Is Niacin (vitamin B3) safe?
Niacin (vitamin B3)
The niacin in a multivitamin is harmless. High-dose nicotinic acid tablets are a drug in all but name, with flushing at 30 mg, liver injury that can be severe with slow-release forms, and raised blood sugar. Two large trials found no heart benefit on top of a statin.
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High confidence- Adult RDA (US)
- 16 mg a day for men, 14 mg for women
- Upper limit, US
- 35 mg a day from supplements and fortified food, set to prevent flushing
- Upper limit, EU
- Nicotinic acid 10 mg a day; nicotinamide 900 mg (EFSA)
- Flushing starts at
- About 30 mg of nicotinic acid
- Liver injury, slow-release niacin
- 12 of 23 patients (52%) in a 1994 trial; none on immediate-release
- Heart outcome trials
- AIM-HIGH (2011) and HPS2-THRIVE (2014) found no benefit added to statins
- Regulators
- EU suspended niacin-laropiprant in 2013; FDA withdrew statin-combination uses in 2016
How the score breaks down
The overall score is the weighted average of these factors. Scoring rules
Safety at usual doses25% of score
45 out of 100, WeakThe US upper limit is 35 mg, yet single-ingredient niacin products in the NIH label database hold 100 to 500 mg, often as nicotinic acid. Flushing starts at about 30 mg, Drug-induced liver injuryLiver damage caused by a medicine, herbal product or supplement. It is usually rare and unpredictable, but it can be serious.More in the glossary has been seen with extended-release niacin at 500 mg a day for two months (Linus Pauling Institute), and HPS2-THRIVE found serious diabetes problems 3.7 percentage points more often at 2 g a day.
Organ toxicity reports20% of score
35 out of 100, PoorLiverToxA free US National Institutes of Health database that summarises what is known about liver injury caused by medicines, herbs and supplements.More in the glossary links high doses and certain formulations to acute Drug-induced liver injuryLiver damage caused by a medicine, herbal product or supplement. It is usually rare and unpredictable, but it can be serious.More in the glossary that can be severe or fatal. In a 1994 JAMA trial, 52% of patients on sustained-release niacin developed liver toxicity, against none on immediate-release.
Interactions20% of score
55 out of 100, FairAdds to the muscle-injury risk of statins and gemfibrozil, raises blood sugar against diabetes drugs, opposes gout drugs such as probenecid, and can itself cause episodes of low blood pressure. Paracetamol, amiodarone and carbamazepine may add to its liver risk.
Product quality20% of score
65 out of 100, FairopenFDA lists recalls where nicotinic acid was used instead of the labelled niacinamide (2012, 2024) and products with more niacin than claimed (2013). Swapping slow-release for immediate-release forms at the same dose has caused severe Drug-induced liver injuryLiver damage caused by a medicine, herbal product or supplement. It is usually rare and unpredictable, but it can be serious.More in the glossary.
Regulatory actions15% of score
60 out of 100, FairThe EMA suspended niacin-laropiprant (Tredaptive) in 2013 because its risks outweighed its benefits. In 2016 the FDA withdrew the statin-combination uses of extended-release niacin. It stays legal as a supplement.
Is niacin safe?
At the 14 to 16 mg a day that adults need, and the amounts in a typical multivitamin, yes. The safety problems start with stand-alone niacin products, which in the NIH Dietary Supplement Label Database typically hold 100 to 500 mg per tablet, many of them as nicotinic acid. At those doses niacin acts as a drug: it changes blood fats, and it brings drug side effects with it, from flushing to Drug-induced liver injuryLiver damage caused by a medicine, herbal product or supplement. It is usually rare and unpredictable, but it can be serious.More in the glossary and higher blood sugar.
That gap is why niacin scores low. The US upper limit is 35 mg a day; a single 500 mg tablet is 14 times that.
Why does niacin make you flush?
