Skip to content
Health Hub

Is NAD+ IV Therapy FDA-Approved?

A pharmacist in a white coat leans on a counter talking with a woman in a mustard coat
A conversation at a pharmacy counter.

We did not find an FDA-approved NAD+ drug product for any use (checked September 27, 2026). FDA's lists name NAD+ in more than one form, and the forms sit in different FDA categories.

Is NAD+ IV therapy FDA-approved?

We did not find an FDA-approved NAD+ (nicotinamide adenine dinucleotide) drug product. FDA's compounding lists (updated May 14, 2026 and March 21, 2025) treat it as a substance that is not part of an approved drug.

Compounded NAD+ products, including IV infusions and injections, are not FDA-approved. FDA states: 'Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.' As of FDA's list updated May 14, 2026, NAD and its reduced form, NADH, are on FDA's list of substances still under evaluation for use in pharmacy compounding, and another form, beta-nicotinamide adenine dinucleotide disodium salt trihydrate, is on FDA's list of substances nominated without adequate support. These listings are not FDA approval, and they are not a finding that NAD+ is safe or effective.

Nicotinamide adenine dinucleotide (NAD) and its reduced form (NADH) are on FDA's list of substances still under evaluation for use in compounding by pharmacies (503A Category 1, as of May 14, 2026). This is not an FDA approval, and it is not a finding that NAD+ is safe or effective.

One salt form of NAD+, beta-nicotinamide adenine dinucleotide disodium salt trihydrate, is in FDA's pharmacy compounding category 'Bulk Drug Substances Nominated Without Adequate Support' (503A Category 3, as of May 14, 2026). FDA's interim policy for pharmacy compounding applies only if, among other conditions, the substance 'appears in 503A Category 1'.

For outsourcing facilities, beta-nicotinamide adenine dinucleotide is on FDA's list of substances under evaluation (503B Category 1, as of March 21, 2025). This is not an FDA approval, and it is not a finding that NAD+ is safe or effective.

How FDA's compounding lists name NAD+ forms. Placement on these lists is not an FDA approval, and it is not a finding that NAD+ is safe or effective.
Form, as the FDA list names itFDA listCategory, as FDA names itList updated
Nicotinamide Adenine Dinucleotide (NAD)503A (pharmacy compounding)Category 1: Bulk Drug Substances Under EvaluationMay 14, 2026
Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)503A (pharmacy compounding)Category 1: Bulk Drug Substances Under EvaluationMay 14, 2026
Beta-Nicotinamide Adenine Dinucleotide Disodium Salt Trihydrate503A (pharmacy compounding)Category 3: Bulk Drug Substances Nominated Without Adequate SupportMay 14, 2026
Beta-Nicotinamide Adenine Dinucleotide503B (outsourcing facilities)Category 1: Bulk Drug Substances Under EvaluationMarch 21, 2025
Beta-nicotinamide adenine dinucleotide disodium salt, trihydrate503B (outsourcing facilities)Category 3March 21, 2025

What "FDA-approved" means

FDA explains that approval 'means a company must demonstrate that its drug or biological product is safe and effective for the intended use and that it can manufacture the product to federal quality standards'. Approval is granted to a specific product for its intended use.

Federal law sets out two compounding pathways: section 503A, for compounding by state-licensed pharmacies, federal facilities and licensed physicians, and section 503B, for outsourcing facilities. FDA keeps a separate list of bulk substances nominated for each pathway: the 503A list and the 503B list.

We did not find an FDA-approved NAD+ drug product for any use (checked September 27, 2026).

What compounded medications are covers this in more depth. For more on FDA approval itself, see how the FDA drug-approval process works.

Compounded availability status

We did not find an FDA-approved NAD+ drug product for any use (checked September 27, 2026).

In a notice titled 'FDA reminds compounders to use ingredients suitable for sterile compounding' (FDA page content current as of October 30, 2024), FDA said it 'is aware of compounders using food-grade nicotinamide adenine dinucleotide (NAD+) sold by repackagers to make intravenous products,' and that food-grade ingredients 'are not suitable for compounding sterile drugs without appropriate processing, due to the high risk of contamination with microbes and endotoxins, which can harm patients.' FDA also said it 'has received adverse event reports following use of NAD+ injectable drugs, including severe chills, shaking, vomiting and fatigue with some requiring medical treatment.' FDA added: 'These reactions are consistent with excessive levels of endotoxins.'

FDA notice

Compounded NAD+ products, including IV infusions and injections, are not FDA-approved. FDA states: 'Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.' As of FDA's list updated May 14, 2026, NAD and its reduced form, NADH, are on FDA's list of substances still under evaluation for use in pharmacy compounding, and another form, beta-nicotinamide adenine dinucleotide disodium salt trihydrate, is on FDA's list of substances nominated without adequate support. These listings are not FDA approval, and they are not a finding that NAD+ is safe or effective.

See NAD+ IV therapy side effects for what small studies report about symptoms during an infusion.

If you have severe symptoms, call 911 or seek emergency care. Report side effects to FDA MedWatch.

What this means for someone considering NAD+ IV therapy

Is NAD+ IV therapy legal? Whether a specific NAD+ IV offering meets federal and state rules is a legal question that this page cannot answer for any one business. A licensed pharmacist, physician or attorney can assess a specific offering.

