Are NAD injections from Amble FDA-approved?
No. Amble states that compounded products are not approved or evaluated for safety, efficacy, or quality by the FDA, and that compounded drugs do not undergo the clinical studies required for commercially available products. Your provider may issue a prescription for a compounded product based on your medical consultation. If you prefer FDA-approved treatments, Amble advises asking your provider about alternatives.
Where does the medication come from?
Sourcing, as stated by Amble
When prescribed, NAD+ injections are dispensed by state-licensed U.S. pharmacies. 503A pharmacies are licensed and regulated by state boards of pharmacy, while 503B outsourcing facilities are registered with the FDA. Both types of facilities operate under state and FDA regulations.
For background on how compounding is regulated, see the FDA’s human drug compounding page.
What side effects does Amble list?
| Treatment | Listed side effects |
|---|---|
| NAD+ injection | Injection site redness, warmth, or mild discomfort; some people may have temporary flushing or headache. |
| Sermorelin injection | Mild irritation or redness at the injection site, headaches, flushing, dizziness, or temporary sleep disturbances. |
| Glutathione injection | Mild redness, swelling, or irritation at the injection site; some people may have temporary nausea or digestive changes. |
| Lipo-B (MIC+B12) injection | Mild soreness, redness, or swelling at the injection site; some people may have mild digestive upset, energy changes, or headaches. |
| Lipo-C injection | Mild soreness, redness, or swelling at the injection site; some people may notice temporary digestive upset or a mild flushed feeling. |
Amble also notes that rarely, allergic reactions such as rash, itching or shortness of breath can occur with Lipo-B and Lipo-C. Talk with your provider before making any changes to treatment.
How do I report a reaction?
Amble encourages users to promptly report side effects or adverse reactions to a licensed healthcare provider and the pharmacy that dispensed the medication. You can also contact the FDA at 1-800-FDA-1088 or visit FDA MedWatch. For emergencies, call 911 or go to your nearest emergency department.
What should I know about Amble’s ads and images?
All advertisements from joinamble.com are paid for by Amble Health, Inc. Some advertisements may feature paid actors or dramatizations; when real customers or endorsements are included, Amble says this will be clearly disclosed. Individual results may vary, and specific outcomes are not guaranteed. Vial images on Amble’s site are stylized for marketing and do not reflect the actual label or size. Full details are on Amble’s important safety information page. Back to the NAD injections online guide.
Common questions
- Are compounded NAD+ injections FDA approved?
- No. Amble states that compounded products are not approved or evaluated for safety, efficacy, or quality by the FDA. Compounded products may still be legally prescribed, and a provider may issue a prescription for a compounded product based on your medical consultation.
- Where do Amble’s NAD+ injections come from?
- When prescribed, NAD+ injections are dispensed by state-licensed U.S. pharmacies. Amble explains that 503A pharmacies are licensed and regulated by state boards of pharmacy, while 503B outsourcing facilities are registered with the FDA, and both operate under state and FDA regulations.
- What are the side effects of NAD+ injections?
- Amble lists possible side effects of NAD+ injections as injection site redness, warmth or mild discomfort, and says some people may experience temporary flushing or headache. Report any side effect to your provider and to the pharmacy that dispensed the medication.
- How do I report a side effect?
- Amble encourages you to promptly report any side effect or adverse reaction to a licensed healthcare provider and the pharmacy that dispensed the medication. You can also report suspected reactions to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
- What should I do in a medical emergency?
- Call 911 or go to your nearest emergency department. Do not wait for a reply through online messaging. Severe allergic reactions, such as swelling of the face, lips, tongue or throat, or trouble breathing, need emergency care right away.
- Can I stop or change my treatment on my own?
- Amble advises consulting your provider before making changes to your treatment. You can reach your provider through secure 24/7 messaging, and your provider may adjust your dose based on your history and response.