Nicotinic acid triggers the skin to release prostaglandin D2, which widens blood vessels. The result is redness, heat and itching over the face, arms and chest, starting at doses as low as 30 mg. The US upper limit of 35 mg was set to prevent exactly this. EFSA's limit for nicotinic acid is lower still, at 10 mg a day.
Flushing is unpleasant but rarely dangerous, and it is the main reason people stop. Niacinamide (nicotinamide), the form used in most multivitamins and fortified foods, rarely causes it, which is why EFSA allows up to 900 mg a day of that form.
Recalls show that this distinction gets lost in factories. In 2012 a liquid supplement was recalled after nicotinic acid was used instead of the intended form, and in 2024 a B-complex product was recalled because it contained nicotinic acid while the label said niacinamide.
Can niacin damage the liver?
Yes, and this is the serious risk. LiverToxA free US National Institutes of Health database that summarises what is known about liver injury caused by medicines, herbs and supplements.More in the glossary, the US government database on Drug-induced liver injuryLiver damage caused by a medicine, herbal product or supplement. It is usually rare and unpredictable, but it can be serious.More in the glossary, says high doses and certain formulations of niacin have caused acute liver injury that can be severe and fatal.
The formulation matters. In a 1994 JAMA trial, 46 patients took increasing doses of either immediate-release or sustained-release niacin. Twelve of 23 on the sustained-release form (52%) developed liver toxicity. None on immediate-release did. The Linus Pauling Institute notes that liver injury has been seen at 750 mg a day of nicotinic acid and with extended-release forms at 500 mg a day for two months, and that severe cases followed patients switching from immediate-release to slow-release tablets at the same dose.
Warning signs are tiredness, nausea, loss of appetite, dark urine and yellow skin or eyes. Anyone taking high-dose niacin should have liver blood tests arranged by a doctor.
Does niacin prevent heart attacks?
For decades niacin was used to raise "good" HDL cholesterol. Two large trials tested whether that helped on top of a statin.
| Trial | Patients | Dose | Result |
|---|---|---|---|
| AIM-HIGH, 2011 | 3,414 with heart disease | 1.5 to 2 g extended-release | Stopped early; events 16.4% vs 16.2% on placebo |
| HPS2-THRIVE, 2014 | 25,673 with vascular disease | 2 g plus laropiprant | Events 13.2% vs 13.7%, not significant; more serious side effects |
HPS2-THRIVE also found new harms: 1.3 percentage points more new diabetes diagnoses, plus more serious bleeding and infections. The European Medicines Agency suspended niacin-laropiprant in January 2013 after reviewing those data, concluding that the benefits no longer outweighed the risks. In 2016 the FDA withdrew the approved uses of extended-release niacin in combination with statins, at the request of the drug makers.
A 2024 study in Nature Medicine added a new question. Researchers found that heart patients with high blood levels of 4PY and 2PY, breakdown products of excess niacin, had about 1.6 to 2 times the risk of heart attack, stroke or death over three years. In mice, 4PY increased inflammation in blood vessel walls. This is an association in heart patients, not proof that supplements cause heart disease, but it points away from the idea that more niacin is better.
Drug interactions
High-dose niacin interacts with several common drugs:
- Statins and gemfibrozil: higher risk of muscle breakdown. Tell your doctor about muscle pain or weakness, especially with atorvastatin or simvastatin.
- Diabetes drugs: niacin raises blood sugar and can undo their effect.
- Gout drugs: niacin reduces uric acid excretion and opposes drugs such as probenecid.
- Blood pressure drugs: niacin itself can cause short drops in blood pressure, so dizziness is more likely.
- Paracetamol, amiodarone and carbamazepine: may add to liver risk.
An antioxidant mix including vitamin E blunted the benefit of simvastatin plus niacin in the three-year HATS trial.
Who should be careful
- People with liver disease, active stomach ulcers, gout or diabetes: talk to your doctor before taking any niacin above multivitamin doses.
- People on statins: do not add niacin for cholesterol without your doctor; it has not been shown to prevent heart attacks.