We could not confirm whether a prescription is required for NAD+ from FDA sources as of September 27, 2026. Ask the clinic directly whether a licensed clinician evaluates patients before treatment, and what that evaluation covers.

We did not find an FDA-approved NAD+ drug product for any use (checked September 27, 2026).

The evidence for NAD+ IV therapy in healthy adults is experimental: in Europe PMC searches through October 1, 2026, we found no controlled trial showing that an NAD+ infusion improves energy, thinking or any other health outcome in healthy adults. Apart from uncontrolled case series on addiction, two trials in people with heart failure and one trial of injections in people with sudden sensorineural hearing loss, the studies of NAD+ by IV or injection that we were able to read reported blood NAD+ levels, other blood markers, infusion times or side effects in small groups of people, not health benefits. [1][2][3][4][5][6][7]

ClinicalTrials.gov lists trials of NAD+ by infusion or injection that had posted no results in the registry when we searched on October 1, 2026: comparisons with nicotinamide riboside in adults the records describe as in good general health, including the registration of the 2024 preprint's trial, which lists an energy scale and a tolerable infusion rate among its outcomes, and the registration of the first trial in the 2026 injection preprint; a 7-day infusion course for blood-vessel aging that had not started recruiting; and trials in people with medical conditions, one of which has since been published. The 2024 preprint reports infusion times for its trial and gives no result for the energy scale, and the 2026 injection preprint says its fatigue and sleep results will be reported elsewhere. [3][4] Where this page says we found no study or no published result, the statement rests on searches of PubMed, Europe PMC and ClinicalTrials.gov run on October 1, 2026 and on earlier Europe PMC searches run on September 27, 28 and 30, 2026; we did not search Embase, the Cochrane Library, Chinese-language databases or the Chinese clinical trial registry. See the NAD+ IV therapy overview for the human studies of NAD+ given by IV infusion or injection and their limits.

Regulatory status checked September 27, 2026. Sources: www.fda.gov/…/download; www.fda.gov/…/download; www.fda.gov/…/download; www.fda.gov/…/fda-reminds-compounders-use-ingredients-suitable-sterile-compounding; www.fda.gov/…/compounding-and-fda-questions-and-answers

Providers who list NAD+ IV therapy

We did not find an FDA-approved NAD+ drug product for any use (checked September 27, 2026).

Compounded NAD+ is not FDA-approved. See FDA's statement.

Find a Provider

A licensed clinician decides whether treatment is appropriate. Treatment is not guaranteed.

References

  1. Grant R, Berg J, Mestayer R, Braidy N, Bennett J, Broom S, Watson J. A pilot study investigating changes in the human plasma and urine NAD+ metabolome during a 6 hour intravenous infusion of NAD+. Front Aging Neurosci. 2019;11:257. doi:10.3389/fnagi.2019.00257. Accessed 2026-09-30.
  2. Reyna K, Heinzen G, Patel N, Ritter M, Siojo A, Legere H, Pojednic R. Intravenous infusion of nicotinamide adenine dinucleotide (NAD+) versus nicotinamide riboside (NR): a retrospective tolerability pilot study in a real-world setting. Front Aging. 2026;7:1652582. doi:10.3389/fragi.2026.1652582. Accessed 2026-09-30.
  3. Hawkins J, Idoine R, Kwon J, Shao A, Dunne E, Hawkins E, Dawson K, Nkrumah-Elie Y. Randomized, placebo-controlled, pilot clinical study evaluating acute Niagen+ IV and NAD+ IV in healthy adults. medRxiv (preprint, not peer reviewed). 2024. doi:10.1101/2024.06.06.24308565. Accessed 2026-10-01.
  4. Nkrumah-Elie Y, Kwon J, Simpson S, Idoine R, Mavoyan J, Russ A, Cavanaugh J, Hawkins L, Fuller K, Jaeger J, Shao A. Preliminary safety analysis of two pilot clinical trials involving injections of Niagen, nicotinamide riboside chloride. medRxiv (preprint, not peer reviewed). 2026. doi:10.64898/2026.04.28.26352007. Accessed 2026-10-01.
  5. Yu X, Xu J, Cao J, Xu Q, Chen H, Yu D, Yao X, Chen K, Ma L. Effect of nicotinamide adenine dinucleotide on heart failure caused by ischemic cardiomyopathy: a randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2026;26(1):97-106. doi:10.1007/s40256-025-00764-7. Accessed 2026-09-30.
  6. Gao M, Guan Y, Yue X, Bao H, Li Q, Zheng Y, Ou Y, Yang H. NAD+ enhanced on hearing recovery in sudden sensorineural hearing loss: randomized controlled trial. Laryngoscope. 2026;136(3):1204-1214. doi:10.1002/lary.70173. Accessed 2026-09-30.
  7. Pei Z, Dong M, Meng X, Yao W, Guo Y, Wang F. Effects of nicotinamide adenine dinucleotide on older patients with heart failure. Rev Cardiovasc Med. 2024;25(8):297. doi:10.31083/j.rcm2508297. Accessed 2026-10-01.

Page information

This page is for general education. It is not medical advice and does not replace a licensed clinician who knows your health history.