The risk profile of a current NAD+ injection cannot be established from a few short IV studies. Formulations, routes and populations differ. FDA’s quality reports document another issue: contamination and manufacturing problems in specific injectable products.
No FDA-approved product-specific safety profile
FDA-approved labeling can report adverse reactions and warnings from the evidence reviewed for that product. NAD+ injections have no FDA-approved product-specific label. They are compounded by pharmacies, and NAD sits in Category 1 of FDA's 503A list, meaning FDA is still evaluating it [2].
Category 1 means under evaluation. FDA’s interim policy describes conditional enforcement discretion while evaluating nominated substances; it does not approve a product, guarantee safety or waive the remaining statutory conditions [3].
IV studies report different tolerability under different protocols
Most human data on injected NAD+ come from IV drips, not the shots sold for home use. Three studies are worth knowing. Two were run by people with a commercial stake in IV NAD+, which the table notes.
| Study | Route | People | Length | Safety finding |
|---|---|---|---|---|
| Reyna 2026 [4] | IV | 6 given NAD+ (8 given NR) | 4 daily infusions, 30-day follow-up | All six reported infusion symptoms that resolved afterward; selected laboratory measures had no significant change. Retrospective commercial-clinic study, no saline control. |
| Grant 2019 [5] | IV | 11 men (8 NAD+, 3 saline) | One 6-hour infusion | No adverse events observed in a small PK pilot; partly funded by NAD+ Research, with clinic/director/consulting relationships disclosed. |
| Yu 2026 [6] | IV | 180 with heart failure (randomized) | 7 days | Authors report it was well tolerated; liver, kidney and glucose labs no different from placebo |
| Home subcutaneous preparations | Under the skin | Not established by the cited IV studies | Product-specific evidence gap | IV results do not establish a reliable home-injection adverse-effect frequency |
Study doses and infusion protocols are not shown. They differed between studies.
The Reyna study is the most detailed on symptoms. All six people given IV NAD+ reported moderate to severe abdominal cramping, diarrhea, nausea, vomiting, faster heart rate, throat pain, congestion and chest pressure during the infusion [4]. The symptoms stopped as soon as each infusion ended. They also forced longer drips, which averaged 97 minutes against 37 minutes for the comparison group.
ALT, AST, hsCRP, BUN/creatinine and TSH did not show significant changes over thirty days. HDL cholesterol fell in the NAD+ group; exploratory findings from six recipients cannot establish causality or long-term safety. All seven authors were employed by the commercial clinic company [4].
The other two studies found less trouble. In Grant 2019, no adverse events were seen during a six-hour drip in eight men [5]. In Yu 2026, a randomized trial in heart-failure patients, the authors called a week of IV NAD+ well tolerated, though they didn't publish a symptom-by-symptom table [6]. Small samples, different protocols and different patients make the three hard to combine.
IV findings do not establish home-injection safety
Several reviewed telehealth product pages describe home subcutaneous injections. The cited studies do not establish the adverse-effect frequency of those preparations. A slow IV infusion and a subcutaneous injection are different exposures; one route’s observations cannot supply another’s safety profile.
Gallagher’s systematic review found no eligible IV or intramuscular NAD+ wellness outcome trial within its January 2010–October 2025 search [7]. That is not a comprehensive subcutaneous safety search and does not include later publications. The benefit question is covered in do NAD+ injections work.
Product quality is the most clearly documented risk
FDA's enforcement database holds 14 recall records for NAD products between 2016 and 2025 [8]. All involve injectable vials or syringes made by pharmacies and similar makers. Most were recalled for "lack of assurance of sterility," meaning the maker couldn't show the product was sterile.
| Year | Records | Class | Main reason |
|---|---|---|---|
| 2016 | 1 | II | Sterility not assured |
| 2017 | 1 | II | Beyond-use date labeling |
| 2018 | 1 | II | Sterility not assured |
| 2019 | 1 | II | Sterility not assured |
| 2020 | 2 | II | Sterility not assured |
| 2022 | 4 | II | Low potency, reconstitution failures, manufacturing deviations, sterility |
| 2025 | 4 | 3 Class II, 1 Class I | Sterility not assured; one for elevated endotoxin |
Query returned 14 product recall records; FDA’s dataset was last updated October 14, 2026. These are records, not a count of harmed patients or independent incidents. Class I is FDA's most serious recall class.
The Class I recall began July 30, 2025, for NAD+ injection vials with elevated endotoxin levels [8]. Endotoxins are fragments of bacteria that can cause fever and chills when injected. A year earlier, FDA had warned that some compounders were making IV products from food-grade NAD+ sold by repackagers [9].
FDA has received adverse event reports following use of NAD+ injectable drugs, including severe chills, shaking, vomiting and fatigue with some requiring medical treatment. These reactions are consistent with excessive levels of endotoxins.[9]
That's the clearest safety lesson in the record. The molecule's own risks are poorly measured, but the risks of a badly made vial are documented.
Who should talk to a prescriber first
Because there's no label, there's no official list of who shouldn't use NAD+ injections. That doesn't mean everyone is a good candidate. These are questions to raise, not rules:
- Pregnant or breastfeeding? The cited studies do not establish safety in those settings; raise this with the prescriber.
- A history of cancer? Ask what evidence supports or limits the proposed treatment.
- A heart condition? A small IV report described faster heart rate and chest pressure during infusion.
- Taking other medicines? Yu added IV NAD+ to standard heart-failure treatment, but that is not a general interaction study. Ask a pharmacist to review the exact preparation and medication list.
Questions to ask a provider before the first shot
- Which pharmacy compounds it, and is it a 503A pharmacy or a 503B outsourcing facility?
- Is each batch tested for sterility and endotoxins?
- What is the beyond-use date, and how should the vial be stored once it arrives?
- Who do I contact if I get chills, fever or a reaction at the injection site?
A preparation meeting all section 503A conditions is exempt from federal CGMP requirements; that exemption does not erase other federal or state obligations. A 503B outsourcing facility is subject to CGMP and FDA risk-based inspection. Neither category makes an NAD+ product FDA-approved [10].
The PeterMD, HealthRX and AgelessRx checks describe each provider’s public disclosures. A named partner is not confirmation of your assigned dispenser or every license. Ask for the exact facility before treatment; our method explains the distinction.
If needles are the worry, nasal sprays are sold too, though they have even less data; see NAD+ nasal spray. Clinic drips are a separate product, covered in NAD+ IV therapy.