- Anyone taking red yeast rice or other cholesterol supplements: combining them stacks liver and muscle risks.
- Buyers: check the form on the label (nicotinic acid, niacinamide or inositol hexanicotinate), and never swap an immediate-release product for a slow-release one at the same dose.
How we scored it
Organ toxicity (35) is the weakest factor: LiverToxA free US National Institutes of Health database that summarises what is known about liver injury caused by medicines, herbs and supplements.More in the glossary documents severe and sometimes fatal Drug-induced liver injuryLiver damage caused by a medicine, herbal product or supplement. It is usually rare and unpredictable, but it can be serious.More in the glossary, and a randomised trial found liver toxicity in half the patients on sustained-release niacin. Dose safety (45) reflects common tablets far above the 35 mg upper limit. Interactions (55) and regulatory actions (60) follow the statin, diabetes and gout problems and the 2013 EU suspension. Quality (65) is held back by recalls where the wrong form of niacin went into the bottle.
Questions people ask
Is niacin flush dangerous?
Usually not. The red, hot, itchy skin comes from blood vessels widening and is short-lived. Flushing with chest pain, fainting or swelling of the face or throat needs urgent medical care.
Is 500 mg of niacin a day safe?
It is 14 times the US upper limit and is a drug dose, not a vitamin dose. At this level niacin can raise liver enzymes, blood sugar and uric acid, so doctors who prescribe it check blood tests. Taking it on your own, especially as a slow-release product, is not advised.
Does niacin lower cholesterol?
Yes, at 1 to 3 grams a day it raises HDL and lowers triglycerides and LDL. But two large trials found that adding niacin to a statin did not prevent heart attacks or strokes. Better blood test numbers did not mean fewer events.
Is niacinamide the same as niacin?
Both are forms of vitamin B3, but they behave differently at high doses. Niacinamide (nicotinamide) does not cause flushing and does not lower cholesterol, and EFSA's upper limit for it is 900 mg a day. Liver problems have been seen at very high doses of 10 g a day or more.
Can niacin damage your liver?
Yes, at high doses. LiverToxA free US National Institutes of Health database that summarises what is known about liver injury caused by medicines, herbs and supplements.More in the glossary lists niacin as a cause of acute Drug-induced liver injuryLiver damage caused by a medicine, herbal product or supplement. It is usually rare and unpredictable, but it can be serious.More in the glossary that can be severe and occasionally fatal. The Linus Pauling Institute notes injury at 500 mg a day of extended-release niacin, but almost all severe cases followed 3 to 9 grams a day for months or years, and switching from immediate-release to slow-release at the same dose has caused serious injury.
Sources
- 1.Niacin (opens in a new tab) · Linus Pauling Institute, Oregon State University, 2018
- 2.LiverTox – Niacin (opens in a new tab) · National Institute of Diabetes and Digestive and Kidney Diseases, 2020
- 3.A comparison of the efficacy and toxic effects of sustained- vs immediate-release niacin in hypercholesterolemic patients (opens in a new tab) · JAMA, 1994
- 4.Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy (AIM-HIGH) (opens in a new tab) · New England Journal of Medicine, 2011
- 5.Effects of extended-release niacin with laropiprant in high-risk patients (HPS2-THRIVE) (opens in a new tab) · New England Journal of Medicine, 2014
- 6.A terminal metabolite of niacin promotes vascular inflammation and contributes to cardiovascular disease risk (opens in a new tab) · Nature Medicine, 2024
- 7.Withdrawal of approval of indications related to the coadministration with statins in applications for niacin extended-release tablets (opens in a new tab) · U.S. Food and Drug Administration (Federal Register), 2016
- 8.Tredaptive, Pelzont and Trevaclyn – referral (opens in a new tab) · European Medicines Agency, 2013
- 9.Dietary Supplement Label Database – niacin products (opens in a new tab) · NIH Office of Dietary Supplements, 2026
- 10.openFDA food enforcement reports – niacin (opens in a new tab) · U.S. Food and Drug Administration, 2026