real exception too: L-lysine is an active ingredient in multiple TGA-Listed (AUST L) complementary medicines, including a product specifically marketed for cold sore prevention. (2) (3) (4) (5)
Does L-lysine actually prevent cold sores?
The evidence is genuinely mixed and depends heavily on dose. A systematic review found that doses below 1 g/day appear ineffective for preventing or treating cold sores unless combined with a low-arginine diet, while a 3 g/day dose showed a statistically significant reduction in recurrence in one trial. However, the overall evidence base is weak -- only 8 of 12 reviewed trials were placebo-controlled, sample sizes were small, and the one randomised trial reviewed by the Cochrane Skin Group was rated 'very low' quality evidence. This should be seen as preliminary, not proven, evidence. (1)
Who should be cautious about taking lysine supplements?
People with cardiovascular disease, gallstones, kidney or liver problems, asthma, or a condition affecting the immune system are specifically advised to use caution, per the evidence reviewed for this page. High lysine intake may also reduce absorption of arginine, an amino acid important for wound healing and blood vessel function, and animal studies have linked high doses to kidney injury, elevated cholesterol, and gallstone formation. Safe maximum doses have not been established for young children, pregnant or breastfeeding women, or people with severe liver or kidney disease -- check with a clinician or pharmacist first if any of this applies to you. (1)
What is the mechanism of action of L-lysine; lysine?
L-lysine is an essential proteinogenic amino acid required for protein synthesis, collagen formation, and calcium absorption, among other roles. Its proposed mechanism for reducing herpes simplex recurrence is competitive inhibition of arginine, an amino acid the herpes simplex virus uses for replication -- a plausible biological mechanism, though the clinical evidence for a meaningful antiviral effect at commonly used doses remains limited per the systematic review reviewed for this dossier. (1)
What class of drug is L-lysine; lysine?
Lysine (L-Lysine) is classed as: Not applicable -- L-lysine is an essential amino acid sold as a dietary/food supplement, not a regulated drug class, in the United States, United Kingdom, European Union, and New Zealand. In Canada it is a licensed Natural Health Product ingredient; in Australia it is an active ingredient in TGA-Listed (AUST L) complementary medicines.. (1) (2)
References
- Singh BK, Bhalla AS (2018). Lysine for Herpes Simplex Prophylaxis: A Review of the Evidence (PMC6419779)PubMed Central (peer-reviewed systematic review) · United States (international evidence base) · accessed 2026-07-31 · source 1
- L-lysine as a dietary ingredient -- FDA dietary supplement regulatory frameworkU.S. Food and Drug Administration -- dietary supplement regulatory framework (Dietary Supplement Health and Education Act, DSHEA, 1994) · United States · accessed 2026-07-31 · source 2
- Natural Health Products licensing framework; L-lysine as a licensable NHP medicinal ingredientHealth Canada -- Natural Health Products framework and Licensed Natural Health Products Database (LNHPD) · Canada · accessed 2026-07-31 · source 3
- L-lysine as an active ingredient in TGA-Listed (AUST L) complementary medicines, including 'Ethical Nutrients Lysine Cold Sore Defence' (ARTG 353838) and 'EZZ L-Lysine Growth Capsule' (ARTG 413522/476307)Australian Therapeutic Goods Administration (TGA), Australian Register of Therapeutic Goods (ARTG) · Australia · accessed 2026-07-31 · source 4
- Dietary Supplements Regulations 1985 -- amino acids (including lysine) as a permitted dietary supplement categoryNew Zealand Ministry for Primary Industries (MPI) / Medsafe -- Dietary Supplements Regulations 1985 (made under the Food Act 2014) · New Zealand · accessed 2026-07-31 · source 5
Brand names by country
Single-ingredient L-lysine; lysine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Generic L-lysine (multiple manufacturer supplement brands; no single universal brand name) (2)dietary supplement not FDA approved drug · commonly 500 mg to 1,000 mg per capsule/tablet, varies by product · Multiple supplement manufacturers; not FDA pre-approved for efficacy
United Kingdom
- Generic L-lysine (multiple manufacturer supplement brands)food supplement not a licensed medicine · varies by product · Multiple supplement manufacturers
Canada
- Generic L-lysine NHP products (Natural Product Number, NPN-licensed) (3)Health Canada NHP licensed · varies by product · Multiple NHP licence holders (individual NPNs)
Australia
- Ethical Nutrients Lysine Cold Sore Defence (Metagenics (Aust) Pty Ltd, ARTG 353838); EZZ L-Lysine Growth Capsule (EZZ Life Science Holdings Ltd, ARTG 413522/476307) (4)TGA ARTG Listed AUST L · varies by product · Metagenics (Aust) Pty Ltd; EZZ Life Science Holdings Ltd
New Zealand
- Generic L-lysine (multiple manufacturer supplement brands) (5)dietary supplement under 1985 regulations · varies by product · Multiple supplement manufacturers
View brands in additional countries.
European Union
Generic L-lysine (multiple manufacturer supplement brands)